The Disturbing Sexual Trend With Real Health Consequences

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Changed
Thu, 07/25/2024 - 09:57

This transcript has been edited for clarity. 

Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?

Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices. 

Now, there’s always been a lot of sexual diversity in the world throughout history. But the main trend that we have focused on in recent years that is important for everyone in medicine to know about is this rapid increase — actually, a really big increase — in what people call “sexual choking,” even though it’s a form of strangulation. The increase is mostly seen in teenagers and young adults. 

We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow. 

Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing? 

Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate. 

For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms. 

Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving. 

Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.

This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail? 

Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too. 

We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody. 

They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations. 

Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about? 

Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention. 

Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there? 

Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation. 

Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.

Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity. 

Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?

Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices. 

Now, there’s always been a lot of sexual diversity in the world throughout history. But the main trend that we have focused on in recent years that is important for everyone in medicine to know about is this rapid increase — actually, a really big increase — in what people call “sexual choking,” even though it’s a form of strangulation. The increase is mostly seen in teenagers and young adults. 

We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow. 

Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing? 

Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate. 

For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms. 

Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving. 

Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.

This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail? 

Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too. 

We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody. 

They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations. 

Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about? 

Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention. 

Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there? 

Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation. 

Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.

Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Rachel S. Rubin, MD: I have an interesting topic for you — kind of shocking, actually. Some of you may have read a story earlier this year in The New York Times about the alarming rise among young people of choking or strangulation during sex. I spoke recently with Dr. Debby Herbenick about this concerning and violent trend. Dr. Herbenick is a well-known sexuality researcher and professor at the Indiana University School of Public Health. Welcome, Dr. Herbenick. Can you tell us about your research into this new trend?

Debby Herbenick, PhD: This is some of the most important research that I’ve done. I’ve been studying sexual behaviors and trends for about 14 years in terms of nationally representative studies that we do. Over time, we noticed a trend of increasing prevalence of rough sex practices. 

Now, there’s always been a lot of sexual diversity in the world throughout history. But the main trend that we have focused on in recent years that is important for everyone in medicine to know about is this rapid increase — actually, a really big increase — in what people call “sexual choking,” even though it’s a form of strangulation. The increase is mostly seen in teenagers and young adults. 

We’ve done US nationally representative surveys as well as college campus representative surveys. We find that consistently across four campus representative surveys that 64% of women report having ever been choked during sex, and around 1 in 3 women (aged 18-24 years) throughout the whole country report having been choked during their most recent sexual activity with another person. They call it choking, but because it involves usually one hand — sometimes two hands or a forearm or an object, like a belt or a cord to tie around the neck — it is technically strangulation, because it’s external pressure to the neck to reduce or stop airflow or blood flow. 

Dr. Rubin: These numbers are staggering, right? Everyone listening now is taking care of someone who has been strangled as a form of sexual pleasure. What does this mean from a safety perspective? And as doctors who are working these patients up for migraines and other health problems, what is the research showing? 

Dr. Herbenick: We certainly are seeing people report recurrent headaches and ringing in the ears. There are things we’ve just barely scratched the surface on. Those of us working in this space believe that for anybody coming in for an unexplained stroke (for example, under age 50), you might consider some imaging to see if they have a dissection. We are hearing about people who, when you really probe to find out whether they’ve had pressure on the neck, they report that indeed that they have. So, we have to be thinking about neurologic symptoms. We know that they’re experiencing these at a pretty high rate. 

For people who are engaging in these practices, they should know about the health risks, but we find that most don’t. They may have heard that if it’s really intense high pressure, that in rare cases people can die, but most have never heard of anything in between. So, they’re not necessarily connecting their voice hoarseness, or the recurrent headaches or the sensitivity to light they are having, to an experience of being choked. We need to be paying attention to neurologic symptoms. 

Most physicians I speak with at conferences say that where they feel like they can step into this conversation is through anticipatory guidance and letting their patients know that they may have heard about this trend, and a lot of people are talking about the health consequences, and I want to share some information with you — not coming at it from a place of shame or judgment, but providing some information so that [patients] actually get some medical facts about this that could be lifesaving. 

Dr. Rubin: I see such a big gap in my medical training. I was taught to say, “Hey, do you smoke, do you drink, do you do drugs? Do you have sex? Men, women, or both?”And that’s it. And then maybe use birth control, and don’t get an STD, thinking about herpes, syphilis, gonorrhea, and chlamydia. We weren’t really trained to talk to patients about what kind of sex they are having, or how to talk to patients in a way that is open-minded but also safety-conscious and how the concept of safe sex is more than wear a condom and use birth control.

This idea of rough sex practices and how to talk to teenagers — maybe our pediatricians should be talking about this. Where do we start in terms of how to bring up these conversations and with what level of detail? 

Dr. Herbenick: We find that some young people are already being asked about some of the effects that might be showing on their bodies. It might be that their provider notices some bruising, or marks on their bodies from other types of rough sex practices like hitting and spanking. So that could be an entry point there. Choking is far more prevalent than slapping, so if you’re seeing some marks on the body, then it’s also a good time to ask about other practices they might be engaging in, especially higher risk ones like choking or strangulation. It’s offering some information and even saying, “Look, I’m not here to shame or judge you. I just want you to have some information about this” and giving them an opportunity to ask questions, too. 

We have found that almost nobody talks with their nurse or doctor, even if they have symptoms after being choked or strangled during sex. Just 1% of women with choking-related symptoms, 7% of men, and far fewer trans and nonbinary young people report talking with a nurse or doctor, mostly because they say it doesn’t seem like a big deal. The symptoms got better quickly. Sometimes they’re afraid of being shamed for their sexual behavior, and that’s why they say they don’t talk with somebody. 

They need some type of open-door anticipatory guidance as a way forward. Not everyone is comfortable directly asking whether a patient is engaging in this, but at least letting people know that you’ve heard of this behavior and providing some medical facts can give us a step forward with creating these conversations. 

Dr. Rubin: Can you tell us where is this research going in terms of next steps? Other things that you’re looking at? And what are you excited about? 

Dr. Herbenick: I’m excited about some work I did with a collaborator and colleague of mine, Dr. Keisuke Kawata, that he led a couple of years ago. He’s a neuroscientist. We were looking at potential cumulative effects on the brain. Now we’re taking some of that research into its next steps. We’re also doing more focused studies on other health consequences and hopefully finding out how we can test different educational messages and get people to learn more fact-based information about this, and then see if that is effective in prevention. 

Dr. Rubin: It sounds like a public health campaign is really needed about how to get the word out there about the health consequences of these activities. We’re asking people often enough. In my clinic, I try to keep it open-ended — tell me what sex looks like. What does it look like, and what do you want it to look like? Because I see a lot of people with problems, but if they don’t bring it to me, I don’t necessarily bring it up to them. Until I heard your lecture, and I thought, oh my gosh, I’m not even asking the right questions. Are you hopeful that there will be more public health messaging out there? 

Dr. Herbenick: I am. Years ago, when the child and adolescent choking game became a thing, the Centers for Disease Control and Prevention (CDC) issued reports about it and warnings to parents. And this is a far, far higher prevalence than that ever was. So, I would love to see organizations like the CDC and medical groups getting involved and educating their members and making statements. This is really impacting a huge generation of girls and women, because when it happens during sex between women and men, the choking is mostly happening to the girls and women. It’s also prevalent among sexual minority individuals. But we are talking about this whole generation of young women and what’s happening to their bodies and their brain health. We really need to step into this conversation. 

Dr. Rubin: Very few of us are sexual medicine–trained physicians, and very few of us feel confident and comfortable talking about sexual health issues. But people are getting hurt. People are having real consequences of these behaviors because of our lack of education, knowledge, and even discussion around it. So thank you for doing this research, because had you not done this research, we wouldn’t have found out that 64% of people are engaging in these types of activities. That is not rare.

Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.

A version of this article first appeared on Medscape.com.

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How to Get Patients Over a Weight Loss Plateau

Article Type
Changed
Wed, 07/24/2024 - 10:10

This transcript has been edited for clarity.

On today’s edition of Beyond BMI, I’ll be discussing weight plateaus. This is something that our patients are very familiar with. Sometimes, they’re happy with their weight when they plateau; sometimes, they’re not. A weight plateau is simply a state of equilibrium.

There’s a common adage that the last 5 pounds are the hardest. When people decrease their calorie intake and increase their activity — as we instruct our patients to do to lose weight — the body starts to fight back because it believes this is a famine state. Our bodies feel that we are running around the jungle looking for food to help us survive a perceived famine state.

The body does a few things to help us keep weight on, and this is what leads to the frustration of not being able to lose those last 5 pounds. The first thing that happens in this process, which is called metabolic adaptation, is that when someone loses weight, the body naturally increases appetite signals from the brain, so the person becomes hungrier. Satiety signals from the stomach also decrease, so they feel more hungry and less full. And finally, stable fat cells form to allow the person to seek out more food without losing weight. This eventually leads the patient to regain weight, or they may plateau at a weight they’re not happy with.

I’m sure you’ve seen many studies looking at weight plateaus and the amount of weight loss people are able to achieve with diet, exercise, and behavior change alone vs the same lifestyle modifications plus medication. Studies show that patients who are taking anti-obesity medications achieve far more weight loss than do those who are not taking medications. The reason is related to the different mechanisms of action of the anti-obesity medications. Patients taking these medications are able to tolerate a lower caloric intake for a longer period of time, thus they’re able to burn more fat cells and lose more weight. Some medications perform this by decreasing appetite signals, so patients can continue to eat a small number of calories. Some medications affect the stability of fat cells. Some medications also increase satiety signals, so patients can move beyond that degree of metabolic adaptation and get beyond their previous plateau.

What can we do for patients who are frustrated with their weight plateau? I recommend taking a dive into their daily routine. Find out how many calories they are eating. Find out how much exercise they are doing and see whether there’s any room to reorganize the day or change their meals to create a caloric deficit. Are they eating things that are not filling enough, so they can’t get to the next meal without having a snack in between? We are looking at the quality of the meals as well and making sure there’s an adequate amount of protein and fiber in their meals to help with those increased appetite signals. We should also make sure these patients are getting adequate fluid intake.

These are all strategies that can help our patients try to get beyond their weight plateaus.

If the patient meets criteria for anti-obesity medication, which means a body mass index (BMI) of 27-29 with a weight-related comorbidity or BMI ≥ 30 with or without a comorbidity, you may want to consider anti-obesity medication to help that patient get beyond the plateau.

Plateaus will occur as a natural process because of the appetite signaling and hormonal changes that occur when patients lose weight from any modality. It’s important that we work with our patients to determine whether their weight plateau is due to metabolic adaptation. If they aren’t meeting their goals and they have weight-related comorbidities, we can use other available modalities to help those patients continue to lose weight. Of course, whenever we are prescribing a medication, we need to make sure that it is safe for the patient and the patient is on board with the potential side effects and risks. And we should always make sure our patients know we are their advocates in their weight journey.

Holly Lofton, clinical associate professor of surgery and medicine, NYU Langone Health, New York, NY, has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity.

On today’s edition of Beyond BMI, I’ll be discussing weight plateaus. This is something that our patients are very familiar with. Sometimes, they’re happy with their weight when they plateau; sometimes, they’re not. A weight plateau is simply a state of equilibrium.

There’s a common adage that the last 5 pounds are the hardest. When people decrease their calorie intake and increase their activity — as we instruct our patients to do to lose weight — the body starts to fight back because it believes this is a famine state. Our bodies feel that we are running around the jungle looking for food to help us survive a perceived famine state.

The body does a few things to help us keep weight on, and this is what leads to the frustration of not being able to lose those last 5 pounds. The first thing that happens in this process, which is called metabolic adaptation, is that when someone loses weight, the body naturally increases appetite signals from the brain, so the person becomes hungrier. Satiety signals from the stomach also decrease, so they feel more hungry and less full. And finally, stable fat cells form to allow the person to seek out more food without losing weight. This eventually leads the patient to regain weight, or they may plateau at a weight they’re not happy with.

I’m sure you’ve seen many studies looking at weight plateaus and the amount of weight loss people are able to achieve with diet, exercise, and behavior change alone vs the same lifestyle modifications plus medication. Studies show that patients who are taking anti-obesity medications achieve far more weight loss than do those who are not taking medications. The reason is related to the different mechanisms of action of the anti-obesity medications. Patients taking these medications are able to tolerate a lower caloric intake for a longer period of time, thus they’re able to burn more fat cells and lose more weight. Some medications perform this by decreasing appetite signals, so patients can continue to eat a small number of calories. Some medications affect the stability of fat cells. Some medications also increase satiety signals, so patients can move beyond that degree of metabolic adaptation and get beyond their previous plateau.

What can we do for patients who are frustrated with their weight plateau? I recommend taking a dive into their daily routine. Find out how many calories they are eating. Find out how much exercise they are doing and see whether there’s any room to reorganize the day or change their meals to create a caloric deficit. Are they eating things that are not filling enough, so they can’t get to the next meal without having a snack in between? We are looking at the quality of the meals as well and making sure there’s an adequate amount of protein and fiber in their meals to help with those increased appetite signals. We should also make sure these patients are getting adequate fluid intake.

These are all strategies that can help our patients try to get beyond their weight plateaus.

If the patient meets criteria for anti-obesity medication, which means a body mass index (BMI) of 27-29 with a weight-related comorbidity or BMI ≥ 30 with or without a comorbidity, you may want to consider anti-obesity medication to help that patient get beyond the plateau.

Plateaus will occur as a natural process because of the appetite signaling and hormonal changes that occur when patients lose weight from any modality. It’s important that we work with our patients to determine whether their weight plateau is due to metabolic adaptation. If they aren’t meeting their goals and they have weight-related comorbidities, we can use other available modalities to help those patients continue to lose weight. Of course, whenever we are prescribing a medication, we need to make sure that it is safe for the patient and the patient is on board with the potential side effects and risks. And we should always make sure our patients know we are their advocates in their weight journey.

Holly Lofton, clinical associate professor of surgery and medicine, NYU Langone Health, New York, NY, has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

On today’s edition of Beyond BMI, I’ll be discussing weight plateaus. This is something that our patients are very familiar with. Sometimes, they’re happy with their weight when they plateau; sometimes, they’re not. A weight plateau is simply a state of equilibrium.

There’s a common adage that the last 5 pounds are the hardest. When people decrease their calorie intake and increase their activity — as we instruct our patients to do to lose weight — the body starts to fight back because it believes this is a famine state. Our bodies feel that we are running around the jungle looking for food to help us survive a perceived famine state.

The body does a few things to help us keep weight on, and this is what leads to the frustration of not being able to lose those last 5 pounds. The first thing that happens in this process, which is called metabolic adaptation, is that when someone loses weight, the body naturally increases appetite signals from the brain, so the person becomes hungrier. Satiety signals from the stomach also decrease, so they feel more hungry and less full. And finally, stable fat cells form to allow the person to seek out more food without losing weight. This eventually leads the patient to regain weight, or they may plateau at a weight they’re not happy with.

I’m sure you’ve seen many studies looking at weight plateaus and the amount of weight loss people are able to achieve with diet, exercise, and behavior change alone vs the same lifestyle modifications plus medication. Studies show that patients who are taking anti-obesity medications achieve far more weight loss than do those who are not taking medications. The reason is related to the different mechanisms of action of the anti-obesity medications. Patients taking these medications are able to tolerate a lower caloric intake for a longer period of time, thus they’re able to burn more fat cells and lose more weight. Some medications perform this by decreasing appetite signals, so patients can continue to eat a small number of calories. Some medications affect the stability of fat cells. Some medications also increase satiety signals, so patients can move beyond that degree of metabolic adaptation and get beyond their previous plateau.

What can we do for patients who are frustrated with their weight plateau? I recommend taking a dive into their daily routine. Find out how many calories they are eating. Find out how much exercise they are doing and see whether there’s any room to reorganize the day or change their meals to create a caloric deficit. Are they eating things that are not filling enough, so they can’t get to the next meal without having a snack in between? We are looking at the quality of the meals as well and making sure there’s an adequate amount of protein and fiber in their meals to help with those increased appetite signals. We should also make sure these patients are getting adequate fluid intake.

These are all strategies that can help our patients try to get beyond their weight plateaus.

If the patient meets criteria for anti-obesity medication, which means a body mass index (BMI) of 27-29 with a weight-related comorbidity or BMI ≥ 30 with or without a comorbidity, you may want to consider anti-obesity medication to help that patient get beyond the plateau.

Plateaus will occur as a natural process because of the appetite signaling and hormonal changes that occur when patients lose weight from any modality. It’s important that we work with our patients to determine whether their weight plateau is due to metabolic adaptation. If they aren’t meeting their goals and they have weight-related comorbidities, we can use other available modalities to help those patients continue to lose weight. Of course, whenever we are prescribing a medication, we need to make sure that it is safe for the patient and the patient is on board with the potential side effects and risks. And we should always make sure our patients know we are their advocates in their weight journey.

Holly Lofton, clinical associate professor of surgery and medicine, NYU Langone Health, New York, NY, has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Avoid These Common Mistakes in Treating Hyperkalemia

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Changed
Tue, 07/23/2024 - 15:12

Hyperkalemia tends to cause panic in healthcare professionals, and rightfully so. On a good day, it causes weakness in the legs; on a bad day, it causes cardiac arrest.

It makes sense that a high potassium level causes clinicians to feel a bit jumpy. This anxiety tends to result in treating the issue by overly restricting potassium in the diet. The problem with this method is that it should be temporary but often isn’t. There are only a few concerns that justify long-term potassium restriction.

As a dietitian, I have seen numerous patients with varying disease states who are terrified of potassium because they were never properly educated on the situation that required restriction or were never notified that their potassium was corrected. 

I’ve seen patients whose potassium level hasn’t been elevated in years refuse banana bread because they were told that they could never eat a banana again. I’ve worked with patients who continued to needlessly restrict, which eventually led to hypokalemia.

Not only does this indicate ineffective education — banana bread is actually a low-potassium food at about 80 mg per slice — but also poor follow-up. 

Potassium has been designated by the United States Department of Agriculture as a nutrient of public health concern due to its underconsumption in the general population. Although there is concern in the public health community that the current guidelines for potassium intake (3500-4700 mg/d) are unattainable, with some professionals arguing for lowering the standard, there remains significant deficiency in the general population. This deficiency has also been connected to increasing rates of hypertension and cardiovascular disease. 
 

Nondietary Causes of Hyperkalemia 

There are many causes of hyperkalemia, of which excessive potassium intake is only one, and an uncommon one at that. A high potassium level should resolve during the course of treatment for metabolic acidosis, hyperglycemia, and dehydration. We may also see resolution with medication changes. But the question remains: Are we relaying this information to patients?

Renal insufficiency is a common cause of hyperkalemia, but it is also a common cause of chronic constipation that can cause hyperkalemia as well. Are we addressing bowel movements with these patients? I often work with patients who aren’t having their bowel movements addressed until the patient themselves voices discomfort. 

Depending upon the urgency of treatment, potassium restriction may be the most effective and efficient way to address an acutely elevated value. However, long-term potassium restriction may not be an appropriate intervention for all patients, even those with kidney conditions.

As a dietitian, I have seen many patients who overly restrict dietary potassium because they had one elevated value. These patients tend to view potassium as the enemy because they were never educated on the actual cause of their hyperkalemia. They were simply given a list of high-potassium foods and told to avoid them. A lack of follow-up education may cause them to avoid those foods forever. 
 

Benefits of Potassium

The problem with this perpetual avoidance of high potassium foods is that a potassium-rich diet has been shown to be exceptionally beneficial. 

Potassium exists in many forms in the Western diet: as a preservative and additive, a salt substitute, and naturally occurring in both animal and plant products. My concern regarding blanket potassium restriction is that potassium-rich plant and animal products can actually be beneficial, even to those with kidney and heart conditions who are most often advised to restrict its intake. 

Adequate potassium intake can

  • Decrease blood pressure by increasing urinary excretion of sodium
  • Improve nephrolithiasis by decreasing urinary excretion of calcium
  • Decrease incidence of metabolic acidosis by providing precursors to bicarbonate that facilitate excretion of potassium
  • Increase bone density in postmenopausal women
  • Decrease risk for stroke and cardiovascular disease in the general population

One study found that metabolic acidosis can be corrected in patients with stage 4 chronic kidney disease, without hyperkalemia, by increasing fruit and vegetable intake when compared with those treated with bicarbonate alone, thus preserving kidney function.

Do I suggest encouraging a patient with acute hyperkalemia to eat a banana? Of course not. But I would suggest finding ways to work with patients who have chronic hyperkalemia to increase intake of potassium-rich plant foods to maintain homeostasis while liberalizing diet and preventing progression of chronic kidney disease. 
 

When to Refer to a Dietitian

In patients for whom a potassium-restricted diet is a necessary long-term treatment of hyperkalemia, education with a registered dietitian can be beneficial. A registered dietitian has the time and expertise to address the areas in the diet where excessive potassium exists without forfeiting other nutritional benefits that come from whole foods like fruits, vegetables, lean protein, legumes, nuts, and seeds in a way that is both realistic and helpful. A dietitian can work with patients to reduce intake of potassium-containing salt substitutes, preservatives, and other additives while still encouraging a whole-food diet rich in antioxidants, fiber, and healthy fats.

Dietitians also provide education on serving size and methods to reduce potassium content of food.

For example, tomatoes are a high-potassium food at 300+ mg per medium-sized tomato. But how often does a patient eat a whole tomato? A slice of tomato on a sandwich or a handful of cherry tomatoes in a salad are actually low in potassium per serving and can provide additional nutrients like vitamin C, beta-carotene, and antioxidants like lycopene, which is linked to a decreased incidence of prostate cancer.

By incorporating the assistance of a registered dietitian into the treatment of chronic hyperkalemia, we can develop individualized restrictions that are realistic for the patient and tailored to their nutritional needs to promote optimal health and thus encourage continued compliance. 

Ms. Winfree is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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Hyperkalemia tends to cause panic in healthcare professionals, and rightfully so. On a good day, it causes weakness in the legs; on a bad day, it causes cardiac arrest.

It makes sense that a high potassium level causes clinicians to feel a bit jumpy. This anxiety tends to result in treating the issue by overly restricting potassium in the diet. The problem with this method is that it should be temporary but often isn’t. There are only a few concerns that justify long-term potassium restriction.

As a dietitian, I have seen numerous patients with varying disease states who are terrified of potassium because they were never properly educated on the situation that required restriction or were never notified that their potassium was corrected. 

I’ve seen patients whose potassium level hasn’t been elevated in years refuse banana bread because they were told that they could never eat a banana again. I’ve worked with patients who continued to needlessly restrict, which eventually led to hypokalemia.

Not only does this indicate ineffective education — banana bread is actually a low-potassium food at about 80 mg per slice — but also poor follow-up. 

Potassium has been designated by the United States Department of Agriculture as a nutrient of public health concern due to its underconsumption in the general population. Although there is concern in the public health community that the current guidelines for potassium intake (3500-4700 mg/d) are unattainable, with some professionals arguing for lowering the standard, there remains significant deficiency in the general population. This deficiency has also been connected to increasing rates of hypertension and cardiovascular disease. 
 

Nondietary Causes of Hyperkalemia 

There are many causes of hyperkalemia, of which excessive potassium intake is only one, and an uncommon one at that. A high potassium level should resolve during the course of treatment for metabolic acidosis, hyperglycemia, and dehydration. We may also see resolution with medication changes. But the question remains: Are we relaying this information to patients?

Renal insufficiency is a common cause of hyperkalemia, but it is also a common cause of chronic constipation that can cause hyperkalemia as well. Are we addressing bowel movements with these patients? I often work with patients who aren’t having their bowel movements addressed until the patient themselves voices discomfort. 

Depending upon the urgency of treatment, potassium restriction may be the most effective and efficient way to address an acutely elevated value. However, long-term potassium restriction may not be an appropriate intervention for all patients, even those with kidney conditions.

As a dietitian, I have seen many patients who overly restrict dietary potassium because they had one elevated value. These patients tend to view potassium as the enemy because they were never educated on the actual cause of their hyperkalemia. They were simply given a list of high-potassium foods and told to avoid them. A lack of follow-up education may cause them to avoid those foods forever. 
 

Benefits of Potassium

The problem with this perpetual avoidance of high potassium foods is that a potassium-rich diet has been shown to be exceptionally beneficial. 

Potassium exists in many forms in the Western diet: as a preservative and additive, a salt substitute, and naturally occurring in both animal and plant products. My concern regarding blanket potassium restriction is that potassium-rich plant and animal products can actually be beneficial, even to those with kidney and heart conditions who are most often advised to restrict its intake. 

Adequate potassium intake can

  • Decrease blood pressure by increasing urinary excretion of sodium
  • Improve nephrolithiasis by decreasing urinary excretion of calcium
  • Decrease incidence of metabolic acidosis by providing precursors to bicarbonate that facilitate excretion of potassium
  • Increase bone density in postmenopausal women
  • Decrease risk for stroke and cardiovascular disease in the general population

One study found that metabolic acidosis can be corrected in patients with stage 4 chronic kidney disease, without hyperkalemia, by increasing fruit and vegetable intake when compared with those treated with bicarbonate alone, thus preserving kidney function.

Do I suggest encouraging a patient with acute hyperkalemia to eat a banana? Of course not. But I would suggest finding ways to work with patients who have chronic hyperkalemia to increase intake of potassium-rich plant foods to maintain homeostasis while liberalizing diet and preventing progression of chronic kidney disease. 
 

When to Refer to a Dietitian

In patients for whom a potassium-restricted diet is a necessary long-term treatment of hyperkalemia, education with a registered dietitian can be beneficial. A registered dietitian has the time and expertise to address the areas in the diet where excessive potassium exists without forfeiting other nutritional benefits that come from whole foods like fruits, vegetables, lean protein, legumes, nuts, and seeds in a way that is both realistic and helpful. A dietitian can work with patients to reduce intake of potassium-containing salt substitutes, preservatives, and other additives while still encouraging a whole-food diet rich in antioxidants, fiber, and healthy fats.

Dietitians also provide education on serving size and methods to reduce potassium content of food.

For example, tomatoes are a high-potassium food at 300+ mg per medium-sized tomato. But how often does a patient eat a whole tomato? A slice of tomato on a sandwich or a handful of cherry tomatoes in a salad are actually low in potassium per serving and can provide additional nutrients like vitamin C, beta-carotene, and antioxidants like lycopene, which is linked to a decreased incidence of prostate cancer.

By incorporating the assistance of a registered dietitian into the treatment of chronic hyperkalemia, we can develop individualized restrictions that are realistic for the patient and tailored to their nutritional needs to promote optimal health and thus encourage continued compliance. 

Ms. Winfree is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Hyperkalemia tends to cause panic in healthcare professionals, and rightfully so. On a good day, it causes weakness in the legs; on a bad day, it causes cardiac arrest.

It makes sense that a high potassium level causes clinicians to feel a bit jumpy. This anxiety tends to result in treating the issue by overly restricting potassium in the diet. The problem with this method is that it should be temporary but often isn’t. There are only a few concerns that justify long-term potassium restriction.

As a dietitian, I have seen numerous patients with varying disease states who are terrified of potassium because they were never properly educated on the situation that required restriction or were never notified that their potassium was corrected. 

I’ve seen patients whose potassium level hasn’t been elevated in years refuse banana bread because they were told that they could never eat a banana again. I’ve worked with patients who continued to needlessly restrict, which eventually led to hypokalemia.

Not only does this indicate ineffective education — banana bread is actually a low-potassium food at about 80 mg per slice — but also poor follow-up. 

Potassium has been designated by the United States Department of Agriculture as a nutrient of public health concern due to its underconsumption in the general population. Although there is concern in the public health community that the current guidelines for potassium intake (3500-4700 mg/d) are unattainable, with some professionals arguing for lowering the standard, there remains significant deficiency in the general population. This deficiency has also been connected to increasing rates of hypertension and cardiovascular disease. 
 

Nondietary Causes of Hyperkalemia 

There are many causes of hyperkalemia, of which excessive potassium intake is only one, and an uncommon one at that. A high potassium level should resolve during the course of treatment for metabolic acidosis, hyperglycemia, and dehydration. We may also see resolution with medication changes. But the question remains: Are we relaying this information to patients?

Renal insufficiency is a common cause of hyperkalemia, but it is also a common cause of chronic constipation that can cause hyperkalemia as well. Are we addressing bowel movements with these patients? I often work with patients who aren’t having their bowel movements addressed until the patient themselves voices discomfort. 

Depending upon the urgency of treatment, potassium restriction may be the most effective and efficient way to address an acutely elevated value. However, long-term potassium restriction may not be an appropriate intervention for all patients, even those with kidney conditions.

As a dietitian, I have seen many patients who overly restrict dietary potassium because they had one elevated value. These patients tend to view potassium as the enemy because they were never educated on the actual cause of their hyperkalemia. They were simply given a list of high-potassium foods and told to avoid them. A lack of follow-up education may cause them to avoid those foods forever. 
 

Benefits of Potassium

The problem with this perpetual avoidance of high potassium foods is that a potassium-rich diet has been shown to be exceptionally beneficial. 

Potassium exists in many forms in the Western diet: as a preservative and additive, a salt substitute, and naturally occurring in both animal and plant products. My concern regarding blanket potassium restriction is that potassium-rich plant and animal products can actually be beneficial, even to those with kidney and heart conditions who are most often advised to restrict its intake. 

Adequate potassium intake can

  • Decrease blood pressure by increasing urinary excretion of sodium
  • Improve nephrolithiasis by decreasing urinary excretion of calcium
  • Decrease incidence of metabolic acidosis by providing precursors to bicarbonate that facilitate excretion of potassium
  • Increase bone density in postmenopausal women
  • Decrease risk for stroke and cardiovascular disease in the general population

One study found that metabolic acidosis can be corrected in patients with stage 4 chronic kidney disease, without hyperkalemia, by increasing fruit and vegetable intake when compared with those treated with bicarbonate alone, thus preserving kidney function.

Do I suggest encouraging a patient with acute hyperkalemia to eat a banana? Of course not. But I would suggest finding ways to work with patients who have chronic hyperkalemia to increase intake of potassium-rich plant foods to maintain homeostasis while liberalizing diet and preventing progression of chronic kidney disease. 
 

When to Refer to a Dietitian

In patients for whom a potassium-restricted diet is a necessary long-term treatment of hyperkalemia, education with a registered dietitian can be beneficial. A registered dietitian has the time and expertise to address the areas in the diet where excessive potassium exists without forfeiting other nutritional benefits that come from whole foods like fruits, vegetables, lean protein, legumes, nuts, and seeds in a way that is both realistic and helpful. A dietitian can work with patients to reduce intake of potassium-containing salt substitutes, preservatives, and other additives while still encouraging a whole-food diet rich in antioxidants, fiber, and healthy fats.

Dietitians also provide education on serving size and methods to reduce potassium content of food.

For example, tomatoes are a high-potassium food at 300+ mg per medium-sized tomato. But how often does a patient eat a whole tomato? A slice of tomato on a sandwich or a handful of cherry tomatoes in a salad are actually low in potassium per serving and can provide additional nutrients like vitamin C, beta-carotene, and antioxidants like lycopene, which is linked to a decreased incidence of prostate cancer.

By incorporating the assistance of a registered dietitian into the treatment of chronic hyperkalemia, we can develop individualized restrictions that are realistic for the patient and tailored to their nutritional needs to promote optimal health and thus encourage continued compliance. 

Ms. Winfree is a renal dietitian in private practice in Mary Esther, Florida. She disclosed no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

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Giving Cash to Improve Health

Article Type
Changed
Tue, 07/23/2024 - 11:47

This transcript has been edited for clarity

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson


But the word “associated” is doing a lot of work there. Many of us feel that poverty itself is causally linked to worse disease outcomes through things like poor access to care and poor access to medicines. 

And there is an argument that the arrow goes the other way; perhaps people with worse illness are more likely to be poor because, in this country at least, being sick is incredibly expensive. 

Causality is what all medical research is fundamentally about. We want to know if A causes B, because if A causes B, then changing A changes B. If poverty causes bad health outcomes, then alleviating poverty should alleviate bad health outcomes.

But that’s a hard proposition to test. You can’t exactly randomize some people to get extra money and some not to, right? Actually, you can. And in Massachusetts, they did.

What happened in Chelsea, Massachusetts, wasn’t exactly a randomized trial of cash supplementation to avoid bad health outcomes. It was actually a government program instituted during the pandemic. Chelsea has a large immigrant population, many of whom are living in poverty. From April to August 2020, the city ran a food distribution program to aid those in need. But the decision was then made to convert the money spent on that program to cash distributions — free of obligations. Chelsea residents making less than 30% of the median income for the Boston metro area — around $30,000 per family — were invited to enter a lottery. Only one member of any given family could enter. If selected, an individual would receive $200 a month, or $300 for a family of two, or $400 for a family of three or more. These payments went on for about 9 months.

The key thing here is that not everyone won the lottery. The lottery picked winners randomly; 1746 individuals were selected to receive the benefits in the form of a reloadable gift card, and 1134 applied but did not receive any assistance. 

This is a perfect natural experiment. As you can see here — and as expected, given that the lottery winners were chosen randomly — winners and losers were similar in terms of age, sex, race, language, income, and more.

Dr. Wilson


Researchers, led by Sumit Agarwal at the Brigham, leveraged that randomization to ask how these cash benefits would affect healthcare utilization. Their results appeared this week in JAMA.

I know what you’re thinking: Is $400 a month really enough to make a difference? Does $400 a month, less than $5000 a year, really fix poverty? We’ll get to that. But I will point out that the average family income of individuals in this study was about $1400 a month. An extra $400 might not change someone’s life, but it may really make a difference.

The primary outcome of this study was ED visits. There are a few ways this could go. Perhaps the money would lead to improved health and thus fewer ED visits. Or perhaps it would help people get transportation to primary care or other services that would offload the ED. Or maybe it would make things worse. Some folks have suggested that cash payments could increase the use of drugs and alcohol, and lead to more ED visits associated with the complications of using those substances.

Here are the actual data. Per 1000 individuals, there were 217 ED visits in the cash-benefit group, 318 in the no-benefit group. That was a statistically significant finding. 

Breaking those ED visits down, you can see that fewer visits resulted in hospital admission, with fewer behavioral health–related visits and — a key finding — fewer visits for substance use disorder. This puts the lie to the idea that cash benefits increase drug use.

Dr. Wilson


But the authors also looked at other causes of healthcare utilization. Outpatient visits were slightly higher in the cash-benefit group, driven largely by an increase in specialty care visits. The authors note that this is likely due to the fact that reaching a specialist often requires more travel, which can be costly. Indeed, this effect was most pronounced among the people living furthest from a specialty center.

Dr. Wilson


Outside of utilization, the researchers examined a variety of individual health markers — things like blood pressure — to see if the cash benefit had any effect. A bit of caution here because these data were available only among those who interacted with the healthcare system, which may bias the results a bit. Regardless, no major differences were seen in blood pressure, weight, hemoglobin A1c, cholesterol, or COVID vaccination.

JAMA


So, it seems that $400 a month doesn’t move the needle too much on risk factors for cardiovascular disease, but the effect on ED visits on their own is fairly impressive.

Is it worth it? The authors did their best to calculate the net effect of this program, accounting for the reduced ED visits and hospitalizations (that’s a big one), but also for the increased number of specialty visits. All told, the program saves about $450 per person in healthcare costs over 9 months. That’s about one seventh of the cost of the overall program.

But remember that they only looked at outcomes for the individual who got the gift cards; it’s likely that there were benefits to their family members as well. And, of course, programs like this can recoup costs indirectly though increases in economic activity, a phenomenon known as the multiplier effect.

I’m not here to tell you whether this program was a good idea; people tend to have quite strong feelings about this sort of thing. But I can tell you what it tells me about healthcare in America. It may not be surprising, but it confirms that access is far from fairly distributed. 

I started this story asking about the arrow of causality between poverty and poor health. The truth is, you probably have causality in both directions. Making people healthier will make them less poor. And, as this study suggests, making them less poor may make them healthier.

Dr. Wilson



 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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This transcript has been edited for clarity

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson


But the word “associated” is doing a lot of work there. Many of us feel that poverty itself is causally linked to worse disease outcomes through things like poor access to care and poor access to medicines. 

And there is an argument that the arrow goes the other way; perhaps people with worse illness are more likely to be poor because, in this country at least, being sick is incredibly expensive. 

Causality is what all medical research is fundamentally about. We want to know if A causes B, because if A causes B, then changing A changes B. If poverty causes bad health outcomes, then alleviating poverty should alleviate bad health outcomes.

But that’s a hard proposition to test. You can’t exactly randomize some people to get extra money and some not to, right? Actually, you can. And in Massachusetts, they did.

What happened in Chelsea, Massachusetts, wasn’t exactly a randomized trial of cash supplementation to avoid bad health outcomes. It was actually a government program instituted during the pandemic. Chelsea has a large immigrant population, many of whom are living in poverty. From April to August 2020, the city ran a food distribution program to aid those in need. But the decision was then made to convert the money spent on that program to cash distributions — free of obligations. Chelsea residents making less than 30% of the median income for the Boston metro area — around $30,000 per family — were invited to enter a lottery. Only one member of any given family could enter. If selected, an individual would receive $200 a month, or $300 for a family of two, or $400 for a family of three or more. These payments went on for about 9 months.

The key thing here is that not everyone won the lottery. The lottery picked winners randomly; 1746 individuals were selected to receive the benefits in the form of a reloadable gift card, and 1134 applied but did not receive any assistance. 

This is a perfect natural experiment. As you can see here — and as expected, given that the lottery winners were chosen randomly — winners and losers were similar in terms of age, sex, race, language, income, and more.

Dr. Wilson


Researchers, led by Sumit Agarwal at the Brigham, leveraged that randomization to ask how these cash benefits would affect healthcare utilization. Their results appeared this week in JAMA.

I know what you’re thinking: Is $400 a month really enough to make a difference? Does $400 a month, less than $5000 a year, really fix poverty? We’ll get to that. But I will point out that the average family income of individuals in this study was about $1400 a month. An extra $400 might not change someone’s life, but it may really make a difference.

The primary outcome of this study was ED visits. There are a few ways this could go. Perhaps the money would lead to improved health and thus fewer ED visits. Or perhaps it would help people get transportation to primary care or other services that would offload the ED. Or maybe it would make things worse. Some folks have suggested that cash payments could increase the use of drugs and alcohol, and lead to more ED visits associated with the complications of using those substances.

Here are the actual data. Per 1000 individuals, there were 217 ED visits in the cash-benefit group, 318 in the no-benefit group. That was a statistically significant finding. 

Breaking those ED visits down, you can see that fewer visits resulted in hospital admission, with fewer behavioral health–related visits and — a key finding — fewer visits for substance use disorder. This puts the lie to the idea that cash benefits increase drug use.

Dr. Wilson


But the authors also looked at other causes of healthcare utilization. Outpatient visits were slightly higher in the cash-benefit group, driven largely by an increase in specialty care visits. The authors note that this is likely due to the fact that reaching a specialist often requires more travel, which can be costly. Indeed, this effect was most pronounced among the people living furthest from a specialty center.

Dr. Wilson


Outside of utilization, the researchers examined a variety of individual health markers — things like blood pressure — to see if the cash benefit had any effect. A bit of caution here because these data were available only among those who interacted with the healthcare system, which may bias the results a bit. Regardless, no major differences were seen in blood pressure, weight, hemoglobin A1c, cholesterol, or COVID vaccination.

JAMA


So, it seems that $400 a month doesn’t move the needle too much on risk factors for cardiovascular disease, but the effect on ED visits on their own is fairly impressive.

Is it worth it? The authors did their best to calculate the net effect of this program, accounting for the reduced ED visits and hospitalizations (that’s a big one), but also for the increased number of specialty visits. All told, the program saves about $450 per person in healthcare costs over 9 months. That’s about one seventh of the cost of the overall program.

But remember that they only looked at outcomes for the individual who got the gift cards; it’s likely that there were benefits to their family members as well. And, of course, programs like this can recoup costs indirectly though increases in economic activity, a phenomenon known as the multiplier effect.

I’m not here to tell you whether this program was a good idea; people tend to have quite strong feelings about this sort of thing. But I can tell you what it tells me about healthcare in America. It may not be surprising, but it confirms that access is far from fairly distributed. 

I started this story asking about the arrow of causality between poverty and poor health. The truth is, you probably have causality in both directions. Making people healthier will make them less poor. And, as this study suggests, making them less poor may make them healthier.

Dr. Wilson



 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity

It doesn’t really matter what disease you are looking at — cancer, heart disease, dementia, drug abuse, psychiatric disorders. In every case, poverty is associated with worse disease. 

Dr. Wilson


But the word “associated” is doing a lot of work there. Many of us feel that poverty itself is causally linked to worse disease outcomes through things like poor access to care and poor access to medicines. 

And there is an argument that the arrow goes the other way; perhaps people with worse illness are more likely to be poor because, in this country at least, being sick is incredibly expensive. 

Causality is what all medical research is fundamentally about. We want to know if A causes B, because if A causes B, then changing A changes B. If poverty causes bad health outcomes, then alleviating poverty should alleviate bad health outcomes.

But that’s a hard proposition to test. You can’t exactly randomize some people to get extra money and some not to, right? Actually, you can. And in Massachusetts, they did.

What happened in Chelsea, Massachusetts, wasn’t exactly a randomized trial of cash supplementation to avoid bad health outcomes. It was actually a government program instituted during the pandemic. Chelsea has a large immigrant population, many of whom are living in poverty. From April to August 2020, the city ran a food distribution program to aid those in need. But the decision was then made to convert the money spent on that program to cash distributions — free of obligations. Chelsea residents making less than 30% of the median income for the Boston metro area — around $30,000 per family — were invited to enter a lottery. Only one member of any given family could enter. If selected, an individual would receive $200 a month, or $300 for a family of two, or $400 for a family of three or more. These payments went on for about 9 months.

The key thing here is that not everyone won the lottery. The lottery picked winners randomly; 1746 individuals were selected to receive the benefits in the form of a reloadable gift card, and 1134 applied but did not receive any assistance. 

This is a perfect natural experiment. As you can see here — and as expected, given that the lottery winners were chosen randomly — winners and losers were similar in terms of age, sex, race, language, income, and more.

Dr. Wilson


Researchers, led by Sumit Agarwal at the Brigham, leveraged that randomization to ask how these cash benefits would affect healthcare utilization. Their results appeared this week in JAMA.

I know what you’re thinking: Is $400 a month really enough to make a difference? Does $400 a month, less than $5000 a year, really fix poverty? We’ll get to that. But I will point out that the average family income of individuals in this study was about $1400 a month. An extra $400 might not change someone’s life, but it may really make a difference.

The primary outcome of this study was ED visits. There are a few ways this could go. Perhaps the money would lead to improved health and thus fewer ED visits. Or perhaps it would help people get transportation to primary care or other services that would offload the ED. Or maybe it would make things worse. Some folks have suggested that cash payments could increase the use of drugs and alcohol, and lead to more ED visits associated with the complications of using those substances.

Here are the actual data. Per 1000 individuals, there were 217 ED visits in the cash-benefit group, 318 in the no-benefit group. That was a statistically significant finding. 

Breaking those ED visits down, you can see that fewer visits resulted in hospital admission, with fewer behavioral health–related visits and — a key finding — fewer visits for substance use disorder. This puts the lie to the idea that cash benefits increase drug use.

Dr. Wilson


But the authors also looked at other causes of healthcare utilization. Outpatient visits were slightly higher in the cash-benefit group, driven largely by an increase in specialty care visits. The authors note that this is likely due to the fact that reaching a specialist often requires more travel, which can be costly. Indeed, this effect was most pronounced among the people living furthest from a specialty center.

Dr. Wilson


Outside of utilization, the researchers examined a variety of individual health markers — things like blood pressure — to see if the cash benefit had any effect. A bit of caution here because these data were available only among those who interacted with the healthcare system, which may bias the results a bit. Regardless, no major differences were seen in blood pressure, weight, hemoglobin A1c, cholesterol, or COVID vaccination.

JAMA


So, it seems that $400 a month doesn’t move the needle too much on risk factors for cardiovascular disease, but the effect on ED visits on their own is fairly impressive.

Is it worth it? The authors did their best to calculate the net effect of this program, accounting for the reduced ED visits and hospitalizations (that’s a big one), but also for the increased number of specialty visits. All told, the program saves about $450 per person in healthcare costs over 9 months. That’s about one seventh of the cost of the overall program.

But remember that they only looked at outcomes for the individual who got the gift cards; it’s likely that there were benefits to their family members as well. And, of course, programs like this can recoup costs indirectly though increases in economic activity, a phenomenon known as the multiplier effect.

I’m not here to tell you whether this program was a good idea; people tend to have quite strong feelings about this sort of thing. But I can tell you what it tells me about healthcare in America. It may not be surprising, but it confirms that access is far from fairly distributed. 

I started this story asking about the arrow of causality between poverty and poor health. The truth is, you probably have causality in both directions. Making people healthier will make them less poor. And, as this study suggests, making them less poor may make them healthier.

Dr. Wilson



 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Which GI Side Effects Should GLP-1 Prescribers Worry About?

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Fri, 07/26/2024 - 14:50

The rapid adoption of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for the treatment of diabetes and weight loss has led to a corresponding interest in their potential side effects. Several recent studies have sought to expound upon what role, if any, GLP-1 RAs may have in increasing the risk for specific gastrointestinal (GI) adverse events. 

Herein is a summary of the most current information on this topic, as well as my best guidance for clinicians on integrating it into the clinical care of their patients. 
 

Aspiration Risks

Albiglutidedulaglutide, exenatide, liraglutidelixisenatidesemaglutide, and tirzepatide are among the class of medications known as GLP-1 RAs. These medications all work by mimicking the action of hormonal incretins, which are released postprandially. Incretins affect the pancreatic glucose-dependent release of insulin, inhibit release of glucagon, stimulate satiety, and reduce gastric emptying. This last effect has raised concerns that patients taking GLP-1 RAs might be at an elevated risk for endoscopy-related aspiration. 

In June 2023, the American Society of Anesthesiologists released recommendations asking providers to consider holding back GLP-1 RAs in patients with scheduled elective procedures. 

In August 2023, five national GI societies — the American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, American Society for Gastrointestinal Endoscopy, and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition — issued their own joint statement on the issue. 

In the absence of sufficient evidence, these groups suggested that healthcare providers “exercise best practices when performing endoscopy on these patients on GLP-1 [RAs].” They called for more data and encouraged key stakeholders to work together to develop the necessary evidence to provide guidance for these patients prior to elective endoscopy. A rapid clinical update issued by the American Gastroenterological Association in 2024 was consistent with these earlier multisociety recommendations. 

Two studies presented at 2024’s Digestive Disease Week provided additional reassurance that concerns about aspiration with these medications were perhaps unwarranted. 

The first (since published in The American Journal of Gastroenterology ) was a case-control study of 16,295 patients undergoing upper endoscopy, among whom 306 were taking GLP-1 RAs. It showed a higher rate of solid gastric residue among those taking GLP-1 RAs compared with controls (14% vs 4%, respectively). Patients who had prolonged fasting and clear liquids for concurrent colonoscopy had lower residue rates (2% vs 11%, respectively). However, there were no recorded incidents of procedural complications or aspiration. 

The second was a retrospective cohort study using TriNetX, a federated cloud-based network pulling millions of data points from multiple US healthcare organizations. It found that the incidence of aspiration pneumonitis and emergent intubation during or immediately after esophagogastroduodenoscopy and colonoscopy among those taking GLP-1 RAs was not increased compared with those not taking these medications. 

These were followed in June 2024 by a systematic review and meta-analysis published by Hiramoto and colleagues, which included 15 studies. The researchers showed a 36-minute prolongation for solid-food emptying and no delay in liquid emptying for patients taking GLP-1 RAs vs controls. The authors concluded that the minimal delay in solid-food emptying would be offset by standard preprocedural fasting periods. 

There is concern that patients with complicated type 2 diabetes may have a bit more of a risk for aspiration. However, this was not supported by an analysis from Barlowe and colleagues, who used a national claims database to identify 15,119 patients with type 2 diabetes on GLP-1 RAs. They found no increased events of pulmonary complications (ie, aspiration, pneumonia, respiratory failure) within 14 days following esophagogastroduodenoscopy. Additional evidence suggests that the risk for aspiration in these patients seems to be offset by prolonged fasting and intake of clear liquids. 

Although physicians clearly need to use clinical judgment when performing endoscopic procedures on these patients, the emerging evidence on safety has been encouraging. 
 

 

 

Association With GI Adverse Events

recent retrospective analysis of real-world data from 10,328 new users of GLP-1 RAs with diabetes/obesity reported that the most common GI adverse events in this cohort were abdominal pain (57.6%), constipation (30.4%), diarrhea (32.7%), nausea and vomiting (23.4%), GI bleeding (15.9%), gastroparesis (5.1%), and pancreatitis (3.4%). 

Notably, dulaglutide and liraglutide had higher rates of abdominal pain, constipation, diarrhea, and nausea and vomiting than did semaglutide and exenatide. Compared with semaglutide, dulaglutide and liraglutide had slightly higher odds of abdominal pain, gastroparesis, and nausea and vomiting. There were no significant differences between the GLP-1 RAs in the risk for GI bleeding or pancreatitis. 

2023 report in JAMA observed that the risk for bowel obstruction is also elevated among patients using these agents for weight loss. Possible reasons for this are currently unknown. 

Studies are needed to analyze possible variations in safety profiles between GLP-1 RAs to better guide selection of these drugs, particularly in patients with GI risk factors. Furthermore, the causal relationship between GLP-1 RAs with other concomitant medications requires further investigation. 

Although relatively infrequent, the risk for GI adverse events should be given special consideration by providers when prescribing them for weight loss, because the risk/benefit ratios may be different from those in patients with diabetes. 
 

A Lack of Hepatic Concerns

GLP-1 RAs have demonstrated a significant impact on body weight and glycemic control, as well as beneficial effects on clinical, biochemical, and histologic markers in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). These favorable changes are evident by reductions in the hepatic cytolysis markers (ie, aspartate aminotransferase and alanine aminotransferase). 

GLP-1 RAs may provide a protective function by reducing the accumulation of hepatic triglycerides and expression of several collagen genes. Some preclinical data suggest a risk reduction for progression to hepatocellular carcinoma, and animal studies indicate that complete suppression of hepatic carcinogenesis is achieved with liraglutide.

The most recent assessment of risk reduction for MASLD progression comes from a Scandinavian cohort analysis of national registries. In looking at 91,479 patients using GLP-1 RAs, investigators demonstrated this treatment was associated with a significant reduction in the composite primary endpoint of hepatocellular carcinoma, as well as both compensated and decompensated cirrhosis

Given the various favorable hepatic effects of GLP-1 RAs, it is likely that the composite benefit on MASLD is multifactorial. The current literature is clear that it is safe to use these agents across the spectrum of MASLD with or without fibrosis, although it must be noted that GLP-1 RAs are not approved by the Food and Drug Administration for this indication. 
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. He disclosed ties with ISOTHRIVE and Johnson & Johnson.

A version of this article appeared on Medscape.com.

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The rapid adoption of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for the treatment of diabetes and weight loss has led to a corresponding interest in their potential side effects. Several recent studies have sought to expound upon what role, if any, GLP-1 RAs may have in increasing the risk for specific gastrointestinal (GI) adverse events. 

Herein is a summary of the most current information on this topic, as well as my best guidance for clinicians on integrating it into the clinical care of their patients. 
 

Aspiration Risks

Albiglutidedulaglutide, exenatide, liraglutidelixisenatidesemaglutide, and tirzepatide are among the class of medications known as GLP-1 RAs. These medications all work by mimicking the action of hormonal incretins, which are released postprandially. Incretins affect the pancreatic glucose-dependent release of insulin, inhibit release of glucagon, stimulate satiety, and reduce gastric emptying. This last effect has raised concerns that patients taking GLP-1 RAs might be at an elevated risk for endoscopy-related aspiration. 

In June 2023, the American Society of Anesthesiologists released recommendations asking providers to consider holding back GLP-1 RAs in patients with scheduled elective procedures. 

In August 2023, five national GI societies — the American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, American Society for Gastrointestinal Endoscopy, and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition — issued their own joint statement on the issue. 

In the absence of sufficient evidence, these groups suggested that healthcare providers “exercise best practices when performing endoscopy on these patients on GLP-1 [RAs].” They called for more data and encouraged key stakeholders to work together to develop the necessary evidence to provide guidance for these patients prior to elective endoscopy. A rapid clinical update issued by the American Gastroenterological Association in 2024 was consistent with these earlier multisociety recommendations. 

Two studies presented at 2024’s Digestive Disease Week provided additional reassurance that concerns about aspiration with these medications were perhaps unwarranted. 

The first (since published in The American Journal of Gastroenterology ) was a case-control study of 16,295 patients undergoing upper endoscopy, among whom 306 were taking GLP-1 RAs. It showed a higher rate of solid gastric residue among those taking GLP-1 RAs compared with controls (14% vs 4%, respectively). Patients who had prolonged fasting and clear liquids for concurrent colonoscopy had lower residue rates (2% vs 11%, respectively). However, there were no recorded incidents of procedural complications or aspiration. 

The second was a retrospective cohort study using TriNetX, a federated cloud-based network pulling millions of data points from multiple US healthcare organizations. It found that the incidence of aspiration pneumonitis and emergent intubation during or immediately after esophagogastroduodenoscopy and colonoscopy among those taking GLP-1 RAs was not increased compared with those not taking these medications. 

These were followed in June 2024 by a systematic review and meta-analysis published by Hiramoto and colleagues, which included 15 studies. The researchers showed a 36-minute prolongation for solid-food emptying and no delay in liquid emptying for patients taking GLP-1 RAs vs controls. The authors concluded that the minimal delay in solid-food emptying would be offset by standard preprocedural fasting periods. 

There is concern that patients with complicated type 2 diabetes may have a bit more of a risk for aspiration. However, this was not supported by an analysis from Barlowe and colleagues, who used a national claims database to identify 15,119 patients with type 2 diabetes on GLP-1 RAs. They found no increased events of pulmonary complications (ie, aspiration, pneumonia, respiratory failure) within 14 days following esophagogastroduodenoscopy. Additional evidence suggests that the risk for aspiration in these patients seems to be offset by prolonged fasting and intake of clear liquids. 

Although physicians clearly need to use clinical judgment when performing endoscopic procedures on these patients, the emerging evidence on safety has been encouraging. 
 

 

 

Association With GI Adverse Events

recent retrospective analysis of real-world data from 10,328 new users of GLP-1 RAs with diabetes/obesity reported that the most common GI adverse events in this cohort were abdominal pain (57.6%), constipation (30.4%), diarrhea (32.7%), nausea and vomiting (23.4%), GI bleeding (15.9%), gastroparesis (5.1%), and pancreatitis (3.4%). 

Notably, dulaglutide and liraglutide had higher rates of abdominal pain, constipation, diarrhea, and nausea and vomiting than did semaglutide and exenatide. Compared with semaglutide, dulaglutide and liraglutide had slightly higher odds of abdominal pain, gastroparesis, and nausea and vomiting. There were no significant differences between the GLP-1 RAs in the risk for GI bleeding or pancreatitis. 

2023 report in JAMA observed that the risk for bowel obstruction is also elevated among patients using these agents for weight loss. Possible reasons for this are currently unknown. 

Studies are needed to analyze possible variations in safety profiles between GLP-1 RAs to better guide selection of these drugs, particularly in patients with GI risk factors. Furthermore, the causal relationship between GLP-1 RAs with other concomitant medications requires further investigation. 

Although relatively infrequent, the risk for GI adverse events should be given special consideration by providers when prescribing them for weight loss, because the risk/benefit ratios may be different from those in patients with diabetes. 
 

A Lack of Hepatic Concerns

GLP-1 RAs have demonstrated a significant impact on body weight and glycemic control, as well as beneficial effects on clinical, biochemical, and histologic markers in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). These favorable changes are evident by reductions in the hepatic cytolysis markers (ie, aspartate aminotransferase and alanine aminotransferase). 

GLP-1 RAs may provide a protective function by reducing the accumulation of hepatic triglycerides and expression of several collagen genes. Some preclinical data suggest a risk reduction for progression to hepatocellular carcinoma, and animal studies indicate that complete suppression of hepatic carcinogenesis is achieved with liraglutide.

The most recent assessment of risk reduction for MASLD progression comes from a Scandinavian cohort analysis of national registries. In looking at 91,479 patients using GLP-1 RAs, investigators demonstrated this treatment was associated with a significant reduction in the composite primary endpoint of hepatocellular carcinoma, as well as both compensated and decompensated cirrhosis

Given the various favorable hepatic effects of GLP-1 RAs, it is likely that the composite benefit on MASLD is multifactorial. The current literature is clear that it is safe to use these agents across the spectrum of MASLD with or without fibrosis, although it must be noted that GLP-1 RAs are not approved by the Food and Drug Administration for this indication. 
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. He disclosed ties with ISOTHRIVE and Johnson & Johnson.

A version of this article appeared on Medscape.com.

The rapid adoption of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for the treatment of diabetes and weight loss has led to a corresponding interest in their potential side effects. Several recent studies have sought to expound upon what role, if any, GLP-1 RAs may have in increasing the risk for specific gastrointestinal (GI) adverse events. 

Herein is a summary of the most current information on this topic, as well as my best guidance for clinicians on integrating it into the clinical care of their patients. 
 

Aspiration Risks

Albiglutidedulaglutide, exenatide, liraglutidelixisenatidesemaglutide, and tirzepatide are among the class of medications known as GLP-1 RAs. These medications all work by mimicking the action of hormonal incretins, which are released postprandially. Incretins affect the pancreatic glucose-dependent release of insulin, inhibit release of glucagon, stimulate satiety, and reduce gastric emptying. This last effect has raised concerns that patients taking GLP-1 RAs might be at an elevated risk for endoscopy-related aspiration. 

In June 2023, the American Society of Anesthesiologists released recommendations asking providers to consider holding back GLP-1 RAs in patients with scheduled elective procedures. 

In August 2023, five national GI societies — the American Gastroenterological Association, American Association for the Study of Liver Diseases, American College of Gastroenterology, American Society for Gastrointestinal Endoscopy, and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition — issued their own joint statement on the issue. 

In the absence of sufficient evidence, these groups suggested that healthcare providers “exercise best practices when performing endoscopy on these patients on GLP-1 [RAs].” They called for more data and encouraged key stakeholders to work together to develop the necessary evidence to provide guidance for these patients prior to elective endoscopy. A rapid clinical update issued by the American Gastroenterological Association in 2024 was consistent with these earlier multisociety recommendations. 

Two studies presented at 2024’s Digestive Disease Week provided additional reassurance that concerns about aspiration with these medications were perhaps unwarranted. 

The first (since published in The American Journal of Gastroenterology ) was a case-control study of 16,295 patients undergoing upper endoscopy, among whom 306 were taking GLP-1 RAs. It showed a higher rate of solid gastric residue among those taking GLP-1 RAs compared with controls (14% vs 4%, respectively). Patients who had prolonged fasting and clear liquids for concurrent colonoscopy had lower residue rates (2% vs 11%, respectively). However, there were no recorded incidents of procedural complications or aspiration. 

The second was a retrospective cohort study using TriNetX, a federated cloud-based network pulling millions of data points from multiple US healthcare organizations. It found that the incidence of aspiration pneumonitis and emergent intubation during or immediately after esophagogastroduodenoscopy and colonoscopy among those taking GLP-1 RAs was not increased compared with those not taking these medications. 

These were followed in June 2024 by a systematic review and meta-analysis published by Hiramoto and colleagues, which included 15 studies. The researchers showed a 36-minute prolongation for solid-food emptying and no delay in liquid emptying for patients taking GLP-1 RAs vs controls. The authors concluded that the minimal delay in solid-food emptying would be offset by standard preprocedural fasting periods. 

There is concern that patients with complicated type 2 diabetes may have a bit more of a risk for aspiration. However, this was not supported by an analysis from Barlowe and colleagues, who used a national claims database to identify 15,119 patients with type 2 diabetes on GLP-1 RAs. They found no increased events of pulmonary complications (ie, aspiration, pneumonia, respiratory failure) within 14 days following esophagogastroduodenoscopy. Additional evidence suggests that the risk for aspiration in these patients seems to be offset by prolonged fasting and intake of clear liquids. 

Although physicians clearly need to use clinical judgment when performing endoscopic procedures on these patients, the emerging evidence on safety has been encouraging. 
 

 

 

Association With GI Adverse Events

recent retrospective analysis of real-world data from 10,328 new users of GLP-1 RAs with diabetes/obesity reported that the most common GI adverse events in this cohort were abdominal pain (57.6%), constipation (30.4%), diarrhea (32.7%), nausea and vomiting (23.4%), GI bleeding (15.9%), gastroparesis (5.1%), and pancreatitis (3.4%). 

Notably, dulaglutide and liraglutide had higher rates of abdominal pain, constipation, diarrhea, and nausea and vomiting than did semaglutide and exenatide. Compared with semaglutide, dulaglutide and liraglutide had slightly higher odds of abdominal pain, gastroparesis, and nausea and vomiting. There were no significant differences between the GLP-1 RAs in the risk for GI bleeding or pancreatitis. 

2023 report in JAMA observed that the risk for bowel obstruction is also elevated among patients using these agents for weight loss. Possible reasons for this are currently unknown. 

Studies are needed to analyze possible variations in safety profiles between GLP-1 RAs to better guide selection of these drugs, particularly in patients with GI risk factors. Furthermore, the causal relationship between GLP-1 RAs with other concomitant medications requires further investigation. 

Although relatively infrequent, the risk for GI adverse events should be given special consideration by providers when prescribing them for weight loss, because the risk/benefit ratios may be different from those in patients with diabetes. 
 

A Lack of Hepatic Concerns

GLP-1 RAs have demonstrated a significant impact on body weight and glycemic control, as well as beneficial effects on clinical, biochemical, and histologic markers in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). These favorable changes are evident by reductions in the hepatic cytolysis markers (ie, aspartate aminotransferase and alanine aminotransferase). 

GLP-1 RAs may provide a protective function by reducing the accumulation of hepatic triglycerides and expression of several collagen genes. Some preclinical data suggest a risk reduction for progression to hepatocellular carcinoma, and animal studies indicate that complete suppression of hepatic carcinogenesis is achieved with liraglutide.

The most recent assessment of risk reduction for MASLD progression comes from a Scandinavian cohort analysis of national registries. In looking at 91,479 patients using GLP-1 RAs, investigators demonstrated this treatment was associated with a significant reduction in the composite primary endpoint of hepatocellular carcinoma, as well as both compensated and decompensated cirrhosis

Given the various favorable hepatic effects of GLP-1 RAs, it is likely that the composite benefit on MASLD is multifactorial. The current literature is clear that it is safe to use these agents across the spectrum of MASLD with or without fibrosis, although it must be noted that GLP-1 RAs are not approved by the Food and Drug Administration for this indication. 
 

Dr. Johnson is professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia, and a past president of the American College of Gastroenterology. He disclosed ties with ISOTHRIVE and Johnson & Johnson.

A version of this article appeared on Medscape.com.

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For Richer, for Poorer: Low-Carb Diets Work for All Incomes

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Thu, 07/18/2024 - 15:50

For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

 

 

Tools and Tips for Clinicians: 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

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For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

 

 

Tools and Tips for Clinicians: 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.

Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.

She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.

“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.” 

Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.

Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.

“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.

Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened. 

“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”

I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.

Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.

Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.

Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis. 

2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides. 

Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.

Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds. 

Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado. 

“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.

Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com

Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.

Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked. 

A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.

Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.

Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.” 

Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice. Eggs and ground beef are less expensive low-carb meal options, and meat, unlike fruits and vegetables, is easy to freeze and doesn’t spoil quickly. These advantages can add up.

A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.

It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.

Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.

When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said. 

Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients. 

This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged. 

OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.) 

Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine. 
 

 

 

Tools and Tips for Clinicians: 

Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.

A version of this article appeared on Medscape.com.

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Pulsed Field Ablation for AF: Are US Electrophysiologists Too Easily Impressed?

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Thu, 07/18/2024 - 15:35

My field of electrophysiology is abuzz with excitement over the new technology of pulsed field ablation (PFA). It dominated 2024’s heart rhythm meetings, and it dominates my private electrophysiologist chat groups. My Google alert for “AF ablation” most often includes notices on PFA and the expansion of the atrial fibrillation ablation market. 

Yet, the excitement does not match the empirical data. 

Despite having strong brains, electrophysiologists adopt new things as if we were emotional shoppers. Our neighbor buys a sports car and we think we need the same car. Left atrial appendage occlusion and subcutaneous defibrillators were past examples. 

The most recent example of soft thinking (especially in the United States) is the enthusiasm and early adoption of first-generation PFA systems for the treatment of AF. 

Readers of cardiac news (including some of my patients) might think PFA has solved the AF puzzle. It has not.

A true breakthrough in AF would be to find its cause. PFA is simply another way to destroy (ablate) cardiac myocytes. PFA uses electrical energy (think shocks) to create pores in the cell membranes of myocytes. It’s delivered through various types of catheters. 

The main theoretical advantage of PFA is cardioselectivity, which is possible because myocytes have lower thresholds for irreversible electroporation than surrounding tissues. The dose of electrical energy that ablates cardiac tissue does not affect surrounding tissues. Cardioselectivity decreases the chance of the most feared complication of standard AF ablation, thermal damage to the esophagus, which is often fatal. The esophagus lies immediately behind the posterior wall of the left atrium and can be inadvertently injured during thermal ablation. 

The challenge in assessing this potential advantage is that thermal esophageal damage is, thankfully, exceedingly rare. Its incidence is in the range of 1 in 10,000 AF ablations. But it might be even lower than that in contemporary practice, because knowledge of esophageal injury has led to innovations that probably have reduced its incidence even further. 

Proponents of PFA would rightly point to the fact that not having to worry about esophageal injury allows operators to add posterior wall ablation to the normal pulmonary vein isolation lesion set. This ability, they would argue, is likely to improve AF ablation outcomes. The problem is that the strongest and most recent trial of posterior wall isolation (with radiofrequency ablation) did not show better outcomes. A more recent observational analysis also showed no benefit to posterior wall isolation (using PFA) over pulmonary vein isolation alone. 
 

What About PFA Efficacy?

I’ve long spoken and written about the lack of progress in AF ablation. In 1998, the first report on ablation of AF showed a 62% arrhythmia-free rate. Two decades later, in the carefully chosen labs treating patients in the CABANA trial, arrhythmia-free rates after AF ablation remain unchanged. We have improved our speed and ability to isolate pulmonary veins, but this has not increased our success in eliminating AF. The reason, I believe, is that we have made little to no progress in understanding the pathophysiology of AF. 

The Food and Drug Administration regulatory trial called ADVENT randomly assigned more than 600 patients to thermal ablation or PFA, and the primary endpoint of ablation success was nearly identical. Single-center studies, observational registries, and single-arm studies have all shown similar efficacy of PFA and thermal ablation. 

Proponents of PFA might argue that these early studies used first-generation PFA systems, and iteration will lead to better efficacy. Perhaps, but we’ve had 20 years of iteration of thermal ablation, and its efficacy has not budged. 
 

 

 

What About PFA Safety?

In the ADVENT randomized trial, safety results were similar, though the one death, caused by cardiac perforation and tamponade, occurred in the PFA arm. In the MANIFEST-17K multinational survey of PFA ablation, safety events were in the range reported with thermal ablation. PFA still involves placing catheters in the heart, and complications such as tamponade, stroke, and vascular damage occur. 

The large MANIFEST-17K survey also exposed two PFA-specific complications: coronary artery spasm, which can occur when PFA is delivered close to coronary arteries; and hemolysis-related kidney failure — severe enough to require dialysis in five patients. Supporters of PFA speculate that hemolysis occurs because electrical energy within the atrium can shred red blood cells. Their solution is to strive for good contact and use hydration. The irony of this latter fix is that one of the best advances in thermal ablation has been catheters that deliver less fluid and less need for diuresis after the procedure. 

No PFA study has shown a decreased incidence of thermal damage to the esophagus with PFA ablation. Of course, this is because it is such a low-incidence event. 

One of my concerns with PFA is brain safety. PFA creates substantial microbubbles in the left atrium, which can then travel north to the brain. In a small series from ADVENT, three patients had brain lesions after PFA vs none with thermal ablation. PFA proponents wrote that brain safety was important to study, but few patients have been systematically studied with brain MRI scans. Asymptomatic brain lesions have been noted after many arterial procedures. The clinical significance of these is not known. As a new technology, and one that creates substantial microbubbles in the left atrium, I agree with the PFA proponents that brain safety should be thoroughly studied — before widespread adoption. 
 

What About Speed and Cost? 

Observational studies from European labs report fast procedure times. I have seen PFA procedures in Europe; they’re fast — typically under an hour. A standard thermal ablation takes me about 60-70 minutes.

I am not sure that US operators can duplicate European procedural times. In the ADVENT regulatory trial, the mean procedure time was 105 minutes and that was in experienced US centers. While this still represents early experience with PFA, the culture of US AF ablation entails far more mapping and extra catheters than I have seen used in European labs. 

Cost is a major issue. It’s hard to sort out exact costs in the United States, but a PFA catheter costs approximately threefold more than a standard ablation catheter. A recent study from Liverpool, England, found that PFA ablation was faster but more expensive than standard thermal ablation because of higher PFA equipment prices. For better or worse, US patients are not directly affected by the higher procedural costs. But the fact remains that PFA adds more costs to the healthcare system. 
 

What Drives the Enthusiasm for First-Generation PFA? 

So why all the enthusiasm? It’s surely not the empirical data. Evidence thus far shows no obvious advantage in safety or efficacy. European use of PFA does seem to reduce procedure time. But in many electrophysiology labs in the United States, the rate-limiting step for AF ablation is not time in the lab but having enough staff to turn rooms around.

The main factor driving early acceptance of PFA relates to basic human nature. It is the fear of missing out. Marketing works on consumers, and it surely works on doctors. Companies that make PFA systems sponsor key opinion leaders to discuss PFA. These companies have beautiful booths in the expo of our meetings; they host dinners and talks. When a hospital in a city does PFA, the other hospitals feel the urge to keep up. It’s hard to be a Top Person in electrophysiology and not be a PFA user. 

One of my favorite comments came from a key opinion leader. He told me that he advised his administration to buy a PFA system, promote that they have it, and keep it in the closet until better systems are released. 

Iteration in the medical device field is tricky. There are negatives to being too harsh on first-generation systems. Early cardiac resynchronization tools, for instance, were horrible. Now CRT is transformative in selected patients with heart failure

It’s possible (but not certain) that electrical ablative therapy will iterate and surpass thermal ablation in the future. Maybe. 

But for now, the enthusiasm for PFA far outstrips its evidence. Until better evidence emerges, I will be a slow adopter. And I hope that our field gathers evidence before widespread adoption makes it impossible to do proper studies. 
 

Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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My field of electrophysiology is abuzz with excitement over the new technology of pulsed field ablation (PFA). It dominated 2024’s heart rhythm meetings, and it dominates my private electrophysiologist chat groups. My Google alert for “AF ablation” most often includes notices on PFA and the expansion of the atrial fibrillation ablation market. 

Yet, the excitement does not match the empirical data. 

Despite having strong brains, electrophysiologists adopt new things as if we were emotional shoppers. Our neighbor buys a sports car and we think we need the same car. Left atrial appendage occlusion and subcutaneous defibrillators were past examples. 

The most recent example of soft thinking (especially in the United States) is the enthusiasm and early adoption of first-generation PFA systems for the treatment of AF. 

Readers of cardiac news (including some of my patients) might think PFA has solved the AF puzzle. It has not.

A true breakthrough in AF would be to find its cause. PFA is simply another way to destroy (ablate) cardiac myocytes. PFA uses electrical energy (think shocks) to create pores in the cell membranes of myocytes. It’s delivered through various types of catheters. 

The main theoretical advantage of PFA is cardioselectivity, which is possible because myocytes have lower thresholds for irreversible electroporation than surrounding tissues. The dose of electrical energy that ablates cardiac tissue does not affect surrounding tissues. Cardioselectivity decreases the chance of the most feared complication of standard AF ablation, thermal damage to the esophagus, which is often fatal. The esophagus lies immediately behind the posterior wall of the left atrium and can be inadvertently injured during thermal ablation. 

The challenge in assessing this potential advantage is that thermal esophageal damage is, thankfully, exceedingly rare. Its incidence is in the range of 1 in 10,000 AF ablations. But it might be even lower than that in contemporary practice, because knowledge of esophageal injury has led to innovations that probably have reduced its incidence even further. 

Proponents of PFA would rightly point to the fact that not having to worry about esophageal injury allows operators to add posterior wall ablation to the normal pulmonary vein isolation lesion set. This ability, they would argue, is likely to improve AF ablation outcomes. The problem is that the strongest and most recent trial of posterior wall isolation (with radiofrequency ablation) did not show better outcomes. A more recent observational analysis also showed no benefit to posterior wall isolation (using PFA) over pulmonary vein isolation alone. 
 

What About PFA Efficacy?

I’ve long spoken and written about the lack of progress in AF ablation. In 1998, the first report on ablation of AF showed a 62% arrhythmia-free rate. Two decades later, in the carefully chosen labs treating patients in the CABANA trial, arrhythmia-free rates after AF ablation remain unchanged. We have improved our speed and ability to isolate pulmonary veins, but this has not increased our success in eliminating AF. The reason, I believe, is that we have made little to no progress in understanding the pathophysiology of AF. 

The Food and Drug Administration regulatory trial called ADVENT randomly assigned more than 600 patients to thermal ablation or PFA, and the primary endpoint of ablation success was nearly identical. Single-center studies, observational registries, and single-arm studies have all shown similar efficacy of PFA and thermal ablation. 

Proponents of PFA might argue that these early studies used first-generation PFA systems, and iteration will lead to better efficacy. Perhaps, but we’ve had 20 years of iteration of thermal ablation, and its efficacy has not budged. 
 

 

 

What About PFA Safety?

In the ADVENT randomized trial, safety results were similar, though the one death, caused by cardiac perforation and tamponade, occurred in the PFA arm. In the MANIFEST-17K multinational survey of PFA ablation, safety events were in the range reported with thermal ablation. PFA still involves placing catheters in the heart, and complications such as tamponade, stroke, and vascular damage occur. 

The large MANIFEST-17K survey also exposed two PFA-specific complications: coronary artery spasm, which can occur when PFA is delivered close to coronary arteries; and hemolysis-related kidney failure — severe enough to require dialysis in five patients. Supporters of PFA speculate that hemolysis occurs because electrical energy within the atrium can shred red blood cells. Their solution is to strive for good contact and use hydration. The irony of this latter fix is that one of the best advances in thermal ablation has been catheters that deliver less fluid and less need for diuresis after the procedure. 

No PFA study has shown a decreased incidence of thermal damage to the esophagus with PFA ablation. Of course, this is because it is such a low-incidence event. 

One of my concerns with PFA is brain safety. PFA creates substantial microbubbles in the left atrium, which can then travel north to the brain. In a small series from ADVENT, three patients had brain lesions after PFA vs none with thermal ablation. PFA proponents wrote that brain safety was important to study, but few patients have been systematically studied with brain MRI scans. Asymptomatic brain lesions have been noted after many arterial procedures. The clinical significance of these is not known. As a new technology, and one that creates substantial microbubbles in the left atrium, I agree with the PFA proponents that brain safety should be thoroughly studied — before widespread adoption. 
 

What About Speed and Cost? 

Observational studies from European labs report fast procedure times. I have seen PFA procedures in Europe; they’re fast — typically under an hour. A standard thermal ablation takes me about 60-70 minutes.

I am not sure that US operators can duplicate European procedural times. In the ADVENT regulatory trial, the mean procedure time was 105 minutes and that was in experienced US centers. While this still represents early experience with PFA, the culture of US AF ablation entails far more mapping and extra catheters than I have seen used in European labs. 

Cost is a major issue. It’s hard to sort out exact costs in the United States, but a PFA catheter costs approximately threefold more than a standard ablation catheter. A recent study from Liverpool, England, found that PFA ablation was faster but more expensive than standard thermal ablation because of higher PFA equipment prices. For better or worse, US patients are not directly affected by the higher procedural costs. But the fact remains that PFA adds more costs to the healthcare system. 
 

What Drives the Enthusiasm for First-Generation PFA? 

So why all the enthusiasm? It’s surely not the empirical data. Evidence thus far shows no obvious advantage in safety or efficacy. European use of PFA does seem to reduce procedure time. But in many electrophysiology labs in the United States, the rate-limiting step for AF ablation is not time in the lab but having enough staff to turn rooms around.

The main factor driving early acceptance of PFA relates to basic human nature. It is the fear of missing out. Marketing works on consumers, and it surely works on doctors. Companies that make PFA systems sponsor key opinion leaders to discuss PFA. These companies have beautiful booths in the expo of our meetings; they host dinners and talks. When a hospital in a city does PFA, the other hospitals feel the urge to keep up. It’s hard to be a Top Person in electrophysiology and not be a PFA user. 

One of my favorite comments came from a key opinion leader. He told me that he advised his administration to buy a PFA system, promote that they have it, and keep it in the closet until better systems are released. 

Iteration in the medical device field is tricky. There are negatives to being too harsh on first-generation systems. Early cardiac resynchronization tools, for instance, were horrible. Now CRT is transformative in selected patients with heart failure

It’s possible (but not certain) that electrical ablative therapy will iterate and surpass thermal ablation in the future. Maybe. 

But for now, the enthusiasm for PFA far outstrips its evidence. Until better evidence emerges, I will be a slow adopter. And I hope that our field gathers evidence before widespread adoption makes it impossible to do proper studies. 
 

Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

My field of electrophysiology is abuzz with excitement over the new technology of pulsed field ablation (PFA). It dominated 2024’s heart rhythm meetings, and it dominates my private electrophysiologist chat groups. My Google alert for “AF ablation” most often includes notices on PFA and the expansion of the atrial fibrillation ablation market. 

Yet, the excitement does not match the empirical data. 

Despite having strong brains, electrophysiologists adopt new things as if we were emotional shoppers. Our neighbor buys a sports car and we think we need the same car. Left atrial appendage occlusion and subcutaneous defibrillators were past examples. 

The most recent example of soft thinking (especially in the United States) is the enthusiasm and early adoption of first-generation PFA systems for the treatment of AF. 

Readers of cardiac news (including some of my patients) might think PFA has solved the AF puzzle. It has not.

A true breakthrough in AF would be to find its cause. PFA is simply another way to destroy (ablate) cardiac myocytes. PFA uses electrical energy (think shocks) to create pores in the cell membranes of myocytes. It’s delivered through various types of catheters. 

The main theoretical advantage of PFA is cardioselectivity, which is possible because myocytes have lower thresholds for irreversible electroporation than surrounding tissues. The dose of electrical energy that ablates cardiac tissue does not affect surrounding tissues. Cardioselectivity decreases the chance of the most feared complication of standard AF ablation, thermal damage to the esophagus, which is often fatal. The esophagus lies immediately behind the posterior wall of the left atrium and can be inadvertently injured during thermal ablation. 

The challenge in assessing this potential advantage is that thermal esophageal damage is, thankfully, exceedingly rare. Its incidence is in the range of 1 in 10,000 AF ablations. But it might be even lower than that in contemporary practice, because knowledge of esophageal injury has led to innovations that probably have reduced its incidence even further. 

Proponents of PFA would rightly point to the fact that not having to worry about esophageal injury allows operators to add posterior wall ablation to the normal pulmonary vein isolation lesion set. This ability, they would argue, is likely to improve AF ablation outcomes. The problem is that the strongest and most recent trial of posterior wall isolation (with radiofrequency ablation) did not show better outcomes. A more recent observational analysis also showed no benefit to posterior wall isolation (using PFA) over pulmonary vein isolation alone. 
 

What About PFA Efficacy?

I’ve long spoken and written about the lack of progress in AF ablation. In 1998, the first report on ablation of AF showed a 62% arrhythmia-free rate. Two decades later, in the carefully chosen labs treating patients in the CABANA trial, arrhythmia-free rates after AF ablation remain unchanged. We have improved our speed and ability to isolate pulmonary veins, but this has not increased our success in eliminating AF. The reason, I believe, is that we have made little to no progress in understanding the pathophysiology of AF. 

The Food and Drug Administration regulatory trial called ADVENT randomly assigned more than 600 patients to thermal ablation or PFA, and the primary endpoint of ablation success was nearly identical. Single-center studies, observational registries, and single-arm studies have all shown similar efficacy of PFA and thermal ablation. 

Proponents of PFA might argue that these early studies used first-generation PFA systems, and iteration will lead to better efficacy. Perhaps, but we’ve had 20 years of iteration of thermal ablation, and its efficacy has not budged. 
 

 

 

What About PFA Safety?

In the ADVENT randomized trial, safety results were similar, though the one death, caused by cardiac perforation and tamponade, occurred in the PFA arm. In the MANIFEST-17K multinational survey of PFA ablation, safety events were in the range reported with thermal ablation. PFA still involves placing catheters in the heart, and complications such as tamponade, stroke, and vascular damage occur. 

The large MANIFEST-17K survey also exposed two PFA-specific complications: coronary artery spasm, which can occur when PFA is delivered close to coronary arteries; and hemolysis-related kidney failure — severe enough to require dialysis in five patients. Supporters of PFA speculate that hemolysis occurs because electrical energy within the atrium can shred red blood cells. Their solution is to strive for good contact and use hydration. The irony of this latter fix is that one of the best advances in thermal ablation has been catheters that deliver less fluid and less need for diuresis after the procedure. 

No PFA study has shown a decreased incidence of thermal damage to the esophagus with PFA ablation. Of course, this is because it is such a low-incidence event. 

One of my concerns with PFA is brain safety. PFA creates substantial microbubbles in the left atrium, which can then travel north to the brain. In a small series from ADVENT, three patients had brain lesions after PFA vs none with thermal ablation. PFA proponents wrote that brain safety was important to study, but few patients have been systematically studied with brain MRI scans. Asymptomatic brain lesions have been noted after many arterial procedures. The clinical significance of these is not known. As a new technology, and one that creates substantial microbubbles in the left atrium, I agree with the PFA proponents that brain safety should be thoroughly studied — before widespread adoption. 
 

What About Speed and Cost? 

Observational studies from European labs report fast procedure times. I have seen PFA procedures in Europe; they’re fast — typically under an hour. A standard thermal ablation takes me about 60-70 minutes.

I am not sure that US operators can duplicate European procedural times. In the ADVENT regulatory trial, the mean procedure time was 105 minutes and that was in experienced US centers. While this still represents early experience with PFA, the culture of US AF ablation entails far more mapping and extra catheters than I have seen used in European labs. 

Cost is a major issue. It’s hard to sort out exact costs in the United States, but a PFA catheter costs approximately threefold more than a standard ablation catheter. A recent study from Liverpool, England, found that PFA ablation was faster but more expensive than standard thermal ablation because of higher PFA equipment prices. For better or worse, US patients are not directly affected by the higher procedural costs. But the fact remains that PFA adds more costs to the healthcare system. 
 

What Drives the Enthusiasm for First-Generation PFA? 

So why all the enthusiasm? It’s surely not the empirical data. Evidence thus far shows no obvious advantage in safety or efficacy. European use of PFA does seem to reduce procedure time. But in many electrophysiology labs in the United States, the rate-limiting step for AF ablation is not time in the lab but having enough staff to turn rooms around.

The main factor driving early acceptance of PFA relates to basic human nature. It is the fear of missing out. Marketing works on consumers, and it surely works on doctors. Companies that make PFA systems sponsor key opinion leaders to discuss PFA. These companies have beautiful booths in the expo of our meetings; they host dinners and talks. When a hospital in a city does PFA, the other hospitals feel the urge to keep up. It’s hard to be a Top Person in electrophysiology and not be a PFA user. 

One of my favorite comments came from a key opinion leader. He told me that he advised his administration to buy a PFA system, promote that they have it, and keep it in the closet until better systems are released. 

Iteration in the medical device field is tricky. There are negatives to being too harsh on first-generation systems. Early cardiac resynchronization tools, for instance, were horrible. Now CRT is transformative in selected patients with heart failure

It’s possible (but not certain) that electrical ablative therapy will iterate and surpass thermal ablation in the future. Maybe. 

But for now, the enthusiasm for PFA far outstrips its evidence. Until better evidence emerges, I will be a slow adopter. And I hope that our field gathers evidence before widespread adoption makes it impossible to do proper studies. 
 

Dr. Mandrola, clinical electrophysiologist, Baptist Medical Associates, Louisville, Kentucky, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Primary Care Internal Medicine Is Dead

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Thu, 08/22/2024 - 19:03
An autobiographical story that affects us all

 

Editor’s Note: This piece was originally published in Dr. Glasser’s bimonthly column in The Jolt, a nonprofit online news organization based in Olympia, Washington. She was inspired to write her story after meeting Christine Laine, MD, one of three female physician presenters at the Sommer Lectures in Portland, Oregon, in May 2024. The article has been edited lightly from the original

Primary care internal medicine — the medical field I chose, loved, and practiced for four decades — is dead. 

The grief and shock I feel about this is personal and transpersonal. The loss of internists (internal medicine physicians) practicing primary care is a major loss to us all. 

From the 1970s to roughly 2020, there were three groups of primary care physicians: family practice, pediatricians, and internists. In their 3-year residencies (after 4 years of medical school), pediatricians trained to care for children and adolescents; internists for adults; and FPs for children, adults, and women and pregnancy. Family practitioners are the most general of the generalists, whereas the others’ training involves comprehensive care of complex patients in their age groups.

How and when the field of primary care internal medicine flourished is my story. 

I was one of those kids who was hyperfocused on science, math, and the human body. By the end of high school, I was considering medicine for my career. 

To learn more, I volunteered at the local hospital. In my typical style, I requested not to be one of those candy stripers serving drinks on the wards. Instead, they put me in the emergency department, where I would transport patients and clean the stretchers. There I was free to watch whatever was going on if I did not interfere with the staff. On my first shift, a 20-year-old drowning victim arrived by ambulance. I watched the entire unsuccessful resuscitation and as shocked and saddened as I was, I knew (in the way only a headstrong 18-year-old can) that medicine was for me. 

It was a fortuitous time to graduate as a female pre-med student. 

In 1975, our country was in the midst of the women’s movement and a national effort to train primary care physicians. I was accepted to my state medical school. The University of Massachusetts Medical School had been established a few years earlier, with its main purpose to train primary care physicians and spread them around the state (especially out of the Boston metropolitan area). The curriculum was designed to expose students to primary care from year one. I was assigned to shadow a general practice physician in inner-city Springfield who saw over 50 patients a day! The patients knew they could see and afford him, so they crammed into his waiting room until their name was called in order of their arrival. No appointments necessary. His chart notes were a few scribbled sentences. I didn’t see myself in that practice exactly, but his work ethic and dedication inspired me. 

Over half of our graduating class chose to train in primary care specialties, and most stayed in-state. It turned out to be a good bet on the part of the government of Massachusetts. 

When I applied for residency in 1980, several internal medicine programs had a focus on primary care, which was my goal. I matched at Providence St. Vincent Hospital in Portland, Oregon, and moved across the country to the Pacific Northwest, never to look back. There, my attendings were doctors like I wanted to be: primary care internists in the community, not in academia. It was the perfect choice and an excellent training program. 

In 1984, I hung out my private practice internal medicine shingle in Hillsboro, Oregon, across the street from the community hospital. My primary care internal medicine colleagues and I shared weekend calls and admitted and cared for our patients in the hospital, and when they were discharged. That is now called “continuity of care.” It was a time when we ate in the doctors’ lounge together, met in hallways, and informally consulted each other about our patients. These were called “curbside consults.” They were invaluable to our ability to provide comprehensive care to our patients in primary care, led to fewer specialty referrals, and were free. That would now be called interprofessional communication and collegiality. 

“Burnout” was not a word you heard. We were busy and happy doing what we had spent 12 years of our precious youth to prepare for. 

What did internists offer to primary care? That also is part of my story. 

When I moved to Olympia, I took a position in the women’s health clinic at the American Lake Veterans Administration Medical Center. 

We were a small group: two family practice doctors, three nurse practitioners, and me, the only internist. Many of our patients were sick and complex. Two of the nurse practitioners (NPs) asked me to take their most complicated patients. Being comfortable with complexity as an internist, I said yes. 

One of the NPs was inappropriately hired, as she had experience in women’s health. She came to me freaked out: “Oh my God, I have no idea how to manage COPD!” The other wanted simpler patients. I don’t blame them for the patient transfers. NPs typically have 3 years of training before they practice, in contrast to primary care physicians’ 8. 

Guess who made friends with the custodian, staying until 8 p.m. most evenings, and who left by 5:30 p.m. 

What was I doing in those extra hours? I was trudging through clerical, yet important, tasks my medical assistant and transcriptionist used to do in private practice. In the 30 minutes allotted for the patient, I needed to focus entirely on them and their multiple complex medical problems. 

What is lost with the death of primary care internal medicine? 

At the recent Sommer Memorial Lectures in Portland, Steven D. Freer, MD, the current director of the residency program where I trained, has not had a single of his eight annual internal medicine graduates choose primary care in several years. Half (two of four) of those in my year did: One went to Tillamook, an underserved area on the Oregon coast, and I to Hillsboro. 

What are internal medicine training graduates doing now? They are becoming hospitalists or, more often, specialists in cardiology, pulmonology, nephrology, oncology, and other more lucrative fields of medicine. 

Why are they not choosing primary care? As when the University of Massachusetts Medical School was established, a shortage of primary care physicians persists and probably is more severe than it was in the 1970s. Massachusetts was proactive. We are already years behind catching up. The shortage is no longer in rural areas alone. 

Christine Laine, MD, who is editor in chief of Annals of Internal Medicine and spoke at the Sommer Memorial Lectures, lives in Philadelphia. Even there, she has lost her own primary care internal medicine physician and cannot find another primary care physician (much less an internist) for herself. 

Washington State, where I live, scores a D grade for our primary care staffing statewide. 

Is there hope for the future of primary care in general? Or for the restoration of primary care internal medicine? 

Maybe. I was relieved to hear from Dr. Freer and Dr. Laine that efforts are beginning to revive the field. 

Just like internists’ patients, the potential restoration of the field will be complex and multilayered. It will require new laws, policies, residency programs, and incentives for students, including debt reduction. Administrative burdens will need to be reduced; de-corporatization and restoring healthcare leadership to those with in-depth medical training will need to be a part of the solution as well. 

Let’s all hope the new resuscitation efforts will be successful for the field of primary care in general and primary care internal medicine specifically. It will be good for healthcare and for your patients! 

Many work for large systems in which they feel powerless to effect change.

Dr. Glasser is a retired internal medicine physician in Olympia, Washington. She can be reached at [email protected].

A version of this article appeared on Medscape.com.

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An autobiographical story that affects us all
An autobiographical story that affects us all

 

Editor’s Note: This piece was originally published in Dr. Glasser’s bimonthly column in The Jolt, a nonprofit online news organization based in Olympia, Washington. She was inspired to write her story after meeting Christine Laine, MD, one of three female physician presenters at the Sommer Lectures in Portland, Oregon, in May 2024. The article has been edited lightly from the original

Primary care internal medicine — the medical field I chose, loved, and practiced for four decades — is dead. 

The grief and shock I feel about this is personal and transpersonal. The loss of internists (internal medicine physicians) practicing primary care is a major loss to us all. 

From the 1970s to roughly 2020, there were three groups of primary care physicians: family practice, pediatricians, and internists. In their 3-year residencies (after 4 years of medical school), pediatricians trained to care for children and adolescents; internists for adults; and FPs for children, adults, and women and pregnancy. Family practitioners are the most general of the generalists, whereas the others’ training involves comprehensive care of complex patients in their age groups.

How and when the field of primary care internal medicine flourished is my story. 

I was one of those kids who was hyperfocused on science, math, and the human body. By the end of high school, I was considering medicine for my career. 

To learn more, I volunteered at the local hospital. In my typical style, I requested not to be one of those candy stripers serving drinks on the wards. Instead, they put me in the emergency department, where I would transport patients and clean the stretchers. There I was free to watch whatever was going on if I did not interfere with the staff. On my first shift, a 20-year-old drowning victim arrived by ambulance. I watched the entire unsuccessful resuscitation and as shocked and saddened as I was, I knew (in the way only a headstrong 18-year-old can) that medicine was for me. 

It was a fortuitous time to graduate as a female pre-med student. 

In 1975, our country was in the midst of the women’s movement and a national effort to train primary care physicians. I was accepted to my state medical school. The University of Massachusetts Medical School had been established a few years earlier, with its main purpose to train primary care physicians and spread them around the state (especially out of the Boston metropolitan area). The curriculum was designed to expose students to primary care from year one. I was assigned to shadow a general practice physician in inner-city Springfield who saw over 50 patients a day! The patients knew they could see and afford him, so they crammed into his waiting room until their name was called in order of their arrival. No appointments necessary. His chart notes were a few scribbled sentences. I didn’t see myself in that practice exactly, but his work ethic and dedication inspired me. 

Over half of our graduating class chose to train in primary care specialties, and most stayed in-state. It turned out to be a good bet on the part of the government of Massachusetts. 

When I applied for residency in 1980, several internal medicine programs had a focus on primary care, which was my goal. I matched at Providence St. Vincent Hospital in Portland, Oregon, and moved across the country to the Pacific Northwest, never to look back. There, my attendings were doctors like I wanted to be: primary care internists in the community, not in academia. It was the perfect choice and an excellent training program. 

In 1984, I hung out my private practice internal medicine shingle in Hillsboro, Oregon, across the street from the community hospital. My primary care internal medicine colleagues and I shared weekend calls and admitted and cared for our patients in the hospital, and when they were discharged. That is now called “continuity of care.” It was a time when we ate in the doctors’ lounge together, met in hallways, and informally consulted each other about our patients. These were called “curbside consults.” They were invaluable to our ability to provide comprehensive care to our patients in primary care, led to fewer specialty referrals, and were free. That would now be called interprofessional communication and collegiality. 

“Burnout” was not a word you heard. We were busy and happy doing what we had spent 12 years of our precious youth to prepare for. 

What did internists offer to primary care? That also is part of my story. 

When I moved to Olympia, I took a position in the women’s health clinic at the American Lake Veterans Administration Medical Center. 

We were a small group: two family practice doctors, three nurse practitioners, and me, the only internist. Many of our patients were sick and complex. Two of the nurse practitioners (NPs) asked me to take their most complicated patients. Being comfortable with complexity as an internist, I said yes. 

One of the NPs was inappropriately hired, as she had experience in women’s health. She came to me freaked out: “Oh my God, I have no idea how to manage COPD!” The other wanted simpler patients. I don’t blame them for the patient transfers. NPs typically have 3 years of training before they practice, in contrast to primary care physicians’ 8. 

Guess who made friends with the custodian, staying until 8 p.m. most evenings, and who left by 5:30 p.m. 

What was I doing in those extra hours? I was trudging through clerical, yet important, tasks my medical assistant and transcriptionist used to do in private practice. In the 30 minutes allotted for the patient, I needed to focus entirely on them and their multiple complex medical problems. 

What is lost with the death of primary care internal medicine? 

At the recent Sommer Memorial Lectures in Portland, Steven D. Freer, MD, the current director of the residency program where I trained, has not had a single of his eight annual internal medicine graduates choose primary care in several years. Half (two of four) of those in my year did: One went to Tillamook, an underserved area on the Oregon coast, and I to Hillsboro. 

What are internal medicine training graduates doing now? They are becoming hospitalists or, more often, specialists in cardiology, pulmonology, nephrology, oncology, and other more lucrative fields of medicine. 

Why are they not choosing primary care? As when the University of Massachusetts Medical School was established, a shortage of primary care physicians persists and probably is more severe than it was in the 1970s. Massachusetts was proactive. We are already years behind catching up. The shortage is no longer in rural areas alone. 

Christine Laine, MD, who is editor in chief of Annals of Internal Medicine and spoke at the Sommer Memorial Lectures, lives in Philadelphia. Even there, she has lost her own primary care internal medicine physician and cannot find another primary care physician (much less an internist) for herself. 

Washington State, where I live, scores a D grade for our primary care staffing statewide. 

Is there hope for the future of primary care in general? Or for the restoration of primary care internal medicine? 

Maybe. I was relieved to hear from Dr. Freer and Dr. Laine that efforts are beginning to revive the field. 

Just like internists’ patients, the potential restoration of the field will be complex and multilayered. It will require new laws, policies, residency programs, and incentives for students, including debt reduction. Administrative burdens will need to be reduced; de-corporatization and restoring healthcare leadership to those with in-depth medical training will need to be a part of the solution as well. 

Let’s all hope the new resuscitation efforts will be successful for the field of primary care in general and primary care internal medicine specifically. It will be good for healthcare and for your patients! 

Many work for large systems in which they feel powerless to effect change.

Dr. Glasser is a retired internal medicine physician in Olympia, Washington. She can be reached at [email protected].

A version of this article appeared on Medscape.com.

 

Editor’s Note: This piece was originally published in Dr. Glasser’s bimonthly column in The Jolt, a nonprofit online news organization based in Olympia, Washington. She was inspired to write her story after meeting Christine Laine, MD, one of three female physician presenters at the Sommer Lectures in Portland, Oregon, in May 2024. The article has been edited lightly from the original

Primary care internal medicine — the medical field I chose, loved, and practiced for four decades — is dead. 

The grief and shock I feel about this is personal and transpersonal. The loss of internists (internal medicine physicians) practicing primary care is a major loss to us all. 

From the 1970s to roughly 2020, there were three groups of primary care physicians: family practice, pediatricians, and internists. In their 3-year residencies (after 4 years of medical school), pediatricians trained to care for children and adolescents; internists for adults; and FPs for children, adults, and women and pregnancy. Family practitioners are the most general of the generalists, whereas the others’ training involves comprehensive care of complex patients in their age groups.

How and when the field of primary care internal medicine flourished is my story. 

I was one of those kids who was hyperfocused on science, math, and the human body. By the end of high school, I was considering medicine for my career. 

To learn more, I volunteered at the local hospital. In my typical style, I requested not to be one of those candy stripers serving drinks on the wards. Instead, they put me in the emergency department, where I would transport patients and clean the stretchers. There I was free to watch whatever was going on if I did not interfere with the staff. On my first shift, a 20-year-old drowning victim arrived by ambulance. I watched the entire unsuccessful resuscitation and as shocked and saddened as I was, I knew (in the way only a headstrong 18-year-old can) that medicine was for me. 

It was a fortuitous time to graduate as a female pre-med student. 

In 1975, our country was in the midst of the women’s movement and a national effort to train primary care physicians. I was accepted to my state medical school. The University of Massachusetts Medical School had been established a few years earlier, with its main purpose to train primary care physicians and spread them around the state (especially out of the Boston metropolitan area). The curriculum was designed to expose students to primary care from year one. I was assigned to shadow a general practice physician in inner-city Springfield who saw over 50 patients a day! The patients knew they could see and afford him, so they crammed into his waiting room until their name was called in order of their arrival. No appointments necessary. His chart notes were a few scribbled sentences. I didn’t see myself in that practice exactly, but his work ethic and dedication inspired me. 

Over half of our graduating class chose to train in primary care specialties, and most stayed in-state. It turned out to be a good bet on the part of the government of Massachusetts. 

When I applied for residency in 1980, several internal medicine programs had a focus on primary care, which was my goal. I matched at Providence St. Vincent Hospital in Portland, Oregon, and moved across the country to the Pacific Northwest, never to look back. There, my attendings were doctors like I wanted to be: primary care internists in the community, not in academia. It was the perfect choice and an excellent training program. 

In 1984, I hung out my private practice internal medicine shingle in Hillsboro, Oregon, across the street from the community hospital. My primary care internal medicine colleagues and I shared weekend calls and admitted and cared for our patients in the hospital, and when they were discharged. That is now called “continuity of care.” It was a time when we ate in the doctors’ lounge together, met in hallways, and informally consulted each other about our patients. These were called “curbside consults.” They were invaluable to our ability to provide comprehensive care to our patients in primary care, led to fewer specialty referrals, and were free. That would now be called interprofessional communication and collegiality. 

“Burnout” was not a word you heard. We were busy and happy doing what we had spent 12 years of our precious youth to prepare for. 

What did internists offer to primary care? That also is part of my story. 

When I moved to Olympia, I took a position in the women’s health clinic at the American Lake Veterans Administration Medical Center. 

We were a small group: two family practice doctors, three nurse practitioners, and me, the only internist. Many of our patients were sick and complex. Two of the nurse practitioners (NPs) asked me to take their most complicated patients. Being comfortable with complexity as an internist, I said yes. 

One of the NPs was inappropriately hired, as she had experience in women’s health. She came to me freaked out: “Oh my God, I have no idea how to manage COPD!” The other wanted simpler patients. I don’t blame them for the patient transfers. NPs typically have 3 years of training before they practice, in contrast to primary care physicians’ 8. 

Guess who made friends with the custodian, staying until 8 p.m. most evenings, and who left by 5:30 p.m. 

What was I doing in those extra hours? I was trudging through clerical, yet important, tasks my medical assistant and transcriptionist used to do in private practice. In the 30 minutes allotted for the patient, I needed to focus entirely on them and their multiple complex medical problems. 

What is lost with the death of primary care internal medicine? 

At the recent Sommer Memorial Lectures in Portland, Steven D. Freer, MD, the current director of the residency program where I trained, has not had a single of his eight annual internal medicine graduates choose primary care in several years. Half (two of four) of those in my year did: One went to Tillamook, an underserved area on the Oregon coast, and I to Hillsboro. 

What are internal medicine training graduates doing now? They are becoming hospitalists or, more often, specialists in cardiology, pulmonology, nephrology, oncology, and other more lucrative fields of medicine. 

Why are they not choosing primary care? As when the University of Massachusetts Medical School was established, a shortage of primary care physicians persists and probably is more severe than it was in the 1970s. Massachusetts was proactive. We are already years behind catching up. The shortage is no longer in rural areas alone. 

Christine Laine, MD, who is editor in chief of Annals of Internal Medicine and spoke at the Sommer Memorial Lectures, lives in Philadelphia. Even there, she has lost her own primary care internal medicine physician and cannot find another primary care physician (much less an internist) for herself. 

Washington State, where I live, scores a D grade for our primary care staffing statewide. 

Is there hope for the future of primary care in general? Or for the restoration of primary care internal medicine? 

Maybe. I was relieved to hear from Dr. Freer and Dr. Laine that efforts are beginning to revive the field. 

Just like internists’ patients, the potential restoration of the field will be complex and multilayered. It will require new laws, policies, residency programs, and incentives for students, including debt reduction. Administrative burdens will need to be reduced; de-corporatization and restoring healthcare leadership to those with in-depth medical training will need to be a part of the solution as well. 

Let’s all hope the new resuscitation efforts will be successful for the field of primary care in general and primary care internal medicine specifically. It will be good for healthcare and for your patients! 

Many work for large systems in which they feel powerless to effect change.

Dr. Glasser is a retired internal medicine physician in Olympia, Washington. She can be reached at [email protected].

A version of this article appeared on Medscape.com.

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Can Diabetes Lead to a False-Positive Alcohol Test?

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This transcript has been edited for clarity. 
 

I’m going to tell you the story of two patients with diabetes who had false-positive alcohol tests. 

The first patient is a patient of mine with type 1 diabetes. He was in a car accident. He hit the car in front of him that hit the car in front of them. Because the cars were quite damaged, the police were summoned. 

At the scene, he had a breathalyzer test. He flunked the breathalyzer test, and he was charged with a DUI. The woman in the middle car got out of her car and said her neck hurt. This then rose this to the level of a DUI with injury to one of the other people, and my patient was charged with a felony. He was taken to jail. 

He told them at the scene and at the jail that he had type 1 diabetes. The reason this is so important is because type 1 diabetes can cause a false-positive breathalyzer test. In particular, this patient of mine had not been eating all day long. He’d been getting his basal insulin through the pump, but he had not given any bolus doses of insulin. He was actually quite ketotic.

When he was put in jail, they took away his cell phone so he could no longer see his glucose levels, and they took away the controller for his Omnipod system. He basically had no way to give bolus doses of insulin. Fortunately, the Omnipod system lasted for a day and a half just by giving him basal. The jail physicians did not give him insulin until he’d been in jail for 3 days. 

This is someone with type 1 diabetes, and their protocol for insulin has something to do with high glucose levels and giving something like a sliding scale of insulin. They were not really prepared for managing somebody with type 1 diabetes who was on an automated insulin delivery system. 

I, along with my patient’s parents, worked very hard to get the jail doctors to finally give him Lantus. Inherent in all of this, it made me aware of a number of different issues. The first is that breathalyzer tests can be falsely positive in people with type 1 diabetes if they are ketotic; therefore, people with type 1 diabetes should ask for a blood test to test their alcohol levels if they think it could be a false positive. 

Second, we need to actually figure out a way to help people with type 1 diabetes who happen to be in jail or in prison because if they don’t have access to a smartphone, they’re not going to be able to run their devices. We need to make sure that devices have receivers that can be used, particularly continuous glucose monitors (CGMs), because CGM is the standard of care for patients and should be so for people who are incarcerated. 

The second case is much shorter and isn’t mine, but it was a letter in The New England Journal of Medicine about a man who was on probation, who was having urine tests to show that he had not been consuming alcohol. He was started on empagliflozin, which, interestingly, made his urine test become falsely positive. 

Why? Well, it’s thought it’s because it caused fermentation of the sugar with the bacteria that was in his urine because the people who were processing the sample hadn’t done it correctly, and they kept it out at room temperature for a prolonged period of time before testing it. The urine samples should be kept refrigerated to prevent this from happening. 

These are two people who had false-positive tests because they had diabetes. I think it’s important that we realize that this can happen, and we need to help our patients deal with these situations.

Dr. Peters is professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.

A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity. 
 

I’m going to tell you the story of two patients with diabetes who had false-positive alcohol tests. 

The first patient is a patient of mine with type 1 diabetes. He was in a car accident. He hit the car in front of him that hit the car in front of them. Because the cars were quite damaged, the police were summoned. 

At the scene, he had a breathalyzer test. He flunked the breathalyzer test, and he was charged with a DUI. The woman in the middle car got out of her car and said her neck hurt. This then rose this to the level of a DUI with injury to one of the other people, and my patient was charged with a felony. He was taken to jail. 

He told them at the scene and at the jail that he had type 1 diabetes. The reason this is so important is because type 1 diabetes can cause a false-positive breathalyzer test. In particular, this patient of mine had not been eating all day long. He’d been getting his basal insulin through the pump, but he had not given any bolus doses of insulin. He was actually quite ketotic.

When he was put in jail, they took away his cell phone so he could no longer see his glucose levels, and they took away the controller for his Omnipod system. He basically had no way to give bolus doses of insulin. Fortunately, the Omnipod system lasted for a day and a half just by giving him basal. The jail physicians did not give him insulin until he’d been in jail for 3 days. 

This is someone with type 1 diabetes, and their protocol for insulin has something to do with high glucose levels and giving something like a sliding scale of insulin. They were not really prepared for managing somebody with type 1 diabetes who was on an automated insulin delivery system. 

I, along with my patient’s parents, worked very hard to get the jail doctors to finally give him Lantus. Inherent in all of this, it made me aware of a number of different issues. The first is that breathalyzer tests can be falsely positive in people with type 1 diabetes if they are ketotic; therefore, people with type 1 diabetes should ask for a blood test to test their alcohol levels if they think it could be a false positive. 

Second, we need to actually figure out a way to help people with type 1 diabetes who happen to be in jail or in prison because if they don’t have access to a smartphone, they’re not going to be able to run their devices. We need to make sure that devices have receivers that can be used, particularly continuous glucose monitors (CGMs), because CGM is the standard of care for patients and should be so for people who are incarcerated. 

The second case is much shorter and isn’t mine, but it was a letter in The New England Journal of Medicine about a man who was on probation, who was having urine tests to show that he had not been consuming alcohol. He was started on empagliflozin, which, interestingly, made his urine test become falsely positive. 

Why? Well, it’s thought it’s because it caused fermentation of the sugar with the bacteria that was in his urine because the people who were processing the sample hadn’t done it correctly, and they kept it out at room temperature for a prolonged period of time before testing it. The urine samples should be kept refrigerated to prevent this from happening. 

These are two people who had false-positive tests because they had diabetes. I think it’s important that we realize that this can happen, and we need to help our patients deal with these situations.

Dr. Peters is professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 
 

I’m going to tell you the story of two patients with diabetes who had false-positive alcohol tests. 

The first patient is a patient of mine with type 1 diabetes. He was in a car accident. He hit the car in front of him that hit the car in front of them. Because the cars were quite damaged, the police were summoned. 

At the scene, he had a breathalyzer test. He flunked the breathalyzer test, and he was charged with a DUI. The woman in the middle car got out of her car and said her neck hurt. This then rose this to the level of a DUI with injury to one of the other people, and my patient was charged with a felony. He was taken to jail. 

He told them at the scene and at the jail that he had type 1 diabetes. The reason this is so important is because type 1 diabetes can cause a false-positive breathalyzer test. In particular, this patient of mine had not been eating all day long. He’d been getting his basal insulin through the pump, but he had not given any bolus doses of insulin. He was actually quite ketotic.

When he was put in jail, they took away his cell phone so he could no longer see his glucose levels, and they took away the controller for his Omnipod system. He basically had no way to give bolus doses of insulin. Fortunately, the Omnipod system lasted for a day and a half just by giving him basal. The jail physicians did not give him insulin until he’d been in jail for 3 days. 

This is someone with type 1 diabetes, and their protocol for insulin has something to do with high glucose levels and giving something like a sliding scale of insulin. They were not really prepared for managing somebody with type 1 diabetes who was on an automated insulin delivery system. 

I, along with my patient’s parents, worked very hard to get the jail doctors to finally give him Lantus. Inherent in all of this, it made me aware of a number of different issues. The first is that breathalyzer tests can be falsely positive in people with type 1 diabetes if they are ketotic; therefore, people with type 1 diabetes should ask for a blood test to test their alcohol levels if they think it could be a false positive. 

Second, we need to actually figure out a way to help people with type 1 diabetes who happen to be in jail or in prison because if they don’t have access to a smartphone, they’re not going to be able to run their devices. We need to make sure that devices have receivers that can be used, particularly continuous glucose monitors (CGMs), because CGM is the standard of care for patients and should be so for people who are incarcerated. 

The second case is much shorter and isn’t mine, but it was a letter in The New England Journal of Medicine about a man who was on probation, who was having urine tests to show that he had not been consuming alcohol. He was started on empagliflozin, which, interestingly, made his urine test become falsely positive. 

Why? Well, it’s thought it’s because it caused fermentation of the sugar with the bacteria that was in his urine because the people who were processing the sample hadn’t done it correctly, and they kept it out at room temperature for a prolonged period of time before testing it. The urine samples should be kept refrigerated to prevent this from happening. 

These are two people who had false-positive tests because they had diabetes. I think it’s important that we realize that this can happen, and we need to help our patients deal with these situations.

Dr. Peters is professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.

A version of this article first appeared on Medscape.com.

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New Mid-Year Vaccine Recommendations From ACIP

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ACIP, the CDC’s Advisory Committee on Immunization Practices, met for 3 days in June. New vaccines and new recommendations for respiratory syncytial virus (RSV), flu, COVID, and a new pneumococcal vaccine were revealed.

RSV Protection

We’ll begin with RSV vaccines for adults aged 60 or older. For this group, shared clinical decision-making is out; it no longer applies. New, more specific recommendations from ACIP for RSV vaccines are both age based and risk based. The age-based recommendation applies to those aged 75 or older, who should receive a single RSV vaccine dose. If they have already received a dose under the old recommendation, they don’t need another one, at least for now.

The risk-based recommendation applies to adults from age 60 up to 75, but only for those with risk factors for severe RSV. These risk factors include lung disease, heart disease, immunocompromise, diabetes, obesity with a BMI of 40 or more, neurologic conditions, neuromuscular conditions, chronic kidney disease, liver disorders, hematologic disorders, frailty, and living in a nursing home or other long-term care facility. Those aged 60-75 with these risk factors should receive the RSV vaccine, and those without them should not receive it. The best time to get the RSV vaccine is late summer, but early fall administration with other adult vaccines is allowed and is acceptable.

Vaccine safety concerns were top of mind as ACIP members began their deliberations. Possible safety concerns for RSV vaccines have been detected for Guillain-Barré syndrome, atrial fibrillation, and idiopathic thrombocytopenic purpura. Safety surveillance updates are still interim and inconclusive. These signals still need further study and clarification. 

Two RSV vaccines have been on the market: one by Pfizer, called Abrysvo, which does not contain an adjuvant; and another one by GSK, called Arexvy, which does contain an adjuvant. With the recent FDA approval of Moderna’s new mRNA RSV vaccine, mRESVIA, there are now three RSV vaccines licensed for those 60 or older. Arexvy is now FDA approved for adults in their 50s. That just happened in early June, but ACIP doesn’t currently recommend it for this fifty-something age group, even for those at high risk for severe RSV disease. This may change with greater clarification of potential vaccine safety concerns.

There is also news about protecting babies from RSV. RSV is the most common cause of hospitalization for infants in the United States, and most hospitalizations for RSV are in healthy, full-term infants. We now have two ways to protect babies: a dose of RSV vaccine given to mom, or a dose of the long-acting monoclonal antibody nirsevimab given to the baby. ACIP clarified that those who received a dose of maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during future pregnancies, but infants born to those who were vaccinated for RSV during a prior pregnancy can receive nirsevimab, which is recommended for infants up to 8 months of age during their first RSV season, and for high-risk infants and toddlers aged 8-19 months during their second RSV season.

Last RSV season, supplies of nirsevimab were limited and doses had to be prioritized. No supply problems are anticipated for the upcoming season. A study published in March showed that nirsevimab was 90% effective at preventing RSV-associated hospitalization for infants in their first RSV season.
 

 

 

COVID

Here’s what’s new for COVID vaccines. A new-formula COVID vaccine will be ready for fall. ACIP voted unanimously to recommend a dose of the updated 2024-2025 COVID vaccine for everyone aged 6 months or older. This is a universal recommendation, just like the one we have for flu. But understand that even though COVID has waned, it’s still more deadly than flu. Most Americans now have some immunity against COVID, but this immunity wanes with time, and it also wanes as the virus keeps changing. These updated vaccines provide an incremental boost to our immunity for the new formula for fall. FDA has directed manufacturers to use a monovalent JN.1 lineage formula, with a preference for the KP.2 strain.

Older adults (aged 75 or older) and children under 6 months old are hit hardest by COVID. The littlest ones are too young to be vaccinated, but they can get protection from maternal vaccination. The uptake for last year’s COVID vaccine has been disappointing. Only 22.5% of adults and 14% of children received a dose of the updated shot. Focus-group discussions highlight the importance of a physician recommendation. Adults and children who receive a healthcare provider’s recommendation to get the COVID vaccine are more likely to get vaccinated. 
 

Pneumococcal Vaccines

On June 17, 2024, a new pneumococcal vaccine, PCV21, was FDA approved for those aged 18 or older under an accelerated-approval pathway. ACIP voted to keep it simple and recommends PCV21 as an option for adults aged 19 or older who currently have an indication to receive a dose of PCV. This new PCV21 vaccine is indicated for prevention of both invasive pneumococcal disease (IPD) and pneumococcal pneumonia. Its brand name is Capvaxive and it’s made by Merck. IPD includes bacteremia, pneumonia, pneumococcal bacteremia, and meningitis.

There are two basic types of pneumococcal vaccines: polysaccharide vaccines (PPSV), which do not produce memory B cells; and PCV conjugate vaccines, which do trigger memory B-cell production and therefore induce greater long-term immunity. PCV21 covers 11 unique serotypes not in PCV20. This is important because many cases of adult disease are caused by subtypes not covered by other FDA-approved pneumococcal vaccines. PCV21 has greater coverage of the serotypes that cause invasive disease in adults as compared with PCV20. PCV20 covers up to 58% of those strains, while PCV21 covers up to 84% of strains responsible for invasive disease in adults. But there’s one serotype missing in PCV21, which may limit the groups who receive it. PCV21 does not cover serotype 4, a major cause of IPD in certain populations. Adults experiencing homelessness are 100-300 times more likely to develop IPD due to serotype 4. So are adults in Alaska, especially Alaska Natives. They have an 88-fold increase in serotype 4 invasive disease. Serotype 4 is covered by other pneumococcal vaccines, so for these patients, PCV20 is likely a better high-valent conjugate vaccine option than PCV21.
 

Flu Vaccines

What’s new for flu? Everyone aged 6 months or older needs a seasonal flu vaccination every year. That’s not new, but there are two new things coming this fall: (1) The seasonal flu vaccine is going trivalent. FDA has removed the Yamagata flu B strain because it no longer appears to be circulating. (2) ACIP made a special off-label recommendation to boost flu protection for solid organ transplant recipients ages 18-64 who are on immunosuppressive medications. These high-risk patients now have the off-label option of receiving one of the higher-dose flu vaccines, including high-dose and adjuvanted flu vaccines, which are FDA approved only for those 65 or older.

Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for American Medical Association; Medical Association of Atlanta; ACIP liaison. Received income in an amount equal to or greater than $250 from American College of Physicians; Medscape; American Medical Association.

A version of this article first appeared on Medscape.com.

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This transcript has been edited for clarity. 

ACIP, the CDC’s Advisory Committee on Immunization Practices, met for 3 days in June. New vaccines and new recommendations for respiratory syncytial virus (RSV), flu, COVID, and a new pneumococcal vaccine were revealed.

RSV Protection

We’ll begin with RSV vaccines for adults aged 60 or older. For this group, shared clinical decision-making is out; it no longer applies. New, more specific recommendations from ACIP for RSV vaccines are both age based and risk based. The age-based recommendation applies to those aged 75 or older, who should receive a single RSV vaccine dose. If they have already received a dose under the old recommendation, they don’t need another one, at least for now.

The risk-based recommendation applies to adults from age 60 up to 75, but only for those with risk factors for severe RSV. These risk factors include lung disease, heart disease, immunocompromise, diabetes, obesity with a BMI of 40 or more, neurologic conditions, neuromuscular conditions, chronic kidney disease, liver disorders, hematologic disorders, frailty, and living in a nursing home or other long-term care facility. Those aged 60-75 with these risk factors should receive the RSV vaccine, and those without them should not receive it. The best time to get the RSV vaccine is late summer, but early fall administration with other adult vaccines is allowed and is acceptable.

Vaccine safety concerns were top of mind as ACIP members began their deliberations. Possible safety concerns for RSV vaccines have been detected for Guillain-Barré syndrome, atrial fibrillation, and idiopathic thrombocytopenic purpura. Safety surveillance updates are still interim and inconclusive. These signals still need further study and clarification. 

Two RSV vaccines have been on the market: one by Pfizer, called Abrysvo, which does not contain an adjuvant; and another one by GSK, called Arexvy, which does contain an adjuvant. With the recent FDA approval of Moderna’s new mRNA RSV vaccine, mRESVIA, there are now three RSV vaccines licensed for those 60 or older. Arexvy is now FDA approved for adults in their 50s. That just happened in early June, but ACIP doesn’t currently recommend it for this fifty-something age group, even for those at high risk for severe RSV disease. This may change with greater clarification of potential vaccine safety concerns.

There is also news about protecting babies from RSV. RSV is the most common cause of hospitalization for infants in the United States, and most hospitalizations for RSV are in healthy, full-term infants. We now have two ways to protect babies: a dose of RSV vaccine given to mom, or a dose of the long-acting monoclonal antibody nirsevimab given to the baby. ACIP clarified that those who received a dose of maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during future pregnancies, but infants born to those who were vaccinated for RSV during a prior pregnancy can receive nirsevimab, which is recommended for infants up to 8 months of age during their first RSV season, and for high-risk infants and toddlers aged 8-19 months during their second RSV season.

Last RSV season, supplies of nirsevimab were limited and doses had to be prioritized. No supply problems are anticipated for the upcoming season. A study published in March showed that nirsevimab was 90% effective at preventing RSV-associated hospitalization for infants in their first RSV season.
 

 

 

COVID

Here’s what’s new for COVID vaccines. A new-formula COVID vaccine will be ready for fall. ACIP voted unanimously to recommend a dose of the updated 2024-2025 COVID vaccine for everyone aged 6 months or older. This is a universal recommendation, just like the one we have for flu. But understand that even though COVID has waned, it’s still more deadly than flu. Most Americans now have some immunity against COVID, but this immunity wanes with time, and it also wanes as the virus keeps changing. These updated vaccines provide an incremental boost to our immunity for the new formula for fall. FDA has directed manufacturers to use a monovalent JN.1 lineage formula, with a preference for the KP.2 strain.

Older adults (aged 75 or older) and children under 6 months old are hit hardest by COVID. The littlest ones are too young to be vaccinated, but they can get protection from maternal vaccination. The uptake for last year’s COVID vaccine has been disappointing. Only 22.5% of adults and 14% of children received a dose of the updated shot. Focus-group discussions highlight the importance of a physician recommendation. Adults and children who receive a healthcare provider’s recommendation to get the COVID vaccine are more likely to get vaccinated. 
 

Pneumococcal Vaccines

On June 17, 2024, a new pneumococcal vaccine, PCV21, was FDA approved for those aged 18 or older under an accelerated-approval pathway. ACIP voted to keep it simple and recommends PCV21 as an option for adults aged 19 or older who currently have an indication to receive a dose of PCV. This new PCV21 vaccine is indicated for prevention of both invasive pneumococcal disease (IPD) and pneumococcal pneumonia. Its brand name is Capvaxive and it’s made by Merck. IPD includes bacteremia, pneumonia, pneumococcal bacteremia, and meningitis.

There are two basic types of pneumococcal vaccines: polysaccharide vaccines (PPSV), which do not produce memory B cells; and PCV conjugate vaccines, which do trigger memory B-cell production and therefore induce greater long-term immunity. PCV21 covers 11 unique serotypes not in PCV20. This is important because many cases of adult disease are caused by subtypes not covered by other FDA-approved pneumococcal vaccines. PCV21 has greater coverage of the serotypes that cause invasive disease in adults as compared with PCV20. PCV20 covers up to 58% of those strains, while PCV21 covers up to 84% of strains responsible for invasive disease in adults. But there’s one serotype missing in PCV21, which may limit the groups who receive it. PCV21 does not cover serotype 4, a major cause of IPD in certain populations. Adults experiencing homelessness are 100-300 times more likely to develop IPD due to serotype 4. So are adults in Alaska, especially Alaska Natives. They have an 88-fold increase in serotype 4 invasive disease. Serotype 4 is covered by other pneumococcal vaccines, so for these patients, PCV20 is likely a better high-valent conjugate vaccine option than PCV21.
 

Flu Vaccines

What’s new for flu? Everyone aged 6 months or older needs a seasonal flu vaccination every year. That’s not new, but there are two new things coming this fall: (1) The seasonal flu vaccine is going trivalent. FDA has removed the Yamagata flu B strain because it no longer appears to be circulating. (2) ACIP made a special off-label recommendation to boost flu protection for solid organ transplant recipients ages 18-64 who are on immunosuppressive medications. These high-risk patients now have the off-label option of receiving one of the higher-dose flu vaccines, including high-dose and adjuvanted flu vaccines, which are FDA approved only for those 65 or older.

Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for American Medical Association; Medical Association of Atlanta; ACIP liaison. Received income in an amount equal to or greater than $250 from American College of Physicians; Medscape; American Medical Association.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

ACIP, the CDC’s Advisory Committee on Immunization Practices, met for 3 days in June. New vaccines and new recommendations for respiratory syncytial virus (RSV), flu, COVID, and a new pneumococcal vaccine were revealed.

RSV Protection

We’ll begin with RSV vaccines for adults aged 60 or older. For this group, shared clinical decision-making is out; it no longer applies. New, more specific recommendations from ACIP for RSV vaccines are both age based and risk based. The age-based recommendation applies to those aged 75 or older, who should receive a single RSV vaccine dose. If they have already received a dose under the old recommendation, they don’t need another one, at least for now.

The risk-based recommendation applies to adults from age 60 up to 75, but only for those with risk factors for severe RSV. These risk factors include lung disease, heart disease, immunocompromise, diabetes, obesity with a BMI of 40 or more, neurologic conditions, neuromuscular conditions, chronic kidney disease, liver disorders, hematologic disorders, frailty, and living in a nursing home or other long-term care facility. Those aged 60-75 with these risk factors should receive the RSV vaccine, and those without them should not receive it. The best time to get the RSV vaccine is late summer, but early fall administration with other adult vaccines is allowed and is acceptable.

Vaccine safety concerns were top of mind as ACIP members began their deliberations. Possible safety concerns for RSV vaccines have been detected for Guillain-Barré syndrome, atrial fibrillation, and idiopathic thrombocytopenic purpura. Safety surveillance updates are still interim and inconclusive. These signals still need further study and clarification. 

Two RSV vaccines have been on the market: one by Pfizer, called Abrysvo, which does not contain an adjuvant; and another one by GSK, called Arexvy, which does contain an adjuvant. With the recent FDA approval of Moderna’s new mRNA RSV vaccine, mRESVIA, there are now three RSV vaccines licensed for those 60 or older. Arexvy is now FDA approved for adults in their 50s. That just happened in early June, but ACIP doesn’t currently recommend it for this fifty-something age group, even for those at high risk for severe RSV disease. This may change with greater clarification of potential vaccine safety concerns.

There is also news about protecting babies from RSV. RSV is the most common cause of hospitalization for infants in the United States, and most hospitalizations for RSV are in healthy, full-term infants. We now have two ways to protect babies: a dose of RSV vaccine given to mom, or a dose of the long-acting monoclonal antibody nirsevimab given to the baby. ACIP clarified that those who received a dose of maternal RSV vaccine during a previous pregnancy are not recommended to receive additional doses during future pregnancies, but infants born to those who were vaccinated for RSV during a prior pregnancy can receive nirsevimab, which is recommended for infants up to 8 months of age during their first RSV season, and for high-risk infants and toddlers aged 8-19 months during their second RSV season.

Last RSV season, supplies of nirsevimab were limited and doses had to be prioritized. No supply problems are anticipated for the upcoming season. A study published in March showed that nirsevimab was 90% effective at preventing RSV-associated hospitalization for infants in their first RSV season.
 

 

 

COVID

Here’s what’s new for COVID vaccines. A new-formula COVID vaccine will be ready for fall. ACIP voted unanimously to recommend a dose of the updated 2024-2025 COVID vaccine for everyone aged 6 months or older. This is a universal recommendation, just like the one we have for flu. But understand that even though COVID has waned, it’s still more deadly than flu. Most Americans now have some immunity against COVID, but this immunity wanes with time, and it also wanes as the virus keeps changing. These updated vaccines provide an incremental boost to our immunity for the new formula for fall. FDA has directed manufacturers to use a monovalent JN.1 lineage formula, with a preference for the KP.2 strain.

Older adults (aged 75 or older) and children under 6 months old are hit hardest by COVID. The littlest ones are too young to be vaccinated, but they can get protection from maternal vaccination. The uptake for last year’s COVID vaccine has been disappointing. Only 22.5% of adults and 14% of children received a dose of the updated shot. Focus-group discussions highlight the importance of a physician recommendation. Adults and children who receive a healthcare provider’s recommendation to get the COVID vaccine are more likely to get vaccinated. 
 

Pneumococcal Vaccines

On June 17, 2024, a new pneumococcal vaccine, PCV21, was FDA approved for those aged 18 or older under an accelerated-approval pathway. ACIP voted to keep it simple and recommends PCV21 as an option for adults aged 19 or older who currently have an indication to receive a dose of PCV. This new PCV21 vaccine is indicated for prevention of both invasive pneumococcal disease (IPD) and pneumococcal pneumonia. Its brand name is Capvaxive and it’s made by Merck. IPD includes bacteremia, pneumonia, pneumococcal bacteremia, and meningitis.

There are two basic types of pneumococcal vaccines: polysaccharide vaccines (PPSV), which do not produce memory B cells; and PCV conjugate vaccines, which do trigger memory B-cell production and therefore induce greater long-term immunity. PCV21 covers 11 unique serotypes not in PCV20. This is important because many cases of adult disease are caused by subtypes not covered by other FDA-approved pneumococcal vaccines. PCV21 has greater coverage of the serotypes that cause invasive disease in adults as compared with PCV20. PCV20 covers up to 58% of those strains, while PCV21 covers up to 84% of strains responsible for invasive disease in adults. But there’s one serotype missing in PCV21, which may limit the groups who receive it. PCV21 does not cover serotype 4, a major cause of IPD in certain populations. Adults experiencing homelessness are 100-300 times more likely to develop IPD due to serotype 4. So are adults in Alaska, especially Alaska Natives. They have an 88-fold increase in serotype 4 invasive disease. Serotype 4 is covered by other pneumococcal vaccines, so for these patients, PCV20 is likely a better high-valent conjugate vaccine option than PCV21.
 

Flu Vaccines

What’s new for flu? Everyone aged 6 months or older needs a seasonal flu vaccination every year. That’s not new, but there are two new things coming this fall: (1) The seasonal flu vaccine is going trivalent. FDA has removed the Yamagata flu B strain because it no longer appears to be circulating. (2) ACIP made a special off-label recommendation to boost flu protection for solid organ transplant recipients ages 18-64 who are on immunosuppressive medications. These high-risk patients now have the off-label option of receiving one of the higher-dose flu vaccines, including high-dose and adjuvanted flu vaccines, which are FDA approved only for those 65 or older.

Sandra Adamson Fryhofer, Adjunct Clinical Associate Professor of Medicine, Emory University School of Medicine, Atlanta, Georgia, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for American Medical Association; Medical Association of Atlanta; ACIP liaison. Received income in an amount equal to or greater than $250 from American College of Physicians; Medscape; American Medical Association.

A version of this article first appeared on Medscape.com.

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