MDedge Endocrinology

The Food and Drug Administration has cleared the Tidepool Loop, a mobile application for use with compatible continuous glucose monitors (CGMs) and insulin pumps to enable automated insulin delivery.

Indicated for people with type 1 diabetes ages 6 years and up, the app algorithm was developed by the diabetes startup Tidepool, which already hosts a cloud-based platform for users to download and review data from different glucose meters, insulin pumps, and CGM systems. The Tidepool Loop project arose from patient-led, open-source initiatives to enable interoperability between the devices.

Olivier Le Moal/Getty Images

“The [FDA] authorization of the Tidepool Loop is a huge win for the type 1 diabetes (T1D) community and is a vital step towards a world where people with T1D can choose the pump, CGM, and algorithm that are best for them – and have all three work together seamlessly,” Aaron Kowalski, PhD, CEO of the advocacy organization JDRF, said in a statement.

JDRF helped support preclinical and clinical research in the development of the Loop algorithm, along with The Leona M. and Harry B. Helmsley Charitable Trust, the Tullman Foundation, and partnerships with device makers and donations from the T1D community.

Available by prescription only, the Tidepool app is for single patient use. It works with designated “integrated CGMs” and “alternate controller enabled pumps” to automatically increase, decrease, or suspend insulin delivery, based on the glucose readings and predicted values. The app can also recommend correction doses, which the user can confirm.

According to an FDA statement:“Tidepool Loop’s algorithm technology is designed to be compatible with other individual interoperable devices that meet prespecified acceptance criteria set forth in a validation and integration plan provided by the sponsor and cleared by the FDA as part of the premarket submission.”

Tidepool is finalizing agreements with the various device manufacturers “to create a seamless experience for both physicians prescribing Tidepool Loop and the patients using it,” according to a company statement.

Tidepool’s initial launch device partners have not yet been announced, but the company “has a development partnership with Dexcom and other yet-to-be-named medical device companies for future inclusion of their components with the Tidepool Loop platform,” the statement says.

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

The Food and Drug Administration has cleared the Tidepool Loop, a mobile application for use with compatible continuous glucose monitors (CGMs) and insulin pumps to enable automated insulin delivery.

Indicated for people with type 1 diabetes ages 6 years and up, the app algorithm was developed by the diabetes startup Tidepool, which already hosts a cloud-based platform for users to download and review data from different glucose meters, insulin pumps, and CGM systems. The Tidepool Loop project arose from patient-led, open-source initiatives to enable interoperability between the devices.

Olivier Le Moal/Getty Images

“The [FDA] authorization of the Tidepool Loop is a huge win for the type 1 diabetes (T1D) community and is a vital step towards a world where people with T1D can choose the pump, CGM, and algorithm that are best for them – and have all three work together seamlessly,” Aaron Kowalski, PhD, CEO of the advocacy organization JDRF, said in a statement.

JDRF helped support preclinical and clinical research in the development of the Loop algorithm, along with The Leona M. and Harry B. Helmsley Charitable Trust, the Tullman Foundation, and partnerships with device makers and donations from the T1D community.

Available by prescription only, the Tidepool app is for single patient use. It works with designated “integrated CGMs” and “alternate controller enabled pumps” to automatically increase, decrease, or suspend insulin delivery, based on the glucose readings and predicted values. The app can also recommend correction doses, which the user can confirm.

According to an FDA statement:“Tidepool Loop’s algorithm technology is designed to be compatible with other individual interoperable devices that meet prespecified acceptance criteria set forth in a validation and integration plan provided by the sponsor and cleared by the FDA as part of the premarket submission.”

Tidepool is finalizing agreements with the various device manufacturers “to create a seamless experience for both physicians prescribing Tidepool Loop and the patients using it,” according to a company statement.

Tidepool’s initial launch device partners have not yet been announced, but the company “has a development partnership with Dexcom and other yet-to-be-named medical device companies for future inclusion of their components with the Tidepool Loop platform,” the statement says.

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

The Food and Drug Administration has cleared the Tidepool Loop, a mobile application for use with compatible continuous glucose monitors (CGMs) and insulin pumps to enable automated insulin delivery.

Indicated for people with type 1 diabetes ages 6 years and up, the app algorithm was developed by the diabetes startup Tidepool, which already hosts a cloud-based platform for users to download and review data from different glucose meters, insulin pumps, and CGM systems. The Tidepool Loop project arose from patient-led, open-source initiatives to enable interoperability between the devices.

Olivier Le Moal/Getty Images

“The [FDA] authorization of the Tidepool Loop is a huge win for the type 1 diabetes (T1D) community and is a vital step towards a world where people with T1D can choose the pump, CGM, and algorithm that are best for them – and have all three work together seamlessly,” Aaron Kowalski, PhD, CEO of the advocacy organization JDRF, said in a statement.

JDRF helped support preclinical and clinical research in the development of the Loop algorithm, along with The Leona M. and Harry B. Helmsley Charitable Trust, the Tullman Foundation, and partnerships with device makers and donations from the T1D community.

Available by prescription only, the Tidepool app is for single patient use. It works with designated “integrated CGMs” and “alternate controller enabled pumps” to automatically increase, decrease, or suspend insulin delivery, based on the glucose readings and predicted values. The app can also recommend correction doses, which the user can confirm.

According to an FDA statement:“Tidepool Loop’s algorithm technology is designed to be compatible with other individual interoperable devices that meet prespecified acceptance criteria set forth in a validation and integration plan provided by the sponsor and cleared by the FDA as part of the premarket submission.”

Tidepool is finalizing agreements with the various device manufacturers “to create a seamless experience for both physicians prescribing Tidepool Loop and the patients using it,” according to a company statement.

Tidepool’s initial launch device partners have not yet been announced, but the company “has a development partnership with Dexcom and other yet-to-be-named medical device companies for future inclusion of their components with the Tidepool Loop platform,” the statement says.

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

A diabetes screening program built into an electronic medical records system identified diabetes or prediabetes in 52% of individuals flagged for abnormal hemoglobin A1c, based on data from more than 2,000 adults.

“Despite the best efforts of clinicians, researchers, and educators, the number of patients living with undiagnosed diabetes is still rising and is currently at approximately 8.5 million, and the number of people unaware of their prediabetes is approximately 77 million,” lead investigator Kristie K. Danielson, PhD, said in an interview. Screening for diabetes is critical to start treatment early, to potentially reverse prediabetes, and to prevent the long-term complications of diabetes and reduced life expectancy.

sittithat tangwitthayaphum/Getty Images

In a pilot study published in JAMA Network Open, Dr. Danielson and colleagues reviewed data from 8,441 adults who visited a single emergency department in Chicago during February–April 2021.

The EMR at the hospital contained a built-in best practice alert (BPA) that flagged patients as being at risk for type 2 diabetes based the American Diabetes Association recommendations; the identification algorithm included age 45 years and older, or those aged 18-44 years with a body mass index of 25 kg/m² or higher, no previous history of diabetes, and no A1c measure in the last 3 years, according to the EMR.

A total of 8,441 adult patients visited the ED during the study period; 2,576 triggered BPA tests, and 2,074 had A1c results for review. Among the patients with A1c results, 52% had elevated values of 5.7% or higher. Of these, a total of 758 individuals were identified with prediabetes (A1c, 5.7%-6.4%), 265 with diabetes (A1c, 6.5%-9.9%), and 62 with severe diabetes (A1c, 10% or higher).

After testing, 352 patients with elevated A1c were contacted by the researchers. The mean age of this group was 52.2 years, 54.5% were women, and nearly two-thirds (64.8%) were non-Hispanic Black. The median income of those contacted was in the 44th percentile, and 50% had public insurance.

Most of those contacted (264 patients) were not aware of a previous diagnosis of prediabetes or diabetes; the remaining 88 had a previous diagnosis, but only 51 self-reported receiving treatment, the researchers noted.

Although the screening program successfully identified a significant number of previously undiagnosed individuals with diabetes, prediabetes, or poorly controlled diabetes, its feasibility in routine practice requires further study, the researchers wrote.

The findings were limited by several factors including the identification of patients previously diagnosed with diabetes but who were not being treated, and the potential bias toward individuals of higher socioeconomic status, the researchers noted. However, the results support further exploration of the program as a way to identify undiagnosed diabetes, especially in underserved populations.
 

Diabetes in underserved groups goes undetected

“We were surprised by the sheer number of people newly diagnosed with diabetes or prediabetes,” which was far greater than expected, commented Dr. Danielson of the University of Illinois at Chicago. “Clearly, we tapped into a new population that has not often been seen by primary care providers or endocrinologists, as is often the case for underserved and vulnerable individuals who visit the emergency department as a first line for health care.”

The screening alert system is straightforward to build into an existing EMR, with technical support, Dr. Danielson said. “In theory, it should be able to be incorporated into other clinical centers and emergency departments. One of the current limitations that we are seeing is that the EMR is still flagging some people already diagnosed with diabetes to be screened for diabetes.” However, “because of this, we also see this as an opportunity to identify and reach out to those with diabetes who are still underserved and not receiving the appropriate diabetes care they need.”

The study results have broader public health implications, Dr. Danielson added. “We have identified a new, large population of people with diabetes who need medical care and diabetes education. This will further add to the burden of health care and costs, and it raises the ethical question of screening and not having full resources readily available to help.

“In my opinion, the study sheds light on a significant issue that will hopefully help drive change at both a health systems and public health level locally and nationally,” she added.

“One of the significant research gaps that has emerged now is how to link these new patients to health care and diabetes education at our institution after they leave the emergency department,” said Dr. Danielson. Diabetes screening in the ED setting is “a very novel area for health system scientists, social workers, and others to now come to the table and collaborate on next steps to help our patients.”

The study was initiated by the investigators, but was supported by a grant from Novo Nordisk to two coauthors. Dr. Danielson also disclosed grant funding from Novo Nordisk during the conduct of the study.

A diabetes screening program built into an electronic medical records system identified diabetes or prediabetes in 52% of individuals flagged for abnormal hemoglobin A1c, based on data from more than 2,000 adults.

“Despite the best efforts of clinicians, researchers, and educators, the number of patients living with undiagnosed diabetes is still rising and is currently at approximately 8.5 million, and the number of people unaware of their prediabetes is approximately 77 million,” lead investigator Kristie K. Danielson, PhD, said in an interview. Screening for diabetes is critical to start treatment early, to potentially reverse prediabetes, and to prevent the long-term complications of diabetes and reduced life expectancy.

sittithat tangwitthayaphum/Getty Images

In a pilot study published in JAMA Network Open, Dr. Danielson and colleagues reviewed data from 8,441 adults who visited a single emergency department in Chicago during February–April 2021.

The EMR at the hospital contained a built-in best practice alert (BPA) that flagged patients as being at risk for type 2 diabetes based the American Diabetes Association recommendations; the identification algorithm included age 45 years and older, or those aged 18-44 years with a body mass index of 25 kg/m² or higher, no previous history of diabetes, and no A1c measure in the last 3 years, according to the EMR.

A total of 8,441 adult patients visited the ED during the study period; 2,576 triggered BPA tests, and 2,074 had A1c results for review. Among the patients with A1c results, 52% had elevated values of 5.7% or higher. Of these, a total of 758 individuals were identified with prediabetes (A1c, 5.7%-6.4%), 265 with diabetes (A1c, 6.5%-9.9%), and 62 with severe diabetes (A1c, 10% or higher).

After testing, 352 patients with elevated A1c were contacted by the researchers. The mean age of this group was 52.2 years, 54.5% were women, and nearly two-thirds (64.8%) were non-Hispanic Black. The median income of those contacted was in the 44th percentile, and 50% had public insurance.

Most of those contacted (264 patients) were not aware of a previous diagnosis of prediabetes or diabetes; the remaining 88 had a previous diagnosis, but only 51 self-reported receiving treatment, the researchers noted.

Although the screening program successfully identified a significant number of previously undiagnosed individuals with diabetes, prediabetes, or poorly controlled diabetes, its feasibility in routine practice requires further study, the researchers wrote.

The findings were limited by several factors including the identification of patients previously diagnosed with diabetes but who were not being treated, and the potential bias toward individuals of higher socioeconomic status, the researchers noted. However, the results support further exploration of the program as a way to identify undiagnosed diabetes, especially in underserved populations.
 

Diabetes in underserved groups goes undetected

“We were surprised by the sheer number of people newly diagnosed with diabetes or prediabetes,” which was far greater than expected, commented Dr. Danielson of the University of Illinois at Chicago. “Clearly, we tapped into a new population that has not often been seen by primary care providers or endocrinologists, as is often the case for underserved and vulnerable individuals who visit the emergency department as a first line for health care.”

The screening alert system is straightforward to build into an existing EMR, with technical support, Dr. Danielson said. “In theory, it should be able to be incorporated into other clinical centers and emergency departments. One of the current limitations that we are seeing is that the EMR is still flagging some people already diagnosed with diabetes to be screened for diabetes.” However, “because of this, we also see this as an opportunity to identify and reach out to those with diabetes who are still underserved and not receiving the appropriate diabetes care they need.”

The study results have broader public health implications, Dr. Danielson added. “We have identified a new, large population of people with diabetes who need medical care and diabetes education. This will further add to the burden of health care and costs, and it raises the ethical question of screening and not having full resources readily available to help.

“In my opinion, the study sheds light on a significant issue that will hopefully help drive change at both a health systems and public health level locally and nationally,” she added.

“One of the significant research gaps that has emerged now is how to link these new patients to health care and diabetes education at our institution after they leave the emergency department,” said Dr. Danielson. Diabetes screening in the ED setting is “a very novel area for health system scientists, social workers, and others to now come to the table and collaborate on next steps to help our patients.”

The study was initiated by the investigators, but was supported by a grant from Novo Nordisk to two coauthors. Dr. Danielson also disclosed grant funding from Novo Nordisk during the conduct of the study.

A diabetes screening program built into an electronic medical records system identified diabetes or prediabetes in 52% of individuals flagged for abnormal hemoglobin A1c, based on data from more than 2,000 adults.

“Despite the best efforts of clinicians, researchers, and educators, the number of patients living with undiagnosed diabetes is still rising and is currently at approximately 8.5 million, and the number of people unaware of their prediabetes is approximately 77 million,” lead investigator Kristie K. Danielson, PhD, said in an interview. Screening for diabetes is critical to start treatment early, to potentially reverse prediabetes, and to prevent the long-term complications of diabetes and reduced life expectancy.

sittithat tangwitthayaphum/Getty Images

In a pilot study published in JAMA Network Open, Dr. Danielson and colleagues reviewed data from 8,441 adults who visited a single emergency department in Chicago during February–April 2021.

The EMR at the hospital contained a built-in best practice alert (BPA) that flagged patients as being at risk for type 2 diabetes based the American Diabetes Association recommendations; the identification algorithm included age 45 years and older, or those aged 18-44 years with a body mass index of 25 kg/m² or higher, no previous history of diabetes, and no A1c measure in the last 3 years, according to the EMR.

A total of 8,441 adult patients visited the ED during the study period; 2,576 triggered BPA tests, and 2,074 had A1c results for review. Among the patients with A1c results, 52% had elevated values of 5.7% or higher. Of these, a total of 758 individuals were identified with prediabetes (A1c, 5.7%-6.4%), 265 with diabetes (A1c, 6.5%-9.9%), and 62 with severe diabetes (A1c, 10% or higher).

After testing, 352 patients with elevated A1c were contacted by the researchers. The mean age of this group was 52.2 years, 54.5% were women, and nearly two-thirds (64.8%) were non-Hispanic Black. The median income of those contacted was in the 44th percentile, and 50% had public insurance.

Most of those contacted (264 patients) were not aware of a previous diagnosis of prediabetes or diabetes; the remaining 88 had a previous diagnosis, but only 51 self-reported receiving treatment, the researchers noted.

Although the screening program successfully identified a significant number of previously undiagnosed individuals with diabetes, prediabetes, or poorly controlled diabetes, its feasibility in routine practice requires further study, the researchers wrote.

The findings were limited by several factors including the identification of patients previously diagnosed with diabetes but who were not being treated, and the potential bias toward individuals of higher socioeconomic status, the researchers noted. However, the results support further exploration of the program as a way to identify undiagnosed diabetes, especially in underserved populations.
 

Diabetes in underserved groups goes undetected

“We were surprised by the sheer number of people newly diagnosed with diabetes or prediabetes,” which was far greater than expected, commented Dr. Danielson of the University of Illinois at Chicago. “Clearly, we tapped into a new population that has not often been seen by primary care providers or endocrinologists, as is often the case for underserved and vulnerable individuals who visit the emergency department as a first line for health care.”

The screening alert system is straightforward to build into an existing EMR, with technical support, Dr. Danielson said. “In theory, it should be able to be incorporated into other clinical centers and emergency departments. One of the current limitations that we are seeing is that the EMR is still flagging some people already diagnosed with diabetes to be screened for diabetes.” However, “because of this, we also see this as an opportunity to identify and reach out to those with diabetes who are still underserved and not receiving the appropriate diabetes care they need.”

The study results have broader public health implications, Dr. Danielson added. “We have identified a new, large population of people with diabetes who need medical care and diabetes education. This will further add to the burden of health care and costs, and it raises the ethical question of screening and not having full resources readily available to help.

“In my opinion, the study sheds light on a significant issue that will hopefully help drive change at both a health systems and public health level locally and nationally,” she added.

“One of the significant research gaps that has emerged now is how to link these new patients to health care and diabetes education at our institution after they leave the emergency department,” said Dr. Danielson. Diabetes screening in the ED setting is “a very novel area for health system scientists, social workers, and others to now come to the table and collaborate on next steps to help our patients.”

The study was initiated by the investigators, but was supported by a grant from Novo Nordisk to two coauthors. Dr. Danielson also disclosed grant funding from Novo Nordisk during the conduct of the study.

Everybody wants a younger heart

As more people live well past 90, scientists have been taking a closer look at how they’ve been doing it. Mostly it boiled down to genetics. You either had it or you didn’t. Well, a recent study suggests that doesn’t have to be true anymore, at least for the heart.

Scientists from the United Kingdom and Italy found an antiaging gene in some centenarians that has shown possible antiaging effects in mice and in human heart cells. A single administration of the mutant antiaging gene, they found, stopped heart function decay in middle-aged mice and even reversed the biological clock by the human equivalent of 10 years in elderly mice.

©ktsimage/thinkstockphotos.com

When the researchers applied the antiaging gene to samples of human heart cells from elderly people with heart problems, the cells “resumed functioning properly, proving to be more efficient in building new blood vessels,” they said in a written statement. It all kind of sounds like something out of Dr. Frankenstein’s lab.
 

I want to believe … in better sleep

The “X-Files” theme song plays. Mulder and Scully are sitting in a diner, breakfast laid out around them. The diner is quiet, with only a few people inside.

Mulder: I’m telling you, Scully, there’s something spooky going on here.

Scully: You mean other than the fact that this town in Georgia looks suspiciously like Vancouver?

Mulder: Not one person we spoke to yesterday has gotten a full night’s sleep since the UFO sighting last month. I’m telling you, they’re here, they’re experimenting.

Scully: Do you really want me to do this to you again?

Mulder: Do what again?

Scully: There’s nothing going on here that can’t be explained by the current research. Why, in January 2023 a study was published revealing a link between poor sleep and belief in paranormal phenomena like UFOS, demons, or ghosts. Which probably explains why you’re on your third cup of coffee for the morning.

Mulder: Scully, you’ve literally been abducted by aliens. Do we have to play this game every time?

Scully: Look, it’s simple. In a sample of nearly 9,000 people, nearly two-thirds of those who reported experiencing sleep paralysis or exploding head syndrome reported believing in UFOs and aliens walking amongst humanity, despite making up just 3% of the overall sample.

Alexandra Gorn/Unsplash

Furthermore, about 60% of those reporting sleep paralysis also reported believing near-death experiences prove the soul lingers on after death, and those with stronger insomnia symptoms were more likely to believe in the devil.

Mulder: Aha!

Scully: Aha what?

Mulder: You’re a devout Christian. You believe in the devil and the soul.

Scully: Yes, but I don’t let it interfere with a good night’s sleep, Mulder. These people saw something strange, convinced themselves it was a UFO, and now they can’t sleep. It’s a vicious cycle. The study authors even said that people experiencing strange nighttime phenomena could interpret this as evidence of aliens or other paranormal beings, thus making them even more susceptible to further sleep disruption and deepening beliefs. Look who I’m talking to.

Mulder: Always with the facts, eh?

Scully: I am a doctor, after all. And if you want more research into how paranormal belief and poor sleep quality are linked, I’d be happy to dig out the literature, because the truth is out there, Mulder.

Mulder: I hate you sometimes.

It’s ChatGPT’s world. We’re just living in it

Have you heard about ChatGPT? The artificial intelligence chatbot was just launched in November and it’s already more important to the Internet than either Vladimir Putin or “Rick and Morty.”

What’s that? You’re wondering why you should care? Well, excuuuuuse us, but we thought you might want to know that ChatGPT is in the process of taking over the world. Let’s take a quick look at what it’s been up to.

“ChatGPT bot passes law school exam”

“ChatGPT passes MBA exam given by a Wharton professor”

“A freelance writer says ChatGPT wrote a $600 article in just 30 seconds”

And here’s one that might be of interest to those of the health care persuasion: “ChatGPT can pass part of the U.S. Medical Licensing Exam.” See? It’s coming for you, too.

The artificial intelligence known as ChatGPT “performed at >50% accuracy across [the three USMLE] examinations, exceeding 60% in most analyses,” a group of researchers wrote on the preprint server medRxiv, noting that 60% is usually the pass threshold for humans taking the exam in any given year.

Mohamed Hassan/PxHere

Everybody wants a younger heart

As more people live well past 90, scientists have been taking a closer look at how they’ve been doing it. Mostly it boiled down to genetics. You either had it or you didn’t. Well, a recent study suggests that doesn’t have to be true anymore, at least for the heart.

Scientists from the United Kingdom and Italy found an antiaging gene in some centenarians that has shown possible antiaging effects in mice and in human heart cells. A single administration of the mutant antiaging gene, they found, stopped heart function decay in middle-aged mice and even reversed the biological clock by the human equivalent of 10 years in elderly mice.

©ktsimage/thinkstockphotos.com

When the researchers applied the antiaging gene to samples of human heart cells from elderly people with heart problems, the cells “resumed functioning properly, proving to be more efficient in building new blood vessels,” they said in a written statement. It all kind of sounds like something out of Dr. Frankenstein’s lab.
 

I want to believe … in better sleep

The “X-Files” theme song plays. Mulder and Scully are sitting in a diner, breakfast laid out around them. The diner is quiet, with only a few people inside.

Mulder: I’m telling you, Scully, there’s something spooky going on here.

Scully: You mean other than the fact that this town in Georgia looks suspiciously like Vancouver?

Mulder: Not one person we spoke to yesterday has gotten a full night’s sleep since the UFO sighting last month. I’m telling you, they’re here, they’re experimenting.

Scully: Do you really want me to do this to you again?

Mulder: Do what again?

Scully: There’s nothing going on here that can’t be explained by the current research. Why, in January 2023 a study was published revealing a link between poor sleep and belief in paranormal phenomena like UFOS, demons, or ghosts. Which probably explains why you’re on your third cup of coffee for the morning.

Mulder: Scully, you’ve literally been abducted by aliens. Do we have to play this game every time?

Scully: Look, it’s simple. In a sample of nearly 9,000 people, nearly two-thirds of those who reported experiencing sleep paralysis or exploding head syndrome reported believing in UFOs and aliens walking amongst humanity, despite making up just 3% of the overall sample.

Alexandra Gorn/Unsplash

Furthermore, about 60% of those reporting sleep paralysis also reported believing near-death experiences prove the soul lingers on after death, and those with stronger insomnia symptoms were more likely to believe in the devil.

Mulder: Aha!

Scully: Aha what?

Mulder: You’re a devout Christian. You believe in the devil and the soul.

Scully: Yes, but I don’t let it interfere with a good night’s sleep, Mulder. These people saw something strange, convinced themselves it was a UFO, and now they can’t sleep. It’s a vicious cycle. The study authors even said that people experiencing strange nighttime phenomena could interpret this as evidence of aliens or other paranormal beings, thus making them even more susceptible to further sleep disruption and deepening beliefs. Look who I’m talking to.

Mulder: Always with the facts, eh?

Scully: I am a doctor, after all. And if you want more research into how paranormal belief and poor sleep quality are linked, I’d be happy to dig out the literature, because the truth is out there, Mulder.

Mulder: I hate you sometimes.

It’s ChatGPT’s world. We’re just living in it

Have you heard about ChatGPT? The artificial intelligence chatbot was just launched in November and it’s already more important to the Internet than either Vladimir Putin or “Rick and Morty.”

What’s that? You’re wondering why you should care? Well, excuuuuuse us, but we thought you might want to know that ChatGPT is in the process of taking over the world. Let’s take a quick look at what it’s been up to.

“ChatGPT bot passes law school exam”

“ChatGPT passes MBA exam given by a Wharton professor”

“A freelance writer says ChatGPT wrote a $600 article in just 30 seconds”

And here’s one that might be of interest to those of the health care persuasion: “ChatGPT can pass part of the U.S. Medical Licensing Exam.” See? It’s coming for you, too.

The artificial intelligence known as ChatGPT “performed at >50% accuracy across [the three USMLE] examinations, exceeding 60% in most analyses,” a group of researchers wrote on the preprint server medRxiv, noting that 60% is usually the pass threshold for humans taking the exam in any given year.

Mohamed Hassan/PxHere

Everybody wants a younger heart

As more people live well past 90, scientists have been taking a closer look at how they’ve been doing it. Mostly it boiled down to genetics. You either had it or you didn’t. Well, a recent study suggests that doesn’t have to be true anymore, at least for the heart.

Scientists from the United Kingdom and Italy found an antiaging gene in some centenarians that has shown possible antiaging effects in mice and in human heart cells. A single administration of the mutant antiaging gene, they found, stopped heart function decay in middle-aged mice and even reversed the biological clock by the human equivalent of 10 years in elderly mice.

©ktsimage/thinkstockphotos.com

When the researchers applied the antiaging gene to samples of human heart cells from elderly people with heart problems, the cells “resumed functioning properly, proving to be more efficient in building new blood vessels,” they said in a written statement. It all kind of sounds like something out of Dr. Frankenstein’s lab.
 

I want to believe … in better sleep

The “X-Files” theme song plays. Mulder and Scully are sitting in a diner, breakfast laid out around them. The diner is quiet, with only a few people inside.

Mulder: I’m telling you, Scully, there’s something spooky going on here.

Scully: You mean other than the fact that this town in Georgia looks suspiciously like Vancouver?

Mulder: Not one person we spoke to yesterday has gotten a full night’s sleep since the UFO sighting last month. I’m telling you, they’re here, they’re experimenting.

Scully: Do you really want me to do this to you again?

Mulder: Do what again?

Scully: There’s nothing going on here that can’t be explained by the current research. Why, in January 2023 a study was published revealing a link between poor sleep and belief in paranormal phenomena like UFOS, demons, or ghosts. Which probably explains why you’re on your third cup of coffee for the morning.

Mulder: Scully, you’ve literally been abducted by aliens. Do we have to play this game every time?

Scully: Look, it’s simple. In a sample of nearly 9,000 people, nearly two-thirds of those who reported experiencing sleep paralysis or exploding head syndrome reported believing in UFOs and aliens walking amongst humanity, despite making up just 3% of the overall sample.

Alexandra Gorn/Unsplash

Furthermore, about 60% of those reporting sleep paralysis also reported believing near-death experiences prove the soul lingers on after death, and those with stronger insomnia symptoms were more likely to believe in the devil.

Mulder: Aha!

Scully: Aha what?

Mulder: You’re a devout Christian. You believe in the devil and the soul.

Scully: Yes, but I don’t let it interfere with a good night’s sleep, Mulder. These people saw something strange, convinced themselves it was a UFO, and now they can’t sleep. It’s a vicious cycle. The study authors even said that people experiencing strange nighttime phenomena could interpret this as evidence of aliens or other paranormal beings, thus making them even more susceptible to further sleep disruption and deepening beliefs. Look who I’m talking to.

Mulder: Always with the facts, eh?

Scully: I am a doctor, after all. And if you want more research into how paranormal belief and poor sleep quality are linked, I’d be happy to dig out the literature, because the truth is out there, Mulder.

Mulder: I hate you sometimes.

It’s ChatGPT’s world. We’re just living in it

Have you heard about ChatGPT? The artificial intelligence chatbot was just launched in November and it’s already more important to the Internet than either Vladimir Putin or “Rick and Morty.”

What’s that? You’re wondering why you should care? Well, excuuuuuse us, but we thought you might want to know that ChatGPT is in the process of taking over the world. Let’s take a quick look at what it’s been up to.

“ChatGPT bot passes law school exam”

“ChatGPT passes MBA exam given by a Wharton professor”

“A freelance writer says ChatGPT wrote a $600 article in just 30 seconds”

And here’s one that might be of interest to those of the health care persuasion: “ChatGPT can pass part of the U.S. Medical Licensing Exam.” See? It’s coming for you, too.

The artificial intelligence known as ChatGPT “performed at >50% accuracy across [the three USMLE] examinations, exceeding 60% in most analyses,” a group of researchers wrote on the preprint server medRxiv, noting that 60% is usually the pass threshold for humans taking the exam in any given year.

Mohamed Hassan/PxHere

For Tammy Rainey, finding a health care provider who knows about gender-affirming care has been a challenge in the rural northern Mississippi town where she lives.

As a transgender woman, Ms. Rainey needs the hormone estrogen, which allows her to physically transition by developing more feminine features. But when she asked her doctor for an estrogen prescription, he said he couldn’t provide that type of care.

“He’s generally a good guy and doesn’t act prejudiced. He gets my name and pronouns right,” said Ms. Rainey. “But when I asked him about hormones, he said, ‘I just don’t feel like I know enough about that. I don’t want to get involved in that.’ ”

So Ms. Rainey drives around 170 miles round trip every 6 months to get a supply of estrogen from a clinic in Memphis, Tenn., to take home with her.

The obstacles Ms. Rainey overcomes to access care illustrate a type of medical inequity that transgender people who live in the rural United States often face: A general lack of education about trans-related care among small-town health professionals who might also be reluctant to learn.

“Medical communities across the country are seeing clearly that there is a knowledge gap in the provision of gender-affirming care,” said Morissa Ladinsky, MD, a pediatrician who co-leads the Youth Multidisciplinary Gender Team at the University of Alabama–Birmingham (UAB).

Accurately counting the number of transgender people in rural America is hindered by a lack of U.S. census data and uniform state data. However, the Movement Advancement Project, a nonprofit organization that advocates for LGBTQ+ issues, used 2014-17 Centers for Disease Control and Prevention data from selected ZIP codes in 35 states to estimate that roughly one in six transgender adults in the United States live in a rural area. When that report was released in 2019, there were an estimated 1.4 million transgender people 13 and older nationwide. That number is now at least 1.6 million, according to the Williams Institute, a nonprofit think tank at the UCLA School of Law.

One in three trans people in rural areas experienced discrimination by a health care provider in the year leading up to the 2015 U.S. Transgender Survey Report, according to an analysis by MAP. A third of all trans individuals report having to teach their doctors about their health care needs to receive appropriate care, and 62% worry about being negatively judged by a health care provider because of their sexual orientation or gender identity, according to data collected by the Williams Institute and other organizations.

A lack of local rural providers knowledgeable in trans care can mean long drives to gender-affirming clinics in metropolitan areas. Rural trans people are three times as likely as are all transgender adults to travel 25-49 miles for routine care.

In Colorado, for example, many trans people outside Denver struggle to find proper care. Those who do have a trans-inclusive provider are more likely to receive wellness exams, less likely to delay care due to discrimination, and less likely to attempt suicide, according to results from the Colorado Transgender Health Survey published in 2018.

Much of the lack of care experienced by trans people is linked to insufficient education on LGBTQ+ health in medical schools across the country. In 2014, the Association of American Medical Colleges, which represents 170 accredited medical schools in the United States and Canada, released its first curriculum guidelines on caring for LGBTQ+ patients. As of 2018, 76% of medical schools included LGBTQ health themes in their curriculum, with half providing three or fewer classes on this topic.

Perhaps because of this, almost 77% of students from 10 medical schools in New England felt “not competent” or “somewhat not competent” in treating gender minority patients, according to a 2018 pilot study. Another paper, published last year, found that even clinicians who work in trans-friendly clinics lack knowledge about hormones, gender-affirming surgical options, and how to use appropriate pronouns and trans-inclusive language.

Throughout medical school, trans care was only briefly mentioned in endocrinology class, said Justin Bailey, MD, who received his medical degree from UAB in 2021 and is now a resident there. “I don’t want to say the wrong thing or use the wrong pronouns, so I was hesitant and a little bit tepid in my approach to interviewing and treating this population of patients,” he said.

On top of insufficient medical school education, some practicing doctors don’t take the time to teach themselves about trans people, said Kathie Moehlig, founder of TransFamily Support Services, a nonprofit organization that offers a range of services to transgender people and their families. They are very well intentioned yet uneducated when it comes to transgender care, she said.

Some medical schools, like the one at UAB, have pushed for change. Since 2017, Dr. Ladinsky and her colleagues have worked to include trans people in their standardized patient program, which gives medical students hands-on experience and feedback by interacting with “patients” in simulated clinical environments.

For example, a trans individual acting as a patient will simulate acid reflux by pretending to have pain in their stomach and chest. Then, over the course of the examination, they will reveal that they are transgender.

In the early years of this program, some students’ bedside manner would change once the patient’s gender identity was revealed, said Elaine Stephens, a trans woman who participates in UAB’s standardized patient program. “Sometimes they would immediately start asking about sexual activity,” Stephens said.

Since UAB launched its program, students’ reactions have improved significantly, she said.

This progress is being replicated by other medical schools, said Ms. Moehlig. “But it’s a slow start, and these are large institutions that take a long time to move forward.”

Advocates also are working outside medical schools to improve care in rural areas. In Colorado, the nonprofit Extension for Community Health Outcomes, or ECHO Colorado, has been offering monthly virtual classes on gender-affirming care to rural providers since 2020. The classes became so popular that the organization created a 4-week boot camp in 2021 for providers to learn about hormone therapy management, proper terminologies, surgical options, and supporting patients’ mental health.

For many years, doctors failed to recognize the need to learn about gender-affirming care, said Caroline Kirsch, DO, director of osteopathic education at the University of Wyoming Family Medicine Residency Program–Casper. In Casper, this led to “a number of patients traveling to Colorado to access care, which is a large burden for them financially,” said Dr. Kirsch, who has participated in the ECHO Colorado program.

“Things that haven’t been as well taught historically in medical school are things that I think many physicians feel anxious about initially,” she said. “The earlier you learn about this type of care in your career, the more likely you are to see its potential and be less anxious about it.”

Educating more providers about trans-related care has become increasingly vital in recent years as gender-affirming clinics nationwide experience a rise in harassment and threats. For instance, Vanderbilt University Medical Center’s Clinic for Transgender Health became the target of far-right hate on social media last year. After growing pressure from Tennessee’s Republican lawmakers, the clinic paused gender-affirmation surgeries on patients younger than 18, potentially leaving many trans individuals without necessary care.

Stephens hopes to see more medical schools include coursework on trans health care. She also wishes for doctors to treat trans people as they would any other patient.

“Just provide quality health care,” she tells the medical students at UAB. “We need health care like everyone else does.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

For Tammy Rainey, finding a health care provider who knows about gender-affirming care has been a challenge in the rural northern Mississippi town where she lives.

As a transgender woman, Ms. Rainey needs the hormone estrogen, which allows her to physically transition by developing more feminine features. But when she asked her doctor for an estrogen prescription, he said he couldn’t provide that type of care.

“He’s generally a good guy and doesn’t act prejudiced. He gets my name and pronouns right,” said Ms. Rainey. “But when I asked him about hormones, he said, ‘I just don’t feel like I know enough about that. I don’t want to get involved in that.’ ”

So Ms. Rainey drives around 170 miles round trip every 6 months to get a supply of estrogen from a clinic in Memphis, Tenn., to take home with her.

The obstacles Ms. Rainey overcomes to access care illustrate a type of medical inequity that transgender people who live in the rural United States often face: A general lack of education about trans-related care among small-town health professionals who might also be reluctant to learn.

“Medical communities across the country are seeing clearly that there is a knowledge gap in the provision of gender-affirming care,” said Morissa Ladinsky, MD, a pediatrician who co-leads the Youth Multidisciplinary Gender Team at the University of Alabama–Birmingham (UAB).

Accurately counting the number of transgender people in rural America is hindered by a lack of U.S. census data and uniform state data. However, the Movement Advancement Project, a nonprofit organization that advocates for LGBTQ+ issues, used 2014-17 Centers for Disease Control and Prevention data from selected ZIP codes in 35 states to estimate that roughly one in six transgender adults in the United States live in a rural area. When that report was released in 2019, there were an estimated 1.4 million transgender people 13 and older nationwide. That number is now at least 1.6 million, according to the Williams Institute, a nonprofit think tank at the UCLA School of Law.

One in three trans people in rural areas experienced discrimination by a health care provider in the year leading up to the 2015 U.S. Transgender Survey Report, according to an analysis by MAP. A third of all trans individuals report having to teach their doctors about their health care needs to receive appropriate care, and 62% worry about being negatively judged by a health care provider because of their sexual orientation or gender identity, according to data collected by the Williams Institute and other organizations.

A lack of local rural providers knowledgeable in trans care can mean long drives to gender-affirming clinics in metropolitan areas. Rural trans people are three times as likely as are all transgender adults to travel 25-49 miles for routine care.

In Colorado, for example, many trans people outside Denver struggle to find proper care. Those who do have a trans-inclusive provider are more likely to receive wellness exams, less likely to delay care due to discrimination, and less likely to attempt suicide, according to results from the Colorado Transgender Health Survey published in 2018.

Much of the lack of care experienced by trans people is linked to insufficient education on LGBTQ+ health in medical schools across the country. In 2014, the Association of American Medical Colleges, which represents 170 accredited medical schools in the United States and Canada, released its first curriculum guidelines on caring for LGBTQ+ patients. As of 2018, 76% of medical schools included LGBTQ health themes in their curriculum, with half providing three or fewer classes on this topic.

Perhaps because of this, almost 77% of students from 10 medical schools in New England felt “not competent” or “somewhat not competent” in treating gender minority patients, according to a 2018 pilot study. Another paper, published last year, found that even clinicians who work in trans-friendly clinics lack knowledge about hormones, gender-affirming surgical options, and how to use appropriate pronouns and trans-inclusive language.

Throughout medical school, trans care was only briefly mentioned in endocrinology class, said Justin Bailey, MD, who received his medical degree from UAB in 2021 and is now a resident there. “I don’t want to say the wrong thing or use the wrong pronouns, so I was hesitant and a little bit tepid in my approach to interviewing and treating this population of patients,” he said.

On top of insufficient medical school education, some practicing doctors don’t take the time to teach themselves about trans people, said Kathie Moehlig, founder of TransFamily Support Services, a nonprofit organization that offers a range of services to transgender people and their families. They are very well intentioned yet uneducated when it comes to transgender care, she said.

Some medical schools, like the one at UAB, have pushed for change. Since 2017, Dr. Ladinsky and her colleagues have worked to include trans people in their standardized patient program, which gives medical students hands-on experience and feedback by interacting with “patients” in simulated clinical environments.

For example, a trans individual acting as a patient will simulate acid reflux by pretending to have pain in their stomach and chest. Then, over the course of the examination, they will reveal that they are transgender.

In the early years of this program, some students’ bedside manner would change once the patient’s gender identity was revealed, said Elaine Stephens, a trans woman who participates in UAB’s standardized patient program. “Sometimes they would immediately start asking about sexual activity,” Stephens said.

Since UAB launched its program, students’ reactions have improved significantly, she said.

This progress is being replicated by other medical schools, said Ms. Moehlig. “But it’s a slow start, and these are large institutions that take a long time to move forward.”

Advocates also are working outside medical schools to improve care in rural areas. In Colorado, the nonprofit Extension for Community Health Outcomes, or ECHO Colorado, has been offering monthly virtual classes on gender-affirming care to rural providers since 2020. The classes became so popular that the organization created a 4-week boot camp in 2021 for providers to learn about hormone therapy management, proper terminologies, surgical options, and supporting patients’ mental health.

For many years, doctors failed to recognize the need to learn about gender-affirming care, said Caroline Kirsch, DO, director of osteopathic education at the University of Wyoming Family Medicine Residency Program–Casper. In Casper, this led to “a number of patients traveling to Colorado to access care, which is a large burden for them financially,” said Dr. Kirsch, who has participated in the ECHO Colorado program.

“Things that haven’t been as well taught historically in medical school are things that I think many physicians feel anxious about initially,” she said. “The earlier you learn about this type of care in your career, the more likely you are to see its potential and be less anxious about it.”

Educating more providers about trans-related care has become increasingly vital in recent years as gender-affirming clinics nationwide experience a rise in harassment and threats. For instance, Vanderbilt University Medical Center’s Clinic for Transgender Health became the target of far-right hate on social media last year. After growing pressure from Tennessee’s Republican lawmakers, the clinic paused gender-affirmation surgeries on patients younger than 18, potentially leaving many trans individuals without necessary care.

Stephens hopes to see more medical schools include coursework on trans health care. She also wishes for doctors to treat trans people as they would any other patient.

“Just provide quality health care,” she tells the medical students at UAB. “We need health care like everyone else does.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

For Tammy Rainey, finding a health care provider who knows about gender-affirming care has been a challenge in the rural northern Mississippi town where she lives.

As a transgender woman, Ms. Rainey needs the hormone estrogen, which allows her to physically transition by developing more feminine features. But when she asked her doctor for an estrogen prescription, he said he couldn’t provide that type of care.

“He’s generally a good guy and doesn’t act prejudiced. He gets my name and pronouns right,” said Ms. Rainey. “But when I asked him about hormones, he said, ‘I just don’t feel like I know enough about that. I don’t want to get involved in that.’ ”

So Ms. Rainey drives around 170 miles round trip every 6 months to get a supply of estrogen from a clinic in Memphis, Tenn., to take home with her.

The obstacles Ms. Rainey overcomes to access care illustrate a type of medical inequity that transgender people who live in the rural United States often face: A general lack of education about trans-related care among small-town health professionals who might also be reluctant to learn.

“Medical communities across the country are seeing clearly that there is a knowledge gap in the provision of gender-affirming care,” said Morissa Ladinsky, MD, a pediatrician who co-leads the Youth Multidisciplinary Gender Team at the University of Alabama–Birmingham (UAB).

Accurately counting the number of transgender people in rural America is hindered by a lack of U.S. census data and uniform state data. However, the Movement Advancement Project, a nonprofit organization that advocates for LGBTQ+ issues, used 2014-17 Centers for Disease Control and Prevention data from selected ZIP codes in 35 states to estimate that roughly one in six transgender adults in the United States live in a rural area. When that report was released in 2019, there were an estimated 1.4 million transgender people 13 and older nationwide. That number is now at least 1.6 million, according to the Williams Institute, a nonprofit think tank at the UCLA School of Law.

One in three trans people in rural areas experienced discrimination by a health care provider in the year leading up to the 2015 U.S. Transgender Survey Report, according to an analysis by MAP. A third of all trans individuals report having to teach their doctors about their health care needs to receive appropriate care, and 62% worry about being negatively judged by a health care provider because of their sexual orientation or gender identity, according to data collected by the Williams Institute and other organizations.

A lack of local rural providers knowledgeable in trans care can mean long drives to gender-affirming clinics in metropolitan areas. Rural trans people are three times as likely as are all transgender adults to travel 25-49 miles for routine care.

In Colorado, for example, many trans people outside Denver struggle to find proper care. Those who do have a trans-inclusive provider are more likely to receive wellness exams, less likely to delay care due to discrimination, and less likely to attempt suicide, according to results from the Colorado Transgender Health Survey published in 2018.

Much of the lack of care experienced by trans people is linked to insufficient education on LGBTQ+ health in medical schools across the country. In 2014, the Association of American Medical Colleges, which represents 170 accredited medical schools in the United States and Canada, released its first curriculum guidelines on caring for LGBTQ+ patients. As of 2018, 76% of medical schools included LGBTQ health themes in their curriculum, with half providing three or fewer classes on this topic.

Perhaps because of this, almost 77% of students from 10 medical schools in New England felt “not competent” or “somewhat not competent” in treating gender minority patients, according to a 2018 pilot study. Another paper, published last year, found that even clinicians who work in trans-friendly clinics lack knowledge about hormones, gender-affirming surgical options, and how to use appropriate pronouns and trans-inclusive language.

Throughout medical school, trans care was only briefly mentioned in endocrinology class, said Justin Bailey, MD, who received his medical degree from UAB in 2021 and is now a resident there. “I don’t want to say the wrong thing or use the wrong pronouns, so I was hesitant and a little bit tepid in my approach to interviewing and treating this population of patients,” he said.

On top of insufficient medical school education, some practicing doctors don’t take the time to teach themselves about trans people, said Kathie Moehlig, founder of TransFamily Support Services, a nonprofit organization that offers a range of services to transgender people and their families. They are very well intentioned yet uneducated when it comes to transgender care, she said.

Some medical schools, like the one at UAB, have pushed for change. Since 2017, Dr. Ladinsky and her colleagues have worked to include trans people in their standardized patient program, which gives medical students hands-on experience and feedback by interacting with “patients” in simulated clinical environments.

For example, a trans individual acting as a patient will simulate acid reflux by pretending to have pain in their stomach and chest. Then, over the course of the examination, they will reveal that they are transgender.

In the early years of this program, some students’ bedside manner would change once the patient’s gender identity was revealed, said Elaine Stephens, a trans woman who participates in UAB’s standardized patient program. “Sometimes they would immediately start asking about sexual activity,” Stephens said.

Since UAB launched its program, students’ reactions have improved significantly, she said.

This progress is being replicated by other medical schools, said Ms. Moehlig. “But it’s a slow start, and these are large institutions that take a long time to move forward.”

Advocates also are working outside medical schools to improve care in rural areas. In Colorado, the nonprofit Extension for Community Health Outcomes, or ECHO Colorado, has been offering monthly virtual classes on gender-affirming care to rural providers since 2020. The classes became so popular that the organization created a 4-week boot camp in 2021 for providers to learn about hormone therapy management, proper terminologies, surgical options, and supporting patients’ mental health.

For many years, doctors failed to recognize the need to learn about gender-affirming care, said Caroline Kirsch, DO, director of osteopathic education at the University of Wyoming Family Medicine Residency Program–Casper. In Casper, this led to “a number of patients traveling to Colorado to access care, which is a large burden for them financially,” said Dr. Kirsch, who has participated in the ECHO Colorado program.

“Things that haven’t been as well taught historically in medical school are things that I think many physicians feel anxious about initially,” she said. “The earlier you learn about this type of care in your career, the more likely you are to see its potential and be less anxious about it.”

Educating more providers about trans-related care has become increasingly vital in recent years as gender-affirming clinics nationwide experience a rise in harassment and threats. For instance, Vanderbilt University Medical Center’s Clinic for Transgender Health became the target of far-right hate on social media last year. After growing pressure from Tennessee’s Republican lawmakers, the clinic paused gender-affirmation surgeries on patients younger than 18, potentially leaving many trans individuals without necessary care.

Stephens hopes to see more medical schools include coursework on trans health care. She also wishes for doctors to treat trans people as they would any other patient.

“Just provide quality health care,” she tells the medical students at UAB. “We need health care like everyone else does.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The selective estrogen receptor modulator ospemifene appears to improve the vaginal microbiome of postmenopausal women with vulvovaginal atrophy (VVA), according to results from a small Italian case-control study in the journal Menopause.

The study sheds microbiological light on the mechanisms of ospemifene and low-dose systemic hormone therapy, which are widely used to treat genitourinary symptoms. Both had a positive effect on vaginal well-being, likely by reducing potentially harmful bacteria and increasing health-promoting acid-friendly microorganisms, writes a group led by M. Cristina Meriggiola, MD, PhD, of the gynecology and physiopathology of human reproduction unit at the University of Bologna, Italy.

VVA occurs in about 50% of postmenopausal women and produces a less favorable, less acidic vaginal microbiome profile than that of unaffected women. “The loss of estrogen leads to lower concentrations of Lactobacilli, bacteria that lower the pH. As a result, other bacterial species fill in the void,” explained Stephanie S. Faubion, MD, MBA, director of the Mayo Clinic Center for Women’s Health in Jacksonville, Fla., and medical director of the North American Menopause Society.

Added Tina Murphy, APN, a NAMS-certified menopause practitioner at Northwestern Medicine Orland Park in Illinois, “When this protective flora declines, then pathogenic bacteria can predominate the microbiome, which can contribute to vaginal irritation, infection, UTI’s, dyspareunia, and discomfort. Balancing and restoring the microbiome can mitigate the effects of estrogen depletion on the vaginal tissue and prevent the untoward effects of the hypoestrogenic state.” While ospemifene and hormone therapy are common therapies for the genitourinary symptoms of menopause, the focus has been on their treatment efficacy, not their effect on the microbiome profile, added Dr. Faubion. Only about 9% of women with menopause-related genitourinary symptoms receive prescription treatment, she added.
 

The study

Of 67 eligible postmenopausal participants in their mid-50s enrolled at a gynecology clinic from April 2019 to February 2020, 39 were diagnosed with VVA and 28 were considered healthy controls. In the atrophic group, 20 were prescribed ospemifene and 19 received hormone treatment.

Only those women with VVA but no menopausal vasomotor symptoms received ospemifene (60 mg/day); symptomatic women received hormone therapy according to guidelines.

The researchers calculated the women’s vaginal health index (VHI) based on elasticity, secretions, pH level, epithelial mucosa, and hydration. They used swabs to assess vaginal maturation index (VMI) by percentages of superficial, intermediate, and parabasal cells. Evaluation of the vaginal microbiome was done with 16S rRNA gene sequencing, and clinical and microbiological analyses were repeated after 3 months.

The vaginal microbiome of atrophic women was characterized by a significant reduction of benign Lactobacillus bacteria (P = .002) and an increase of potentially pathogenic Streptococcus (P = .008) and Sneathia (P = .02) bacteria.

The vaginal microbiome of women with VVA was depleted, within the Lactobacillus genus, in the L. crispatus species, a hallmark of vaginal health that has significant antimicrobial activity against endogenous and exogenous pathogens.

Furthermore, there was a positive correlation between the VHI/VMI and Lactobacillus abundance (P = .002 and P = 0.035, respectively).

While the lactic acid–producing Lactobacillus and Bifidobacterium genera were strongly associated with healthy controls, the characteristics of VVA patients were strongly associated with Streptococcus, Prevotella, Alloscardovia, and Staphylococcus.

Both therapeutic approaches effectively improved vaginal indices but by different routes. Systemic hormone treatment induced changes in minority bacterial groups in the vaginal microbiome, whereas ospemifene eliminated specific harmful bacterial taxa, such as Staphylococcus (P = .04) and Clostridium (P = .01). Both treatments induced a trend in the increase of beneficial Bifidobacteria.

A 2022 study reported that vaginal estradiol tablets significantly changed the vaginal microbiota in postmenopausal women compared with vaginal moisturizer or placebo, but the reductions in bothersome symptoms were similar.
 

The future

“Areas for future study include the assessment of changes in the vaginal microbiome, proteomic profiles, and immunologic markers with various treatments and the associations between these changes and genitourinary symptoms,” Dr. Faubion said. She added that, while there may be a role at some point for oral or topical probiotics, “Thus far, probiotics have not demonstrated significant benefits.”

Meanwhile, said Ms. Murphy, “There are many options available that may benefit our patients. As a provider, meeting with your patient, discussing her concerns and individual risk factors is the most important part of choosing the correct treatment plan.”

The authors call for further studies to confirm the observed modifications of the vaginal ecosystem. In the meantime, Dr. Meriggiola said in an interview, “My best advice to physicians is to ask women if they have this problem. Do not ignore it; be proactive and treat. There are many options on the market for genitourinary symptoms – not just for postmenopausal women but breast cancer survivors as well.”

Dr. Meriggiola’s group is planning to study ospemifene in cancer patients, whose quality of life is severely affected by VVA.

This study received no financial support. Dr. Meriggiola reported past financial relationships with Shionogi Limited, Teramex, Organon, Italfarmaco, MDS Italia, and Bayer. Coauthor Dr. Baldassarre disclosed past financial relationships with Shionogi. Ms. Murphy disclosed no relevant conflicts of interest with respect to her comments. Dr. Faubion is medical director of the North American Menopause Society and editor of the journal Menopause.

The selective estrogen receptor modulator ospemifene appears to improve the vaginal microbiome of postmenopausal women with vulvovaginal atrophy (VVA), according to results from a small Italian case-control study in the journal Menopause.

The study sheds microbiological light on the mechanisms of ospemifene and low-dose systemic hormone therapy, which are widely used to treat genitourinary symptoms. Both had a positive effect on vaginal well-being, likely by reducing potentially harmful bacteria and increasing health-promoting acid-friendly microorganisms, writes a group led by M. Cristina Meriggiola, MD, PhD, of the gynecology and physiopathology of human reproduction unit at the University of Bologna, Italy.

VVA occurs in about 50% of postmenopausal women and produces a less favorable, less acidic vaginal microbiome profile than that of unaffected women. “The loss of estrogen leads to lower concentrations of Lactobacilli, bacteria that lower the pH. As a result, other bacterial species fill in the void,” explained Stephanie S. Faubion, MD, MBA, director of the Mayo Clinic Center for Women’s Health in Jacksonville, Fla., and medical director of the North American Menopause Society.

Added Tina Murphy, APN, a NAMS-certified menopause practitioner at Northwestern Medicine Orland Park in Illinois, “When this protective flora declines, then pathogenic bacteria can predominate the microbiome, which can contribute to vaginal irritation, infection, UTI’s, dyspareunia, and discomfort. Balancing and restoring the microbiome can mitigate the effects of estrogen depletion on the vaginal tissue and prevent the untoward effects of the hypoestrogenic state.” While ospemifene and hormone therapy are common therapies for the genitourinary symptoms of menopause, the focus has been on their treatment efficacy, not their effect on the microbiome profile, added Dr. Faubion. Only about 9% of women with menopause-related genitourinary symptoms receive prescription treatment, she added.
 

The study

Of 67 eligible postmenopausal participants in their mid-50s enrolled at a gynecology clinic from April 2019 to February 2020, 39 were diagnosed with VVA and 28 were considered healthy controls. In the atrophic group, 20 were prescribed ospemifene and 19 received hormone treatment.

Only those women with VVA but no menopausal vasomotor symptoms received ospemifene (60 mg/day); symptomatic women received hormone therapy according to guidelines.

The researchers calculated the women’s vaginal health index (VHI) based on elasticity, secretions, pH level, epithelial mucosa, and hydration. They used swabs to assess vaginal maturation index (VMI) by percentages of superficial, intermediate, and parabasal cells. Evaluation of the vaginal microbiome was done with 16S rRNA gene sequencing, and clinical and microbiological analyses were repeated after 3 months.

The vaginal microbiome of atrophic women was characterized by a significant reduction of benign Lactobacillus bacteria (P = .002) and an increase of potentially pathogenic Streptococcus (P = .008) and Sneathia (P = .02) bacteria.

The vaginal microbiome of women with VVA was depleted, within the Lactobacillus genus, in the L. crispatus species, a hallmark of vaginal health that has significant antimicrobial activity against endogenous and exogenous pathogens.

Furthermore, there was a positive correlation between the VHI/VMI and Lactobacillus abundance (P = .002 and P = 0.035, respectively).

While the lactic acid–producing Lactobacillus and Bifidobacterium genera were strongly associated with healthy controls, the characteristics of VVA patients were strongly associated with Streptococcus, Prevotella, Alloscardovia, and Staphylococcus.

Both therapeutic approaches effectively improved vaginal indices but by different routes. Systemic hormone treatment induced changes in minority bacterial groups in the vaginal microbiome, whereas ospemifene eliminated specific harmful bacterial taxa, such as Staphylococcus (P = .04) and Clostridium (P = .01). Both treatments induced a trend in the increase of beneficial Bifidobacteria.

A 2022 study reported that vaginal estradiol tablets significantly changed the vaginal microbiota in postmenopausal women compared with vaginal moisturizer or placebo, but the reductions in bothersome symptoms were similar.
 

The future

“Areas for future study include the assessment of changes in the vaginal microbiome, proteomic profiles, and immunologic markers with various treatments and the associations between these changes and genitourinary symptoms,” Dr. Faubion said. She added that, while there may be a role at some point for oral or topical probiotics, “Thus far, probiotics have not demonstrated significant benefits.”

Meanwhile, said Ms. Murphy, “There are many options available that may benefit our patients. As a provider, meeting with your patient, discussing her concerns and individual risk factors is the most important part of choosing the correct treatment plan.”

The authors call for further studies to confirm the observed modifications of the vaginal ecosystem. In the meantime, Dr. Meriggiola said in an interview, “My best advice to physicians is to ask women if they have this problem. Do not ignore it; be proactive and treat. There are many options on the market for genitourinary symptoms – not just for postmenopausal women but breast cancer survivors as well.”

Dr. Meriggiola’s group is planning to study ospemifene in cancer patients, whose quality of life is severely affected by VVA.

This study received no financial support. Dr. Meriggiola reported past financial relationships with Shionogi Limited, Teramex, Organon, Italfarmaco, MDS Italia, and Bayer. Coauthor Dr. Baldassarre disclosed past financial relationships with Shionogi. Ms. Murphy disclosed no relevant conflicts of interest with respect to her comments. Dr. Faubion is medical director of the North American Menopause Society and editor of the journal Menopause.

The selective estrogen receptor modulator ospemifene appears to improve the vaginal microbiome of postmenopausal women with vulvovaginal atrophy (VVA), according to results from a small Italian case-control study in the journal Menopause.

The study sheds microbiological light on the mechanisms of ospemifene and low-dose systemic hormone therapy, which are widely used to treat genitourinary symptoms. Both had a positive effect on vaginal well-being, likely by reducing potentially harmful bacteria and increasing health-promoting acid-friendly microorganisms, writes a group led by M. Cristina Meriggiola, MD, PhD, of the gynecology and physiopathology of human reproduction unit at the University of Bologna, Italy.

VVA occurs in about 50% of postmenopausal women and produces a less favorable, less acidic vaginal microbiome profile than that of unaffected women. “The loss of estrogen leads to lower concentrations of Lactobacilli, bacteria that lower the pH. As a result, other bacterial species fill in the void,” explained Stephanie S. Faubion, MD, MBA, director of the Mayo Clinic Center for Women’s Health in Jacksonville, Fla., and medical director of the North American Menopause Society.

Added Tina Murphy, APN, a NAMS-certified menopause practitioner at Northwestern Medicine Orland Park in Illinois, “When this protective flora declines, then pathogenic bacteria can predominate the microbiome, which can contribute to vaginal irritation, infection, UTI’s, dyspareunia, and discomfort. Balancing and restoring the microbiome can mitigate the effects of estrogen depletion on the vaginal tissue and prevent the untoward effects of the hypoestrogenic state.” While ospemifene and hormone therapy are common therapies for the genitourinary symptoms of menopause, the focus has been on their treatment efficacy, not their effect on the microbiome profile, added Dr. Faubion. Only about 9% of women with menopause-related genitourinary symptoms receive prescription treatment, she added.
 

The study

Of 67 eligible postmenopausal participants in their mid-50s enrolled at a gynecology clinic from April 2019 to February 2020, 39 were diagnosed with VVA and 28 were considered healthy controls. In the atrophic group, 20 were prescribed ospemifene and 19 received hormone treatment.

Only those women with VVA but no menopausal vasomotor symptoms received ospemifene (60 mg/day); symptomatic women received hormone therapy according to guidelines.

The researchers calculated the women’s vaginal health index (VHI) based on elasticity, secretions, pH level, epithelial mucosa, and hydration. They used swabs to assess vaginal maturation index (VMI) by percentages of superficial, intermediate, and parabasal cells. Evaluation of the vaginal microbiome was done with 16S rRNA gene sequencing, and clinical and microbiological analyses were repeated after 3 months.

The vaginal microbiome of atrophic women was characterized by a significant reduction of benign Lactobacillus bacteria (P = .002) and an increase of potentially pathogenic Streptococcus (P = .008) and Sneathia (P = .02) bacteria.

The vaginal microbiome of women with VVA was depleted, within the Lactobacillus genus, in the L. crispatus species, a hallmark of vaginal health that has significant antimicrobial activity against endogenous and exogenous pathogens.

Furthermore, there was a positive correlation between the VHI/VMI and Lactobacillus abundance (P = .002 and P = 0.035, respectively).

While the lactic acid–producing Lactobacillus and Bifidobacterium genera were strongly associated with healthy controls, the characteristics of VVA patients were strongly associated with Streptococcus, Prevotella, Alloscardovia, and Staphylococcus.

Both therapeutic approaches effectively improved vaginal indices but by different routes. Systemic hormone treatment induced changes in minority bacterial groups in the vaginal microbiome, whereas ospemifene eliminated specific harmful bacterial taxa, such as Staphylococcus (P = .04) and Clostridium (P = .01). Both treatments induced a trend in the increase of beneficial Bifidobacteria.

A 2022 study reported that vaginal estradiol tablets significantly changed the vaginal microbiota in postmenopausal women compared with vaginal moisturizer or placebo, but the reductions in bothersome symptoms were similar.
 

The future

“Areas for future study include the assessment of changes in the vaginal microbiome, proteomic profiles, and immunologic markers with various treatments and the associations between these changes and genitourinary symptoms,” Dr. Faubion said. She added that, while there may be a role at some point for oral or topical probiotics, “Thus far, probiotics have not demonstrated significant benefits.”

Meanwhile, said Ms. Murphy, “There are many options available that may benefit our patients. As a provider, meeting with your patient, discussing her concerns and individual risk factors is the most important part of choosing the correct treatment plan.”

The authors call for further studies to confirm the observed modifications of the vaginal ecosystem. In the meantime, Dr. Meriggiola said in an interview, “My best advice to physicians is to ask women if they have this problem. Do not ignore it; be proactive and treat. There are many options on the market for genitourinary symptoms – not just for postmenopausal women but breast cancer survivors as well.”

Dr. Meriggiola’s group is planning to study ospemifene in cancer patients, whose quality of life is severely affected by VVA.

This study received no financial support. Dr. Meriggiola reported past financial relationships with Shionogi Limited, Teramex, Organon, Italfarmaco, MDS Italia, and Bayer. Coauthor Dr. Baldassarre disclosed past financial relationships with Shionogi. Ms. Murphy disclosed no relevant conflicts of interest with respect to her comments. Dr. Faubion is medical director of the North American Menopause Society and editor of the journal Menopause.

Individuals with diabetes who are forced to switch to high-deductible health plans have more episodes of severe hypo- and hyperglycemia compared with those on conventional insurance plans, according to a new study.

Previous studies have shown that people with diabetes who are enrolled in high-deductible health plans (HDHPs) have an increased financial burden, lower medication adherence, and more low-severity emergency department visits, and they delay care for cardiovascular conditions.  

But no study has looked at the plans’ impact on acute diabetes complications and glycemic control, wrote the authors in JAMA Network Open.

They found evidence that the high-dollar plans were associated with increased odds of severe hypoglycemic and hyperglycemic events, and that the risk increased with each successive year of enrollment. Low-income individuals, Blacks, and Hispanics were disproportionately more impacted, noted senior author Rozalina G. McCoy, MD, Mayo Clinic, Rochester, Minn., and colleagues.

Overall, “enrollees may be rationing or forgoing necessary care, which is detrimental to their health and ultimately increases the morbidity, mortality, and costs associated with diabetes,” they concluded.

A systematic review of eight studies published in Endocrine Practice in 2021 backs up this latest finding. That analysis reported enrollees in HDHPs often forgo routine care and monitoring, and that they have lower medication adherence, leading to an increase in total health care expenditures for emergency department visits, hospitalizations, and preventable complications.
 

Increased frequency of hypoglycemia is detrimental

The new study published in JAMA Network Open was based on data for adults enrolled in private insurance programs from 2010 to 2018. Researchers analyzed medical and pharmacy claims data contained in a large health insurance claims database, comparing adults with diabetes who had been in an HDHP for at least 1 year (and after a year of being in a conventional plan), with those who were in a conventional plan.

They identified 42,326 individuals who had been switched from a conventional plan to an HDHP. Of those, 7,375 (17.4%) were Black, 5,740 (13.6%) were Hispanic, 26,572 (62.8%) were non-Hispanic White, and 6,880 (16.3%) had a household income below $40,000 a year.

Baseline characteristics of the 202,729 people in conventional plans were similar to those in the HDHP group. 

The median deductible for individuals in the HDHP group was $1,500 and for families it was $3,000, compared with $350 and $800, respectively, for those in conventional plans.

The odds of having any severe hypoglycemic event were significantly higher in the HDHP group (odds ratio [OR], 1.11; P < .001). Each year of HDHP enrollment increased the odds of a hypoglycemia-related ED or hospital visit by 2% (OR, 1.02; P = .04).  

Aware that only a small number of severe hypoglycemic events, as well as an unknown number of such events, result in an emergency department visit or hospitalization, and that “the decision to seek ED or hospital care may be influenced by health plan assignment,” the authors also looked at office visits where severe, or any, hypoglycemia or hyperglycemia was coded or documented.

The proportion of HDHP enrollees where hypoglycemia was coded was 14% higher than for conventional plan enrollees (OR, 1.14; P < .001), with each year of the high-dollar plan enrollment increasing these odds by 6% (OR, 1.06; P < .001).

The tally of hypoglycemic events is an underestimate because HDHP enrollees might forgo ambulatory care for cost-related reasons, wrote the authors. Hypoglycemia might also be treated at home. But that is not necessarily a positive, they noted.

“The increased frequency of severe hypoglycemia – no matter where managed and discussed – is a sign of detrimental effects of HDHP enrollment for people living with diabetes.”

They found that individuals of racial and ethnic minorities were less likely than were White patients to have an increase in hypoglycemia-related office visits, which suggests that those patients were deferring care, wrote Dr. McCoy and colleagues.

Switching to an HDHP was associated with a significant increase in the odds of having at least one hyperglycemia-related ED or hospital visit per year (OR, 1.25; P < .001). Each successive year in the plan increased these odds by 5% (OR, 1.05; P = .02). However, the authors found no increase in hyperglycemia-related office visits.

“Because severe dysglycemic events may be prevented with optimal glycemic management, the increase in the frequency of their occurrence suggests important gaps in access to and implementation of diabetes therapy,” wrote the authors.

They noted that people with diabetes already face high out-of-pocket expenses. A high-deductible plan might make care even less affordable, they wrote.

“Individuals may be forced to ration medications, glucose-monitoring supplies, diabetes self-management education, food, and other essential cares to the detriment of their health,” they noted.

The authors added that because the study was observational, they could not delve into the root causes of the glycemic events or whether, for instance, any HDHP enrollees also had health savings accounts (HSAs) that might help defray costs.

They suggested that employers offer a wide variety of health plans, or if they are offering only a high-deductible plan that they be more transparent about potential costs. “Previous studies have shown that enrollees are not fully aware of the details within their health plans and may be focusing on reducing the cost of monthly premiums – not overall care – when choosing health plans.”

The authors said employers should find ways to fund HSAs for people with low incomes – those who appear to be most vulnerable to the effects of HDHPs. 

A study published in JAMA Internal Medicine in 2017 found that low-income and HSA-eligible individuals with diabetes switched to an HDHP had major increases in emergency department visits for preventable acute diabetes complications.

The study was funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Mayo Clinic K2R Research Award, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. McCoy has reported receiving grants from the NIDDK, AARP, and the Patient-Centered Outcomes Research Institute, and personal fees from Emmi for the development of patient education materials about diabetes outside the submitted work.

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

Individuals with diabetes who are forced to switch to high-deductible health plans have more episodes of severe hypo- and hyperglycemia compared with those on conventional insurance plans, according to a new study.

Previous studies have shown that people with diabetes who are enrolled in high-deductible health plans (HDHPs) have an increased financial burden, lower medication adherence, and more low-severity emergency department visits, and they delay care for cardiovascular conditions.  

But no study has looked at the plans’ impact on acute diabetes complications and glycemic control, wrote the authors in JAMA Network Open.

They found evidence that the high-dollar plans were associated with increased odds of severe hypoglycemic and hyperglycemic events, and that the risk increased with each successive year of enrollment. Low-income individuals, Blacks, and Hispanics were disproportionately more impacted, noted senior author Rozalina G. McCoy, MD, Mayo Clinic, Rochester, Minn., and colleagues.

Overall, “enrollees may be rationing or forgoing necessary care, which is detrimental to their health and ultimately increases the morbidity, mortality, and costs associated with diabetes,” they concluded.

A systematic review of eight studies published in Endocrine Practice in 2021 backs up this latest finding. That analysis reported enrollees in HDHPs often forgo routine care and monitoring, and that they have lower medication adherence, leading to an increase in total health care expenditures for emergency department visits, hospitalizations, and preventable complications.
 

Increased frequency of hypoglycemia is detrimental

The new study published in JAMA Network Open was based on data for adults enrolled in private insurance programs from 2010 to 2018. Researchers analyzed medical and pharmacy claims data contained in a large health insurance claims database, comparing adults with diabetes who had been in an HDHP for at least 1 year (and after a year of being in a conventional plan), with those who were in a conventional plan.

They identified 42,326 individuals who had been switched from a conventional plan to an HDHP. Of those, 7,375 (17.4%) were Black, 5,740 (13.6%) were Hispanic, 26,572 (62.8%) were non-Hispanic White, and 6,880 (16.3%) had a household income below $40,000 a year.

Baseline characteristics of the 202,729 people in conventional plans were similar to those in the HDHP group. 

The median deductible for individuals in the HDHP group was $1,500 and for families it was $3,000, compared with $350 and $800, respectively, for those in conventional plans.

The odds of having any severe hypoglycemic event were significantly higher in the HDHP group (odds ratio [OR], 1.11; P < .001). Each year of HDHP enrollment increased the odds of a hypoglycemia-related ED or hospital visit by 2% (OR, 1.02; P = .04).  

Aware that only a small number of severe hypoglycemic events, as well as an unknown number of such events, result in an emergency department visit or hospitalization, and that “the decision to seek ED or hospital care may be influenced by health plan assignment,” the authors also looked at office visits where severe, or any, hypoglycemia or hyperglycemia was coded or documented.

The proportion of HDHP enrollees where hypoglycemia was coded was 14% higher than for conventional plan enrollees (OR, 1.14; P < .001), with each year of the high-dollar plan enrollment increasing these odds by 6% (OR, 1.06; P < .001).

The tally of hypoglycemic events is an underestimate because HDHP enrollees might forgo ambulatory care for cost-related reasons, wrote the authors. Hypoglycemia might also be treated at home. But that is not necessarily a positive, they noted.

“The increased frequency of severe hypoglycemia – no matter where managed and discussed – is a sign of detrimental effects of HDHP enrollment for people living with diabetes.”

They found that individuals of racial and ethnic minorities were less likely than were White patients to have an increase in hypoglycemia-related office visits, which suggests that those patients were deferring care, wrote Dr. McCoy and colleagues.

Switching to an HDHP was associated with a significant increase in the odds of having at least one hyperglycemia-related ED or hospital visit per year (OR, 1.25; P < .001). Each successive year in the plan increased these odds by 5% (OR, 1.05; P = .02). However, the authors found no increase in hyperglycemia-related office visits.

“Because severe dysglycemic events may be prevented with optimal glycemic management, the increase in the frequency of their occurrence suggests important gaps in access to and implementation of diabetes therapy,” wrote the authors.

They noted that people with diabetes already face high out-of-pocket expenses. A high-deductible plan might make care even less affordable, they wrote.

“Individuals may be forced to ration medications, glucose-monitoring supplies, diabetes self-management education, food, and other essential cares to the detriment of their health,” they noted.

The authors added that because the study was observational, they could not delve into the root causes of the glycemic events or whether, for instance, any HDHP enrollees also had health savings accounts (HSAs) that might help defray costs.

They suggested that employers offer a wide variety of health plans, or if they are offering only a high-deductible plan that they be more transparent about potential costs. “Previous studies have shown that enrollees are not fully aware of the details within their health plans and may be focusing on reducing the cost of monthly premiums – not overall care – when choosing health plans.”

The authors said employers should find ways to fund HSAs for people with low incomes – those who appear to be most vulnerable to the effects of HDHPs. 

A study published in JAMA Internal Medicine in 2017 found that low-income and HSA-eligible individuals with diabetes switched to an HDHP had major increases in emergency department visits for preventable acute diabetes complications.

The study was funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Mayo Clinic K2R Research Award, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. McCoy has reported receiving grants from the NIDDK, AARP, and the Patient-Centered Outcomes Research Institute, and personal fees from Emmi for the development of patient education materials about diabetes outside the submitted work.

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

Individuals with diabetes who are forced to switch to high-deductible health plans have more episodes of severe hypo- and hyperglycemia compared with those on conventional insurance plans, according to a new study.

Previous studies have shown that people with diabetes who are enrolled in high-deductible health plans (HDHPs) have an increased financial burden, lower medication adherence, and more low-severity emergency department visits, and they delay care for cardiovascular conditions.  

But no study has looked at the plans’ impact on acute diabetes complications and glycemic control, wrote the authors in JAMA Network Open.

They found evidence that the high-dollar plans were associated with increased odds of severe hypoglycemic and hyperglycemic events, and that the risk increased with each successive year of enrollment. Low-income individuals, Blacks, and Hispanics were disproportionately more impacted, noted senior author Rozalina G. McCoy, MD, Mayo Clinic, Rochester, Minn., and colleagues.

Overall, “enrollees may be rationing or forgoing necessary care, which is detrimental to their health and ultimately increases the morbidity, mortality, and costs associated with diabetes,” they concluded.

A systematic review of eight studies published in Endocrine Practice in 2021 backs up this latest finding. That analysis reported enrollees in HDHPs often forgo routine care and monitoring, and that they have lower medication adherence, leading to an increase in total health care expenditures for emergency department visits, hospitalizations, and preventable complications.
 

Increased frequency of hypoglycemia is detrimental

The new study published in JAMA Network Open was based on data for adults enrolled in private insurance programs from 2010 to 2018. Researchers analyzed medical and pharmacy claims data contained in a large health insurance claims database, comparing adults with diabetes who had been in an HDHP for at least 1 year (and after a year of being in a conventional plan), with those who were in a conventional plan.

They identified 42,326 individuals who had been switched from a conventional plan to an HDHP. Of those, 7,375 (17.4%) were Black, 5,740 (13.6%) were Hispanic, 26,572 (62.8%) were non-Hispanic White, and 6,880 (16.3%) had a household income below $40,000 a year.

Baseline characteristics of the 202,729 people in conventional plans were similar to those in the HDHP group. 

The median deductible for individuals in the HDHP group was $1,500 and for families it was $3,000, compared with $350 and $800, respectively, for those in conventional plans.

The odds of having any severe hypoglycemic event were significantly higher in the HDHP group (odds ratio [OR], 1.11; P < .001). Each year of HDHP enrollment increased the odds of a hypoglycemia-related ED or hospital visit by 2% (OR, 1.02; P = .04).  

Aware that only a small number of severe hypoglycemic events, as well as an unknown number of such events, result in an emergency department visit or hospitalization, and that “the decision to seek ED or hospital care may be influenced by health plan assignment,” the authors also looked at office visits where severe, or any, hypoglycemia or hyperglycemia was coded or documented.

The proportion of HDHP enrollees where hypoglycemia was coded was 14% higher than for conventional plan enrollees (OR, 1.14; P < .001), with each year of the high-dollar plan enrollment increasing these odds by 6% (OR, 1.06; P < .001).

The tally of hypoglycemic events is an underestimate because HDHP enrollees might forgo ambulatory care for cost-related reasons, wrote the authors. Hypoglycemia might also be treated at home. But that is not necessarily a positive, they noted.

“The increased frequency of severe hypoglycemia – no matter where managed and discussed – is a sign of detrimental effects of HDHP enrollment for people living with diabetes.”

They found that individuals of racial and ethnic minorities were less likely than were White patients to have an increase in hypoglycemia-related office visits, which suggests that those patients were deferring care, wrote Dr. McCoy and colleagues.

Switching to an HDHP was associated with a significant increase in the odds of having at least one hyperglycemia-related ED or hospital visit per year (OR, 1.25; P < .001). Each successive year in the plan increased these odds by 5% (OR, 1.05; P = .02). However, the authors found no increase in hyperglycemia-related office visits.

“Because severe dysglycemic events may be prevented with optimal glycemic management, the increase in the frequency of their occurrence suggests important gaps in access to and implementation of diabetes therapy,” wrote the authors.

They noted that people with diabetes already face high out-of-pocket expenses. A high-deductible plan might make care even less affordable, they wrote.

“Individuals may be forced to ration medications, glucose-monitoring supplies, diabetes self-management education, food, and other essential cares to the detriment of their health,” they noted.

The authors added that because the study was observational, they could not delve into the root causes of the glycemic events or whether, for instance, any HDHP enrollees also had health savings accounts (HSAs) that might help defray costs.

They suggested that employers offer a wide variety of health plans, or if they are offering only a high-deductible plan that they be more transparent about potential costs. “Previous studies have shown that enrollees are not fully aware of the details within their health plans and may be focusing on reducing the cost of monthly premiums – not overall care – when choosing health plans.”

The authors said employers should find ways to fund HSAs for people with low incomes – those who appear to be most vulnerable to the effects of HDHPs. 

A study published in JAMA Internal Medicine in 2017 found that low-income and HSA-eligible individuals with diabetes switched to an HDHP had major increases in emergency department visits for preventable acute diabetes complications.

The study was funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Mayo Clinic K2R Research Award, and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. McCoy has reported receiving grants from the NIDDK, AARP, and the Patient-Centered Outcomes Research Institute, and personal fees from Emmi for the development of patient education materials about diabetes outside the submitted work.

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

PCSK9 inhibitors may best be known for their powerful LDL-lowering effects but are less appreciated as anti-inflammatory agents with potential beyond cardiovascular health.

In a small pilot trial, for example, patients hospitalized with severe COVID-19 who received a single injection of PCSK9 inhibitor became less sick and more likely to survive than those given a placebo. Their 30-day risk of death or intubation fell significantly, as did their levels of the inflammatory cytokine interleukin 6 (IL-6).

Indeed, survival gains in the PCSK9-inhibitor group were greatest among patients with higher baseline concentrations of IL-6. Although the trial wasn’t powered for clinical outcomes, it suggests the drugs’ efficacy in COVID-19 tracks with intensity of inflammation, proposes a report published  in the Journal of the American College of Cardiology.

Therefore, “PCSK9 inhibition may represent a novel therapeutic pathway in addition to currently recommended therapeutic approaches for severe COVID-19,” conclude the authors, led by Eliano P. Navarese, MD, PhD, Nicolaus Copernicus University, Bydgoszcz, Poland.
 

PCSK9 inhibitors as anti-inflammatories

Although the study was small and only hypothesis-generating, the fact that outcomes for actively treated patients were proportional to baseline IL-6 levels “strongly suggests that PCSK9 inhibition can directly modulate inflammation in COVID-19,” argues an editorial accompanying the report.

The study adds to “our clinical arsenal against COVID-19,” and likely sheds light on “mechanisms through which PCSK9 inhibition dually modulates lipoprotein metabolism and inflammation,” write Sascha N. Goonewardena, MD, University of Michigan, Ann Arbor, and Robert S. Rosenson, MD, Icahn School of Medicine at Mount Sinai, New York.

The results are consistent with prior evidence that the drugs are anti-inflammatory at least partly because of their interference with inflammatory pathways triggered by PCSK9 and mediated by IL-6, as described by Dr. Navarese and colleagues.

Indeed, they write, PCSK9 inhibitors may improve COVID outcomes mostly through mechanisms unrelated to LDL-receptor expression, “including direct inhibition of PCSK9-triggered inflammation.”

If true, the authors observe, it might explain “why the positive findings of the present study have not been consistently observed in trials involving other lipid-lowering agents, such as statins.” Those drugs are well-known to decrease levels of the inflammatory biomarker C-reactive protein.

In patients with stable coronary disease, in whom inflammation is typically tracked by measuring CRP, “the PCSK9 inhibitors have not been shown to have an anti-inflammatory effect,” Dr. Rosenson further explained.

But the current study’s patients with acute, severe COVID-19, a “profound inflammatory insult” with upregulation of IL-6, were “a good population” for evaluating the drugs’ potential anti-inflammatory effects, Dr. Rosenson said in an interview. The results “are quite enticing but require corroboration in a larger trial.”
 

A single injection

The IMPACT-SIRIO 5 trial entered 60 adults hospitalized with severe COVID-19 and elevated IL-6 at four centers in Poland. Patients with other known active infections were excluded.  

They were randomly assigned double-blind to receive a 140 mg injection of evolocumab (Repatha) or placebo. The 2 groups were similar with respect to demographics, body-mass index, time since symptom onset, and treatments for managing COVID-19 and its complications.

Rates of death or need for intubation at 30 days, the primary endpoint, were 23.3% in the PCSK9-inhibitor group and 53.3% for controls, a risk difference of 30% (95% confidence interval –53.4% to –6.6%). The median durations of oxygen therapy were significantly different at 13 days and 20 days, respectively, the report states.

Serum IL-6 levels fell further over 30 days in the PCSK9-inhibitor group (–56% vs. –21% among controls). A drop by more than 90% was seen in 60% of patients in the PCSK9-inhibitor group and in 27% of controls.

The average hospital stay was shorter for those getting the PCSK9 inhibitor, compared with placebo, 16 days versus 22 days, and their 30-day mortality was numerically lower, 16% versus 33.3%.

Patients’ baseline IL-6 levels above the median, the report states, had a lower mortality on the PCSK9 inhibitor versus placebo (risk difference –37.5%; 95% CI –68.2% to –6.70%).

A larger trial to corroborate these results would potentially enter similar patients hospitalized with COVID-19 with reproducible evidence of an ongoing cytokine storm, such as elevated levels of IL-6, who would be assigned to either a PCSK9 inhibitor or placebo, Dr. Rosenson proposed.

Although the current primary endpoint that combines mortality and intubation was “reasonable” for a small pilot trial, he said, if the researchers embark on a larger study, “they’ll want to look at those events separately.”

Dr. Navarese discloses receiving speaker and consultancy fees from Amgen, Sanofi-Regeneron, Bayer; and grants from Abbott. Disclosures for the other authors are in the report. Rosenson discloses receiving research funding to his institution from Amgen, Arrowhead, Eli Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, CRISPR Therapeutics, Eli Lilly, Lipigon, Novartis, Precision Biosciences, Regeneron, Ultragenyx, and Verve; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer; and owning stock in MediMergent. Dr. Goonewardena reports no relevant financial relationships.

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

PCSK9 inhibitors may best be known for their powerful LDL-lowering effects but are less appreciated as anti-inflammatory agents with potential beyond cardiovascular health.

In a small pilot trial, for example, patients hospitalized with severe COVID-19 who received a single injection of PCSK9 inhibitor became less sick and more likely to survive than those given a placebo. Their 30-day risk of death or intubation fell significantly, as did their levels of the inflammatory cytokine interleukin 6 (IL-6).

Indeed, survival gains in the PCSK9-inhibitor group were greatest among patients with higher baseline concentrations of IL-6. Although the trial wasn’t powered for clinical outcomes, it suggests the drugs’ efficacy in COVID-19 tracks with intensity of inflammation, proposes a report published  in the Journal of the American College of Cardiology.

Therefore, “PCSK9 inhibition may represent a novel therapeutic pathway in addition to currently recommended therapeutic approaches for severe COVID-19,” conclude the authors, led by Eliano P. Navarese, MD, PhD, Nicolaus Copernicus University, Bydgoszcz, Poland.
 

PCSK9 inhibitors as anti-inflammatories

Although the study was small and only hypothesis-generating, the fact that outcomes for actively treated patients were proportional to baseline IL-6 levels “strongly suggests that PCSK9 inhibition can directly modulate inflammation in COVID-19,” argues an editorial accompanying the report.

The study adds to “our clinical arsenal against COVID-19,” and likely sheds light on “mechanisms through which PCSK9 inhibition dually modulates lipoprotein metabolism and inflammation,” write Sascha N. Goonewardena, MD, University of Michigan, Ann Arbor, and Robert S. Rosenson, MD, Icahn School of Medicine at Mount Sinai, New York.

The results are consistent with prior evidence that the drugs are anti-inflammatory at least partly because of their interference with inflammatory pathways triggered by PCSK9 and mediated by IL-6, as described by Dr. Navarese and colleagues.

Indeed, they write, PCSK9 inhibitors may improve COVID outcomes mostly through mechanisms unrelated to LDL-receptor expression, “including direct inhibition of PCSK9-triggered inflammation.”

If true, the authors observe, it might explain “why the positive findings of the present study have not been consistently observed in trials involving other lipid-lowering agents, such as statins.” Those drugs are well-known to decrease levels of the inflammatory biomarker C-reactive protein.

In patients with stable coronary disease, in whom inflammation is typically tracked by measuring CRP, “the PCSK9 inhibitors have not been shown to have an anti-inflammatory effect,” Dr. Rosenson further explained.

But the current study’s patients with acute, severe COVID-19, a “profound inflammatory insult” with upregulation of IL-6, were “a good population” for evaluating the drugs’ potential anti-inflammatory effects, Dr. Rosenson said in an interview. The results “are quite enticing but require corroboration in a larger trial.”
 

A single injection

The IMPACT-SIRIO 5 trial entered 60 adults hospitalized with severe COVID-19 and elevated IL-6 at four centers in Poland. Patients with other known active infections were excluded.  

They were randomly assigned double-blind to receive a 140 mg injection of evolocumab (Repatha) or placebo. The 2 groups were similar with respect to demographics, body-mass index, time since symptom onset, and treatments for managing COVID-19 and its complications.

Rates of death or need for intubation at 30 days, the primary endpoint, were 23.3% in the PCSK9-inhibitor group and 53.3% for controls, a risk difference of 30% (95% confidence interval –53.4% to –6.6%). The median durations of oxygen therapy were significantly different at 13 days and 20 days, respectively, the report states.

Serum IL-6 levels fell further over 30 days in the PCSK9-inhibitor group (–56% vs. –21% among controls). A drop by more than 90% was seen in 60% of patients in the PCSK9-inhibitor group and in 27% of controls.

The average hospital stay was shorter for those getting the PCSK9 inhibitor, compared with placebo, 16 days versus 22 days, and their 30-day mortality was numerically lower, 16% versus 33.3%.

Patients’ baseline IL-6 levels above the median, the report states, had a lower mortality on the PCSK9 inhibitor versus placebo (risk difference –37.5%; 95% CI –68.2% to –6.70%).

A larger trial to corroborate these results would potentially enter similar patients hospitalized with COVID-19 with reproducible evidence of an ongoing cytokine storm, such as elevated levels of IL-6, who would be assigned to either a PCSK9 inhibitor or placebo, Dr. Rosenson proposed.

Although the current primary endpoint that combines mortality and intubation was “reasonable” for a small pilot trial, he said, if the researchers embark on a larger study, “they’ll want to look at those events separately.”

Dr. Navarese discloses receiving speaker and consultancy fees from Amgen, Sanofi-Regeneron, Bayer; and grants from Abbott. Disclosures for the other authors are in the report. Rosenson discloses receiving research funding to his institution from Amgen, Arrowhead, Eli Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, CRISPR Therapeutics, Eli Lilly, Lipigon, Novartis, Precision Biosciences, Regeneron, Ultragenyx, and Verve; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer; and owning stock in MediMergent. Dr. Goonewardena reports no relevant financial relationships.

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

PCSK9 inhibitors may best be known for their powerful LDL-lowering effects but are less appreciated as anti-inflammatory agents with potential beyond cardiovascular health.

In a small pilot trial, for example, patients hospitalized with severe COVID-19 who received a single injection of PCSK9 inhibitor became less sick and more likely to survive than those given a placebo. Their 30-day risk of death or intubation fell significantly, as did their levels of the inflammatory cytokine interleukin 6 (IL-6).

Indeed, survival gains in the PCSK9-inhibitor group were greatest among patients with higher baseline concentrations of IL-6. Although the trial wasn’t powered for clinical outcomes, it suggests the drugs’ efficacy in COVID-19 tracks with intensity of inflammation, proposes a report published  in the Journal of the American College of Cardiology.

Therefore, “PCSK9 inhibition may represent a novel therapeutic pathway in addition to currently recommended therapeutic approaches for severe COVID-19,” conclude the authors, led by Eliano P. Navarese, MD, PhD, Nicolaus Copernicus University, Bydgoszcz, Poland.
 

PCSK9 inhibitors as anti-inflammatories

Although the study was small and only hypothesis-generating, the fact that outcomes for actively treated patients were proportional to baseline IL-6 levels “strongly suggests that PCSK9 inhibition can directly modulate inflammation in COVID-19,” argues an editorial accompanying the report.

The study adds to “our clinical arsenal against COVID-19,” and likely sheds light on “mechanisms through which PCSK9 inhibition dually modulates lipoprotein metabolism and inflammation,” write Sascha N. Goonewardena, MD, University of Michigan, Ann Arbor, and Robert S. Rosenson, MD, Icahn School of Medicine at Mount Sinai, New York.

The results are consistent with prior evidence that the drugs are anti-inflammatory at least partly because of their interference with inflammatory pathways triggered by PCSK9 and mediated by IL-6, as described by Dr. Navarese and colleagues.

Indeed, they write, PCSK9 inhibitors may improve COVID outcomes mostly through mechanisms unrelated to LDL-receptor expression, “including direct inhibition of PCSK9-triggered inflammation.”

If true, the authors observe, it might explain “why the positive findings of the present study have not been consistently observed in trials involving other lipid-lowering agents, such as statins.” Those drugs are well-known to decrease levels of the inflammatory biomarker C-reactive protein.

In patients with stable coronary disease, in whom inflammation is typically tracked by measuring CRP, “the PCSK9 inhibitors have not been shown to have an anti-inflammatory effect,” Dr. Rosenson further explained.

But the current study’s patients with acute, severe COVID-19, a “profound inflammatory insult” with upregulation of IL-6, were “a good population” for evaluating the drugs’ potential anti-inflammatory effects, Dr. Rosenson said in an interview. The results “are quite enticing but require corroboration in a larger trial.”
 

A single injection

The IMPACT-SIRIO 5 trial entered 60 adults hospitalized with severe COVID-19 and elevated IL-6 at four centers in Poland. Patients with other known active infections were excluded.  

They were randomly assigned double-blind to receive a 140 mg injection of evolocumab (Repatha) or placebo. The 2 groups were similar with respect to demographics, body-mass index, time since symptom onset, and treatments for managing COVID-19 and its complications.

Rates of death or need for intubation at 30 days, the primary endpoint, were 23.3% in the PCSK9-inhibitor group and 53.3% for controls, a risk difference of 30% (95% confidence interval –53.4% to –6.6%). The median durations of oxygen therapy were significantly different at 13 days and 20 days, respectively, the report states.

Serum IL-6 levels fell further over 30 days in the PCSK9-inhibitor group (–56% vs. –21% among controls). A drop by more than 90% was seen in 60% of patients in the PCSK9-inhibitor group and in 27% of controls.

The average hospital stay was shorter for those getting the PCSK9 inhibitor, compared with placebo, 16 days versus 22 days, and their 30-day mortality was numerically lower, 16% versus 33.3%.

Patients’ baseline IL-6 levels above the median, the report states, had a lower mortality on the PCSK9 inhibitor versus placebo (risk difference –37.5%; 95% CI –68.2% to –6.70%).

A larger trial to corroborate these results would potentially enter similar patients hospitalized with COVID-19 with reproducible evidence of an ongoing cytokine storm, such as elevated levels of IL-6, who would be assigned to either a PCSK9 inhibitor or placebo, Dr. Rosenson proposed.

Although the current primary endpoint that combines mortality and intubation was “reasonable” for a small pilot trial, he said, if the researchers embark on a larger study, “they’ll want to look at those events separately.”

Dr. Navarese discloses receiving speaker and consultancy fees from Amgen, Sanofi-Regeneron, Bayer; and grants from Abbott. Disclosures for the other authors are in the report. Rosenson discloses receiving research funding to his institution from Amgen, Arrowhead, Eli Lilly, Novartis, and Regeneron; consulting fees from Amgen, Arrowhead, CRISPR Therapeutics, Eli Lilly, Lipigon, Novartis, Precision Biosciences, Regeneron, Ultragenyx, and Verve; speaking fees from Amgen, Kowa, and Regeneron; and royalties from Wolters Kluwer; and owning stock in MediMergent. Dr. Goonewardena reports no relevant financial relationships.

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

The U.S. Food and Drug Administration has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes.
 

Olivier Le Moal/Getty Images

The once-daily 20-mg oral sodium-glucose cotransporter 2 (SGLT2) inhibitor is indicated as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes, but not type 1 diabetes. It can be used in adults with an estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m².

Approval was based on results from 23 clinical trials with more than 5,000 participants, including more than 300 patients with stage 3 kidney disease (eGFR < 60 and > 30 mL/min per 1.73 m²).

In the phase 3 studies, bexagliflozin significantly reduced hemoglobin A1c and fasting blood glucose at 24 weeks as monotherapy or as add-on to metformin and other glucose-lowering drugs and combinations. It also produced modest reductions in body weight and systolic blood pressure.

In the phase 3 Bexagliflozin Efficacy and Safety Trial (BEST) cardiovascular outcomes trial, the drug met its efficacy and safety objectives in patients at high cardiovascular risk. Noninferiority was demonstrated for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.

“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, MD, director of the Translational Research Center at Massachusetts General Hospital, Boston, in a press release from TheracosBio.

“Being involved in all of the clinical trials for Brenzavvy, I am greatly impressed with the efficacy of the drug in reducing blood glucose levels and I believe it is an important addition to the SGLT2 inhibitor class of drugs.”

As with other SGLT2 inhibitors, adverse events seen in the trials include ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier’s gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.

Bexagliflozin joins an already crowded field of SGLT2 inhibitors, some of which have been approved for additional cardiovascular and kidney indications.

Of interest, bexagliflozin was approved by the FDA for diabetes in cats in December 2022, as the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes not previously treated with insulin.

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

The U.S. Food and Drug Administration has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes.
 

Olivier Le Moal/Getty Images

The once-daily 20-mg oral sodium-glucose cotransporter 2 (SGLT2) inhibitor is indicated as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes, but not type 1 diabetes. It can be used in adults with an estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m².

Approval was based on results from 23 clinical trials with more than 5,000 participants, including more than 300 patients with stage 3 kidney disease (eGFR < 60 and > 30 mL/min per 1.73 m²).

In the phase 3 studies, bexagliflozin significantly reduced hemoglobin A1c and fasting blood glucose at 24 weeks as monotherapy or as add-on to metformin and other glucose-lowering drugs and combinations. It also produced modest reductions in body weight and systolic blood pressure.

In the phase 3 Bexagliflozin Efficacy and Safety Trial (BEST) cardiovascular outcomes trial, the drug met its efficacy and safety objectives in patients at high cardiovascular risk. Noninferiority was demonstrated for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.

“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, MD, director of the Translational Research Center at Massachusetts General Hospital, Boston, in a press release from TheracosBio.

“Being involved in all of the clinical trials for Brenzavvy, I am greatly impressed with the efficacy of the drug in reducing blood glucose levels and I believe it is an important addition to the SGLT2 inhibitor class of drugs.”

As with other SGLT2 inhibitors, adverse events seen in the trials include ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier’s gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.

Bexagliflozin joins an already crowded field of SGLT2 inhibitors, some of which have been approved for additional cardiovascular and kidney indications.

Of interest, bexagliflozin was approved by the FDA for diabetes in cats in December 2022, as the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes not previously treated with insulin.

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

The U.S. Food and Drug Administration has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes.
 

Olivier Le Moal/Getty Images

The once-daily 20-mg oral sodium-glucose cotransporter 2 (SGLT2) inhibitor is indicated as an adjunct to diet and exercise to improve glycemic control for those with type 2 diabetes, but not type 1 diabetes. It can be used in adults with an estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m².

Approval was based on results from 23 clinical trials with more than 5,000 participants, including more than 300 patients with stage 3 kidney disease (eGFR < 60 and > 30 mL/min per 1.73 m²).

In the phase 3 studies, bexagliflozin significantly reduced hemoglobin A1c and fasting blood glucose at 24 weeks as monotherapy or as add-on to metformin and other glucose-lowering drugs and combinations. It also produced modest reductions in body weight and systolic blood pressure.

In the phase 3 Bexagliflozin Efficacy and Safety Trial (BEST) cardiovascular outcomes trial, the drug met its efficacy and safety objectives in patients at high cardiovascular risk. Noninferiority was demonstrated for the composite outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina.

“As a class of drugs, SGLT2 inhibitors have shown tremendous benefit in treating adults with type 2 diabetes,” said Mason Freeman, MD, director of the Translational Research Center at Massachusetts General Hospital, Boston, in a press release from TheracosBio.

“Being involved in all of the clinical trials for Brenzavvy, I am greatly impressed with the efficacy of the drug in reducing blood glucose levels and I believe it is an important addition to the SGLT2 inhibitor class of drugs.”

As with other SGLT2 inhibitors, adverse events seen in the trials include ketoacidosis, lower limb amputation, volume depletion, urosepsis, pyelonephritis, Fournier’s gangrene, genital mycotic infections, and hypoglycemia when used with insulin or insulin secretagogues.

Bexagliflozin joins an already crowded field of SGLT2 inhibitors, some of which have been approved for additional cardiovascular and kidney indications.

Of interest, bexagliflozin was approved by the FDA for diabetes in cats in December 2022, as the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes not previously treated with insulin.

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

Doctors do not appear to be bouncing back from the pandemic’s early days – their happiness at and away from work continues to be significantly lower than before the pandemic. Physicians reported similar levels of unhappiness in 2022 too.

Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*

“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.

“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”

Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.

Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.

While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.

“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.

Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.

Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.

Physicians’ personal life suffers

Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.

“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.

That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.

More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.

When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.

“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
 

Prioritize your well-being

Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”

Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.

A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.

Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”

She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”

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

Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.

Doctors do not appear to be bouncing back from the pandemic’s early days – their happiness at and away from work continues to be significantly lower than before the pandemic. Physicians reported similar levels of unhappiness in 2022 too.

Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*

“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.

“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”

Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.

Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.

While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.

“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.

Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.

Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.

Physicians’ personal life suffers

Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.

“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.

That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.

More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.

When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.

“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
 

Prioritize your well-being

Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”

Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.

A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.

Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”

She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”

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

Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.

Doctors do not appear to be bouncing back from the pandemic’s early days – their happiness at and away from work continues to be significantly lower than before the pandemic. Physicians reported similar levels of unhappiness in 2022 too.

Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*

“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.

“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”

Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.

Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.

While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.

“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.

Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.

Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.

Physicians’ personal life suffers

Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.

“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.

That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.

More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.

When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.

“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
 

Prioritize your well-being

Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”

Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.

A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.

Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”

She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”

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

Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

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

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

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

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

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