Clinical Endocrinology News

She went by the name “Dr. Roxy” on social media and became something of a sensation on TikTok, where she livestreamed her patients’ operations. Ultimately, however, plastic surgeon Katharine Roxanne Grawe, MD, lost her medical license based partly on her “life-altering, reckless treatment,” heightened by her social media fame. In July, the Ohio state medical board permanently revoked Dr. Grawe’s license after twice reprimanding her for her failure to meet the standard of care. The board also determined that, by livestreaming procedures, she placed her patients in danger of immediate and serious harm.

Although most doctors don’t use social media to the degree that Dr. Grawe did, using the various platforms – from X (formerly Twitter) to Facebook, Instagram, and TikTok – can be a slippery slope. Medscape’s Physician Behavior Report 2023 revealed that doctors have seen their share of unprofessional or offensive social media use from their peers. Nearly 7 in 10 said it is unethical for a doctor to act rudely, offensively, or unprofessionally on social media, even if their medical practice isn’t mentioned. As one physician put it: “Professional is not a 9-to-5 descriptor.”

In today’s world, social media use is almost a given. Doctors must tread cautiously when they approach it – maybe even more so. “There’s still a stigma attached,” said Liudmila Schafer, MD, an oncologist with The Doctor Connect, a career consulting firm. “Physicians face a tougher challenge due to societal expectations of perfection, with greater consequences for mistakes. We’re under constant ‘observation’ from peers, employers, and patients.”

Beverly Hills plastic surgeon Jay Calvert, MD, says he holds firm boundaries with how he uses social media. “I do comedy on the side, but it’s not acceptable for me as a doctor to share that on social media,” he said. “People want doctors who are professional, and I’m always concerned about how I present myself.”

Dr. Calvert said it is fairly easy to spot doctors who cross the line with social media. “You have to hold yourself back when posting. Doing things like dancing in the OR are out of whack with the profession.”

According to Dr. Schafer, a definite line to avoid crossing is offering medical advice or guidance on social media. “You also can’t discuss confidential practice details, respond to unfamiliar contacts, or discuss institutional policies without permission,” she said. “It’s important to add disclaimers if a personal scientific opinion is shared without reference [or] research or with unchecked sources.”
 

Navigating the many social media sites

Each social media platform has its pros and cons. Doctors need to determine why to use them and what the payback of each might be. Dr. Schafer uses multiple sites, including LinkedIn, Facebook, Instagram, X, Threads, YouTube, and, to a lesser degree, Clubhouse. How and what she posts on each varies. “I use them almost 95% professionally,” she said. “It’s challenging to meet and engage in person, so that is where social media helps.”

Stephen Pribut, MD, a Washington-based podiatrist, likes to use X as an information source. He follows pretty simple rules when it comes to what he tweets and shares on various sites: “I stay away from politics and religion,” he said. “I also avoid controversial topics online, such as vaccines.”

Joseph Daibes, DO, who specializes in cardiovascular medicine at New Jersey Heart and Vein, Clifton, said he has changed how he uses social media. “Initially, I was a passive consumer, but as I recognized the importance of accurate medical information online, I became more active in weighing in responsibly, occasionally sharing studies, debunking myths, and engaging in meaningful conversations,” he said. “Social media can get dangerous, so we have a duty to use it responsibly, and I cannot stress that enough.”

For plastic surgeons like Dr. Calvert, the visual platforms such as Instagram can prove invaluable for marketing purposes. “I’ve been using Instagram since 2012, and it’s been my most positive experience,” he said. “I don’t generate business from it, but I use it to back up my qualifications as a surgeon.”

Potential patients like to scroll through posts by plastic surgeons to learn what their finished product looks like, Dr. Calvert said. In many cases, plastic surgeons hire social media experts to cultivate their content. “I’ve hired and fired social media managers over the years, ultimately deciding I should develop my own content,” he said. “I want people to see the same doctor on social media that they will see in the office. I like an authentic presentation, not glitzy.”
 

Social media gone wrong

Dr. Calvert said that in the world of plastic surgery, some doctors use social media to present “before and after” compilations that in his opinion aren’t necessarily fully authentic, and this rubs him wrong. “There’s a bit of ‘cheating’ in some of these posts, using filters, making the ‘befores’ particularly bad, and other tricks,” he said.

Dr. Daibes has also seen his share of social media misuse: ”Red flags include oversharing personal indulgences, engaging in online spats, or making unfounded medical claims,” he said. “It’s essential to remember our role as educators and advocates, and to present ourselves in a way that upholds the dignity of our profession.”

At the end of the day, social media can have positive uses for physicians, and it is clearly here to stay. The onus for responsible use ultimately falls to the physicians using it.

Dr. Daibes emphasizes the fact that a doctor’s words carry weight – perhaps more so than those of other professionals. “The added scrutiny is good because it keeps us accountable; it’s crucial that our information is accurate,” he said. “The downside is that the scrutiny can be stifling at times and lead to self-censorship, even on nonmedical matters.”

Physicians have suggested eight guidelines for doctors to follow when using social media:

• Remember that you represent your profession, even if posting on personal accounts.
• Never post from the operating room, the emergency department, or any sort of medical space.
• If you’re employed, before you post, check with your employer to see whether they have any rules or guidance surrounding social media.
• Never use social media to badmouth colleagues, hospitals, or other healthcare organizations.
• Never use social media to dispense medical advice.
• Steer clear of the obvious hot-button issues, like religion and politics.
• Always protect patient privacy when posting.
• Be careful with how and whom you engage on social media.

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

She went by the name “Dr. Roxy” on social media and became something of a sensation on TikTok, where she livestreamed her patients’ operations. Ultimately, however, plastic surgeon Katharine Roxanne Grawe, MD, lost her medical license based partly on her “life-altering, reckless treatment,” heightened by her social media fame. In July, the Ohio state medical board permanently revoked Dr. Grawe’s license after twice reprimanding her for her failure to meet the standard of care. The board also determined that, by livestreaming procedures, she placed her patients in danger of immediate and serious harm.

Although most doctors don’t use social media to the degree that Dr. Grawe did, using the various platforms – from X (formerly Twitter) to Facebook, Instagram, and TikTok – can be a slippery slope. Medscape’s Physician Behavior Report 2023 revealed that doctors have seen their share of unprofessional or offensive social media use from their peers. Nearly 7 in 10 said it is unethical for a doctor to act rudely, offensively, or unprofessionally on social media, even if their medical practice isn’t mentioned. As one physician put it: “Professional is not a 9-to-5 descriptor.”

In today’s world, social media use is almost a given. Doctors must tread cautiously when they approach it – maybe even more so. “There’s still a stigma attached,” said Liudmila Schafer, MD, an oncologist with The Doctor Connect, a career consulting firm. “Physicians face a tougher challenge due to societal expectations of perfection, with greater consequences for mistakes. We’re under constant ‘observation’ from peers, employers, and patients.”

Beverly Hills plastic surgeon Jay Calvert, MD, says he holds firm boundaries with how he uses social media. “I do comedy on the side, but it’s not acceptable for me as a doctor to share that on social media,” he said. “People want doctors who are professional, and I’m always concerned about how I present myself.”

Dr. Calvert said it is fairly easy to spot doctors who cross the line with social media. “You have to hold yourself back when posting. Doing things like dancing in the OR are out of whack with the profession.”

According to Dr. Schafer, a definite line to avoid crossing is offering medical advice or guidance on social media. “You also can’t discuss confidential practice details, respond to unfamiliar contacts, or discuss institutional policies without permission,” she said. “It’s important to add disclaimers if a personal scientific opinion is shared without reference [or] research or with unchecked sources.”
 

Navigating the many social media sites

Each social media platform has its pros and cons. Doctors need to determine why to use them and what the payback of each might be. Dr. Schafer uses multiple sites, including LinkedIn, Facebook, Instagram, X, Threads, YouTube, and, to a lesser degree, Clubhouse. How and what she posts on each varies. “I use them almost 95% professionally,” she said. “It’s challenging to meet and engage in person, so that is where social media helps.”

Stephen Pribut, MD, a Washington-based podiatrist, likes to use X as an information source. He follows pretty simple rules when it comes to what he tweets and shares on various sites: “I stay away from politics and religion,” he said. “I also avoid controversial topics online, such as vaccines.”

Joseph Daibes, DO, who specializes in cardiovascular medicine at New Jersey Heart and Vein, Clifton, said he has changed how he uses social media. “Initially, I was a passive consumer, but as I recognized the importance of accurate medical information online, I became more active in weighing in responsibly, occasionally sharing studies, debunking myths, and engaging in meaningful conversations,” he said. “Social media can get dangerous, so we have a duty to use it responsibly, and I cannot stress that enough.”

For plastic surgeons like Dr. Calvert, the visual platforms such as Instagram can prove invaluable for marketing purposes. “I’ve been using Instagram since 2012, and it’s been my most positive experience,” he said. “I don’t generate business from it, but I use it to back up my qualifications as a surgeon.”

Potential patients like to scroll through posts by plastic surgeons to learn what their finished product looks like, Dr. Calvert said. In many cases, plastic surgeons hire social media experts to cultivate their content. “I’ve hired and fired social media managers over the years, ultimately deciding I should develop my own content,” he said. “I want people to see the same doctor on social media that they will see in the office. I like an authentic presentation, not glitzy.”
 

Social media gone wrong

Dr. Calvert said that in the world of plastic surgery, some doctors use social media to present “before and after” compilations that in his opinion aren’t necessarily fully authentic, and this rubs him wrong. “There’s a bit of ‘cheating’ in some of these posts, using filters, making the ‘befores’ particularly bad, and other tricks,” he said.

Dr. Daibes has also seen his share of social media misuse: ”Red flags include oversharing personal indulgences, engaging in online spats, or making unfounded medical claims,” he said. “It’s essential to remember our role as educators and advocates, and to present ourselves in a way that upholds the dignity of our profession.”

At the end of the day, social media can have positive uses for physicians, and it is clearly here to stay. The onus for responsible use ultimately falls to the physicians using it.

Dr. Daibes emphasizes the fact that a doctor’s words carry weight – perhaps more so than those of other professionals. “The added scrutiny is good because it keeps us accountable; it’s crucial that our information is accurate,” he said. “The downside is that the scrutiny can be stifling at times and lead to self-censorship, even on nonmedical matters.”

Physicians have suggested eight guidelines for doctors to follow when using social media:

• Remember that you represent your profession, even if posting on personal accounts.
• Never post from the operating room, the emergency department, or any sort of medical space.
• If you’re employed, before you post, check with your employer to see whether they have any rules or guidance surrounding social media.
• Never use social media to badmouth colleagues, hospitals, or other healthcare organizations.
• Never use social media to dispense medical advice.
• Steer clear of the obvious hot-button issues, like religion and politics.
• Always protect patient privacy when posting.
• Be careful with how and whom you engage on social media.

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

She went by the name “Dr. Roxy” on social media and became something of a sensation on TikTok, where she livestreamed her patients’ operations. Ultimately, however, plastic surgeon Katharine Roxanne Grawe, MD, lost her medical license based partly on her “life-altering, reckless treatment,” heightened by her social media fame. In July, the Ohio state medical board permanently revoked Dr. Grawe’s license after twice reprimanding her for her failure to meet the standard of care. The board also determined that, by livestreaming procedures, she placed her patients in danger of immediate and serious harm.

Although most doctors don’t use social media to the degree that Dr. Grawe did, using the various platforms – from X (formerly Twitter) to Facebook, Instagram, and TikTok – can be a slippery slope. Medscape’s Physician Behavior Report 2023 revealed that doctors have seen their share of unprofessional or offensive social media use from their peers. Nearly 7 in 10 said it is unethical for a doctor to act rudely, offensively, or unprofessionally on social media, even if their medical practice isn’t mentioned. As one physician put it: “Professional is not a 9-to-5 descriptor.”

In today’s world, social media use is almost a given. Doctors must tread cautiously when they approach it – maybe even more so. “There’s still a stigma attached,” said Liudmila Schafer, MD, an oncologist with The Doctor Connect, a career consulting firm. “Physicians face a tougher challenge due to societal expectations of perfection, with greater consequences for mistakes. We’re under constant ‘observation’ from peers, employers, and patients.”

Beverly Hills plastic surgeon Jay Calvert, MD, says he holds firm boundaries with how he uses social media. “I do comedy on the side, but it’s not acceptable for me as a doctor to share that on social media,” he said. “People want doctors who are professional, and I’m always concerned about how I present myself.”

Dr. Calvert said it is fairly easy to spot doctors who cross the line with social media. “You have to hold yourself back when posting. Doing things like dancing in the OR are out of whack with the profession.”

According to Dr. Schafer, a definite line to avoid crossing is offering medical advice or guidance on social media. “You also can’t discuss confidential practice details, respond to unfamiliar contacts, or discuss institutional policies without permission,” she said. “It’s important to add disclaimers if a personal scientific opinion is shared without reference [or] research or with unchecked sources.”
 

Navigating the many social media sites

Each social media platform has its pros and cons. Doctors need to determine why to use them and what the payback of each might be. Dr. Schafer uses multiple sites, including LinkedIn, Facebook, Instagram, X, Threads, YouTube, and, to a lesser degree, Clubhouse. How and what she posts on each varies. “I use them almost 95% professionally,” she said. “It’s challenging to meet and engage in person, so that is where social media helps.”

Stephen Pribut, MD, a Washington-based podiatrist, likes to use X as an information source. He follows pretty simple rules when it comes to what he tweets and shares on various sites: “I stay away from politics and religion,” he said. “I also avoid controversial topics online, such as vaccines.”

Joseph Daibes, DO, who specializes in cardiovascular medicine at New Jersey Heart and Vein, Clifton, said he has changed how he uses social media. “Initially, I was a passive consumer, but as I recognized the importance of accurate medical information online, I became more active in weighing in responsibly, occasionally sharing studies, debunking myths, and engaging in meaningful conversations,” he said. “Social media can get dangerous, so we have a duty to use it responsibly, and I cannot stress that enough.”

For plastic surgeons like Dr. Calvert, the visual platforms such as Instagram can prove invaluable for marketing purposes. “I’ve been using Instagram since 2012, and it’s been my most positive experience,” he said. “I don’t generate business from it, but I use it to back up my qualifications as a surgeon.”

Potential patients like to scroll through posts by plastic surgeons to learn what their finished product looks like, Dr. Calvert said. In many cases, plastic surgeons hire social media experts to cultivate their content. “I’ve hired and fired social media managers over the years, ultimately deciding I should develop my own content,” he said. “I want people to see the same doctor on social media that they will see in the office. I like an authentic presentation, not glitzy.”
 

Social media gone wrong

Dr. Calvert said that in the world of plastic surgery, some doctors use social media to present “before and after” compilations that in his opinion aren’t necessarily fully authentic, and this rubs him wrong. “There’s a bit of ‘cheating’ in some of these posts, using filters, making the ‘befores’ particularly bad, and other tricks,” he said.

Dr. Daibes has also seen his share of social media misuse: ”Red flags include oversharing personal indulgences, engaging in online spats, or making unfounded medical claims,” he said. “It’s essential to remember our role as educators and advocates, and to present ourselves in a way that upholds the dignity of our profession.”

At the end of the day, social media can have positive uses for physicians, and it is clearly here to stay. The onus for responsible use ultimately falls to the physicians using it.

Dr. Daibes emphasizes the fact that a doctor’s words carry weight – perhaps more so than those of other professionals. “The added scrutiny is good because it keeps us accountable; it’s crucial that our information is accurate,” he said. “The downside is that the scrutiny can be stifling at times and lead to self-censorship, even on nonmedical matters.”

Physicians have suggested eight guidelines for doctors to follow when using social media:

• Remember that you represent your profession, even if posting on personal accounts.
• Never post from the operating room, the emergency department, or any sort of medical space.
• If you’re employed, before you post, check with your employer to see whether they have any rules or guidance surrounding social media.
• Never use social media to badmouth colleagues, hospitals, or other healthcare organizations.
• Never use social media to dispense medical advice.
• Steer clear of the obvious hot-button issues, like religion and politics.
• Always protect patient privacy when posting.
• Be careful with how and whom you engage on social media.

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

Use of A1c levels for the diagnosis of type 2 diabetes (T2D) in women younger than 50 years may lead to underdiagnosis, owing to the effects of menstrual blood loss on A1c readings, shows the first study of its kind.

The analysis estimates that an additional 17% of undiagnosed women younger than 50 years could be reclassified as having T2D, and that women under 50 had an A1c distribution that was markedly lower than that of men under 50, by a mean of 1.6 mmol/mol.

In a study that will be presented at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), the researchers wanted to investigate whether a contributing factor to late diagnosis of T2D in women under 50 may be the difference in A1c levels due to hemoglobin replacement linked to menstrual blood loss.

The study was published online in Diabetes Therapy. “If the threshold for diagnosis of diabetes ... was lowered by 2 mmol/mol in women under the age of 50, an additional 17% of these women (approximately equivalent to 35,000 women in England and Wales) would be diagnosed with diabetes ... which may contribute to up to 64% of the difference in mortality rates between men/women with diabetes mellitus aged 16-50 years,” the researchers noted.

They added that A1c levels in women under 50 years were found to be consistently lower than those in men, and with A1c levels in women reaching the equivalent of those in men up to 10 years later, this “may result in delayed diagnosis of diabetes mellitus in premenopausal women.”

Noting that the study was observational, senior author Adrian Heald, MD, consultant endocrinologist, Salford (England) Royal NHS Foundation Trust, said that it “may be the case that prediabetes and type 2 diabetes in women are not being spotted because the set point needs to be slightly lower, but a systematic study sampling from the population of at-risk individuals is needed further to our findings.

“We also need to refer back to use of the glucose tolerance test, because A1c has been used for the past 15 years but it is not the gold standard,” added Dr. Heald. “Clinicians have often wondered if patients might be missed with A1c measurement, or even overdiagnosed.”

Lucy Chambers, PhD, from Diabetes UK, acknowledged that the research was valuable but added: “More research on sex differences in thresholds for a type 2 diagnosis is needed to inform any changes to clinical practice. In the meantime, we encourage clinicians to follow the current guidance of not ruling out type 2 diabetes based on a one-off A1c below the diagnostic threshold.”

But in support of greater understanding around the sex differences in A1c diagnostic thresholds, Dr. Chambers added: “Receiving an accurate and timely diagnosis ensures that women get the treatment and support needed to manage their type 2 diabetes and avoid long-term complications, including heart disease, where sex-based inequalities in care already contribute to poorer outcomes for women.” 
 

Effect of A1c reference range on T2D diagnosis and associated CVD

Compared with men, women with T2D have poorer glycemic control; a higher risk for cardiovascular (CV) complications; reduced life expectancy (5.3 years shorter vs. 4.5 years shorter); and a higher risk factor burden, such as obesity and hypertension at diagnosis.

In addition, T2D is a stronger risk factor for CV disease (CVD) in women than in men, and those aged 35-59 years who receive a diagnosis have the highest relative CV death risk across all age and sex groups.

The researchers pointed out that previous studies have observed differences in A1c relative to menopause, and they too found that “A1c levels rose after the age of 50 in women.”

However, they noted that the implication of differing A1c reference ranges on delayed diabetes diagnosis with worsening CV risk profile had not been previously recognized and that their study “[h]ighlights for the first time that, while 1.6 mmol/mol may appear only a small difference in terms of laboratory measurement, at population level this has implications for significant number of premenopausal women.”

The researchers initially observed the trend in local data in Salford, in the northwest of England. “These ... data highlighted that women seemed to be diagnosed with type 2 diabetes at an older age, so we wanted to examine what the source of that might be,” study author Mike Stedman, BSc, director, Res Consortium, Andover, England, said in an interview.

Dr. Stedman and his colleagues assessed the sex and age differences of A1c in individuals who had not been diagnosed with diabetes (A1c ≤ 48 mmol/mol [≤ 6.5%]). “We looked at data from other labs [in addition to those in Salford, totaling 938,678 people] to see if this was a local phenomenon. They could only provide more recent data, but these also showed a similar pattern,” he added.

Finally, Dr. Stedman, Dr. Heald, and their colleagues estimated the possible national impact by extrapolating findings based on population data from the UK Office of National Statistics and on National Diabetes Audit data for type 2 diabetes prevalence and related excess mortality. This brought them to the conclusion that T2D would be diagnosed in an additional 17% of women if the threshold were lowered by 2 mmol/mol, to 46 mmol/mol, in women under 50 years.
 

Lower A1c in women under 50 may delay T2D diagnosis by up to 10 years

The analysis found that the median A1c increased with age, with values in women younger than 50 years consistently being 1 mmol/mol lower than values in men. In contrast, A1c values in women over 50 years were equivalent to those in men.

However, at age 50 years, compared with men, A1c in women was found to lag by approximately 5 years. Women under 50 had an A1c distribution that was lower than that of men by an average of 1.6 mmol/mol (4.7% of mean; P < .0001), whereas this difference in individuals aged 50 years or older was less pronounced (P < .0001).

The authors wrote that “an undermeasurement of approximately 1.6 mmol/mol A1c in women may delay their diabetes ... diagnosis by up to 10 years.”

Further analysis showed that, at an A1c of 48 mmol/mol, 50% fewer women than men under the age of 50 could be diagnosed with T2D, whereas only 20% fewer women than men aged 50 years or older could be diagnosed with T2D.

Lowering the A1c threshold for diagnosis of T2D from 48 mmol/mol to 46 mmol/mol in women under 50 led to an estimate that an additional 35,345 undiagnosed women in England could be reclassified as having a T2D diagnosis.

The authors pointed out that “gender difference in adverse cardiovascular risk factors are known to be present prior to the development of [type 2] diabetes” and that “once diagnosed, atherosclerotic CVD prevalence is twice as high in patients with diabetes ... compared to those without a diagnosis.”

Dr. Heald added that there is always the possibility that other factors might be at play and that the work posed questions rather than presented answers.

Taking a pragmatic view, the researchers suggested that “one alternative approach may be to offer further assessment using fasting plasma glucose or oral glucose tolerance testing in those with A1c values of 46 or 47 mmol/mol.”

“In anyone with an early diagnosis of type 2 diabetes, in addition to dietary modification and especially if there is cardiovascular risk, then one might start them on metformin due to the cardiovascular benefits as well as the sugar-lowering effects,” said Dr. Heald, adding that “we certainly don’t want women missing out on metformin that could have huge benefits in the longer term.”

Dr. Stedman and Dr. Heald declared no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; and no other relationships or activities that could appear to have influenced the submitted work. Dr. Chambers has declared no conflicts.

A version of this article appeared on Medscape.com.

Use of A1c levels for the diagnosis of type 2 diabetes (T2D) in women younger than 50 years may lead to underdiagnosis, owing to the effects of menstrual blood loss on A1c readings, shows the first study of its kind.

The analysis estimates that an additional 17% of undiagnosed women younger than 50 years could be reclassified as having T2D, and that women under 50 had an A1c distribution that was markedly lower than that of men under 50, by a mean of 1.6 mmol/mol.

In a study that will be presented at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), the researchers wanted to investigate whether a contributing factor to late diagnosis of T2D in women under 50 may be the difference in A1c levels due to hemoglobin replacement linked to menstrual blood loss.

The study was published online in Diabetes Therapy. “If the threshold for diagnosis of diabetes ... was lowered by 2 mmol/mol in women under the age of 50, an additional 17% of these women (approximately equivalent to 35,000 women in England and Wales) would be diagnosed with diabetes ... which may contribute to up to 64% of the difference in mortality rates between men/women with diabetes mellitus aged 16-50 years,” the researchers noted.

They added that A1c levels in women under 50 years were found to be consistently lower than those in men, and with A1c levels in women reaching the equivalent of those in men up to 10 years later, this “may result in delayed diagnosis of diabetes mellitus in premenopausal women.”

Noting that the study was observational, senior author Adrian Heald, MD, consultant endocrinologist, Salford (England) Royal NHS Foundation Trust, said that it “may be the case that prediabetes and type 2 diabetes in women are not being spotted because the set point needs to be slightly lower, but a systematic study sampling from the population of at-risk individuals is needed further to our findings.

“We also need to refer back to use of the glucose tolerance test, because A1c has been used for the past 15 years but it is not the gold standard,” added Dr. Heald. “Clinicians have often wondered if patients might be missed with A1c measurement, or even overdiagnosed.”

Lucy Chambers, PhD, from Diabetes UK, acknowledged that the research was valuable but added: “More research on sex differences in thresholds for a type 2 diagnosis is needed to inform any changes to clinical practice. In the meantime, we encourage clinicians to follow the current guidance of not ruling out type 2 diabetes based on a one-off A1c below the diagnostic threshold.”

But in support of greater understanding around the sex differences in A1c diagnostic thresholds, Dr. Chambers added: “Receiving an accurate and timely diagnosis ensures that women get the treatment and support needed to manage their type 2 diabetes and avoid long-term complications, including heart disease, where sex-based inequalities in care already contribute to poorer outcomes for women.” 
 

Effect of A1c reference range on T2D diagnosis and associated CVD

Compared with men, women with T2D have poorer glycemic control; a higher risk for cardiovascular (CV) complications; reduced life expectancy (5.3 years shorter vs. 4.5 years shorter); and a higher risk factor burden, such as obesity and hypertension at diagnosis.

In addition, T2D is a stronger risk factor for CV disease (CVD) in women than in men, and those aged 35-59 years who receive a diagnosis have the highest relative CV death risk across all age and sex groups.

The researchers pointed out that previous studies have observed differences in A1c relative to menopause, and they too found that “A1c levels rose after the age of 50 in women.”

However, they noted that the implication of differing A1c reference ranges on delayed diabetes diagnosis with worsening CV risk profile had not been previously recognized and that their study “[h]ighlights for the first time that, while 1.6 mmol/mol may appear only a small difference in terms of laboratory measurement, at population level this has implications for significant number of premenopausal women.”

The researchers initially observed the trend in local data in Salford, in the northwest of England. “These ... data highlighted that women seemed to be diagnosed with type 2 diabetes at an older age, so we wanted to examine what the source of that might be,” study author Mike Stedman, BSc, director, Res Consortium, Andover, England, said in an interview.

Dr. Stedman and his colleagues assessed the sex and age differences of A1c in individuals who had not been diagnosed with diabetes (A1c ≤ 48 mmol/mol [≤ 6.5%]). “We looked at data from other labs [in addition to those in Salford, totaling 938,678 people] to see if this was a local phenomenon. They could only provide more recent data, but these also showed a similar pattern,” he added.

Finally, Dr. Stedman, Dr. Heald, and their colleagues estimated the possible national impact by extrapolating findings based on population data from the UK Office of National Statistics and on National Diabetes Audit data for type 2 diabetes prevalence and related excess mortality. This brought them to the conclusion that T2D would be diagnosed in an additional 17% of women if the threshold were lowered by 2 mmol/mol, to 46 mmol/mol, in women under 50 years.
 

Lower A1c in women under 50 may delay T2D diagnosis by up to 10 years

The analysis found that the median A1c increased with age, with values in women younger than 50 years consistently being 1 mmol/mol lower than values in men. In contrast, A1c values in women over 50 years were equivalent to those in men.

However, at age 50 years, compared with men, A1c in women was found to lag by approximately 5 years. Women under 50 had an A1c distribution that was lower than that of men by an average of 1.6 mmol/mol (4.7% of mean; P < .0001), whereas this difference in individuals aged 50 years or older was less pronounced (P < .0001).

The authors wrote that “an undermeasurement of approximately 1.6 mmol/mol A1c in women may delay their diabetes ... diagnosis by up to 10 years.”

Further analysis showed that, at an A1c of 48 mmol/mol, 50% fewer women than men under the age of 50 could be diagnosed with T2D, whereas only 20% fewer women than men aged 50 years or older could be diagnosed with T2D.

Lowering the A1c threshold for diagnosis of T2D from 48 mmol/mol to 46 mmol/mol in women under 50 led to an estimate that an additional 35,345 undiagnosed women in England could be reclassified as having a T2D diagnosis.

The authors pointed out that “gender difference in adverse cardiovascular risk factors are known to be present prior to the development of [type 2] diabetes” and that “once diagnosed, atherosclerotic CVD prevalence is twice as high in patients with diabetes ... compared to those without a diagnosis.”

Dr. Heald added that there is always the possibility that other factors might be at play and that the work posed questions rather than presented answers.

Taking a pragmatic view, the researchers suggested that “one alternative approach may be to offer further assessment using fasting plasma glucose or oral glucose tolerance testing in those with A1c values of 46 or 47 mmol/mol.”

“In anyone with an early diagnosis of type 2 diabetes, in addition to dietary modification and especially if there is cardiovascular risk, then one might start them on metformin due to the cardiovascular benefits as well as the sugar-lowering effects,” said Dr. Heald, adding that “we certainly don’t want women missing out on metformin that could have huge benefits in the longer term.”

Dr. Stedman and Dr. Heald declared no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; and no other relationships or activities that could appear to have influenced the submitted work. Dr. Chambers has declared no conflicts.

A version of this article appeared on Medscape.com.

Use of A1c levels for the diagnosis of type 2 diabetes (T2D) in women younger than 50 years may lead to underdiagnosis, owing to the effects of menstrual blood loss on A1c readings, shows the first study of its kind.

The analysis estimates that an additional 17% of undiagnosed women younger than 50 years could be reclassified as having T2D, and that women under 50 had an A1c distribution that was markedly lower than that of men under 50, by a mean of 1.6 mmol/mol.

In a study that will be presented at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), the researchers wanted to investigate whether a contributing factor to late diagnosis of T2D in women under 50 may be the difference in A1c levels due to hemoglobin replacement linked to menstrual blood loss.

The study was published online in Diabetes Therapy. “If the threshold for diagnosis of diabetes ... was lowered by 2 mmol/mol in women under the age of 50, an additional 17% of these women (approximately equivalent to 35,000 women in England and Wales) would be diagnosed with diabetes ... which may contribute to up to 64% of the difference in mortality rates between men/women with diabetes mellitus aged 16-50 years,” the researchers noted.

They added that A1c levels in women under 50 years were found to be consistently lower than those in men, and with A1c levels in women reaching the equivalent of those in men up to 10 years later, this “may result in delayed diagnosis of diabetes mellitus in premenopausal women.”

Noting that the study was observational, senior author Adrian Heald, MD, consultant endocrinologist, Salford (England) Royal NHS Foundation Trust, said that it “may be the case that prediabetes and type 2 diabetes in women are not being spotted because the set point needs to be slightly lower, but a systematic study sampling from the population of at-risk individuals is needed further to our findings.

“We also need to refer back to use of the glucose tolerance test, because A1c has been used for the past 15 years but it is not the gold standard,” added Dr. Heald. “Clinicians have often wondered if patients might be missed with A1c measurement, or even overdiagnosed.”

Lucy Chambers, PhD, from Diabetes UK, acknowledged that the research was valuable but added: “More research on sex differences in thresholds for a type 2 diagnosis is needed to inform any changes to clinical practice. In the meantime, we encourage clinicians to follow the current guidance of not ruling out type 2 diabetes based on a one-off A1c below the diagnostic threshold.”

But in support of greater understanding around the sex differences in A1c diagnostic thresholds, Dr. Chambers added: “Receiving an accurate and timely diagnosis ensures that women get the treatment and support needed to manage their type 2 diabetes and avoid long-term complications, including heart disease, where sex-based inequalities in care already contribute to poorer outcomes for women.” 
 

Effect of A1c reference range on T2D diagnosis and associated CVD

Compared with men, women with T2D have poorer glycemic control; a higher risk for cardiovascular (CV) complications; reduced life expectancy (5.3 years shorter vs. 4.5 years shorter); and a higher risk factor burden, such as obesity and hypertension at diagnosis.

In addition, T2D is a stronger risk factor for CV disease (CVD) in women than in men, and those aged 35-59 years who receive a diagnosis have the highest relative CV death risk across all age and sex groups.

The researchers pointed out that previous studies have observed differences in A1c relative to menopause, and they too found that “A1c levels rose after the age of 50 in women.”

However, they noted that the implication of differing A1c reference ranges on delayed diabetes diagnosis with worsening CV risk profile had not been previously recognized and that their study “[h]ighlights for the first time that, while 1.6 mmol/mol may appear only a small difference in terms of laboratory measurement, at population level this has implications for significant number of premenopausal women.”

The researchers initially observed the trend in local data in Salford, in the northwest of England. “These ... data highlighted that women seemed to be diagnosed with type 2 diabetes at an older age, so we wanted to examine what the source of that might be,” study author Mike Stedman, BSc, director, Res Consortium, Andover, England, said in an interview.

Dr. Stedman and his colleagues assessed the sex and age differences of A1c in individuals who had not been diagnosed with diabetes (A1c ≤ 48 mmol/mol [≤ 6.5%]). “We looked at data from other labs [in addition to those in Salford, totaling 938,678 people] to see if this was a local phenomenon. They could only provide more recent data, but these also showed a similar pattern,” he added.

Finally, Dr. Stedman, Dr. Heald, and their colleagues estimated the possible national impact by extrapolating findings based on population data from the UK Office of National Statistics and on National Diabetes Audit data for type 2 diabetes prevalence and related excess mortality. This brought them to the conclusion that T2D would be diagnosed in an additional 17% of women if the threshold were lowered by 2 mmol/mol, to 46 mmol/mol, in women under 50 years.
 

Lower A1c in women under 50 may delay T2D diagnosis by up to 10 years

The analysis found that the median A1c increased with age, with values in women younger than 50 years consistently being 1 mmol/mol lower than values in men. In contrast, A1c values in women over 50 years were equivalent to those in men.

However, at age 50 years, compared with men, A1c in women was found to lag by approximately 5 years. Women under 50 had an A1c distribution that was lower than that of men by an average of 1.6 mmol/mol (4.7% of mean; P < .0001), whereas this difference in individuals aged 50 years or older was less pronounced (P < .0001).

The authors wrote that “an undermeasurement of approximately 1.6 mmol/mol A1c in women may delay their diabetes ... diagnosis by up to 10 years.”

Further analysis showed that, at an A1c of 48 mmol/mol, 50% fewer women than men under the age of 50 could be diagnosed with T2D, whereas only 20% fewer women than men aged 50 years or older could be diagnosed with T2D.

Lowering the A1c threshold for diagnosis of T2D from 48 mmol/mol to 46 mmol/mol in women under 50 led to an estimate that an additional 35,345 undiagnosed women in England could be reclassified as having a T2D diagnosis.

The authors pointed out that “gender difference in adverse cardiovascular risk factors are known to be present prior to the development of [type 2] diabetes” and that “once diagnosed, atherosclerotic CVD prevalence is twice as high in patients with diabetes ... compared to those without a diagnosis.”

Dr. Heald added that there is always the possibility that other factors might be at play and that the work posed questions rather than presented answers.

Taking a pragmatic view, the researchers suggested that “one alternative approach may be to offer further assessment using fasting plasma glucose or oral glucose tolerance testing in those with A1c values of 46 or 47 mmol/mol.”

“In anyone with an early diagnosis of type 2 diabetes, in addition to dietary modification and especially if there is cardiovascular risk, then one might start them on metformin due to the cardiovascular benefits as well as the sugar-lowering effects,” said Dr. Heald, adding that “we certainly don’t want women missing out on metformin that could have huge benefits in the longer term.”

Dr. Stedman and Dr. Heald declared no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; and no other relationships or activities that could appear to have influenced the submitted work. Dr. Chambers has declared no conflicts.

A version of this article appeared on Medscape.com.

In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.

The scourge of antibiotic resistance

Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.

A pioneering approach: zoo poo as bioactive goldmine

Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.

What are bacteriophages?

Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).

Findings and future directions

Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.

While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising. Phages isolated from the feces could potentially be incorporated into dressings for ulcers, creating a novel treatment modality that is both effective and cost-saving.

We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.

The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.

This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.

Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.

The scourge of antibiotic resistance

Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.

A pioneering approach: zoo poo as bioactive goldmine

Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.

What are bacteriophages?

Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).

Findings and future directions

Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.

While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising. Phages isolated from the feces could potentially be incorporated into dressings for ulcers, creating a novel treatment modality that is both effective and cost-saving.

We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.

The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.

This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.

Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.

The scourge of antibiotic resistance

Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.

A pioneering approach: zoo poo as bioactive goldmine

Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.

What are bacteriophages?

Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).

Findings and future directions

Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.

While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising. Phages isolated from the feces could potentially be incorporated into dressings for ulcers, creating a novel treatment modality that is both effective and cost-saving.

We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.

The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.

This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.

Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Postoperative parathyroid hormone (PTH) showed 100% sensitivity in predicting postthyroidectomy hypocalcemia, according to the results of a prospective study of 60 patients.

Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.

In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.

During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”

Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.

The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.

The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.

“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.

“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.

The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.

So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.

The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.

“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
 

More proof of PTH’s predictive power

“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.

“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.

In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.

For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.” 

However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.

The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

Postoperative parathyroid hormone (PTH) showed 100% sensitivity in predicting postthyroidectomy hypocalcemia, according to the results of a prospective study of 60 patients.

Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.

In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.

During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”

Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.

The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.

The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.

“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.

“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.

The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.

So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.

The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.

“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
 

More proof of PTH’s predictive power

“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.

“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.

In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.

For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.” 

However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.

The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

Postoperative parathyroid hormone (PTH) showed 100% sensitivity in predicting postthyroidectomy hypocalcemia, according to the results of a prospective study of 60 patients.

Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.

In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.

During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”

Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.

The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.

The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.

“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.

“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.

The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.

So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.

The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.

“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
 

More proof of PTH’s predictive power

“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.

“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.

In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.

For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.” 

However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.

The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

TOPLINE:

Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.

METHODOLOGY:

• Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
• The trial was conducted between September 2021 and August 2022.

TAKEAWAY:

• Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
• The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
• Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
• No treatment-related severe adverse events were reported.

IN PRACTICE:

“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”

SOURCE:

Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.

DISCLOSURES:

The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.

A version of this article appeared on Medscape.com.

TOPLINE:

Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.

METHODOLOGY:

• Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
• The trial was conducted between September 2021 and August 2022.

TAKEAWAY:

• Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
• The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
• Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
• No treatment-related severe adverse events were reported.

IN PRACTICE:

“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”

SOURCE:

Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.

DISCLOSURES:

The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.

A version of this article appeared on Medscape.com.

TOPLINE:

Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.

METHODOLOGY:

• Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
• The trial was conducted between September 2021 and August 2022.

TAKEAWAY:

• Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
• The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
• Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
• No treatment-related severe adverse events were reported.

IN PRACTICE:

“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”

SOURCE:

Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.

DISCLOSURES:

The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.

A version of this article appeared on Medscape.com.

WASHINGTON – Adding the PD-1 inhibitor pembrolizumab to the established combination of dabrafenib and trametinib (DT) significantly improves survival outcomes in BRAF V600E-mutated anaplastic thyroid cancer - particularly when administered in a neoadjuvant fashion, prior to surgery. Overall survival rates in the study exceeded 5 years.

“The very long median overall survival in the study’s neoadjuvant group is quite remarkable for a group of patients who used to have a very poor prognosis,” senior author Maria E. Cabanillas, MD, associate professor in the department of endocrine neoplasia and hormonal disorders at the University of Texas MD Anderson Cancer Center in Houston, said in an interview.

“This median overall survival definitely exceeds any other treatments thus far in BRAF-mutated anaplastic thyroid cancer.”

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

Anaplastic thyroid cancer, though rare, is the most aggressive form of thyroid cancer. It accounts for just 1% of the cancers but causes about 50% of thyroid cancer mortality.

The historical median overall survival is 5-6 months.

With research in recent years showing that as many as 40% of anaplastic thyroid cancers harbor BRAF V600E mutations, the door has opened for potential benefits with the combination of the BRAF inhibitor dabrafenib with the MEK-inhibitor drug trametinib.

The treatment combination was shown in research that included the phase 2 ROAR trial to yield important responses. It was approved by the Food and Drug Administration in 2018 for locally advanced or metastatic BRAF V600E-mutant anaplastic thyroid cancer, as well as other cancers.

However, a key caveat of DT is that patients eventually develop resistance mutations, leading to disease progression.

To overcome the problem, Dr. Cabanillas and her team found two key strategies that show promise – the addition of immunotherapy, such as pembrolizumab to DT, and the use of a neoadjuvant approach, with surgery performed after an initial response to the triplet therapy.
 

Triple therapy showed highly favorable results

In a study presented at the 2022 ATA annual meeting, researchers reported on the triple therapy of BRAF/MEK inhibitors vemurafenib and cobimetinib plus immunotherapy with atezolizumab. Results were highly favorable, with an overall response rate of 72% and an impressive 2-year survival of 67%.

However, a major limitation was that the study lacked a control arm. In the current study, the addition of pembrolizumab to DT was compared with DT alone. The investigators also sought to determine the survival benefits of a neoadjuvant strategy.

For the study, first author Sarah Hamidi, MD, also of the MD Anderson Cancer Center, and her colleagues identified 94 patients with BRAF-mutated anaplastic thyroid cancer who were treated either with first‐line DT or DT plus pembrolizumab between 2014 and 2023, either outside of a trial or in a reported clinical trial.

The study compared three treatment regimens – DT alone (n = 23), DT with pembrolizumab added before or after disease progression (n = 48), and DT with neoadjuvant pembrolizumab added prior to or after surgery (n = 23).

There were no significant differences in baseline characteristics between the groups. Metastatic disease was present at the start of treatment among 87.0% of the DT group, 79.2% of the pembrolizumab group prior to or after disease progression, and 65.2% of the neoadjuvant pembrolizumab group.

The median follow-up of the three groups was 102 months, 28 months, and 42 months, respectively. The median overall survival was 9 months with DT alone, vs. 17 months with DT plus pembrolizumab before or after progression and 63 months with neoadjuvant pembrolizumab plus DT (P < .001).

The 12- and 24-month survival rates with DT alone were 33.7% and 28.9%, respectively; for DT plus pembrolizumab before or after progression, the rates were 60.2% and 36.5%; and for neoadjuvant pembrolizumab plus DT, the rates were 80.7% and 74.5%.

In an analysis that did not include the neoadjuvant group, median progression-free survival was significantly longer with DT plus pembrolizumab as an initial treatment (11.0 months) compared with DT alone (4.0 months; P  =  .049).

A subanalysis that evaluated the timing of the addition of pembrolizumab to DT before or after disease progression showed no significant differences between the two in median overall survival (17 months vs. 16 months; P = .554).

“This is valuable information, especially for centers where pembrolizumab cannot be easily obtained as a first-line therapy for anaplastic thyroid cancer,” Dr. Hamidi said in presenting the findings.

She noted, however, that the results should be interpreted with caution, given the small number of patients who received pembrolizumab before progression (n = 34) and especially after progression (n = 14).

In terms of safety, there were no grade 5 adverse events (AEs); 32.4% of patients experienced immune‐related AEs, most frequently, colitis and hepatitis.
 

Therapies “improve survival”

Overall, the results are important, Dr. Cabanillas said.

The results are “very exciting when you think about the fact that 10 years ago, patients with anaplastic thyroid cancer had a median overall survival measured in months, and now we see that those with a BRAF mutation have a real chance at survival when managed appropriately from the start,” she told this news organization.

She noted that a key caveat is the study’s retrospective nature. Other important considerations are that pembrolizumab adds toxicity as well as cost, and it is largely used off label in anaplastic thyroid cancer.

Nevertheless, “it does feel like there needs to be a call to action in the guidelines for this disease so that it includes neoadjuvant DT or DT plus pembrolizumab as the primary treatment of patients with BRAF-mutated anaplastic thyroid cancer because the initial treatment is critical here,” Dr. Cabanillas said.

She added that a phase 2 trial with neoadjuvant DT plus pembrolizumab is ongoing. Enrollment is expected to be completed soon.

Commenting on the findings, Sarimar Agosto Salgado, MD, of the department of head and neck – endocrine oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla., who was a comoderator of the session, said the results are encouraging.

“These findings are promising because they open the landscape of options of therapies that we can provide these patients,” she said in an interview.

“Anaplastic thyroid cancer has been a disease with a very short survival despite aggressive therapies, but we are seeing that not only have these therapies been able to improve survival but also patients’ quality of life.”

Particularly encouraging is how quickly the therapies can work, Dr. Salgado added.

“Many times when patients present to the clinic, the rapid response to these systemic therapies can even [allow them to avoid] having a tracheostomy, and we’re also seeing that some of these patients are able to go from unresectable disease to resectable disease, and then by having the main tumor out, their survival improves.

“So, this is definitely a big ray of hope for these patients.”

Dr. Cabanillas has received research funding from Merck. Dr. Hamidi has disclosed no relevant financial relationships. Dr. Salgado has relationships with Lilly and Exelixis.
 

A version of this article appeared on Medscape.com.

WASHINGTON – Adding the PD-1 inhibitor pembrolizumab to the established combination of dabrafenib and trametinib (DT) significantly improves survival outcomes in BRAF V600E-mutated anaplastic thyroid cancer - particularly when administered in a neoadjuvant fashion, prior to surgery. Overall survival rates in the study exceeded 5 years.

“The very long median overall survival in the study’s neoadjuvant group is quite remarkable for a group of patients who used to have a very poor prognosis,” senior author Maria E. Cabanillas, MD, associate professor in the department of endocrine neoplasia and hormonal disorders at the University of Texas MD Anderson Cancer Center in Houston, said in an interview.

“This median overall survival definitely exceeds any other treatments thus far in BRAF-mutated anaplastic thyroid cancer.”

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

Anaplastic thyroid cancer, though rare, is the most aggressive form of thyroid cancer. It accounts for just 1% of the cancers but causes about 50% of thyroid cancer mortality.

The historical median overall survival is 5-6 months.

With research in recent years showing that as many as 40% of anaplastic thyroid cancers harbor BRAF V600E mutations, the door has opened for potential benefits with the combination of the BRAF inhibitor dabrafenib with the MEK-inhibitor drug trametinib.

The treatment combination was shown in research that included the phase 2 ROAR trial to yield important responses. It was approved by the Food and Drug Administration in 2018 for locally advanced or metastatic BRAF V600E-mutant anaplastic thyroid cancer, as well as other cancers.

However, a key caveat of DT is that patients eventually develop resistance mutations, leading to disease progression.

To overcome the problem, Dr. Cabanillas and her team found two key strategies that show promise – the addition of immunotherapy, such as pembrolizumab to DT, and the use of a neoadjuvant approach, with surgery performed after an initial response to the triplet therapy.
 

Triple therapy showed highly favorable results

In a study presented at the 2022 ATA annual meeting, researchers reported on the triple therapy of BRAF/MEK inhibitors vemurafenib and cobimetinib plus immunotherapy with atezolizumab. Results were highly favorable, with an overall response rate of 72% and an impressive 2-year survival of 67%.

However, a major limitation was that the study lacked a control arm. In the current study, the addition of pembrolizumab to DT was compared with DT alone. The investigators also sought to determine the survival benefits of a neoadjuvant strategy.

For the study, first author Sarah Hamidi, MD, also of the MD Anderson Cancer Center, and her colleagues identified 94 patients with BRAF-mutated anaplastic thyroid cancer who were treated either with first‐line DT or DT plus pembrolizumab between 2014 and 2023, either outside of a trial or in a reported clinical trial.

The study compared three treatment regimens – DT alone (n = 23), DT with pembrolizumab added before or after disease progression (n = 48), and DT with neoadjuvant pembrolizumab added prior to or after surgery (n = 23).

There were no significant differences in baseline characteristics between the groups. Metastatic disease was present at the start of treatment among 87.0% of the DT group, 79.2% of the pembrolizumab group prior to or after disease progression, and 65.2% of the neoadjuvant pembrolizumab group.

The median follow-up of the three groups was 102 months, 28 months, and 42 months, respectively. The median overall survival was 9 months with DT alone, vs. 17 months with DT plus pembrolizumab before or after progression and 63 months with neoadjuvant pembrolizumab plus DT (P < .001).

The 12- and 24-month survival rates with DT alone were 33.7% and 28.9%, respectively; for DT plus pembrolizumab before or after progression, the rates were 60.2% and 36.5%; and for neoadjuvant pembrolizumab plus DT, the rates were 80.7% and 74.5%.

In an analysis that did not include the neoadjuvant group, median progression-free survival was significantly longer with DT plus pembrolizumab as an initial treatment (11.0 months) compared with DT alone (4.0 months; P  =  .049).

A subanalysis that evaluated the timing of the addition of pembrolizumab to DT before or after disease progression showed no significant differences between the two in median overall survival (17 months vs. 16 months; P = .554).

“This is valuable information, especially for centers where pembrolizumab cannot be easily obtained as a first-line therapy for anaplastic thyroid cancer,” Dr. Hamidi said in presenting the findings.

She noted, however, that the results should be interpreted with caution, given the small number of patients who received pembrolizumab before progression (n = 34) and especially after progression (n = 14).

In terms of safety, there were no grade 5 adverse events (AEs); 32.4% of patients experienced immune‐related AEs, most frequently, colitis and hepatitis.
 

Therapies “improve survival”

Overall, the results are important, Dr. Cabanillas said.

The results are “very exciting when you think about the fact that 10 years ago, patients with anaplastic thyroid cancer had a median overall survival measured in months, and now we see that those with a BRAF mutation have a real chance at survival when managed appropriately from the start,” she told this news organization.

She noted that a key caveat is the study’s retrospective nature. Other important considerations are that pembrolizumab adds toxicity as well as cost, and it is largely used off label in anaplastic thyroid cancer.

Nevertheless, “it does feel like there needs to be a call to action in the guidelines for this disease so that it includes neoadjuvant DT or DT plus pembrolizumab as the primary treatment of patients with BRAF-mutated anaplastic thyroid cancer because the initial treatment is critical here,” Dr. Cabanillas said.

She added that a phase 2 trial with neoadjuvant DT plus pembrolizumab is ongoing. Enrollment is expected to be completed soon.

Commenting on the findings, Sarimar Agosto Salgado, MD, of the department of head and neck – endocrine oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla., who was a comoderator of the session, said the results are encouraging.

“These findings are promising because they open the landscape of options of therapies that we can provide these patients,” she said in an interview.

“Anaplastic thyroid cancer has been a disease with a very short survival despite aggressive therapies, but we are seeing that not only have these therapies been able to improve survival but also patients’ quality of life.”

Particularly encouraging is how quickly the therapies can work, Dr. Salgado added.

“Many times when patients present to the clinic, the rapid response to these systemic therapies can even [allow them to avoid] having a tracheostomy, and we’re also seeing that some of these patients are able to go from unresectable disease to resectable disease, and then by having the main tumor out, their survival improves.

“So, this is definitely a big ray of hope for these patients.”

Dr. Cabanillas has received research funding from Merck. Dr. Hamidi has disclosed no relevant financial relationships. Dr. Salgado has relationships with Lilly and Exelixis.
 

A version of this article appeared on Medscape.com.

WASHINGTON – Adding the PD-1 inhibitor pembrolizumab to the established combination of dabrafenib and trametinib (DT) significantly improves survival outcomes in BRAF V600E-mutated anaplastic thyroid cancer - particularly when administered in a neoadjuvant fashion, prior to surgery. Overall survival rates in the study exceeded 5 years.

“The very long median overall survival in the study’s neoadjuvant group is quite remarkable for a group of patients who used to have a very poor prognosis,” senior author Maria E. Cabanillas, MD, associate professor in the department of endocrine neoplasia and hormonal disorders at the University of Texas MD Anderson Cancer Center in Houston, said in an interview.

“This median overall survival definitely exceeds any other treatments thus far in BRAF-mutated anaplastic thyroid cancer.”

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

Anaplastic thyroid cancer, though rare, is the most aggressive form of thyroid cancer. It accounts for just 1% of the cancers but causes about 50% of thyroid cancer mortality.

The historical median overall survival is 5-6 months.

With research in recent years showing that as many as 40% of anaplastic thyroid cancers harbor BRAF V600E mutations, the door has opened for potential benefits with the combination of the BRAF inhibitor dabrafenib with the MEK-inhibitor drug trametinib.

The treatment combination was shown in research that included the phase 2 ROAR trial to yield important responses. It was approved by the Food and Drug Administration in 2018 for locally advanced or metastatic BRAF V600E-mutant anaplastic thyroid cancer, as well as other cancers.

However, a key caveat of DT is that patients eventually develop resistance mutations, leading to disease progression.

To overcome the problem, Dr. Cabanillas and her team found two key strategies that show promise – the addition of immunotherapy, such as pembrolizumab to DT, and the use of a neoadjuvant approach, with surgery performed after an initial response to the triplet therapy.
 

Triple therapy showed highly favorable results

In a study presented at the 2022 ATA annual meeting, researchers reported on the triple therapy of BRAF/MEK inhibitors vemurafenib and cobimetinib plus immunotherapy with atezolizumab. Results were highly favorable, with an overall response rate of 72% and an impressive 2-year survival of 67%.

However, a major limitation was that the study lacked a control arm. In the current study, the addition of pembrolizumab to DT was compared with DT alone. The investigators also sought to determine the survival benefits of a neoadjuvant strategy.

For the study, first author Sarah Hamidi, MD, also of the MD Anderson Cancer Center, and her colleagues identified 94 patients with BRAF-mutated anaplastic thyroid cancer who were treated either with first‐line DT or DT plus pembrolizumab between 2014 and 2023, either outside of a trial or in a reported clinical trial.

The study compared three treatment regimens – DT alone (n = 23), DT with pembrolizumab added before or after disease progression (n = 48), and DT with neoadjuvant pembrolizumab added prior to or after surgery (n = 23).

There were no significant differences in baseline characteristics between the groups. Metastatic disease was present at the start of treatment among 87.0% of the DT group, 79.2% of the pembrolizumab group prior to or after disease progression, and 65.2% of the neoadjuvant pembrolizumab group.

The median follow-up of the three groups was 102 months, 28 months, and 42 months, respectively. The median overall survival was 9 months with DT alone, vs. 17 months with DT plus pembrolizumab before or after progression and 63 months with neoadjuvant pembrolizumab plus DT (P < .001).

The 12- and 24-month survival rates with DT alone were 33.7% and 28.9%, respectively; for DT plus pembrolizumab before or after progression, the rates were 60.2% and 36.5%; and for neoadjuvant pembrolizumab plus DT, the rates were 80.7% and 74.5%.

In an analysis that did not include the neoadjuvant group, median progression-free survival was significantly longer with DT plus pembrolizumab as an initial treatment (11.0 months) compared with DT alone (4.0 months; P  =  .049).

A subanalysis that evaluated the timing of the addition of pembrolizumab to DT before or after disease progression showed no significant differences between the two in median overall survival (17 months vs. 16 months; P = .554).

“This is valuable information, especially for centers where pembrolizumab cannot be easily obtained as a first-line therapy for anaplastic thyroid cancer,” Dr. Hamidi said in presenting the findings.

She noted, however, that the results should be interpreted with caution, given the small number of patients who received pembrolizumab before progression (n = 34) and especially after progression (n = 14).

In terms of safety, there were no grade 5 adverse events (AEs); 32.4% of patients experienced immune‐related AEs, most frequently, colitis and hepatitis.
 

Therapies “improve survival”

Overall, the results are important, Dr. Cabanillas said.

The results are “very exciting when you think about the fact that 10 years ago, patients with anaplastic thyroid cancer had a median overall survival measured in months, and now we see that those with a BRAF mutation have a real chance at survival when managed appropriately from the start,” she told this news organization.

She noted that a key caveat is the study’s retrospective nature. Other important considerations are that pembrolizumab adds toxicity as well as cost, and it is largely used off label in anaplastic thyroid cancer.

Nevertheless, “it does feel like there needs to be a call to action in the guidelines for this disease so that it includes neoadjuvant DT or DT plus pembrolizumab as the primary treatment of patients with BRAF-mutated anaplastic thyroid cancer because the initial treatment is critical here,” Dr. Cabanillas said.

She added that a phase 2 trial with neoadjuvant DT plus pembrolizumab is ongoing. Enrollment is expected to be completed soon.

Commenting on the findings, Sarimar Agosto Salgado, MD, of the department of head and neck – endocrine oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla., who was a comoderator of the session, said the results are encouraging.

“These findings are promising because they open the landscape of options of therapies that we can provide these patients,” she said in an interview.

“Anaplastic thyroid cancer has been a disease with a very short survival despite aggressive therapies, but we are seeing that not only have these therapies been able to improve survival but also patients’ quality of life.”

Particularly encouraging is how quickly the therapies can work, Dr. Salgado added.

“Many times when patients present to the clinic, the rapid response to these systemic therapies can even [allow them to avoid] having a tracheostomy, and we’re also seeing that some of these patients are able to go from unresectable disease to resectable disease, and then by having the main tumor out, their survival improves.

“So, this is definitely a big ray of hope for these patients.”

Dr. Cabanillas has received research funding from Merck. Dr. Hamidi has disclosed no relevant financial relationships. Dr. Salgado has relationships with Lilly and Exelixis.
 

A version of this article appeared on Medscape.com.

PHILADELPHIA – The prescribing, counseling, and use of hormone therapy (HT) to treat menopausal symptoms is substantially more common among white women than among Black women, according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.

The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.

The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.

Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.

Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.

Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
 

Complex reasons

Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.

Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.

“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.

At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.

“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”

Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.

“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
 

Educating clinicians

Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.

“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.

Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.

“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.

A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.

Dr. MacPhedran added that education for clinicians is key as well.

“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”

Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.

Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.

Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.

The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.

The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.

PHILADELPHIA – The prescribing, counseling, and use of hormone therapy (HT) to treat menopausal symptoms is substantially more common among white women than among Black women, according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.

The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.

The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.

Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.

Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.

Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
 

Complex reasons

Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.

Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.

“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.

At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.

“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”

Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.

“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
 

Educating clinicians

Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.

“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.

Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.

“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.

A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.

Dr. MacPhedran added that education for clinicians is key as well.

“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”

Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.

Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.

Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.

The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.

The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.

PHILADELPHIA – The prescribing, counseling, and use of hormone therapy (HT) to treat menopausal symptoms is substantially more common among white women than among Black women, according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).

“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.

The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.

The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.

Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.

Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.

Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
 

Complex reasons

Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.

Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.

“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.

At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.

“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”

Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.

“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
 

Educating clinicians

Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.

“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.

Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.

“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.

A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.

Dr. MacPhedran added that education for clinicians is key as well.

“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”

Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.

Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.

Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.

The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.

The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.

A 36-year-old woman presents to your office for assistance with weight loss. She usually weighs around 150 lb, but she had two pregnancies in the past 4 years and has gained 70 lb. Her current weight is 220 lb with a body mass index (BMI) of 36.6 kg/m2, and she has been unable to lose any weight despite diet and exercise. She reports back pain and generalized fatigue but is primarily worried about developing type 2 diabetes, which runs in her family. Her insurance covers weight loss medications, but she is asking if she can take “Ozempic off-label” or “compounded semaglutide” instead because Wegovy isn’t available at her local pharmacy.

More and more people are turning to “medical weight management” to drop pounds and improve their health. This is a strategy that adds pharmacotherapy to lifestyle modifications to treat the chronic disease of obesity, and it is analogous to the treatment of high blood pressure or high cholesterol with medications.

This patient meets the criteria set forth by the American Heart Association, American College of Cardiology, and The Obesity Society for the management of obesity with antiobesity medications:

• BMI ≥ 30 or BMI ≥ 27 with weight-related comorbidities and
• Has been unable to achieve ≥ 5% weight loss with lifestyle changes alone.

Several U.S. Food and Drug Administration–approved antiobesity medications have been proven to cause clinically significant weight loss:

• orlistat (Alli or Xenical).
• phentermine/topiramate (Qsymia).
• naltrexone/bupropion (Contrave).
• liraglutide 3.0 mg subcutaneously daily (Saxenda).
• semaglutide 2.4 mg subcutaneously weekly (Wegovy).

When considering an antiobesity medication for a patient, it’s important to discuss efficacy, side-effect profile, contraindications, cost and coverage, and long-term use.

In this commentary, we’ll specifically focus on semaglutide (Wegovy) as it is currently the most effective FDA-approved medication for weight loss.
 

Efficacy

In a phase 3 clinical trial, patients on semaglutide 2.4 mg weekly lost an average of 15% of their body weight at 68 weeks, or approximately 33 lb. It is important to note that there is variability in treatment response to semaglutide 2.4 mg, just like with any other medication. About 1 in 3 individuals lost ≥ 20% of their weight, but about 1 in every 10 patients did not lose any weight.

In this patient, who has a family history of type 2 diabetes, weight loss with semaglutide 2.4 mg will probably reduce her risk of developing diabetes. With just 5%-10% weight loss, she will see improvements in her blood glucose, blood pressure, and cholesterol. Even greater weight loss (≥ 10%) has been associated with resolution of fatty liver and sleep apnea.
 

Side effects

Before starting semaglutide, patients should be counseled about potential gastrointestinal side effects, including nausea, upset stomach, diarrhea, constipation, and reflux.

Side effects can be managed with dietary modifications, over-the-counter treatments, and slow dose escalation. Some common tips include:

• Eat slowly.
• Eat a bland diet.
• Avoid fatty or fried foods.
• Avoid lying down immediately after eating.
• Prioritize water and fiber intake to mitigate constipation.
• Use over-the-counter treatments as needed (for example, laxative for constipation).

Most of these side effects are present only during dose escalation and resolve once the patient is on a stable dose.

Patients should be counseled about the less than 1% risk for gallbladder issues or pancreatitis. They should be instructed to go to an urgent care or emergency room if they develop severe abdominal pain, recurrent vomiting, or the inability to eat or drink.
 

Contraindications

We don’t prescribe GLP-1 receptor agonists, including semaglutide 2.4 mg, in patients with a personal or family history of medullary thyroid cancer. GLP-1 agonists are contraindicated in patients with a history of pancreatitis or gastroparesis. All FDA-approved antiobesity medications are contraindicated in women who are breastfeeding or trying for pregnancy. If this patient would like to pursue pregnancy again, semaglutide 2.4 mg should be stopped 2 months prior to conception.

Access

In this case, the patient’s insurance covered semaglutide 2.4 mg with a copay of $25 per month. Without insurance, semaglutide 2.4 mg (Wegovy) costs about $1,400 per month, and semaglutide 2.0 mg (Ozempic), the formulation approved for type 2 diabetes, costs up to $1,000 per month. These price ranges are often cost-prohibitive and unsustainable, especially because these medications are intended for long-term use.

Currently, Medicare does not cover antiobesity medications nor do most state Medicaid plans. Therefore, these medications are usually not considered by patients who have Medicare or Medicaid insurance.

Because insurance coverage varies and out-of-pocket costs can be prohibitive, many individuals seek other ways of acquiring semaglutide. The off-label use of semaglutide 2.0 mg (Ozempic) for obesity is scientifically supported and safe, whereas the use of compounded semaglutide is risky due to lack of regulation.

Compounded semaglutide should be avoided, given that these products are not controlled by the FDA, and adverse events have been reported in connection with compounded semaglutide.

In our clinical practice, patients have reported advertisements for “generic semaglutide” compounded with vitamins like vitamin B12 or B6. This is a significant area of concern because some vitamins (for instance, vitamin B6) are toxic at high doses.

We discussed the dangers of compounded semaglutide with our patient and told her that this isn’t something we recommend prescribing. If the patient didn’t want to wait for semaglutide 2.4 mg to be available at her pharmacy, we discussed alternative medications used for the management of obesity, such as other FDA-approved GLP-1 agonists (that is, liraglutide 3.0 mg) and off-label medications. In this case, the patient opted to wait for semaglutide 2.4 mg because she preferred a weekly injectable medication, given her busy lifestyle as a new mom.

Dr. Schmitz, of Weill Cornell Medicine, New York, disclosed no relevant financial relationships. Dr. Tchang, of Weill Cornell Medicine and the Iris Cantor Women's Health Center, both in New York, serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk, and has received income from Gelesis.

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

A 36-year-old woman presents to your office for assistance with weight loss. She usually weighs around 150 lb, but she had two pregnancies in the past 4 years and has gained 70 lb. Her current weight is 220 lb with a body mass index (BMI) of 36.6 kg/m2, and she has been unable to lose any weight despite diet and exercise. She reports back pain and generalized fatigue but is primarily worried about developing type 2 diabetes, which runs in her family. Her insurance covers weight loss medications, but she is asking if she can take “Ozempic off-label” or “compounded semaglutide” instead because Wegovy isn’t available at her local pharmacy.

More and more people are turning to “medical weight management” to drop pounds and improve their health. This is a strategy that adds pharmacotherapy to lifestyle modifications to treat the chronic disease of obesity, and it is analogous to the treatment of high blood pressure or high cholesterol with medications.

This patient meets the criteria set forth by the American Heart Association, American College of Cardiology, and The Obesity Society for the management of obesity with antiobesity medications:

• BMI ≥ 30 or BMI ≥ 27 with weight-related comorbidities and
• Has been unable to achieve ≥ 5% weight loss with lifestyle changes alone.

Several U.S. Food and Drug Administration–approved antiobesity medications have been proven to cause clinically significant weight loss:

• orlistat (Alli or Xenical).
• phentermine/topiramate (Qsymia).
• naltrexone/bupropion (Contrave).
• liraglutide 3.0 mg subcutaneously daily (Saxenda).
• semaglutide 2.4 mg subcutaneously weekly (Wegovy).

When considering an antiobesity medication for a patient, it’s important to discuss efficacy, side-effect profile, contraindications, cost and coverage, and long-term use.

In this commentary, we’ll specifically focus on semaglutide (Wegovy) as it is currently the most effective FDA-approved medication for weight loss.
 

Efficacy

In a phase 3 clinical trial, patients on semaglutide 2.4 mg weekly lost an average of 15% of their body weight at 68 weeks, or approximately 33 lb. It is important to note that there is variability in treatment response to semaglutide 2.4 mg, just like with any other medication. About 1 in 3 individuals lost ≥ 20% of their weight, but about 1 in every 10 patients did not lose any weight.

In this patient, who has a family history of type 2 diabetes, weight loss with semaglutide 2.4 mg will probably reduce her risk of developing diabetes. With just 5%-10% weight loss, she will see improvements in her blood glucose, blood pressure, and cholesterol. Even greater weight loss (≥ 10%) has been associated with resolution of fatty liver and sleep apnea.
 

Side effects

Before starting semaglutide, patients should be counseled about potential gastrointestinal side effects, including nausea, upset stomach, diarrhea, constipation, and reflux.

Side effects can be managed with dietary modifications, over-the-counter treatments, and slow dose escalation. Some common tips include:

• Eat slowly.
• Eat a bland diet.
• Avoid fatty or fried foods.
• Avoid lying down immediately after eating.
• Prioritize water and fiber intake to mitigate constipation.
• Use over-the-counter treatments as needed (for example, laxative for constipation).

Most of these side effects are present only during dose escalation and resolve once the patient is on a stable dose.

Patients should be counseled about the less than 1% risk for gallbladder issues or pancreatitis. They should be instructed to go to an urgent care or emergency room if they develop severe abdominal pain, recurrent vomiting, or the inability to eat or drink.
 

Contraindications

We don’t prescribe GLP-1 receptor agonists, including semaglutide 2.4 mg, in patients with a personal or family history of medullary thyroid cancer. GLP-1 agonists are contraindicated in patients with a history of pancreatitis or gastroparesis. All FDA-approved antiobesity medications are contraindicated in women who are breastfeeding or trying for pregnancy. If this patient would like to pursue pregnancy again, semaglutide 2.4 mg should be stopped 2 months prior to conception.

Access

In this case, the patient’s insurance covered semaglutide 2.4 mg with a copay of $25 per month. Without insurance, semaglutide 2.4 mg (Wegovy) costs about $1,400 per month, and semaglutide 2.0 mg (Ozempic), the formulation approved for type 2 diabetes, costs up to $1,000 per month. These price ranges are often cost-prohibitive and unsustainable, especially because these medications are intended for long-term use.

Currently, Medicare does not cover antiobesity medications nor do most state Medicaid plans. Therefore, these medications are usually not considered by patients who have Medicare or Medicaid insurance.

Because insurance coverage varies and out-of-pocket costs can be prohibitive, many individuals seek other ways of acquiring semaglutide. The off-label use of semaglutide 2.0 mg (Ozempic) for obesity is scientifically supported and safe, whereas the use of compounded semaglutide is risky due to lack of regulation.

Compounded semaglutide should be avoided, given that these products are not controlled by the FDA, and adverse events have been reported in connection with compounded semaglutide.

In our clinical practice, patients have reported advertisements for “generic semaglutide” compounded with vitamins like vitamin B12 or B6. This is a significant area of concern because some vitamins (for instance, vitamin B6) are toxic at high doses.

We discussed the dangers of compounded semaglutide with our patient and told her that this isn’t something we recommend prescribing. If the patient didn’t want to wait for semaglutide 2.4 mg to be available at her pharmacy, we discussed alternative medications used for the management of obesity, such as other FDA-approved GLP-1 agonists (that is, liraglutide 3.0 mg) and off-label medications. In this case, the patient opted to wait for semaglutide 2.4 mg because she preferred a weekly injectable medication, given her busy lifestyle as a new mom.

Dr. Schmitz, of Weill Cornell Medicine, New York, disclosed no relevant financial relationships. Dr. Tchang, of Weill Cornell Medicine and the Iris Cantor Women's Health Center, both in New York, serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk, and has received income from Gelesis.

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

A 36-year-old woman presents to your office for assistance with weight loss. She usually weighs around 150 lb, but she had two pregnancies in the past 4 years and has gained 70 lb. Her current weight is 220 lb with a body mass index (BMI) of 36.6 kg/m2, and she has been unable to lose any weight despite diet and exercise. She reports back pain and generalized fatigue but is primarily worried about developing type 2 diabetes, which runs in her family. Her insurance covers weight loss medications, but she is asking if she can take “Ozempic off-label” or “compounded semaglutide” instead because Wegovy isn’t available at her local pharmacy.

More and more people are turning to “medical weight management” to drop pounds and improve their health. This is a strategy that adds pharmacotherapy to lifestyle modifications to treat the chronic disease of obesity, and it is analogous to the treatment of high blood pressure or high cholesterol with medications.

This patient meets the criteria set forth by the American Heart Association, American College of Cardiology, and The Obesity Society for the management of obesity with antiobesity medications:

• BMI ≥ 30 or BMI ≥ 27 with weight-related comorbidities and
• Has been unable to achieve ≥ 5% weight loss with lifestyle changes alone.

Several U.S. Food and Drug Administration–approved antiobesity medications have been proven to cause clinically significant weight loss:

• orlistat (Alli or Xenical).
• phentermine/topiramate (Qsymia).
• naltrexone/bupropion (Contrave).
• liraglutide 3.0 mg subcutaneously daily (Saxenda).
• semaglutide 2.4 mg subcutaneously weekly (Wegovy).

When considering an antiobesity medication for a patient, it’s important to discuss efficacy, side-effect profile, contraindications, cost and coverage, and long-term use.

In this commentary, we’ll specifically focus on semaglutide (Wegovy) as it is currently the most effective FDA-approved medication for weight loss.
 

Efficacy

In a phase 3 clinical trial, patients on semaglutide 2.4 mg weekly lost an average of 15% of their body weight at 68 weeks, or approximately 33 lb. It is important to note that there is variability in treatment response to semaglutide 2.4 mg, just like with any other medication. About 1 in 3 individuals lost ≥ 20% of their weight, but about 1 in every 10 patients did not lose any weight.

In this patient, who has a family history of type 2 diabetes, weight loss with semaglutide 2.4 mg will probably reduce her risk of developing diabetes. With just 5%-10% weight loss, she will see improvements in her blood glucose, blood pressure, and cholesterol. Even greater weight loss (≥ 10%) has been associated with resolution of fatty liver and sleep apnea.
 

Side effects

Before starting semaglutide, patients should be counseled about potential gastrointestinal side effects, including nausea, upset stomach, diarrhea, constipation, and reflux.

Side effects can be managed with dietary modifications, over-the-counter treatments, and slow dose escalation. Some common tips include:

• Eat slowly.
• Eat a bland diet.
• Avoid fatty or fried foods.
• Avoid lying down immediately after eating.
• Prioritize water and fiber intake to mitigate constipation.
• Use over-the-counter treatments as needed (for example, laxative for constipation).

Most of these side effects are present only during dose escalation and resolve once the patient is on a stable dose.

Patients should be counseled about the less than 1% risk for gallbladder issues or pancreatitis. They should be instructed to go to an urgent care or emergency room if they develop severe abdominal pain, recurrent vomiting, or the inability to eat or drink.
 

Contraindications

We don’t prescribe GLP-1 receptor agonists, including semaglutide 2.4 mg, in patients with a personal or family history of medullary thyroid cancer. GLP-1 agonists are contraindicated in patients with a history of pancreatitis or gastroparesis. All FDA-approved antiobesity medications are contraindicated in women who are breastfeeding or trying for pregnancy. If this patient would like to pursue pregnancy again, semaglutide 2.4 mg should be stopped 2 months prior to conception.

Access

In this case, the patient’s insurance covered semaglutide 2.4 mg with a copay of $25 per month. Without insurance, semaglutide 2.4 mg (Wegovy) costs about $1,400 per month, and semaglutide 2.0 mg (Ozempic), the formulation approved for type 2 diabetes, costs up to $1,000 per month. These price ranges are often cost-prohibitive and unsustainable, especially because these medications are intended for long-term use.

Currently, Medicare does not cover antiobesity medications nor do most state Medicaid plans. Therefore, these medications are usually not considered by patients who have Medicare or Medicaid insurance.

Because insurance coverage varies and out-of-pocket costs can be prohibitive, many individuals seek other ways of acquiring semaglutide. The off-label use of semaglutide 2.0 mg (Ozempic) for obesity is scientifically supported and safe, whereas the use of compounded semaglutide is risky due to lack of regulation.

Compounded semaglutide should be avoided, given that these products are not controlled by the FDA, and adverse events have been reported in connection with compounded semaglutide.

In our clinical practice, patients have reported advertisements for “generic semaglutide” compounded with vitamins like vitamin B12 or B6. This is a significant area of concern because some vitamins (for instance, vitamin B6) are toxic at high doses.

We discussed the dangers of compounded semaglutide with our patient and told her that this isn’t something we recommend prescribing. If the patient didn’t want to wait for semaglutide 2.4 mg to be available at her pharmacy, we discussed alternative medications used for the management of obesity, such as other FDA-approved GLP-1 agonists (that is, liraglutide 3.0 mg) and off-label medications. In this case, the patient opted to wait for semaglutide 2.4 mg because she preferred a weekly injectable medication, given her busy lifestyle as a new mom.

Dr. Schmitz, of Weill Cornell Medicine, New York, disclosed no relevant financial relationships. Dr. Tchang, of Weill Cornell Medicine and the Iris Cantor Women's Health Center, both in New York, serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for Gelesis and Novo Nordisk, and has received income from Gelesis.

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

TOPLINE:

Use of a novel clinical-decision support tool and shared decision-making in elderly patients with type 2 diabetes managed in a primary care practice and at high risk for hypoglycemic episodes led to a 46% decrease in the number of at-risk patients and discontinuation of hypoglycemic agents in 20% in a prospective, 6-month, single-arm study with 94 patients.

METHODOLOGY:

• The HypoPrevent study enrolled 94 people from a Pennsylvania primary care practice who were at least 65 years old with type 2 diabetes and at risk for hypoglycemia because of treatment with insulin or sulfonylureas, and having a hemoglobin A1c of less than 7.0%.
• Clinicians and patients used a newly devised hypoglycemia reduction clinical-decision support tool developed by the Endocrine Society and a health care consulting company to help guide shared decision-making for a goal A1c level, potential changes to treatment, and other steps to reduce the risk of hypoglycemia.
• Primary outcomes during 6-month follow-up were impact of the intervention on A1c, changes in use of insulin or sulfonylureas, change in the number of study patients at risk for hypoglycemia, and impact on the incidence of nonsevere hypoglycemic events (NSHEs) measured with the Treatment-Related Impact Measure–Non-severe Hypoglycemic Events (TRIM-HYPO) survey.

TAKEAWAY:

• Patients averaged 74 years old, 57% were women, 95% were White, 61% had diabetes for more than 10 years, 48% had chronic kidney disease, 51% were on insulin, 47% on a sulfonylurea, and 80 of the 94 enrolled patients completed all three study visits.
• Nineteen patients (20%) reduced their dose of or discontinued insulin or sulfonylurea.
• In patients with both baseline and follow-up A1c measures, A1c rose from 6.29% at baseline to 6.82%.
• Fifty patients set an A1c goal and had a timely follow-up A1c measurement, and in this subgroup the number of patients at risk for hypoglycemia decreased by 46%, a significant change.
• Patients who reported at least one NSHE at baseline had a significant reduction between the baseline survey and follow-up visits in both the total score as well as each of the five scored domains.

IN PRACTICE:

The HypoPrevent study results “show the potential of a decision support tool and shared decision making to reduce the risk of hypoglycemia in older persons with type 2 diabetes,” and that “the tested decision tool can be effectively used by a busy primary care practice with positive results,” concluded the researchers in their report.

SOURCE:

The HypoPrevent study was funded and organized by the Endocrine Society in collaboration with a multicenter team of researchers. The report appeared in the Journal of the American Geriatrics Society.

LIMITATIONS:

Lack of a control group makes it impossible to conclusively determine whether the intervention led to the observed increases in A1c levels, nor can the study exclude regression to the mean as the cause for lowered A1c levels.

DISCLOSURES:

The study received funding from Abbott, Lilly, Merck, Novo Nordisk, and Sanofi. Two coauthors had individual disclosures listed in the report; the other six coauthors had no disclosures.

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

TOPLINE:

Use of a novel clinical-decision support tool and shared decision-making in elderly patients with type 2 diabetes managed in a primary care practice and at high risk for hypoglycemic episodes led to a 46% decrease in the number of at-risk patients and discontinuation of hypoglycemic agents in 20% in a prospective, 6-month, single-arm study with 94 patients.

METHODOLOGY:

• The HypoPrevent study enrolled 94 people from a Pennsylvania primary care practice who were at least 65 years old with type 2 diabetes and at risk for hypoglycemia because of treatment with insulin or sulfonylureas, and having a hemoglobin A1c of less than 7.0%.
• Clinicians and patients used a newly devised hypoglycemia reduction clinical-decision support tool developed by the Endocrine Society and a health care consulting company to help guide shared decision-making for a goal A1c level, potential changes to treatment, and other steps to reduce the risk of hypoglycemia.
• Primary outcomes during 6-month follow-up were impact of the intervention on A1c, changes in use of insulin or sulfonylureas, change in the number of study patients at risk for hypoglycemia, and impact on the incidence of nonsevere hypoglycemic events (NSHEs) measured with the Treatment-Related Impact Measure–Non-severe Hypoglycemic Events (TRIM-HYPO) survey.

TAKEAWAY:

• Patients averaged 74 years old, 57% were women, 95% were White, 61% had diabetes for more than 10 years, 48% had chronic kidney disease, 51% were on insulin, 47% on a sulfonylurea, and 80 of the 94 enrolled patients completed all three study visits.
• Nineteen patients (20%) reduced their dose of or discontinued insulin or sulfonylurea.
• In patients with both baseline and follow-up A1c measures, A1c rose from 6.29% at baseline to 6.82%.
• Fifty patients set an A1c goal and had a timely follow-up A1c measurement, and in this subgroup the number of patients at risk for hypoglycemia decreased by 46%, a significant change.
• Patients who reported at least one NSHE at baseline had a significant reduction between the baseline survey and follow-up visits in both the total score as well as each of the five scored domains.

IN PRACTICE:

The HypoPrevent study results “show the potential of a decision support tool and shared decision making to reduce the risk of hypoglycemia in older persons with type 2 diabetes,” and that “the tested decision tool can be effectively used by a busy primary care practice with positive results,” concluded the researchers in their report.

SOURCE:

The HypoPrevent study was funded and organized by the Endocrine Society in collaboration with a multicenter team of researchers. The report appeared in the Journal of the American Geriatrics Society.

LIMITATIONS:

Lack of a control group makes it impossible to conclusively determine whether the intervention led to the observed increases in A1c levels, nor can the study exclude regression to the mean as the cause for lowered A1c levels.

DISCLOSURES:

The study received funding from Abbott, Lilly, Merck, Novo Nordisk, and Sanofi. Two coauthors had individual disclosures listed in the report; the other six coauthors had no disclosures.

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

TOPLINE:

Use of a novel clinical-decision support tool and shared decision-making in elderly patients with type 2 diabetes managed in a primary care practice and at high risk for hypoglycemic episodes led to a 46% decrease in the number of at-risk patients and discontinuation of hypoglycemic agents in 20% in a prospective, 6-month, single-arm study with 94 patients.

METHODOLOGY:

• The HypoPrevent study enrolled 94 people from a Pennsylvania primary care practice who were at least 65 years old with type 2 diabetes and at risk for hypoglycemia because of treatment with insulin or sulfonylureas, and having a hemoglobin A1c of less than 7.0%.
• Clinicians and patients used a newly devised hypoglycemia reduction clinical-decision support tool developed by the Endocrine Society and a health care consulting company to help guide shared decision-making for a goal A1c level, potential changes to treatment, and other steps to reduce the risk of hypoglycemia.
• Primary outcomes during 6-month follow-up were impact of the intervention on A1c, changes in use of insulin or sulfonylureas, change in the number of study patients at risk for hypoglycemia, and impact on the incidence of nonsevere hypoglycemic events (NSHEs) measured with the Treatment-Related Impact Measure–Non-severe Hypoglycemic Events (TRIM-HYPO) survey.

TAKEAWAY:

• Patients averaged 74 years old, 57% were women, 95% were White, 61% had diabetes for more than 10 years, 48% had chronic kidney disease, 51% were on insulin, 47% on a sulfonylurea, and 80 of the 94 enrolled patients completed all three study visits.
• Nineteen patients (20%) reduced their dose of or discontinued insulin or sulfonylurea.
• In patients with both baseline and follow-up A1c measures, A1c rose from 6.29% at baseline to 6.82%.
• Fifty patients set an A1c goal and had a timely follow-up A1c measurement, and in this subgroup the number of patients at risk for hypoglycemia decreased by 46%, a significant change.
• Patients who reported at least one NSHE at baseline had a significant reduction between the baseline survey and follow-up visits in both the total score as well as each of the five scored domains.

IN PRACTICE:

The HypoPrevent study results “show the potential of a decision support tool and shared decision making to reduce the risk of hypoglycemia in older persons with type 2 diabetes,” and that “the tested decision tool can be effectively used by a busy primary care practice with positive results,” concluded the researchers in their report.

SOURCE:

The HypoPrevent study was funded and organized by the Endocrine Society in collaboration with a multicenter team of researchers. The report appeared in the Journal of the American Geriatrics Society.

LIMITATIONS:

Lack of a control group makes it impossible to conclusively determine whether the intervention led to the observed increases in A1c levels, nor can the study exclude regression to the mean as the cause for lowered A1c levels.

DISCLOSURES:

The study received funding from Abbott, Lilly, Merck, Novo Nordisk, and Sanofi. Two coauthors had individual disclosures listed in the report; the other six coauthors had no disclosures.

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

TOPLINE:

Dyspareunia is a major indicator of urinary tract infections, being present in 83% of cases. The symptom is especially accurate at identifying UTIs in nonmenopausal women, researchers have found.

METHODOLOGY:

• Dyspareunia is a common symptom of UTIs, especially in premenopausal women, but is rarely inquired about during patient evaluations, according to researchers from Florida Atlantic University. 
• In 2010, the researchers found that among 3,000 of their female Latinx patients aged 17-72 years in South Florida, 80% of those with UTIs reported experiencing pain during sexual intercourse. 
• Since then, they have studied an additional 2,500 patients from the same population.

TAKEAWAY:

• Among all 5,500 patients, 83% of those who had UTIs experienced dyspareunia.
• Eighty percent of women of reproductive age with dyspareunia had an undiagnosed UTI.
• During the perimenopausal and postmenopausal years, dyspareunia was more often associated with genitourinary syndrome than UTIs.
• Ninety-four percent of women with UTI-associated dyspareunia responded positively to antibiotics.

IN PRACTICE:

“We have found that this symptom is extremely important as part of the symptomatology of UTI [and is] frequently found along with the classical symptoms,” the researchers reported. “Why has something so clear, so frequently present, never been described? The answer is simple: Physicians and patients do not talk about sex, despite dyspareunia being more a clinical symptom than a sexual one. Medical schools and residency programs in all areas, especially in obstetrics and gynecology, urology, and psychiatry, have been neglecting the education of physicians-in-training in this important aspect of human health. In conclusion, this is [proof] of how medicine has sometimes been influenced by religion, culture, and social norms far away from science.”

SOURCE:

The data were presented at the 2023 meeting of the Menopause Society. The study was led by Alberto Dominguez-Bali, MD, from Florida Atlantic University, Boca Raton, Fla.

LIMITATIONS:

The study authors reported no limitations.

DISCLOSURES:

The authors reported no relevant financial relationships.

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

TOPLINE:

Dyspareunia is a major indicator of urinary tract infections, being present in 83% of cases. The symptom is especially accurate at identifying UTIs in nonmenopausal women, researchers have found.

METHODOLOGY:

• Dyspareunia is a common symptom of UTIs, especially in premenopausal women, but is rarely inquired about during patient evaluations, according to researchers from Florida Atlantic University. 
• In 2010, the researchers found that among 3,000 of their female Latinx patients aged 17-72 years in South Florida, 80% of those with UTIs reported experiencing pain during sexual intercourse. 
• Since then, they have studied an additional 2,500 patients from the same population.

TAKEAWAY:

• Among all 5,500 patients, 83% of those who had UTIs experienced dyspareunia.
• Eighty percent of women of reproductive age with dyspareunia had an undiagnosed UTI.
• During the perimenopausal and postmenopausal years, dyspareunia was more often associated with genitourinary syndrome than UTIs.
• Ninety-four percent of women with UTI-associated dyspareunia responded positively to antibiotics.

IN PRACTICE:

“We have found that this symptom is extremely important as part of the symptomatology of UTI [and is] frequently found along with the classical symptoms,” the researchers reported. “Why has something so clear, so frequently present, never been described? The answer is simple: Physicians and patients do not talk about sex, despite dyspareunia being more a clinical symptom than a sexual one. Medical schools and residency programs in all areas, especially in obstetrics and gynecology, urology, and psychiatry, have been neglecting the education of physicians-in-training in this important aspect of human health. In conclusion, this is [proof] of how medicine has sometimes been influenced by religion, culture, and social norms far away from science.”

SOURCE:

The data were presented at the 2023 meeting of the Menopause Society. The study was led by Alberto Dominguez-Bali, MD, from Florida Atlantic University, Boca Raton, Fla.

LIMITATIONS:

The study authors reported no limitations.

DISCLOSURES:

The authors reported no relevant financial relationships.

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

TOPLINE:

Dyspareunia is a major indicator of urinary tract infections, being present in 83% of cases. The symptom is especially accurate at identifying UTIs in nonmenopausal women, researchers have found.

METHODOLOGY:

• Dyspareunia is a common symptom of UTIs, especially in premenopausal women, but is rarely inquired about during patient evaluations, according to researchers from Florida Atlantic University. 
• In 2010, the researchers found that among 3,000 of their female Latinx patients aged 17-72 years in South Florida, 80% of those with UTIs reported experiencing pain during sexual intercourse. 
• Since then, they have studied an additional 2,500 patients from the same population.

TAKEAWAY:

• Among all 5,500 patients, 83% of those who had UTIs experienced dyspareunia.
• Eighty percent of women of reproductive age with dyspareunia had an undiagnosed UTI.
• During the perimenopausal and postmenopausal years, dyspareunia was more often associated with genitourinary syndrome than UTIs.
• Ninety-four percent of women with UTI-associated dyspareunia responded positively to antibiotics.

IN PRACTICE:

“We have found that this symptom is extremely important as part of the symptomatology of UTI [and is] frequently found along with the classical symptoms,” the researchers reported. “Why has something so clear, so frequently present, never been described? The answer is simple: Physicians and patients do not talk about sex, despite dyspareunia being more a clinical symptom than a sexual one. Medical schools and residency programs in all areas, especially in obstetrics and gynecology, urology, and psychiatry, have been neglecting the education of physicians-in-training in this important aspect of human health. In conclusion, this is [proof] of how medicine has sometimes been influenced by religion, culture, and social norms far away from science.”

SOURCE:

The data were presented at the 2023 meeting of the Menopause Society. The study was led by Alberto Dominguez-Bali, MD, from Florida Atlantic University, Boca Raton, Fla.

LIMITATIONS:

The study authors reported no limitations.

DISCLOSURES:

The authors reported no relevant financial relationships.

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