Clinician Reviews

The American College of Cardiology has released an Expert Consensus Decision Pathway (ECDP) on the management of heart failure with preserved ejection fraction (HFpEF).

The 44-page document highlights the “critical need” to accurately diagnose HFpEF to permit timely implementation of evidence- and guideline-based therapies to improve patient outcomes.

Although the incidence of overall HF in the United States appears to be stable or declining, the incidence of HFpEF continues to rise in tandem with increasing age and burdens of obesity, sedentary lifestyle, and cardiometabolic disorders.

HFpEF now accounts for more than one half of HF cases but remains “underrecognized” in everyday clinical practice, said the writing group, led by Michelle Kittleson, MD, PhD, professor of medicine, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.

HFpEF is a complex condition, often with multiple overlapping comorbidities, including hypertension, diabetes, obesity, and sleep apnea; optimal management requires a multidisciplinary approach, the writing group said.

The ECDP on HFpEF lays out a structure for diagnosis, clinical decision-making, management of comorbidities, implementation of the latest guideline-directed medical therapy (pharmacologic and nonpharmacologic), and equitable delivery of care.

The document was published online in the Journal of the American College of Cardiology.

It aligns with and builds on recommendations from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

“HFpEF is one of the most pressing diagnostic and therapeutic challenges in clinical medicine today given its increasing prevalence, under diagnosis, poor prognosis, limited therapeutic options, and substantial burden on the health care system worldwide,” wrote the authors of a companion scientific statement on HFpEF.

Despite these challenges, the success of recent sodium-glucose cotransporter 2 inhibitor trials has shown that HFpEF is treatable, Barry Borlaug, MD, department of cardiovascular medicine, Mayo Clinic, Rochester, Minn., and coauthors pointed out.

They noted that “ongoing large-scale studies of HFpEF pathobiology, an increasing number of translational studies spanning the gap between the bedside and the bench, and numerous clinical trials of novel therapeutics in HFpEF offer a glimpse of hope toward a future of reduced prevalence, morbidity, and mortality associated with HFpEF, which would be a major advance for population health.”

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

The American College of Cardiology has released an Expert Consensus Decision Pathway (ECDP) on the management of heart failure with preserved ejection fraction (HFpEF).

The 44-page document highlights the “critical need” to accurately diagnose HFpEF to permit timely implementation of evidence- and guideline-based therapies to improve patient outcomes.

Although the incidence of overall HF in the United States appears to be stable or declining, the incidence of HFpEF continues to rise in tandem with increasing age and burdens of obesity, sedentary lifestyle, and cardiometabolic disorders.

HFpEF now accounts for more than one half of HF cases but remains “underrecognized” in everyday clinical practice, said the writing group, led by Michelle Kittleson, MD, PhD, professor of medicine, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.

HFpEF is a complex condition, often with multiple overlapping comorbidities, including hypertension, diabetes, obesity, and sleep apnea; optimal management requires a multidisciplinary approach, the writing group said.

The ECDP on HFpEF lays out a structure for diagnosis, clinical decision-making, management of comorbidities, implementation of the latest guideline-directed medical therapy (pharmacologic and nonpharmacologic), and equitable delivery of care.

The document was published online in the Journal of the American College of Cardiology.

It aligns with and builds on recommendations from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

“HFpEF is one of the most pressing diagnostic and therapeutic challenges in clinical medicine today given its increasing prevalence, under diagnosis, poor prognosis, limited therapeutic options, and substantial burden on the health care system worldwide,” wrote the authors of a companion scientific statement on HFpEF.

Despite these challenges, the success of recent sodium-glucose cotransporter 2 inhibitor trials has shown that HFpEF is treatable, Barry Borlaug, MD, department of cardiovascular medicine, Mayo Clinic, Rochester, Minn., and coauthors pointed out.

They noted that “ongoing large-scale studies of HFpEF pathobiology, an increasing number of translational studies spanning the gap between the bedside and the bench, and numerous clinical trials of novel therapeutics in HFpEF offer a glimpse of hope toward a future of reduced prevalence, morbidity, and mortality associated with HFpEF, which would be a major advance for population health.”

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

The American College of Cardiology has released an Expert Consensus Decision Pathway (ECDP) on the management of heart failure with preserved ejection fraction (HFpEF).

The 44-page document highlights the “critical need” to accurately diagnose HFpEF to permit timely implementation of evidence- and guideline-based therapies to improve patient outcomes.

Although the incidence of overall HF in the United States appears to be stable or declining, the incidence of HFpEF continues to rise in tandem with increasing age and burdens of obesity, sedentary lifestyle, and cardiometabolic disorders.

HFpEF now accounts for more than one half of HF cases but remains “underrecognized” in everyday clinical practice, said the writing group, led by Michelle Kittleson, MD, PhD, professor of medicine, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.

HFpEF is a complex condition, often with multiple overlapping comorbidities, including hypertension, diabetes, obesity, and sleep apnea; optimal management requires a multidisciplinary approach, the writing group said.

The ECDP on HFpEF lays out a structure for diagnosis, clinical decision-making, management of comorbidities, implementation of the latest guideline-directed medical therapy (pharmacologic and nonpharmacologic), and equitable delivery of care.

The document was published online in the Journal of the American College of Cardiology.

It aligns with and builds on recommendations from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

“HFpEF is one of the most pressing diagnostic and therapeutic challenges in clinical medicine today given its increasing prevalence, under diagnosis, poor prognosis, limited therapeutic options, and substantial burden on the health care system worldwide,” wrote the authors of a companion scientific statement on HFpEF.

Despite these challenges, the success of recent sodium-glucose cotransporter 2 inhibitor trials has shown that HFpEF is treatable, Barry Borlaug, MD, department of cardiovascular medicine, Mayo Clinic, Rochester, Minn., and coauthors pointed out.

They noted that “ongoing large-scale studies of HFpEF pathobiology, an increasing number of translational studies spanning the gap between the bedside and the bench, and numerous clinical trials of novel therapeutics in HFpEF offer a glimpse of hope toward a future of reduced prevalence, morbidity, and mortality associated with HFpEF, which would be a major advance for population health.”

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

This discussion was recorded on April 6, 2023. This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining us today is Dr. Lewis Nelson, professor and chair of emergency medicine at Rutgers New Jersey Medical School and a certified medical toxicologist.

Today, we will be discussing an important and disturbing Gen Z trend circulating on social media, known as blackout rage gallon, or BORG.

Welcome, Lewis.

Lewis S. Nelson, MD: Thanks for having me.

Dr. Glatter: Thanks so much for joining us. This trend that’s been circulating on social media is really disturbing. It has elements that focus on binge drinking: Talking about taking a jug; emptying half of it out; and putting one fifth of vodka and some electrolytes, caffeine, or other things too is just incredibly disturbing. Teens and parents are looking at this. I’ll let you jump into the discussion.

Dr. Nelson: You’re totally right, it is disturbing. Binge drinking is a huge problem in this country in general. It’s a particular problem with young people – teenagers and young adults. I don’t think people appreciate the dangers associated with binge drinking, such as the amount of alcohol they consume and some of the unintended consequences of doing that.

To frame things quickly, we think there are probably around six people a day in the United States who die of alcohol poisoning. Alcohol poisoning basically is binge drinking to such an extent that you die of the alcohol itself. You’re not dying of a car crash or doing something that injures you. You’re dying of the alcohol. You’re drinking so much that your breathing slows, it stops, you have heart rhythm disturbances, and so on. It totals about 2,200 people a year in the United States.

Dr. Glatter: That’s alarming. For this trend, their argument is that half of the gallon is water. Therefore, I’m fine. I can drink it over 8-12 hours and it’s not an issue. How would you respond to that?

Dr. Nelson: Well, alcohol is alcohol. It’s all about how much you take in over what time period. I guess, in concept, it could be safer if you do it right. That’s not the way it’s been, so to speak, marketed on the various social media platforms. It’s meant to be a way to protect yourself from having your drink spiked or eating or ingesting contaminants from other people’s mouths when you share glasses or dip cups into communal pots like jungle juice or something.

Clearly, if you’re going to drink a large amount of alcohol over a short or long period of time, you do run the risk of having significant consequences, including bad decision-making if you’re just a little drunk all the way down to that of the complications you described about alcohol poisoning.

Dr. Glatter: There has been a comment made that this could be a form of harm reduction. The point of harm reduction is that we run trials, we validate it, and we test it. This, certainly in my mind, is no form of true harm reduction. I think you would agree.

Dr. Nelson: Many things that are marketed as harm reduction aren’t. There could be some aspects of this that could be considered harm reduction. You may believe – and there’s no reason not to – that protecting your drink is a good idea. If you’re at a bar and you leave your glass open and somebody put something in it, you can be drugged. Drug-facilitated sexual assault, for example, is a big issue. That means you have to leave your glass unattended. If you tend to your glass, it’s probably fine. One of the ways of harm reduction they mention is that by having a cap and having this bottle with you at all times, that can’t happen.

Now, in fairness, by far the drug most commonly associated with sexual assault is alcohol. It’s not gamma-hydroxybutyrate or ketamine. It’s not the other things that people are concerned about. Those happen, but those are small problems in the big picture. It’s drinking too much.

A form of harm reduction that you can comment on perhaps is that you make this drink concoction yourself, so you know what is in there. You can take that bottle, pour out half the water, and fill up the other half with water and nobody’s going to know. More likely, the way they say you should do it is you take your gallon jug, you pour it out, and you fill it up with one fifth of vodka.

One fifth of vodka is the same amount of volume as a bottle of wine. At 750 mL, that’s a huge amount of alcohol. If you measure the number of shots in that bottle, it’s about 17 shots. Even if you drink that over 6 hours, that’s still several shots an hour. That’s a large amount of alcohol. You might do two or three shots once and then not drink for a few hours. To sit and drink two or three shots an hour for 6 hours, that’s just an exceptional amount of alcohol.

They flavorize it and add caffeine, which only adds to the risk. It doesn’t make it in any way safer. With the volume, 1 gal of water or equivalent over a short period of time in and of itself could be a problem. There’s a large amount of mismessaging here. Whether something’s harm reduction, it could flip around to be easily construed or understood as being harmful.

Not to mention, the idea that when you make something safer, one of the unintended consequences of harm reduction is what we call risk compensation. This is best probably described as what’s called the Peltzman effect. The way that we think about airbags and seatbelts is that they’re going to reduce car crash deaths; and they do, but people drive faster and more recklessly because they know they’re safe.

This is a well-described problem in epidemiology: You expect a certain amount of harm reduction through some implemented process, but you don’t meet that because people take increased risks.

Dr. Glatter: Right. The idea of not developing a hangover is common among many teens and 20-somethings, thinking that because there’s hydration there, because half of it is water, it’s just not going to happen. There’s your “harm reduction,” but your judgment’s impaired. It’s day drinking at its best, all day long. Then someone has the idea to get behind the wheel. These are the disastrous consequences that we all fear.

Dr. Nelson: There is a great example, perhaps of an unintended consequence of harm reduction. By putting caffeine in it, depending on how much caffeine you put in, some of these mixtures can have up to 1,000 mg of caffeine. Remember, a cup of coffee is about 1-200 mg, so you’re talking about several cups of coffee. The idea is that you will not be able to sense, as you normally do, how drunk you are. You’re not going to be a sleepy drunk, you’re going to be an awake drunk.

The idea that you’re going to have to drive so you’re going to drink a strong cup of black coffee before you go driving, you’re not going to drive any better. I can assure you that. You’re going to be more awake, perhaps, and not fall asleep at the wheel, but you’re still going to have psychomotor impairment. Your judgment is going to be impaired. There’s nothing good that comes with adding caffeine except that you’re going to be awake.

From a hangover perspective, there are many things that we’ve guessed at or suggested as either prevention or cures for hangovers. I don’t doubt that you’re going to have some volume depletion if you drink a large amount of alcohol. Alcohol’s a diuretic, so you’re going to lose more volume than you bring in.

Hydrating is probably always a good idea, but there is hydrating and then there’s overhydrating. We don’t need volumes like that. If you drink a cup or two of water, you’re probably fine. You don’t need to drink half a gallon of water. That can lead to problems like delusional hyponatremia, and so forth. There’s not any clear benefit to doing it.

If you want to prevent a hangover, one of the ways you might do it is by using vodka. There are nice data that show that clear alcohols typically, particularly vodka, don’t have many of the congeners that make the specific forms of alcohol what they are. Bourbon smells and tastes like bourbon because of these little molecules, these alkalis and ketones and amino acids and things that make it taste and smell the way it does. That’s true for all the other alcohols.

Vodka has the least amount of that. Even wine and beer have those in them, but vodka is basically alcohol mixed with water. It’s probably the least hangover-prone of all the alcohols; but still, if you drink a lot of vodka, you’re going to have a hangover. It’s just a dose-response curve to how much alcohol you drink, to how drunk you get, and to how much of a hangover you’re going to have.

Dr. Glatter: The hangover is really what it’s about because people want to be functional the next day. There are many companies out there that market hangover remedies, but people are using this as the hangover remedy in a way that’s socially accepted. That’s a good point you make.

The question is how do we get the message out to parents and teens? What’s the best way you feel to really sound the alarm here?

Dr. Nelson: These are challenging issues. We face this all the time with all the sorts of social media in particular. Most parents are not as savvy on social media as their kids are. You have to know what your children are doing. You should know what they’re listening to and watching. You do have to pay attention to the media directed at parents that will inform you a little bit about what your kids are doing. You have to talk with your kids and make sure they understand what it is that they’re doing.

We do this with our kids for some things. Hopefully, we talk about drinking, smoking, sex, and other things with our children (like driving if they get to that stage) and make sure they understand what the risks are and how to mitigate those risks. Being an attentive parent is part of it.

Sometimes you need outside messengers to do it. We’d like to believe that these social media companies are able to police themselves – at least they pay lip service to the fact they do. They have warnings that they’ll take things down that aren’t socially appropriate. Whether they do or not, I don’t know, because you keep seeing things about BORG on these media sites. If they are doing it, they’re not doing it efficiently or quickly enough.

Dr. Glatter: There has to be some censorship. These are young persons who are impressionable, who have developing brains, who are looking at this, thinking that if it’s out there on social media, such as TikTok or Instagram, then it’s okay to do so. That message has to be driven home.

Dr. Nelson: That’s a great point, and it’s tough. We know there’s been debate over the liability of social media or what they post, and whether or not they should be held liable like a more conventional media company or not. That’s politics and philosophy, and we’re probably not going to solve it here.

All these things wind up going viral and there’s probably got to be some filter on things that go viral. Maybe they need to have a bit more attentiveness to that when those things start happening. Now, clearly not every one of these is viral. When you think about some of the challenges we’ve seen in the past, such as the Tide Pod challenge and cinnamon challenge, some of these things could be quickly figured out to be dangerous.

I remember that the ice bucket challenge for amyotrophic lateral sclerosis was pretty benign. You pour a bucket of water over your head, and people aren’t really getting hurt. That’s fun and good, and let people go out and do that. That could pass through the filter. When you start to see people drinking excessive amounts of alcohol, it doesn’t take an emergency physician to know that’s not a good thing. Any parent should know that if my kid drinks half a bottle or a bottle of vodka over a short period of time, that just can’t be okay.

Dr. Glatter: It’s a public health issue. That’s what we need to elevate it to because ultimately that’s what it impacts: welfare and safety.

Speaking of buckets, there’s a new bucket challenge, wherein unsuspecting people have a bucket put on their head, can’t breathe, and then pass out. There’s been a number of these reported and actually filmed on social media. Here’s another example of dangerous types of behavior that essentially are a form of assault. Unsuspecting people suffer injuries from young children and teens trying to play pranks.

Again, had there not been this medium, we wouldn’t necessarily see the extent of the injuries. I guess going forward, the next step would be to send a message to colleges that there should be some form of warning if this trend is seen, at least from a public health standpoint.

Dr. Nelson: Education is a necessary thing to do, but it’s almost never the real solution to a problem. We can educate people as best we can that they need to do things right. At some point, we’re going to need to regulate it or manage it somehow.

Whether it’s through a carrot or a stick approach, or whether you want to give people kudos for doing the right thing or punish them for doing something wrong, that’s a tough decision to make and one that is going to be made by a parent or guardian, a school official, or law enforcement. Somehow, we have to figure out how to make this happen.

There’s not going to be a single size that fits all for this. At some level, we have to do something to educate and regulate. The balance between those two things is going to be political and philosophical in nature.

Dr. Glatter: Right, and the element of peer pressure and conformity in this is really part of the element. If we try to remove that aspect of it, then often these trends would go away. That aspect of conformity and peer pressure is instrumental in fueling these trends. Maybe we can make a full gallon of water be the trend without any alcohol in there.

Dr. Nelson: We say water is only water, but as a medical toxicologist, I can tell you that one of the foundations in medical toxicology is that everything is toxic. It’s just the dose that determines the toxicity. Oxygen is toxic, water is toxic. Everything’s toxic if you take enough of it.

We know that whether it’s psychogenic or intentional, polydipsia by drinking excessive amounts of water, especially without electrolytes, is one of the reasons they say you should add electrolytes. That’s all relative as well, because depending on the electrolyte and how much you put in and things like that, that could also become dangerous. Drinking excessive amounts of water like they’re suggesting, which sounds like a good thing to prevent hangover and so on, can in and of itself be a problem too.

Dr. Glatter: Right, and we know that there’s no magic bullet for a hangover. Obviously, abstinence is the only thing that truly works.

Dr. Nelson: Or moderation.

Dr. Glatter: Until research proves further.

Thank you so much. You’ve made some really important points. Thank you for talking about the BORG phenomenon, how it relates to society in general, and what we can do to try to change people’s perception of alcohol and the bigger picture of binge drinking. I really appreciate it.

Dr. Nelson: Thanks, Rob, for having me. It’s an important topic and hopefully we can get a handle on this. I appreciate your time.

Dr. Glatter is an attending physician at Lenox Hill Hospital in New York City and assistant professor of emergency medicine at Hofstra University, Hempstead, N.Y. Dr. Nelson is professor and chair of the department of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School, Newark. He is a member of the board of directors of the American Board of Emergency Medicine, the Accreditation Council for Continuing Medical Education, and Association of Academic Chairs in Emergency Medicine and is past-president of the American College of Medical Toxicology. Dr. Glatter and Dr. Nelson disclosed no relevant financial relationships.

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

This discussion was recorded on April 6, 2023. This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining us today is Dr. Lewis Nelson, professor and chair of emergency medicine at Rutgers New Jersey Medical School and a certified medical toxicologist.

Today, we will be discussing an important and disturbing Gen Z trend circulating on social media, known as blackout rage gallon, or BORG.

Welcome, Lewis.

Lewis S. Nelson, MD: Thanks for having me.

Dr. Glatter: Thanks so much for joining us. This trend that’s been circulating on social media is really disturbing. It has elements that focus on binge drinking: Talking about taking a jug; emptying half of it out; and putting one fifth of vodka and some electrolytes, caffeine, or other things too is just incredibly disturbing. Teens and parents are looking at this. I’ll let you jump into the discussion.

Dr. Nelson: You’re totally right, it is disturbing. Binge drinking is a huge problem in this country in general. It’s a particular problem with young people – teenagers and young adults. I don’t think people appreciate the dangers associated with binge drinking, such as the amount of alcohol they consume and some of the unintended consequences of doing that.

To frame things quickly, we think there are probably around six people a day in the United States who die of alcohol poisoning. Alcohol poisoning basically is binge drinking to such an extent that you die of the alcohol itself. You’re not dying of a car crash or doing something that injures you. You’re dying of the alcohol. You’re drinking so much that your breathing slows, it stops, you have heart rhythm disturbances, and so on. It totals about 2,200 people a year in the United States.

Dr. Glatter: That’s alarming. For this trend, their argument is that half of the gallon is water. Therefore, I’m fine. I can drink it over 8-12 hours and it’s not an issue. How would you respond to that?

Dr. Nelson: Well, alcohol is alcohol. It’s all about how much you take in over what time period. I guess, in concept, it could be safer if you do it right. That’s not the way it’s been, so to speak, marketed on the various social media platforms. It’s meant to be a way to protect yourself from having your drink spiked or eating or ingesting contaminants from other people’s mouths when you share glasses or dip cups into communal pots like jungle juice or something.

Clearly, if you’re going to drink a large amount of alcohol over a short or long period of time, you do run the risk of having significant consequences, including bad decision-making if you’re just a little drunk all the way down to that of the complications you described about alcohol poisoning.

Dr. Glatter: There has been a comment made that this could be a form of harm reduction. The point of harm reduction is that we run trials, we validate it, and we test it. This, certainly in my mind, is no form of true harm reduction. I think you would agree.

Dr. Nelson: Many things that are marketed as harm reduction aren’t. There could be some aspects of this that could be considered harm reduction. You may believe – and there’s no reason not to – that protecting your drink is a good idea. If you’re at a bar and you leave your glass open and somebody put something in it, you can be drugged. Drug-facilitated sexual assault, for example, is a big issue. That means you have to leave your glass unattended. If you tend to your glass, it’s probably fine. One of the ways of harm reduction they mention is that by having a cap and having this bottle with you at all times, that can’t happen.

Now, in fairness, by far the drug most commonly associated with sexual assault is alcohol. It’s not gamma-hydroxybutyrate or ketamine. It’s not the other things that people are concerned about. Those happen, but those are small problems in the big picture. It’s drinking too much.

A form of harm reduction that you can comment on perhaps is that you make this drink concoction yourself, so you know what is in there. You can take that bottle, pour out half the water, and fill up the other half with water and nobody’s going to know. More likely, the way they say you should do it is you take your gallon jug, you pour it out, and you fill it up with one fifth of vodka.

One fifth of vodka is the same amount of volume as a bottle of wine. At 750 mL, that’s a huge amount of alcohol. If you measure the number of shots in that bottle, it’s about 17 shots. Even if you drink that over 6 hours, that’s still several shots an hour. That’s a large amount of alcohol. You might do two or three shots once and then not drink for a few hours. To sit and drink two or three shots an hour for 6 hours, that’s just an exceptional amount of alcohol.

They flavorize it and add caffeine, which only adds to the risk. It doesn’t make it in any way safer. With the volume, 1 gal of water or equivalent over a short period of time in and of itself could be a problem. There’s a large amount of mismessaging here. Whether something’s harm reduction, it could flip around to be easily construed or understood as being harmful.

Not to mention, the idea that when you make something safer, one of the unintended consequences of harm reduction is what we call risk compensation. This is best probably described as what’s called the Peltzman effect. The way that we think about airbags and seatbelts is that they’re going to reduce car crash deaths; and they do, but people drive faster and more recklessly because they know they’re safe.

This is a well-described problem in epidemiology: You expect a certain amount of harm reduction through some implemented process, but you don’t meet that because people take increased risks.

Dr. Glatter: Right. The idea of not developing a hangover is common among many teens and 20-somethings, thinking that because there’s hydration there, because half of it is water, it’s just not going to happen. There’s your “harm reduction,” but your judgment’s impaired. It’s day drinking at its best, all day long. Then someone has the idea to get behind the wheel. These are the disastrous consequences that we all fear.

Dr. Nelson: There is a great example, perhaps of an unintended consequence of harm reduction. By putting caffeine in it, depending on how much caffeine you put in, some of these mixtures can have up to 1,000 mg of caffeine. Remember, a cup of coffee is about 1-200 mg, so you’re talking about several cups of coffee. The idea is that you will not be able to sense, as you normally do, how drunk you are. You’re not going to be a sleepy drunk, you’re going to be an awake drunk.

The idea that you’re going to have to drive so you’re going to drink a strong cup of black coffee before you go driving, you’re not going to drive any better. I can assure you that. You’re going to be more awake, perhaps, and not fall asleep at the wheel, but you’re still going to have psychomotor impairment. Your judgment is going to be impaired. There’s nothing good that comes with adding caffeine except that you’re going to be awake.

From a hangover perspective, there are many things that we’ve guessed at or suggested as either prevention or cures for hangovers. I don’t doubt that you’re going to have some volume depletion if you drink a large amount of alcohol. Alcohol’s a diuretic, so you’re going to lose more volume than you bring in.

Hydrating is probably always a good idea, but there is hydrating and then there’s overhydrating. We don’t need volumes like that. If you drink a cup or two of water, you’re probably fine. You don’t need to drink half a gallon of water. That can lead to problems like delusional hyponatremia, and so forth. There’s not any clear benefit to doing it.

If you want to prevent a hangover, one of the ways you might do it is by using vodka. There are nice data that show that clear alcohols typically, particularly vodka, don’t have many of the congeners that make the specific forms of alcohol what they are. Bourbon smells and tastes like bourbon because of these little molecules, these alkalis and ketones and amino acids and things that make it taste and smell the way it does. That’s true for all the other alcohols.

Vodka has the least amount of that. Even wine and beer have those in them, but vodka is basically alcohol mixed with water. It’s probably the least hangover-prone of all the alcohols; but still, if you drink a lot of vodka, you’re going to have a hangover. It’s just a dose-response curve to how much alcohol you drink, to how drunk you get, and to how much of a hangover you’re going to have.

Dr. Glatter: The hangover is really what it’s about because people want to be functional the next day. There are many companies out there that market hangover remedies, but people are using this as the hangover remedy in a way that’s socially accepted. That’s a good point you make.

The question is how do we get the message out to parents and teens? What’s the best way you feel to really sound the alarm here?

Dr. Nelson: These are challenging issues. We face this all the time with all the sorts of social media in particular. Most parents are not as savvy on social media as their kids are. You have to know what your children are doing. You should know what they’re listening to and watching. You do have to pay attention to the media directed at parents that will inform you a little bit about what your kids are doing. You have to talk with your kids and make sure they understand what it is that they’re doing.

We do this with our kids for some things. Hopefully, we talk about drinking, smoking, sex, and other things with our children (like driving if they get to that stage) and make sure they understand what the risks are and how to mitigate those risks. Being an attentive parent is part of it.

Sometimes you need outside messengers to do it. We’d like to believe that these social media companies are able to police themselves – at least they pay lip service to the fact they do. They have warnings that they’ll take things down that aren’t socially appropriate. Whether they do or not, I don’t know, because you keep seeing things about BORG on these media sites. If they are doing it, they’re not doing it efficiently or quickly enough.

Dr. Glatter: There has to be some censorship. These are young persons who are impressionable, who have developing brains, who are looking at this, thinking that if it’s out there on social media, such as TikTok or Instagram, then it’s okay to do so. That message has to be driven home.

Dr. Nelson: That’s a great point, and it’s tough. We know there’s been debate over the liability of social media or what they post, and whether or not they should be held liable like a more conventional media company or not. That’s politics and philosophy, and we’re probably not going to solve it here.

All these things wind up going viral and there’s probably got to be some filter on things that go viral. Maybe they need to have a bit more attentiveness to that when those things start happening. Now, clearly not every one of these is viral. When you think about some of the challenges we’ve seen in the past, such as the Tide Pod challenge and cinnamon challenge, some of these things could be quickly figured out to be dangerous.

I remember that the ice bucket challenge for amyotrophic lateral sclerosis was pretty benign. You pour a bucket of water over your head, and people aren’t really getting hurt. That’s fun and good, and let people go out and do that. That could pass through the filter. When you start to see people drinking excessive amounts of alcohol, it doesn’t take an emergency physician to know that’s not a good thing. Any parent should know that if my kid drinks half a bottle or a bottle of vodka over a short period of time, that just can’t be okay.

Dr. Glatter: It’s a public health issue. That’s what we need to elevate it to because ultimately that’s what it impacts: welfare and safety.

Speaking of buckets, there’s a new bucket challenge, wherein unsuspecting people have a bucket put on their head, can’t breathe, and then pass out. There’s been a number of these reported and actually filmed on social media. Here’s another example of dangerous types of behavior that essentially are a form of assault. Unsuspecting people suffer injuries from young children and teens trying to play pranks.

Again, had there not been this medium, we wouldn’t necessarily see the extent of the injuries. I guess going forward, the next step would be to send a message to colleges that there should be some form of warning if this trend is seen, at least from a public health standpoint.

Dr. Nelson: Education is a necessary thing to do, but it’s almost never the real solution to a problem. We can educate people as best we can that they need to do things right. At some point, we’re going to need to regulate it or manage it somehow.

Whether it’s through a carrot or a stick approach, or whether you want to give people kudos for doing the right thing or punish them for doing something wrong, that’s a tough decision to make and one that is going to be made by a parent or guardian, a school official, or law enforcement. Somehow, we have to figure out how to make this happen.

There’s not going to be a single size that fits all for this. At some level, we have to do something to educate and regulate. The balance between those two things is going to be political and philosophical in nature.

Dr. Glatter: Right, and the element of peer pressure and conformity in this is really part of the element. If we try to remove that aspect of it, then often these trends would go away. That aspect of conformity and peer pressure is instrumental in fueling these trends. Maybe we can make a full gallon of water be the trend without any alcohol in there.

Dr. Nelson: We say water is only water, but as a medical toxicologist, I can tell you that one of the foundations in medical toxicology is that everything is toxic. It’s just the dose that determines the toxicity. Oxygen is toxic, water is toxic. Everything’s toxic if you take enough of it.

We know that whether it’s psychogenic or intentional, polydipsia by drinking excessive amounts of water, especially without electrolytes, is one of the reasons they say you should add electrolytes. That’s all relative as well, because depending on the electrolyte and how much you put in and things like that, that could also become dangerous. Drinking excessive amounts of water like they’re suggesting, which sounds like a good thing to prevent hangover and so on, can in and of itself be a problem too.

Dr. Glatter: Right, and we know that there’s no magic bullet for a hangover. Obviously, abstinence is the only thing that truly works.

Dr. Nelson: Or moderation.

Dr. Glatter: Until research proves further.

Thank you so much. You’ve made some really important points. Thank you for talking about the BORG phenomenon, how it relates to society in general, and what we can do to try to change people’s perception of alcohol and the bigger picture of binge drinking. I really appreciate it.

Dr. Nelson: Thanks, Rob, for having me. It’s an important topic and hopefully we can get a handle on this. I appreciate your time.

Dr. Glatter is an attending physician at Lenox Hill Hospital in New York City and assistant professor of emergency medicine at Hofstra University, Hempstead, N.Y. Dr. Nelson is professor and chair of the department of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School, Newark. He is a member of the board of directors of the American Board of Emergency Medicine, the Accreditation Council for Continuing Medical Education, and Association of Academic Chairs in Emergency Medicine and is past-president of the American College of Medical Toxicology. Dr. Glatter and Dr. Nelson disclosed no relevant financial relationships.

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

This discussion was recorded on April 6, 2023. This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining us today is Dr. Lewis Nelson, professor and chair of emergency medicine at Rutgers New Jersey Medical School and a certified medical toxicologist.

Today, we will be discussing an important and disturbing Gen Z trend circulating on social media, known as blackout rage gallon, or BORG.

Welcome, Lewis.

Lewis S. Nelson, MD: Thanks for having me.

Dr. Glatter: Thanks so much for joining us. This trend that’s been circulating on social media is really disturbing. It has elements that focus on binge drinking: Talking about taking a jug; emptying half of it out; and putting one fifth of vodka and some electrolytes, caffeine, or other things too is just incredibly disturbing. Teens and parents are looking at this. I’ll let you jump into the discussion.

Dr. Nelson: You’re totally right, it is disturbing. Binge drinking is a huge problem in this country in general. It’s a particular problem with young people – teenagers and young adults. I don’t think people appreciate the dangers associated with binge drinking, such as the amount of alcohol they consume and some of the unintended consequences of doing that.

To frame things quickly, we think there are probably around six people a day in the United States who die of alcohol poisoning. Alcohol poisoning basically is binge drinking to such an extent that you die of the alcohol itself. You’re not dying of a car crash or doing something that injures you. You’re dying of the alcohol. You’re drinking so much that your breathing slows, it stops, you have heart rhythm disturbances, and so on. It totals about 2,200 people a year in the United States.

Dr. Glatter: That’s alarming. For this trend, their argument is that half of the gallon is water. Therefore, I’m fine. I can drink it over 8-12 hours and it’s not an issue. How would you respond to that?

Dr. Nelson: Well, alcohol is alcohol. It’s all about how much you take in over what time period. I guess, in concept, it could be safer if you do it right. That’s not the way it’s been, so to speak, marketed on the various social media platforms. It’s meant to be a way to protect yourself from having your drink spiked or eating or ingesting contaminants from other people’s mouths when you share glasses or dip cups into communal pots like jungle juice or something.

Clearly, if you’re going to drink a large amount of alcohol over a short or long period of time, you do run the risk of having significant consequences, including bad decision-making if you’re just a little drunk all the way down to that of the complications you described about alcohol poisoning.

Dr. Glatter: There has been a comment made that this could be a form of harm reduction. The point of harm reduction is that we run trials, we validate it, and we test it. This, certainly in my mind, is no form of true harm reduction. I think you would agree.

Dr. Nelson: Many things that are marketed as harm reduction aren’t. There could be some aspects of this that could be considered harm reduction. You may believe – and there’s no reason not to – that protecting your drink is a good idea. If you’re at a bar and you leave your glass open and somebody put something in it, you can be drugged. Drug-facilitated sexual assault, for example, is a big issue. That means you have to leave your glass unattended. If you tend to your glass, it’s probably fine. One of the ways of harm reduction they mention is that by having a cap and having this bottle with you at all times, that can’t happen.

Now, in fairness, by far the drug most commonly associated with sexual assault is alcohol. It’s not gamma-hydroxybutyrate or ketamine. It’s not the other things that people are concerned about. Those happen, but those are small problems in the big picture. It’s drinking too much.

A form of harm reduction that you can comment on perhaps is that you make this drink concoction yourself, so you know what is in there. You can take that bottle, pour out half the water, and fill up the other half with water and nobody’s going to know. More likely, the way they say you should do it is you take your gallon jug, you pour it out, and you fill it up with one fifth of vodka.

One fifth of vodka is the same amount of volume as a bottle of wine. At 750 mL, that’s a huge amount of alcohol. If you measure the number of shots in that bottle, it’s about 17 shots. Even if you drink that over 6 hours, that’s still several shots an hour. That’s a large amount of alcohol. You might do two or three shots once and then not drink for a few hours. To sit and drink two or three shots an hour for 6 hours, that’s just an exceptional amount of alcohol.

They flavorize it and add caffeine, which only adds to the risk. It doesn’t make it in any way safer. With the volume, 1 gal of water or equivalent over a short period of time in and of itself could be a problem. There’s a large amount of mismessaging here. Whether something’s harm reduction, it could flip around to be easily construed or understood as being harmful.

Not to mention, the idea that when you make something safer, one of the unintended consequences of harm reduction is what we call risk compensation. This is best probably described as what’s called the Peltzman effect. The way that we think about airbags and seatbelts is that they’re going to reduce car crash deaths; and they do, but people drive faster and more recklessly because they know they’re safe.

This is a well-described problem in epidemiology: You expect a certain amount of harm reduction through some implemented process, but you don’t meet that because people take increased risks.

Dr. Glatter: Right. The idea of not developing a hangover is common among many teens and 20-somethings, thinking that because there’s hydration there, because half of it is water, it’s just not going to happen. There’s your “harm reduction,” but your judgment’s impaired. It’s day drinking at its best, all day long. Then someone has the idea to get behind the wheel. These are the disastrous consequences that we all fear.

Dr. Nelson: There is a great example, perhaps of an unintended consequence of harm reduction. By putting caffeine in it, depending on how much caffeine you put in, some of these mixtures can have up to 1,000 mg of caffeine. Remember, a cup of coffee is about 1-200 mg, so you’re talking about several cups of coffee. The idea is that you will not be able to sense, as you normally do, how drunk you are. You’re not going to be a sleepy drunk, you’re going to be an awake drunk.

The idea that you’re going to have to drive so you’re going to drink a strong cup of black coffee before you go driving, you’re not going to drive any better. I can assure you that. You’re going to be more awake, perhaps, and not fall asleep at the wheel, but you’re still going to have psychomotor impairment. Your judgment is going to be impaired. There’s nothing good that comes with adding caffeine except that you’re going to be awake.

From a hangover perspective, there are many things that we’ve guessed at or suggested as either prevention or cures for hangovers. I don’t doubt that you’re going to have some volume depletion if you drink a large amount of alcohol. Alcohol’s a diuretic, so you’re going to lose more volume than you bring in.

Hydrating is probably always a good idea, but there is hydrating and then there’s overhydrating. We don’t need volumes like that. If you drink a cup or two of water, you’re probably fine. You don’t need to drink half a gallon of water. That can lead to problems like delusional hyponatremia, and so forth. There’s not any clear benefit to doing it.

If you want to prevent a hangover, one of the ways you might do it is by using vodka. There are nice data that show that clear alcohols typically, particularly vodka, don’t have many of the congeners that make the specific forms of alcohol what they are. Bourbon smells and tastes like bourbon because of these little molecules, these alkalis and ketones and amino acids and things that make it taste and smell the way it does. That’s true for all the other alcohols.

Vodka has the least amount of that. Even wine and beer have those in them, but vodka is basically alcohol mixed with water. It’s probably the least hangover-prone of all the alcohols; but still, if you drink a lot of vodka, you’re going to have a hangover. It’s just a dose-response curve to how much alcohol you drink, to how drunk you get, and to how much of a hangover you’re going to have.

Dr. Glatter: The hangover is really what it’s about because people want to be functional the next day. There are many companies out there that market hangover remedies, but people are using this as the hangover remedy in a way that’s socially accepted. That’s a good point you make.

The question is how do we get the message out to parents and teens? What’s the best way you feel to really sound the alarm here?

Dr. Nelson: These are challenging issues. We face this all the time with all the sorts of social media in particular. Most parents are not as savvy on social media as their kids are. You have to know what your children are doing. You should know what they’re listening to and watching. You do have to pay attention to the media directed at parents that will inform you a little bit about what your kids are doing. You have to talk with your kids and make sure they understand what it is that they’re doing.

We do this with our kids for some things. Hopefully, we talk about drinking, smoking, sex, and other things with our children (like driving if they get to that stage) and make sure they understand what the risks are and how to mitigate those risks. Being an attentive parent is part of it.

Sometimes you need outside messengers to do it. We’d like to believe that these social media companies are able to police themselves – at least they pay lip service to the fact they do. They have warnings that they’ll take things down that aren’t socially appropriate. Whether they do or not, I don’t know, because you keep seeing things about BORG on these media sites. If they are doing it, they’re not doing it efficiently or quickly enough.

Dr. Glatter: There has to be some censorship. These are young persons who are impressionable, who have developing brains, who are looking at this, thinking that if it’s out there on social media, such as TikTok or Instagram, then it’s okay to do so. That message has to be driven home.

Dr. Nelson: That’s a great point, and it’s tough. We know there’s been debate over the liability of social media or what they post, and whether or not they should be held liable like a more conventional media company or not. That’s politics and philosophy, and we’re probably not going to solve it here.

All these things wind up going viral and there’s probably got to be some filter on things that go viral. Maybe they need to have a bit more attentiveness to that when those things start happening. Now, clearly not every one of these is viral. When you think about some of the challenges we’ve seen in the past, such as the Tide Pod challenge and cinnamon challenge, some of these things could be quickly figured out to be dangerous.

I remember that the ice bucket challenge for amyotrophic lateral sclerosis was pretty benign. You pour a bucket of water over your head, and people aren’t really getting hurt. That’s fun and good, and let people go out and do that. That could pass through the filter. When you start to see people drinking excessive amounts of alcohol, it doesn’t take an emergency physician to know that’s not a good thing. Any parent should know that if my kid drinks half a bottle or a bottle of vodka over a short period of time, that just can’t be okay.

Dr. Glatter: It’s a public health issue. That’s what we need to elevate it to because ultimately that’s what it impacts: welfare and safety.

Speaking of buckets, there’s a new bucket challenge, wherein unsuspecting people have a bucket put on their head, can’t breathe, and then pass out. There’s been a number of these reported and actually filmed on social media. Here’s another example of dangerous types of behavior that essentially are a form of assault. Unsuspecting people suffer injuries from young children and teens trying to play pranks.

Again, had there not been this medium, we wouldn’t necessarily see the extent of the injuries. I guess going forward, the next step would be to send a message to colleges that there should be some form of warning if this trend is seen, at least from a public health standpoint.

Dr. Nelson: Education is a necessary thing to do, but it’s almost never the real solution to a problem. We can educate people as best we can that they need to do things right. At some point, we’re going to need to regulate it or manage it somehow.

Whether it’s through a carrot or a stick approach, or whether you want to give people kudos for doing the right thing or punish them for doing something wrong, that’s a tough decision to make and one that is going to be made by a parent or guardian, a school official, or law enforcement. Somehow, we have to figure out how to make this happen.

There’s not going to be a single size that fits all for this. At some level, we have to do something to educate and regulate. The balance between those two things is going to be political and philosophical in nature.

Dr. Glatter: Right, and the element of peer pressure and conformity in this is really part of the element. If we try to remove that aspect of it, then often these trends would go away. That aspect of conformity and peer pressure is instrumental in fueling these trends. Maybe we can make a full gallon of water be the trend without any alcohol in there.

Dr. Nelson: We say water is only water, but as a medical toxicologist, I can tell you that one of the foundations in medical toxicology is that everything is toxic. It’s just the dose that determines the toxicity. Oxygen is toxic, water is toxic. Everything’s toxic if you take enough of it.

We know that whether it’s psychogenic or intentional, polydipsia by drinking excessive amounts of water, especially without electrolytes, is one of the reasons they say you should add electrolytes. That’s all relative as well, because depending on the electrolyte and how much you put in and things like that, that could also become dangerous. Drinking excessive amounts of water like they’re suggesting, which sounds like a good thing to prevent hangover and so on, can in and of itself be a problem too.

Dr. Glatter: Right, and we know that there’s no magic bullet for a hangover. Obviously, abstinence is the only thing that truly works.

Dr. Nelson: Or moderation.

Dr. Glatter: Until research proves further.

Thank you so much. You’ve made some really important points. Thank you for talking about the BORG phenomenon, how it relates to society in general, and what we can do to try to change people’s perception of alcohol and the bigger picture of binge drinking. I really appreciate it.

Dr. Nelson: Thanks, Rob, for having me. It’s an important topic and hopefully we can get a handle on this. I appreciate your time.

Dr. Glatter is an attending physician at Lenox Hill Hospital in New York City and assistant professor of emergency medicine at Hofstra University, Hempstead, N.Y. Dr. Nelson is professor and chair of the department of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School, Newark. He is a member of the board of directors of the American Board of Emergency Medicine, the Accreditation Council for Continuing Medical Education, and Association of Academic Chairs in Emergency Medicine and is past-president of the American College of Medical Toxicology. Dr. Glatter and Dr. Nelson disclosed no relevant financial relationships.

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

The combination of a patient-specific mRNA-based cancer vaccine (mRNA-4157/V940, Moderna and Merck) and the immune checkpoint inhibitor pembrolizumab significantly improved recurrence-free survival for patients with high-risk melanoma compared with pembrolizumab alone, according to the latest data from the KEYNOTE-942 trial.

This recurrence-free survival benefit corresponded to a 44% reduced risk of recurrence or death in patients who received the personalized vaccine plus pembrolizumab compared with the immunotherapy alone.

The randomized phase 2b trial is the first to show a positive result for a cancer vaccine in a randomized trial. The results, if confirmed in further studies, hold promise for treating other solid tumors with sensitivity to the programmed death-1 (PD-1) protein, investigators said.

“KEYNOTE-942 is the first randomized study to demonstrate improvement in recurrence-free survival in melanoma, or in any cancer in my view, with an individualized neoantigen vaccine approach,” trial investigator Jeffrey S. Weber, MD, PhD, of NYU Langone Perlmutter Cancer Center in New York, said during an oral abstract session at the annual meeting of the American Association for Cancer Research.

“I have every confidence that this strategy will be expanded to other histologies that are PD-1 sensitive, such as non–small cell lung cancer, renal cell cancer, hepatocellular cancer, gastroesophageal cancer, et cetera,” Dr. Weber said.

Invited discussant Margaret Callahan, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, called the results “exciting,” especially in light of previous results in cancer vaccine trials. “Despite hundreds of formulations and dozens of studies, cancer vaccines have been disappointing so far, and have largely failed to have a meaningful impact in oncology,” she said.
 

A promising personalized vaccine

The mRNA vaccine is individually tailored and encodes up to 34 patient-specific tumor neoantigens. The vaccine also acts as an adjuvant to strengthen the immune response.

Dr. Weber said that the “mRNA 4157 is what one would call an individualized neoantigen therapy. It will target an individual patient’s unique tumor mutations, and the revelation over the last 5-10 years, is that, for better or worse, virtually all the neoantigens are unique to an individual patient. There are very, very few true universal neoantigens, or at least universal neoantigens that could have clinical utility.”

The vaccines are developed from tumor biopsy tissues that then undergo whole exome and RNA sequencing to identify single nucleotide variants that are present in the tumor but not in normal tissue.

The findings are then fed into a computer algorithm that identifies potential neoepitope peptides that would bind well to the patient’s human leukocyte antigen (HLA) type and could evoke strong T-cell responses.

“Once they’re chosen, you concatenate the sequences together into a single-strand mRNA vaccine, it’s packaged with nanoparticles to encapsulate it, and there you have your mRNA vaccine,” Dr. Weber explained.

In the KEYNOTE-942 trial, the investigators randomly assigned patients with completely resected high-risk cutaneous melanoma on a 2:1 basis to receive mRNA-4157 via intramuscular injection every 3 weeks for a total of nine doses, plus intravenous pembrolizumab every 3 weeks for 18 cycles (107 patients) or pembrolizumab alone (50 patients). Median follow-up was 101 weeks in the combination group and 105 weeks in the pembrolizumab group.

Overall, the 18-month recurrence-free survival rates were 78.6% in the combination arm and 62.2% in the pembrolizumab arm. The recurrence-free survival rates corresponded to a 44% reduced risk of recurrence or death in patients who received the personalized vaccine plus pembrolizumab compared with those who received only pembrolizumab (hazard ratio [HR] for recurrence, 0.561; P =.0266).

Grade 3 or greater adverse events occurred in 25% of patients in the combination group and 18% of patients in the pembrolizumab group. The most common grade 3 event associated with the vaccine was fatigue. No grade 4 adverse events or deaths were associated with the vaccine, and the addition of the vaccine to pembrolizumab did not appear to increase risk for immune-mediated adverse events.

In a subanalysis, Dr. Weber and colleagues explored the relationship between tumor mutational burden and recurrence-free survival. Higher tumor mutational burden may mean more neoepitopes to target, which is helpful when developing personalized neoantigen vaccines, explained coinvestigator Ryan Sullivan, MD, associate director of the melanoma program at Mass General Cancer Center, Boston, who presented the subanalysis results.

The investigators performed whole exome and whole transcriptome sequencing of baseline tumor biopsy samples to determine the mutational burden of tumors and defined a high mutational burden as 10 or more mutations per megabase.

Overall, in the combination group, patients with a higher tumor mutational burden at baseline showed improved outcomes (HR, 0.652; 95% confidence interval [CI], 0.284-1.494), as did patients with a lower tumor mutational burden (HR, 0.586; 95% CI, 0.243-1.415).

The authors found the same was true for patients with high vs. low tumor inflammation scores (high: HR, 0.576; 95% CI, 0.209-1.591 vs. low: HR, 0.528; 95% CI, 0.253-1.101) and higher PD-L1 expression (PD-L1 positive: HR, 0.485; 95% CI, 0.226-1.039 vs. PD-L1 negative: HR, 0.162; 95% CI, 0.038-0.685).

The hazard ratios crossed 1, which suggest that the combination was similarly effective in all patient subsets, said Dr. Sullivan.

Dr. Callahan also highlighted that the P value was based on a one-side log-rank test, “a relatively low bar to jump over” and that there were slight imbalances in both PD-1 expression status and tumor mutational burden – both of which favored the vaccine group and may be associated with better recurrence-free survival.

The 16% difference in recurrence-free survival seen with the combination vs. pembrolizumab alone, if confirmed in further studies, “is clinically meaningful for high-risk patients,” said Dr. Callahan. “The authors are to be congratulated for presenting the first randomized study of a neoantigen vaccine with a clinical efficacy primary endpoint, and this is a trial that incorporates many of the lessons we’ve learned along the years.”

Dr. Sullivan also commented on the promising results. “The field of cancer vaccines is a wasteland of failed clinical trials after some initial promising data, so to have something like this where it does appear that this vaccine strategy works is good not only for patients with melanoma but for those people who have dedicated their lives to trying to develop cancer vaccines,” he said in an interview.

KEYNOTE-942 was funded by Moderna with collaboration from Merck. Dr. Weber has financial relationships with Merck, Moderna, and other companies. Dr. Sullivan has served as a paid consultant for Merck and has received research funding from the company. Dr. Callahan disclosed a consulting/advisory role with Moderna, Merck, and others.
 

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

The combination of a patient-specific mRNA-based cancer vaccine (mRNA-4157/V940, Moderna and Merck) and the immune checkpoint inhibitor pembrolizumab significantly improved recurrence-free survival for patients with high-risk melanoma compared with pembrolizumab alone, according to the latest data from the KEYNOTE-942 trial.

This recurrence-free survival benefit corresponded to a 44% reduced risk of recurrence or death in patients who received the personalized vaccine plus pembrolizumab compared with the immunotherapy alone.

The randomized phase 2b trial is the first to show a positive result for a cancer vaccine in a randomized trial. The results, if confirmed in further studies, hold promise for treating other solid tumors with sensitivity to the programmed death-1 (PD-1) protein, investigators said.

“KEYNOTE-942 is the first randomized study to demonstrate improvement in recurrence-free survival in melanoma, or in any cancer in my view, with an individualized neoantigen vaccine approach,” trial investigator Jeffrey S. Weber, MD, PhD, of NYU Langone Perlmutter Cancer Center in New York, said during an oral abstract session at the annual meeting of the American Association for Cancer Research.

“I have every confidence that this strategy will be expanded to other histologies that are PD-1 sensitive, such as non–small cell lung cancer, renal cell cancer, hepatocellular cancer, gastroesophageal cancer, et cetera,” Dr. Weber said.

Invited discussant Margaret Callahan, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, called the results “exciting,” especially in light of previous results in cancer vaccine trials. “Despite hundreds of formulations and dozens of studies, cancer vaccines have been disappointing so far, and have largely failed to have a meaningful impact in oncology,” she said.
 

A promising personalized vaccine

The mRNA vaccine is individually tailored and encodes up to 34 patient-specific tumor neoantigens. The vaccine also acts as an adjuvant to strengthen the immune response.

Dr. Weber said that the “mRNA 4157 is what one would call an individualized neoantigen therapy. It will target an individual patient’s unique tumor mutations, and the revelation over the last 5-10 years, is that, for better or worse, virtually all the neoantigens are unique to an individual patient. There are very, very few true universal neoantigens, or at least universal neoantigens that could have clinical utility.”

The vaccines are developed from tumor biopsy tissues that then undergo whole exome and RNA sequencing to identify single nucleotide variants that are present in the tumor but not in normal tissue.

The findings are then fed into a computer algorithm that identifies potential neoepitope peptides that would bind well to the patient’s human leukocyte antigen (HLA) type and could evoke strong T-cell responses.

“Once they’re chosen, you concatenate the sequences together into a single-strand mRNA vaccine, it’s packaged with nanoparticles to encapsulate it, and there you have your mRNA vaccine,” Dr. Weber explained.

In the KEYNOTE-942 trial, the investigators randomly assigned patients with completely resected high-risk cutaneous melanoma on a 2:1 basis to receive mRNA-4157 via intramuscular injection every 3 weeks for a total of nine doses, plus intravenous pembrolizumab every 3 weeks for 18 cycles (107 patients) or pembrolizumab alone (50 patients). Median follow-up was 101 weeks in the combination group and 105 weeks in the pembrolizumab group.

Overall, the 18-month recurrence-free survival rates were 78.6% in the combination arm and 62.2% in the pembrolizumab arm. The recurrence-free survival rates corresponded to a 44% reduced risk of recurrence or death in patients who received the personalized vaccine plus pembrolizumab compared with those who received only pembrolizumab (hazard ratio [HR] for recurrence, 0.561; P =.0266).

Grade 3 or greater adverse events occurred in 25% of patients in the combination group and 18% of patients in the pembrolizumab group. The most common grade 3 event associated with the vaccine was fatigue. No grade 4 adverse events or deaths were associated with the vaccine, and the addition of the vaccine to pembrolizumab did not appear to increase risk for immune-mediated adverse events.

In a subanalysis, Dr. Weber and colleagues explored the relationship between tumor mutational burden and recurrence-free survival. Higher tumor mutational burden may mean more neoepitopes to target, which is helpful when developing personalized neoantigen vaccines, explained coinvestigator Ryan Sullivan, MD, associate director of the melanoma program at Mass General Cancer Center, Boston, who presented the subanalysis results.

The investigators performed whole exome and whole transcriptome sequencing of baseline tumor biopsy samples to determine the mutational burden of tumors and defined a high mutational burden as 10 or more mutations per megabase.

Overall, in the combination group, patients with a higher tumor mutational burden at baseline showed improved outcomes (HR, 0.652; 95% confidence interval [CI], 0.284-1.494), as did patients with a lower tumor mutational burden (HR, 0.586; 95% CI, 0.243-1.415).

The authors found the same was true for patients with high vs. low tumor inflammation scores (high: HR, 0.576; 95% CI, 0.209-1.591 vs. low: HR, 0.528; 95% CI, 0.253-1.101) and higher PD-L1 expression (PD-L1 positive: HR, 0.485; 95% CI, 0.226-1.039 vs. PD-L1 negative: HR, 0.162; 95% CI, 0.038-0.685).

The hazard ratios crossed 1, which suggest that the combination was similarly effective in all patient subsets, said Dr. Sullivan.

Dr. Callahan also highlighted that the P value was based on a one-side log-rank test, “a relatively low bar to jump over” and that there were slight imbalances in both PD-1 expression status and tumor mutational burden – both of which favored the vaccine group and may be associated with better recurrence-free survival.

The 16% difference in recurrence-free survival seen with the combination vs. pembrolizumab alone, if confirmed in further studies, “is clinically meaningful for high-risk patients,” said Dr. Callahan. “The authors are to be congratulated for presenting the first randomized study of a neoantigen vaccine with a clinical efficacy primary endpoint, and this is a trial that incorporates many of the lessons we’ve learned along the years.”

Dr. Sullivan also commented on the promising results. “The field of cancer vaccines is a wasteland of failed clinical trials after some initial promising data, so to have something like this where it does appear that this vaccine strategy works is good not only for patients with melanoma but for those people who have dedicated their lives to trying to develop cancer vaccines,” he said in an interview.

KEYNOTE-942 was funded by Moderna with collaboration from Merck. Dr. Weber has financial relationships with Merck, Moderna, and other companies. Dr. Sullivan has served as a paid consultant for Merck and has received research funding from the company. Dr. Callahan disclosed a consulting/advisory role with Moderna, Merck, and others.
 

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

The combination of a patient-specific mRNA-based cancer vaccine (mRNA-4157/V940, Moderna and Merck) and the immune checkpoint inhibitor pembrolizumab significantly improved recurrence-free survival for patients with high-risk melanoma compared with pembrolizumab alone, according to the latest data from the KEYNOTE-942 trial.

This recurrence-free survival benefit corresponded to a 44% reduced risk of recurrence or death in patients who received the personalized vaccine plus pembrolizumab compared with the immunotherapy alone.

The randomized phase 2b trial is the first to show a positive result for a cancer vaccine in a randomized trial. The results, if confirmed in further studies, hold promise for treating other solid tumors with sensitivity to the programmed death-1 (PD-1) protein, investigators said.

“KEYNOTE-942 is the first randomized study to demonstrate improvement in recurrence-free survival in melanoma, or in any cancer in my view, with an individualized neoantigen vaccine approach,” trial investigator Jeffrey S. Weber, MD, PhD, of NYU Langone Perlmutter Cancer Center in New York, said during an oral abstract session at the annual meeting of the American Association for Cancer Research.

“I have every confidence that this strategy will be expanded to other histologies that are PD-1 sensitive, such as non–small cell lung cancer, renal cell cancer, hepatocellular cancer, gastroesophageal cancer, et cetera,” Dr. Weber said.

Invited discussant Margaret Callahan, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, called the results “exciting,” especially in light of previous results in cancer vaccine trials. “Despite hundreds of formulations and dozens of studies, cancer vaccines have been disappointing so far, and have largely failed to have a meaningful impact in oncology,” she said.
 

A promising personalized vaccine

The mRNA vaccine is individually tailored and encodes up to 34 patient-specific tumor neoantigens. The vaccine also acts as an adjuvant to strengthen the immune response.

Dr. Weber said that the “mRNA 4157 is what one would call an individualized neoantigen therapy. It will target an individual patient’s unique tumor mutations, and the revelation over the last 5-10 years, is that, for better or worse, virtually all the neoantigens are unique to an individual patient. There are very, very few true universal neoantigens, or at least universal neoantigens that could have clinical utility.”

The vaccines are developed from tumor biopsy tissues that then undergo whole exome and RNA sequencing to identify single nucleotide variants that are present in the tumor but not in normal tissue.

The findings are then fed into a computer algorithm that identifies potential neoepitope peptides that would bind well to the patient’s human leukocyte antigen (HLA) type and could evoke strong T-cell responses.

“Once they’re chosen, you concatenate the sequences together into a single-strand mRNA vaccine, it’s packaged with nanoparticles to encapsulate it, and there you have your mRNA vaccine,” Dr. Weber explained.

In the KEYNOTE-942 trial, the investigators randomly assigned patients with completely resected high-risk cutaneous melanoma on a 2:1 basis to receive mRNA-4157 via intramuscular injection every 3 weeks for a total of nine doses, plus intravenous pembrolizumab every 3 weeks for 18 cycles (107 patients) or pembrolizumab alone (50 patients). Median follow-up was 101 weeks in the combination group and 105 weeks in the pembrolizumab group.

Overall, the 18-month recurrence-free survival rates were 78.6% in the combination arm and 62.2% in the pembrolizumab arm. The recurrence-free survival rates corresponded to a 44% reduced risk of recurrence or death in patients who received the personalized vaccine plus pembrolizumab compared with those who received only pembrolizumab (hazard ratio [HR] for recurrence, 0.561; P =.0266).

Grade 3 or greater adverse events occurred in 25% of patients in the combination group and 18% of patients in the pembrolizumab group. The most common grade 3 event associated with the vaccine was fatigue. No grade 4 adverse events or deaths were associated with the vaccine, and the addition of the vaccine to pembrolizumab did not appear to increase risk for immune-mediated adverse events.

In a subanalysis, Dr. Weber and colleagues explored the relationship between tumor mutational burden and recurrence-free survival. Higher tumor mutational burden may mean more neoepitopes to target, which is helpful when developing personalized neoantigen vaccines, explained coinvestigator Ryan Sullivan, MD, associate director of the melanoma program at Mass General Cancer Center, Boston, who presented the subanalysis results.

The investigators performed whole exome and whole transcriptome sequencing of baseline tumor biopsy samples to determine the mutational burden of tumors and defined a high mutational burden as 10 or more mutations per megabase.

Overall, in the combination group, patients with a higher tumor mutational burden at baseline showed improved outcomes (HR, 0.652; 95% confidence interval [CI], 0.284-1.494), as did patients with a lower tumor mutational burden (HR, 0.586; 95% CI, 0.243-1.415).

The authors found the same was true for patients with high vs. low tumor inflammation scores (high: HR, 0.576; 95% CI, 0.209-1.591 vs. low: HR, 0.528; 95% CI, 0.253-1.101) and higher PD-L1 expression (PD-L1 positive: HR, 0.485; 95% CI, 0.226-1.039 vs. PD-L1 negative: HR, 0.162; 95% CI, 0.038-0.685).

The hazard ratios crossed 1, which suggest that the combination was similarly effective in all patient subsets, said Dr. Sullivan.

Dr. Callahan also highlighted that the P value was based on a one-side log-rank test, “a relatively low bar to jump over” and that there were slight imbalances in both PD-1 expression status and tumor mutational burden – both of which favored the vaccine group and may be associated with better recurrence-free survival.

The 16% difference in recurrence-free survival seen with the combination vs. pembrolizumab alone, if confirmed in further studies, “is clinically meaningful for high-risk patients,” said Dr. Callahan. “The authors are to be congratulated for presenting the first randomized study of a neoantigen vaccine with a clinical efficacy primary endpoint, and this is a trial that incorporates many of the lessons we’ve learned along the years.”

Dr. Sullivan also commented on the promising results. “The field of cancer vaccines is a wasteland of failed clinical trials after some initial promising data, so to have something like this where it does appear that this vaccine strategy works is good not only for patients with melanoma but for those people who have dedicated their lives to trying to develop cancer vaccines,” he said in an interview.

KEYNOTE-942 was funded by Moderna with collaboration from Merck. Dr. Weber has financial relationships with Merck, Moderna, and other companies. Dr. Sullivan has served as a paid consultant for Merck and has received research funding from the company. Dr. Callahan disclosed a consulting/advisory role with Moderna, Merck, and others.
 

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

In a phase 2 clinical trial of a potential treatment for fatigue associated with long COVID-19, people who received the medicine reported positive results over those receiving a placebo.

The study was conducted by researchers at the University of Oxford, England, and published in eClinical Medicine.

It was one of the first randomized double-blind placebo controlled trial for a possible treatment for long COVID, according to a press release from the university. 

“People living with long COVID in the trial who received AXA1125 had a significant improvement in fatigue compared to those who received a placebo,” the university reported.

Forty-one people participated. They had fatigue for 18 months beforehand. All completed the study, and none reported serious side effects.

AXA1125 was developed by U.S. pharmaceutical company Axcella Therapeutics.

“Potential causes [of long COVID fatigue] include reduced mitochondrial function and cellular bioenergetics,” the researchers reported.

“AXA1125 was tested in long COVID fatigue as previous data from Axcella showed effects on cellular energetics and inflammation. Emerging data on long COVID suggests that the virus targets the mitochondrial, which are essential to normal energy generation and control of inflammation,” the university noted in its press release. “AXA1125 may improve energy generation and reduce the amount of inflammation in the body.”

The study’s authors wrote that AXA1125 was tied to a “significant reduction in 28-day Chalder Fatigue Questionnaire score relative to placebo.” They said participants who reported less fatigue also had better mitochondrial health and walked farther in a 6-minute test.
 

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

In a phase 2 clinical trial of a potential treatment for fatigue associated with long COVID-19, people who received the medicine reported positive results over those receiving a placebo.

The study was conducted by researchers at the University of Oxford, England, and published in eClinical Medicine.

It was one of the first randomized double-blind placebo controlled trial for a possible treatment for long COVID, according to a press release from the university. 

“People living with long COVID in the trial who received AXA1125 had a significant improvement in fatigue compared to those who received a placebo,” the university reported.

Forty-one people participated. They had fatigue for 18 months beforehand. All completed the study, and none reported serious side effects.

AXA1125 was developed by U.S. pharmaceutical company Axcella Therapeutics.

“Potential causes [of long COVID fatigue] include reduced mitochondrial function and cellular bioenergetics,” the researchers reported.

“AXA1125 was tested in long COVID fatigue as previous data from Axcella showed effects on cellular energetics and inflammation. Emerging data on long COVID suggests that the virus targets the mitochondrial, which are essential to normal energy generation and control of inflammation,” the university noted in its press release. “AXA1125 may improve energy generation and reduce the amount of inflammation in the body.”

The study’s authors wrote that AXA1125 was tied to a “significant reduction in 28-day Chalder Fatigue Questionnaire score relative to placebo.” They said participants who reported less fatigue also had better mitochondrial health and walked farther in a 6-minute test.
 

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

In a phase 2 clinical trial of a potential treatment for fatigue associated with long COVID-19, people who received the medicine reported positive results over those receiving a placebo.

The study was conducted by researchers at the University of Oxford, England, and published in eClinical Medicine.

It was one of the first randomized double-blind placebo controlled trial for a possible treatment for long COVID, according to a press release from the university. 

“People living with long COVID in the trial who received AXA1125 had a significant improvement in fatigue compared to those who received a placebo,” the university reported.

Forty-one people participated. They had fatigue for 18 months beforehand. All completed the study, and none reported serious side effects.

AXA1125 was developed by U.S. pharmaceutical company Axcella Therapeutics.

“Potential causes [of long COVID fatigue] include reduced mitochondrial function and cellular bioenergetics,” the researchers reported.

“AXA1125 was tested in long COVID fatigue as previous data from Axcella showed effects on cellular energetics and inflammation. Emerging data on long COVID suggests that the virus targets the mitochondrial, which are essential to normal energy generation and control of inflammation,” the university noted in its press release. “AXA1125 may improve energy generation and reduce the amount of inflammation in the body.”

The study’s authors wrote that AXA1125 was tied to a “significant reduction in 28-day Chalder Fatigue Questionnaire score relative to placebo.” They said participants who reported less fatigue also had better mitochondrial health and walked farther in a 6-minute test.
 

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

COVID can more than triple the chance of being diagnosed with type 2 diabetes within a year of being infected, according to a new Canadian study.

Men who had even a mild case of COVID were significantly more likely than were noninfected men to be diagnosed with type 2 diabetes. Women didn’t have an increased risk unless they were severely ill.

Both men and women who had severe cases were at the highest risk. People who were hospitalized for COVID treatment had more than a doubled risk of being diagnosed with type 2 diabetes, and those who were admitted to intensive care units had more than a tripled risk.

“This is definitely a concern in terms of long-term outcomes,” researcher and University of British Columbia professor Naveed Z. Janjua, PhD, told The New York Times. “With a respiratory infection, you usually think, ‘Seven or eight days and I’m done with it, that’s it.’ [But] here we’re seeing lingering effects that are lifelong.”

The study was published in JAMA Network Open. Researchers analyzed health data from 2020 and 2021 for 629,935 people, 20% of whom were diagnosed with COVID during that time. Most people in the study had not been vaccinated because vaccines were not widely available then. The health information came from a registry maintained by public health officials in British Columbia. The follow-up period was 257 days.

The authors cautioned that their findings could not say that COVID causes type 2 diabetes; rather, in a commentary published along with the study, Pamela B. Davis, MD, PhD, said the link makes sense because COVID is known to impact the pancreas.

“Such a stress may move a patient from a prediabetic state into diabetes,” wrote Dr. Davis, former dean of Case Western Reserve University, Cleveland, where she is now a professor.

The researchers estimated that the increased pattern of diagnoses of diabetes following COVID infection could increase the rate of the disease occurring in the general population by 3%-5% overall.
 

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

COVID can more than triple the chance of being diagnosed with type 2 diabetes within a year of being infected, according to a new Canadian study.

Men who had even a mild case of COVID were significantly more likely than were noninfected men to be diagnosed with type 2 diabetes. Women didn’t have an increased risk unless they were severely ill.

Both men and women who had severe cases were at the highest risk. People who were hospitalized for COVID treatment had more than a doubled risk of being diagnosed with type 2 diabetes, and those who were admitted to intensive care units had more than a tripled risk.

“This is definitely a concern in terms of long-term outcomes,” researcher and University of British Columbia professor Naveed Z. Janjua, PhD, told The New York Times. “With a respiratory infection, you usually think, ‘Seven or eight days and I’m done with it, that’s it.’ [But] here we’re seeing lingering effects that are lifelong.”

The study was published in JAMA Network Open. Researchers analyzed health data from 2020 and 2021 for 629,935 people, 20% of whom were diagnosed with COVID during that time. Most people in the study had not been vaccinated because vaccines were not widely available then. The health information came from a registry maintained by public health officials in British Columbia. The follow-up period was 257 days.

The authors cautioned that their findings could not say that COVID causes type 2 diabetes; rather, in a commentary published along with the study, Pamela B. Davis, MD, PhD, said the link makes sense because COVID is known to impact the pancreas.

“Such a stress may move a patient from a prediabetic state into diabetes,” wrote Dr. Davis, former dean of Case Western Reserve University, Cleveland, where she is now a professor.

The researchers estimated that the increased pattern of diagnoses of diabetes following COVID infection could increase the rate of the disease occurring in the general population by 3%-5% overall.
 

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

COVID can more than triple the chance of being diagnosed with type 2 diabetes within a year of being infected, according to a new Canadian study.

Men who had even a mild case of COVID were significantly more likely than were noninfected men to be diagnosed with type 2 diabetes. Women didn’t have an increased risk unless they were severely ill.

Both men and women who had severe cases were at the highest risk. People who were hospitalized for COVID treatment had more than a doubled risk of being diagnosed with type 2 diabetes, and those who were admitted to intensive care units had more than a tripled risk.

“This is definitely a concern in terms of long-term outcomes,” researcher and University of British Columbia professor Naveed Z. Janjua, PhD, told The New York Times. “With a respiratory infection, you usually think, ‘Seven or eight days and I’m done with it, that’s it.’ [But] here we’re seeing lingering effects that are lifelong.”

The study was published in JAMA Network Open. Researchers analyzed health data from 2020 and 2021 for 629,935 people, 20% of whom were diagnosed with COVID during that time. Most people in the study had not been vaccinated because vaccines were not widely available then. The health information came from a registry maintained by public health officials in British Columbia. The follow-up period was 257 days.

The authors cautioned that their findings could not say that COVID causes type 2 diabetes; rather, in a commentary published along with the study, Pamela B. Davis, MD, PhD, said the link makes sense because COVID is known to impact the pancreas.

“Such a stress may move a patient from a prediabetic state into diabetes,” wrote Dr. Davis, former dean of Case Western Reserve University, Cleveland, where she is now a professor.

The researchers estimated that the increased pattern of diagnoses of diabetes following COVID infection could increase the rate of the disease occurring in the general population by 3%-5% overall.
 

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

Poor diets account for most newly diagnosed type 2 diabetes cases worldwide, a new analysis has found.

More specifically, the modeling study showed that roughly 14 million cases of type 2 diabetes – or 70% of total type 2 diabetes diagnoses in 2018 – were linked with a poor diet, found Meghan O’Hearn, a doctoral student at the Friedman School of Nutrition Science and Policy, Tufts University, Boston, and colleagues. The study was published online in Nature Medicine.

The results also indicate that the greatest burdens of type 2 diabetes were accounted for by excess wheat intake and refined rice (24.6%), excess processed meat consumption (20.3%), and inadequate whole-grain consumption (26.1%). Factors such as drinking too much fruit juice and not eating enough nonstarchy vegetables, nuts, or seeds, had less of an impact on new cases of the disease, the researchers determined.

“These findings can help inform nutritional priorities for clinicians, policymakers, and private sector actors as they encourage healthier dietary choices that address this global epidemic,” Ms. O’Hearn said in a press release.

Prior research has suggested that poor diet contributes to about 40% of type 2 diabetes cases worldwide, the researchers note.

The team attributes their finding of a 70% contribution to the new information in their analysis, such as the first-ever inclusion of refined grains, which was one of the top contributors to diabetes burden, and updated data on dietary habits based on national individual-level dietary surveys rather than agricultural estimates. 

“Our study suggests poor carbohydrate quality is a leading driver of diet-attributable type 2 diabetes globally and with important variation by nation and over time,” said senior author Dariush Mozaffarian, MD, DrPh, MPH, who is the Jean Mayer Professor of Nutrition at the Friedman School of Nutrition Science and Policy.

“These new findings reveal critical areas for national and global focus to improve nutrition and reduce devastating burdens of diabetes,” he noted.

“Left unchecked and with incidence only projected to rise, type 2 diabetes will continue to impact population health, economic productivity, [and] health care system capacity, [as well as] drive health inequities worldwide,” Ms. O’Hearn said.
 

It’s about reducing harmful dietary components

Ms. O’Hearn and colleagues set out to fill information gaps in knowledge about how the global burden of diet-associated type 2 diabetes is impacted by disparities and other factors known to influence risk, including dietary components.

They used information from the Global Dietary Database to study dietary intake in 184 nations from 1990 to 2018. They also studied demographics from multiple sources, estimates of type 2 diabetes incidence around the world, and data on food choices, including the effect of 11 dietary factors, from prior research.

They found that there were 8.6 million more cases of type 2 diabetes in 2018 than in 1990 because of poor diet. 

Regionally, Central and Eastern Europe and Central Asia had the greatest number of type 2 diabetes cases linked to diet, particularly Poland and Russia, where diets tend to be rich in red meat, processed meat, and potatoes. Incidence was also high in Latin America and the Caribbean, especially in Colombia and Mexico, which was attributed to high consumption of sugary drinks and processed meat and low intake of whole grains.

Regions where diet had less of an impact on type 2 diabetes cases included South Asia and sub-Saharan Africa, although the largest increases in type 2 diabetes due to poor diet between 1990 and 2018 were observed in sub-Saharan Africa.

Diet-attributable type 2 diabetes was generally larger among urban versus rural residents and higher versus lower educated individuals, except in high-income countries, Central and Eastern Europe, and Central Asia, where burdens were larger in rural residents and in lower educated individuals.

Notably, women had lower proportions of diet-related type 2 diabetes, compared with men, and these proportions were inversely related to age.

Excess intake of harmful dietary factors contributed a greater percentage of the burden of type 2 diabetes globally (60.8%) than did insufficient intake of protective dietary factors (39.2%).

“Future research should address whether more complex diet–type 2 diabetes dose–response relationships exist,” the authors conclude.

Ms. O’Hearn has reported receiving research funding from the Gates Foundation, as well as the National Institutes of Health and Vail Innovative Global Research and employment with Food Systems for the Future. Dr. Mozaffarian has reported receiving funding from the National Institutes of Health, the Gates Foundation, the Rockefeller Foundation, Vail Innovative Global Research, and the Kaiser Permanente Fund at East Bay Community Foundation; personal fees from Acasti Pharma, Barilla, Danone, and Motif FoodWorks; is on the scientific advisory board for Beren Therapeutics, Brightseed, Calibrate, DiscernDx, Elysium Health, Filtricine, HumanCo, January, Perfect Day, Tiny Organics and (ended) Day Two and Season Health; has stock ownership in Calibrate and HumanCo; and receives chapter royalties from UpToDate.

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

Poor diets account for most newly diagnosed type 2 diabetes cases worldwide, a new analysis has found.

More specifically, the modeling study showed that roughly 14 million cases of type 2 diabetes – or 70% of total type 2 diabetes diagnoses in 2018 – were linked with a poor diet, found Meghan O’Hearn, a doctoral student at the Friedman School of Nutrition Science and Policy, Tufts University, Boston, and colleagues. The study was published online in Nature Medicine.

The results also indicate that the greatest burdens of type 2 diabetes were accounted for by excess wheat intake and refined rice (24.6%), excess processed meat consumption (20.3%), and inadequate whole-grain consumption (26.1%). Factors such as drinking too much fruit juice and not eating enough nonstarchy vegetables, nuts, or seeds, had less of an impact on new cases of the disease, the researchers determined.

“These findings can help inform nutritional priorities for clinicians, policymakers, and private sector actors as they encourage healthier dietary choices that address this global epidemic,” Ms. O’Hearn said in a press release.

Prior research has suggested that poor diet contributes to about 40% of type 2 diabetes cases worldwide, the researchers note.

The team attributes their finding of a 70% contribution to the new information in their analysis, such as the first-ever inclusion of refined grains, which was one of the top contributors to diabetes burden, and updated data on dietary habits based on national individual-level dietary surveys rather than agricultural estimates. 

“Our study suggests poor carbohydrate quality is a leading driver of diet-attributable type 2 diabetes globally and with important variation by nation and over time,” said senior author Dariush Mozaffarian, MD, DrPh, MPH, who is the Jean Mayer Professor of Nutrition at the Friedman School of Nutrition Science and Policy.

“These new findings reveal critical areas for national and global focus to improve nutrition and reduce devastating burdens of diabetes,” he noted.

“Left unchecked and with incidence only projected to rise, type 2 diabetes will continue to impact population health, economic productivity, [and] health care system capacity, [as well as] drive health inequities worldwide,” Ms. O’Hearn said.
 

It’s about reducing harmful dietary components

Ms. O’Hearn and colleagues set out to fill information gaps in knowledge about how the global burden of diet-associated type 2 diabetes is impacted by disparities and other factors known to influence risk, including dietary components.

They used information from the Global Dietary Database to study dietary intake in 184 nations from 1990 to 2018. They also studied demographics from multiple sources, estimates of type 2 diabetes incidence around the world, and data on food choices, including the effect of 11 dietary factors, from prior research.

They found that there were 8.6 million more cases of type 2 diabetes in 2018 than in 1990 because of poor diet. 

Regionally, Central and Eastern Europe and Central Asia had the greatest number of type 2 diabetes cases linked to diet, particularly Poland and Russia, where diets tend to be rich in red meat, processed meat, and potatoes. Incidence was also high in Latin America and the Caribbean, especially in Colombia and Mexico, which was attributed to high consumption of sugary drinks and processed meat and low intake of whole grains.

Regions where diet had less of an impact on type 2 diabetes cases included South Asia and sub-Saharan Africa, although the largest increases in type 2 diabetes due to poor diet between 1990 and 2018 were observed in sub-Saharan Africa.

Diet-attributable type 2 diabetes was generally larger among urban versus rural residents and higher versus lower educated individuals, except in high-income countries, Central and Eastern Europe, and Central Asia, where burdens were larger in rural residents and in lower educated individuals.

Notably, women had lower proportions of diet-related type 2 diabetes, compared with men, and these proportions were inversely related to age.

Excess intake of harmful dietary factors contributed a greater percentage of the burden of type 2 diabetes globally (60.8%) than did insufficient intake of protective dietary factors (39.2%).

“Future research should address whether more complex diet–type 2 diabetes dose–response relationships exist,” the authors conclude.

Ms. O’Hearn has reported receiving research funding from the Gates Foundation, as well as the National Institutes of Health and Vail Innovative Global Research and employment with Food Systems for the Future. Dr. Mozaffarian has reported receiving funding from the National Institutes of Health, the Gates Foundation, the Rockefeller Foundation, Vail Innovative Global Research, and the Kaiser Permanente Fund at East Bay Community Foundation; personal fees from Acasti Pharma, Barilla, Danone, and Motif FoodWorks; is on the scientific advisory board for Beren Therapeutics, Brightseed, Calibrate, DiscernDx, Elysium Health, Filtricine, HumanCo, January, Perfect Day, Tiny Organics and (ended) Day Two and Season Health; has stock ownership in Calibrate and HumanCo; and receives chapter royalties from UpToDate.

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

Poor diets account for most newly diagnosed type 2 diabetes cases worldwide, a new analysis has found.

More specifically, the modeling study showed that roughly 14 million cases of type 2 diabetes – or 70% of total type 2 diabetes diagnoses in 2018 – were linked with a poor diet, found Meghan O’Hearn, a doctoral student at the Friedman School of Nutrition Science and Policy, Tufts University, Boston, and colleagues. The study was published online in Nature Medicine.

The results also indicate that the greatest burdens of type 2 diabetes were accounted for by excess wheat intake and refined rice (24.6%), excess processed meat consumption (20.3%), and inadequate whole-grain consumption (26.1%). Factors such as drinking too much fruit juice and not eating enough nonstarchy vegetables, nuts, or seeds, had less of an impact on new cases of the disease, the researchers determined.

“These findings can help inform nutritional priorities for clinicians, policymakers, and private sector actors as they encourage healthier dietary choices that address this global epidemic,” Ms. O’Hearn said in a press release.

Prior research has suggested that poor diet contributes to about 40% of type 2 diabetes cases worldwide, the researchers note.

The team attributes their finding of a 70% contribution to the new information in their analysis, such as the first-ever inclusion of refined grains, which was one of the top contributors to diabetes burden, and updated data on dietary habits based on national individual-level dietary surveys rather than agricultural estimates. 

“Our study suggests poor carbohydrate quality is a leading driver of diet-attributable type 2 diabetes globally and with important variation by nation and over time,” said senior author Dariush Mozaffarian, MD, DrPh, MPH, who is the Jean Mayer Professor of Nutrition at the Friedman School of Nutrition Science and Policy.

“These new findings reveal critical areas for national and global focus to improve nutrition and reduce devastating burdens of diabetes,” he noted.

“Left unchecked and with incidence only projected to rise, type 2 diabetes will continue to impact population health, economic productivity, [and] health care system capacity, [as well as] drive health inequities worldwide,” Ms. O’Hearn said.
 

It’s about reducing harmful dietary components

Ms. O’Hearn and colleagues set out to fill information gaps in knowledge about how the global burden of diet-associated type 2 diabetes is impacted by disparities and other factors known to influence risk, including dietary components.

They used information from the Global Dietary Database to study dietary intake in 184 nations from 1990 to 2018. They also studied demographics from multiple sources, estimates of type 2 diabetes incidence around the world, and data on food choices, including the effect of 11 dietary factors, from prior research.

They found that there were 8.6 million more cases of type 2 diabetes in 2018 than in 1990 because of poor diet. 

Regionally, Central and Eastern Europe and Central Asia had the greatest number of type 2 diabetes cases linked to diet, particularly Poland and Russia, where diets tend to be rich in red meat, processed meat, and potatoes. Incidence was also high in Latin America and the Caribbean, especially in Colombia and Mexico, which was attributed to high consumption of sugary drinks and processed meat and low intake of whole grains.

Regions where diet had less of an impact on type 2 diabetes cases included South Asia and sub-Saharan Africa, although the largest increases in type 2 diabetes due to poor diet between 1990 and 2018 were observed in sub-Saharan Africa.

Diet-attributable type 2 diabetes was generally larger among urban versus rural residents and higher versus lower educated individuals, except in high-income countries, Central and Eastern Europe, and Central Asia, where burdens were larger in rural residents and in lower educated individuals.

Notably, women had lower proportions of diet-related type 2 diabetes, compared with men, and these proportions were inversely related to age.

Excess intake of harmful dietary factors contributed a greater percentage of the burden of type 2 diabetes globally (60.8%) than did insufficient intake of protective dietary factors (39.2%).

“Future research should address whether more complex diet–type 2 diabetes dose–response relationships exist,” the authors conclude.

Ms. O’Hearn has reported receiving research funding from the Gates Foundation, as well as the National Institutes of Health and Vail Innovative Global Research and employment with Food Systems for the Future. Dr. Mozaffarian has reported receiving funding from the National Institutes of Health, the Gates Foundation, the Rockefeller Foundation, Vail Innovative Global Research, and the Kaiser Permanente Fund at East Bay Community Foundation; personal fees from Acasti Pharma, Barilla, Danone, and Motif FoodWorks; is on the scientific advisory board for Beren Therapeutics, Brightseed, Calibrate, DiscernDx, Elysium Health, Filtricine, HumanCo, January, Perfect Day, Tiny Organics and (ended) Day Two and Season Health; has stock ownership in Calibrate and HumanCo; and receives chapter royalties from UpToDate.

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

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

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

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

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

The Centers for Disease Control and Prevention has endorsed a plan to “allow” people over age 65 and those who are immunocompromised to get a second dose of the COVID-19 bivalent booster.

This backs the Food and Drug Administration’s authorization April 18 of the additional shot.

“Following FDA regulatory action, CDC has taken steps to simplify COVID-19 vaccine recommendations and allow more flexibility for people at higher risk who want the option of added protection from additional COVID-19 vaccine doses,” the CDC said in a statement.

The agency is following the recommendations made by its Advisory Committee on Immunization Practices (ACIP). While there was no vote, the group reaffirmed its commitment to boosters overall, proposing that all Americans over age 6 who have not had a bivalent mRNA COVID-19 booster vaccine go ahead and get one.

But most others who’ve already had the bivalent shot – which targets the original COVID strain and the two Omicron variants BA.4 and BA.5 – should wait until the fall to get whatever updated vaccine is available.

The panel did carve out exceptions for people over age 65 and those who are immunocompromised because they are at higher risk for severe COVID-19 complications, Evelyn Twentyman, MD, MPH, the lead official in the CDC’s COVID-19 Vaccine Policy Unit, said during the meeting.

People over 65 can now choose to get a second bivalent mRNA booster shot as long as it has been at least 4 months since the last one, she said, and people who are immunocompromised also should have the flexibility to receive one or more additional bivalent boosters at least 2 months after an initial dose.

Regardless of whether someone is unvaccinated, and regardless of how many single-strain COVID vaccines an individual has previously received, they should get a mRNA bivalent shot, Dr. Twentyman said.

If an individual has already received a bivalent mRNA booster – made by either Pfizer/BioNTech or Moderna – “your vaccination is complete,” she said. “No doses indicated at this time, come back and see us in autumn of 2023.”

The CDC is trying to encourage more people to get the updated COVID shot, as just 17% of Americans of any age have received a bivalent booster and only 43% of those age 65 and over.

The CDC followed the FDA’s lead in its statement, phasing out the original single-strain COVID vaccine, saying it will no longer be recommended for use in the United States.
 

‘Unnecessary drama’ over children’s recs

The CDC panel mostly followed the FDA’s guidance on who should get a booster, but many ACIP members expressed consternation and confusion about what was being recommended for children.

For children aged 6 months to 4 years, the CDC will offer tables to help physicians determine how many bivalent doses to give, depending on the child’s vaccination history.

All children those ages should get at least two vaccine doses, one of which is bivalent, Dr. Twentyman said. For children in that age group who have already received a monovalent series and a bivalent dose, “their vaccination is complete,” she said.

For 5-year-olds, the recommendations will be similar if they received a Pfizer monovalent series, but the shot regimen will have to be customized if they had previously received a Moderna shot, because of differences in the dosages.

ACIP member Sarah S. Long, MD, professor of pediatrics, Drexel University, Philadelphia, said that it was unclear why a set age couldn’t be established for COVID-19 vaccination as it had been for other immunizations.

“We picked 60 months for most immunizations in children,” Dr. Long said. “Immunologically there is not a difference between a 4-, a 5- and a 6-year-old.

“There isn’t a reason to have all this unnecessary drama around those ages,” she said, adding that having the different ages would make it harder for pediatricians to appropriately stock vaccines.

Dr. Twentyman said that the CDC would be providing more detailed guidance on its COVID-19 website soon and would be holding a call with health care professionals to discuss the updated recommendations on May 11.
 

New vaccine by fall

CDC and ACIP members both said they hoped to have an even simpler vaccine schedule by the fall, when it is anticipated that the FDA may have authorized a new, updated bivalent vaccine that targets other COVID variants.

“We all recognize this is a work in progress,” said ACIP Chair Grace M. Lee, MD, MPH, acknowledging that there is continued confusion over COVID-19 vaccination.

“The goal really is to try to simplify things over time to be able to help communicate with our provider community, and our patients and families what vaccine is right for them, when do they need it, and how often should they get it,” said Dr. Lee, professor of pediatrics, Stanford (Calif.) University.
 

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

Drinking sugar-sweetened beverages (SSBs) increases the risk of cardiovascular disease and all-cause death in people with type 2 diabetes, reveals a U.S. study that also suggests switching to coffee, tea, or low-fat milk may diminish these risks.

The researchers examined data on almost 15,500 participants with type 2 diabetes from two major studies, finding that the highest level of consumption of SSBs was associated with a 20% increased risk of all-cause mortality and a 25% raised risk of cardiovascular disease, compared with consumption of the least amounts of these products.

The research, published in BMJ, also showed that drinking coffee, tea, plain water, and low-fat milk reduced the risk of all-cause death and that switching from SSBs to the other beverages was linked to lower mortality.

“Overall, these results provide additional evidence that emphasizes the importance of beverage choices in maintaining overall health among adults with diabetes,” say senior author Le Ma, PhD, department of nutrition, Harvard School of Public Health, Boston, and colleagues.

“Collectively, these findings all point in the same direction. Lower consumption of SSBs and higher consumption of coffee, tea, plain water, or low-fat milk are optimal for better health outcomes in adults with type 2 diabetes,” Nita G. Forouhi, MD, PhD, emphasizes in an accompanying editorial.


 

Choice of drink matters

Dr. Forouhi, from the University of Cambridge (England), warned, however, that the findings “cannot be considered cause and effect,” despite the large-scale analysis.

Moreover, “questions remain,” such as the impact of beverage consumption on coronary heart disease and stroke risk, and cancer mortality, with the current study providing “inconclusive” data on the latter.

There was also no data on the addition of sugar to tea or coffee, “so the comparative health effects of unsweetened and sweetened hot beverages remain unclear,” Dr. Forouhi points out. Also unknown is whether the type of tea consumed has a differential effect.

Despite these and other reservations, she says that overall, “Choice of beverage clearly matters.”

“The case for avoiding sugar-sweetened beverages is compelling, and it is supported by various fiscal measures in more than 45 countries. It is reasonable to shift the focus to drinks that are most likely to have positive health impacts: coffee, tea, plain water, and low-fat milk,” she notes.

Dr. Forouhi ends by underlining that the current findings tally with those seen in the general population, so “one important message is that having diabetes does not have to be especially restrictive.”
 

Expanding the evidence

It was estimated that 537 million adults worldwide had type 2 diabetes in 2021, a figure set to increase to 783 million by 2045, say the authors.

Individuals with type 2 diabetes have an increased risk of cardiovascular disease, among many other comorbidities, as well as premature death. Dietary interventions can play an important role in managing these risks.

Recommendations on the healthiest beverages to drink are largely based on evidence from the general population, and data are limited on the best options for adults with type 2 diabetes, who have altered metabolism, the researchers note.

To expand on this, they examined data from the Nurses’ Health Study, which enrolled female registered nurses aged 30-55 years and was initiated in 1976, and the Health Professionals Follow-Up Study, which included male health professionals aged 40-75 years and was initiated in 1996.

For the current analysis, 11,399 women and 4,087 men with type 2 diabetes were included from the two studies, of whom 2,715 were diagnosed before study entry.

Participants’ average daily beverage intake was assessed using a validated food frequency questionnaire administered every 2-4 years. SSBs included caffeinated and caffeine-free colas, other carbonated SSBs, and noncarbonated SSBs, such as fruit punches, lemonades, or other fruit drinks.

During 285,967 person-years of follow-up, there were 7,638 (49.3%) deaths, and 3,447 (22.3%) cases of incident cardiovascular disease were documented during 248,447 person-years of follow-up.

Fully adjusted multivariate analysis comparing the lowest and highest beverage intake indicated that SSBs were associated with a significant increase in all-cause mortality, at a pooled hazard ratio of 1.20, or 1.08 for each additional serving per day (P = .01).

In contrast, the associations between all-cause mortality and consumption of artificially sweetened beverages, fruit juice, and full-fat milk were not significant, whereas coffee (HR, 0.74), tea (HR, 0.79), plain water (HR, 0.77), and low-fat milk (HR, 0.88) were linked to a reduced risk.

The team reported that there were similar associations between beverage intake and cardiovascular disease incidence, at an HR of 1.25 for SSBs, as well as for cardiovascular disease mortality, at an HR of 1.29.

Participants who increased their tea, coffee, and low-fat milk consumption during the course of the study had lower all-cause mortality than those who did not. Switching from SSBs to other beverages was also associated with lower mortality.

The researchers note, however, that there are “several potential limitations” to their study, including that “individual beverage consumption may be correlated with other dietary and lifestyle risk factors for cardiovascular disease incidence and mortality among adults with [type 2] diabetes.”

The study was sponsored by the National Institutes of Health. Dr. Ma has reported no relevant financial relationships. Disclosures for the other authors are listed with the article. Dr. Forouhi has declared receiving support from the U.K. Medical Research Council Epidemiology Unit and U.K. National Institute for Health and Care Research Biomedical Research Centre Cambridge.

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

Drinking sugar-sweetened beverages (SSBs) increases the risk of cardiovascular disease and all-cause death in people with type 2 diabetes, reveals a U.S. study that also suggests switching to coffee, tea, or low-fat milk may diminish these risks.

The researchers examined data on almost 15,500 participants with type 2 diabetes from two major studies, finding that the highest level of consumption of SSBs was associated with a 20% increased risk of all-cause mortality and a 25% raised risk of cardiovascular disease, compared with consumption of the least amounts of these products.

The research, published in BMJ, also showed that drinking coffee, tea, plain water, and low-fat milk reduced the risk of all-cause death and that switching from SSBs to the other beverages was linked to lower mortality.

“Overall, these results provide additional evidence that emphasizes the importance of beverage choices in maintaining overall health among adults with diabetes,” say senior author Le Ma, PhD, department of nutrition, Harvard School of Public Health, Boston, and colleagues.

“Collectively, these findings all point in the same direction. Lower consumption of SSBs and higher consumption of coffee, tea, plain water, or low-fat milk are optimal for better health outcomes in adults with type 2 diabetes,” Nita G. Forouhi, MD, PhD, emphasizes in an accompanying editorial.


 

Choice of drink matters

Dr. Forouhi, from the University of Cambridge (England), warned, however, that the findings “cannot be considered cause and effect,” despite the large-scale analysis.

Moreover, “questions remain,” such as the impact of beverage consumption on coronary heart disease and stroke risk, and cancer mortality, with the current study providing “inconclusive” data on the latter.

There was also no data on the addition of sugar to tea or coffee, “so the comparative health effects of unsweetened and sweetened hot beverages remain unclear,” Dr. Forouhi points out. Also unknown is whether the type of tea consumed has a differential effect.

Despite these and other reservations, she says that overall, “Choice of beverage clearly matters.”

“The case for avoiding sugar-sweetened beverages is compelling, and it is supported by various fiscal measures in more than 45 countries. It is reasonable to shift the focus to drinks that are most likely to have positive health impacts: coffee, tea, plain water, and low-fat milk,” she notes.

Dr. Forouhi ends by underlining that the current findings tally with those seen in the general population, so “one important message is that having diabetes does not have to be especially restrictive.”
 

Expanding the evidence

It was estimated that 537 million adults worldwide had type 2 diabetes in 2021, a figure set to increase to 783 million by 2045, say the authors.

Individuals with type 2 diabetes have an increased risk of cardiovascular disease, among many other comorbidities, as well as premature death. Dietary interventions can play an important role in managing these risks.

Recommendations on the healthiest beverages to drink are largely based on evidence from the general population, and data are limited on the best options for adults with type 2 diabetes, who have altered metabolism, the researchers note.

To expand on this, they examined data from the Nurses’ Health Study, which enrolled female registered nurses aged 30-55 years and was initiated in 1976, and the Health Professionals Follow-Up Study, which included male health professionals aged 40-75 years and was initiated in 1996.

For the current analysis, 11,399 women and 4,087 men with type 2 diabetes were included from the two studies, of whom 2,715 were diagnosed before study entry.

Participants’ average daily beverage intake was assessed using a validated food frequency questionnaire administered every 2-4 years. SSBs included caffeinated and caffeine-free colas, other carbonated SSBs, and noncarbonated SSBs, such as fruit punches, lemonades, or other fruit drinks.

During 285,967 person-years of follow-up, there were 7,638 (49.3%) deaths, and 3,447 (22.3%) cases of incident cardiovascular disease were documented during 248,447 person-years of follow-up.

Fully adjusted multivariate analysis comparing the lowest and highest beverage intake indicated that SSBs were associated with a significant increase in all-cause mortality, at a pooled hazard ratio of 1.20, or 1.08 for each additional serving per day (P = .01).

In contrast, the associations between all-cause mortality and consumption of artificially sweetened beverages, fruit juice, and full-fat milk were not significant, whereas coffee (HR, 0.74), tea (HR, 0.79), plain water (HR, 0.77), and low-fat milk (HR, 0.88) were linked to a reduced risk.

The team reported that there were similar associations between beverage intake and cardiovascular disease incidence, at an HR of 1.25 for SSBs, as well as for cardiovascular disease mortality, at an HR of 1.29.

Participants who increased their tea, coffee, and low-fat milk consumption during the course of the study had lower all-cause mortality than those who did not. Switching from SSBs to other beverages was also associated with lower mortality.

The researchers note, however, that there are “several potential limitations” to their study, including that “individual beverage consumption may be correlated with other dietary and lifestyle risk factors for cardiovascular disease incidence and mortality among adults with [type 2] diabetes.”

The study was sponsored by the National Institutes of Health. Dr. Ma has reported no relevant financial relationships. Disclosures for the other authors are listed with the article. Dr. Forouhi has declared receiving support from the U.K. Medical Research Council Epidemiology Unit and U.K. National Institute for Health and Care Research Biomedical Research Centre Cambridge.

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

Drinking sugar-sweetened beverages (SSBs) increases the risk of cardiovascular disease and all-cause death in people with type 2 diabetes, reveals a U.S. study that also suggests switching to coffee, tea, or low-fat milk may diminish these risks.

The researchers examined data on almost 15,500 participants with type 2 diabetes from two major studies, finding that the highest level of consumption of SSBs was associated with a 20% increased risk of all-cause mortality and a 25% raised risk of cardiovascular disease, compared with consumption of the least amounts of these products.

The research, published in BMJ, also showed that drinking coffee, tea, plain water, and low-fat milk reduced the risk of all-cause death and that switching from SSBs to the other beverages was linked to lower mortality.

“Overall, these results provide additional evidence that emphasizes the importance of beverage choices in maintaining overall health among adults with diabetes,” say senior author Le Ma, PhD, department of nutrition, Harvard School of Public Health, Boston, and colleagues.

“Collectively, these findings all point in the same direction. Lower consumption of SSBs and higher consumption of coffee, tea, plain water, or low-fat milk are optimal for better health outcomes in adults with type 2 diabetes,” Nita G. Forouhi, MD, PhD, emphasizes in an accompanying editorial.


 

Choice of drink matters

Dr. Forouhi, from the University of Cambridge (England), warned, however, that the findings “cannot be considered cause and effect,” despite the large-scale analysis.

Moreover, “questions remain,” such as the impact of beverage consumption on coronary heart disease and stroke risk, and cancer mortality, with the current study providing “inconclusive” data on the latter.

There was also no data on the addition of sugar to tea or coffee, “so the comparative health effects of unsweetened and sweetened hot beverages remain unclear,” Dr. Forouhi points out. Also unknown is whether the type of tea consumed has a differential effect.

Despite these and other reservations, she says that overall, “Choice of beverage clearly matters.”

“The case for avoiding sugar-sweetened beverages is compelling, and it is supported by various fiscal measures in more than 45 countries. It is reasonable to shift the focus to drinks that are most likely to have positive health impacts: coffee, tea, plain water, and low-fat milk,” she notes.

Dr. Forouhi ends by underlining that the current findings tally with those seen in the general population, so “one important message is that having diabetes does not have to be especially restrictive.”
 

Expanding the evidence

It was estimated that 537 million adults worldwide had type 2 diabetes in 2021, a figure set to increase to 783 million by 2045, say the authors.

Individuals with type 2 diabetes have an increased risk of cardiovascular disease, among many other comorbidities, as well as premature death. Dietary interventions can play an important role in managing these risks.

Recommendations on the healthiest beverages to drink are largely based on evidence from the general population, and data are limited on the best options for adults with type 2 diabetes, who have altered metabolism, the researchers note.

To expand on this, they examined data from the Nurses’ Health Study, which enrolled female registered nurses aged 30-55 years and was initiated in 1976, and the Health Professionals Follow-Up Study, which included male health professionals aged 40-75 years and was initiated in 1996.

For the current analysis, 11,399 women and 4,087 men with type 2 diabetes were included from the two studies, of whom 2,715 were diagnosed before study entry.

Participants’ average daily beverage intake was assessed using a validated food frequency questionnaire administered every 2-4 years. SSBs included caffeinated and caffeine-free colas, other carbonated SSBs, and noncarbonated SSBs, such as fruit punches, lemonades, or other fruit drinks.

During 285,967 person-years of follow-up, there were 7,638 (49.3%) deaths, and 3,447 (22.3%) cases of incident cardiovascular disease were documented during 248,447 person-years of follow-up.

Fully adjusted multivariate analysis comparing the lowest and highest beverage intake indicated that SSBs were associated with a significant increase in all-cause mortality, at a pooled hazard ratio of 1.20, or 1.08 for each additional serving per day (P = .01).

In contrast, the associations between all-cause mortality and consumption of artificially sweetened beverages, fruit juice, and full-fat milk were not significant, whereas coffee (HR, 0.74), tea (HR, 0.79), plain water (HR, 0.77), and low-fat milk (HR, 0.88) were linked to a reduced risk.

The team reported that there were similar associations between beverage intake and cardiovascular disease incidence, at an HR of 1.25 for SSBs, as well as for cardiovascular disease mortality, at an HR of 1.29.

Participants who increased their tea, coffee, and low-fat milk consumption during the course of the study had lower all-cause mortality than those who did not. Switching from SSBs to other beverages was also associated with lower mortality.

The researchers note, however, that there are “several potential limitations” to their study, including that “individual beverage consumption may be correlated with other dietary and lifestyle risk factors for cardiovascular disease incidence and mortality among adults with [type 2] diabetes.”

The study was sponsored by the National Institutes of Health. Dr. Ma has reported no relevant financial relationships. Disclosures for the other authors are listed with the article. Dr. Forouhi has declared receiving support from the U.K. Medical Research Council Epidemiology Unit and U.K. National Institute for Health and Care Research Biomedical Research Centre Cambridge.

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

My son needed a physical for his football team, and we couldn’t get an appointment. So, we went to the urgent care next to the H Mart in Cary, N.C. While I was waiting, I thought, let me go get a coffee or an iced tea at the H Mart. They have this French bakery in there.

I went in and ordered my drink, and I was waiting in line. I saw this woman pass me running with a baby. Another woman – I found out later it was her sister – was running after her, and she said: “Call 911!”

“I don’t have my phone,” I said. I left my phone with my son; he was using it.

The lady came running back holding the baby. She was hysterical, screaming: “My baby’s not breathing!”

I said: “Are you okay?” And she just handed me the baby. The baby was gray, and there was blood in her nose and mouth. The woman said: “She’s my baby. She’s 1 week old.”

I was trying to think very quickly. I didn’t see any bubbles in the blood around the baby’s nose or mouth to tell me if she was breathing. She was just limp. The mom was still screaming, but I couldn’t even hear her anymore. It was like I was having an out-of-body experience. All I could hear were my thoughts: “I need to put this baby down to start CPR. Someone was calling 911. I should go in the front of the store to save time, so EMS doesn’t have to look for me when they come.”

I started moving and trying to clean the blood from the baby’s face with her blanket. At the front of the store, I saw a display of rice bags. I put the baby on top of one of the bags. “Okay, where do I check for a pulse on a baby?” I took care of adults, never pediatric patients, never babies. She was so tiny. I put my hand on her chest and felt nothing. No heartbeat. She still wasn’t breathing.

People were around me, but I couldn’t see or hear anybody. All I was thinking was: “What can I do for this patient right now?” I started CPR with two fingers. Nothing was happening. It wasn’t that long, but it felt like forever for me. I couldn’t do mouth-to-mouth because there was so much blood on her face. I still don’t know what caused the bleeding.

It was COVID time, so I had my mask on. I was, like: “You know what? Screw this. She’s a 1-week-old baby. Her lungs are tiny. Maybe I don’t have to do mouth-to-mouth. I can just blow in her mouth.” I took off my mask and opened her mouth. I took a deep breath and blew a little bit of air in her mouth. I continued CPR for maybe 5 or 10 seconds.

And then she gasped! She opened her eyes, but they were rolled up. I was still doing CPR, and maybe 2 second after that, I could feel under my hand a very rapid heart rate. I took my hand away and lifted her up.

Just then the EMS got there. I gave them the baby and said: “I did CPR. I don’t know how long it lasted.” The EMS person looked at me, said: “Thank you for what you did. Now we need you to help us with mom.” I said, “okay.”

I turned around, and the mom was still screaming and crying. I asked one of the ladies that worked there, “Can you get me water?” She brought it, and I gave some to the mom, and she started talking to EMS.

People were asking me: “What happened? What happened?” It’s funny, I guess the nurse in me didn’t want to give out information. And I didn’t want to ask for information. I was thinking about privacy. I said, “I don’t know,” and walked away.

The mom’s sister came and hugged me and said thank you. I was still in this out-of-body zone, and I just wanted to get the hell out of there. So, I left. I went to my car and when I got in it, I started shaking and sweating and crying.

I had been so calm in the moment, not thinking about if the baby was going to survive or not. I didn’t know how long she was without oxygen, if she would have some anoxic brain injury or stroke. I’m a mom, too. I would have been just as terrified as that mom. I just hoped there was a chance that she could take her baby home.

I went back to the urgent care, and my son was, like, “are you okay?” I said: “You will not believe this. I just did CPR on a baby.” He said: “Oh. Okay.” I don’t think he even knew what that meant.

I’ve been an ICU nurse since 2008. I’ve been in very critical moments with patients, life or death situations. I help save people all the time at the hospital. Most of the time, you know what you’re getting. You can prepare. You have everything you need, and everyone knows what to do. You know what the worst will look like. You know the outcome.

But this was something else. You read about things like this. You hear about them. But you never think it’ll happen to you – until it happens.

I couldn’t stop thinking about the baby. So, 2 days later, I posted on Next Door to see if somebody would read it and say, “hey, the baby survived.” I was amazed at how many people responded, but no one knew the family.

The local news got hold of me and asked me to do a story. I told them, “the only way I can do a story is if the baby survived. I’m not going to do a story about a dead baby, and the mom has to live through it again.”

The reporter called me later on that day and said she had talked to the police. They said the family was visiting from out of state. The baby went to the hospital and was discharged home 2 days later. I said, “okay, then I can talk.”

When the news story came out, I started getting texts from people at work the same night. So many people were reaching out. Even people from out of state. But I never heard from the family. No one knew how to reach them.

Since I was very young, I wanted to work in a hospital, to help people. It really brings me joy, seeing somebody go home, knowing, yes, we did this. It’s a great feeling. I love this job. I wouldn’t trade it for anything.

I just wish I had asked the mom’s name. Because I always think about that baby. I always wonder, what did she become? I hope somebody reads this who might know that little girl. It would be so nice to meet her one day.

Ms. Diallo is an ICU nurse and now works as nurse care coordinator at the University of North Carolina’s Children’s Neurology Clinic in Chapel Hill.
 

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

My son needed a physical for his football team, and we couldn’t get an appointment. So, we went to the urgent care next to the H Mart in Cary, N.C. While I was waiting, I thought, let me go get a coffee or an iced tea at the H Mart. They have this French bakery in there.

I went in and ordered my drink, and I was waiting in line. I saw this woman pass me running with a baby. Another woman – I found out later it was her sister – was running after her, and she said: “Call 911!”

“I don’t have my phone,” I said. I left my phone with my son; he was using it.

The lady came running back holding the baby. She was hysterical, screaming: “My baby’s not breathing!”

I said: “Are you okay?” And she just handed me the baby. The baby was gray, and there was blood in her nose and mouth. The woman said: “She’s my baby. She’s 1 week old.”

I was trying to think very quickly. I didn’t see any bubbles in the blood around the baby’s nose or mouth to tell me if she was breathing. She was just limp. The mom was still screaming, but I couldn’t even hear her anymore. It was like I was having an out-of-body experience. All I could hear were my thoughts: “I need to put this baby down to start CPR. Someone was calling 911. I should go in the front of the store to save time, so EMS doesn’t have to look for me when they come.”

I started moving and trying to clean the blood from the baby’s face with her blanket. At the front of the store, I saw a display of rice bags. I put the baby on top of one of the bags. “Okay, where do I check for a pulse on a baby?” I took care of adults, never pediatric patients, never babies. She was so tiny. I put my hand on her chest and felt nothing. No heartbeat. She still wasn’t breathing.

People were around me, but I couldn’t see or hear anybody. All I was thinking was: “What can I do for this patient right now?” I started CPR with two fingers. Nothing was happening. It wasn’t that long, but it felt like forever for me. I couldn’t do mouth-to-mouth because there was so much blood on her face. I still don’t know what caused the bleeding.

It was COVID time, so I had my mask on. I was, like: “You know what? Screw this. She’s a 1-week-old baby. Her lungs are tiny. Maybe I don’t have to do mouth-to-mouth. I can just blow in her mouth.” I took off my mask and opened her mouth. I took a deep breath and blew a little bit of air in her mouth. I continued CPR for maybe 5 or 10 seconds.

And then she gasped! She opened her eyes, but they were rolled up. I was still doing CPR, and maybe 2 second after that, I could feel under my hand a very rapid heart rate. I took my hand away and lifted her up.

Just then the EMS got there. I gave them the baby and said: “I did CPR. I don’t know how long it lasted.” The EMS person looked at me, said: “Thank you for what you did. Now we need you to help us with mom.” I said, “okay.”

I turned around, and the mom was still screaming and crying. I asked one of the ladies that worked there, “Can you get me water?” She brought it, and I gave some to the mom, and she started talking to EMS.

People were asking me: “What happened? What happened?” It’s funny, I guess the nurse in me didn’t want to give out information. And I didn’t want to ask for information. I was thinking about privacy. I said, “I don’t know,” and walked away.

The mom’s sister came and hugged me and said thank you. I was still in this out-of-body zone, and I just wanted to get the hell out of there. So, I left. I went to my car and when I got in it, I started shaking and sweating and crying.

I had been so calm in the moment, not thinking about if the baby was going to survive or not. I didn’t know how long she was without oxygen, if she would have some anoxic brain injury or stroke. I’m a mom, too. I would have been just as terrified as that mom. I just hoped there was a chance that she could take her baby home.

I went back to the urgent care, and my son was, like, “are you okay?” I said: “You will not believe this. I just did CPR on a baby.” He said: “Oh. Okay.” I don’t think he even knew what that meant.

I’ve been an ICU nurse since 2008. I’ve been in very critical moments with patients, life or death situations. I help save people all the time at the hospital. Most of the time, you know what you’re getting. You can prepare. You have everything you need, and everyone knows what to do. You know what the worst will look like. You know the outcome.

But this was something else. You read about things like this. You hear about them. But you never think it’ll happen to you – until it happens.

I couldn’t stop thinking about the baby. So, 2 days later, I posted on Next Door to see if somebody would read it and say, “hey, the baby survived.” I was amazed at how many people responded, but no one knew the family.

The local news got hold of me and asked me to do a story. I told them, “the only way I can do a story is if the baby survived. I’m not going to do a story about a dead baby, and the mom has to live through it again.”

The reporter called me later on that day and said she had talked to the police. They said the family was visiting from out of state. The baby went to the hospital and was discharged home 2 days later. I said, “okay, then I can talk.”

When the news story came out, I started getting texts from people at work the same night. So many people were reaching out. Even people from out of state. But I never heard from the family. No one knew how to reach them.

Since I was very young, I wanted to work in a hospital, to help people. It really brings me joy, seeing somebody go home, knowing, yes, we did this. It’s a great feeling. I love this job. I wouldn’t trade it for anything.

I just wish I had asked the mom’s name. Because I always think about that baby. I always wonder, what did she become? I hope somebody reads this who might know that little girl. It would be so nice to meet her one day.

Ms. Diallo is an ICU nurse and now works as nurse care coordinator at the University of North Carolina’s Children’s Neurology Clinic in Chapel Hill.
 

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

My son needed a physical for his football team, and we couldn’t get an appointment. So, we went to the urgent care next to the H Mart in Cary, N.C. While I was waiting, I thought, let me go get a coffee or an iced tea at the H Mart. They have this French bakery in there.

I went in and ordered my drink, and I was waiting in line. I saw this woman pass me running with a baby. Another woman – I found out later it was her sister – was running after her, and she said: “Call 911!”

“I don’t have my phone,” I said. I left my phone with my son; he was using it.

The lady came running back holding the baby. She was hysterical, screaming: “My baby’s not breathing!”

I said: “Are you okay?” And she just handed me the baby. The baby was gray, and there was blood in her nose and mouth. The woman said: “She’s my baby. She’s 1 week old.”

I was trying to think very quickly. I didn’t see any bubbles in the blood around the baby’s nose or mouth to tell me if she was breathing. She was just limp. The mom was still screaming, but I couldn’t even hear her anymore. It was like I was having an out-of-body experience. All I could hear were my thoughts: “I need to put this baby down to start CPR. Someone was calling 911. I should go in the front of the store to save time, so EMS doesn’t have to look for me when they come.”

I started moving and trying to clean the blood from the baby’s face with her blanket. At the front of the store, I saw a display of rice bags. I put the baby on top of one of the bags. “Okay, where do I check for a pulse on a baby?” I took care of adults, never pediatric patients, never babies. She was so tiny. I put my hand on her chest and felt nothing. No heartbeat. She still wasn’t breathing.

People were around me, but I couldn’t see or hear anybody. All I was thinking was: “What can I do for this patient right now?” I started CPR with two fingers. Nothing was happening. It wasn’t that long, but it felt like forever for me. I couldn’t do mouth-to-mouth because there was so much blood on her face. I still don’t know what caused the bleeding.

It was COVID time, so I had my mask on. I was, like: “You know what? Screw this. She’s a 1-week-old baby. Her lungs are tiny. Maybe I don’t have to do mouth-to-mouth. I can just blow in her mouth.” I took off my mask and opened her mouth. I took a deep breath and blew a little bit of air in her mouth. I continued CPR for maybe 5 or 10 seconds.

And then she gasped! She opened her eyes, but they were rolled up. I was still doing CPR, and maybe 2 second after that, I could feel under my hand a very rapid heart rate. I took my hand away and lifted her up.

Just then the EMS got there. I gave them the baby and said: “I did CPR. I don’t know how long it lasted.” The EMS person looked at me, said: “Thank you for what you did. Now we need you to help us with mom.” I said, “okay.”

I turned around, and the mom was still screaming and crying. I asked one of the ladies that worked there, “Can you get me water?” She brought it, and I gave some to the mom, and she started talking to EMS.

People were asking me: “What happened? What happened?” It’s funny, I guess the nurse in me didn’t want to give out information. And I didn’t want to ask for information. I was thinking about privacy. I said, “I don’t know,” and walked away.

The mom’s sister came and hugged me and said thank you. I was still in this out-of-body zone, and I just wanted to get the hell out of there. So, I left. I went to my car and when I got in it, I started shaking and sweating and crying.

I had been so calm in the moment, not thinking about if the baby was going to survive or not. I didn’t know how long she was without oxygen, if she would have some anoxic brain injury or stroke. I’m a mom, too. I would have been just as terrified as that mom. I just hoped there was a chance that she could take her baby home.

I went back to the urgent care, and my son was, like, “are you okay?” I said: “You will not believe this. I just did CPR on a baby.” He said: “Oh. Okay.” I don’t think he even knew what that meant.

I’ve been an ICU nurse since 2008. I’ve been in very critical moments with patients, life or death situations. I help save people all the time at the hospital. Most of the time, you know what you’re getting. You can prepare. You have everything you need, and everyone knows what to do. You know what the worst will look like. You know the outcome.

But this was something else. You read about things like this. You hear about them. But you never think it’ll happen to you – until it happens.

I couldn’t stop thinking about the baby. So, 2 days later, I posted on Next Door to see if somebody would read it and say, “hey, the baby survived.” I was amazed at how many people responded, but no one knew the family.

The local news got hold of me and asked me to do a story. I told them, “the only way I can do a story is if the baby survived. I’m not going to do a story about a dead baby, and the mom has to live through it again.”

The reporter called me later on that day and said she had talked to the police. They said the family was visiting from out of state. The baby went to the hospital and was discharged home 2 days later. I said, “okay, then I can talk.”

When the news story came out, I started getting texts from people at work the same night. So many people were reaching out. Even people from out of state. But I never heard from the family. No one knew how to reach them.

Since I was very young, I wanted to work in a hospital, to help people. It really brings me joy, seeing somebody go home, knowing, yes, we did this. It’s a great feeling. I love this job. I wouldn’t trade it for anything.

I just wish I had asked the mom’s name. Because I always think about that baby. I always wonder, what did she become? I hope somebody reads this who might know that little girl. It would be so nice to meet her one day.

Ms. Diallo is an ICU nurse and now works as nurse care coordinator at the University of North Carolina’s Children’s Neurology Clinic in Chapel Hill.
 

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

A green adaptation to the traditional Mediterranean diet improves proximal aortic stiffness (PAS), a distinct marker of vascular aging and increased cardiovascular risk, according to an exploratory post hoc analysis of the DIRECT-PLUS randomized clinical trial.

The green Mediterranean diet is distinct from the traditional Mediterranean diet because of its more abundant dietary polyphenols, from green tea and a Wolffia globosa (Mankai) plant green shake, and lower intake of red or processed meat.

NataliTerr/Fotolia.com

Independent of weight loss, the modified green Mediterranean diet regressed PAS by 15%, the traditional Mediterranean diet by 7.3%, and the healthy dietary guideline–based diet by 4.8%, the study team observed.

“The DIRECT-PLUS trial research team was the first to introduce the concept of the green-Mediterranean/high polyphenols diet,” lead researcher Iris Shai, RD, PhD, with Ben-Gurion University of the Negev, Be’er-Sheva, Israel, told this news organization.

This diet promoted “dramatic proximal aortic de-stiffening” as assessed by MRI over 18 months in roughly 300 participants with abdominal obesity/dyslipidemia. “To date, no dietary strategies have been shown to impact vascular aging physiology,” Dr. Shai said.

The analysis was published online in the Journal of the American College of Cardiology.  


 

Not all healthy diets are equal

Of the 294 participants, 281 had valid PAS measurements at baseline. The baseline PAS (6.1 m/s) was similar across intervention groups (P = .20). Increased PAS was associated with aging, hypertension, dyslipidemia, diabetes, and visceral adiposity (P < .05).

After 18 months’ intervention (retention rate 89.8%), all diet groups showed significant PAS reductions: –0.05 m/s with the standard healthy diet (4.8%), –0.08 m/s with the traditional Mediterranean diet (7.3%) and –0.15 the green Mediterranean diet (15%).

In the multivariable model, the green Mediterranean dieters had greater PAS reduction than did the healthy-diet and Mediterranean dieters (P = .003 and P = .032, respectively).

The researchers caution that DIRECT-PLUS had multiple endpoints and this exploratory post hoc analysis might be sensitive to type I statistical error and should be considered “hypothesis-generating.”
 

High-quality study, believable results

Reached for comment on the study, Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart in New York, said, “There is not a lot of high-quality research on diet, and I would call this high-quality research in as much as they used randomization which most dietary studies don’t do.

“The greener Mediterranean diet seemed to be the best one on the surrogate marker of MRI-defined aortic stiffness,” Dr. Bhatt, professor of cardiovascular medicine, Icahn School of Medicine at Mount Sinai, who wasn’t involved in the study, told this news organization.

“It makes sense that a diet that has more green in it, more polyphenols, would be healthier. This has been shown in some other studies, that these plant-based polyphenols might have various cardiovascular protective aspects to them,” Dr. Bhatt said.

Overall, he said the results are “quite believable, with the caveat that it would be nice to see the results reproduced in a more diverse and larger sample.”

“There is emerging evidence that diets that are higher in fresh fruits and vegetables and whole grains and lower in overall caloric intake, in general, seem to be good diets to reduce cardiovascular risk factors and maybe even reduce actual cardiovascular risk,” Dr. Bhatt added.

The study was funded by grants from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), the Rosetrees Trust, Israel Ministry of Health, Israel Ministry of Science and Technology, and the California Walnuts Commission. Dr. Shai and Dr. Bhatt have no relevant conflicts of interest.
 

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

A green adaptation to the traditional Mediterranean diet improves proximal aortic stiffness (PAS), a distinct marker of vascular aging and increased cardiovascular risk, according to an exploratory post hoc analysis of the DIRECT-PLUS randomized clinical trial.

The green Mediterranean diet is distinct from the traditional Mediterranean diet because of its more abundant dietary polyphenols, from green tea and a Wolffia globosa (Mankai) plant green shake, and lower intake of red or processed meat.

NataliTerr/Fotolia.com

Independent of weight loss, the modified green Mediterranean diet regressed PAS by 15%, the traditional Mediterranean diet by 7.3%, and the healthy dietary guideline–based diet by 4.8%, the study team observed.

“The DIRECT-PLUS trial research team was the first to introduce the concept of the green-Mediterranean/high polyphenols diet,” lead researcher Iris Shai, RD, PhD, with Ben-Gurion University of the Negev, Be’er-Sheva, Israel, told this news organization.

This diet promoted “dramatic proximal aortic de-stiffening” as assessed by MRI over 18 months in roughly 300 participants with abdominal obesity/dyslipidemia. “To date, no dietary strategies have been shown to impact vascular aging physiology,” Dr. Shai said.

The analysis was published online in the Journal of the American College of Cardiology.  


 

Not all healthy diets are equal

Of the 294 participants, 281 had valid PAS measurements at baseline. The baseline PAS (6.1 m/s) was similar across intervention groups (P = .20). Increased PAS was associated with aging, hypertension, dyslipidemia, diabetes, and visceral adiposity (P < .05).

After 18 months’ intervention (retention rate 89.8%), all diet groups showed significant PAS reductions: –0.05 m/s with the standard healthy diet (4.8%), –0.08 m/s with the traditional Mediterranean diet (7.3%) and –0.15 the green Mediterranean diet (15%).

In the multivariable model, the green Mediterranean dieters had greater PAS reduction than did the healthy-diet and Mediterranean dieters (P = .003 and P = .032, respectively).

The researchers caution that DIRECT-PLUS had multiple endpoints and this exploratory post hoc analysis might be sensitive to type I statistical error and should be considered “hypothesis-generating.”
 

High-quality study, believable results

Reached for comment on the study, Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart in New York, said, “There is not a lot of high-quality research on diet, and I would call this high-quality research in as much as they used randomization which most dietary studies don’t do.

“The greener Mediterranean diet seemed to be the best one on the surrogate marker of MRI-defined aortic stiffness,” Dr. Bhatt, professor of cardiovascular medicine, Icahn School of Medicine at Mount Sinai, who wasn’t involved in the study, told this news organization.

“It makes sense that a diet that has more green in it, more polyphenols, would be healthier. This has been shown in some other studies, that these plant-based polyphenols might have various cardiovascular protective aspects to them,” Dr. Bhatt said.

Overall, he said the results are “quite believable, with the caveat that it would be nice to see the results reproduced in a more diverse and larger sample.”

“There is emerging evidence that diets that are higher in fresh fruits and vegetables and whole grains and lower in overall caloric intake, in general, seem to be good diets to reduce cardiovascular risk factors and maybe even reduce actual cardiovascular risk,” Dr. Bhatt added.

The study was funded by grants from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), the Rosetrees Trust, Israel Ministry of Health, Israel Ministry of Science and Technology, and the California Walnuts Commission. Dr. Shai and Dr. Bhatt have no relevant conflicts of interest.
 

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

A green adaptation to the traditional Mediterranean diet improves proximal aortic stiffness (PAS), a distinct marker of vascular aging and increased cardiovascular risk, according to an exploratory post hoc analysis of the DIRECT-PLUS randomized clinical trial.

The green Mediterranean diet is distinct from the traditional Mediterranean diet because of its more abundant dietary polyphenols, from green tea and a Wolffia globosa (Mankai) plant green shake, and lower intake of red or processed meat.

NataliTerr/Fotolia.com

Independent of weight loss, the modified green Mediterranean diet regressed PAS by 15%, the traditional Mediterranean diet by 7.3%, and the healthy dietary guideline–based diet by 4.8%, the study team observed.

“The DIRECT-PLUS trial research team was the first to introduce the concept of the green-Mediterranean/high polyphenols diet,” lead researcher Iris Shai, RD, PhD, with Ben-Gurion University of the Negev, Be’er-Sheva, Israel, told this news organization.

This diet promoted “dramatic proximal aortic de-stiffening” as assessed by MRI over 18 months in roughly 300 participants with abdominal obesity/dyslipidemia. “To date, no dietary strategies have been shown to impact vascular aging physiology,” Dr. Shai said.

The analysis was published online in the Journal of the American College of Cardiology.  


 

Not all healthy diets are equal

Of the 294 participants, 281 had valid PAS measurements at baseline. The baseline PAS (6.1 m/s) was similar across intervention groups (P = .20). Increased PAS was associated with aging, hypertension, dyslipidemia, diabetes, and visceral adiposity (P < .05).

After 18 months’ intervention (retention rate 89.8%), all diet groups showed significant PAS reductions: –0.05 m/s with the standard healthy diet (4.8%), –0.08 m/s with the traditional Mediterranean diet (7.3%) and –0.15 the green Mediterranean diet (15%).

In the multivariable model, the green Mediterranean dieters had greater PAS reduction than did the healthy-diet and Mediterranean dieters (P = .003 and P = .032, respectively).

The researchers caution that DIRECT-PLUS had multiple endpoints and this exploratory post hoc analysis might be sensitive to type I statistical error and should be considered “hypothesis-generating.”
 

High-quality study, believable results

Reached for comment on the study, Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart in New York, said, “There is not a lot of high-quality research on diet, and I would call this high-quality research in as much as they used randomization which most dietary studies don’t do.

“The greener Mediterranean diet seemed to be the best one on the surrogate marker of MRI-defined aortic stiffness,” Dr. Bhatt, professor of cardiovascular medicine, Icahn School of Medicine at Mount Sinai, who wasn’t involved in the study, told this news organization.

“It makes sense that a diet that has more green in it, more polyphenols, would be healthier. This has been shown in some other studies, that these plant-based polyphenols might have various cardiovascular protective aspects to them,” Dr. Bhatt said.

Overall, he said the results are “quite believable, with the caveat that it would be nice to see the results reproduced in a more diverse and larger sample.”

“There is emerging evidence that diets that are higher in fresh fruits and vegetables and whole grains and lower in overall caloric intake, in general, seem to be good diets to reduce cardiovascular risk factors and maybe even reduce actual cardiovascular risk,” Dr. Bhatt added.

The study was funded by grants from the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), the Rosetrees Trust, Israel Ministry of Health, Israel Ministry of Science and Technology, and the California Walnuts Commission. Dr. Shai and Dr. Bhatt have no relevant conflicts of interest.
 

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