User login
Don’t Fear Hormone Therapy, but Prescribe It Correctly
This transcript has been edited for clarity.
Rachel S. Rubin, MD: As a sexual medicine specialist, I treat a lot of menopause. Why? Because menopausal complaints are not just hot flashes and night sweats; we see so many sexual health problems: genital urinary syndrome of menopause (GUSM), low libido, pain with sex, arousal disorders, orgasm disorders. I am joined today with a superstar in the menopause field, Dr. Stephanie Faubion. Introduce yourself to our amazing listeners.
Stephanie S. Faubion, MD, MBA: I am Stephanie Faubion, director of the Mayo Clinic Center for Women’s Health and medical director for the Menopause Society.
Dr. Rubin: That is a very short introduction for a very impressive person who really is an authority, if you’ve ever read an article about menopause. I asked Dr. Faubion if she spends all her time talking to reporters. But it’s very important because menopause is having a moment. We can’t go a day without seeing a headline, an Instagram story, or something; my feed is full of menopause information. Why do you think menopause is having a moment right now?
Dr. Faubion: It’s a well-deserved moment and should have happened a long time ago. It’s having a moment for several reasons. The generation of women experiencing perimenopause and menopause is different now; they are less willing to suffer in silence, which is a great thing. We’ve also created a little bit of a care vacuum. The Women’s Health Initiative (WHI) study came out in 2002, and after that, we really left women with few choices about what to take to manage their symptoms. That created a vacuum.
After that, clinicians decided they no longer needed to worry about being educated about menopause because there was really nothing to do for menopause if we weren’t going to use hormone therapy. Where we’ve come to now is women are having symptoms; they’re having a problem. It’s affecting all aspects of their lives: their relationships, their quality of life, their ability to work. And they’re saying, “Hey, this isn’t right. We need to do something about this.” There’s still very little research in this area. We have a lot more to do. They’re demanding answers, as they should.
Dr. Rubin: We have quite a lot of tools in our toolbox that are evidence based, that really work and help people. I always say to my patients, “You have a generation of clinicians who were not taught how to do this well. Hormones are not all good or all bad, all right or all wrong, but they require some understanding of when to use them and how to safely use them.” That way, you can avoid your patients going to the snake oil salesmen down the street selling non–evidence-based treatments.
One article that came out this year that I thought was really fascinating was about what we are calling NFLM: not feeling like myself. I will tell you, I think it’s brilliant because there is not a woman aged 40 or above who doesn’t deeply connect with the idea of NFLM. Can you speak to the symptoms of perimenopause and menopause beyond hot flashes and night sweats? I named a few sexual symptoms earlier. We’re really learning about all these new areas to understand, what is perimenopause?
Dr. Faubion: Very rarely does a woman come in and say, “I have hot flashes” and I say, “Well, is that all you have?” “Yep. That’s all I have. I just have a couple of hot flashes.” That almost never happens, as you know. Menopause is not just about hot flashes, although that’s one of the most common symptoms. Hot flashes also occur at night. We call them night sweats when that happens. But there’s the sleep disturbance, which is probably not just related to night sweats but a lot of other things as well. Mood symptoms can be crazy. A lot of women come in with descriptions of irritability, just not feeling right, or feeling anxious. Another common symptom that we’re learning about is joint aches.
It’s important to remember when we’re talking about these symptoms that estrogen affects every tissue and organ system in the body. And when you lose it, you have effects in pretty much every tissue and organ system in the body. So, it’s not just about hot flashes and night sweats. We’ve also learned recently that women in perimenopause can have the same symptoms that women have after menopause. It’s not just that it starts at menopause.
Dr. Rubin: This is really important because we are speaking to the primary care world. The way medicine is set up, you’re allowed to have one problem. If you have more than one problem, I don’t know what to do. You go in the crazy bucket of we’re not interested or we don’t have time to take care of you. But menopause is never one problem. So, the disaster here is that these women are getting diagnosed with a mental health condition, with fibromyalgia, with dry eye, with sexual dysfunction, with depression or anxiety. They’re getting 10 diagnoses for what is actually one underlying hypogonadal problem.
Dr. Faubion: That’s exactly right. I’ve seen a woman at the Mayo Clinic, who came to me as a general internist, not even knowing I did menopause. She traveled across the country to see me. She’s gaining weight, she’s losing her hair, she’s sweating. She thinks there is something horribly wrong with her, like she must have cancer or something. When you put it all together — the palpitations and the rest — it was all menopause. Think of the expense to come to the Mayo Clinic and be evaluated for that. But no one, including her, had put together the fact that all of these symptoms were related to menopause. You’re exactly right. Sometimes women don’t even recognize that it’s all related.
Dr. Rubin: For the primary care viewers, we were raised on the idea that hormones cause cancer. Can you speak to that? What are the data in 2024? Am I going to die if I take hormone therapy? Am I going to risk blood clots and horrible cancers?
Dr. Faubion: To be brief, we now know who the best candidates are for hormone therapy, and we can really minimize risk. We also know that there are differences between the formulations that we use, the route of delivery, and the dose. We can really individualize this for the woman.
When it comes down to cancer risk, the WHI found that if you have a uterus and you’re taking both an estrogen and a progestogen (specifically conjugated equine estrogen and medroxyprogesterone acetate), the risk for breast cancer was increased slightly. When I say “slightly,” I’m talking the same as the increase in breast cancer risk of drinking one to two glasses of wine a night, or being overweight, or being inactive. We are really talking about less than one case per thousand women per year after about 5 years of hormone therapy. So, it’s a very small increased risk.
In contrast, the data showed that the risk for breast cancer did not appear to be increased in women who did not have a uterus and were using conjugated equine estrogen alone, either during the study or in the 18-year follow-up. The blood clot risk associated with estrogen-containing hormone therapy can be minimized with transdermal preparations of estrogen, particularly with lower doses. Overall, we don’t see that these risks are prohibitive for most women, and if they are having bothersome symptoms, they can use an estrogen-containing product safely.
Dr. Rubin: We can learn new things, right? For example, the new GLP-1 drugs, which is also very fascinating — using those in perimenopause and menopause. A GLP-1 deficiency may be increased as you go to perimenopause and menopause. By adding back hormones, maybe we can help keep muscle around, keep mental health better, and keep bones stronger, because osteoporosis and fractures kill more people than breast cancer does.
So, as a primary care clinician, how do we learn to write prescriptions for hormone therapy? How do we learn how to counsel patients properly? Do we have to go back and take a fellowship? How do I learn how to integrate the evidence into my practice?
Dr. Faubion: An easy thing to do to gain confidence is take a course. The North American Menopause Society has an annual meeting in Chicago in September, and we do a Menopause 101 course for clinicians there. It’s also available online. There are ways to get this information in a digestible way to where you can learn the basics: Here’s where I start; here’s how I need to follow it up. It’s really not that difficult to get into this.
As to your point about the GLP-1 drugs, we all have to learn new things every day because treatments change, drugs change, etc. Although hormones have been out there for a long time, many clinicians haven’t had the experience of treating menopausal women. I would put a plea out to my primary care colleagues in internal medicine and family medicine that you need to be doing this. Think about it — you already are the expert on brain health and bone health and heart health. You should be the most comfortable in dealing with hormone therapy that has effects throughout the entire body. It’s important for us as primary care providers to really have a handle on this and to be the owners of managing menopause for women in midlife.
Dr. Rubin: I couldn’t agree more. As a sexual medicine doctor, treating menopausal women is actually what fuels my soul and stops all burnout because they get better. My clinic is full of a fifty-something-year-old people who come back and they say sex is good. “My relationship is good.” “I’m kicking butt at work.” I have a patient who just started law school because she feels good, and she says, “I’m keeping up with the 20-year-olds.” It is incredible to see people who feel terrible and then watch them blossom and get better. There’s nothing that fuels my soul more than these patients.
What is exciting you in the menopause world? What are you hopeful for down the road with some of these new initiatives coming out?
Dr. Faubion: The fact that we have a president of the United States and a National Institutes of Health who are more interested in looking at menopause is amazing. It’s an exciting time; there’s more interest, and more research funding seems to be available for the United States.
In terms of clinical management, we now have so many options available to women. We’ve been talking about hormone therapy, but we now have nonhormonal medications out there as well that are on the market, such as fezolinetant, a neurokinin 3 inhibitor that came out last year. There’s probably another one coming out in the next year or so. So, women have lots of options, and for the first time, we can really individualize treatment for women and look at what symptoms are bothering them, and how best to get them back to where they should be.
We’re also starting a menopause-in-the-workplace initiative with the Menopause Society and really kind of tackling that one. We know that a lot of women are missing work, not taking a promotion, or avoiding a leadership role because of their menopause symptoms. Women should never be in the position of compromising their work lives because of menopause symptoms. This is something we can help women with.
Dr. Rubin: Our big takeaway today is: Believe your patients when they come to you, and they’ve driven and parked and arranged childcare, and showed up to your office and waited to see you. When they’re telling you that they have all these symptoms and they’re not feeling like themselves, maybe before you jump straight to the SSRI or just say, “Do some yoga and deep breathing,” maybe really dive into the menopause literature and understand the pros and cons, and the risks and benefits of hormone therapy. We do it with so many other things. We can do it with hormone therapy as well. It is not a one-size-fits-all. We do need to talk to our patients, customize their care, and really figure out what they care about and what they want. Patients are able to understand risks and benefits and can make good decisions for themselves.
Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington, DC. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Rachel S. Rubin, MD: As a sexual medicine specialist, I treat a lot of menopause. Why? Because menopausal complaints are not just hot flashes and night sweats; we see so many sexual health problems: genital urinary syndrome of menopause (GUSM), low libido, pain with sex, arousal disorders, orgasm disorders. I am joined today with a superstar in the menopause field, Dr. Stephanie Faubion. Introduce yourself to our amazing listeners.
Stephanie S. Faubion, MD, MBA: I am Stephanie Faubion, director of the Mayo Clinic Center for Women’s Health and medical director for the Menopause Society.
Dr. Rubin: That is a very short introduction for a very impressive person who really is an authority, if you’ve ever read an article about menopause. I asked Dr. Faubion if she spends all her time talking to reporters. But it’s very important because menopause is having a moment. We can’t go a day without seeing a headline, an Instagram story, or something; my feed is full of menopause information. Why do you think menopause is having a moment right now?
Dr. Faubion: It’s a well-deserved moment and should have happened a long time ago. It’s having a moment for several reasons. The generation of women experiencing perimenopause and menopause is different now; they are less willing to suffer in silence, which is a great thing. We’ve also created a little bit of a care vacuum. The Women’s Health Initiative (WHI) study came out in 2002, and after that, we really left women with few choices about what to take to manage their symptoms. That created a vacuum.
After that, clinicians decided they no longer needed to worry about being educated about menopause because there was really nothing to do for menopause if we weren’t going to use hormone therapy. Where we’ve come to now is women are having symptoms; they’re having a problem. It’s affecting all aspects of their lives: their relationships, their quality of life, their ability to work. And they’re saying, “Hey, this isn’t right. We need to do something about this.” There’s still very little research in this area. We have a lot more to do. They’re demanding answers, as they should.
Dr. Rubin: We have quite a lot of tools in our toolbox that are evidence based, that really work and help people. I always say to my patients, “You have a generation of clinicians who were not taught how to do this well. Hormones are not all good or all bad, all right or all wrong, but they require some understanding of when to use them and how to safely use them.” That way, you can avoid your patients going to the snake oil salesmen down the street selling non–evidence-based treatments.
One article that came out this year that I thought was really fascinating was about what we are calling NFLM: not feeling like myself. I will tell you, I think it’s brilliant because there is not a woman aged 40 or above who doesn’t deeply connect with the idea of NFLM. Can you speak to the symptoms of perimenopause and menopause beyond hot flashes and night sweats? I named a few sexual symptoms earlier. We’re really learning about all these new areas to understand, what is perimenopause?
Dr. Faubion: Very rarely does a woman come in and say, “I have hot flashes” and I say, “Well, is that all you have?” “Yep. That’s all I have. I just have a couple of hot flashes.” That almost never happens, as you know. Menopause is not just about hot flashes, although that’s one of the most common symptoms. Hot flashes also occur at night. We call them night sweats when that happens. But there’s the sleep disturbance, which is probably not just related to night sweats but a lot of other things as well. Mood symptoms can be crazy. A lot of women come in with descriptions of irritability, just not feeling right, or feeling anxious. Another common symptom that we’re learning about is joint aches.
It’s important to remember when we’re talking about these symptoms that estrogen affects every tissue and organ system in the body. And when you lose it, you have effects in pretty much every tissue and organ system in the body. So, it’s not just about hot flashes and night sweats. We’ve also learned recently that women in perimenopause can have the same symptoms that women have after menopause. It’s not just that it starts at menopause.
Dr. Rubin: This is really important because we are speaking to the primary care world. The way medicine is set up, you’re allowed to have one problem. If you have more than one problem, I don’t know what to do. You go in the crazy bucket of we’re not interested or we don’t have time to take care of you. But menopause is never one problem. So, the disaster here is that these women are getting diagnosed with a mental health condition, with fibromyalgia, with dry eye, with sexual dysfunction, with depression or anxiety. They’re getting 10 diagnoses for what is actually one underlying hypogonadal problem.
Dr. Faubion: That’s exactly right. I’ve seen a woman at the Mayo Clinic, who came to me as a general internist, not even knowing I did menopause. She traveled across the country to see me. She’s gaining weight, she’s losing her hair, she’s sweating. She thinks there is something horribly wrong with her, like she must have cancer or something. When you put it all together — the palpitations and the rest — it was all menopause. Think of the expense to come to the Mayo Clinic and be evaluated for that. But no one, including her, had put together the fact that all of these symptoms were related to menopause. You’re exactly right. Sometimes women don’t even recognize that it’s all related.
Dr. Rubin: For the primary care viewers, we were raised on the idea that hormones cause cancer. Can you speak to that? What are the data in 2024? Am I going to die if I take hormone therapy? Am I going to risk blood clots and horrible cancers?
Dr. Faubion: To be brief, we now know who the best candidates are for hormone therapy, and we can really minimize risk. We also know that there are differences between the formulations that we use, the route of delivery, and the dose. We can really individualize this for the woman.
When it comes down to cancer risk, the WHI found that if you have a uterus and you’re taking both an estrogen and a progestogen (specifically conjugated equine estrogen and medroxyprogesterone acetate), the risk for breast cancer was increased slightly. When I say “slightly,” I’m talking the same as the increase in breast cancer risk of drinking one to two glasses of wine a night, or being overweight, or being inactive. We are really talking about less than one case per thousand women per year after about 5 years of hormone therapy. So, it’s a very small increased risk.
In contrast, the data showed that the risk for breast cancer did not appear to be increased in women who did not have a uterus and were using conjugated equine estrogen alone, either during the study or in the 18-year follow-up. The blood clot risk associated with estrogen-containing hormone therapy can be minimized with transdermal preparations of estrogen, particularly with lower doses. Overall, we don’t see that these risks are prohibitive for most women, and if they are having bothersome symptoms, they can use an estrogen-containing product safely.
Dr. Rubin: We can learn new things, right? For example, the new GLP-1 drugs, which is also very fascinating — using those in perimenopause and menopause. A GLP-1 deficiency may be increased as you go to perimenopause and menopause. By adding back hormones, maybe we can help keep muscle around, keep mental health better, and keep bones stronger, because osteoporosis and fractures kill more people than breast cancer does.
So, as a primary care clinician, how do we learn to write prescriptions for hormone therapy? How do we learn how to counsel patients properly? Do we have to go back and take a fellowship? How do I learn how to integrate the evidence into my practice?
Dr. Faubion: An easy thing to do to gain confidence is take a course. The North American Menopause Society has an annual meeting in Chicago in September, and we do a Menopause 101 course for clinicians there. It’s also available online. There are ways to get this information in a digestible way to where you can learn the basics: Here’s where I start; here’s how I need to follow it up. It’s really not that difficult to get into this.
As to your point about the GLP-1 drugs, we all have to learn new things every day because treatments change, drugs change, etc. Although hormones have been out there for a long time, many clinicians haven’t had the experience of treating menopausal women. I would put a plea out to my primary care colleagues in internal medicine and family medicine that you need to be doing this. Think about it — you already are the expert on brain health and bone health and heart health. You should be the most comfortable in dealing with hormone therapy that has effects throughout the entire body. It’s important for us as primary care providers to really have a handle on this and to be the owners of managing menopause for women in midlife.
Dr. Rubin: I couldn’t agree more. As a sexual medicine doctor, treating menopausal women is actually what fuels my soul and stops all burnout because they get better. My clinic is full of a fifty-something-year-old people who come back and they say sex is good. “My relationship is good.” “I’m kicking butt at work.” I have a patient who just started law school because she feels good, and she says, “I’m keeping up with the 20-year-olds.” It is incredible to see people who feel terrible and then watch them blossom and get better. There’s nothing that fuels my soul more than these patients.
What is exciting you in the menopause world? What are you hopeful for down the road with some of these new initiatives coming out?
Dr. Faubion: The fact that we have a president of the United States and a National Institutes of Health who are more interested in looking at menopause is amazing. It’s an exciting time; there’s more interest, and more research funding seems to be available for the United States.
In terms of clinical management, we now have so many options available to women. We’ve been talking about hormone therapy, but we now have nonhormonal medications out there as well that are on the market, such as fezolinetant, a neurokinin 3 inhibitor that came out last year. There’s probably another one coming out in the next year or so. So, women have lots of options, and for the first time, we can really individualize treatment for women and look at what symptoms are bothering them, and how best to get them back to where they should be.
We’re also starting a menopause-in-the-workplace initiative with the Menopause Society and really kind of tackling that one. We know that a lot of women are missing work, not taking a promotion, or avoiding a leadership role because of their menopause symptoms. Women should never be in the position of compromising their work lives because of menopause symptoms. This is something we can help women with.
Dr. Rubin: Our big takeaway today is: Believe your patients when they come to you, and they’ve driven and parked and arranged childcare, and showed up to your office and waited to see you. When they’re telling you that they have all these symptoms and they’re not feeling like themselves, maybe before you jump straight to the SSRI or just say, “Do some yoga and deep breathing,” maybe really dive into the menopause literature and understand the pros and cons, and the risks and benefits of hormone therapy. We do it with so many other things. We can do it with hormone therapy as well. It is not a one-size-fits-all. We do need to talk to our patients, customize their care, and really figure out what they care about and what they want. Patients are able to understand risks and benefits and can make good decisions for themselves.
Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington, DC. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Rachel S. Rubin, MD: As a sexual medicine specialist, I treat a lot of menopause. Why? Because menopausal complaints are not just hot flashes and night sweats; we see so many sexual health problems: genital urinary syndrome of menopause (GUSM), low libido, pain with sex, arousal disorders, orgasm disorders. I am joined today with a superstar in the menopause field, Dr. Stephanie Faubion. Introduce yourself to our amazing listeners.
Stephanie S. Faubion, MD, MBA: I am Stephanie Faubion, director of the Mayo Clinic Center for Women’s Health and medical director for the Menopause Society.
Dr. Rubin: That is a very short introduction for a very impressive person who really is an authority, if you’ve ever read an article about menopause. I asked Dr. Faubion if she spends all her time talking to reporters. But it’s very important because menopause is having a moment. We can’t go a day without seeing a headline, an Instagram story, or something; my feed is full of menopause information. Why do you think menopause is having a moment right now?
Dr. Faubion: It’s a well-deserved moment and should have happened a long time ago. It’s having a moment for several reasons. The generation of women experiencing perimenopause and menopause is different now; they are less willing to suffer in silence, which is a great thing. We’ve also created a little bit of a care vacuum. The Women’s Health Initiative (WHI) study came out in 2002, and after that, we really left women with few choices about what to take to manage their symptoms. That created a vacuum.
After that, clinicians decided they no longer needed to worry about being educated about menopause because there was really nothing to do for menopause if we weren’t going to use hormone therapy. Where we’ve come to now is women are having symptoms; they’re having a problem. It’s affecting all aspects of their lives: their relationships, their quality of life, their ability to work. And they’re saying, “Hey, this isn’t right. We need to do something about this.” There’s still very little research in this area. We have a lot more to do. They’re demanding answers, as they should.
Dr. Rubin: We have quite a lot of tools in our toolbox that are evidence based, that really work and help people. I always say to my patients, “You have a generation of clinicians who were not taught how to do this well. Hormones are not all good or all bad, all right or all wrong, but they require some understanding of when to use them and how to safely use them.” That way, you can avoid your patients going to the snake oil salesmen down the street selling non–evidence-based treatments.
One article that came out this year that I thought was really fascinating was about what we are calling NFLM: not feeling like myself. I will tell you, I think it’s brilliant because there is not a woman aged 40 or above who doesn’t deeply connect with the idea of NFLM. Can you speak to the symptoms of perimenopause and menopause beyond hot flashes and night sweats? I named a few sexual symptoms earlier. We’re really learning about all these new areas to understand, what is perimenopause?
Dr. Faubion: Very rarely does a woman come in and say, “I have hot flashes” and I say, “Well, is that all you have?” “Yep. That’s all I have. I just have a couple of hot flashes.” That almost never happens, as you know. Menopause is not just about hot flashes, although that’s one of the most common symptoms. Hot flashes also occur at night. We call them night sweats when that happens. But there’s the sleep disturbance, which is probably not just related to night sweats but a lot of other things as well. Mood symptoms can be crazy. A lot of women come in with descriptions of irritability, just not feeling right, or feeling anxious. Another common symptom that we’re learning about is joint aches.
It’s important to remember when we’re talking about these symptoms that estrogen affects every tissue and organ system in the body. And when you lose it, you have effects in pretty much every tissue and organ system in the body. So, it’s not just about hot flashes and night sweats. We’ve also learned recently that women in perimenopause can have the same symptoms that women have after menopause. It’s not just that it starts at menopause.
Dr. Rubin: This is really important because we are speaking to the primary care world. The way medicine is set up, you’re allowed to have one problem. If you have more than one problem, I don’t know what to do. You go in the crazy bucket of we’re not interested or we don’t have time to take care of you. But menopause is never one problem. So, the disaster here is that these women are getting diagnosed with a mental health condition, with fibromyalgia, with dry eye, with sexual dysfunction, with depression or anxiety. They’re getting 10 diagnoses for what is actually one underlying hypogonadal problem.
Dr. Faubion: That’s exactly right. I’ve seen a woman at the Mayo Clinic, who came to me as a general internist, not even knowing I did menopause. She traveled across the country to see me. She’s gaining weight, she’s losing her hair, she’s sweating. She thinks there is something horribly wrong with her, like she must have cancer or something. When you put it all together — the palpitations and the rest — it was all menopause. Think of the expense to come to the Mayo Clinic and be evaluated for that. But no one, including her, had put together the fact that all of these symptoms were related to menopause. You’re exactly right. Sometimes women don’t even recognize that it’s all related.
Dr. Rubin: For the primary care viewers, we were raised on the idea that hormones cause cancer. Can you speak to that? What are the data in 2024? Am I going to die if I take hormone therapy? Am I going to risk blood clots and horrible cancers?
Dr. Faubion: To be brief, we now know who the best candidates are for hormone therapy, and we can really minimize risk. We also know that there are differences between the formulations that we use, the route of delivery, and the dose. We can really individualize this for the woman.
When it comes down to cancer risk, the WHI found that if you have a uterus and you’re taking both an estrogen and a progestogen (specifically conjugated equine estrogen and medroxyprogesterone acetate), the risk for breast cancer was increased slightly. When I say “slightly,” I’m talking the same as the increase in breast cancer risk of drinking one to two glasses of wine a night, or being overweight, or being inactive. We are really talking about less than one case per thousand women per year after about 5 years of hormone therapy. So, it’s a very small increased risk.
In contrast, the data showed that the risk for breast cancer did not appear to be increased in women who did not have a uterus and were using conjugated equine estrogen alone, either during the study or in the 18-year follow-up. The blood clot risk associated with estrogen-containing hormone therapy can be minimized with transdermal preparations of estrogen, particularly with lower doses. Overall, we don’t see that these risks are prohibitive for most women, and if they are having bothersome symptoms, they can use an estrogen-containing product safely.
Dr. Rubin: We can learn new things, right? For example, the new GLP-1 drugs, which is also very fascinating — using those in perimenopause and menopause. A GLP-1 deficiency may be increased as you go to perimenopause and menopause. By adding back hormones, maybe we can help keep muscle around, keep mental health better, and keep bones stronger, because osteoporosis and fractures kill more people than breast cancer does.
So, as a primary care clinician, how do we learn to write prescriptions for hormone therapy? How do we learn how to counsel patients properly? Do we have to go back and take a fellowship? How do I learn how to integrate the evidence into my practice?
Dr. Faubion: An easy thing to do to gain confidence is take a course. The North American Menopause Society has an annual meeting in Chicago in September, and we do a Menopause 101 course for clinicians there. It’s also available online. There are ways to get this information in a digestible way to where you can learn the basics: Here’s where I start; here’s how I need to follow it up. It’s really not that difficult to get into this.
As to your point about the GLP-1 drugs, we all have to learn new things every day because treatments change, drugs change, etc. Although hormones have been out there for a long time, many clinicians haven’t had the experience of treating menopausal women. I would put a plea out to my primary care colleagues in internal medicine and family medicine that you need to be doing this. Think about it — you already are the expert on brain health and bone health and heart health. You should be the most comfortable in dealing with hormone therapy that has effects throughout the entire body. It’s important for us as primary care providers to really have a handle on this and to be the owners of managing menopause for women in midlife.
Dr. Rubin: I couldn’t agree more. As a sexual medicine doctor, treating menopausal women is actually what fuels my soul and stops all burnout because they get better. My clinic is full of a fifty-something-year-old people who come back and they say sex is good. “My relationship is good.” “I’m kicking butt at work.” I have a patient who just started law school because she feels good, and she says, “I’m keeping up with the 20-year-olds.” It is incredible to see people who feel terrible and then watch them blossom and get better. There’s nothing that fuels my soul more than these patients.
What is exciting you in the menopause world? What are you hopeful for down the road with some of these new initiatives coming out?
Dr. Faubion: The fact that we have a president of the United States and a National Institutes of Health who are more interested in looking at menopause is amazing. It’s an exciting time; there’s more interest, and more research funding seems to be available for the United States.
In terms of clinical management, we now have so many options available to women. We’ve been talking about hormone therapy, but we now have nonhormonal medications out there as well that are on the market, such as fezolinetant, a neurokinin 3 inhibitor that came out last year. There’s probably another one coming out in the next year or so. So, women have lots of options, and for the first time, we can really individualize treatment for women and look at what symptoms are bothering them, and how best to get them back to where they should be.
We’re also starting a menopause-in-the-workplace initiative with the Menopause Society and really kind of tackling that one. We know that a lot of women are missing work, not taking a promotion, or avoiding a leadership role because of their menopause symptoms. Women should never be in the position of compromising their work lives because of menopause symptoms. This is something we can help women with.
Dr. Rubin: Our big takeaway today is: Believe your patients when they come to you, and they’ve driven and parked and arranged childcare, and showed up to your office and waited to see you. When they’re telling you that they have all these symptoms and they’re not feeling like themselves, maybe before you jump straight to the SSRI or just say, “Do some yoga and deep breathing,” maybe really dive into the menopause literature and understand the pros and cons, and the risks and benefits of hormone therapy. We do it with so many other things. We can do it with hormone therapy as well. It is not a one-size-fits-all. We do need to talk to our patients, customize their care, and really figure out what they care about and what they want. Patients are able to understand risks and benefits and can make good decisions for themselves.
Dr. Rubin is an assistant clinical professor, Department of Urology, at Georgetown University, Washington, DC. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
Online Diagnosis of Sexually Transmitted Infections? Ethicist Says We Are Nowhere Close
This transcript has been edited for clarity.
There has been a large amount of news lately about dating online and dating apps. Probably the most common way younger people find potential partners is to go online and see who’s there that they might want to meet.
Online dating is also notorious for being full of scammers. There are all kinds of people out there that you have to be careful of, who are trying to rip you off by saying, “Send me money, I’m in trouble,” or “Now that we have a relationship, will you support my particular entrepreneurial idea?” Certainly, dangers are there.
Another danger we don’t talk much about is meeting people who have sexually transmitted diseases. That’s been a problem before websites and before dating apps. I think the opportunity of meeting more people — strangers, people you don’t really know — who may not tell you the truth about their health, and particularly their sexual health, is really out there.
It’s always good medical advice to tell people to practice safe sex, and that often involves a man wearing a condom. It certainly is the case that we want to attend not just to the prevention of unwanted pregnancy but also to the transmission of diseases. I think it’s very important to tell women of reproductive age to get their HPV shot to try to reduce cancers in their reproductive systems, or sometimes in men — anal cancers, or even being a transmitter of disease.
Even then, certainly one wants to recommend that, in an age where some people are going to meet many partners that they don’t know well or don’t have much background with, it’s wise to try to prevent diseases using the vaccines we’ve got, using the contraceptive methods that will prevent disease transmission, and reminding people to ask about sex life.
I did come across a website that just startled me. It’s called HeHealth, and basically it says to men, if you are conscientious about your sex life, take a picture of your penis, send it to us, and we have doctors — I presume they’re US doctors but I don’t know — who will diagnose venereal diseases based on that picture. I presume women could also say, “Before we have sex, or now that we’re approaching that possibility, I want you to send a picture to this company on this website.”
Now, a couple of reminders. I think we all know this, but just because you’re not manifesting symptoms on your reproductive organs doesn’t mean you don’t have a sexual disease. It’s not a reliable measure. Yes, maybe you could have somebody say: “Oh, that looks nasty. I’m not sure you ought to have sex right now, and maybe you should go get some treatment.” This is going to miss many cases and is not a reliable indicator that your partner is safe in terms of not transmitting diseases to you.
It also isn’t clear what they do with these images. Do they keep them? Who can see them? Could they resell them? What sort of privacy protection have you got if you decide to use this?
There’s another issue here, which is, if they misdiagnose someone and you do catch a sexual disease, who’s liable? Can you go after them for using doctors who weren’t competent or transmitting images that weren’t really adequate because you didn’t know how to take that picture properly when you sent that off to them? There are many unknowns.
The bottom line is that we’re in a different world, I think, of romance. We’re in a world where some people are going to meet more partners. Some people are going to meet more strangers. One approach is to have us take pictures of ourselves, send them off to who knows where, and ask for a green light to go ahead and have sexual relations. I don’t think we’re anywhere close to being able to rely on that as a way to avoid the risks of unprotected sexual behavior.
We do know what to do in dealing with patients who are sexually active. First, we have to ask them. Then we’ve got to recommend available vaccinations to prevent the transmission of some cancers, the HPV vaccine. Then they need that reminder about safe sexual practices not only to protect against unwanted pregnancy, but still, in this day and age, to protect against syphilis, which is on the rise, plus HIV, gonorrhea, chlamydia, and other sexually transmissible diseases.
I’m not going to rely on the penis picture to make the world safe for sex. I think we have to still use the old-fashioned techniques of education and prevention to do the best we can.
Dr. Caplan is director of the Division of Medical Ethics at New York University Langone Medical Center, New York City. He reported conflicts of interest with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
There has been a large amount of news lately about dating online and dating apps. Probably the most common way younger people find potential partners is to go online and see who’s there that they might want to meet.
Online dating is also notorious for being full of scammers. There are all kinds of people out there that you have to be careful of, who are trying to rip you off by saying, “Send me money, I’m in trouble,” or “Now that we have a relationship, will you support my particular entrepreneurial idea?” Certainly, dangers are there.
Another danger we don’t talk much about is meeting people who have sexually transmitted diseases. That’s been a problem before websites and before dating apps. I think the opportunity of meeting more people — strangers, people you don’t really know — who may not tell you the truth about their health, and particularly their sexual health, is really out there.
It’s always good medical advice to tell people to practice safe sex, and that often involves a man wearing a condom. It certainly is the case that we want to attend not just to the prevention of unwanted pregnancy but also to the transmission of diseases. I think it’s very important to tell women of reproductive age to get their HPV shot to try to reduce cancers in their reproductive systems, or sometimes in men — anal cancers, or even being a transmitter of disease.
Even then, certainly one wants to recommend that, in an age where some people are going to meet many partners that they don’t know well or don’t have much background with, it’s wise to try to prevent diseases using the vaccines we’ve got, using the contraceptive methods that will prevent disease transmission, and reminding people to ask about sex life.
I did come across a website that just startled me. It’s called HeHealth, and basically it says to men, if you are conscientious about your sex life, take a picture of your penis, send it to us, and we have doctors — I presume they’re US doctors but I don’t know — who will diagnose venereal diseases based on that picture. I presume women could also say, “Before we have sex, or now that we’re approaching that possibility, I want you to send a picture to this company on this website.”
Now, a couple of reminders. I think we all know this, but just because you’re not manifesting symptoms on your reproductive organs doesn’t mean you don’t have a sexual disease. It’s not a reliable measure. Yes, maybe you could have somebody say: “Oh, that looks nasty. I’m not sure you ought to have sex right now, and maybe you should go get some treatment.” This is going to miss many cases and is not a reliable indicator that your partner is safe in terms of not transmitting diseases to you.
It also isn’t clear what they do with these images. Do they keep them? Who can see them? Could they resell them? What sort of privacy protection have you got if you decide to use this?
There’s another issue here, which is, if they misdiagnose someone and you do catch a sexual disease, who’s liable? Can you go after them for using doctors who weren’t competent or transmitting images that weren’t really adequate because you didn’t know how to take that picture properly when you sent that off to them? There are many unknowns.
The bottom line is that we’re in a different world, I think, of romance. We’re in a world where some people are going to meet more partners. Some people are going to meet more strangers. One approach is to have us take pictures of ourselves, send them off to who knows where, and ask for a green light to go ahead and have sexual relations. I don’t think we’re anywhere close to being able to rely on that as a way to avoid the risks of unprotected sexual behavior.
We do know what to do in dealing with patients who are sexually active. First, we have to ask them. Then we’ve got to recommend available vaccinations to prevent the transmission of some cancers, the HPV vaccine. Then they need that reminder about safe sexual practices not only to protect against unwanted pregnancy, but still, in this day and age, to protect against syphilis, which is on the rise, plus HIV, gonorrhea, chlamydia, and other sexually transmissible diseases.
I’m not going to rely on the penis picture to make the world safe for sex. I think we have to still use the old-fashioned techniques of education and prevention to do the best we can.
Dr. Caplan is director of the Division of Medical Ethics at New York University Langone Medical Center, New York City. He reported conflicts of interest with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
There has been a large amount of news lately about dating online and dating apps. Probably the most common way younger people find potential partners is to go online and see who’s there that they might want to meet.
Online dating is also notorious for being full of scammers. There are all kinds of people out there that you have to be careful of, who are trying to rip you off by saying, “Send me money, I’m in trouble,” or “Now that we have a relationship, will you support my particular entrepreneurial idea?” Certainly, dangers are there.
Another danger we don’t talk much about is meeting people who have sexually transmitted diseases. That’s been a problem before websites and before dating apps. I think the opportunity of meeting more people — strangers, people you don’t really know — who may not tell you the truth about their health, and particularly their sexual health, is really out there.
It’s always good medical advice to tell people to practice safe sex, and that often involves a man wearing a condom. It certainly is the case that we want to attend not just to the prevention of unwanted pregnancy but also to the transmission of diseases. I think it’s very important to tell women of reproductive age to get their HPV shot to try to reduce cancers in their reproductive systems, or sometimes in men — anal cancers, or even being a transmitter of disease.
Even then, certainly one wants to recommend that, in an age where some people are going to meet many partners that they don’t know well or don’t have much background with, it’s wise to try to prevent diseases using the vaccines we’ve got, using the contraceptive methods that will prevent disease transmission, and reminding people to ask about sex life.
I did come across a website that just startled me. It’s called HeHealth, and basically it says to men, if you are conscientious about your sex life, take a picture of your penis, send it to us, and we have doctors — I presume they’re US doctors but I don’t know — who will diagnose venereal diseases based on that picture. I presume women could also say, “Before we have sex, or now that we’re approaching that possibility, I want you to send a picture to this company on this website.”
Now, a couple of reminders. I think we all know this, but just because you’re not manifesting symptoms on your reproductive organs doesn’t mean you don’t have a sexual disease. It’s not a reliable measure. Yes, maybe you could have somebody say: “Oh, that looks nasty. I’m not sure you ought to have sex right now, and maybe you should go get some treatment.” This is going to miss many cases and is not a reliable indicator that your partner is safe in terms of not transmitting diseases to you.
It also isn’t clear what they do with these images. Do they keep them? Who can see them? Could they resell them? What sort of privacy protection have you got if you decide to use this?
There’s another issue here, which is, if they misdiagnose someone and you do catch a sexual disease, who’s liable? Can you go after them for using doctors who weren’t competent or transmitting images that weren’t really adequate because you didn’t know how to take that picture properly when you sent that off to them? There are many unknowns.
The bottom line is that we’re in a different world, I think, of romance. We’re in a world where some people are going to meet more partners. Some people are going to meet more strangers. One approach is to have us take pictures of ourselves, send them off to who knows where, and ask for a green light to go ahead and have sexual relations. I don’t think we’re anywhere close to being able to rely on that as a way to avoid the risks of unprotected sexual behavior.
We do know what to do in dealing with patients who are sexually active. First, we have to ask them. Then we’ve got to recommend available vaccinations to prevent the transmission of some cancers, the HPV vaccine. Then they need that reminder about safe sexual practices not only to protect against unwanted pregnancy, but still, in this day and age, to protect against syphilis, which is on the rise, plus HIV, gonorrhea, chlamydia, and other sexually transmissible diseases.
I’m not going to rely on the penis picture to make the world safe for sex. I think we have to still use the old-fashioned techniques of education and prevention to do the best we can.
Dr. Caplan is director of the Division of Medical Ethics at New York University Langone Medical Center, New York City. He reported conflicts of interest with Johnson & Johnson’s Panel for Compassionate Drug Use and Medscape.
A version of this article first appeared on Medscape.com.
Low Hydroxychloroquine Levels in Early Pregnancy Tied to Greater Flares in SLE
TOPLINE:
A study reveals that hydroxychloroquine levels during the first trimester in pregnant women with systemic lupus erythematosus (SLE) are linked to severe maternal flares but not to adverse pregnancy outcomes.
METHODOLOGY:
- Researchers included pregnant women with SLE (median age, 32.1 years; median duration of disease, 8.3 years) who were enrolled in an ongoing French prospective observational study and were receiving hydroxychloroquine.
- The study assessed hydroxychloroquine blood levels during the first trimester. It defined severe nonadherence as having levels < 200 ng/mL and classified levels < 500 ng/mL as subtherapeutic.
- Primary outcomes were maternal flares during pregnancy and adverse pregnancy outcomes, including fetal/neonatal death and preterm delivery.
TAKEAWAY:
- Overall, 32 women experienced at least one flare during the second and third trimester; four had severe flares.
- The rates of severe maternal SLE flares were significantly associated with hydroxychloroquine levels in the first trimester that were classified as subtherapeutic (8.8% vs 0.7% with above subtherapeutic levels, P = .02) and severely nonadherent (13.3% vs 1.3% with above severely nonadherent levels, P = .04).
- There was no significant difference in adverse pregnancy outcomes by hydroxychloroquine level, suggesting its specific effect on maternal health rather than fetal health.
IN PRACTICE:
According to the authors, “this study supports hydroxychloroquine blood level assessment in pregnant women with SLE, as a predictor of severe maternal disease activity in pregnancy.”
SOURCE:
The study was led by Gelsomina Alle, MD, Assistance Publique-Hôpitaux de Paris, Paris, France. It was published online in Rheumatology.
LIMITATIONS:
The study’s sample size limited the ability to perform multivariate analyses for severe flares. Patients had to have an ongoing pregnancy at 12 weeks to be included, potentially excluding those with early pregnancy loss. The study only observed first-trimester hydroxychloroquine levels, not accounting for adherence variations throughout pregnancy.
DISCLOSURES:
The study funding source was not disclosed. Several authors declared financial relationships with pharmaceutical companies, including research support and consulting fees.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A study reveals that hydroxychloroquine levels during the first trimester in pregnant women with systemic lupus erythematosus (SLE) are linked to severe maternal flares but not to adverse pregnancy outcomes.
METHODOLOGY:
- Researchers included pregnant women with SLE (median age, 32.1 years; median duration of disease, 8.3 years) who were enrolled in an ongoing French prospective observational study and were receiving hydroxychloroquine.
- The study assessed hydroxychloroquine blood levels during the first trimester. It defined severe nonadherence as having levels < 200 ng/mL and classified levels < 500 ng/mL as subtherapeutic.
- Primary outcomes were maternal flares during pregnancy and adverse pregnancy outcomes, including fetal/neonatal death and preterm delivery.
TAKEAWAY:
- Overall, 32 women experienced at least one flare during the second and third trimester; four had severe flares.
- The rates of severe maternal SLE flares were significantly associated with hydroxychloroquine levels in the first trimester that were classified as subtherapeutic (8.8% vs 0.7% with above subtherapeutic levels, P = .02) and severely nonadherent (13.3% vs 1.3% with above severely nonadherent levels, P = .04).
- There was no significant difference in adverse pregnancy outcomes by hydroxychloroquine level, suggesting its specific effect on maternal health rather than fetal health.
IN PRACTICE:
According to the authors, “this study supports hydroxychloroquine blood level assessment in pregnant women with SLE, as a predictor of severe maternal disease activity in pregnancy.”
SOURCE:
The study was led by Gelsomina Alle, MD, Assistance Publique-Hôpitaux de Paris, Paris, France. It was published online in Rheumatology.
LIMITATIONS:
The study’s sample size limited the ability to perform multivariate analyses for severe flares. Patients had to have an ongoing pregnancy at 12 weeks to be included, potentially excluding those with early pregnancy loss. The study only observed first-trimester hydroxychloroquine levels, not accounting for adherence variations throughout pregnancy.
DISCLOSURES:
The study funding source was not disclosed. Several authors declared financial relationships with pharmaceutical companies, including research support and consulting fees.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A study reveals that hydroxychloroquine levels during the first trimester in pregnant women with systemic lupus erythematosus (SLE) are linked to severe maternal flares but not to adverse pregnancy outcomes.
METHODOLOGY:
- Researchers included pregnant women with SLE (median age, 32.1 years; median duration of disease, 8.3 years) who were enrolled in an ongoing French prospective observational study and were receiving hydroxychloroquine.
- The study assessed hydroxychloroquine blood levels during the first trimester. It defined severe nonadherence as having levels < 200 ng/mL and classified levels < 500 ng/mL as subtherapeutic.
- Primary outcomes were maternal flares during pregnancy and adverse pregnancy outcomes, including fetal/neonatal death and preterm delivery.
TAKEAWAY:
- Overall, 32 women experienced at least one flare during the second and third trimester; four had severe flares.
- The rates of severe maternal SLE flares were significantly associated with hydroxychloroquine levels in the first trimester that were classified as subtherapeutic (8.8% vs 0.7% with above subtherapeutic levels, P = .02) and severely nonadherent (13.3% vs 1.3% with above severely nonadherent levels, P = .04).
- There was no significant difference in adverse pregnancy outcomes by hydroxychloroquine level, suggesting its specific effect on maternal health rather than fetal health.
IN PRACTICE:
According to the authors, “this study supports hydroxychloroquine blood level assessment in pregnant women with SLE, as a predictor of severe maternal disease activity in pregnancy.”
SOURCE:
The study was led by Gelsomina Alle, MD, Assistance Publique-Hôpitaux de Paris, Paris, France. It was published online in Rheumatology.
LIMITATIONS:
The study’s sample size limited the ability to perform multivariate analyses for severe flares. Patients had to have an ongoing pregnancy at 12 weeks to be included, potentially excluding those with early pregnancy loss. The study only observed first-trimester hydroxychloroquine levels, not accounting for adherence variations throughout pregnancy.
DISCLOSURES:
The study funding source was not disclosed. Several authors declared financial relationships with pharmaceutical companies, including research support and consulting fees.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Atopic Dermatitis: Study Compares Prevalence by Gender, Age, and Ethnic Background
than adults from other ethnic backgrounds.
Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.
“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.
“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”
Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.
More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.
In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.
When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.
On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).
“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”
Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”
In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”
Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.
A version of this article appeared on Medscape.com .
than adults from other ethnic backgrounds.
Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.
“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.
“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”
Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.
More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.
In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.
When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.
On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).
“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”
Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”
In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”
Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.
A version of this article appeared on Medscape.com .
than adults from other ethnic backgrounds.
Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.
“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.
“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”
Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.
More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.
In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.
When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.
On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).
“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”
Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”
In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”
Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.
A version of this article appeared on Medscape.com .
Magnesium Sulfate’s Ability to Reduce Cerebral Palsy in Preterm Birth Reaffirmed
An updated Cochrane Systematic Review of magnesium sulfate administered before preterm birth for neuroprotection has reaffirmed that the compound significantly reduces the risk of cerebral palsy and has added the finding that it also may reduce the risk of severe neonatal intraventricular hemorrhage.
Still unknown, however, is whether the effects of magnesium sulfate vary according to patient characteristics such as gestational age, or by treatment characteristics such as timing and dose. “We need further research to determine exactly who to treat, and when and how, to ideally standardize clinical practice recommendations across the world,” said Emily S. Shepherd, PhD, lead author of the review.
Magnesium sulfate is widely used for preterm cerebral palsy prevention but variance in national and local recommendations for its use may impede its optimal uptake in some places, she and her co-investigators wrote in the review.
In the United States, the American College of Obstetricians and Gynecologists advises institutions to develop their own guidelines regarding inclusion criteria and treatment regimens “in accordance with one of the larger trials.” (ACOG’s Committee Opinion on Magnesium Sulfate Before Anticipated Preterm Birth for Neuroprotection was originally published in 2010 and was reaffirmed in 2023.)
In a Master Class column on magnesium sulfate for neuroprotection published earlier this year in Ob.Gyn. News, Irina Burd, MD, PhD, wrote that most hospitals in the United States have chosen a higher dose of magnesium sulfate administered up to 31 weeks’ gestation (6-g bolus, followed by 2 g/hour), in keeping with the protocols used in the BEAM trial published by the National Institute of Child Health and Human Development (NICHD). Dr. Burd is the Sylvan Frieman, MD, Endowed Professor and chair of the department of obstetrics, gynecology and reproductive sciences at the University of Maryland School of Medicine, Baltimore, Maryland.
The new Cochrane review included six randomized controlled trials (including the NICHD trial) covering 5917 pregnant participants and 6759 fetuses. Eligibility criteria varied, but all the RCTs included patients in preterm labor or with expected or planned imminent preterm birth at less than 34 weeks’ gestation.
Treatment regimens varied: three trials administered a 4-g loading dose only, and three included a maintenance dose (a 4-6-g loading dose and a 1-2 g/hour maintenance dose). “Although we attempted to explore variation through subgroup analyses, the ability to do this was limited,” the researchers wrote.
Up to 2 years of corrected age, magnesium sulfate reduced the risk of cerebral palsy compared with placebo (relative risk, 0.71; 95% confidence interval (CI), 0.57-0.89) and death or cerebral palsy (RR, 0.87; 95% CI, 0.77-0.98), with a high-certainty grade of evidence. The number needed to treat to prevent one case of cerebral palsy was 60 and the number needed to treat death or cerebral palsy was 56. The impact on severe intracranial hemorrhage (RR, 0.76; 95% CI, 0.60-0.98), a secondary outcome, was backed by moderate-certainty evidence.
Compared with the 2009 Cochrane review, the new study includes two new randomized controlled trials. One of which, the MAGENTA trial, administered magnesium sulfate at 30-34 weeks gestation and included new school-age follow-up data from two previously included trials. While the available data suggest little to no difference in outcomes at school age, more follow-up data are needed to assess this with greater certainty, the reviewers wrote.
While severe adverse outcomes (death, cardiac or respiratory arrest) for pregnant individuals appear not to have increased in pregnant patients who received magnesium sulfate (low-certainty evidence), the compound “probably increased maternal adverse effects severe enough to stop treatment,” the reviewers report (average RR, 3.21; 95% CI, 1.88-5.48; moderate-certainty evidence).
Side effects that were more frequent among women receiving magnesium sulfate include hypotension, tachycardia, warmth over body/flushing, nausea or vomiting, sweating, and dizziness.
“Treatment cessation due to such side effects was in the context of trials being conducted to establish benefit,” noted Dr. Shepherd, of the University of Adelaide in Australia. “With benefit now shown, these side effects may be viewed as comparatively minor/generally tolerable considering the potential benefits for children.”
Proving the neuroprotective value of magnesium sulfate took many years, Dr. Burd explained in the Master Class, as none of the randomized controlled trials analyzed in eventual meta-analyses and systematic reviews had reached their primary endpoints. It wasn’t until researchers obtained unpublished data and conducted these analyses and reviews that a significant effect of magnesium sulfate on cerebral palsy could be seen. Dr. Burd and other researchers are now working to better understand its biologic plausibility and precise mechanisms of action.
Dr. Shepherd disclosed that she is a former editor for Cochrane Pregnancy and Childbirth and current sign-off editor for Cochrane Central Editorial Service but reported having no involvement in the editorial processing of the review. Other authors disclosed that they were investigators for included trials and/or have published opinions in medical journals related to magnesium sulfate to reduce cerebral palsy. Dr. Burd reported no disclosures.
An updated Cochrane Systematic Review of magnesium sulfate administered before preterm birth for neuroprotection has reaffirmed that the compound significantly reduces the risk of cerebral palsy and has added the finding that it also may reduce the risk of severe neonatal intraventricular hemorrhage.
Still unknown, however, is whether the effects of magnesium sulfate vary according to patient characteristics such as gestational age, or by treatment characteristics such as timing and dose. “We need further research to determine exactly who to treat, and when and how, to ideally standardize clinical practice recommendations across the world,” said Emily S. Shepherd, PhD, lead author of the review.
Magnesium sulfate is widely used for preterm cerebral palsy prevention but variance in national and local recommendations for its use may impede its optimal uptake in some places, she and her co-investigators wrote in the review.
In the United States, the American College of Obstetricians and Gynecologists advises institutions to develop their own guidelines regarding inclusion criteria and treatment regimens “in accordance with one of the larger trials.” (ACOG’s Committee Opinion on Magnesium Sulfate Before Anticipated Preterm Birth for Neuroprotection was originally published in 2010 and was reaffirmed in 2023.)
In a Master Class column on magnesium sulfate for neuroprotection published earlier this year in Ob.Gyn. News, Irina Burd, MD, PhD, wrote that most hospitals in the United States have chosen a higher dose of magnesium sulfate administered up to 31 weeks’ gestation (6-g bolus, followed by 2 g/hour), in keeping with the protocols used in the BEAM trial published by the National Institute of Child Health and Human Development (NICHD). Dr. Burd is the Sylvan Frieman, MD, Endowed Professor and chair of the department of obstetrics, gynecology and reproductive sciences at the University of Maryland School of Medicine, Baltimore, Maryland.
The new Cochrane review included six randomized controlled trials (including the NICHD trial) covering 5917 pregnant participants and 6759 fetuses. Eligibility criteria varied, but all the RCTs included patients in preterm labor or with expected or planned imminent preterm birth at less than 34 weeks’ gestation.
Treatment regimens varied: three trials administered a 4-g loading dose only, and three included a maintenance dose (a 4-6-g loading dose and a 1-2 g/hour maintenance dose). “Although we attempted to explore variation through subgroup analyses, the ability to do this was limited,” the researchers wrote.
Up to 2 years of corrected age, magnesium sulfate reduced the risk of cerebral palsy compared with placebo (relative risk, 0.71; 95% confidence interval (CI), 0.57-0.89) and death or cerebral palsy (RR, 0.87; 95% CI, 0.77-0.98), with a high-certainty grade of evidence. The number needed to treat to prevent one case of cerebral palsy was 60 and the number needed to treat death or cerebral palsy was 56. The impact on severe intracranial hemorrhage (RR, 0.76; 95% CI, 0.60-0.98), a secondary outcome, was backed by moderate-certainty evidence.
Compared with the 2009 Cochrane review, the new study includes two new randomized controlled trials. One of which, the MAGENTA trial, administered magnesium sulfate at 30-34 weeks gestation and included new school-age follow-up data from two previously included trials. While the available data suggest little to no difference in outcomes at school age, more follow-up data are needed to assess this with greater certainty, the reviewers wrote.
While severe adverse outcomes (death, cardiac or respiratory arrest) for pregnant individuals appear not to have increased in pregnant patients who received magnesium sulfate (low-certainty evidence), the compound “probably increased maternal adverse effects severe enough to stop treatment,” the reviewers report (average RR, 3.21; 95% CI, 1.88-5.48; moderate-certainty evidence).
Side effects that were more frequent among women receiving magnesium sulfate include hypotension, tachycardia, warmth over body/flushing, nausea or vomiting, sweating, and dizziness.
“Treatment cessation due to such side effects was in the context of trials being conducted to establish benefit,” noted Dr. Shepherd, of the University of Adelaide in Australia. “With benefit now shown, these side effects may be viewed as comparatively minor/generally tolerable considering the potential benefits for children.”
Proving the neuroprotective value of magnesium sulfate took many years, Dr. Burd explained in the Master Class, as none of the randomized controlled trials analyzed in eventual meta-analyses and systematic reviews had reached their primary endpoints. It wasn’t until researchers obtained unpublished data and conducted these analyses and reviews that a significant effect of magnesium sulfate on cerebral palsy could be seen. Dr. Burd and other researchers are now working to better understand its biologic plausibility and precise mechanisms of action.
Dr. Shepherd disclosed that she is a former editor for Cochrane Pregnancy and Childbirth and current sign-off editor for Cochrane Central Editorial Service but reported having no involvement in the editorial processing of the review. Other authors disclosed that they were investigators for included trials and/or have published opinions in medical journals related to magnesium sulfate to reduce cerebral palsy. Dr. Burd reported no disclosures.
An updated Cochrane Systematic Review of magnesium sulfate administered before preterm birth for neuroprotection has reaffirmed that the compound significantly reduces the risk of cerebral palsy and has added the finding that it also may reduce the risk of severe neonatal intraventricular hemorrhage.
Still unknown, however, is whether the effects of magnesium sulfate vary according to patient characteristics such as gestational age, or by treatment characteristics such as timing and dose. “We need further research to determine exactly who to treat, and when and how, to ideally standardize clinical practice recommendations across the world,” said Emily S. Shepherd, PhD, lead author of the review.
Magnesium sulfate is widely used for preterm cerebral palsy prevention but variance in national and local recommendations for its use may impede its optimal uptake in some places, she and her co-investigators wrote in the review.
In the United States, the American College of Obstetricians and Gynecologists advises institutions to develop their own guidelines regarding inclusion criteria and treatment regimens “in accordance with one of the larger trials.” (ACOG’s Committee Opinion on Magnesium Sulfate Before Anticipated Preterm Birth for Neuroprotection was originally published in 2010 and was reaffirmed in 2023.)
In a Master Class column on magnesium sulfate for neuroprotection published earlier this year in Ob.Gyn. News, Irina Burd, MD, PhD, wrote that most hospitals in the United States have chosen a higher dose of magnesium sulfate administered up to 31 weeks’ gestation (6-g bolus, followed by 2 g/hour), in keeping with the protocols used in the BEAM trial published by the National Institute of Child Health and Human Development (NICHD). Dr. Burd is the Sylvan Frieman, MD, Endowed Professor and chair of the department of obstetrics, gynecology and reproductive sciences at the University of Maryland School of Medicine, Baltimore, Maryland.
The new Cochrane review included six randomized controlled trials (including the NICHD trial) covering 5917 pregnant participants and 6759 fetuses. Eligibility criteria varied, but all the RCTs included patients in preterm labor or with expected or planned imminent preterm birth at less than 34 weeks’ gestation.
Treatment regimens varied: three trials administered a 4-g loading dose only, and three included a maintenance dose (a 4-6-g loading dose and a 1-2 g/hour maintenance dose). “Although we attempted to explore variation through subgroup analyses, the ability to do this was limited,” the researchers wrote.
Up to 2 years of corrected age, magnesium sulfate reduced the risk of cerebral palsy compared with placebo (relative risk, 0.71; 95% confidence interval (CI), 0.57-0.89) and death or cerebral palsy (RR, 0.87; 95% CI, 0.77-0.98), with a high-certainty grade of evidence. The number needed to treat to prevent one case of cerebral palsy was 60 and the number needed to treat death or cerebral palsy was 56. The impact on severe intracranial hemorrhage (RR, 0.76; 95% CI, 0.60-0.98), a secondary outcome, was backed by moderate-certainty evidence.
Compared with the 2009 Cochrane review, the new study includes two new randomized controlled trials. One of which, the MAGENTA trial, administered magnesium sulfate at 30-34 weeks gestation and included new school-age follow-up data from two previously included trials. While the available data suggest little to no difference in outcomes at school age, more follow-up data are needed to assess this with greater certainty, the reviewers wrote.
While severe adverse outcomes (death, cardiac or respiratory arrest) for pregnant individuals appear not to have increased in pregnant patients who received magnesium sulfate (low-certainty evidence), the compound “probably increased maternal adverse effects severe enough to stop treatment,” the reviewers report (average RR, 3.21; 95% CI, 1.88-5.48; moderate-certainty evidence).
Side effects that were more frequent among women receiving magnesium sulfate include hypotension, tachycardia, warmth over body/flushing, nausea or vomiting, sweating, and dizziness.
“Treatment cessation due to such side effects was in the context of trials being conducted to establish benefit,” noted Dr. Shepherd, of the University of Adelaide in Australia. “With benefit now shown, these side effects may be viewed as comparatively minor/generally tolerable considering the potential benefits for children.”
Proving the neuroprotective value of magnesium sulfate took many years, Dr. Burd explained in the Master Class, as none of the randomized controlled trials analyzed in eventual meta-analyses and systematic reviews had reached their primary endpoints. It wasn’t until researchers obtained unpublished data and conducted these analyses and reviews that a significant effect of magnesium sulfate on cerebral palsy could be seen. Dr. Burd and other researchers are now working to better understand its biologic plausibility and precise mechanisms of action.
Dr. Shepherd disclosed that she is a former editor for Cochrane Pregnancy and Childbirth and current sign-off editor for Cochrane Central Editorial Service but reported having no involvement in the editorial processing of the review. Other authors disclosed that they were investigators for included trials and/or have published opinions in medical journals related to magnesium sulfate to reduce cerebral palsy. Dr. Burd reported no disclosures.
COCHRANE DATABASE SYSTEMATIC REVIEW
Metformin Gets a Reproductive Reprieve — For Diabetic Moms and Dads Alike
For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.
Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.
The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,
In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.
“On the one hand, metformin can cross the placenta and might directly affect the fetus. On the other hand, poor blood sugar control is a risk factor for birth defects,” she continued. “Insulin in combination with metformin might control blood sugar better than using insulin alone, which may lower the risk of birth defects.”
Switched to insulin monotherapy or prescribed additional insulin within 90 days of their last menstrual period, mothers were assessed for nonchromosomal fetal malformations and nonlive births, spontaneous abortion, and termination. Continuing metformin or adding insulin to metformin in early pregnancy resulted in little to no increased risk for major malformations in infants.
The estimated risk for nonlive birth was 32.7% with insulin monotherapy and 34.3% with insulin plus metformin polytherapy, for a risk ratio (RR) of 1.02 (95% confidence interval (CI), 1.01-1.04).
In addition, the estimated risk for live birth with congenital malformations was 8.0% (5.70-10.2) under insulin monotherapy and 5.7% under insulin plus metformin (95% CI, 4.5-7.3), amounting to a risk ratio of 0.72 (0.51-1.09).
While the results may involve residual confounding by participants’ glycemic control and body mass index, Dr. Chiu said, “Our findings suggest that the current clinical recommendations to switch from metformin to insulin before pregnancy, due to concerns about birth defects, may require reconsideration.”
She noted that previous trials showed adding metformin to insulin in mid-late pregnancy also improved blood sugar control with no increase in risk of birth defects. “However, most of these studies started treatment too late — between 10 and 34 weeks of pregnancy — to determine if metformin could cause birth defects.”
Observational studies found that women with pregestational diabetes who used noninsulin antidiabetics (mainly metformin) in the first trimester had a lower risk of birth defects, compared with those who used insulin, Dr. Chiu added. “However, comparing metformin with insulin may have some biases because women who used metformin generally have less severe diabetes than those who used insulin.”
Aligning with these reassuring findings, a randomized, placebo-controlled trial reported that adding metformin to insulin did not lead to a higher incidence of neonatal morbidity and mortality and was associated with better maternal glycemic control and reduced maternal weight gain. Metformin-exposed offspring, however, had lower birth weights and a higher incidence of being small for gestational age.
Similarly, a recent Nordic register study of more than 3.7 million infants also found no evidence of an increased risk of major defects with the use of metformin vs insulin in the first trimester.
Despite such reassuring findings, however, Dr. Chiu stressed the need to study other pregnancy and infant outcomes as well as the safety of other oral antidiabetics during pregnancy.
Metformin in Fathers
Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.
The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.
“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”
The prevalence of MCMs in the cohort was 4.7% in children of fathers unexposed to diabetes medications (n = 381,041), compared with 6.2% in children of fathers exposed during preconception spermatogenesis to metformin (n = 1730).
By these crude numbers, children with preconception paternal metformin exposure had a nearly 30% increased odds of MCMs. But whereas the crude odds ratio (OR) for MCMs with paternal metformin exposure in all formulations was 1.28 (95% CI, 1.01-1.64), the adjusted OR was 1.00 (95% CI, 0.76 -1.31). Within specific regimens, the adjusted OR was 0.86 (95% CI, 0.60-1.23) for metformin in monotherapy and 1.36 (95% CI, 1.00-1.85) for metformin in polytherapy.
At the outset, Dr. Rotem’s group hypothesized that any crude associations between metformin in polytherapy and birth defects could potentially be explained by poorer underlying parental cardiometabolic risk profiles in those taking multiple diabetes medications. Compared with that of unexposed fathers, the prevalence of cardiometabolic morbidity was indeed substantially higher among both fathers who used metformin during spermatogenesis and their spouses.
In addition, these fathers were more likely to be older, to be smokers, and to have fertility problems. Similarly, mothers were more likely to have cardiovascular comorbidity and to have had fertility problems when the father used metformin.
Moreover, children born to men who used diabetes medications before conception were much more likely to have mothers who also had diabetes and other metabolic conditions, Dr. Rotem noted. “This makes sense since we know that many of these conditions are affected by diet and lifestyle factors that are probably shared across individuals living in the same household.”
Recent research has shown that paternal health and behavior before conception can affect offspring development and long-term health. Characteristics including obesity, diabetes, and metabolic syndrome are seen to affect offspring via complex indirect and direct mechanisms, both genetic and nongenetic.
Doing little to dispel safety concerns, a recent Danish national study reported a link between preconception paternal metformin and major birth defects, particularly genital birth defects in boys. That study, however, lacked data on medication adherence and glycemic control.
“These are well-conducted studies, but it would be useful to see them replicated in different populations, as the sample sizes eligible for analysis are relatively small and some of the confidence intervals are wide,” said Robert W. Platt, PhD, a professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal, Canada. “However, the results suggest that type 2 diabetics can focus on the most effective treatment pathway for their condition. Metformin does not appear to confer an increased risk of congenital malformations.”
According to an accompanying editorial by Sarah Martins da Silva. MBChB, MD, a reproductive medicine specialist at the University of Dundee in Scotland, the Israeli findings highlight the importance of factoring the sometimes overlooked issue of paternal health into reproductive planning and prenatal care. She stressed that individual risks and benefits should always be carefully considered and results interpreted with caution since such studies lack information on glycemic control. “Nonetheless, these recent analyses suggest that metformin is a safe and effective treatment option for T2D for men and women trying to conceive as well as for managing hyperglycemia in pregnant women in the first trimester,” she wrote and agreed that it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy.
The studies by Dr. Chiu and Dr. Rotem were funded by the National Institutes of Health. Dr. Chiu and Dr. Rotem had no competing interests to declare. Dr. Hernandez Diaz, a coauthor on both studies, reported funding from Takeda and consulting for Moderna, Johnson & Johnson, and UCB. Several authors reported support from government and not-for-profit research funding agencies. Dr. Platt disclosed no competing interests. Editorial commentator Dr. Martins da Silva disclosed consulting, speaking, travel, and advisory fees from, variously, Dyneval, Ferring Pharmaceutical, Merck, IBSA, and Gedeon Richer.
For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.
Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.
The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,
In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.
“On the one hand, metformin can cross the placenta and might directly affect the fetus. On the other hand, poor blood sugar control is a risk factor for birth defects,” she continued. “Insulin in combination with metformin might control blood sugar better than using insulin alone, which may lower the risk of birth defects.”
Switched to insulin monotherapy or prescribed additional insulin within 90 days of their last menstrual period, mothers were assessed for nonchromosomal fetal malformations and nonlive births, spontaneous abortion, and termination. Continuing metformin or adding insulin to metformin in early pregnancy resulted in little to no increased risk for major malformations in infants.
The estimated risk for nonlive birth was 32.7% with insulin monotherapy and 34.3% with insulin plus metformin polytherapy, for a risk ratio (RR) of 1.02 (95% confidence interval (CI), 1.01-1.04).
In addition, the estimated risk for live birth with congenital malformations was 8.0% (5.70-10.2) under insulin monotherapy and 5.7% under insulin plus metformin (95% CI, 4.5-7.3), amounting to a risk ratio of 0.72 (0.51-1.09).
While the results may involve residual confounding by participants’ glycemic control and body mass index, Dr. Chiu said, “Our findings suggest that the current clinical recommendations to switch from metformin to insulin before pregnancy, due to concerns about birth defects, may require reconsideration.”
She noted that previous trials showed adding metformin to insulin in mid-late pregnancy also improved blood sugar control with no increase in risk of birth defects. “However, most of these studies started treatment too late — between 10 and 34 weeks of pregnancy — to determine if metformin could cause birth defects.”
Observational studies found that women with pregestational diabetes who used noninsulin antidiabetics (mainly metformin) in the first trimester had a lower risk of birth defects, compared with those who used insulin, Dr. Chiu added. “However, comparing metformin with insulin may have some biases because women who used metformin generally have less severe diabetes than those who used insulin.”
Aligning with these reassuring findings, a randomized, placebo-controlled trial reported that adding metformin to insulin did not lead to a higher incidence of neonatal morbidity and mortality and was associated with better maternal glycemic control and reduced maternal weight gain. Metformin-exposed offspring, however, had lower birth weights and a higher incidence of being small for gestational age.
Similarly, a recent Nordic register study of more than 3.7 million infants also found no evidence of an increased risk of major defects with the use of metformin vs insulin in the first trimester.
Despite such reassuring findings, however, Dr. Chiu stressed the need to study other pregnancy and infant outcomes as well as the safety of other oral antidiabetics during pregnancy.
Metformin in Fathers
Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.
The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.
“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”
The prevalence of MCMs in the cohort was 4.7% in children of fathers unexposed to diabetes medications (n = 381,041), compared with 6.2% in children of fathers exposed during preconception spermatogenesis to metformin (n = 1730).
By these crude numbers, children with preconception paternal metformin exposure had a nearly 30% increased odds of MCMs. But whereas the crude odds ratio (OR) for MCMs with paternal metformin exposure in all formulations was 1.28 (95% CI, 1.01-1.64), the adjusted OR was 1.00 (95% CI, 0.76 -1.31). Within specific regimens, the adjusted OR was 0.86 (95% CI, 0.60-1.23) for metformin in monotherapy and 1.36 (95% CI, 1.00-1.85) for metformin in polytherapy.
At the outset, Dr. Rotem’s group hypothesized that any crude associations between metformin in polytherapy and birth defects could potentially be explained by poorer underlying parental cardiometabolic risk profiles in those taking multiple diabetes medications. Compared with that of unexposed fathers, the prevalence of cardiometabolic morbidity was indeed substantially higher among both fathers who used metformin during spermatogenesis and their spouses.
In addition, these fathers were more likely to be older, to be smokers, and to have fertility problems. Similarly, mothers were more likely to have cardiovascular comorbidity and to have had fertility problems when the father used metformin.
Moreover, children born to men who used diabetes medications before conception were much more likely to have mothers who also had diabetes and other metabolic conditions, Dr. Rotem noted. “This makes sense since we know that many of these conditions are affected by diet and lifestyle factors that are probably shared across individuals living in the same household.”
Recent research has shown that paternal health and behavior before conception can affect offspring development and long-term health. Characteristics including obesity, diabetes, and metabolic syndrome are seen to affect offspring via complex indirect and direct mechanisms, both genetic and nongenetic.
Doing little to dispel safety concerns, a recent Danish national study reported a link between preconception paternal metformin and major birth defects, particularly genital birth defects in boys. That study, however, lacked data on medication adherence and glycemic control.
“These are well-conducted studies, but it would be useful to see them replicated in different populations, as the sample sizes eligible for analysis are relatively small and some of the confidence intervals are wide,” said Robert W. Platt, PhD, a professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal, Canada. “However, the results suggest that type 2 diabetics can focus on the most effective treatment pathway for their condition. Metformin does not appear to confer an increased risk of congenital malformations.”
According to an accompanying editorial by Sarah Martins da Silva. MBChB, MD, a reproductive medicine specialist at the University of Dundee in Scotland, the Israeli findings highlight the importance of factoring the sometimes overlooked issue of paternal health into reproductive planning and prenatal care. She stressed that individual risks and benefits should always be carefully considered and results interpreted with caution since such studies lack information on glycemic control. “Nonetheless, these recent analyses suggest that metformin is a safe and effective treatment option for T2D for men and women trying to conceive as well as for managing hyperglycemia in pregnant women in the first trimester,” she wrote and agreed that it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy.
The studies by Dr. Chiu and Dr. Rotem were funded by the National Institutes of Health. Dr. Chiu and Dr. Rotem had no competing interests to declare. Dr. Hernandez Diaz, a coauthor on both studies, reported funding from Takeda and consulting for Moderna, Johnson & Johnson, and UCB. Several authors reported support from government and not-for-profit research funding agencies. Dr. Platt disclosed no competing interests. Editorial commentator Dr. Martins da Silva disclosed consulting, speaking, travel, and advisory fees from, variously, Dyneval, Ferring Pharmaceutical, Merck, IBSA, and Gedeon Richer.
For decades it’s been thought that preconception use of the oral antidiabetic metformin by mothers and fathers might result in adverse fetal outcomes, including congenital malformations and stillbirths.
Women with type 2 diabetes (T2D) are often advised to switch to insulin before or during early pregnancy out of concern for fetal safety. But two studies from the Harvard T.H. Chan School of Public Health in Boston, Massachusetts — one in mothers, the other in fathers — report that metformin, a common and cost-effective antidiabetic agent, is not associated with a significant increased risk of teratogenicity and negative perinatal outcomes. The studies appear in Annals of Internal Medicine.
The studies may make it easier for physicians to reassure diabetic parents-to-be about the safety of metformin use before conception and in early pregnancy,
In the context of sparse existing safety data, the maternal analysis looked at Medicaid data on 12,489 mothers (mean age, about 30) receiving metformin for pregestational T2D during the period 2000-2018. “Many women become pregnant while still taking noninsulin oral antidiabetics, mostly metformin, and one safety concern is whether metformin could cause birth defects,” lead author Yu-Han Chiu, MD, ScD, an epidemiologist, said in an interview, commenting on the impetus for the study.
“On the one hand, metformin can cross the placenta and might directly affect the fetus. On the other hand, poor blood sugar control is a risk factor for birth defects,” she continued. “Insulin in combination with metformin might control blood sugar better than using insulin alone, which may lower the risk of birth defects.”
Switched to insulin monotherapy or prescribed additional insulin within 90 days of their last menstrual period, mothers were assessed for nonchromosomal fetal malformations and nonlive births, spontaneous abortion, and termination. Continuing metformin or adding insulin to metformin in early pregnancy resulted in little to no increased risk for major malformations in infants.
The estimated risk for nonlive birth was 32.7% with insulin monotherapy and 34.3% with insulin plus metformin polytherapy, for a risk ratio (RR) of 1.02 (95% confidence interval (CI), 1.01-1.04).
In addition, the estimated risk for live birth with congenital malformations was 8.0% (5.70-10.2) under insulin monotherapy and 5.7% under insulin plus metformin (95% CI, 4.5-7.3), amounting to a risk ratio of 0.72 (0.51-1.09).
While the results may involve residual confounding by participants’ glycemic control and body mass index, Dr. Chiu said, “Our findings suggest that the current clinical recommendations to switch from metformin to insulin before pregnancy, due to concerns about birth defects, may require reconsideration.”
She noted that previous trials showed adding metformin to insulin in mid-late pregnancy also improved blood sugar control with no increase in risk of birth defects. “However, most of these studies started treatment too late — between 10 and 34 weeks of pregnancy — to determine if metformin could cause birth defects.”
Observational studies found that women with pregestational diabetes who used noninsulin antidiabetics (mainly metformin) in the first trimester had a lower risk of birth defects, compared with those who used insulin, Dr. Chiu added. “However, comparing metformin with insulin may have some biases because women who used metformin generally have less severe diabetes than those who used insulin.”
Aligning with these reassuring findings, a randomized, placebo-controlled trial reported that adding metformin to insulin did not lead to a higher incidence of neonatal morbidity and mortality and was associated with better maternal glycemic control and reduced maternal weight gain. Metformin-exposed offspring, however, had lower birth weights and a higher incidence of being small for gestational age.
Similarly, a recent Nordic register study of more than 3.7 million infants also found no evidence of an increased risk of major defects with the use of metformin vs insulin in the first trimester.
Despite such reassuring findings, however, Dr. Chiu stressed the need to study other pregnancy and infant outcomes as well as the safety of other oral antidiabetics during pregnancy.
Metformin in Fathers
Turning to fathers, a much larger cohort study by Harvard T.H. Chan investigators looked at the effect of paternal metformin use and also found it to be safe.
The Harvard investigators analyzed diabetic men in 383,851 live births from 1999 to 2020 in an Israeli health fund cohort, excluding those with diabetic spouses. Across different T2D medication groups, paternal age ranged from about 35 to about 43 years. The data revealed that paternal use of metformin monotherapy in the preconception sperm production period was, after adjustment of crude numbers, not associated with major congenital malformations (MCMs) in newborns.
“While metformin has an overall good safety profile, it can lower androgen levels, and there had been some concerns that its use in fathers could alter the sperm, causing adverse effects to the fetus,” lead author and neuroepidemiologist Ran S. Rotem, MD, ScD, of the Harvard School of Public Health, Boston, Massachusetts, said in interview. “Given the increasing prevalence of diabetes in young individuals, more fathers are conceiving a child while using the medication, which could lead to a substantial population effect even if the individual risk is low. But our study suggests that the medication is safe to use by fathers before conception.”
The prevalence of MCMs in the cohort was 4.7% in children of fathers unexposed to diabetes medications (n = 381,041), compared with 6.2% in children of fathers exposed during preconception spermatogenesis to metformin (n = 1730).
By these crude numbers, children with preconception paternal metformin exposure had a nearly 30% increased odds of MCMs. But whereas the crude odds ratio (OR) for MCMs with paternal metformin exposure in all formulations was 1.28 (95% CI, 1.01-1.64), the adjusted OR was 1.00 (95% CI, 0.76 -1.31). Within specific regimens, the adjusted OR was 0.86 (95% CI, 0.60-1.23) for metformin in monotherapy and 1.36 (95% CI, 1.00-1.85) for metformin in polytherapy.
At the outset, Dr. Rotem’s group hypothesized that any crude associations between metformin in polytherapy and birth defects could potentially be explained by poorer underlying parental cardiometabolic risk profiles in those taking multiple diabetes medications. Compared with that of unexposed fathers, the prevalence of cardiometabolic morbidity was indeed substantially higher among both fathers who used metformin during spermatogenesis and their spouses.
In addition, these fathers were more likely to be older, to be smokers, and to have fertility problems. Similarly, mothers were more likely to have cardiovascular comorbidity and to have had fertility problems when the father used metformin.
Moreover, children born to men who used diabetes medications before conception were much more likely to have mothers who also had diabetes and other metabolic conditions, Dr. Rotem noted. “This makes sense since we know that many of these conditions are affected by diet and lifestyle factors that are probably shared across individuals living in the same household.”
Recent research has shown that paternal health and behavior before conception can affect offspring development and long-term health. Characteristics including obesity, diabetes, and metabolic syndrome are seen to affect offspring via complex indirect and direct mechanisms, both genetic and nongenetic.
Doing little to dispel safety concerns, a recent Danish national study reported a link between preconception paternal metformin and major birth defects, particularly genital birth defects in boys. That study, however, lacked data on medication adherence and glycemic control.
“These are well-conducted studies, but it would be useful to see them replicated in different populations, as the sample sizes eligible for analysis are relatively small and some of the confidence intervals are wide,” said Robert W. Platt, PhD, a professor in the departments of Pediatrics and of Epidemiology, Biostatistics, and Occupational Health at McGill University in Montreal, Canada. “However, the results suggest that type 2 diabetics can focus on the most effective treatment pathway for their condition. Metformin does not appear to confer an increased risk of congenital malformations.”
According to an accompanying editorial by Sarah Martins da Silva. MBChB, MD, a reproductive medicine specialist at the University of Dundee in Scotland, the Israeli findings highlight the importance of factoring the sometimes overlooked issue of paternal health into reproductive planning and prenatal care. She stressed that individual risks and benefits should always be carefully considered and results interpreted with caution since such studies lack information on glycemic control. “Nonetheless, these recent analyses suggest that metformin is a safe and effective treatment option for T2D for men and women trying to conceive as well as for managing hyperglycemia in pregnant women in the first trimester,” she wrote and agreed that it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy.
The studies by Dr. Chiu and Dr. Rotem were funded by the National Institutes of Health. Dr. Chiu and Dr. Rotem had no competing interests to declare. Dr. Hernandez Diaz, a coauthor on both studies, reported funding from Takeda and consulting for Moderna, Johnson & Johnson, and UCB. Several authors reported support from government and not-for-profit research funding agencies. Dr. Platt disclosed no competing interests. Editorial commentator Dr. Martins da Silva disclosed consulting, speaking, travel, and advisory fees from, variously, Dyneval, Ferring Pharmaceutical, Merck, IBSA, and Gedeon Richer.
FDA Expands Pembrolizumab Approval for Endometrial Cancer
The Food and Drug Administration has expanded the indication for pembrolizumab (Keytruda, Merck) to include the use of the targeted immunotherapy agent plus chemotherapy followed by single-agent pembrolizumab in adults with primary advanced or recurrent endometrial cancer.
Approval in this setting was granted following priority review and was based on efficacy demonstrated in the randomized, placebo-controlled, phase 3 KEYNOTE-868/NRG-GY018 trial. The multicenter trial showed improved progression-free survival (PFS) with chemotherapy plus pembrolizumab versus chemotherapy plus placebo in patients with stage 3 or 4 disease or stage IVB recurrent disease in two cohorts: 222 patients with mismatch repair (MMR) deficiency, and 588 patients with MMR proficiency.
Among the MMR-deficient patients, median PFS was not reached in the treatment arm and was 6.5 months in the control arm (hazard ratio, 0.30). Among the MMR-proficient patients, the median PFS was 11.1 versus 8.5 months in the study arms, respectively (HR, 0.60), according to an FDA press release.
Patients in both cohorts were randomized 1:1 to receive 200 mg of either pembrolizumab or placebo every 3 weeks, followed by paclitaxel at a dose of 175 mg/m2 and carboplatin at a dose of AUC 5 mg/mL/min for six cycles and then 400 mg of pembrolizumab or placebo every 6 weeks for up to 14 cycles.
“Adverse reactions associated with pembrolizumab and chemotherapy were generally similar to those previously reported for pembrolizumab or chemotherapy with the exception of a higher incidence of rash,” the FDA noted.
According to the full prescribing information for pembrolizumab, the recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or for up to 24 months.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has expanded the indication for pembrolizumab (Keytruda, Merck) to include the use of the targeted immunotherapy agent plus chemotherapy followed by single-agent pembrolizumab in adults with primary advanced or recurrent endometrial cancer.
Approval in this setting was granted following priority review and was based on efficacy demonstrated in the randomized, placebo-controlled, phase 3 KEYNOTE-868/NRG-GY018 trial. The multicenter trial showed improved progression-free survival (PFS) with chemotherapy plus pembrolizumab versus chemotherapy plus placebo in patients with stage 3 or 4 disease or stage IVB recurrent disease in two cohorts: 222 patients with mismatch repair (MMR) deficiency, and 588 patients with MMR proficiency.
Among the MMR-deficient patients, median PFS was not reached in the treatment arm and was 6.5 months in the control arm (hazard ratio, 0.30). Among the MMR-proficient patients, the median PFS was 11.1 versus 8.5 months in the study arms, respectively (HR, 0.60), according to an FDA press release.
Patients in both cohorts were randomized 1:1 to receive 200 mg of either pembrolizumab or placebo every 3 weeks, followed by paclitaxel at a dose of 175 mg/m2 and carboplatin at a dose of AUC 5 mg/mL/min for six cycles and then 400 mg of pembrolizumab or placebo every 6 weeks for up to 14 cycles.
“Adverse reactions associated with pembrolizumab and chemotherapy were generally similar to those previously reported for pembrolizumab or chemotherapy with the exception of a higher incidence of rash,” the FDA noted.
According to the full prescribing information for pembrolizumab, the recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or for up to 24 months.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has expanded the indication for pembrolizumab (Keytruda, Merck) to include the use of the targeted immunotherapy agent plus chemotherapy followed by single-agent pembrolizumab in adults with primary advanced or recurrent endometrial cancer.
Approval in this setting was granted following priority review and was based on efficacy demonstrated in the randomized, placebo-controlled, phase 3 KEYNOTE-868/NRG-GY018 trial. The multicenter trial showed improved progression-free survival (PFS) with chemotherapy plus pembrolizumab versus chemotherapy plus placebo in patients with stage 3 or 4 disease or stage IVB recurrent disease in two cohorts: 222 patients with mismatch repair (MMR) deficiency, and 588 patients with MMR proficiency.
Among the MMR-deficient patients, median PFS was not reached in the treatment arm and was 6.5 months in the control arm (hazard ratio, 0.30). Among the MMR-proficient patients, the median PFS was 11.1 versus 8.5 months in the study arms, respectively (HR, 0.60), according to an FDA press release.
Patients in both cohorts were randomized 1:1 to receive 200 mg of either pembrolizumab or placebo every 3 weeks, followed by paclitaxel at a dose of 175 mg/m2 and carboplatin at a dose of AUC 5 mg/mL/min for six cycles and then 400 mg of pembrolizumab or placebo every 6 weeks for up to 14 cycles.
“Adverse reactions associated with pembrolizumab and chemotherapy were generally similar to those previously reported for pembrolizumab or chemotherapy with the exception of a higher incidence of rash,” the FDA noted.
According to the full prescribing information for pembrolizumab, the recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or for up to 24 months.
A version of this article first appeared on Medscape.com.
Polycystic Ovarian Syndrome: New Science Offers Old Remedy
An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.
“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.
Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.
In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.
Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
What the Researchers Did
To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.
“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.
Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.
In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.
“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.
Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
What’s Next?
A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.
And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.
Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)
And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.
A version of this article first appeared on Medscape.com.
An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.
“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.
Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.
In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.
Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
What the Researchers Did
To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.
“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.
Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.
In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.
“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.
Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
What’s Next?
A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.
And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.
Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)
And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.
A version of this article first appeared on Medscape.com.
An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.
“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.
Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.
In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.
Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
What the Researchers Did
To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.
“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.
Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.
In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.
“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.
Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
What’s Next?
A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.
And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.
Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)
And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.
A version of this article first appeared on Medscape.com.
FROM SCIENCE
Surviving to Thriving: Enhancing Quality of Life in Breast Cancer
Advances in breast cancer detection and treatment over the past decades have led to an increase in the number of women diagnosed at earlier stages and successfully treated, ushering in a new era of survivorship.
According to the American Cancer Society, there are currently roughly four million breast cancer survivors in the United States, including those still receiving treatment. The mortality rates for women with breast cancer have been decreasing since 1989, with an overall decline of 42% through 2021.
As the population of breast cancer survivors continues to grow, developing and delivering comprehensive survivorship care is crucial, Thelma Brown told attendees at the American Society of Clinical Oncology (ASCO) 2024 annual meeting. Ms. Brown’s talk was part of an educational session focused on addressing issues among early breast cancer survivors, evolving practices in breast cancer surveillance, and mitigating recurrence risk.
The challenges following breast cancer diagnosis and treatment can be both visible and invisible, said Ms. Brown, a patient advocate and member of the Breast Cancer Working Group at the University of Alabama at Birmingham.
Up to 90% of early breast cancer survivors experience long-term effects from treatment, which often include fatigue, loss of mobility, chronic pain, peripheral neuropathy, lymphedema, and infertility.
Survivors face an elevated risk for depression, anxiety, and fear of recurrence. “Fear of recurrence is a big issue, and it’s almost universal,” she noted.
Cancer treatment is also costly, leading to financial toxicity for many patients, which also “affects adherence to treatment and overall family well-being,” Ms. Brown explained. Survivors may struggle to access financial assistance due to complex eligibility requirements and a lack of awareness about available resources.
There is a need for holistic and coordinated survivorship care that includes management of long-term effects and surveillance for recurrence to help breast cancer survivors to transition from merely surviving to thriving, said Ms. Brown.
Surveilling and Mitigating Recurrence
Surveillance in patients with breast cancer post treatment remains a debated area, particularly when it comes to detecting distant recurrences, David Cescon, MD, PhD, with Princess Margaret Cancer Center, University Health Network, Toronto, said in his talk.
While breast imaging standards are well established, systemic surveillance through imaging and laboratory tests for asymptomatic patients lacks consensus and uniform guidelines, he explained.
Several clinical trials conducted from the late 1980s to the early 2000s showed no survival benefit from intensive surveillance strategies, including imaging and laboratory tests, compared to routine clinical follow-up. Some studies even demonstrated a trend toward harm, given the number of false positives.
These studies formed the basis for guidelines that discourage surveillance among asymptomatic survivors. Currently, no major guideline organization — the National Comprehensive Cancer Network, ASCO, and the European Society for Medical Oncology — recommends routine (nonbreast) radiologic surveillance or laboratory tests for detecting asymptomatic distant breast cancer recurrence, Dr. Cescon said.
Yet, that may change in the coming years, he told attendees.
Ongoing prospective studies will hopefully generate high-quality evidence on the effectiveness of modern surveillance techniques, particularly detection of circulating tumor DNA (ctDNA) and its effect on survival and quality of life, said Dr. Cescon.
These liquid biopsy assays have shown promise in identifying minimal residual disease before radiographic recurrence, he explained. Retrospective studies suggest high prognostic value, with nearly all patients with detectable ctDNA post therapy experiencing recurrence.
He cautioned, however, that while sensitive ctDNA tests exist and have clinical validity in identifying minimal residual disease, “their clinical utility has not yet been demonstrated,” Dr. Cescon said, adding that any surveillance strategy must consider the psychological effect of frequent testing and the potential for false positives or negatives.
The ultimate goal is preventing disease recurrence, said Neil M. Iyengar, MD, with Memorial Sloan Kettering Cancer Center in New York, in his talk on mitigating recurrence risk.
Lifestyle modifications are an important targeted intervention for patients entering the survivorship phase, with a “robust level of evidence” supporting their use to mitigate adverse effects associated with cancer therapy and improve quality of life, he told attendees. Most notably, smoking cessation, healthy dietary patterns, physical activity, and reduced alcohol have been associated with improvements in breast cancer outcomes.
Going forward, it will be important to “understand the antitumor potential of lifestyle modification and how we can wield this type of intervention as a precision tool to potentially enhance the effects of cancer therapy and potentially cancer biology,” said Dr. Iyengar.
Ms. Brown disclosed relationships with AstraZeneca. Dr. Cescon disclosed relationships with AstraZeneca, Gilead Sciences, Daiichi Sankyo Europe GmbH, Eisai, GlaxoSmithKline, and other companies. Dr. Iyengar disclosed relationships with Curio Science, DAVA Oncology, Novartis, Pfizer, and others.
A version of this article first appeared on Medscape.com.
Advances in breast cancer detection and treatment over the past decades have led to an increase in the number of women diagnosed at earlier stages and successfully treated, ushering in a new era of survivorship.
According to the American Cancer Society, there are currently roughly four million breast cancer survivors in the United States, including those still receiving treatment. The mortality rates for women with breast cancer have been decreasing since 1989, with an overall decline of 42% through 2021.
As the population of breast cancer survivors continues to grow, developing and delivering comprehensive survivorship care is crucial, Thelma Brown told attendees at the American Society of Clinical Oncology (ASCO) 2024 annual meeting. Ms. Brown’s talk was part of an educational session focused on addressing issues among early breast cancer survivors, evolving practices in breast cancer surveillance, and mitigating recurrence risk.
The challenges following breast cancer diagnosis and treatment can be both visible and invisible, said Ms. Brown, a patient advocate and member of the Breast Cancer Working Group at the University of Alabama at Birmingham.
Up to 90% of early breast cancer survivors experience long-term effects from treatment, which often include fatigue, loss of mobility, chronic pain, peripheral neuropathy, lymphedema, and infertility.
Survivors face an elevated risk for depression, anxiety, and fear of recurrence. “Fear of recurrence is a big issue, and it’s almost universal,” she noted.
Cancer treatment is also costly, leading to financial toxicity for many patients, which also “affects adherence to treatment and overall family well-being,” Ms. Brown explained. Survivors may struggle to access financial assistance due to complex eligibility requirements and a lack of awareness about available resources.
There is a need for holistic and coordinated survivorship care that includes management of long-term effects and surveillance for recurrence to help breast cancer survivors to transition from merely surviving to thriving, said Ms. Brown.
Surveilling and Mitigating Recurrence
Surveillance in patients with breast cancer post treatment remains a debated area, particularly when it comes to detecting distant recurrences, David Cescon, MD, PhD, with Princess Margaret Cancer Center, University Health Network, Toronto, said in his talk.
While breast imaging standards are well established, systemic surveillance through imaging and laboratory tests for asymptomatic patients lacks consensus and uniform guidelines, he explained.
Several clinical trials conducted from the late 1980s to the early 2000s showed no survival benefit from intensive surveillance strategies, including imaging and laboratory tests, compared to routine clinical follow-up. Some studies even demonstrated a trend toward harm, given the number of false positives.
These studies formed the basis for guidelines that discourage surveillance among asymptomatic survivors. Currently, no major guideline organization — the National Comprehensive Cancer Network, ASCO, and the European Society for Medical Oncology — recommends routine (nonbreast) radiologic surveillance or laboratory tests for detecting asymptomatic distant breast cancer recurrence, Dr. Cescon said.
Yet, that may change in the coming years, he told attendees.
Ongoing prospective studies will hopefully generate high-quality evidence on the effectiveness of modern surveillance techniques, particularly detection of circulating tumor DNA (ctDNA) and its effect on survival and quality of life, said Dr. Cescon.
These liquid biopsy assays have shown promise in identifying minimal residual disease before radiographic recurrence, he explained. Retrospective studies suggest high prognostic value, with nearly all patients with detectable ctDNA post therapy experiencing recurrence.
He cautioned, however, that while sensitive ctDNA tests exist and have clinical validity in identifying minimal residual disease, “their clinical utility has not yet been demonstrated,” Dr. Cescon said, adding that any surveillance strategy must consider the psychological effect of frequent testing and the potential for false positives or negatives.
The ultimate goal is preventing disease recurrence, said Neil M. Iyengar, MD, with Memorial Sloan Kettering Cancer Center in New York, in his talk on mitigating recurrence risk.
Lifestyle modifications are an important targeted intervention for patients entering the survivorship phase, with a “robust level of evidence” supporting their use to mitigate adverse effects associated with cancer therapy and improve quality of life, he told attendees. Most notably, smoking cessation, healthy dietary patterns, physical activity, and reduced alcohol have been associated with improvements in breast cancer outcomes.
Going forward, it will be important to “understand the antitumor potential of lifestyle modification and how we can wield this type of intervention as a precision tool to potentially enhance the effects of cancer therapy and potentially cancer biology,” said Dr. Iyengar.
Ms. Brown disclosed relationships with AstraZeneca. Dr. Cescon disclosed relationships with AstraZeneca, Gilead Sciences, Daiichi Sankyo Europe GmbH, Eisai, GlaxoSmithKline, and other companies. Dr. Iyengar disclosed relationships with Curio Science, DAVA Oncology, Novartis, Pfizer, and others.
A version of this article first appeared on Medscape.com.
Advances in breast cancer detection and treatment over the past decades have led to an increase in the number of women diagnosed at earlier stages and successfully treated, ushering in a new era of survivorship.
According to the American Cancer Society, there are currently roughly four million breast cancer survivors in the United States, including those still receiving treatment. The mortality rates for women with breast cancer have been decreasing since 1989, with an overall decline of 42% through 2021.
As the population of breast cancer survivors continues to grow, developing and delivering comprehensive survivorship care is crucial, Thelma Brown told attendees at the American Society of Clinical Oncology (ASCO) 2024 annual meeting. Ms. Brown’s talk was part of an educational session focused on addressing issues among early breast cancer survivors, evolving practices in breast cancer surveillance, and mitigating recurrence risk.
The challenges following breast cancer diagnosis and treatment can be both visible and invisible, said Ms. Brown, a patient advocate and member of the Breast Cancer Working Group at the University of Alabama at Birmingham.
Up to 90% of early breast cancer survivors experience long-term effects from treatment, which often include fatigue, loss of mobility, chronic pain, peripheral neuropathy, lymphedema, and infertility.
Survivors face an elevated risk for depression, anxiety, and fear of recurrence. “Fear of recurrence is a big issue, and it’s almost universal,” she noted.
Cancer treatment is also costly, leading to financial toxicity for many patients, which also “affects adherence to treatment and overall family well-being,” Ms. Brown explained. Survivors may struggle to access financial assistance due to complex eligibility requirements and a lack of awareness about available resources.
There is a need for holistic and coordinated survivorship care that includes management of long-term effects and surveillance for recurrence to help breast cancer survivors to transition from merely surviving to thriving, said Ms. Brown.
Surveilling and Mitigating Recurrence
Surveillance in patients with breast cancer post treatment remains a debated area, particularly when it comes to detecting distant recurrences, David Cescon, MD, PhD, with Princess Margaret Cancer Center, University Health Network, Toronto, said in his talk.
While breast imaging standards are well established, systemic surveillance through imaging and laboratory tests for asymptomatic patients lacks consensus and uniform guidelines, he explained.
Several clinical trials conducted from the late 1980s to the early 2000s showed no survival benefit from intensive surveillance strategies, including imaging and laboratory tests, compared to routine clinical follow-up. Some studies even demonstrated a trend toward harm, given the number of false positives.
These studies formed the basis for guidelines that discourage surveillance among asymptomatic survivors. Currently, no major guideline organization — the National Comprehensive Cancer Network, ASCO, and the European Society for Medical Oncology — recommends routine (nonbreast) radiologic surveillance or laboratory tests for detecting asymptomatic distant breast cancer recurrence, Dr. Cescon said.
Yet, that may change in the coming years, he told attendees.
Ongoing prospective studies will hopefully generate high-quality evidence on the effectiveness of modern surveillance techniques, particularly detection of circulating tumor DNA (ctDNA) and its effect on survival and quality of life, said Dr. Cescon.
These liquid biopsy assays have shown promise in identifying minimal residual disease before radiographic recurrence, he explained. Retrospective studies suggest high prognostic value, with nearly all patients with detectable ctDNA post therapy experiencing recurrence.
He cautioned, however, that while sensitive ctDNA tests exist and have clinical validity in identifying minimal residual disease, “their clinical utility has not yet been demonstrated,” Dr. Cescon said, adding that any surveillance strategy must consider the psychological effect of frequent testing and the potential for false positives or negatives.
The ultimate goal is preventing disease recurrence, said Neil M. Iyengar, MD, with Memorial Sloan Kettering Cancer Center in New York, in his talk on mitigating recurrence risk.
Lifestyle modifications are an important targeted intervention for patients entering the survivorship phase, with a “robust level of evidence” supporting their use to mitigate adverse effects associated with cancer therapy and improve quality of life, he told attendees. Most notably, smoking cessation, healthy dietary patterns, physical activity, and reduced alcohol have been associated with improvements in breast cancer outcomes.
Going forward, it will be important to “understand the antitumor potential of lifestyle modification and how we can wield this type of intervention as a precision tool to potentially enhance the effects of cancer therapy and potentially cancer biology,” said Dr. Iyengar.
Ms. Brown disclosed relationships with AstraZeneca. Dr. Cescon disclosed relationships with AstraZeneca, Gilead Sciences, Daiichi Sankyo Europe GmbH, Eisai, GlaxoSmithKline, and other companies. Dr. Iyengar disclosed relationships with Curio Science, DAVA Oncology, Novartis, Pfizer, and others.
A version of this article first appeared on Medscape.com.
FROM ASCO 2024
Recurrent UTI Rates High Among Older Women, Diagnosing Accurately Is Complicated
TOPLINE:
Accurately diagnosing recurrent urinary tract infections (rUTIs) in older women is challenging and requires careful weighing of the risks and benefits of various treatments, according to a new clinical insight published in JAMA Internal Medicine.
METHODOLOGY:
- Women aged > 65 years have double the rUTI rates compared with younger women, but detecting the condition is more complicated due to age-related conditions, such as overactive bladder related to menopause.
- Overuse of antibiotics can increase their risk of contracting antibiotic-resistant organisms and can lead to pulmonary or hepatic toxic effects in women with reduced kidney function.
- Up to 20% of older women have bacteria in their urine, which may or may not reflect a rUTI.
- Diagnosing rUTIs is complicated if women have dementia or cognitive decline, which can hinder recollection of symptoms.
TAKEAWAYS:
- Clinicians should consider only testing older female patients for rUTIs when symptoms are present and consider all possibilities before making a diagnosis.
- Vaginal estrogen may be an effective treatment, although the authors of the clinical review note a lack of a uniform formulation to recommend. However, oral estrogen use is not supported by evidence, and clinicians should instead consider vaginal creams or rings.
- The drug methenamine may be as effective as antibiotics but may not be safe for women with comorbidities. Evidence supports daily use at 1 g.
- Cranberry supplements and behavioral changes may be helpful, but evidence is limited, including among women living in long-term care facilities.
IN PRACTICE:
“Shared decision-making is especially important when diagnosis of an rUTI episode in older women is unclear ... in these cases, clinicians should acknowledge limitations in the evidence and invite patients or their caregivers to discuss preferences about presumptive treatment, weighing the possibility of earlier symptom relief or decreased UTI complications against the risk of adverse drug effects or multidrug resistance.”
SOURCE:
The paper was led by Alison J. Huang, MD, MAS, an internal medicine specialist and researcher in the Department of Medicine at the University of California, San Francisco.
LIMITATIONS:
The authors reported no limitations.
DISCLOSURES:
Dr. Huang received grants from the National Institutes of Health. Other authors reported receiving grants from the Agency for Healthcare Research and Quality, the US Department of Veterans Affairs, the Kahn Foundation, and Nanovibronix.
Cranberry supplements and behavioral changes may be helpful, but evidence is limited, including among women living in long-term care facilities.
A version of this article first appeared on Medscape.com.
TOPLINE:
Accurately diagnosing recurrent urinary tract infections (rUTIs) in older women is challenging and requires careful weighing of the risks and benefits of various treatments, according to a new clinical insight published in JAMA Internal Medicine.
METHODOLOGY:
- Women aged > 65 years have double the rUTI rates compared with younger women, but detecting the condition is more complicated due to age-related conditions, such as overactive bladder related to menopause.
- Overuse of antibiotics can increase their risk of contracting antibiotic-resistant organisms and can lead to pulmonary or hepatic toxic effects in women with reduced kidney function.
- Up to 20% of older women have bacteria in their urine, which may or may not reflect a rUTI.
- Diagnosing rUTIs is complicated if women have dementia or cognitive decline, which can hinder recollection of symptoms.
TAKEAWAYS:
- Clinicians should consider only testing older female patients for rUTIs when symptoms are present and consider all possibilities before making a diagnosis.
- Vaginal estrogen may be an effective treatment, although the authors of the clinical review note a lack of a uniform formulation to recommend. However, oral estrogen use is not supported by evidence, and clinicians should instead consider vaginal creams or rings.
- The drug methenamine may be as effective as antibiotics but may not be safe for women with comorbidities. Evidence supports daily use at 1 g.
- Cranberry supplements and behavioral changes may be helpful, but evidence is limited, including among women living in long-term care facilities.
IN PRACTICE:
“Shared decision-making is especially important when diagnosis of an rUTI episode in older women is unclear ... in these cases, clinicians should acknowledge limitations in the evidence and invite patients or their caregivers to discuss preferences about presumptive treatment, weighing the possibility of earlier symptom relief or decreased UTI complications against the risk of adverse drug effects or multidrug resistance.”
SOURCE:
The paper was led by Alison J. Huang, MD, MAS, an internal medicine specialist and researcher in the Department of Medicine at the University of California, San Francisco.
LIMITATIONS:
The authors reported no limitations.
DISCLOSURES:
Dr. Huang received grants from the National Institutes of Health. Other authors reported receiving grants from the Agency for Healthcare Research and Quality, the US Department of Veterans Affairs, the Kahn Foundation, and Nanovibronix.
Cranberry supplements and behavioral changes may be helpful, but evidence is limited, including among women living in long-term care facilities.
A version of this article first appeared on Medscape.com.
TOPLINE:
Accurately diagnosing recurrent urinary tract infections (rUTIs) in older women is challenging and requires careful weighing of the risks and benefits of various treatments, according to a new clinical insight published in JAMA Internal Medicine.
METHODOLOGY:
- Women aged > 65 years have double the rUTI rates compared with younger women, but detecting the condition is more complicated due to age-related conditions, such as overactive bladder related to menopause.
- Overuse of antibiotics can increase their risk of contracting antibiotic-resistant organisms and can lead to pulmonary or hepatic toxic effects in women with reduced kidney function.
- Up to 20% of older women have bacteria in their urine, which may or may not reflect a rUTI.
- Diagnosing rUTIs is complicated if women have dementia or cognitive decline, which can hinder recollection of symptoms.
TAKEAWAYS:
- Clinicians should consider only testing older female patients for rUTIs when symptoms are present and consider all possibilities before making a diagnosis.
- Vaginal estrogen may be an effective treatment, although the authors of the clinical review note a lack of a uniform formulation to recommend. However, oral estrogen use is not supported by evidence, and clinicians should instead consider vaginal creams or rings.
- The drug methenamine may be as effective as antibiotics but may not be safe for women with comorbidities. Evidence supports daily use at 1 g.
- Cranberry supplements and behavioral changes may be helpful, but evidence is limited, including among women living in long-term care facilities.
IN PRACTICE:
“Shared decision-making is especially important when diagnosis of an rUTI episode in older women is unclear ... in these cases, clinicians should acknowledge limitations in the evidence and invite patients or their caregivers to discuss preferences about presumptive treatment, weighing the possibility of earlier symptom relief or decreased UTI complications against the risk of adverse drug effects or multidrug resistance.”
SOURCE:
The paper was led by Alison J. Huang, MD, MAS, an internal medicine specialist and researcher in the Department of Medicine at the University of California, San Francisco.
LIMITATIONS:
The authors reported no limitations.
DISCLOSURES:
Dr. Huang received grants from the National Institutes of Health. Other authors reported receiving grants from the Agency for Healthcare Research and Quality, the US Department of Veterans Affairs, the Kahn Foundation, and Nanovibronix.
Cranberry supplements and behavioral changes may be helpful, but evidence is limited, including among women living in long-term care facilities.
A version of this article first appeared on Medscape.com.