Clinical Endocrinology News

After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

This transcript has been edited for clarity.

Recently, the Supreme Court of the United States struck down the use of affirmative action in admissions to colleges, universities, medical schools, and nursing schools. This has led to an enormous amount of worry and concern, particularly in medical school admissions in the world I’m in, where people start to say that diversity matters. Diversity is important.

I know many deans of medical schools immediately sent out messages of reassurance to their students, saying New York University or Stanford or Harvard or Minnesota or Case Western is still deeply concerned about diversity, and we’re going to do what we can to preserve attention to diversity.

I’ve served on admissions at a number of schools over the years for med school. I understand – and have been told – that diversity is important, and according to the Supreme Court, not explicitly by race. There are obviously many variables to take into account when trying to keep diversity at the forefront of admissions.

At the schools I’ve been at, including Columbia, NYU, University of Pittsburgh, University of Minnesota, and University of Pennsylvania, there are plenty of qualified students. Happily, we’ve always been engaged in some effort to try and whittle down the class to the size that we can manage and accept, and many qualified students don’t get admitted.

The first order of business for me is not to worry about how to maintain diversity. It’s to recognize that we need more doctors, nurses, and mental health care providers. I will, in a second, say a few words about diversity and where it fits into admissions, but I want to make the point clearly that what we should be doing is trying to expand the pool of students who are going to become doctors, nurses, mental health care providers, and social workers.

There are too many early retirements. We don’t have the person power we need to manage the health care challenges of an aging population. Let’s not get lost in arguing about what characteristics ought to get you into the finest medical schools. Let’s realize that we have to expand the number of schools we have.

We better be working pretty hard to expand our physician assistant programs, to make sure that we give full authority to qualified dentists and nurses who can help deliver some clinical care. We need more folks. That’s really where the battle ought to be: How do we get that done and how do we get it done quickly, not arguing about who’s in, who’s out, and why.

That said, diversity to me has never meant just race. I’m always interested in gender orientation, disability, and geographic input. Sometimes in decisions that you’re looking at, when I have students in front of me, they tell me they play a musical instrument or about the obstacles they had to overcome to get to medical school. Some of them will say they were involved in 4-H and did rodeo in high school or junior high school, which makes them a diverse potential student with characteristics that maybe some others don’t bring.

I’m not against diversity. I think having a rich set of experiences in any class – medicine, nursing, whatever it’s going to be – is beneficial to the students. They learn from each other. It is sometimes said that it’s also good for patients. I’m a little less excited about that, because I think our training goal should be to make every medical student and nursing student qualified to treat anybody.

I don’t think that, just because you’re Latinx or gay, that’s going to make a gay patient feel better. I think we should teach our students how to give care to everybody that they encounter. They shouldn’t have to match up characteristics to feel like they’re going to get quality care. That isn’t the right reason.

Diversity is important, I think, to teach our students, to broaden our research, and to make sure that bias doesn’t creep in to how we teach, learn, or behave. When you have a diverse set of providers, they can call that out and be on the alert for it, and that’s very important.

I also believe that we should think widely and broadly about diversity. Maybe race is out, but certainly other experiences related to income, background, struggle that got you to the point where you’re applying to medical school, motivation, the kinds of experiences you might have had caring for an elderly person, dealing with a disability or learning disability, and trying to overcome, let’s say, going to school in a poor area with not such a wonderful school, really help in terms of forming professionalism, empathy, and a caring point of view.

To me, the main goal is to expand our workforce. The secondary goal is to stay diverse, because we get better providers when we do so.

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

This transcript has been edited for clarity.

Recently, the Supreme Court of the United States struck down the use of affirmative action in admissions to colleges, universities, medical schools, and nursing schools. This has led to an enormous amount of worry and concern, particularly in medical school admissions in the world I’m in, where people start to say that diversity matters. Diversity is important.

I know many deans of medical schools immediately sent out messages of reassurance to their students, saying New York University or Stanford or Harvard or Minnesota or Case Western is still deeply concerned about diversity, and we’re going to do what we can to preserve attention to diversity.

I’ve served on admissions at a number of schools over the years for med school. I understand – and have been told – that diversity is important, and according to the Supreme Court, not explicitly by race. There are obviously many variables to take into account when trying to keep diversity at the forefront of admissions.

At the schools I’ve been at, including Columbia, NYU, University of Pittsburgh, University of Minnesota, and University of Pennsylvania, there are plenty of qualified students. Happily, we’ve always been engaged in some effort to try and whittle down the class to the size that we can manage and accept, and many qualified students don’t get admitted.

The first order of business for me is not to worry about how to maintain diversity. It’s to recognize that we need more doctors, nurses, and mental health care providers. I will, in a second, say a few words about diversity and where it fits into admissions, but I want to make the point clearly that what we should be doing is trying to expand the pool of students who are going to become doctors, nurses, mental health care providers, and social workers.

There are too many early retirements. We don’t have the person power we need to manage the health care challenges of an aging population. Let’s not get lost in arguing about what characteristics ought to get you into the finest medical schools. Let’s realize that we have to expand the number of schools we have.

We better be working pretty hard to expand our physician assistant programs, to make sure that we give full authority to qualified dentists and nurses who can help deliver some clinical care. We need more folks. That’s really where the battle ought to be: How do we get that done and how do we get it done quickly, not arguing about who’s in, who’s out, and why.

That said, diversity to me has never meant just race. I’m always interested in gender orientation, disability, and geographic input. Sometimes in decisions that you’re looking at, when I have students in front of me, they tell me they play a musical instrument or about the obstacles they had to overcome to get to medical school. Some of them will say they were involved in 4-H and did rodeo in high school or junior high school, which makes them a diverse potential student with characteristics that maybe some others don’t bring.

I’m not against diversity. I think having a rich set of experiences in any class – medicine, nursing, whatever it’s going to be – is beneficial to the students. They learn from each other. It is sometimes said that it’s also good for patients. I’m a little less excited about that, because I think our training goal should be to make every medical student and nursing student qualified to treat anybody.

I don’t think that, just because you’re Latinx or gay, that’s going to make a gay patient feel better. I think we should teach our students how to give care to everybody that they encounter. They shouldn’t have to match up characteristics to feel like they’re going to get quality care. That isn’t the right reason.

Diversity is important, I think, to teach our students, to broaden our research, and to make sure that bias doesn’t creep in to how we teach, learn, or behave. When you have a diverse set of providers, they can call that out and be on the alert for it, and that’s very important.

I also believe that we should think widely and broadly about diversity. Maybe race is out, but certainly other experiences related to income, background, struggle that got you to the point where you’re applying to medical school, motivation, the kinds of experiences you might have had caring for an elderly person, dealing with a disability or learning disability, and trying to overcome, let’s say, going to school in a poor area with not such a wonderful school, really help in terms of forming professionalism, empathy, and a caring point of view.

To me, the main goal is to expand our workforce. The secondary goal is to stay diverse, because we get better providers when we do so.

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

This transcript has been edited for clarity.

Recently, the Supreme Court of the United States struck down the use of affirmative action in admissions to colleges, universities, medical schools, and nursing schools. This has led to an enormous amount of worry and concern, particularly in medical school admissions in the world I’m in, where people start to say that diversity matters. Diversity is important.

I know many deans of medical schools immediately sent out messages of reassurance to their students, saying New York University or Stanford or Harvard or Minnesota or Case Western is still deeply concerned about diversity, and we’re going to do what we can to preserve attention to diversity.

I’ve served on admissions at a number of schools over the years for med school. I understand – and have been told – that diversity is important, and according to the Supreme Court, not explicitly by race. There are obviously many variables to take into account when trying to keep diversity at the forefront of admissions.

At the schools I’ve been at, including Columbia, NYU, University of Pittsburgh, University of Minnesota, and University of Pennsylvania, there are plenty of qualified students. Happily, we’ve always been engaged in some effort to try and whittle down the class to the size that we can manage and accept, and many qualified students don’t get admitted.

The first order of business for me is not to worry about how to maintain diversity. It’s to recognize that we need more doctors, nurses, and mental health care providers. I will, in a second, say a few words about diversity and where it fits into admissions, but I want to make the point clearly that what we should be doing is trying to expand the pool of students who are going to become doctors, nurses, mental health care providers, and social workers.

There are too many early retirements. We don’t have the person power we need to manage the health care challenges of an aging population. Let’s not get lost in arguing about what characteristics ought to get you into the finest medical schools. Let’s realize that we have to expand the number of schools we have.

We better be working pretty hard to expand our physician assistant programs, to make sure that we give full authority to qualified dentists and nurses who can help deliver some clinical care. We need more folks. That’s really where the battle ought to be: How do we get that done and how do we get it done quickly, not arguing about who’s in, who’s out, and why.

That said, diversity to me has never meant just race. I’m always interested in gender orientation, disability, and geographic input. Sometimes in decisions that you’re looking at, when I have students in front of me, they tell me they play a musical instrument or about the obstacles they had to overcome to get to medical school. Some of them will say they were involved in 4-H and did rodeo in high school or junior high school, which makes them a diverse potential student with characteristics that maybe some others don’t bring.

I’m not against diversity. I think having a rich set of experiences in any class – medicine, nursing, whatever it’s going to be – is beneficial to the students. They learn from each other. It is sometimes said that it’s also good for patients. I’m a little less excited about that, because I think our training goal should be to make every medical student and nursing student qualified to treat anybody.

I don’t think that, just because you’re Latinx or gay, that’s going to make a gay patient feel better. I think we should teach our students how to give care to everybody that they encounter. They shouldn’t have to match up characteristics to feel like they’re going to get quality care. That isn’t the right reason.

Diversity is important, I think, to teach our students, to broaden our research, and to make sure that bias doesn’t creep in to how we teach, learn, or behave. When you have a diverse set of providers, they can call that out and be on the alert for it, and that’s very important.

I also believe that we should think widely and broadly about diversity. Maybe race is out, but certainly other experiences related to income, background, struggle that got you to the point where you’re applying to medical school, motivation, the kinds of experiences you might have had caring for an elderly person, dealing with a disability or learning disability, and trying to overcome, let’s say, going to school in a poor area with not such a wonderful school, really help in terms of forming professionalism, empathy, and a caring point of view.

To me, the main goal is to expand our workforce. The secondary goal is to stay diverse, because we get better providers when we do so.

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

A noteworthy shift recently occurred in the field of hepatology, but it didn’t stem from a clinical trial or medical finding. Instead, the change arose from a matter of semantics.

In a special article published online in the journal Hepatology, a diverse international consensus group introduced new terminology for one of the world’s most rapidly growing diseases.

The term nonalcoholic fatty liver disease (NAFLD) was to be officially retired, replaced with a more precise and descriptive term – metabolic dysfunction–associated steatotic liver disease (MASLD).

In addition, steatotic liver disease (SLD) would be used as an umbrella term encompassing both MASLD and a new subcategory, MetALD, for individuals with MASLD whose alcohol consumption ranges from 140 to 350 g/wk for women and from 210 to 420 g/wk for men. Nonalcoholic steatohepatitis (NASH) would be known as metabolic dysfunction-associated steatohepatitis (MASH).

The new terminology represents small changes with significant implications, especially for patients with MetALD, said the NAFLD nomenclature consensus group’s co-lead, Mary E. Rinella, MD, professor of medicine at University of Chicago and director of the metabolic and fatty liver program at University of Chicago Hospitals.

“The only really new thing we did is identify a group of people who meet criteria for MASLD and also drink more than the allowable limit,” she said. “There are tons of these patients who were not being considered before. Now they’re in a category by themselves, where they are going to be able to be studied and better understood.”
 

Why make a change?

The unveiling of the new nomenclature marked the culmination of 3 years of dedicated work that was built upon decades of growing understanding about the pathophysiologic underpinnings of these disease states.

The terms NAFLD and NASH emerged in 1980 to describe patients with chronic liver disease who denied excessive alcohol consumption. However, in the past 2 decades, it became increasingly evident that the existing terminology was inadequate, the consensus group’s co-lead, Philip Newsome, PhD, said in an interview.

“There was a strong desire for a name that describes what the condition is, rather than what it isn’t; avoiding use of stigmatizing terms, such as fatty and alcoholic; and finally, a nomenclature that could recognize the coexistence of conditions,” said Dr. Newsome, former secretary general of the European Association for the Study of the Liver (EASL), and director of the Centre for Liver and Gastrointestinal Research at the University of Birmingham, England.

These forces, combined with the recognition that NAFLD and alcohol-related liver disease shared biological processes, created momentum for change.

The idea gained traction with a 2020 article that proposed “MAFLD” as a more suitable term because it would link the disease with its known cardiometabolic risks, Dr. Rinella explained.

“We thought that paper was going to be the beginning of a conversation, but what happened instead is it became a full-court press,” Dr. Rinella said.

Dr. Rinella and Dr. Newsome then spearheaded a study to determine whether content experts and patients supported change. The process was led by three prominent international liver societies: EASL, the American Association for the Study of Liver Diseases (AASLD), and the Asociación Latinoamericana para el Estudio del Hígado. The organizations received input from 236 panelists from 56 countries, reflecting the diverse voices essential for addressing a disease with an expanding global prevalence rate.

In this globalized world, you cannot make a decision from on high and then expect everybody to just adopt it, Dr. Rinella noted.

The panel utilized a modified Delphi consensus approach, necessitating a supermajority of respondents (67%) to vote in favor of the changes. Seventy-four percent felt that the current nomenclature was sufficiently flawed to consider a name change, and 89% preferred terminology that describes the underlying cause of the disease. A supermajority felt that having “metabolic disease or dysfunction” in the name would help patients better understand their disease (72%) and help health care professionals better explain or understand the disease (80%).

The participants settled on the new terminology, and the study resulted in a conclusion: “The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification.”

It was by no means a simple or straightforward task, according to Dr. Rinella. “Anytime you have a contentious issue and you engage a broad range of stakeholders, many of which you know are in disagreement, you’re going to have a difficult time reaching consensus,” she said.
 

Reassuring reluctant adopters

The backing of international liver societies will be crucial to ensuring the smooth and relatively swift adoption of the new nomenclature. The AASLD announced in July that it would begin this process by holding conversations with key stakeholders, including the Food and Drug Administration, patient organizations, and pharmaceutical industry representatives.

“By engaging external groups, we have gained valuable insights into potential roadblocks or barriers that may impede the full implementation of the new MASLD nomenclature,” AASLD President Norah Terrault, MD, MPH, FAASLD, told this news organization. “Knowing the types of issues they face will allow us to build an implementation plan that will help guide the field through adoption.”

Even with buy-in from key stakeholders, implementing the changes will be no small feat. It’s a “vast undertaking” that may result in short-term frustrations for some groups, Dr. Terrault said.

“For instance, researchers whose work commenced under the old nomenclature may not be able to alter their research papers and will need to publish under the old nomenclature, which may impact which journals their research could be published in,” she said. “Some patient advocacy groups may have the old nomenclature in their names, resulting in a need to rebrand and revise their educational resources. Patient materials need to be updated. Primary care professionals need to be educated. The list goes on.”

These changes demand both patience and time, Dr. Terrault said. This applies to those tasked with persuading colleagues and patients, as well as clinicians, many of whom have already expressed some resistance to the updated terminology.

The panel anticipated pushback from clinicians who still advocate for NAFLD. However, Dr. Rinella countered that a diagnosis of MASLD requires only one cardiometabolic risk factor and has 99% overlap in most populations. In contrast, the MAFLD diagnostic criteria put forward in 2020 proposed even more restrictive cardiometabolic criteria and greater tolerance for alcohol consumption and would alter the disease natural history, she said.

Concerns have also been raised that replacing NAFLD with MASLD might complicate the value of prior research efforts. However, this should not be a cause for concern, as extensive examination across multiple populations has demonstrated near complete overlap between the two definitions, Dr. Rinella said. Biomarker development, natural history studies, and drug development research will remain unaffected, she said.

Some detractors argue that the term “fatty” is sufficiently descriptive and not stigmatizing. However, Dr. Newsome contends that the panel’s research unequivocally disproves this notion.

“Our Delphi process demonstrated very clearly that over 50% felt it was stigmatizing, and in particular, there were clear supportive views for this change from many patient groups,” he noted. “The new nomenclature empowers patients to explain what the condition means without the use of emotional language.”
 

An opportunity to improve care

One compelling way to persuade reluctant adopters of the new nomenclature’s value is to highlight the opportunities it presents.

The updated terminology opens avenues for research and clinical improvements for patients who meet MASLD criteria and consume alcohol at higher levels (MetALD), Dr. Newsome said.

“There are questions about the relative contribution of these two factors to liver injury, and I see this as an opportunity to explore this area further,” he said.

Hepatologists should embrace this change as a means of increasing awareness regarding the metabolic origins of the disease, Dr. Rinella said. This, in turn, will help identify more patients who require treatment but who are currently overlooked by the existing system, she noted.

“Right now, only around 1% of people with advanced disease are being identified by primary care physicians,” she said. “Hopefully, by elevating the role of metabolic disease, primary care physicians, endocrinologists, and gastroenterologists will be able to identify more patients and bring them to care before they develop cirrhosis.”

Such an outcome would signify much more than a mere semantic shift; it would represent a major advancement in the diagnosis and management of the disease.

A version of this article appeared on Medscape.com.

A noteworthy shift recently occurred in the field of hepatology, but it didn’t stem from a clinical trial or medical finding. Instead, the change arose from a matter of semantics.

In a special article published online in the journal Hepatology, a diverse international consensus group introduced new terminology for one of the world’s most rapidly growing diseases.

The term nonalcoholic fatty liver disease (NAFLD) was to be officially retired, replaced with a more precise and descriptive term – metabolic dysfunction–associated steatotic liver disease (MASLD).

In addition, steatotic liver disease (SLD) would be used as an umbrella term encompassing both MASLD and a new subcategory, MetALD, for individuals with MASLD whose alcohol consumption ranges from 140 to 350 g/wk for women and from 210 to 420 g/wk for men. Nonalcoholic steatohepatitis (NASH) would be known as metabolic dysfunction-associated steatohepatitis (MASH).

The new terminology represents small changes with significant implications, especially for patients with MetALD, said the NAFLD nomenclature consensus group’s co-lead, Mary E. Rinella, MD, professor of medicine at University of Chicago and director of the metabolic and fatty liver program at University of Chicago Hospitals.

“The only really new thing we did is identify a group of people who meet criteria for MASLD and also drink more than the allowable limit,” she said. “There are tons of these patients who were not being considered before. Now they’re in a category by themselves, where they are going to be able to be studied and better understood.”
 

Why make a change?

The unveiling of the new nomenclature marked the culmination of 3 years of dedicated work that was built upon decades of growing understanding about the pathophysiologic underpinnings of these disease states.

The terms NAFLD and NASH emerged in 1980 to describe patients with chronic liver disease who denied excessive alcohol consumption. However, in the past 2 decades, it became increasingly evident that the existing terminology was inadequate, the consensus group’s co-lead, Philip Newsome, PhD, said in an interview.

“There was a strong desire for a name that describes what the condition is, rather than what it isn’t; avoiding use of stigmatizing terms, such as fatty and alcoholic; and finally, a nomenclature that could recognize the coexistence of conditions,” said Dr. Newsome, former secretary general of the European Association for the Study of the Liver (EASL), and director of the Centre for Liver and Gastrointestinal Research at the University of Birmingham, England.

These forces, combined with the recognition that NAFLD and alcohol-related liver disease shared biological processes, created momentum for change.

The idea gained traction with a 2020 article that proposed “MAFLD” as a more suitable term because it would link the disease with its known cardiometabolic risks, Dr. Rinella explained.

“We thought that paper was going to be the beginning of a conversation, but what happened instead is it became a full-court press,” Dr. Rinella said.

Dr. Rinella and Dr. Newsome then spearheaded a study to determine whether content experts and patients supported change. The process was led by three prominent international liver societies: EASL, the American Association for the Study of Liver Diseases (AASLD), and the Asociación Latinoamericana para el Estudio del Hígado. The organizations received input from 236 panelists from 56 countries, reflecting the diverse voices essential for addressing a disease with an expanding global prevalence rate.

In this globalized world, you cannot make a decision from on high and then expect everybody to just adopt it, Dr. Rinella noted.

The panel utilized a modified Delphi consensus approach, necessitating a supermajority of respondents (67%) to vote in favor of the changes. Seventy-four percent felt that the current nomenclature was sufficiently flawed to consider a name change, and 89% preferred terminology that describes the underlying cause of the disease. A supermajority felt that having “metabolic disease or dysfunction” in the name would help patients better understand their disease (72%) and help health care professionals better explain or understand the disease (80%).

The participants settled on the new terminology, and the study resulted in a conclusion: “The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification.”

It was by no means a simple or straightforward task, according to Dr. Rinella. “Anytime you have a contentious issue and you engage a broad range of stakeholders, many of which you know are in disagreement, you’re going to have a difficult time reaching consensus,” she said.
 

Reassuring reluctant adopters

The backing of international liver societies will be crucial to ensuring the smooth and relatively swift adoption of the new nomenclature. The AASLD announced in July that it would begin this process by holding conversations with key stakeholders, including the Food and Drug Administration, patient organizations, and pharmaceutical industry representatives.

“By engaging external groups, we have gained valuable insights into potential roadblocks or barriers that may impede the full implementation of the new MASLD nomenclature,” AASLD President Norah Terrault, MD, MPH, FAASLD, told this news organization. “Knowing the types of issues they face will allow us to build an implementation plan that will help guide the field through adoption.”

Even with buy-in from key stakeholders, implementing the changes will be no small feat. It’s a “vast undertaking” that may result in short-term frustrations for some groups, Dr. Terrault said.

“For instance, researchers whose work commenced under the old nomenclature may not be able to alter their research papers and will need to publish under the old nomenclature, which may impact which journals their research could be published in,” she said. “Some patient advocacy groups may have the old nomenclature in their names, resulting in a need to rebrand and revise their educational resources. Patient materials need to be updated. Primary care professionals need to be educated. The list goes on.”

These changes demand both patience and time, Dr. Terrault said. This applies to those tasked with persuading colleagues and patients, as well as clinicians, many of whom have already expressed some resistance to the updated terminology.

The panel anticipated pushback from clinicians who still advocate for NAFLD. However, Dr. Rinella countered that a diagnosis of MASLD requires only one cardiometabolic risk factor and has 99% overlap in most populations. In contrast, the MAFLD diagnostic criteria put forward in 2020 proposed even more restrictive cardiometabolic criteria and greater tolerance for alcohol consumption and would alter the disease natural history, she said.

Concerns have also been raised that replacing NAFLD with MASLD might complicate the value of prior research efforts. However, this should not be a cause for concern, as extensive examination across multiple populations has demonstrated near complete overlap between the two definitions, Dr. Rinella said. Biomarker development, natural history studies, and drug development research will remain unaffected, she said.

Some detractors argue that the term “fatty” is sufficiently descriptive and not stigmatizing. However, Dr. Newsome contends that the panel’s research unequivocally disproves this notion.

“Our Delphi process demonstrated very clearly that over 50% felt it was stigmatizing, and in particular, there were clear supportive views for this change from many patient groups,” he noted. “The new nomenclature empowers patients to explain what the condition means without the use of emotional language.”
 

An opportunity to improve care

One compelling way to persuade reluctant adopters of the new nomenclature’s value is to highlight the opportunities it presents.

The updated terminology opens avenues for research and clinical improvements for patients who meet MASLD criteria and consume alcohol at higher levels (MetALD), Dr. Newsome said.

“There are questions about the relative contribution of these two factors to liver injury, and I see this as an opportunity to explore this area further,” he said.

Hepatologists should embrace this change as a means of increasing awareness regarding the metabolic origins of the disease, Dr. Rinella said. This, in turn, will help identify more patients who require treatment but who are currently overlooked by the existing system, she noted.

“Right now, only around 1% of people with advanced disease are being identified by primary care physicians,” she said. “Hopefully, by elevating the role of metabolic disease, primary care physicians, endocrinologists, and gastroenterologists will be able to identify more patients and bring them to care before they develop cirrhosis.”

Such an outcome would signify much more than a mere semantic shift; it would represent a major advancement in the diagnosis and management of the disease.

A version of this article appeared on Medscape.com.

A noteworthy shift recently occurred in the field of hepatology, but it didn’t stem from a clinical trial or medical finding. Instead, the change arose from a matter of semantics.

In a special article published online in the journal Hepatology, a diverse international consensus group introduced new terminology for one of the world’s most rapidly growing diseases.

The term nonalcoholic fatty liver disease (NAFLD) was to be officially retired, replaced with a more precise and descriptive term – metabolic dysfunction–associated steatotic liver disease (MASLD).

In addition, steatotic liver disease (SLD) would be used as an umbrella term encompassing both MASLD and a new subcategory, MetALD, for individuals with MASLD whose alcohol consumption ranges from 140 to 350 g/wk for women and from 210 to 420 g/wk for men. Nonalcoholic steatohepatitis (NASH) would be known as metabolic dysfunction-associated steatohepatitis (MASH).

The new terminology represents small changes with significant implications, especially for patients with MetALD, said the NAFLD nomenclature consensus group’s co-lead, Mary E. Rinella, MD, professor of medicine at University of Chicago and director of the metabolic and fatty liver program at University of Chicago Hospitals.

“The only really new thing we did is identify a group of people who meet criteria for MASLD and also drink more than the allowable limit,” she said. “There are tons of these patients who were not being considered before. Now they’re in a category by themselves, where they are going to be able to be studied and better understood.”
 

Why make a change?

The unveiling of the new nomenclature marked the culmination of 3 years of dedicated work that was built upon decades of growing understanding about the pathophysiologic underpinnings of these disease states.

The terms NAFLD and NASH emerged in 1980 to describe patients with chronic liver disease who denied excessive alcohol consumption. However, in the past 2 decades, it became increasingly evident that the existing terminology was inadequate, the consensus group’s co-lead, Philip Newsome, PhD, said in an interview.

“There was a strong desire for a name that describes what the condition is, rather than what it isn’t; avoiding use of stigmatizing terms, such as fatty and alcoholic; and finally, a nomenclature that could recognize the coexistence of conditions,” said Dr. Newsome, former secretary general of the European Association for the Study of the Liver (EASL), and director of the Centre for Liver and Gastrointestinal Research at the University of Birmingham, England.

These forces, combined with the recognition that NAFLD and alcohol-related liver disease shared biological processes, created momentum for change.

The idea gained traction with a 2020 article that proposed “MAFLD” as a more suitable term because it would link the disease with its known cardiometabolic risks, Dr. Rinella explained.

“We thought that paper was going to be the beginning of a conversation, but what happened instead is it became a full-court press,” Dr. Rinella said.

Dr. Rinella and Dr. Newsome then spearheaded a study to determine whether content experts and patients supported change. The process was led by three prominent international liver societies: EASL, the American Association for the Study of Liver Diseases (AASLD), and the Asociación Latinoamericana para el Estudio del Hígado. The organizations received input from 236 panelists from 56 countries, reflecting the diverse voices essential for addressing a disease with an expanding global prevalence rate.

In this globalized world, you cannot make a decision from on high and then expect everybody to just adopt it, Dr. Rinella noted.

The panel utilized a modified Delphi consensus approach, necessitating a supermajority of respondents (67%) to vote in favor of the changes. Seventy-four percent felt that the current nomenclature was sufficiently flawed to consider a name change, and 89% preferred terminology that describes the underlying cause of the disease. A supermajority felt that having “metabolic disease or dysfunction” in the name would help patients better understand their disease (72%) and help health care professionals better explain or understand the disease (80%).

The participants settled on the new terminology, and the study resulted in a conclusion: “The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification.”

It was by no means a simple or straightforward task, according to Dr. Rinella. “Anytime you have a contentious issue and you engage a broad range of stakeholders, many of which you know are in disagreement, you’re going to have a difficult time reaching consensus,” she said.
 

Reassuring reluctant adopters

The backing of international liver societies will be crucial to ensuring the smooth and relatively swift adoption of the new nomenclature. The AASLD announced in July that it would begin this process by holding conversations with key stakeholders, including the Food and Drug Administration, patient organizations, and pharmaceutical industry representatives.

“By engaging external groups, we have gained valuable insights into potential roadblocks or barriers that may impede the full implementation of the new MASLD nomenclature,” AASLD President Norah Terrault, MD, MPH, FAASLD, told this news organization. “Knowing the types of issues they face will allow us to build an implementation plan that will help guide the field through adoption.”

Even with buy-in from key stakeholders, implementing the changes will be no small feat. It’s a “vast undertaking” that may result in short-term frustrations for some groups, Dr. Terrault said.

“For instance, researchers whose work commenced under the old nomenclature may not be able to alter their research papers and will need to publish under the old nomenclature, which may impact which journals their research could be published in,” she said. “Some patient advocacy groups may have the old nomenclature in their names, resulting in a need to rebrand and revise their educational resources. Patient materials need to be updated. Primary care professionals need to be educated. The list goes on.”

These changes demand both patience and time, Dr. Terrault said. This applies to those tasked with persuading colleagues and patients, as well as clinicians, many of whom have already expressed some resistance to the updated terminology.

The panel anticipated pushback from clinicians who still advocate for NAFLD. However, Dr. Rinella countered that a diagnosis of MASLD requires only one cardiometabolic risk factor and has 99% overlap in most populations. In contrast, the MAFLD diagnostic criteria put forward in 2020 proposed even more restrictive cardiometabolic criteria and greater tolerance for alcohol consumption and would alter the disease natural history, she said.

Concerns have also been raised that replacing NAFLD with MASLD might complicate the value of prior research efforts. However, this should not be a cause for concern, as extensive examination across multiple populations has demonstrated near complete overlap between the two definitions, Dr. Rinella said. Biomarker development, natural history studies, and drug development research will remain unaffected, she said.

Some detractors argue that the term “fatty” is sufficiently descriptive and not stigmatizing. However, Dr. Newsome contends that the panel’s research unequivocally disproves this notion.

“Our Delphi process demonstrated very clearly that over 50% felt it was stigmatizing, and in particular, there were clear supportive views for this change from many patient groups,” he noted. “The new nomenclature empowers patients to explain what the condition means without the use of emotional language.”
 

An opportunity to improve care

One compelling way to persuade reluctant adopters of the new nomenclature’s value is to highlight the opportunities it presents.

The updated terminology opens avenues for research and clinical improvements for patients who meet MASLD criteria and consume alcohol at higher levels (MetALD), Dr. Newsome said.

“There are questions about the relative contribution of these two factors to liver injury, and I see this as an opportunity to explore this area further,” he said.

Hepatologists should embrace this change as a means of increasing awareness regarding the metabolic origins of the disease, Dr. Rinella said. This, in turn, will help identify more patients who require treatment but who are currently overlooked by the existing system, she noted.

“Right now, only around 1% of people with advanced disease are being identified by primary care physicians,” she said. “Hopefully, by elevating the role of metabolic disease, primary care physicians, endocrinologists, and gastroenterologists will be able to identify more patients and bring them to care before they develop cirrhosis.”

Such an outcome would signify much more than a mere semantic shift; it would represent a major advancement in the diagnosis and management of the disease.

A version of this article appeared on Medscape.com.

PHILADELPHIA – Women with obesity experience greater menopausal symptoms but substantially less relief from hormone therapy (HT) than women without obesity, according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).

More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said

“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”

Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m² or greater.

The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).

There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.

Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).

The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
 

Women with obesity are undertreated

Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.

“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”

Mayo Clinic

Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.

“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.

Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.

Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.

Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.

The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.

PHILADELPHIA – Women with obesity experience greater menopausal symptoms but substantially less relief from hormone therapy (HT) than women without obesity, according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).

More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said

“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”

Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m² or greater.

The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).

There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.

Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).

The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
 

Women with obesity are undertreated

Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.

“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”

Mayo Clinic

Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.

“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.

Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.

Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.

Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.

The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.

PHILADELPHIA – Women with obesity experience greater menopausal symptoms but substantially less relief from hormone therapy (HT) than women without obesity, according to a small, retrospective study presented at the annual meeting of the Menopause Society (formerly the North American Menopause Society).

More than 40% of women over age 40 in the United States have obesity, presenter Anita Pershad, MD, an ob.gyn. medical resident at Eastern Virginia Medical School, Norfolk, told attendees. Yet most of the large-scale studies investigating perimenopausal and postmenopausal hormone therapy included participants without major medical comorbidities, so little data exist on how effectively HT works in women with these comorbidities, she said

“The main takeaway of our study is that obesity may worsen a woman’s menopausal symptoms and limit the amount of relief she gets from hormone therapy,” Dr. Pershad said in an interview. “It remains unclear if hormone therapy is less effective in women with obesity overall, or if the expected efficacy can be achieved with alternative design and administration routes. A potential mechanism of action for the observed decreased effect could be due to adipose tissue acting as a heat insulator, promoting the effects of vasomotor symptoms.”

Dr. Pershad and her colleagues conducted a retrospective review of the medical records of 119 patients who presented to a menopause clinic at a Midsouth urban academic medical center between July 2018 and December 2022. Obesity was defined as having a body mass index (BMI) of 30 kg/m² or greater.

The patients with and without obesity were similar in terms of age, duration of menopause, use of hormone therapy, and therapy acceptance, but patients with obesity were more likely to identify themselves as Black (71% vs. 40%). Women with obesity were also significantly more likely than women without obesity to report vasomotor symptoms (74% vs. 45%, P = .002), genitourinary/vulvovaginal symptoms (60% vs. 21%, P < .001), mood disturbances (11% vs. 0%, P = .18), and decreased libido (29% vs. 11%, P = .017).

There were no significant differences in comorbidities between women with and without obesity, and among women who received systemic or localized HT, the same standard dosing was used for both groups.

Women with obesity were much less likely to see a satisfying reduction in their menopausal symptoms than women without obesity (odds ratio 0.07, 95% confidence interval, 0.01-0.64; P = .006), though the subgroups for each category of HT were small. Among the 20 women receiving systemic hormone therapy, only 1 of the 12 with obesity (8.3%) reported improvement in symptoms, compared with 7 of the 8 women without obesity (88%; P = .0004). Among 33 women using localized hormone therapy, 46% of the 24 women with obesity vs. 89% of the 9 women without obesity experienced symptom improvement (P = .026).

The proportions of women reporting relief from only lifestyle modifications or from nonhormonal medications, such as SSRIs/SNRIs, trazodone, and clonidine, were not statistically different. There were 33 women who relied only on lifestyle modifications, with 31% of the 16 women with obesity and 59% of the 17 women without obesity reporting improvement in their symptoms (P = .112). Similarly, among the 33 women using nonhormonal medications, 75% of the 20 women with obesity and 77% of the 13 women without obesity experienced relief (P = .9).
 

Women with obesity are undertreated

Dr. Pershad emphasized the need to improve care and counseling for diverse patients seeking treatment for menopausal symptoms.

“More research is needed to examine how women with medical comorbidities are uniquely impacted by menopause and respond to therapies,” Dr. Pershad said in an interview. “This can be achieved by actively including more diverse patient populations in women’s health studies, burdened by the social determinants of health and medical comorbidities such as obesity.”

Mayo Clinic

Stephanie S. Faubion, MD, MBA, director for Mayo Clinic’s Center for Women’s Health, Rochester, Minn., and medical director for The Menopause Society, was not surprised by the findings, particularly given that women with obesity tend to have more hot flashes and night sweats as a result of their extra weight. However, dosage data was not adjusted for BMI in the study and data on hormone levels was unavailable, she said, so it’s difficult to determine from the data whether HT was less effective for women with obesity or whether they were underdosed.

“I think women with obesity are undertreated,” Dr. Faubion said in an interview. “My guess is people are afraid. Women with obesity also may have other comorbidities,” such as hypertension and diabetes, she said, and “the greater the number of cardiovascular risk factors, the higher risk hormone therapy is.” Providers may therefore be leery of prescribing HT or prescribing it at an appropriately high enough dose to treat menopausal symptoms.

Common practice is to start patients at the lowest dose and titrate up according to symptoms, but “if people are afraid of it, they’re going to start the lowest dose” and may not increase it, Dr. Faubion said. She noted that other nonhormonal options are available, though providers should be conscientious about selecting ones whose adverse events do not include weight gain.

Although the study focused on an understudied population within hormone therapy research, the study was limited by its small size, low overall use of hormone therapy, recall bias, and the researchers’ inability to control for other medications the participants may have been taking.

Dr. Pershad said she is continuing research to try to identify the mechanisms underlying the reduced efficacy in women with obesity.

The research did not use any external funding. Dr. Pershad had no industry disclosures, but her colleagues reported honoraria from or speaking for TherapeuticsMD, Astella Pharma, Scynexis, Pharmavite, and Pfizer. Dr. Faubion had no disclosures.

With physicians under increasing pressure to see more patients in shorter office visits, developing a social media presence may offer valuable opportunities to connect with patients, explain procedures, combat misinformation, talk through a published article, and even share a joke or meme.

But there are caveats for doctors posting on social media platforms. This news organization spoke to four doctors who successfully use social media. Here is what they want you to know before you post – and how to make your posts personable and helpful to patients and your practice simultaneously.
 

Use social media for the right reasons

While you’re under no obligation to build a social media presence, if you’re going to do it, be sure your intentions are solid, said Don S. Dizon, MD, professor of medicine and professor of surgery at Brown University, Providence, R.I. Dr. Dizon, as @DoctorDon, has 44,700 TikTok followers and uses the platform to answer cancer-related questions.

“It should be your altruism that motivates you to post,” said Dr. Dizon, who is also associate director of community outreach and engagement at the Legorreta Cancer Center in Providence, R.I., and director of medical oncology at Rhode Island Hospital. “What we can do for society at large is to provide our input into issues, add informed opinions where there’s controversy, and address misinformation.”

If you don’t know where to start, consider seeking a digital mentor to talk through your options.

“You may never meet this person, but you should choose them if you like their style, their content, their delivery, and their perspective,” Dr. Dizon said. “Find another doctor out there on social media whom you feel you can emulate. Take your time, too. Soon enough, you’ll develop your own style and your own online persona.”
 

Post clear, accurate information

If you want to be lighthearted on social media, that’s your choice. But Jennifer Trachtenberg, a pediatrician with nearly 7,000 Instagram followers in New York who posts as @askdrjen, prefers to offer vaccine scheduling tips, alert parents about COVID-19 rates, and offer advice on cold and flu prevention.

“Right now, I’m mainly doing this to educate patients and make them aware of topics that I think are important and that I see my patients needing more information on,” she said. “We have to be clear: People take what we say seriously. So, while it’s important to be relatable, it’s even more important to share evidence-based information.”
 

Many patients get their information on social media

While patients once came to the doctor armed with information sourced via “Doctor Google,” today, just as many patients use social media to learn about their condition or the medications they’re taking.

Unfortunately, a recent Ohio State University, Columbus, study found that the majority of gynecologic cancer advice on TikTok, for example, was either misleading or inaccurate.

“This misinformation should be a motivator for physicians to explore the social media space,” Dr. Dizon said. “Our voices need to be on there.”
 

Break down barriers – and make connections

Mike Natter, MD, an endocrinologist in New York, has type 1 diabetes. This informs his work – and his life – and he’s passionate about sharing it with his 117,000 followers as @mike.natter on Instagram.

“A lot of type 1s follow me, so there’s an advocacy component to what I do,” he said. “I enjoy being able to raise awareness and keep people up to date on the newest research and treatment.”

But that’s not all: Dr. Natter is also an artist who went to art school before he went to medical school, and his account is rife with his cartoons and illustrations about everything from valvular disease to diabetic ketoacidosis.

“I found that I was drawing a lot of my notes in medical school,” he said. “When I drew my notes, I did quite well, and I think that using art and illustration is a great tool. It breaks down barriers and makes health information all the more accessible to everyone.”
 

Share your expertise as a doctor – and a person

As a mom and pediatrician, Krupa Playforth, MD, who practices in Vienna, Va., knows that what she posts carries weight. So, whether she’s writing about backpack safety tips, choking hazards, or separation anxiety, her followers can rest assured that she’s posting responsibly.

“Pediatricians often underestimate how smart parents are,” said Dr. Playforth, who has three kids, ages 8, 5, and 2, and has 137,000 followers on @thepediatricianmom, her Instagram account. “Their anxiety comes from an understandable place, which is why I see my role as that of a parent and pediatrician who can translate the knowledge pediatricians have into something parents can understand.”

Dr. Playforth, who jumped on social media during COVID-19 and experienced a positive response in her local community, said being on social media is imperative if you’re a pediatrician.

“This is the future of pediatric medicine in particular,” she said. “A lot of pediatricians don’t want to embrace social media, but I think that’s a mistake. After all, while parents think pediatricians have all the answers, when we think of our own children, most doctors are like other parents – we can’t think objectively about our kids. It’s helpful for me to share that and to help parents feel less alone.”

If you’re not yet using social media to the best of your physician abilities, you might take a shot at becoming widely recognizable. Pick a preferred platform, answer common patient questions, dispel medical myths, provide pertinent information, and let your personality shine.

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

With physicians under increasing pressure to see more patients in shorter office visits, developing a social media presence may offer valuable opportunities to connect with patients, explain procedures, combat misinformation, talk through a published article, and even share a joke or meme.

But there are caveats for doctors posting on social media platforms. This news organization spoke to four doctors who successfully use social media. Here is what they want you to know before you post – and how to make your posts personable and helpful to patients and your practice simultaneously.
 

Use social media for the right reasons

While you’re under no obligation to build a social media presence, if you’re going to do it, be sure your intentions are solid, said Don S. Dizon, MD, professor of medicine and professor of surgery at Brown University, Providence, R.I. Dr. Dizon, as @DoctorDon, has 44,700 TikTok followers and uses the platform to answer cancer-related questions.

“It should be your altruism that motivates you to post,” said Dr. Dizon, who is also associate director of community outreach and engagement at the Legorreta Cancer Center in Providence, R.I., and director of medical oncology at Rhode Island Hospital. “What we can do for society at large is to provide our input into issues, add informed opinions where there’s controversy, and address misinformation.”

If you don’t know where to start, consider seeking a digital mentor to talk through your options.

“You may never meet this person, but you should choose them if you like their style, their content, their delivery, and their perspective,” Dr. Dizon said. “Find another doctor out there on social media whom you feel you can emulate. Take your time, too. Soon enough, you’ll develop your own style and your own online persona.”
 

Post clear, accurate information

If you want to be lighthearted on social media, that’s your choice. But Jennifer Trachtenberg, a pediatrician with nearly 7,000 Instagram followers in New York who posts as @askdrjen, prefers to offer vaccine scheduling tips, alert parents about COVID-19 rates, and offer advice on cold and flu prevention.

“Right now, I’m mainly doing this to educate patients and make them aware of topics that I think are important and that I see my patients needing more information on,” she said. “We have to be clear: People take what we say seriously. So, while it’s important to be relatable, it’s even more important to share evidence-based information.”
 

Many patients get their information on social media

While patients once came to the doctor armed with information sourced via “Doctor Google,” today, just as many patients use social media to learn about their condition or the medications they’re taking.

Unfortunately, a recent Ohio State University, Columbus, study found that the majority of gynecologic cancer advice on TikTok, for example, was either misleading or inaccurate.

“This misinformation should be a motivator for physicians to explore the social media space,” Dr. Dizon said. “Our voices need to be on there.”
 

Break down barriers – and make connections

Mike Natter, MD, an endocrinologist in New York, has type 1 diabetes. This informs his work – and his life – and he’s passionate about sharing it with his 117,000 followers as @mike.natter on Instagram.

“A lot of type 1s follow me, so there’s an advocacy component to what I do,” he said. “I enjoy being able to raise awareness and keep people up to date on the newest research and treatment.”

But that’s not all: Dr. Natter is also an artist who went to art school before he went to medical school, and his account is rife with his cartoons and illustrations about everything from valvular disease to diabetic ketoacidosis.

“I found that I was drawing a lot of my notes in medical school,” he said. “When I drew my notes, I did quite well, and I think that using art and illustration is a great tool. It breaks down barriers and makes health information all the more accessible to everyone.”
 

Share your expertise as a doctor – and a person

As a mom and pediatrician, Krupa Playforth, MD, who practices in Vienna, Va., knows that what she posts carries weight. So, whether she’s writing about backpack safety tips, choking hazards, or separation anxiety, her followers can rest assured that she’s posting responsibly.

“Pediatricians often underestimate how smart parents are,” said Dr. Playforth, who has three kids, ages 8, 5, and 2, and has 137,000 followers on @thepediatricianmom, her Instagram account. “Their anxiety comes from an understandable place, which is why I see my role as that of a parent and pediatrician who can translate the knowledge pediatricians have into something parents can understand.”

Dr. Playforth, who jumped on social media during COVID-19 and experienced a positive response in her local community, said being on social media is imperative if you’re a pediatrician.

“This is the future of pediatric medicine in particular,” she said. “A lot of pediatricians don’t want to embrace social media, but I think that’s a mistake. After all, while parents think pediatricians have all the answers, when we think of our own children, most doctors are like other parents – we can’t think objectively about our kids. It’s helpful for me to share that and to help parents feel less alone.”

If you’re not yet using social media to the best of your physician abilities, you might take a shot at becoming widely recognizable. Pick a preferred platform, answer common patient questions, dispel medical myths, provide pertinent information, and let your personality shine.

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

With physicians under increasing pressure to see more patients in shorter office visits, developing a social media presence may offer valuable opportunities to connect with patients, explain procedures, combat misinformation, talk through a published article, and even share a joke or meme.

But there are caveats for doctors posting on social media platforms. This news organization spoke to four doctors who successfully use social media. Here is what they want you to know before you post – and how to make your posts personable and helpful to patients and your practice simultaneously.
 

Use social media for the right reasons

While you’re under no obligation to build a social media presence, if you’re going to do it, be sure your intentions are solid, said Don S. Dizon, MD, professor of medicine and professor of surgery at Brown University, Providence, R.I. Dr. Dizon, as @DoctorDon, has 44,700 TikTok followers and uses the platform to answer cancer-related questions.

“It should be your altruism that motivates you to post,” said Dr. Dizon, who is also associate director of community outreach and engagement at the Legorreta Cancer Center in Providence, R.I., and director of medical oncology at Rhode Island Hospital. “What we can do for society at large is to provide our input into issues, add informed opinions where there’s controversy, and address misinformation.”

If you don’t know where to start, consider seeking a digital mentor to talk through your options.

“You may never meet this person, but you should choose them if you like their style, their content, their delivery, and their perspective,” Dr. Dizon said. “Find another doctor out there on social media whom you feel you can emulate. Take your time, too. Soon enough, you’ll develop your own style and your own online persona.”
 

Post clear, accurate information

If you want to be lighthearted on social media, that’s your choice. But Jennifer Trachtenberg, a pediatrician with nearly 7,000 Instagram followers in New York who posts as @askdrjen, prefers to offer vaccine scheduling tips, alert parents about COVID-19 rates, and offer advice on cold and flu prevention.

“Right now, I’m mainly doing this to educate patients and make them aware of topics that I think are important and that I see my patients needing more information on,” she said. “We have to be clear: People take what we say seriously. So, while it’s important to be relatable, it’s even more important to share evidence-based information.”
 

Many patients get their information on social media

While patients once came to the doctor armed with information sourced via “Doctor Google,” today, just as many patients use social media to learn about their condition or the medications they’re taking.

Unfortunately, a recent Ohio State University, Columbus, study found that the majority of gynecologic cancer advice on TikTok, for example, was either misleading or inaccurate.

“This misinformation should be a motivator for physicians to explore the social media space,” Dr. Dizon said. “Our voices need to be on there.”
 

Break down barriers – and make connections

Mike Natter, MD, an endocrinologist in New York, has type 1 diabetes. This informs his work – and his life – and he’s passionate about sharing it with his 117,000 followers as @mike.natter on Instagram.

“A lot of type 1s follow me, so there’s an advocacy component to what I do,” he said. “I enjoy being able to raise awareness and keep people up to date on the newest research and treatment.”

But that’s not all: Dr. Natter is also an artist who went to art school before he went to medical school, and his account is rife with his cartoons and illustrations about everything from valvular disease to diabetic ketoacidosis.

“I found that I was drawing a lot of my notes in medical school,” he said. “When I drew my notes, I did quite well, and I think that using art and illustration is a great tool. It breaks down barriers and makes health information all the more accessible to everyone.”
 

Share your expertise as a doctor – and a person

As a mom and pediatrician, Krupa Playforth, MD, who practices in Vienna, Va., knows that what she posts carries weight. So, whether she’s writing about backpack safety tips, choking hazards, or separation anxiety, her followers can rest assured that she’s posting responsibly.

“Pediatricians often underestimate how smart parents are,” said Dr. Playforth, who has three kids, ages 8, 5, and 2, and has 137,000 followers on @thepediatricianmom, her Instagram account. “Their anxiety comes from an understandable place, which is why I see my role as that of a parent and pediatrician who can translate the knowledge pediatricians have into something parents can understand.”

Dr. Playforth, who jumped on social media during COVID-19 and experienced a positive response in her local community, said being on social media is imperative if you’re a pediatrician.

“This is the future of pediatric medicine in particular,” she said. “A lot of pediatricians don’t want to embrace social media, but I think that’s a mistake. After all, while parents think pediatricians have all the answers, when we think of our own children, most doctors are like other parents – we can’t think objectively about our kids. It’s helpful for me to share that and to help parents feel less alone.”

If you’re not yet using social media to the best of your physician abilities, you might take a shot at becoming widely recognizable. Pick a preferred platform, answer common patient questions, dispel medical myths, provide pertinent information, and let your personality shine.

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

Once weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide (Ozempic, Novo Nordisk) significantly improved hemoglobin A1c level and body weight for up to 3 years in a large cohort of adults with type 2 diabetes, show real-world data from Israel.

Treatment with semaglutide was associated with reductions in both A1c (–0.77%; P < .001) and body weight (–4.7 kg; P < .001) at 6 months of treatment. These reductions were maintained for up to 3 years and, in particular, in those patients with higher adherence to the therapy.

Avraham Karasik, MD, from the Institute of Research and Innovation at Maccabi Health Services, Tel Aviv, led the study and presented the work as a poster at this year’s annual meeting of the European Association for the Study of Diabetes.

“We found a clinically relevant improvement in blood sugar control and weight loss after 6 months of treatment, comparable with that seen in randomized trials,” said Dr. Karasik during an interview. “Importantly, these effects were sustained for up to 3 years, supporting the use of once weekly semaglutide for the long-term management of type 2 diabetes.”

Esther Walden, RN, deputy head of care at Diabetes UK, appreciated that the real-world findings reflected those seen in the randomized controlled trials. “This study suggests that improvements in blood sugars and weight loss can potentially be sustained in the longer term for adults with type 2 diabetes taking semaglutide as prescribed.”
 

Large scale, long term, and real world

Dr. Karasik explained that in Israel, there are many early adopters of once weekly semaglutide, and as such, it made for a large sample size, with a significant use duration for the retrospective study. “It’s a popular drug and there are lots of questions about durability of effect,” he pointed out.

Though evidence from randomized controlled trials support the effectiveness of once weekly semaglutide to treat type 2 diabetes, these studies are mostly of relatively short follow-up, explained Dr. Karasik, pointing out that long-term, large-scale, real-world data are needed. “In real life, people are acting differently to the trial setting and some adhere while others don’t, so it was interesting to see the durability as well as what happens when people discontinue treatment or adhere less.”

“Unsurprisingly, people who had a higher proportion of days covered ([PDC]; the total days of semaglutide use as a proportion of the total number of days followed up) had a higher effect,” explained Dr. Karasik, adding that, “if you don’t take it, it doesn’t work.”

A total of 23,442 patients were included in the study, with 6,049 followed up for 2 years or more. Mean baseline A1c was 7.6%-7.9%; body mass index (BMI) was 33.7-33.8 kg/m²; metformin was taken by 84%-88% of participants; insulin was taken by 30%; and 31% were treated with another GLP-1 RA prior to receiving semaglutide.

For study inclusion, participants were required to have had redeemed at least one prescription for subcutaneous semaglutide (0.25, 0.5, or 1 mg), and had at least one A1c measurement 12 months before and around 6 months after the start of semaglutide.

The primary outcome was change in A1c from baseline to the end of the follow-up at 6, 12, 18, 24, 30, and 36 months. Key secondary outcomes included change in body weight from baseline to the end of the follow-up (36 months); change in A1c and body weight in subgroups of patients who were persistently on therapy (at 12, 24, 36 months); and change in A1c and body weight in subgroups stratified by baseline characteristics. There was also an exploratory outcome, which was change in A1c and weight after treatment discontinuation. Dr. Karasik presented some of these results in his poster.

Median follow-up was 17.6 months in the total population and was 29.9 months in those who persisted with therapy for 2 years or more. “We have over 23,000 participants so it’s a large group, and these are not selected patients so the generalizability is better.”
 

Three-year sustained effect

Results from the total population showed that A1c lowered by a mean of 0.77% (from 7.6% to 6.8%) and body weight reduced by 4.7 kg (from 94.1 kg to 89.7 kg) after 6 months of treatment. These reductions were maintained during 3 years of follow-up in around 1,000 patients.

A significant 75% of participants adhered to once weekly semaglutide (PDC of more than 60%) within the first 6 months. In patients who used semaglutide for at least 2 years, those with high adherence (PDC of at least 80%) showed an A1c reduction of 0.76% after 24 months and of 0.43% after 36 months. Body weight was reduced by 6.0 kg after 24 months and 5.8 kg after 36 months.

Reductions in both A1c and weight were lower in patients with PDC of below 60%, compared with those with PDC of 60%-79% or 80% or over (statistically significant difference of P < .05 for between-groups differences for both outcomes across maximum follow-up time).

As expected, among patients who were GLP-1 RA–naive, reductions in A1c level and body weight were more pronounced, compared with GLP-1 RA–experienced patients (A1c reduction, –0.87% vs. –0.54%; weight loss, –5.5 kg vs. –3.0 kg, respectively; P < .001 for between-groups difference for both outcomes).

Dr. Karasik reported that some patients who stopped taking semaglutide did not regain weight immediately and that this potential residual effect after treatment discontinuation merits additional investigation. “This is not like in the randomized controlled trials. I don’t know how to interpret it, but that’s the observation. A1c did increase a little when they stopped therapy, compared to those with PDC [of 60%-79% or 80% or over] (P < .05 for between-groups difference for both outcomes in most follow-up time).”

He also highlighted that in regard to the long-term outcomes, “unlike many drugs where the effect fades out with time, here we don’t see that happening. This is another encouraging point.”

Dr. Karasik declares speaker fees and grants from Novo Nordisk, Boehringer Ingelheim, and AstraZeneca. The study was supported by Novo Nordisk.

A version of this article appeared on Medscape.com.

Once weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide (Ozempic, Novo Nordisk) significantly improved hemoglobin A1c level and body weight for up to 3 years in a large cohort of adults with type 2 diabetes, show real-world data from Israel.

Treatment with semaglutide was associated with reductions in both A1c (–0.77%; P < .001) and body weight (–4.7 kg; P < .001) at 6 months of treatment. These reductions were maintained for up to 3 years and, in particular, in those patients with higher adherence to the therapy.

Avraham Karasik, MD, from the Institute of Research and Innovation at Maccabi Health Services, Tel Aviv, led the study and presented the work as a poster at this year’s annual meeting of the European Association for the Study of Diabetes.

“We found a clinically relevant improvement in blood sugar control and weight loss after 6 months of treatment, comparable with that seen in randomized trials,” said Dr. Karasik during an interview. “Importantly, these effects were sustained for up to 3 years, supporting the use of once weekly semaglutide for the long-term management of type 2 diabetes.”

Esther Walden, RN, deputy head of care at Diabetes UK, appreciated that the real-world findings reflected those seen in the randomized controlled trials. “This study suggests that improvements in blood sugars and weight loss can potentially be sustained in the longer term for adults with type 2 diabetes taking semaglutide as prescribed.”
 

Large scale, long term, and real world

Dr. Karasik explained that in Israel, there are many early adopters of once weekly semaglutide, and as such, it made for a large sample size, with a significant use duration for the retrospective study. “It’s a popular drug and there are lots of questions about durability of effect,” he pointed out.

Though evidence from randomized controlled trials support the effectiveness of once weekly semaglutide to treat type 2 diabetes, these studies are mostly of relatively short follow-up, explained Dr. Karasik, pointing out that long-term, large-scale, real-world data are needed. “In real life, people are acting differently to the trial setting and some adhere while others don’t, so it was interesting to see the durability as well as what happens when people discontinue treatment or adhere less.”

“Unsurprisingly, people who had a higher proportion of days covered ([PDC]; the total days of semaglutide use as a proportion of the total number of days followed up) had a higher effect,” explained Dr. Karasik, adding that, “if you don’t take it, it doesn’t work.”

A total of 23,442 patients were included in the study, with 6,049 followed up for 2 years or more. Mean baseline A1c was 7.6%-7.9%; body mass index (BMI) was 33.7-33.8 kg/m²; metformin was taken by 84%-88% of participants; insulin was taken by 30%; and 31% were treated with another GLP-1 RA prior to receiving semaglutide.

For study inclusion, participants were required to have had redeemed at least one prescription for subcutaneous semaglutide (0.25, 0.5, or 1 mg), and had at least one A1c measurement 12 months before and around 6 months after the start of semaglutide.

The primary outcome was change in A1c from baseline to the end of the follow-up at 6, 12, 18, 24, 30, and 36 months. Key secondary outcomes included change in body weight from baseline to the end of the follow-up (36 months); change in A1c and body weight in subgroups of patients who were persistently on therapy (at 12, 24, 36 months); and change in A1c and body weight in subgroups stratified by baseline characteristics. There was also an exploratory outcome, which was change in A1c and weight after treatment discontinuation. Dr. Karasik presented some of these results in his poster.

Median follow-up was 17.6 months in the total population and was 29.9 months in those who persisted with therapy for 2 years or more. “We have over 23,000 participants so it’s a large group, and these are not selected patients so the generalizability is better.”
 

Three-year sustained effect

Results from the total population showed that A1c lowered by a mean of 0.77% (from 7.6% to 6.8%) and body weight reduced by 4.7 kg (from 94.1 kg to 89.7 kg) after 6 months of treatment. These reductions were maintained during 3 years of follow-up in around 1,000 patients.

A significant 75% of participants adhered to once weekly semaglutide (PDC of more than 60%) within the first 6 months. In patients who used semaglutide for at least 2 years, those with high adherence (PDC of at least 80%) showed an A1c reduction of 0.76% after 24 months and of 0.43% after 36 months. Body weight was reduced by 6.0 kg after 24 months and 5.8 kg after 36 months.

Reductions in both A1c and weight were lower in patients with PDC of below 60%, compared with those with PDC of 60%-79% or 80% or over (statistically significant difference of P < .05 for between-groups differences for both outcomes across maximum follow-up time).

As expected, among patients who were GLP-1 RA–naive, reductions in A1c level and body weight were more pronounced, compared with GLP-1 RA–experienced patients (A1c reduction, –0.87% vs. –0.54%; weight loss, –5.5 kg vs. –3.0 kg, respectively; P < .001 for between-groups difference for both outcomes).

Dr. Karasik reported that some patients who stopped taking semaglutide did not regain weight immediately and that this potential residual effect after treatment discontinuation merits additional investigation. “This is not like in the randomized controlled trials. I don’t know how to interpret it, but that’s the observation. A1c did increase a little when they stopped therapy, compared to those with PDC [of 60%-79% or 80% or over] (P < .05 for between-groups difference for both outcomes in most follow-up time).”

He also highlighted that in regard to the long-term outcomes, “unlike many drugs where the effect fades out with time, here we don’t see that happening. This is another encouraging point.”

Dr. Karasik declares speaker fees and grants from Novo Nordisk, Boehringer Ingelheim, and AstraZeneca. The study was supported by Novo Nordisk.

A version of this article appeared on Medscape.com.

Once weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide (Ozempic, Novo Nordisk) significantly improved hemoglobin A1c level and body weight for up to 3 years in a large cohort of adults with type 2 diabetes, show real-world data from Israel.

Treatment with semaglutide was associated with reductions in both A1c (–0.77%; P < .001) and body weight (–4.7 kg; P < .001) at 6 months of treatment. These reductions were maintained for up to 3 years and, in particular, in those patients with higher adherence to the therapy.

Avraham Karasik, MD, from the Institute of Research and Innovation at Maccabi Health Services, Tel Aviv, led the study and presented the work as a poster at this year’s annual meeting of the European Association for the Study of Diabetes.

“We found a clinically relevant improvement in blood sugar control and weight loss after 6 months of treatment, comparable with that seen in randomized trials,” said Dr. Karasik during an interview. “Importantly, these effects were sustained for up to 3 years, supporting the use of once weekly semaglutide for the long-term management of type 2 diabetes.”

Esther Walden, RN, deputy head of care at Diabetes UK, appreciated that the real-world findings reflected those seen in the randomized controlled trials. “This study suggests that improvements in blood sugars and weight loss can potentially be sustained in the longer term for adults with type 2 diabetes taking semaglutide as prescribed.”
 

Large scale, long term, and real world

Dr. Karasik explained that in Israel, there are many early adopters of once weekly semaglutide, and as such, it made for a large sample size, with a significant use duration for the retrospective study. “It’s a popular drug and there are lots of questions about durability of effect,” he pointed out.

Though evidence from randomized controlled trials support the effectiveness of once weekly semaglutide to treat type 2 diabetes, these studies are mostly of relatively short follow-up, explained Dr. Karasik, pointing out that long-term, large-scale, real-world data are needed. “In real life, people are acting differently to the trial setting and some adhere while others don’t, so it was interesting to see the durability as well as what happens when people discontinue treatment or adhere less.”

“Unsurprisingly, people who had a higher proportion of days covered ([PDC]; the total days of semaglutide use as a proportion of the total number of days followed up) had a higher effect,” explained Dr. Karasik, adding that, “if you don’t take it, it doesn’t work.”

A total of 23,442 patients were included in the study, with 6,049 followed up for 2 years or more. Mean baseline A1c was 7.6%-7.9%; body mass index (BMI) was 33.7-33.8 kg/m²; metformin was taken by 84%-88% of participants; insulin was taken by 30%; and 31% were treated with another GLP-1 RA prior to receiving semaglutide.

For study inclusion, participants were required to have had redeemed at least one prescription for subcutaneous semaglutide (0.25, 0.5, or 1 mg), and had at least one A1c measurement 12 months before and around 6 months after the start of semaglutide.

The primary outcome was change in A1c from baseline to the end of the follow-up at 6, 12, 18, 24, 30, and 36 months. Key secondary outcomes included change in body weight from baseline to the end of the follow-up (36 months); change in A1c and body weight in subgroups of patients who were persistently on therapy (at 12, 24, 36 months); and change in A1c and body weight in subgroups stratified by baseline characteristics. There was also an exploratory outcome, which was change in A1c and weight after treatment discontinuation. Dr. Karasik presented some of these results in his poster.

Median follow-up was 17.6 months in the total population and was 29.9 months in those who persisted with therapy for 2 years or more. “We have over 23,000 participants so it’s a large group, and these are not selected patients so the generalizability is better.”
 

Three-year sustained effect

Results from the total population showed that A1c lowered by a mean of 0.77% (from 7.6% to 6.8%) and body weight reduced by 4.7 kg (from 94.1 kg to 89.7 kg) after 6 months of treatment. These reductions were maintained during 3 years of follow-up in around 1,000 patients.

A significant 75% of participants adhered to once weekly semaglutide (PDC of more than 60%) within the first 6 months. In patients who used semaglutide for at least 2 years, those with high adherence (PDC of at least 80%) showed an A1c reduction of 0.76% after 24 months and of 0.43% after 36 months. Body weight was reduced by 6.0 kg after 24 months and 5.8 kg after 36 months.

Reductions in both A1c and weight were lower in patients with PDC of below 60%, compared with those with PDC of 60%-79% or 80% or over (statistically significant difference of P < .05 for between-groups differences for both outcomes across maximum follow-up time).

As expected, among patients who were GLP-1 RA–naive, reductions in A1c level and body weight were more pronounced, compared with GLP-1 RA–experienced patients (A1c reduction, –0.87% vs. –0.54%; weight loss, –5.5 kg vs. –3.0 kg, respectively; P < .001 for between-groups difference for both outcomes).

Dr. Karasik reported that some patients who stopped taking semaglutide did not regain weight immediately and that this potential residual effect after treatment discontinuation merits additional investigation. “This is not like in the randomized controlled trials. I don’t know how to interpret it, but that’s the observation. A1c did increase a little when they stopped therapy, compared to those with PDC [of 60%-79% or 80% or over] (P < .05 for between-groups difference for both outcomes in most follow-up time).”

He also highlighted that in regard to the long-term outcomes, “unlike many drugs where the effect fades out with time, here we don’t see that happening. This is another encouraging point.”

Dr. Karasik declares speaker fees and grants from Novo Nordisk, Boehringer Ingelheim, and AstraZeneca. The study was supported by Novo Nordisk.

A version of this article appeared on Medscape.com.

WASHINGTON – The routine practice of holding use of blood-thinning medications at the time of an ultrasound-guided thyroid nodule fine needle aspiration (FNA) biopsy shows no significant safety benefit in preventing the risk of complications such as hematomas or nondiagnostic results; however, experts suggest using individualized decision-making with the practice.

“Our data indicates that there is no need to routinely hold anticoagulation or antiplatelet therapy prior to thyroid nodule FNA biopsy,” first author Michelle Lundholm, MD, of the Cleveland Clinic said in an interview.

“[The practice] impacts neither the safety of the FNA procedure nor the adequacy of the sample,” she said.

The late-breaking research was presented at the annual meeting of the American Thyroid Association.

Key concerns in the use of anticoagulants and/or antiplatelet medications during thyroid nodule FNA biopsy include the increased risk of postprocedural hematoma or nondiagnostic results, with, for instance, one study showing higher rates of nondiagnostic results among patients remaining on aspirin therapy during the FNA biopsy.

However, holding the medically indicated therapies can have risks of its own, including concerns of thrombotic events such as deep vein thrombosis or stroke. However, evidence comparing the risks with each strategy in thyroid nodule FNA is lacking.

To investigate, Dr. Lundholm and colleagues conducted a review of data on 2,945 patients who had undergone a total of 4,741 thyroid nodule FNAs in the Cleveland Clinic’s diverse network of centers between 2010 and 2023. The patients had a mean age of 66.2; 69.6% were female and 75.7% were White.

All patients had an active prescription for an anticoagulant or antiplatelet medication up to 10 days prior to their thyroid nodule FNA biopsy. Specifically, 73.7% were on 81 mg aspirin, 8.5% were on 325 mg aspirin, 7.4% were taking other antiplatelet medication such as clopidogrel or ticagrelor; 7.0% were on warfarin, 8.2% were on a direct oral anticoagulant (DOAC); 6.3% were on heparin products; and 10.3% of patients were on two or more blood-thinning medications.

The results show that, overall, 13.0% (n =  614) of the thyroid nodule FNA biopsies had nondiagnostic results, which is within the average rates in the literature ranging from 6% to 36%, Dr. Lundholm noted.

Blood-thinning medications were held in 20.8% of the FNA biopsies, however, there were no differences in nondiagnostic results between those who had drugs held (12.2%) or who continued on the medications (13.2%; P  = .41).

After multivariate adjustment for age and sex, the lack of significant differences in receiving nondiagnostic results among those who did or did not continue blood thinners was consistent overall (odds ratio, 1.10; P = .38), and in the specific groups of 81 mg aspirin (OR, 1.00; P = .99); 325 mg aspirin or clopidogrel/ticagrelor (OR, 1.50; P = .15); or warfarin, DOAC, or heparin/enoxaparin (OR, 1.27; P = .27).

In terms of hematoma risk, ED records within 48 hours of the FNA showed that such events were rare, with only one hematoma occurring overall, involving a patient who was on 81 mg of aspirin for secondary stroke prevention that was not interrupted for FNA biopsy. The patient was discharged and did not require medical intervention.  

Four other hematomas occurred among patients who were not being treated with blood thinners, with none requiring intervention.

The findings indicate that “hematoma can happen in any patient, but rarely requires intervention,” Dr. Lundholm said.

However, while thrombotic events were also rare, serious events occurred in three patients within 48 hours of the thyroid nodule FNA biopsy when a blood thinner was withheld, including ischemic strokes among two patients who were on a DOAC and 81 mg of aspirin that were withheld, and one MI occurring in a patient on a DOAC that was held for the FNA.

Unlike hematomas, the thrombotic events each had significant long‐term sequelae, Dr. Lundholm noted.

“Having these ischemic strokes and heart attack really led to a change in these patients’ lives,” she said. “While we can never assume that [the events occurred] because the blood-thinner therapy was held, the timing within 48 hours is certainly very suspicious.”

There were no deep vein thrombosis or pulmonary embolism events.
 

Withholding practices vary

In a previous survey of 60 clinicians conducted by Dr. Lundholm and colleagues, wide variation was reported in the rates of withholding antiplatelet or anticoagulant medications prior to thyroid nodule FNA biopsy.

The survey of endocrinologists, interventional radiologists, and ear, nose, and throat providers showed rates of withholding 81 mg of aspirin prior to FNA biopsy of just 13.3%, withholding 325 mg of aspirin, 15%, other antiplatelets, 41.7%, warfarin, 73.3%, DOACs, 43.3%, and heparin, 43.3%.

“We found heterogeneity in withholding patterns even within the same department,” she said. “This is reflective of the fact that evidence is mixed.”

Guidelines on the issue from the Society of Interventional Radiology and the International Society on Thrombosis and Hemostasis recommend that providers consider the balance of the procedure and patient bleeding risk versus the clotting risk, Dr. Lundholm noted.

However, a caveat is that those recommendations are based on pooled data from similar minimal risk procedures, she explained.

“There is a lack of data on bleeding risks for individual interventions like thyroid biopsy, and, as such, there is no specific procedure-related risk determination.”

Meanwhile, Dr. Lundholm said that notable limitations regarding the current research include that the study may not have caught all patient cases that presented with complications to an outside ED.

Furthermore, the study results pertain to the safety of blood thinners in routine use, with key aspects that can influence complication rates, such as provider experience, needle size, and nodule features unavailable for analysis.
 

At MD Anderson, case-by-case

Commenting on the research, Anastasios Maniakas, MD, PhD, of the department of head and neck surgery, division of surgery, University of Texas MD Anderson Cancer Center, Houston, said the study is important, noting that, at his institution, the approach regarding holding blood-thinning medications is generally determined on an individual basis.

“I think this was a good study, but I don’t think it’s practice changing because these decisions may differ on a case-by-case basis,” Dr. Maniakas, who comoderated the session, said in an interview.

“At MD Anderson, we probably have one of the highest volumes in the country for thyroid nodule FNAs, and we do hold blood thinners because we often have to do more significant biopsies, with multiple passages and larger needles to be used,” Dr. Maniakas said.

“If you’re going to use perhaps the smallest possible gauge needle, then I think it is reasonable to not hold blood thinners, but if you’re going to be doing multiple passages and you need to do a core biopsy and use a large needle, then it is wiser to try to hold the medications for a day or 2.

“We haven’t had any complications, but I think there’s still a lot of apprehension to not hold blood thinners,” Dr. Maniakas said. “So, overall, I think the message is that it has to be on a case-by-case basis.”

Dr. Lundholm and Dr. Maniakas reported no relevant financial relationships.

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

WASHINGTON – The routine practice of holding use of blood-thinning medications at the time of an ultrasound-guided thyroid nodule fine needle aspiration (FNA) biopsy shows no significant safety benefit in preventing the risk of complications such as hematomas or nondiagnostic results; however, experts suggest using individualized decision-making with the practice.

“Our data indicates that there is no need to routinely hold anticoagulation or antiplatelet therapy prior to thyroid nodule FNA biopsy,” first author Michelle Lundholm, MD, of the Cleveland Clinic said in an interview.

“[The practice] impacts neither the safety of the FNA procedure nor the adequacy of the sample,” she said.

The late-breaking research was presented at the annual meeting of the American Thyroid Association.

Key concerns in the use of anticoagulants and/or antiplatelet medications during thyroid nodule FNA biopsy include the increased risk of postprocedural hematoma or nondiagnostic results, with, for instance, one study showing higher rates of nondiagnostic results among patients remaining on aspirin therapy during the FNA biopsy.

However, holding the medically indicated therapies can have risks of its own, including concerns of thrombotic events such as deep vein thrombosis or stroke. However, evidence comparing the risks with each strategy in thyroid nodule FNA is lacking.

To investigate, Dr. Lundholm and colleagues conducted a review of data on 2,945 patients who had undergone a total of 4,741 thyroid nodule FNAs in the Cleveland Clinic’s diverse network of centers between 2010 and 2023. The patients had a mean age of 66.2; 69.6% were female and 75.7% were White.

All patients had an active prescription for an anticoagulant or antiplatelet medication up to 10 days prior to their thyroid nodule FNA biopsy. Specifically, 73.7% were on 81 mg aspirin, 8.5% were on 325 mg aspirin, 7.4% were taking other antiplatelet medication such as clopidogrel or ticagrelor; 7.0% were on warfarin, 8.2% were on a direct oral anticoagulant (DOAC); 6.3% were on heparin products; and 10.3% of patients were on two or more blood-thinning medications.

The results show that, overall, 13.0% (n =  614) of the thyroid nodule FNA biopsies had nondiagnostic results, which is within the average rates in the literature ranging from 6% to 36%, Dr. Lundholm noted.

Blood-thinning medications were held in 20.8% of the FNA biopsies, however, there were no differences in nondiagnostic results between those who had drugs held (12.2%) or who continued on the medications (13.2%; P  = .41).

After multivariate adjustment for age and sex, the lack of significant differences in receiving nondiagnostic results among those who did or did not continue blood thinners was consistent overall (odds ratio, 1.10; P = .38), and in the specific groups of 81 mg aspirin (OR, 1.00; P = .99); 325 mg aspirin or clopidogrel/ticagrelor (OR, 1.50; P = .15); or warfarin, DOAC, or heparin/enoxaparin (OR, 1.27; P = .27).

In terms of hematoma risk, ED records within 48 hours of the FNA showed that such events were rare, with only one hematoma occurring overall, involving a patient who was on 81 mg of aspirin for secondary stroke prevention that was not interrupted for FNA biopsy. The patient was discharged and did not require medical intervention.  

Four other hematomas occurred among patients who were not being treated with blood thinners, with none requiring intervention.

The findings indicate that “hematoma can happen in any patient, but rarely requires intervention,” Dr. Lundholm said.

However, while thrombotic events were also rare, serious events occurred in three patients within 48 hours of the thyroid nodule FNA biopsy when a blood thinner was withheld, including ischemic strokes among two patients who were on a DOAC and 81 mg of aspirin that were withheld, and one MI occurring in a patient on a DOAC that was held for the FNA.

Unlike hematomas, the thrombotic events each had significant long‐term sequelae, Dr. Lundholm noted.

“Having these ischemic strokes and heart attack really led to a change in these patients’ lives,” she said. “While we can never assume that [the events occurred] because the blood-thinner therapy was held, the timing within 48 hours is certainly very suspicious.”

There were no deep vein thrombosis or pulmonary embolism events.
 

Withholding practices vary

In a previous survey of 60 clinicians conducted by Dr. Lundholm and colleagues, wide variation was reported in the rates of withholding antiplatelet or anticoagulant medications prior to thyroid nodule FNA biopsy.

The survey of endocrinologists, interventional radiologists, and ear, nose, and throat providers showed rates of withholding 81 mg of aspirin prior to FNA biopsy of just 13.3%, withholding 325 mg of aspirin, 15%, other antiplatelets, 41.7%, warfarin, 73.3%, DOACs, 43.3%, and heparin, 43.3%.

“We found heterogeneity in withholding patterns even within the same department,” she said. “This is reflective of the fact that evidence is mixed.”

Guidelines on the issue from the Society of Interventional Radiology and the International Society on Thrombosis and Hemostasis recommend that providers consider the balance of the procedure and patient bleeding risk versus the clotting risk, Dr. Lundholm noted.

However, a caveat is that those recommendations are based on pooled data from similar minimal risk procedures, she explained.

“There is a lack of data on bleeding risks for individual interventions like thyroid biopsy, and, as such, there is no specific procedure-related risk determination.”

Meanwhile, Dr. Lundholm said that notable limitations regarding the current research include that the study may not have caught all patient cases that presented with complications to an outside ED.

Furthermore, the study results pertain to the safety of blood thinners in routine use, with key aspects that can influence complication rates, such as provider experience, needle size, and nodule features unavailable for analysis.
 

At MD Anderson, case-by-case

Commenting on the research, Anastasios Maniakas, MD, PhD, of the department of head and neck surgery, division of surgery, University of Texas MD Anderson Cancer Center, Houston, said the study is important, noting that, at his institution, the approach regarding holding blood-thinning medications is generally determined on an individual basis.

“I think this was a good study, but I don’t think it’s practice changing because these decisions may differ on a case-by-case basis,” Dr. Maniakas, who comoderated the session, said in an interview.

“At MD Anderson, we probably have one of the highest volumes in the country for thyroid nodule FNAs, and we do hold blood thinners because we often have to do more significant biopsies, with multiple passages and larger needles to be used,” Dr. Maniakas said.

“If you’re going to use perhaps the smallest possible gauge needle, then I think it is reasonable to not hold blood thinners, but if you’re going to be doing multiple passages and you need to do a core biopsy and use a large needle, then it is wiser to try to hold the medications for a day or 2.

“We haven’t had any complications, but I think there’s still a lot of apprehension to not hold blood thinners,” Dr. Maniakas said. “So, overall, I think the message is that it has to be on a case-by-case basis.”

Dr. Lundholm and Dr. Maniakas reported no relevant financial relationships.

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

WASHINGTON – The routine practice of holding use of blood-thinning medications at the time of an ultrasound-guided thyroid nodule fine needle aspiration (FNA) biopsy shows no significant safety benefit in preventing the risk of complications such as hematomas or nondiagnostic results; however, experts suggest using individualized decision-making with the practice.

“Our data indicates that there is no need to routinely hold anticoagulation or antiplatelet therapy prior to thyroid nodule FNA biopsy,” first author Michelle Lundholm, MD, of the Cleveland Clinic said in an interview.

“[The practice] impacts neither the safety of the FNA procedure nor the adequacy of the sample,” she said.

The late-breaking research was presented at the annual meeting of the American Thyroid Association.

Key concerns in the use of anticoagulants and/or antiplatelet medications during thyroid nodule FNA biopsy include the increased risk of postprocedural hematoma or nondiagnostic results, with, for instance, one study showing higher rates of nondiagnostic results among patients remaining on aspirin therapy during the FNA biopsy.

However, holding the medically indicated therapies can have risks of its own, including concerns of thrombotic events such as deep vein thrombosis or stroke. However, evidence comparing the risks with each strategy in thyroid nodule FNA is lacking.

To investigate, Dr. Lundholm and colleagues conducted a review of data on 2,945 patients who had undergone a total of 4,741 thyroid nodule FNAs in the Cleveland Clinic’s diverse network of centers between 2010 and 2023. The patients had a mean age of 66.2; 69.6% were female and 75.7% were White.

All patients had an active prescription for an anticoagulant or antiplatelet medication up to 10 days prior to their thyroid nodule FNA biopsy. Specifically, 73.7% were on 81 mg aspirin, 8.5% were on 325 mg aspirin, 7.4% were taking other antiplatelet medication such as clopidogrel or ticagrelor; 7.0% were on warfarin, 8.2% were on a direct oral anticoagulant (DOAC); 6.3% were on heparin products; and 10.3% of patients were on two or more blood-thinning medications.

The results show that, overall, 13.0% (n =  614) of the thyroid nodule FNA biopsies had nondiagnostic results, which is within the average rates in the literature ranging from 6% to 36%, Dr. Lundholm noted.

Blood-thinning medications were held in 20.8% of the FNA biopsies, however, there were no differences in nondiagnostic results between those who had drugs held (12.2%) or who continued on the medications (13.2%; P  = .41).

After multivariate adjustment for age and sex, the lack of significant differences in receiving nondiagnostic results among those who did or did not continue blood thinners was consistent overall (odds ratio, 1.10; P = .38), and in the specific groups of 81 mg aspirin (OR, 1.00; P = .99); 325 mg aspirin or clopidogrel/ticagrelor (OR, 1.50; P = .15); or warfarin, DOAC, or heparin/enoxaparin (OR, 1.27; P = .27).

In terms of hematoma risk, ED records within 48 hours of the FNA showed that such events were rare, with only one hematoma occurring overall, involving a patient who was on 81 mg of aspirin for secondary stroke prevention that was not interrupted for FNA biopsy. The patient was discharged and did not require medical intervention.  

Four other hematomas occurred among patients who were not being treated with blood thinners, with none requiring intervention.

The findings indicate that “hematoma can happen in any patient, but rarely requires intervention,” Dr. Lundholm said.

However, while thrombotic events were also rare, serious events occurred in three patients within 48 hours of the thyroid nodule FNA biopsy when a blood thinner was withheld, including ischemic strokes among two patients who were on a DOAC and 81 mg of aspirin that were withheld, and one MI occurring in a patient on a DOAC that was held for the FNA.

Unlike hematomas, the thrombotic events each had significant long‐term sequelae, Dr. Lundholm noted.

“Having these ischemic strokes and heart attack really led to a change in these patients’ lives,” she said. “While we can never assume that [the events occurred] because the blood-thinner therapy was held, the timing within 48 hours is certainly very suspicious.”

There were no deep vein thrombosis or pulmonary embolism events.
 

Withholding practices vary

In a previous survey of 60 clinicians conducted by Dr. Lundholm and colleagues, wide variation was reported in the rates of withholding antiplatelet or anticoagulant medications prior to thyroid nodule FNA biopsy.

The survey of endocrinologists, interventional radiologists, and ear, nose, and throat providers showed rates of withholding 81 mg of aspirin prior to FNA biopsy of just 13.3%, withholding 325 mg of aspirin, 15%, other antiplatelets, 41.7%, warfarin, 73.3%, DOACs, 43.3%, and heparin, 43.3%.

“We found heterogeneity in withholding patterns even within the same department,” she said. “This is reflective of the fact that evidence is mixed.”

Guidelines on the issue from the Society of Interventional Radiology and the International Society on Thrombosis and Hemostasis recommend that providers consider the balance of the procedure and patient bleeding risk versus the clotting risk, Dr. Lundholm noted.

However, a caveat is that those recommendations are based on pooled data from similar minimal risk procedures, she explained.

“There is a lack of data on bleeding risks for individual interventions like thyroid biopsy, and, as such, there is no specific procedure-related risk determination.”

Meanwhile, Dr. Lundholm said that notable limitations regarding the current research include that the study may not have caught all patient cases that presented with complications to an outside ED.

Furthermore, the study results pertain to the safety of blood thinners in routine use, with key aspects that can influence complication rates, such as provider experience, needle size, and nodule features unavailable for analysis.
 

At MD Anderson, case-by-case

Commenting on the research, Anastasios Maniakas, MD, PhD, of the department of head and neck surgery, division of surgery, University of Texas MD Anderson Cancer Center, Houston, said the study is important, noting that, at his institution, the approach regarding holding blood-thinning medications is generally determined on an individual basis.

“I think this was a good study, but I don’t think it’s practice changing because these decisions may differ on a case-by-case basis,” Dr. Maniakas, who comoderated the session, said in an interview.

“At MD Anderson, we probably have one of the highest volumes in the country for thyroid nodule FNAs, and we do hold blood thinners because we often have to do more significant biopsies, with multiple passages and larger needles to be used,” Dr. Maniakas said.

“If you’re going to use perhaps the smallest possible gauge needle, then I think it is reasonable to not hold blood thinners, but if you’re going to be doing multiple passages and you need to do a core biopsy and use a large needle, then it is wiser to try to hold the medications for a day or 2.

“We haven’t had any complications, but I think there’s still a lot of apprehension to not hold blood thinners,” Dr. Maniakas said. “So, overall, I think the message is that it has to be on a case-by-case basis.”

Dr. Lundholm and Dr. Maniakas reported no relevant financial relationships.

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

HAMBURG, GERMANY – Once-weekly tirzepatide (Mounjaro, Lilly) added to insulin glargine resulted in greater reductions in hemoglobin A1c along with more weight loss and less hypoglycemia, compared with prandial insulin lispro (Humalog, Sanofi), for patients with inadequately controlled type 2 diabetes, show data from the SURPASS-6 randomized clinical trial.

Tirzepatide led to a statistically and clinically significant reduction in mean A1c, at −2.1%, compared with insulin lispro, at −1.1%, by week 52. It also resulted in a higher percentage of participants meeting an A1c target of less than 7.0%, wrote the researchers, whose study was presented at the annual meeting of the European Association for the Study of Diabetes and was published simultaneously in JAMA.

Also, daily insulin glargine use was substantially lower among participants who received tirzepatide, compared with insulin lispro. Insulin glargine was administered at a dosage 13 IU/day; insulin lispro was administered at a dosage of 62 IU/day. “At the highest dose, some patients stopped their insulin [glargine] in the tirzepatide arm,” said Juan Pablo Frias, MD, medical director and principal investigator of Velocity Clinical Research, Los Angeles, who presented the findings. “We demonstrated clinically meaningful and superior glycemic and body weight control with tirzepatide compared with insulin lispro, while tirzepatide was also associated with less clinically significant hypoglycemia.”

Weight improved for participants who received tirzepatide compared with those who received insulin lispro, at –10 kg and +4 kg respectively. The rate of clinically significant hypoglycemia (blood glucose < 54 mg/dL) or severe hypoglycemia was tenfold lower with tirzepatide, compared with insulin lispro.

The session dedicated to tirzepatide was comoderated by Apostolos Tsapas, MD, professor of medicine and diabetes, Aristotle University, Thessaloniki, Greece, and Konstantinos Toulis, MD, consultant in endocrinology and diabetes, General Military Hospital, Thessaloniki, Greece. Dr. Toulis remarked that, in the chronic disease setting, management and treatment intensification are challenging to integrate, and there are barriers to adoption in routine practice. “This is particularly true when it adds complexity, as in the case of multiple prandial insulin injections on top of basal insulin in suboptimally treated individuals with type 2 diabetes.

“Demonstrating superiority over insulin lispro in terms of the so-called trio of A1c, weight loss, and hypoglycemic events, tirzepatide offers both a simpler to adhere to and a more efficacious treatment intensification option.” He noted that, while long-term safety data are awaited, “this seems to be a definite step forward from any viewpoint, with the possible exception of the taxpayer’s perspective.”

Dr. Tsapas added: “These data further support the very high dual glucose and weight efficacy of tirzepatide and the primary role of incretin-related therapies amongst the injectables for the treatment of type 2 diabetes.”
 

Tirzepatide 5, 10, 15 mg vs. insulin lispro in addition to insulin glargine

The researchers aimed to assess the efficacy and safety of adding once-weekly tirzepatide, compared with thrice-daily prandial insulin lispro, as an adjunctive therapy to insulin glargine for patients with type 2 diabetes that was inadequately controlled with basal insulin.

Tirzepatide activates the body’s receptors for glucose-dependent insulinotropic polypeptide and glucagonlike peptide–1 (GLP-1). The study authors noted that “recent guidelines support adding an injectable incretin-related therapy such as GLP-1 receptor agonist for glycemic control, rather than basal insulin, when oral medications are inadequate.”

The open-label, phase 3b clinical trial drew data from 135 sites across 15 countries and included 1,428 adults with type 2 diabetes who were taking basal insulin. Participants were randomly assigned in a 1:1:1:3 ratio to receive once-weekly subcutaneous injections of tirzepatide (5 mg [n = 243], 10 mg [n = 238], or 15 mg [n = 236]) or prandial thrice-daily insulin lispro (n = 708).

Both arms were well matched. The average age was 60 years, and 60% of participants were women. The average amount of time patients had type 2 diabetes was 14 years; 85% of participants continued taking metformin. The average A1c level was 8.8% at baseline. Patients were categorized as having obesity (average body mass index, 33 kg/m²). The average insulin glargine dose was 46 units, or 0.5 units/kg.

Outcomes included noninferiority of tirzepatide (pooled cohort) compared with insulin lispro, both in addition to insulin glargine; and A1c change from baseline to week 52 (noninferiority margin, 0.3%). Key secondary endpoints included change in body weight and percentage of participants who achieved an A1c target of less than 7.0%.

About 90% of participants who received the study drug completed the study, said Dr. Frias. “Only 0.5% of tirzepatide patients needed rescue therapy, while only 2% of the insulin lispro did.”

Prior to optimization, the average insulin glargine dose was 42 IU/kg; during optimization, it rose to an average of 46 IU/kg. “At 52 weeks, those on basal-bolus insulin found their insulin glargine dose stayed flat while insulin lispro was 62 units,” reported Dr. Frias. “The three tirzepatide doses show a reduction in insulin glargine, such that the pooled dose reached an average of 11 units, while 20% actually came off their basal insulin altogether [pooled tirzepatide].”

Tirzepatide (pooled) led to the recommended A1c target of less than 7.0% for 68% of patients versus 36% of patients in the insulin lispro group.

About 68% of the patients who received tirzepatide (pooled) achieved the recommended A1c target of less than 7.0% versus 36% of patients in the insulin lispro group.

“Individual tirzepatide doses and pooled doses showed significant reduction in A1c and up to a 2.5% reduction,” Dr. Frias added. “Normoglycemia was obtained by a greater proportion of patients on tirzepatide doses versus basal-bolus insulin – one-third in the 15-mg tirzepatide dose.”
 

Body weight reduction of 10% or more with tirzepatide

Further, at week 52, weight loss of 5% or more was achieved by 75.4% of participants in the pooled tirzepatide group, compared with 6.3% in the prandial lispro group. The weight loss was accompanied by clinically relevant improvements in cardiometabolic parameters.

In an exploratory analysis, weight loss of 10% or more was achieved by a mean of 48.9% of pooled tirzepatide-treated participants at week 52, compared with 2% of those taking insulin lispro, said Dr. Frias.

“It is possible that the body weight loss induced by tirzepatide therapy and its reported effect in reducing liver fat content may have led to an improvement in insulin sensitivity and decreased insulin requirements,” wrote the researchers in their article.

Hypoglycemia risk and the weight gain observed with complex insulin regimens that include prandial insulin have been main limitations to optimally up-titrate insulin therapy in clinical practice, wrote the authors.

Dr. Frias noted that, in this study, 48% of patients who received insulin lispro experienced clinically significant hypoglycemia, while only 10% of patients in the tirzepatide arms did. “This was 0.4 episodes per patient-year versus 4.4 in tirzepatide and insulin lispro respectively.”

There were more reports of adverse events among the tirzepatide groups than the insulin lispro group. “Typically, with tirzepatide, the commonest adverse events were GI in origin and were mild to moderate.” Rates were 14%-26% for nausea, 11%-15% for diarrhea, and 5%-13% for vomiting.

The study was sponsored by Eli Lilly. Dr. Frias has received grants from Eli Lilly paid to his institution during the conduct of the study and grants, personal fees, or nonfinancial support from Boehringer Ingelheim, Pfizer, Merck, Altimmune, 89BIO, Akero, Carmot Therapeutics, Intercept, Janssen, Madrigal, Novartis, Eli Lilly, Sanofi, and Novo Nordisk outside the submitted work. Dr. Toulis and Dr. Tsapas declared no relevant disclosures.

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

HAMBURG, GERMANY – Once-weekly tirzepatide (Mounjaro, Lilly) added to insulin glargine resulted in greater reductions in hemoglobin A1c along with more weight loss and less hypoglycemia, compared with prandial insulin lispro (Humalog, Sanofi), for patients with inadequately controlled type 2 diabetes, show data from the SURPASS-6 randomized clinical trial.

Tirzepatide led to a statistically and clinically significant reduction in mean A1c, at −2.1%, compared with insulin lispro, at −1.1%, by week 52. It also resulted in a higher percentage of participants meeting an A1c target of less than 7.0%, wrote the researchers, whose study was presented at the annual meeting of the European Association for the Study of Diabetes and was published simultaneously in JAMA.

Also, daily insulin glargine use was substantially lower among participants who received tirzepatide, compared with insulin lispro. Insulin glargine was administered at a dosage 13 IU/day; insulin lispro was administered at a dosage of 62 IU/day. “At the highest dose, some patients stopped their insulin [glargine] in the tirzepatide arm,” said Juan Pablo Frias, MD, medical director and principal investigator of Velocity Clinical Research, Los Angeles, who presented the findings. “We demonstrated clinically meaningful and superior glycemic and body weight control with tirzepatide compared with insulin lispro, while tirzepatide was also associated with less clinically significant hypoglycemia.”

Weight improved for participants who received tirzepatide compared with those who received insulin lispro, at –10 kg and +4 kg respectively. The rate of clinically significant hypoglycemia (blood glucose < 54 mg/dL) or severe hypoglycemia was tenfold lower with tirzepatide, compared with insulin lispro.

The session dedicated to tirzepatide was comoderated by Apostolos Tsapas, MD, professor of medicine and diabetes, Aristotle University, Thessaloniki, Greece, and Konstantinos Toulis, MD, consultant in endocrinology and diabetes, General Military Hospital, Thessaloniki, Greece. Dr. Toulis remarked that, in the chronic disease setting, management and treatment intensification are challenging to integrate, and there are barriers to adoption in routine practice. “This is particularly true when it adds complexity, as in the case of multiple prandial insulin injections on top of basal insulin in suboptimally treated individuals with type 2 diabetes.

“Demonstrating superiority over insulin lispro in terms of the so-called trio of A1c, weight loss, and hypoglycemic events, tirzepatide offers both a simpler to adhere to and a more efficacious treatment intensification option.” He noted that, while long-term safety data are awaited, “this seems to be a definite step forward from any viewpoint, with the possible exception of the taxpayer’s perspective.”

Dr. Tsapas added: “These data further support the very high dual glucose and weight efficacy of tirzepatide and the primary role of incretin-related therapies amongst the injectables for the treatment of type 2 diabetes.”
 

Tirzepatide 5, 10, 15 mg vs. insulin lispro in addition to insulin glargine

The researchers aimed to assess the efficacy and safety of adding once-weekly tirzepatide, compared with thrice-daily prandial insulin lispro, as an adjunctive therapy to insulin glargine for patients with type 2 diabetes that was inadequately controlled with basal insulin.

Tirzepatide activates the body’s receptors for glucose-dependent insulinotropic polypeptide and glucagonlike peptide–1 (GLP-1). The study authors noted that “recent guidelines support adding an injectable incretin-related therapy such as GLP-1 receptor agonist for glycemic control, rather than basal insulin, when oral medications are inadequate.”

The open-label, phase 3b clinical trial drew data from 135 sites across 15 countries and included 1,428 adults with type 2 diabetes who were taking basal insulin. Participants were randomly assigned in a 1:1:1:3 ratio to receive once-weekly subcutaneous injections of tirzepatide (5 mg [n = 243], 10 mg [n = 238], or 15 mg [n = 236]) or prandial thrice-daily insulin lispro (n = 708).

Both arms were well matched. The average age was 60 years, and 60% of participants were women. The average amount of time patients had type 2 diabetes was 14 years; 85% of participants continued taking metformin. The average A1c level was 8.8% at baseline. Patients were categorized as having obesity (average body mass index, 33 kg/m²). The average insulin glargine dose was 46 units, or 0.5 units/kg.

Outcomes included noninferiority of tirzepatide (pooled cohort) compared with insulin lispro, both in addition to insulin glargine; and A1c change from baseline to week 52 (noninferiority margin, 0.3%). Key secondary endpoints included change in body weight and percentage of participants who achieved an A1c target of less than 7.0%.

About 90% of participants who received the study drug completed the study, said Dr. Frias. “Only 0.5% of tirzepatide patients needed rescue therapy, while only 2% of the insulin lispro did.”

Prior to optimization, the average insulin glargine dose was 42 IU/kg; during optimization, it rose to an average of 46 IU/kg. “At 52 weeks, those on basal-bolus insulin found their insulin glargine dose stayed flat while insulin lispro was 62 units,” reported Dr. Frias. “The three tirzepatide doses show a reduction in insulin glargine, such that the pooled dose reached an average of 11 units, while 20% actually came off their basal insulin altogether [pooled tirzepatide].”

Tirzepatide (pooled) led to the recommended A1c target of less than 7.0% for 68% of patients versus 36% of patients in the insulin lispro group.

About 68% of the patients who received tirzepatide (pooled) achieved the recommended A1c target of less than 7.0% versus 36% of patients in the insulin lispro group.

“Individual tirzepatide doses and pooled doses showed significant reduction in A1c and up to a 2.5% reduction,” Dr. Frias added. “Normoglycemia was obtained by a greater proportion of patients on tirzepatide doses versus basal-bolus insulin – one-third in the 15-mg tirzepatide dose.”
 

Body weight reduction of 10% or more with tirzepatide

Further, at week 52, weight loss of 5% or more was achieved by 75.4% of participants in the pooled tirzepatide group, compared with 6.3% in the prandial lispro group. The weight loss was accompanied by clinically relevant improvements in cardiometabolic parameters.

In an exploratory analysis, weight loss of 10% or more was achieved by a mean of 48.9% of pooled tirzepatide-treated participants at week 52, compared with 2% of those taking insulin lispro, said Dr. Frias.

“It is possible that the body weight loss induced by tirzepatide therapy and its reported effect in reducing liver fat content may have led to an improvement in insulin sensitivity and decreased insulin requirements,” wrote the researchers in their article.

Hypoglycemia risk and the weight gain observed with complex insulin regimens that include prandial insulin have been main limitations to optimally up-titrate insulin therapy in clinical practice, wrote the authors.

Dr. Frias noted that, in this study, 48% of patients who received insulin lispro experienced clinically significant hypoglycemia, while only 10% of patients in the tirzepatide arms did. “This was 0.4 episodes per patient-year versus 4.4 in tirzepatide and insulin lispro respectively.”

There were more reports of adverse events among the tirzepatide groups than the insulin lispro group. “Typically, with tirzepatide, the commonest adverse events were GI in origin and were mild to moderate.” Rates were 14%-26% for nausea, 11%-15% for diarrhea, and 5%-13% for vomiting.

The study was sponsored by Eli Lilly. Dr. Frias has received grants from Eli Lilly paid to his institution during the conduct of the study and grants, personal fees, or nonfinancial support from Boehringer Ingelheim, Pfizer, Merck, Altimmune, 89BIO, Akero, Carmot Therapeutics, Intercept, Janssen, Madrigal, Novartis, Eli Lilly, Sanofi, and Novo Nordisk outside the submitted work. Dr. Toulis and Dr. Tsapas declared no relevant disclosures.

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

HAMBURG, GERMANY – Once-weekly tirzepatide (Mounjaro, Lilly) added to insulin glargine resulted in greater reductions in hemoglobin A1c along with more weight loss and less hypoglycemia, compared with prandial insulin lispro (Humalog, Sanofi), for patients with inadequately controlled type 2 diabetes, show data from the SURPASS-6 randomized clinical trial.

Tirzepatide led to a statistically and clinically significant reduction in mean A1c, at −2.1%, compared with insulin lispro, at −1.1%, by week 52. It also resulted in a higher percentage of participants meeting an A1c target of less than 7.0%, wrote the researchers, whose study was presented at the annual meeting of the European Association for the Study of Diabetes and was published simultaneously in JAMA.

Also, daily insulin glargine use was substantially lower among participants who received tirzepatide, compared with insulin lispro. Insulin glargine was administered at a dosage 13 IU/day; insulin lispro was administered at a dosage of 62 IU/day. “At the highest dose, some patients stopped their insulin [glargine] in the tirzepatide arm,” said Juan Pablo Frias, MD, medical director and principal investigator of Velocity Clinical Research, Los Angeles, who presented the findings. “We demonstrated clinically meaningful and superior glycemic and body weight control with tirzepatide compared with insulin lispro, while tirzepatide was also associated with less clinically significant hypoglycemia.”

Weight improved for participants who received tirzepatide compared with those who received insulin lispro, at –10 kg and +4 kg respectively. The rate of clinically significant hypoglycemia (blood glucose < 54 mg/dL) or severe hypoglycemia was tenfold lower with tirzepatide, compared with insulin lispro.

The session dedicated to tirzepatide was comoderated by Apostolos Tsapas, MD, professor of medicine and diabetes, Aristotle University, Thessaloniki, Greece, and Konstantinos Toulis, MD, consultant in endocrinology and diabetes, General Military Hospital, Thessaloniki, Greece. Dr. Toulis remarked that, in the chronic disease setting, management and treatment intensification are challenging to integrate, and there are barriers to adoption in routine practice. “This is particularly true when it adds complexity, as in the case of multiple prandial insulin injections on top of basal insulin in suboptimally treated individuals with type 2 diabetes.

“Demonstrating superiority over insulin lispro in terms of the so-called trio of A1c, weight loss, and hypoglycemic events, tirzepatide offers both a simpler to adhere to and a more efficacious treatment intensification option.” He noted that, while long-term safety data are awaited, “this seems to be a definite step forward from any viewpoint, with the possible exception of the taxpayer’s perspective.”

Dr. Tsapas added: “These data further support the very high dual glucose and weight efficacy of tirzepatide and the primary role of incretin-related therapies amongst the injectables for the treatment of type 2 diabetes.”
 

Tirzepatide 5, 10, 15 mg vs. insulin lispro in addition to insulin glargine

The researchers aimed to assess the efficacy and safety of adding once-weekly tirzepatide, compared with thrice-daily prandial insulin lispro, as an adjunctive therapy to insulin glargine for patients with type 2 diabetes that was inadequately controlled with basal insulin.

Tirzepatide activates the body’s receptors for glucose-dependent insulinotropic polypeptide and glucagonlike peptide–1 (GLP-1). The study authors noted that “recent guidelines support adding an injectable incretin-related therapy such as GLP-1 receptor agonist for glycemic control, rather than basal insulin, when oral medications are inadequate.”

The open-label, phase 3b clinical trial drew data from 135 sites across 15 countries and included 1,428 adults with type 2 diabetes who were taking basal insulin. Participants were randomly assigned in a 1:1:1:3 ratio to receive once-weekly subcutaneous injections of tirzepatide (5 mg [n = 243], 10 mg [n = 238], or 15 mg [n = 236]) or prandial thrice-daily insulin lispro (n = 708).

Both arms were well matched. The average age was 60 years, and 60% of participants were women. The average amount of time patients had type 2 diabetes was 14 years; 85% of participants continued taking metformin. The average A1c level was 8.8% at baseline. Patients were categorized as having obesity (average body mass index, 33 kg/m²). The average insulin glargine dose was 46 units, or 0.5 units/kg.

Outcomes included noninferiority of tirzepatide (pooled cohort) compared with insulin lispro, both in addition to insulin glargine; and A1c change from baseline to week 52 (noninferiority margin, 0.3%). Key secondary endpoints included change in body weight and percentage of participants who achieved an A1c target of less than 7.0%.

About 90% of participants who received the study drug completed the study, said Dr. Frias. “Only 0.5% of tirzepatide patients needed rescue therapy, while only 2% of the insulin lispro did.”

Prior to optimization, the average insulin glargine dose was 42 IU/kg; during optimization, it rose to an average of 46 IU/kg. “At 52 weeks, those on basal-bolus insulin found their insulin glargine dose stayed flat while insulin lispro was 62 units,” reported Dr. Frias. “The three tirzepatide doses show a reduction in insulin glargine, such that the pooled dose reached an average of 11 units, while 20% actually came off their basal insulin altogether [pooled tirzepatide].”

Tirzepatide (pooled) led to the recommended A1c target of less than 7.0% for 68% of patients versus 36% of patients in the insulin lispro group.

About 68% of the patients who received tirzepatide (pooled) achieved the recommended A1c target of less than 7.0% versus 36% of patients in the insulin lispro group.

“Individual tirzepatide doses and pooled doses showed significant reduction in A1c and up to a 2.5% reduction,” Dr. Frias added. “Normoglycemia was obtained by a greater proportion of patients on tirzepatide doses versus basal-bolus insulin – one-third in the 15-mg tirzepatide dose.”
 

Body weight reduction of 10% or more with tirzepatide

Further, at week 52, weight loss of 5% or more was achieved by 75.4% of participants in the pooled tirzepatide group, compared with 6.3% in the prandial lispro group. The weight loss was accompanied by clinically relevant improvements in cardiometabolic parameters.

In an exploratory analysis, weight loss of 10% or more was achieved by a mean of 48.9% of pooled tirzepatide-treated participants at week 52, compared with 2% of those taking insulin lispro, said Dr. Frias.

“It is possible that the body weight loss induced by tirzepatide therapy and its reported effect in reducing liver fat content may have led to an improvement in insulin sensitivity and decreased insulin requirements,” wrote the researchers in their article.

Hypoglycemia risk and the weight gain observed with complex insulin regimens that include prandial insulin have been main limitations to optimally up-titrate insulin therapy in clinical practice, wrote the authors.

Dr. Frias noted that, in this study, 48% of patients who received insulin lispro experienced clinically significant hypoglycemia, while only 10% of patients in the tirzepatide arms did. “This was 0.4 episodes per patient-year versus 4.4 in tirzepatide and insulin lispro respectively.”

There were more reports of adverse events among the tirzepatide groups than the insulin lispro group. “Typically, with tirzepatide, the commonest adverse events were GI in origin and were mild to moderate.” Rates were 14%-26% for nausea, 11%-15% for diarrhea, and 5%-13% for vomiting.

The study was sponsored by Eli Lilly. Dr. Frias has received grants from Eli Lilly paid to his institution during the conduct of the study and grants, personal fees, or nonfinancial support from Boehringer Ingelheim, Pfizer, Merck, Altimmune, 89BIO, Akero, Carmot Therapeutics, Intercept, Janssen, Madrigal, Novartis, Eli Lilly, Sanofi, and Novo Nordisk outside the submitted work. Dr. Toulis and Dr. Tsapas declared no relevant disclosures.

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

PHILADELPHIA – Cognitive behavioral therapy (CBT) was effective in addressing peri- and postmenopausal women’s sexual concerns, according to a small study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society). Four CBT sessions specifically focused on sexual concerns resulted in decreased sexual distress and concern, reduced depressive and menopausal symptoms, and increased sexual desire and functioning, as well as improved body image and relationship satisfaction.

An estimated 68%-87% of perimenopausal and postmenopausal women report sexual concerns, Sheryl Green, PhD, CPsych, an associate professor of psychiatry and behavioral neurosciences at McMaster University and a psychologist at St. Joseph’s Healthcare’s Women’s Health Concerns Clinic, both in Hamilton, Ont., told attendees at the meeting.

“Sexual concerns over the menopausal transition are not just physical, but they’re also psychological and emotional,” Dr. Green said. “Three common challenges include decreased sexual desire, a reduction in physical arousal and ability to achieve an orgasm, and sexual pain and discomfort during intercourse.”

The reasons for these concerns are multifactorial, she said. Decreased sexual desire can stem from stress, medical problems, their relationship with their partner, or other causes. A woman’s difficulty with reduced physical arousal or ability to have an orgasm can result from changes in hormone levels and vaginal changes, such as vaginal atrophy, which can also contribute to the sexual pain or discomfort reported by 17%-45% of postmenopausal women.

Two pharmacologic treatments exist for sexual concerns: oral flibanserin (Addyi) and injectable bremelanotide (Vyleesi). But many women may be unable or unwilling to take medication for their concerns. Previous research from Lori Brotto has found cognitive behavioral therapy and mindfulness interventions to effectively improve sexual functioning in women treated for gynecologic cancer and in women without a history of cancer.

“Sexual function needs to be understood from a bio-psychosocial model, looking at the biologic factors, the psychological factors, the sociocultural factors, and the interpersonal factors,” Sheryl Kingsberg, PhD, a professor of psychiatry and reproductive biology at Case Western Reserve University and a psychologist at University Hospitals in Cleveland, said in an interview.

“They can all overlap, and the clinician can ask a few pointed questions that help identify what the source of the problem is,” said Dr. Kingsberg, who was not involved in this study. She noted that the International Society for the Study of Women’s Sexual Health has an algorithm that can help in determining the source of the problems.

“Sometimes it’s going to be a biologic condition for which pharmacologic options are nice, but even if it is primarily pharmacologic, psychotherapy is always useful,” Dr. Kingsberg said. “Once the problem is there, even if it’s biologically based, then you have all the things in terms of the cognitive distortion, anxiety,” and other issues that a cognitive behavioral approach can help address. “And access is now much wider because of telehealth,” she added.
 

‘Psychology of menopause’

The study led by Dr. Green focused on peri- and postmenopausal women, with an average age of 50, who were experiencing primary sexual concerns based on a score of at least 26 on the Female Sexual Function Index (FSFI). Among the 20 women recruited for the study, 6 had already been prescribed hormone therapy for sexual concerns.

All reported decreased sexual desire, 17 reported decreased sexual arousal, 14 had body image dissatisfaction related to sexual concerns, and 6 reported urogenital problems. Nine of the women were in full remission from major depressive disorder, one had post-traumatic stress syndrome, and one had subclinical generalized anxiety disorder.

After spending 4 weeks on a wait list as self-control group for the study, the 15 women who completed the trial underwent four individual CBT sessions focusing on sexual concerns. The first session focused on psychoeducation and thought monitoring, and the second focused on cognitive distortions, cognitive strategies, and unhelpful beliefs or expectations related to sexual concerns. The third session looked at the role of problematic behaviors and behavioral experiments, and the fourth focused on continuation of strategies, long-term goals, and maintaining gains.

The participants completed eight measures at baseline, after the 4 weeks on the wait list, and after the four CBT sessions to assess the following:

• Sexual satisfaction, distress, and desire, using the FSFI, the Female Sexual Distress Scale-Revised (FSDS-R), and the Female Sexual Desire Questionnaire (FSDQ).
• Menopause symptoms, using the Greene Climacteric Scale (GCS).
• Body image, using the Dresden Body Image Questionnaire (DBIQ).
• Relationship satisfaction, using the Couples Satisfaction Index (CSI).
• Depression, using the Beck Depression Inventory-II (BDI-II).
• Anxiety, using the Hamilton Anxiety Rating Scale (HAM-A).

The women did not experience any significant changes while on the wait list except a slight decrease on the FSDQ concern subscale. Following the CBT sessions, however, the women experienced a significant decrease in sexual distress and concern as well as an increase in sexual dyadic desire and sexual functioning (P = .003 for FSFI, P = .002 for FSDS-R, and P = .003 for FSDQ).

Participants also experienced a decrease in depression (P < .0001) and menopausal symptoms (P = .001) and an increase in body-image satisfaction (P = .018) and relationship satisfaction (P = .0011) after the CBT sessions. The researchers assessed participants’ satisfaction with the Client Satisfaction Questionnaire after the CBT sessions and reported some of the qualitative findings.

“The treatment program was able to assist me with recognizing that some of my sexual concerns were normal, emotional as well as physical and hormonal, and provided me the ability to delve more deeply into the psychology of menopause and how to work through symptoms and concerns in more manageable pieces,” one participant wrote. Another found helpful the “homework exercises of recognizing a thought/feeling/emotion surrounding how I feel about myself/body and working through. More positive thought pattern/restructuring a response the most helpful.”

The main complaint about the program was that it was too short, with women wanting more sessions to help continue their progress.
 

Not an ‘either-or’ approach

Dr. Kingsberg said ISSWSH has a variety of sexual medicine practitioners, including providers who can provide CBT for sexual concerns, and the American Association of Sexuality Educators, Counselors and Therapists has a referral directory.

“Keeping in mind the bio-psychosocial model, sometimes psychotherapy is going to be a really effective treatment for sexual concerns,” Dr. Kingsberg said. “Sometimes the pharmacologic option is going to be a really effective treatment for some concerns, and sometimes the combination is going to have a really nice treatment effect. So it’s not a one-size-fits-all, and it doesn’t have to be an either-or.”

The sexual concerns of women still do not get adequately addressed in medical schools and residencies, Dr. Kingsberg said, which is distinctly different from how male sexual concerns are addressed in health care.

“Erectile dysfunction is kind of in the norm, and women are still a little hesitant to bring up their sexual concerns,” Dr. Kingsberg said. “They don’t know if it’s appropriate and they’re hoping that their clinician will ask.”

One way clinicians can do that is with a global question for all their patients: “Most of my patients have sexual questions or concerns; what concerns do you have?”

“They don’t have to go through a checklist of 10 things,” Dr. Kingsberg said. If the patient does not bring anything up, providers can then ask a single follow up question: “Do you have any concerns with desire, arousal, orgasm, or pain?” That question, Dr. Kingsberg said, covers the four main areas of concern.

The study was funded by the Canadian Institute of Health Research. Dr. Green reported no disclosures. Dr. Kingsberg has consulted for or served on the advisory board for Alloy, Astellas, Bayer, Dare Bioscience, Freya, Reunion Neuroscience, Materna Medical, Madorra, Palatin, Pfizer, ReJoy, Sprout, Strategic Science Technologies, and MsMedicine.

PHILADELPHIA – Cognitive behavioral therapy (CBT) was effective in addressing peri- and postmenopausal women’s sexual concerns, according to a small study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society). Four CBT sessions specifically focused on sexual concerns resulted in decreased sexual distress and concern, reduced depressive and menopausal symptoms, and increased sexual desire and functioning, as well as improved body image and relationship satisfaction.

An estimated 68%-87% of perimenopausal and postmenopausal women report sexual concerns, Sheryl Green, PhD, CPsych, an associate professor of psychiatry and behavioral neurosciences at McMaster University and a psychologist at St. Joseph’s Healthcare’s Women’s Health Concerns Clinic, both in Hamilton, Ont., told attendees at the meeting.

“Sexual concerns over the menopausal transition are not just physical, but they’re also psychological and emotional,” Dr. Green said. “Three common challenges include decreased sexual desire, a reduction in physical arousal and ability to achieve an orgasm, and sexual pain and discomfort during intercourse.”

The reasons for these concerns are multifactorial, she said. Decreased sexual desire can stem from stress, medical problems, their relationship with their partner, or other causes. A woman’s difficulty with reduced physical arousal or ability to have an orgasm can result from changes in hormone levels and vaginal changes, such as vaginal atrophy, which can also contribute to the sexual pain or discomfort reported by 17%-45% of postmenopausal women.

Two pharmacologic treatments exist for sexual concerns: oral flibanserin (Addyi) and injectable bremelanotide (Vyleesi). But many women may be unable or unwilling to take medication for their concerns. Previous research from Lori Brotto has found cognitive behavioral therapy and mindfulness interventions to effectively improve sexual functioning in women treated for gynecologic cancer and in women without a history of cancer.

“Sexual function needs to be understood from a bio-psychosocial model, looking at the biologic factors, the psychological factors, the sociocultural factors, and the interpersonal factors,” Sheryl Kingsberg, PhD, a professor of psychiatry and reproductive biology at Case Western Reserve University and a psychologist at University Hospitals in Cleveland, said in an interview.

“They can all overlap, and the clinician can ask a few pointed questions that help identify what the source of the problem is,” said Dr. Kingsberg, who was not involved in this study. She noted that the International Society for the Study of Women’s Sexual Health has an algorithm that can help in determining the source of the problems.

“Sometimes it’s going to be a biologic condition for which pharmacologic options are nice, but even if it is primarily pharmacologic, psychotherapy is always useful,” Dr. Kingsberg said. “Once the problem is there, even if it’s biologically based, then you have all the things in terms of the cognitive distortion, anxiety,” and other issues that a cognitive behavioral approach can help address. “And access is now much wider because of telehealth,” she added.
 

‘Psychology of menopause’

The study led by Dr. Green focused on peri- and postmenopausal women, with an average age of 50, who were experiencing primary sexual concerns based on a score of at least 26 on the Female Sexual Function Index (FSFI). Among the 20 women recruited for the study, 6 had already been prescribed hormone therapy for sexual concerns.

All reported decreased sexual desire, 17 reported decreased sexual arousal, 14 had body image dissatisfaction related to sexual concerns, and 6 reported urogenital problems. Nine of the women were in full remission from major depressive disorder, one had post-traumatic stress syndrome, and one had subclinical generalized anxiety disorder.

After spending 4 weeks on a wait list as self-control group for the study, the 15 women who completed the trial underwent four individual CBT sessions focusing on sexual concerns. The first session focused on psychoeducation and thought monitoring, and the second focused on cognitive distortions, cognitive strategies, and unhelpful beliefs or expectations related to sexual concerns. The third session looked at the role of problematic behaviors and behavioral experiments, and the fourth focused on continuation of strategies, long-term goals, and maintaining gains.

The participants completed eight measures at baseline, after the 4 weeks on the wait list, and after the four CBT sessions to assess the following:

• Sexual satisfaction, distress, and desire, using the FSFI, the Female Sexual Distress Scale-Revised (FSDS-R), and the Female Sexual Desire Questionnaire (FSDQ).
• Menopause symptoms, using the Greene Climacteric Scale (GCS).
• Body image, using the Dresden Body Image Questionnaire (DBIQ).
• Relationship satisfaction, using the Couples Satisfaction Index (CSI).
• Depression, using the Beck Depression Inventory-II (BDI-II).
• Anxiety, using the Hamilton Anxiety Rating Scale (HAM-A).

The women did not experience any significant changes while on the wait list except a slight decrease on the FSDQ concern subscale. Following the CBT sessions, however, the women experienced a significant decrease in sexual distress and concern as well as an increase in sexual dyadic desire and sexual functioning (P = .003 for FSFI, P = .002 for FSDS-R, and P = .003 for FSDQ).

Participants also experienced a decrease in depression (P < .0001) and menopausal symptoms (P = .001) and an increase in body-image satisfaction (P = .018) and relationship satisfaction (P = .0011) after the CBT sessions. The researchers assessed participants’ satisfaction with the Client Satisfaction Questionnaire after the CBT sessions and reported some of the qualitative findings.

“The treatment program was able to assist me with recognizing that some of my sexual concerns were normal, emotional as well as physical and hormonal, and provided me the ability to delve more deeply into the psychology of menopause and how to work through symptoms and concerns in more manageable pieces,” one participant wrote. Another found helpful the “homework exercises of recognizing a thought/feeling/emotion surrounding how I feel about myself/body and working through. More positive thought pattern/restructuring a response the most helpful.”

The main complaint about the program was that it was too short, with women wanting more sessions to help continue their progress.
 

Not an ‘either-or’ approach

Dr. Kingsberg said ISSWSH has a variety of sexual medicine practitioners, including providers who can provide CBT for sexual concerns, and the American Association of Sexuality Educators, Counselors and Therapists has a referral directory.

“Keeping in mind the bio-psychosocial model, sometimes psychotherapy is going to be a really effective treatment for sexual concerns,” Dr. Kingsberg said. “Sometimes the pharmacologic option is going to be a really effective treatment for some concerns, and sometimes the combination is going to have a really nice treatment effect. So it’s not a one-size-fits-all, and it doesn’t have to be an either-or.”

The sexual concerns of women still do not get adequately addressed in medical schools and residencies, Dr. Kingsberg said, which is distinctly different from how male sexual concerns are addressed in health care.

“Erectile dysfunction is kind of in the norm, and women are still a little hesitant to bring up their sexual concerns,” Dr. Kingsberg said. “They don’t know if it’s appropriate and they’re hoping that their clinician will ask.”

One way clinicians can do that is with a global question for all their patients: “Most of my patients have sexual questions or concerns; what concerns do you have?”

“They don’t have to go through a checklist of 10 things,” Dr. Kingsberg said. If the patient does not bring anything up, providers can then ask a single follow up question: “Do you have any concerns with desire, arousal, orgasm, or pain?” That question, Dr. Kingsberg said, covers the four main areas of concern.

The study was funded by the Canadian Institute of Health Research. Dr. Green reported no disclosures. Dr. Kingsberg has consulted for or served on the advisory board for Alloy, Astellas, Bayer, Dare Bioscience, Freya, Reunion Neuroscience, Materna Medical, Madorra, Palatin, Pfizer, ReJoy, Sprout, Strategic Science Technologies, and MsMedicine.

PHILADELPHIA – Cognitive behavioral therapy (CBT) was effective in addressing peri- and postmenopausal women’s sexual concerns, according to a small study presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society). Four CBT sessions specifically focused on sexual concerns resulted in decreased sexual distress and concern, reduced depressive and menopausal symptoms, and increased sexual desire and functioning, as well as improved body image and relationship satisfaction.

An estimated 68%-87% of perimenopausal and postmenopausal women report sexual concerns, Sheryl Green, PhD, CPsych, an associate professor of psychiatry and behavioral neurosciences at McMaster University and a psychologist at St. Joseph’s Healthcare’s Women’s Health Concerns Clinic, both in Hamilton, Ont., told attendees at the meeting.

“Sexual concerns over the menopausal transition are not just physical, but they’re also psychological and emotional,” Dr. Green said. “Three common challenges include decreased sexual desire, a reduction in physical arousal and ability to achieve an orgasm, and sexual pain and discomfort during intercourse.”

The reasons for these concerns are multifactorial, she said. Decreased sexual desire can stem from stress, medical problems, their relationship with their partner, or other causes. A woman’s difficulty with reduced physical arousal or ability to have an orgasm can result from changes in hormone levels and vaginal changes, such as vaginal atrophy, which can also contribute to the sexual pain or discomfort reported by 17%-45% of postmenopausal women.

Two pharmacologic treatments exist for sexual concerns: oral flibanserin (Addyi) and injectable bremelanotide (Vyleesi). But many women may be unable or unwilling to take medication for their concerns. Previous research from Lori Brotto has found cognitive behavioral therapy and mindfulness interventions to effectively improve sexual functioning in women treated for gynecologic cancer and in women without a history of cancer.

“Sexual function needs to be understood from a bio-psychosocial model, looking at the biologic factors, the psychological factors, the sociocultural factors, and the interpersonal factors,” Sheryl Kingsberg, PhD, a professor of psychiatry and reproductive biology at Case Western Reserve University and a psychologist at University Hospitals in Cleveland, said in an interview.

“They can all overlap, and the clinician can ask a few pointed questions that help identify what the source of the problem is,” said Dr. Kingsberg, who was not involved in this study. She noted that the International Society for the Study of Women’s Sexual Health has an algorithm that can help in determining the source of the problems.

“Sometimes it’s going to be a biologic condition for which pharmacologic options are nice, but even if it is primarily pharmacologic, psychotherapy is always useful,” Dr. Kingsberg said. “Once the problem is there, even if it’s biologically based, then you have all the things in terms of the cognitive distortion, anxiety,” and other issues that a cognitive behavioral approach can help address. “And access is now much wider because of telehealth,” she added.
 

‘Psychology of menopause’

The study led by Dr. Green focused on peri- and postmenopausal women, with an average age of 50, who were experiencing primary sexual concerns based on a score of at least 26 on the Female Sexual Function Index (FSFI). Among the 20 women recruited for the study, 6 had already been prescribed hormone therapy for sexual concerns.

All reported decreased sexual desire, 17 reported decreased sexual arousal, 14 had body image dissatisfaction related to sexual concerns, and 6 reported urogenital problems. Nine of the women were in full remission from major depressive disorder, one had post-traumatic stress syndrome, and one had subclinical generalized anxiety disorder.

After spending 4 weeks on a wait list as self-control group for the study, the 15 women who completed the trial underwent four individual CBT sessions focusing on sexual concerns. The first session focused on psychoeducation and thought monitoring, and the second focused on cognitive distortions, cognitive strategies, and unhelpful beliefs or expectations related to sexual concerns. The third session looked at the role of problematic behaviors and behavioral experiments, and the fourth focused on continuation of strategies, long-term goals, and maintaining gains.

The participants completed eight measures at baseline, after the 4 weeks on the wait list, and after the four CBT sessions to assess the following:

• Sexual satisfaction, distress, and desire, using the FSFI, the Female Sexual Distress Scale-Revised (FSDS-R), and the Female Sexual Desire Questionnaire (FSDQ).
• Menopause symptoms, using the Greene Climacteric Scale (GCS).
• Body image, using the Dresden Body Image Questionnaire (DBIQ).
• Relationship satisfaction, using the Couples Satisfaction Index (CSI).
• Depression, using the Beck Depression Inventory-II (BDI-II).
• Anxiety, using the Hamilton Anxiety Rating Scale (HAM-A).

The women did not experience any significant changes while on the wait list except a slight decrease on the FSDQ concern subscale. Following the CBT sessions, however, the women experienced a significant decrease in sexual distress and concern as well as an increase in sexual dyadic desire and sexual functioning (P = .003 for FSFI, P = .002 for FSDS-R, and P = .003 for FSDQ).

Participants also experienced a decrease in depression (P < .0001) and menopausal symptoms (P = .001) and an increase in body-image satisfaction (P = .018) and relationship satisfaction (P = .0011) after the CBT sessions. The researchers assessed participants’ satisfaction with the Client Satisfaction Questionnaire after the CBT sessions and reported some of the qualitative findings.

“The treatment program was able to assist me with recognizing that some of my sexual concerns were normal, emotional as well as physical and hormonal, and provided me the ability to delve more deeply into the psychology of menopause and how to work through symptoms and concerns in more manageable pieces,” one participant wrote. Another found helpful the “homework exercises of recognizing a thought/feeling/emotion surrounding how I feel about myself/body and working through. More positive thought pattern/restructuring a response the most helpful.”

The main complaint about the program was that it was too short, with women wanting more sessions to help continue their progress.
 

Not an ‘either-or’ approach

Dr. Kingsberg said ISSWSH has a variety of sexual medicine practitioners, including providers who can provide CBT for sexual concerns, and the American Association of Sexuality Educators, Counselors and Therapists has a referral directory.

“Keeping in mind the bio-psychosocial model, sometimes psychotherapy is going to be a really effective treatment for sexual concerns,” Dr. Kingsberg said. “Sometimes the pharmacologic option is going to be a really effective treatment for some concerns, and sometimes the combination is going to have a really nice treatment effect. So it’s not a one-size-fits-all, and it doesn’t have to be an either-or.”

The sexual concerns of women still do not get adequately addressed in medical schools and residencies, Dr. Kingsberg said, which is distinctly different from how male sexual concerns are addressed in health care.

“Erectile dysfunction is kind of in the norm, and women are still a little hesitant to bring up their sexual concerns,” Dr. Kingsberg said. “They don’t know if it’s appropriate and they’re hoping that their clinician will ask.”

One way clinicians can do that is with a global question for all their patients: “Most of my patients have sexual questions or concerns; what concerns do you have?”

“They don’t have to go through a checklist of 10 things,” Dr. Kingsberg said. If the patient does not bring anything up, providers can then ask a single follow up question: “Do you have any concerns with desire, arousal, orgasm, or pain?” That question, Dr. Kingsberg said, covers the four main areas of concern.

The study was funded by the Canadian Institute of Health Research. Dr. Green reported no disclosures. Dr. Kingsberg has consulted for or served on the advisory board for Alloy, Astellas, Bayer, Dare Bioscience, Freya, Reunion Neuroscience, Materna Medical, Madorra, Palatin, Pfizer, ReJoy, Sprout, Strategic Science Technologies, and MsMedicine.

HAMBURG – Initiating metformin treatment at gestational diabetes diagnosis was associated with improved glycemic control and reduced gestational weight gain, according to the results of a randomized, placebo-controlled trial.

Overall, the trial’s primary outcome, a composite of insulin initiation or a fasting glucose level ≥ 5.1 mmol/L (92 mg/dL) at gestation weeks 32 or 38, did not differ between women with gestational diabetes randomly assigned to either placebo or metformin. However, women taking metformin were significantly less likely to require insulin and had significantly lower fasting blood glucose levels at weeks 32 and 38.

“With a composite outcome it’s more difficult to find a positive result ... So, although the primary composite outcome was not positive, the components of the primary outcome that are clinically meaningful were positive,” lead study author Fidelma Dunne, PhD, professor and endocrine consultant at the University of Galway, Ireland, said in an interview.

There were no differences in maternal or neonatal morbidities, but there was a nonsignificant increase in small for gestational age (SGA), a finding that has been seen in some but not all previous studies of metformin use in gestational diabetes.

Dr. Dunne presented the findings on Oct. 3 at the annual meeting of the European Association for the Study of Diabetes. The results were simultaneously published in JAMA.

Current recommendations from the United Kingdom’s National Institute for Health and Care Excellence say metformin is a suitable first-line therapy for gestational diabetes. However, both the American Diabetes Association and the Society of Maternal-Fetal Medicine do not, particularly for pregnancies with hypertension or preeclampsia or in those who are at risk for intrauterine growth restriction.

“Gestational diabetes is now reaching epidemic proportions. And of course, the vast majority of these women are in low- and middle-income countries where insulin might not be available, or the storage may not allow it to be used effectively. If you have a medication that in the majority of women is safe and effective it may actually help a lot of women in [those regions],” Dr. Dunne said.

Moreover, she noted, “women with gestational diabetes are testing their sugar with finger pricks four to seven times per day and we ask them to take insulin one to four times a day. So if you can relieve any of that pain related to treatment of their condition than that is a benefit for the women as well.”

Asked to comment, Katrien Benhalima, MD, PhD, of University Hospital Gasthuisberg, KU Leuven, Belgium, said, “I think it’s an interesting study because they investigated something novel, to initiate immediately metformin or placebo. Normally what we do with gestational diabetes is once we get the diagnosis, we treat them with lifestyle, and if that’s insufficient then we start with medical therapy. So this is a novel approach.”

She also agreed with Dr. Dunne that the lack of significance for the primary outcome “isn’t an issue of power but it is a composite outcome. If you look at the individual outcomes, as can be expected, the women taking metformin had less need for insulin treatment.”

But, Dr. Benhalima said, the study still leaves open the SGA issue. “It wasn’t significant, but it’s still something we are worried about in the sense that we feel we need more data, especially in the long-term for the offspring health ... You really need to follow them for 10 years or longer to see an effect.”

So for now, Dr. Benhalima said that she wouldn’t use metformin as a first-line treatment for gestational diabetes. “Normally if lifestyle isn’t enough we will still start insulin ... Another issue is why would you offer everybody medical treatment when pregnancy outcomes can be met with lifestyle alone?”

Then again, she added, “of course metformin is easier than an injection. Treatment satisfaction is improved, and the cost is less.”
 

Primary outcome didn’t differ, but study findings point toward metformin benefit

The double-blind, placebo-controlled trial was conducted at two sites in Ireland, with 510 individuals (535 gestational diabetes pregnancies) enrolled between June 2017 and September 2022. In addition to usual care, they were randomly assigned 1:1 to either placebo or metformin (maximum 2,500 mg) at the time of gestational diabetes diagnosis and continued until delivery.

The primary outcome, a composite of insulin initiation or a fasting glucose ≥ 5.1 mmol/L at gestation weeks 32 or 38, did not differ significantly between the two groups, with risk ratio 0.89 (P = 0.13).

Insulin initiation occurred in 38.4% of the metformin and 51.1% of the placebo groups (relative risk, 0.75, P = .004). The amount of insulin required at the last assessment prior to delivery did not differ between the two groups (P = .17).

Mean fasting glucose was significantly lower with metformin vs. placebo at gestational week 32 (4.9 vs. 5.0 mmol/L; P = .03) and at gestational week 38 (4.5 vs 4.7 mmol/L; P < .001).

On average, those in the metformin group gained less weight between randomization and delivery (0.8 kg vs. 2.0 kg; P = .003).

Gestational week at delivery didn’t differ between the groups, both 39.1 weeks, nor did preterm births prior to 37 weeks’ gestation (9.2% metformin vs. 6.5% placebo; P = .33) or any other pregnancy-related complications.

More participants in the metformin group said that they would choose the drug compared with placebo (76.2% vs. 67.1%, P = .04).

Mean birth weight was lower in the metformin group compared with placebo, 3,393 g vs. 3,506 g (P = .005), with fewer weighing > 4,000 g (7.6% vs. 14.8%; P = .02) or being large for gestational age, i.e., above the 90th percentile (6.5% vs. 14.9%; P = .003).

Proportions of offspring that were SGA (less than 10th percentile) were 5.7% in the metformin group vs. 2.7% with placebo (P = .13).

There were no other significant differences in neonatal variables.

Dr. Dunne told this news organization that her group has recently received funding for long-term follow-up of the SGA offspring. “As other papers have pointed out, if there’s any hint of SGA that’s really important to follow up. So we’re now beginning our longitudinal follow up of the mother and infants to see if the small number that were SGA will in fact turn out to have an increase in body mass index and weight in their childhood and adolescent years.”

The trial was funded by the Health Review Board (HRB) of Ireland, coordinated by the HRB-Clinical Research Facility Galway, and sponsored by the University of Galway, Ireland. Metformin and matched placebo were provided by Merck Healthcare KGaA, Darmstadt, Germany (operating as EMD Serono in the United States), and blood glucose monitoring strips were provided by Ascensia.

Dr. Dunne reported nonfinancial support from Merck and matched placebo and nonfinancial support from Ascensia during the conduct of the study. Dr. Benhalima receives research funds from Flemish Research Fund, study medication from Novo Nordisk, and devices and unrestricted grants from Medtronic and Dexcom.

A version of this article appeared on Medscape.com.

HAMBURG – Initiating metformin treatment at gestational diabetes diagnosis was associated with improved glycemic control and reduced gestational weight gain, according to the results of a randomized, placebo-controlled trial.

Overall, the trial’s primary outcome, a composite of insulin initiation or a fasting glucose level ≥ 5.1 mmol/L (92 mg/dL) at gestation weeks 32 or 38, did not differ between women with gestational diabetes randomly assigned to either placebo or metformin. However, women taking metformin were significantly less likely to require insulin and had significantly lower fasting blood glucose levels at weeks 32 and 38.

“With a composite outcome it’s more difficult to find a positive result ... So, although the primary composite outcome was not positive, the components of the primary outcome that are clinically meaningful were positive,” lead study author Fidelma Dunne, PhD, professor and endocrine consultant at the University of Galway, Ireland, said in an interview.

There were no differences in maternal or neonatal morbidities, but there was a nonsignificant increase in small for gestational age (SGA), a finding that has been seen in some but not all previous studies of metformin use in gestational diabetes.

Dr. Dunne presented the findings on Oct. 3 at the annual meeting of the European Association for the Study of Diabetes. The results were simultaneously published in JAMA.

Current recommendations from the United Kingdom’s National Institute for Health and Care Excellence say metformin is a suitable first-line therapy for gestational diabetes. However, both the American Diabetes Association and the Society of Maternal-Fetal Medicine do not, particularly for pregnancies with hypertension or preeclampsia or in those who are at risk for intrauterine growth restriction.

“Gestational diabetes is now reaching epidemic proportions. And of course, the vast majority of these women are in low- and middle-income countries where insulin might not be available, or the storage may not allow it to be used effectively. If you have a medication that in the majority of women is safe and effective it may actually help a lot of women in [those regions],” Dr. Dunne said.

Moreover, she noted, “women with gestational diabetes are testing their sugar with finger pricks four to seven times per day and we ask them to take insulin one to four times a day. So if you can relieve any of that pain related to treatment of their condition than that is a benefit for the women as well.”

Asked to comment, Katrien Benhalima, MD, PhD, of University Hospital Gasthuisberg, KU Leuven, Belgium, said, “I think it’s an interesting study because they investigated something novel, to initiate immediately metformin or placebo. Normally what we do with gestational diabetes is once we get the diagnosis, we treat them with lifestyle, and if that’s insufficient then we start with medical therapy. So this is a novel approach.”

She also agreed with Dr. Dunne that the lack of significance for the primary outcome “isn’t an issue of power but it is a composite outcome. If you look at the individual outcomes, as can be expected, the women taking metformin had less need for insulin treatment.”

But, Dr. Benhalima said, the study still leaves open the SGA issue. “It wasn’t significant, but it’s still something we are worried about in the sense that we feel we need more data, especially in the long-term for the offspring health ... You really need to follow them for 10 years or longer to see an effect.”

So for now, Dr. Benhalima said that she wouldn’t use metformin as a first-line treatment for gestational diabetes. “Normally if lifestyle isn’t enough we will still start insulin ... Another issue is why would you offer everybody medical treatment when pregnancy outcomes can be met with lifestyle alone?”

Then again, she added, “of course metformin is easier than an injection. Treatment satisfaction is improved, and the cost is less.”
 

Primary outcome didn’t differ, but study findings point toward metformin benefit

The double-blind, placebo-controlled trial was conducted at two sites in Ireland, with 510 individuals (535 gestational diabetes pregnancies) enrolled between June 2017 and September 2022. In addition to usual care, they were randomly assigned 1:1 to either placebo or metformin (maximum 2,500 mg) at the time of gestational diabetes diagnosis and continued until delivery.

The primary outcome, a composite of insulin initiation or a fasting glucose ≥ 5.1 mmol/L at gestation weeks 32 or 38, did not differ significantly between the two groups, with risk ratio 0.89 (P = 0.13).

Insulin initiation occurred in 38.4% of the metformin and 51.1% of the placebo groups (relative risk, 0.75, P = .004). The amount of insulin required at the last assessment prior to delivery did not differ between the two groups (P = .17).

Mean fasting glucose was significantly lower with metformin vs. placebo at gestational week 32 (4.9 vs. 5.0 mmol/L; P = .03) and at gestational week 38 (4.5 vs 4.7 mmol/L; P < .001).

On average, those in the metformin group gained less weight between randomization and delivery (0.8 kg vs. 2.0 kg; P = .003).

Gestational week at delivery didn’t differ between the groups, both 39.1 weeks, nor did preterm births prior to 37 weeks’ gestation (9.2% metformin vs. 6.5% placebo; P = .33) or any other pregnancy-related complications.

More participants in the metformin group said that they would choose the drug compared with placebo (76.2% vs. 67.1%, P = .04).

Mean birth weight was lower in the metformin group compared with placebo, 3,393 g vs. 3,506 g (P = .005), with fewer weighing > 4,000 g (7.6% vs. 14.8%; P = .02) or being large for gestational age, i.e., above the 90th percentile (6.5% vs. 14.9%; P = .003).

Proportions of offspring that were SGA (less than 10th percentile) were 5.7% in the metformin group vs. 2.7% with placebo (P = .13).

There were no other significant differences in neonatal variables.

Dr. Dunne told this news organization that her group has recently received funding for long-term follow-up of the SGA offspring. “As other papers have pointed out, if there’s any hint of SGA that’s really important to follow up. So we’re now beginning our longitudinal follow up of the mother and infants to see if the small number that were SGA will in fact turn out to have an increase in body mass index and weight in their childhood and adolescent years.”

The trial was funded by the Health Review Board (HRB) of Ireland, coordinated by the HRB-Clinical Research Facility Galway, and sponsored by the University of Galway, Ireland. Metformin and matched placebo were provided by Merck Healthcare KGaA, Darmstadt, Germany (operating as EMD Serono in the United States), and blood glucose monitoring strips were provided by Ascensia.

Dr. Dunne reported nonfinancial support from Merck and matched placebo and nonfinancial support from Ascensia during the conduct of the study. Dr. Benhalima receives research funds from Flemish Research Fund, study medication from Novo Nordisk, and devices and unrestricted grants from Medtronic and Dexcom.

A version of this article appeared on Medscape.com.

HAMBURG – Initiating metformin treatment at gestational diabetes diagnosis was associated with improved glycemic control and reduced gestational weight gain, according to the results of a randomized, placebo-controlled trial.

Overall, the trial’s primary outcome, a composite of insulin initiation or a fasting glucose level ≥ 5.1 mmol/L (92 mg/dL) at gestation weeks 32 or 38, did not differ between women with gestational diabetes randomly assigned to either placebo or metformin. However, women taking metformin were significantly less likely to require insulin and had significantly lower fasting blood glucose levels at weeks 32 and 38.

“With a composite outcome it’s more difficult to find a positive result ... So, although the primary composite outcome was not positive, the components of the primary outcome that are clinically meaningful were positive,” lead study author Fidelma Dunne, PhD, professor and endocrine consultant at the University of Galway, Ireland, said in an interview.

There were no differences in maternal or neonatal morbidities, but there was a nonsignificant increase in small for gestational age (SGA), a finding that has been seen in some but not all previous studies of metformin use in gestational diabetes.

Dr. Dunne presented the findings on Oct. 3 at the annual meeting of the European Association for the Study of Diabetes. The results were simultaneously published in JAMA.

Current recommendations from the United Kingdom’s National Institute for Health and Care Excellence say metformin is a suitable first-line therapy for gestational diabetes. However, both the American Diabetes Association and the Society of Maternal-Fetal Medicine do not, particularly for pregnancies with hypertension or preeclampsia or in those who are at risk for intrauterine growth restriction.

“Gestational diabetes is now reaching epidemic proportions. And of course, the vast majority of these women are in low- and middle-income countries where insulin might not be available, or the storage may not allow it to be used effectively. If you have a medication that in the majority of women is safe and effective it may actually help a lot of women in [those regions],” Dr. Dunne said.

Moreover, she noted, “women with gestational diabetes are testing their sugar with finger pricks four to seven times per day and we ask them to take insulin one to four times a day. So if you can relieve any of that pain related to treatment of their condition than that is a benefit for the women as well.”

Asked to comment, Katrien Benhalima, MD, PhD, of University Hospital Gasthuisberg, KU Leuven, Belgium, said, “I think it’s an interesting study because they investigated something novel, to initiate immediately metformin or placebo. Normally what we do with gestational diabetes is once we get the diagnosis, we treat them with lifestyle, and if that’s insufficient then we start with medical therapy. So this is a novel approach.”

She also agreed with Dr. Dunne that the lack of significance for the primary outcome “isn’t an issue of power but it is a composite outcome. If you look at the individual outcomes, as can be expected, the women taking metformin had less need for insulin treatment.”

But, Dr. Benhalima said, the study still leaves open the SGA issue. “It wasn’t significant, but it’s still something we are worried about in the sense that we feel we need more data, especially in the long-term for the offspring health ... You really need to follow them for 10 years or longer to see an effect.”

So for now, Dr. Benhalima said that she wouldn’t use metformin as a first-line treatment for gestational diabetes. “Normally if lifestyle isn’t enough we will still start insulin ... Another issue is why would you offer everybody medical treatment when pregnancy outcomes can be met with lifestyle alone?”

Then again, she added, “of course metformin is easier than an injection. Treatment satisfaction is improved, and the cost is less.”
 

Primary outcome didn’t differ, but study findings point toward metformin benefit

The double-blind, placebo-controlled trial was conducted at two sites in Ireland, with 510 individuals (535 gestational diabetes pregnancies) enrolled between June 2017 and September 2022. In addition to usual care, they were randomly assigned 1:1 to either placebo or metformin (maximum 2,500 mg) at the time of gestational diabetes diagnosis and continued until delivery.

The primary outcome, a composite of insulin initiation or a fasting glucose ≥ 5.1 mmol/L at gestation weeks 32 or 38, did not differ significantly between the two groups, with risk ratio 0.89 (P = 0.13).

Insulin initiation occurred in 38.4% of the metformin and 51.1% of the placebo groups (relative risk, 0.75, P = .004). The amount of insulin required at the last assessment prior to delivery did not differ between the two groups (P = .17).

Mean fasting glucose was significantly lower with metformin vs. placebo at gestational week 32 (4.9 vs. 5.0 mmol/L; P = .03) and at gestational week 38 (4.5 vs 4.7 mmol/L; P < .001).

On average, those in the metformin group gained less weight between randomization and delivery (0.8 kg vs. 2.0 kg; P = .003).

Gestational week at delivery didn’t differ between the groups, both 39.1 weeks, nor did preterm births prior to 37 weeks’ gestation (9.2% metformin vs. 6.5% placebo; P = .33) or any other pregnancy-related complications.

More participants in the metformin group said that they would choose the drug compared with placebo (76.2% vs. 67.1%, P = .04).

Mean birth weight was lower in the metformin group compared with placebo, 3,393 g vs. 3,506 g (P = .005), with fewer weighing > 4,000 g (7.6% vs. 14.8%; P = .02) or being large for gestational age, i.e., above the 90th percentile (6.5% vs. 14.9%; P = .003).

Proportions of offspring that were SGA (less than 10th percentile) were 5.7% in the metformin group vs. 2.7% with placebo (P = .13).

There were no other significant differences in neonatal variables.

Dr. Dunne told this news organization that her group has recently received funding for long-term follow-up of the SGA offspring. “As other papers have pointed out, if there’s any hint of SGA that’s really important to follow up. So we’re now beginning our longitudinal follow up of the mother and infants to see if the small number that were SGA will in fact turn out to have an increase in body mass index and weight in their childhood and adolescent years.”

The trial was funded by the Health Review Board (HRB) of Ireland, coordinated by the HRB-Clinical Research Facility Galway, and sponsored by the University of Galway, Ireland. Metformin and matched placebo were provided by Merck Healthcare KGaA, Darmstadt, Germany (operating as EMD Serono in the United States), and blood glucose monitoring strips were provided by Ascensia.

Dr. Dunne reported nonfinancial support from Merck and matched placebo and nonfinancial support from Ascensia during the conduct of the study. Dr. Benhalima receives research funds from Flemish Research Fund, study medication from Novo Nordisk, and devices and unrestricted grants from Medtronic and Dexcom.

A version of this article appeared on Medscape.com.