Clinical Endocrinology News

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

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

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

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

A more definitive picture of how some hormones and moisturizers can offer relief to women experiencing vaginal dryness or painful intercourse during menopause was published in a recent systematic review in Annals of Internal Medicine. However, researchers noted scant long-term data on the safety of these products.

Vaginal dryness and challenges with intercourse and urination are among the symptoms of genitourinary syndrome of menopause (GSM). Hormones such as vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), or oral ospemifene are common treatments, along with moisturizers.

“The main finding is that commonly used therapies are likely to be effective for the common symptoms people have for GSM,” particularly vaginal dryness and painful intercourse, said Elisheva Danan, MD, MPH, a primary care physician and health services researcher at the Minneapolis VA Health Care System and assistant professor of medicine at the University of Minnesota Medical School in Minneapolis, who was the lead study author.

Many women might recognize hot flashes as connected to menopause, Dr. Danan said, as these tend to occur with the cessation of the menstrual cycle. However, genitourinary effects may not manifest until a few years later and worsen over time, when the connection to menopause is less clear.

“Women might not bring it up or think there’s a treatment that can work,” Dr. Danan said.

The systematic review may provide clinicians with more evidence of specific treatments to recommend. However, most of the trials included in the analysis studied treatment periods of 12 weeks or less, so the safety of long-term use is unclear.

“One question that hasn’t been answered yet in clinical trials is whether there could be a risk of uterine cancer with extended use of any of these treatments,” Dr. Danan said, because vaginal estrogen or ospemifene could stimulate growth of the uterine lining.

The studies Dr. Danan and colleagues found showed no increased risk for uterine cancer, but Dr, Danan noted that the maximum follow-up was 1 year, and study participants had a low risk for cancer to begin with. She advised that clinicians closely monitor women with risk factors if they use hormones to treat GSM indefinitely.
 

Forty-Six Randomized Controlled Trials, Many Open Questions

Dr. Danan and her colleagues conducted a systematic review of 46 randomized controlled trials, meant to inform an upcoming clinical practice guideline from the American Urological Association on treatment of GSM. Dr. Danan’s work was funded by the Patient-Centered Outcomes Research Institute.

Studies evaluated vaginal estrogen (22), other hormones such as vaginal oxytocin or vaginal testosterone (16), vaginal moisturizers (4), and multiple interventions (4).

Included trials lasted at least 8 weeks and included at least 20 postmenopausal women; most treatments lasted 12 weeks or less. Studies used varying definitions of GSM, and no head-to-head trials of different treatments were found.

Researchers used the Core Outcomes in Menopause (COMMA) framework, developed in 2021 to standardize outcomes research in menopause care and to understand treatment effectiveness. They applied this framework retroactively, as almost all the studies in the review were written before the COMMA framework existed.

Hormonal treatments were associated with reduced pain during intercourse and decreased vaginal dryness; moisturizers were linked to reduced dryness.

Vaginal estrogen did not reduce pain during intercourse as consistently as DHEA or oral ospemifene, per the review. Dr. Danan and her coauthors said this could be because the DHEA and ospemifene trials were larger and more uniformly conducted than those for vaginal estrogen. Even so, vaginal estrogen outperformed placebo at reducing painful intercourse.

But given the short timeframe of most studies and the differing definitions of GSM symptoms, Dr. Danan cautioned that all their conclusions have low certainty.

Few studies examined whether these treatments reduced vaginal itchiness or difficulties with urination. And the authors found no evidence for the benefit of oral DHEA, raloxifene, bazedoxifene, vaginal oxytocin, or vaginal testosterone for GSM treatment.

In an accompanying report, the researchers found no evidence for the benefits of treatments such as vaginal testosterone or vaginal laser therapy.

Stephanie Faubion, MD, MBA, medical director for the North American Menopause Society and director of the Mayo Clinic Center for Women’s Health, Rochester, Minnesota, wrote an accompanying editorial noting that the patients represented in the GSM treatment clinical trials were not diverse and that the exclusion criteria generally meant that women with cardiovascular challenges or cancer were not included.

“That’s one of the biggest questions — what is the safety in women with cardiovascular risk factors or history of a blood clot or history of a cancer? The data is just completely absent there,” Dr. Faubion said.
 

The Connection Between GSM and Urinary Tract Infections (UTIs)

“Genitourinary syndrome of menopause is not just a little bit of vaginal dryness that can be cured with moisturizers and lubricants, but the syndrome can lead to recurrent urinary tract infections, which are extremely harmful and dangerous to our patients and cost the healthcare system a lot of money,” said Rachel Rubin, MD, a urologist and sexual medicine specialist in Bethesda, Maryland.

Lubricants and moisturizers can all help with the symptoms of GSM, at least in the short term, Dr. Rubin noted. But only hormones can get to the root of the problem and reduce the risk for a recurrent UTI (rUTI), Dr. Rubin added, noting that the American Urological Association recommends the use of vaginal estrogen to reduce the risk for rUTIs and is developing the clinical practice guidelines for GSM.

Dr. Danan’s review did not address the association between UTIs and GSM, but Dr. Rubin said she sees the link in clinical practice.

“Recurrent urinary tract infections occur because of GSM, because of the lack of hormones to the tissue,” sometimes when a woman is in her 60s or 70s and thinks menopause is long over, Dr. Rubin said.

The reality is that women may need to take hormones for decades to reduce the risk for UTIs, another reason longer-term safety data are needed, Dr. Rubin said.

Dr. Danan, Dr. Faubion, and Dr. Rubin reported no relevant financial relationships.

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

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

MRI-derived abdominal adipose tissue is linked to chronic musculoskeletal pain in multiple sites. The association is stronger in women, suggesting sex differences in fat distribution and hormones.

METHODOLOGY:

• Researchers used data from the UK Biobank, a large population-based cohort study, to investigate the associations between MRI-measured abdominal adipose tissue and chronic musculoskeletal pain.
• A total of 32,409 participants (50.8% women; mean age, 55.0 ± 7.4 years) were included in the analysis, with abdominal MRI scans performed at two imaging visits.
• Pain in the neck/shoulder, back, hip, knee, or “all over the body” was assessed, and participants were categorized based on the number of chronic pain sites.
• Mixed-effects ordinal, multinomial, and logistic regression models were used to analyze the associations between visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and their ratio with chronic pain.

TAKEAWAY:

• According to the authors, there was a dose-response association between VAT, SAT, and their ratio with the number of chronic pain sites in both women and men.
• Higher levels of abdominal adipose tissue were associated with greater odds of reporting chronic pain in both sexes, with effect estimates being relatively larger in women.
• The researchers found that the VAT/SAT ratio was associated with the number of chronic pain sites and chronic pain in both sexes, reflecting differences in fat distribution and hormones.
• The study suggested that excessive abdominal adipose tissue may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain.

IN PRACTICE:

“Abdominal adipose tissue was associated with chronic musculoskeletal pain, suggesting that excessive and ectopic fat depositions may be involved in the pathogenesis of multisite and widespread chronic musculoskeletal pain,” wrote the authors of the study.

SOURCE:

This study was led by Zemene Demelash Kifle, University of Tasmania Menzies Institute for Medical Research in Hobart, Australia. It was published online in Regional Anesthesia & Pain Medicine.

LIMITATIONS: 

The study’s limitations included the use of a pain questionnaire that did not assess pain severity, which limited the ability to examine the relationship between fat measures and pain severity. Additionally, MRI was conducted on only two occasions, which may have not captured patterns and fluctuations in chronic pain sites. The relatively small size of the imaging sample, compared with the original baseline sample limited the generalizability of the findings. The predominant White ethnicity of participants also limited the generalizability to diverse populations.

DISCLOSURES:

The study was supported by grants from the Australian National Health and Medical Research Council (NHMRC). Mr. Kifle disclosed receiving grants from the Australian NHMRC. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

MADRID — Night owls — individuals with late chronotypes — may be at an increased risk for type 2 diabetes (T2D), beyond the risks conferred by an unhealthy lifestyle, research presented at the annual meeting of the European Association for the Study of Diabetes suggested.

In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.

“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.

“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”

“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”

The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.

Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.

During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.

Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm² more visceral fat, and 14% more liver fat.
 

Body Clock Out of Sync?

“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.

“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”

Might trying to adjust chronotype earlier in life have an effect on risk?

“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”

Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.

“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”

Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”

Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”

Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.

“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.

“However environmental factors and family history can play an important role too,” he added.

Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.

No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.

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

MADRID — Night owls — individuals with late chronotypes — may be at an increased risk for type 2 diabetes (T2D), beyond the risks conferred by an unhealthy lifestyle, research presented at the annual meeting of the European Association for the Study of Diabetes suggested.

In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.

“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.

“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”

“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”

The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.

Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.

During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.

Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm² more visceral fat, and 14% more liver fat.
 

Body Clock Out of Sync?

“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.

“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”

Might trying to adjust chronotype earlier in life have an effect on risk?

“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”

Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.

“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”

Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”

Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”

Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.

“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.

“However environmental factors and family history can play an important role too,” he added.

Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.

No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.

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

MADRID — Night owls — individuals with late chronotypes — may be at an increased risk for type 2 diabetes (T2D), beyond the risks conferred by an unhealthy lifestyle, research presented at the annual meeting of the European Association for the Study of Diabetes suggested.

In the study, night owls were almost 50% more likely to develop T2D than those who went to sleep earlier.

“The magnitude of this risk was more than I expected, [although] residual confounding may have occurred,” said Jeroen van der Velde, PhD, Leiden University Medical Center in the Netherlands, who presented the study.

“Late chronotype has previously been associated with unhealthy lifestyle and overweight or obesity and, subsequently, cardiometabolic diseases,” he said in an interview. However, although the current study found that individuals with late chronotypes did indeed have larger waists and more visceral fat, “we (and others) believe that lifestyle cannot fully explain the relation between late chronotype and metabolic disorders.”

“In addition,” he noted, “previous studies that observed that late chronotype is associated with overweight or obesity mainly focused on body mass index [BMI]. However, BMI alone does not provide accurate information regarding fat distribution in the body. People with similar BMI may have different underlying fat distribution, and this may be more relevant than BMI for metabolic risk.”

The researchers examined associations between chronotype and BMI, waist circumference, visceral fat, liver fat, and the risk for T2D in a middle-aged population from the Netherlands Epidemiology of Obesity study. Among the 5026 participants, the mean age was 56 years, 54% were women, and mean BMI was 30.

Using data from the study, the study investigators calculated the midpoint of sleep (MPS) and divided participants into three chronotypes: Early MPS < 2:30 PM (20% of participants); intermediate MPS 2:30–4:00 PM (reference category; 60% of participants); and late MPS ≥ 4:00 PM (20% of participants). BMI and waist circumference were measured in all participants, and visceral fat and liver fat were measured in 1576 participants using MRI scans and MR spectroscopy, respectively.

During a median follow-up of 6.6 years, 225 participants were diagnosed with T2D. After adjustment for age, sex, education, physical activity, smoking, alcohol intake, diet quality, sleep quality and duration, and total body fat, participants with a late chronotype had a 46% increased risk for T2D.

Further, those with a late chronotype had 0.7 higher BMI, 1.9-cm larger waist circumference, 7 cm² more visceral fat, and 14% more liver fat.
 

Body Clock Out of Sync?

“Late chronotype was associated with increased ectopic body fat and with an increased risk of T2D independent of lifestyle factors and is an emerging risk factor for metabolic diseases,” the researchers concluded.

“A likely explanation is that the circadian rhythm or body clock in late chronotypes is out of sync with the work and social schedules followed by society,” Dr. van der Velde suggested. “This can lead to circadian misalignment, which we know can lead to metabolic disturbances and ultimately type 2 diabetes.”

Might trying to adjust chronotype earlier in life have an effect on risk?

“Chronotype, as measured via midpoint of sleep, does change a lot in the first 30 years or so in life,” he said. “After that it seems to stabilize. I suppose that if you adapt an intermediate or early chronotype around the age of 30 years, this will help to maintain an earlier chronotype later in life, although we cannot answer this from our study.”

Nevertheless, with respect to T2D risk, “chronotype is likely only part of the puzzle,” he noted.

“People with late chronotypes typically eat late in the evening, and this has also been associated with adverse metabolic effects. At this stage, we do not know if a person changes his/her chronotype that this will also lead to metabolic improvements. More research is needed before we can make recommendations regarding chronotype and timing of other lifestyle behaviors.”

Commenting on the study, Gianluca Iacobellis, MD, PhD, director of the University of Miami Hospital Diabetes Service, Coral Gables, Florida, said: “Interesting data. Altering the physiological circadian rhythm can affect the complex hormonal system — including cortisol, ghrelin, leptin, and serotonin — that regulates insulin sensitivity, glucose, and blood pressure control. The night owl may become more insulin resistant and therefore at higher risk of developing diabetes.”

Like Dr. van der Velde, he noted that “late sleep may be associated with night binging that can cause weight gain and ultimately obesity, further increasing the risk of diabetes.”

Dr. Iacobellis’s group recently showed that vital exhaustion, which is characterized by fatigue and loss of vigor, is associated with a higher cardiovascular risk for and markers of visceral adiposity.

“Abnormal circadian rhythms can be easily associated with vital exhaustion,” he said. Therefore, night owls with more visceral than peripheral fat accumulation might also be at higher cardiometabolic risk through that mechanism.

“However environmental factors and family history can play an important role too,” he added.

Regardless of the mechanisms involved, “preventive actions should be taken to educate teenagers and individuals at higher risk to have healthy sleep habits,” Dr. Iacobellis concluded.

No information regarding funding was provided; Dr. van der Velde and Dr. Iacobellis reported no conflicts of interest.

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

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.

New COVID-19 vaccines formulated for better protection against the currently circulating variants have been approved by the US Food and Drug Administration.

The COVID vaccines available this fall have been updated to better match the currently circulating COVID strains, said William Schaffner, MD, professor of medicine in the Division of Infectious Diseases at Vanderbilt University, Nashville, Tennessee, in an interview.

“The Pfizer and Moderna vaccines — both mRNA vaccines — target the KP.2 variant, while the Novavax vaccine targets the JN.1 variant, which is a predecessor to KP.2,” said Dr. Schaffner, who also serves as a spokesperson for the National Foundation for Infectious Diseases. “The Novavax vaccine is a protein adjuvant vaccine made in a more traditional fashion and may appeal to those who remain hesitant about receiving an mRNA vaccine,” he explained. However, all three vaccines are designed to protect against severe COVID illness and reduce the likelihood of hospitalization, he said.
 

Who Needs It?

“The CDC’s Advisory Committee on Immunization Practices (ACIP) continues to recommend that everyone in the United States who is age 6 months and older receive the updated COVID vaccine this fall, along with influenza vaccine,” Dr. Schaffner said.

“This was not a surprise because COVID will produce a sizable winter outbreak,” he predicted. Although older people and those who have chronic medical conditions such as heart or lung disease, diabetes, or other immunocompromising conditions suffer the most serious impact of COVID, he said. “The virus can strike anyone, even the young and healthy.” The risk for long COVID persists as well, he pointed out.

The ACIP recommendation is endorsed by the American Academy of Pediatrics and other professional organizations, Dr. Shaffner said.

A frequently asked question is whether the COVID and flu vaccines can be given at the same time, and the answer is yes, according to a statement from the Centers for Disease Control and Prevention (CDC).

“The optimal time to be vaccinated is late September and anytime during October in order to get the benefit of protection through the winter,” Dr. Schaffner said.

As with earlier versions of the COVID-19 vaccine, side effects vary from person to person. Reported side effects of the updated vaccine are similar to those seen with earlier versions and may include injection site pain, redness and swelling, fatigue, headache, muscle pain, chills, nausea, and fever, but most of these are short-lived, according to the CDC.
 

Clinical Guidance

The CDC’s clinical guidance for COVID-19 vaccination outlines more specific guidance for vaccination based on age, vaccination history, and immunocompromised status and will be updated as needed.

A notable difference in the latest guidance is the recommendation of only one shot for adults aged 65 years and older who are NOT moderately or severely immunocompromised. For those who are moderately or severely immunocompromised, the CDC recommends two to three doses of the same brand of vaccine.

Dr. Schaffner strongly encouraged clinicians to recommend the COVID-19 vaccination for all eligible patients. “COVID is a nasty virus that can cause serious disease in anyone,” and protection from previous vaccination or prior infection has likely waned, he said.

Dr. Schaffner also encouraged healthcare professionals and their families to lead by example. “We should all be vaccinated and let our patients know that we are vaccinated and that we want all our patents to be protected,” he said.

The updated COVID-19 vaccination recommendations have become much simpler for clinicians and patients, with a single messenger RNA (mRNA) vaccine required for anyone older than 5 years, said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

“The recommendations are a bit more complex for children under 5 years old receiving their first vaccination; they require two to three doses depending on the brand,” he said. “It is important to review the latest recommendations to plan the doses with the correct interval timing. Considering the doses may be 3-4 weeks apart, start early,” he advised.
 

One-Time Dosing

Although the updated mRNA vaccine is currently recommended as a one-time dose, Dr. Cennimo said he can envision a scenario later in the season when a second dose is recommended for the elderly and those at high risk for severe illness. Dr. Cennimo said that he strongly agrees with the recommendations that everyone aged 6 months and older receive an updated COVID-19 vaccine. Older age remains the prime risk factor, but anyone can become infected, he said.

Predicting a prime time to get vaccinated is tricky because no one knows when the expected rise in winter cases will occur, said Dr. Cennimo.

“We know from years of flu vaccine data that some number of people who delay the vaccine will never return and will miss protection,” he said. Therefore, delaying vaccination is not recommended. Dr. Cennimo plans to follow his habit of getting vaccinated in early October. “I anticipate the maximal effectiveness of the vaccine will carry me through the winter,” he said.

Data support the safety and effectiveness for both flu and COVID vaccines if they are given together, and some research on earlier versions of COVID vaccines suggested that receiving flu and COVID vaccines together might increase the antibody response against COVID, but similar studies of the updated version have not been done, Dr. Cennimo said.

Clinicians may have to overcome the barrier of COVID fatigue to encourage vaccination, Dr. Cennimo said. Many people say they “want it to be over,” he said, but SARS-CoV-2, established as a viral respiratory infection, shows no signs of disappearing. In addition, new data continue to show higher mortality associated with COVID-19 than with influenza, he said.

“We need to explain to our patients that COVID-19 is still here and is still dangerous. The yearly influenza vaccination campaigns should have established and normalized the idea of an updated vaccine targeted for the season’s predicated strains is expected,” he emphasized. “We now have years of safety data behind these vaccines, and we need to make a strong recommendation for this protection,” he said.

COVID-19 vaccines are covered by private insurance, as well as by Medicare and Medicaid, according to the CDC. Vaccination for uninsured children is covered through the Vaccines for Children Program.

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

New COVID-19 vaccines formulated for better protection against the currently circulating variants have been approved by the US Food and Drug Administration.

The COVID vaccines available this fall have been updated to better match the currently circulating COVID strains, said William Schaffner, MD, professor of medicine in the Division of Infectious Diseases at Vanderbilt University, Nashville, Tennessee, in an interview.

“The Pfizer and Moderna vaccines — both mRNA vaccines — target the KP.2 variant, while the Novavax vaccine targets the JN.1 variant, which is a predecessor to KP.2,” said Dr. Schaffner, who also serves as a spokesperson for the National Foundation for Infectious Diseases. “The Novavax vaccine is a protein adjuvant vaccine made in a more traditional fashion and may appeal to those who remain hesitant about receiving an mRNA vaccine,” he explained. However, all three vaccines are designed to protect against severe COVID illness and reduce the likelihood of hospitalization, he said.
 

Who Needs It?

“The CDC’s Advisory Committee on Immunization Practices (ACIP) continues to recommend that everyone in the United States who is age 6 months and older receive the updated COVID vaccine this fall, along with influenza vaccine,” Dr. Schaffner said.

“This was not a surprise because COVID will produce a sizable winter outbreak,” he predicted. Although older people and those who have chronic medical conditions such as heart or lung disease, diabetes, or other immunocompromising conditions suffer the most serious impact of COVID, he said. “The virus can strike anyone, even the young and healthy.” The risk for long COVID persists as well, he pointed out.

The ACIP recommendation is endorsed by the American Academy of Pediatrics and other professional organizations, Dr. Shaffner said.

A frequently asked question is whether the COVID and flu vaccines can be given at the same time, and the answer is yes, according to a statement from the Centers for Disease Control and Prevention (CDC).

“The optimal time to be vaccinated is late September and anytime during October in order to get the benefit of protection through the winter,” Dr. Schaffner said.

As with earlier versions of the COVID-19 vaccine, side effects vary from person to person. Reported side effects of the updated vaccine are similar to those seen with earlier versions and may include injection site pain, redness and swelling, fatigue, headache, muscle pain, chills, nausea, and fever, but most of these are short-lived, according to the CDC.
 

Clinical Guidance

The CDC’s clinical guidance for COVID-19 vaccination outlines more specific guidance for vaccination based on age, vaccination history, and immunocompromised status and will be updated as needed.

A notable difference in the latest guidance is the recommendation of only one shot for adults aged 65 years and older who are NOT moderately or severely immunocompromised. For those who are moderately or severely immunocompromised, the CDC recommends two to three doses of the same brand of vaccine.

Dr. Schaffner strongly encouraged clinicians to recommend the COVID-19 vaccination for all eligible patients. “COVID is a nasty virus that can cause serious disease in anyone,” and protection from previous vaccination or prior infection has likely waned, he said.

Dr. Schaffner also encouraged healthcare professionals and their families to lead by example. “We should all be vaccinated and let our patients know that we are vaccinated and that we want all our patents to be protected,” he said.

The updated COVID-19 vaccination recommendations have become much simpler for clinicians and patients, with a single messenger RNA (mRNA) vaccine required for anyone older than 5 years, said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

“The recommendations are a bit more complex for children under 5 years old receiving their first vaccination; they require two to three doses depending on the brand,” he said. “It is important to review the latest recommendations to plan the doses with the correct interval timing. Considering the doses may be 3-4 weeks apart, start early,” he advised.
 

One-Time Dosing

Although the updated mRNA vaccine is currently recommended as a one-time dose, Dr. Cennimo said he can envision a scenario later in the season when a second dose is recommended for the elderly and those at high risk for severe illness. Dr. Cennimo said that he strongly agrees with the recommendations that everyone aged 6 months and older receive an updated COVID-19 vaccine. Older age remains the prime risk factor, but anyone can become infected, he said.

Predicting a prime time to get vaccinated is tricky because no one knows when the expected rise in winter cases will occur, said Dr. Cennimo.

“We know from years of flu vaccine data that some number of people who delay the vaccine will never return and will miss protection,” he said. Therefore, delaying vaccination is not recommended. Dr. Cennimo plans to follow his habit of getting vaccinated in early October. “I anticipate the maximal effectiveness of the vaccine will carry me through the winter,” he said.

Data support the safety and effectiveness for both flu and COVID vaccines if they are given together, and some research on earlier versions of COVID vaccines suggested that receiving flu and COVID vaccines together might increase the antibody response against COVID, but similar studies of the updated version have not been done, Dr. Cennimo said.

Clinicians may have to overcome the barrier of COVID fatigue to encourage vaccination, Dr. Cennimo said. Many people say they “want it to be over,” he said, but SARS-CoV-2, established as a viral respiratory infection, shows no signs of disappearing. In addition, new data continue to show higher mortality associated with COVID-19 than with influenza, he said.

“We need to explain to our patients that COVID-19 is still here and is still dangerous. The yearly influenza vaccination campaigns should have established and normalized the idea of an updated vaccine targeted for the season’s predicated strains is expected,” he emphasized. “We now have years of safety data behind these vaccines, and we need to make a strong recommendation for this protection,” he said.

COVID-19 vaccines are covered by private insurance, as well as by Medicare and Medicaid, according to the CDC. Vaccination for uninsured children is covered through the Vaccines for Children Program.

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

New COVID-19 vaccines formulated for better protection against the currently circulating variants have been approved by the US Food and Drug Administration.

The COVID vaccines available this fall have been updated to better match the currently circulating COVID strains, said William Schaffner, MD, professor of medicine in the Division of Infectious Diseases at Vanderbilt University, Nashville, Tennessee, in an interview.

“The Pfizer and Moderna vaccines — both mRNA vaccines — target the KP.2 variant, while the Novavax vaccine targets the JN.1 variant, which is a predecessor to KP.2,” said Dr. Schaffner, who also serves as a spokesperson for the National Foundation for Infectious Diseases. “The Novavax vaccine is a protein adjuvant vaccine made in a more traditional fashion and may appeal to those who remain hesitant about receiving an mRNA vaccine,” he explained. However, all three vaccines are designed to protect against severe COVID illness and reduce the likelihood of hospitalization, he said.
 

Who Needs It?

“The CDC’s Advisory Committee on Immunization Practices (ACIP) continues to recommend that everyone in the United States who is age 6 months and older receive the updated COVID vaccine this fall, along with influenza vaccine,” Dr. Schaffner said.

“This was not a surprise because COVID will produce a sizable winter outbreak,” he predicted. Although older people and those who have chronic medical conditions such as heart or lung disease, diabetes, or other immunocompromising conditions suffer the most serious impact of COVID, he said. “The virus can strike anyone, even the young and healthy.” The risk for long COVID persists as well, he pointed out.

The ACIP recommendation is endorsed by the American Academy of Pediatrics and other professional organizations, Dr. Shaffner said.

A frequently asked question is whether the COVID and flu vaccines can be given at the same time, and the answer is yes, according to a statement from the Centers for Disease Control and Prevention (CDC).

“The optimal time to be vaccinated is late September and anytime during October in order to get the benefit of protection through the winter,” Dr. Schaffner said.

As with earlier versions of the COVID-19 vaccine, side effects vary from person to person. Reported side effects of the updated vaccine are similar to those seen with earlier versions and may include injection site pain, redness and swelling, fatigue, headache, muscle pain, chills, nausea, and fever, but most of these are short-lived, according to the CDC.
 

Clinical Guidance

The CDC’s clinical guidance for COVID-19 vaccination outlines more specific guidance for vaccination based on age, vaccination history, and immunocompromised status and will be updated as needed.

A notable difference in the latest guidance is the recommendation of only one shot for adults aged 65 years and older who are NOT moderately or severely immunocompromised. For those who are moderately or severely immunocompromised, the CDC recommends two to three doses of the same brand of vaccine.

Dr. Schaffner strongly encouraged clinicians to recommend the COVID-19 vaccination for all eligible patients. “COVID is a nasty virus that can cause serious disease in anyone,” and protection from previous vaccination or prior infection has likely waned, he said.

Dr. Schaffner also encouraged healthcare professionals and their families to lead by example. “We should all be vaccinated and let our patients know that we are vaccinated and that we want all our patents to be protected,” he said.

The updated COVID-19 vaccination recommendations have become much simpler for clinicians and patients, with a single messenger RNA (mRNA) vaccine required for anyone older than 5 years, said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.

“The recommendations are a bit more complex for children under 5 years old receiving their first vaccination; they require two to three doses depending on the brand,” he said. “It is important to review the latest recommendations to plan the doses with the correct interval timing. Considering the doses may be 3-4 weeks apart, start early,” he advised.
 

One-Time Dosing

Although the updated mRNA vaccine is currently recommended as a one-time dose, Dr. Cennimo said he can envision a scenario later in the season when a second dose is recommended for the elderly and those at high risk for severe illness. Dr. Cennimo said that he strongly agrees with the recommendations that everyone aged 6 months and older receive an updated COVID-19 vaccine. Older age remains the prime risk factor, but anyone can become infected, he said.

Predicting a prime time to get vaccinated is tricky because no one knows when the expected rise in winter cases will occur, said Dr. Cennimo.

“We know from years of flu vaccine data that some number of people who delay the vaccine will never return and will miss protection,” he said. Therefore, delaying vaccination is not recommended. Dr. Cennimo plans to follow his habit of getting vaccinated in early October. “I anticipate the maximal effectiveness of the vaccine will carry me through the winter,” he said.

Data support the safety and effectiveness for both flu and COVID vaccines if they are given together, and some research on earlier versions of COVID vaccines suggested that receiving flu and COVID vaccines together might increase the antibody response against COVID, but similar studies of the updated version have not been done, Dr. Cennimo said.

Clinicians may have to overcome the barrier of COVID fatigue to encourage vaccination, Dr. Cennimo said. Many people say they “want it to be over,” he said, but SARS-CoV-2, established as a viral respiratory infection, shows no signs of disappearing. In addition, new data continue to show higher mortality associated with COVID-19 than with influenza, he said.

“We need to explain to our patients that COVID-19 is still here and is still dangerous. The yearly influenza vaccination campaigns should have established and normalized the idea of an updated vaccine targeted for the season’s predicated strains is expected,” he emphasized. “We now have years of safety data behind these vaccines, and we need to make a strong recommendation for this protection,” he said.

COVID-19 vaccines are covered by private insurance, as well as by Medicare and Medicaid, according to the CDC. Vaccination for uninsured children is covered through the Vaccines for Children Program.

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

With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

With huge shifts over the past decade in the way doctors are employed — half of all doctors now work for a health system or large medical group — the idea of unionizing is not only being explored but gaining traction within the profession. In fact, 8% of the physician workforce (or 70,000 physicians) belong to a union, according to statistics gathered in 2022.

Exact numbers are hard to come by, and, interestingly, although the American Medical Association (AMA) “ supports the right of physicians to engage in collective bargaining,” the organization doesn’t track union membership among physicians, according to an AMA spokesperson. 
 

Forming a Union

One challenge is that forming a union is not only time-consuming but also difficult, owing to several barriers. For starters, the laws dictating unionization differ by state, and the rules governing unionization vary if a hospital is public or private. If there’s enough momentum from doctors leading unionization efforts, approval from hospital leaders is required before an official election can be requested from the National Labor Relations Board.

That said, for doctors who are in a union — the two most popular are the Union of American Physicians and Dentists and the Doctors Council branch of the Service Employees International Union (SEIU)—the benefits are immense, especially because union members can focus on what matters, such as providing the best patient care possible.

For a profession that historically has not been unionized, this year alone, nine medical residency programs at hospitals such as Stanford Health, Montefiore Medical Center, and the University of Pennsylvania, formed unions, reported WBUR in Boston.
 

Belonging Matters 

“When you build a relationship with your patients, it’s special, and that connection isn’t replaceable,” said Nicholas VenOsdel, MD, a pediatrician at Allina Health Primary Care in Hastings, Minnesota, and a union member of the Doctors Council. “However, a lot of us have felt like that hasn’t been respected as the climate of healthcare has changed so fast.”

In fact, autonomy over how much time doctors spend with patients is driving a lot of interest in unionization.

“We don’t necessarily have that autonomy now,” said Amber Higgins, MD, an emergency physician and an obstetrician at ChristianaCare, a hospital network in Newark, Delaware, and a member of the Doctors Council. “There are so many other demands, whether it’s billing, patient documentation, or other demands from the employer, and all of that takes time away from patient care.”

Another primary driver of physician unionization is the physician burnout epidemic. Physicians collectively complain that they spend more time on electronic health record documentation and bureaucratic administration. Yet if unions can improve these working conditions, the benefit to physicians and their patients would be a welcome change.

Union members are bullish and believe that having a cohesive voice will make a difference.

“We need to use our collective voices to get back to focusing on patient care instead of staring at a computer screen for 80% of the day,” Dr. Higgins told this news organization. “So much of medicine involves getting to the correct diagnosis, listening to patients, observing them, and building a relationship with them. We need time to build that.”

With corporate consolidation and a profit-driven mandate by healthcare systems, doctors are increasingly frustrated and feel that their voices haven’t been heard enough when it comes to issues like workplace safety, working hours, and benefits, said Stuart Bussey, MD, JD, a family practice physician and president of the Union of American Physicians and Dentists in Sacramento, California. 

However, he adds that urging doctors to join together to fight for a better working environment hasn’t been easy.

“Doctors are individualists, and they don’t know how to work in packs like hospital administrators do,” said Dr. Bussey. “They’re hard to organize, but I want them to understand that unless they join hands, sign petitions, and speak as one voice, they’re going to lose out on an amazing opportunity.”
 

Overcoming Misperceptions About Unions

One barrier to doctors getting involved is the sentiment that unions might do the opposite of what’s intended — that is, they might further reduce a doctor’s autonomy and work flexibility. Or there may be a perception that the drive to join a union is predicated on making more money. 

Though he’s now in a union, Dr. VenOsdel, who has been in a hospital-based practice for 7 years, admits that he initially felt very differently about unions than he does today.

“Even though I have family members in healthcare unions, I had a neutral to even slightly negative view of unions,” said Dr. VenOsdel. “It took me working directly with the Minnesota Nurses Association and the Doctors Council to learn the other side of the story.”

Armed with more information, he began lobbying for stricter rules about how his state’s large healthcare systems were closing hospitals and ending much-needed community services.

“I remember standing at the Capitol in Minnesota and telling one of the members that I once felt negatively about unions,” he added. “I realized then that I only knew what employers were telling me via such things as emails about strikes — that information was all being shared from the employers’ perspective.”

The other misperception is that unions only exist to argue against management, including against colleagues who are also part of the management structure, said Dr. Higgins.

“Some doctors perceive being in a union as ‘how can those same leaders also be in a union,’” she said. She feels that they currently don’t have leadership representing them that can help with such things as restructuring their support teams or getting them help with certain tasks. “That’s another way unions can help.” 
 

Social Justice Plays a Role

For Dr. VenOsdel, being part of a union has helped him return to what he calls the “art” of medicine.

“Philosophically, the union gave me an option for change in what felt like a hopeless situation,” he said. “It wasn’t just that I was tossing the keys to someone else and saying, ‘I can’t fix this.’ Instead, we’re taking the reins back and fixing things ourselves.”

Bussey argues that as the uneven balance between administrators and providers in many healthcare organizations grows, the time to consider forming a union is now.

“We’re in a $4 trillion medical industrial revolution,” he said. “Administrators and bureaucrats are multiplying 30-fold times vs providers, and most of that $4 trillion supports things that don’t contribute to the doctor-patient relationship.”

Furthermore, union proponents say that where a one-on-one relationship between doctor and patient once existed, that has now been “triangulated” to include administrators.

“We’ve lost power in every way,” Dr. Bussey said. “We have the degrees, the liability, and the knowledge — we should have more power to make our workplaces safer and better.”

Ultimately, for some unionized doctors, the very holding of a union card is rooted in supporting social justice issues.

“When doctors realize how powerful a tool a union can be for social justice and change, this will alter perceptions of unions within our profession,” Dr. VenOsdel said. “Our union helps give us a voice to stand up for other staff who aren’t unionized and, most importantly, to stand up for the patients who need us.”
 

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

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

Tirzepatide (Zepbound) is not in shortage for now, but the weight loss drug has remained inaccessible to people without insurance coverage who can’t afford to pay out of pocket. Now, its manufacturer, Eli Lilly, has introduced a new formulation it says will “significantly expand” the supply. But not all endocrinologists are enthusiastic.

As of August 27, LillyDirect made 2.5-mg and 5-mg single-dose vials of tirzepatide available to self-pay patients with an on-label electronic prescription. Lilly’s announcement said the single-dose vials “are priced at a 50% or greater discount compared to the list price of all other incretin (glucagon-like peptide 1 receptor agonists or GLP-1) medicines for obesity.”

For a 4-week supply of the weekly injections, the discount at LillyDirect translates to $399 for a 2.5-mg single-dose vial ($99.75 per vial) and $549 for the 5-mg dose ($137.25 per vial), which the company noted was “in line with the Zepbound savings program for noncovered individuals.” (The new direct single-dose prescriptions cannot be filled at community or retail pharmacies.)

“In a clinical study, the 5-mg maintenance dose helped patients achieve an average of 15% weight loss after 72 weeks of treatment and has been a powerful tool for millions of people with obesity looking to lose weight and keep it off,” according to the announcement.

The clinical study, which is not named or referenced in the announcement, is SURMOUNT-1, a Lilly spokesperson said in an interview. Yet, that study also found that patients achieved an average weight loss of 19.5% with 10-mg doses and 20.9% with 15-mg doses of tirzepatide. Furthermore, the percentage of participants achieving body weight reductions of ≥ 5% was 85% (5 mg), 89% (10 mg), and 91% (15 mg), showing the benefits of higher doses.

And there’s the rub.
 

‘Only Two Different Doses’

Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the University of Southern California, Los Angeles, said in an interview: “My concern is, they’re only providing two different doses, 2.5 mg and 5 mg. You get somebody on it, and then they still have to go back to the traditional pens. I’m very opposed to getting patients connected to a medication they can’t then continue to take.

“Now we have starter doses that are easy to come by,” she said. “But the problem isn’t starting. The problem for all of these patients is chronic continuation of the right dose of the drug, and out-of-pocket costs become exorbitantly higher when they have to self-purchase the pens for the higher doses.

“Yes, the 5-mg dose has benefits, but not the same as higher doses,” she continued. “I have nobody for whom 5 mg is the right dose. They have to take more, sometimes within a month or 2 of starting, in order to achieve the kind of weight loss they need.”

If their insurance doesn’t cover the drug, “what are they going to do to stay on 5 mg? Or pay a crapload of money to buy three of the 5-mg doses to reach a higher dose?”

Michael Weintraub, MD, clinical assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine in New York City, said that, “for many, this lower monthly cost is attainable and is a significant advancement in increasing access. For others, however, an out-of-pocket monthly cost of $349-549 for a chronic medication is still unaffordable.”

And like Dr. Peters, he said, “some patients do not lose a clinically significant amount of weight with 2.5 mg or 5 mg and require higher doses. There is no way of prescribing a higher dose of Zepbound vials, so patients would have to resort to the higher-dose auto-injector pens that are still double the price.”

A Lilly spokesperson countered in a comment: “Offering Zepbound single-dose vials in higher dosage strengths could increase the potential for dose splitting, which is not contemplated by the FDA [Food and Drug Adminstration]–approved label and may pose patient safety risks.”

But Dr. Peters wondered: “Wouldn’t dose splitting of a known-to-be-pure compound be better than getting it at a compounding pharmacy that lacks purity/safety? The one message from all of this is that patients need to know what they’re getting into. They’re starting a drug that can help with weight loss, but they’re going to be on a sub-max dose. And a higher dose is going to be double the price.”

In addition, said Robert F. Kushner, MD, a professor at Northwestern University Feinberg School of Medicine in Chicago, Illinois, “for the lower-dose vials, instead of administering the drug with a self-auto-injection pen, patients will need to use a needle and syringe and draw up the dose from a vial. This will take a higher skill level and health literacy that may be challenging for some patients. Patients may need additional training on how to use this new formulation. That will take additional time and resources, such as a demonstration in the office or referral to video.”

The Lilly news release noted that “patients can also purchase ancillary supplies, like syringes and needles, and will have access to important patient-friendly instructional materials on correctly administering the medicine via needle and syringe.”
 

Protection From Compounders?

According to the Lilly spokesperson, the launch of Zepbound vials “furthers our commitment to helping patients avoid the risks associated with compounded products by providing patients another option for access to genuine Lilly medicine.”

Indeed, said Jaime Almandoz, MD, medical director of the Weight Wellness Program and associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, “The introduction of Zepbound/tirzepatide in single-dose vials should improve access to evidence-based obesity treatments, reducing potential risks associated with compounded additives and eliminating the need for patients to calculate correct medication doses,” which have led to accidental overdoses of compounded semaglutide.

Lilly’s spokesperson added: “We have taken multiple steps — including publishing an open letter and launching lilly.com/real-medicine — to warn the public about the risks posed by the proliferation of counterfeit, fake, unsafe, or untested knockoffs of Lilly’s genuine medicines.”

But whether these steps are strong enough to overcome the realities of cost and the need for affordable higher doses remains to be seen.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a statement that the new version of Zepbound “is great news for patients. It’s a much more rational and care-focused response to the remarkable demand for their drug than the lawsuits and cease-and-desist letters Lilly has been raining down on compounding pharmacies.”

“For 20 months now,” he continued, “compounders have been a lifeline for many patients, filling prescriptions for compounded tirzepatide injection at a time when the FDA-approved drug has been in shortage. We’ll be eager to see whether Lilly’s direct-to-patient approach actually works.”

Dr. Almandoz affirmed: “Everyone wants to see improved access to evidence-based obesity care. It’s crucial to ensure patients receive the most appropriate interventions, whether it is lifestyle changes, medications, or bariatric surgery,” he said. “There are resources available, [including his recent paper], for nutrition and lifestyle modifications specifically for patients taking obesity medications, which can help clinicians guide their patients toward better health.”

Dr. Almandoz is a member of advisory boards and consults for: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. Dr. Kushner is an adviser to Eli Lilly and Novo Nordisk. Dr. Peters and Dr. Weintraub declared no competing interests.

A version of this article appeared on Medscape.com.

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

In the setting of isocaloric eating, time-restricted eating (TRE) did not reduce weight or improve glucose homeostasis relative to a usual eating pattern (UEP), a small randomized controlled trial found.

The results suggested that any effects of TRE on weight observed in prior studies may be due to reductions in caloric intake and not timing, according to Nisa M. Maruthur, MD, MHS, of the Division of General Internal Medicine at the Johns Hopkins School of Medicine in Baltimore, and colleagues.

Published in Annals of Internal Medicine, the 12-week trial randomly assigned 41 adults aged 18-69 years with obesity and prediabetes or diet-controlled diabetes 1:1 as follows: To TRE, involving a 10-hour eating window with 80% of calories consumed before 1 PM, or to UEP, involving a ≤ 16-hour window, with at least 50% of calories consumed after 5 PM. The regimen in each group was based on the OmniHeart unsaturated fat diet and the SPICE study.

“The diet was similar to the DASH [Dietary Approaches to Stop Hypertension] diet for hypertension and maybe a bit higher in unsaturated fat and micronutrients,” said study co-author Scott J. Pilla, MD, MHS, an assistant professor of medicine at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. For each participant, macro- and micronutrient content remained constant throughout the study period, with total calories individually determined at baseline and ranging from 1600 to 3500 kcal/d. “That differs from some TRE studies in which calories were adjusted according to whether participants lost or gained weight,” he said. “This was a purely mechanistic study to determine the impact of time of eating alone with no change in calories.”

The Cohort

The mean age was 59 years, 93% of patients were women, and 93% were Black. The mean body mass index was 36, and the mean baseline weight was 96.2 kg — 95.6 kg in the TRE group and 103.7 kg in the UEP group.

At 12 weeks, weight decreased comparably by 2.3 kg (95% CI, 1.0-3.5) in the TRE group and by 2.6 kg (95% CI, 1.5-3.7) in the UEP group. Change in glycemic measures did not differ between the two groups.

Interestingly, self-reporting questionnaires revealed a slight reduction in physical activity in the TRE group, an effect that requires further study. “We don’t know why but anecdotally, some TRE participants said they tended to go to bed earlier,” Dr. Pilla said. Earlier bedtimes may put an end sooner to the daily eating pattern.

Subanalyses of the data are ongoing and will be published later.

“In the context of several clinical trials that suggest a benefit of TRE, our findings suggest that if or when TRE interventions induce weight loss, it is likely in part due to a reduction in energy intake, and therefore, clinicians can counsel patients that TRE may help them lose weight by decreasing their caloric intake,” the authors wrote.

In an accompanying editorial, Krista A. Varady, PhD, and Vanessa M. Oddo, PhD, of the Department of Kinesiology and Nutrition at the University of Illinois–Chicago, said the study results have important clinical implications. “Many patients stop following standard-care diets (such as daily calorie restriction) because they become frustrated with having to monitor food intake vigilantly each day,” they wrote.

Gastroenterologists and Obesity

Of late, support has grown for gastroenterologists to become actively involved in obesity treatment — even to “take ownership” of this field.

In a 2023 article in Gut, Michael Camilleri, MD, AGAF, a gastroenterologist at the Mayo Clinic in Rochester, Minnesota, made the case for the natural fit between gastrointestinal (GI) specialists and obesity management. He noted that obesity is a significant risk factor for GI, pancreatic, and liver diseases. It can even affect inflammatory bowel disease.

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

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Metformin significantly improved symptoms and resulted in hair regrowth in Black women with treatment-refractory central centrifugal cicatricial alopecia (CCCA), in a retrospective case series.

METHODOLOGY:

• Researchers conducted a case series involving 12 Black women in their 30s, 40s, and 50s, with biopsy-confirmed, treatment-refractory CCCA, a chronic inflammatory hair disorder characterized by permanent hair loss, from the Johns Hopkins University alopecia clinic.
• Participants received CCCA treatment for at least 6 months and had stagnant or worsening symptoms before oral extended-release metformin (500 mg daily) was added to treatment. (Treatments included topical clobetasol, compounded minoxidil, and platelet-rich plasma injections.)
• Scalp biopsies were collected from four patients before and after metformin treatment to evaluate gene expression changes.
• Changes in clinical symptoms were assessed, including pruritus, inflammation, pain, scalp resistance, and hair regrowth, following initiation of metformin treatment.

TAKEAWAY:

• Metformin led to significant clinical improvement in eight patients, which included reductions in scalp pain, scalp resistance, pruritus, and inflammation. However, two patients experienced worsening symptoms.
• Six patients showed clinical evidence of hair regrowth after at least 6 months of metformin treatment with one experiencing hair loss again 3 months after discontinuing treatment.
• Transcriptomic analysis revealed 34 upregulated genes, which included upregulated of 23 hair keratin-associated proteins, and pathways related to keratinization, epidermis development, and the hair cycle. In addition, eight genes were downregulated, with pathways that included those associated with extracellular matrix organization, collagen fibril organization, and collagen metabolism.
• Gene set variation analysis showed reduced expression of T helper 17 cell and epithelial-mesenchymal transition pathways and elevated adenosine monophosphate kinase signaling and keratin-associated proteins after treatment with metformin.

IN PRACTICE:

“Metformin’s ability to concomitantly target fibrosis and inflammation provides a plausible mechanism for its therapeutic effects in CCCA and other fibrosing alopecia disorders,” the authors concluded. But, they added, “larger prospective, placebo-controlled randomized clinical trials are needed to rigorously evaluate metformin’s efficacy and optimal dosing for treatment of cicatricial alopecias.”

SOURCE:

The study was led by Aaron Bao, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, and was published online on September 4 in JAMA Dermatology.

LIMITATIONS:

A small sample size, retrospective design, lack of a placebo control group, and the single-center setting limited the generalizability of the study findings. In addition, the absence of a validated activity or severity scale for CCCA and the single posttreatment sampling limit the assessment and comparison of clinical symptoms and transcriptomic changes.

DISCLOSURES:

The study was supported by the American Academy of Dermatology. One author reported several ties with pharmaceutical companies, a pending patent, and authorship for the UpToDate section on CCCA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An impaired central sensitivity to thyroid hormone may be associated with an increased risk for death in patients with chronic kidney disease (CKD) and normal thyroid function.

METHODOLOGY:

• Previous studies have shown that abnormal levels of thyroid-stimulating hormone (TSH) are associated with a higher mortality risk in patients with CKD, but whether the risk extends to those with normal thyroid function remains controversial.
• Researchers investigated the association between central sensitivity to thyroid hormone and the risk for all-cause mortality in 1303 euthyroid patients with CKD (mean age, 60 years; 59% women) from the National Health and Nutrition Examination Survey database (2007-2012).
• All participants had CKD stages I-IV, defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m² and/or a urinary albumin to urinary creatinine ratio ≥ 30 mg/g.
• The central sensitivity to thyroid hormone was primarily evaluated using a new central thyroid hormone resistance index, the Thyroid Feedback Quantile–based Index (TFQI), using free thyroxine and TSH concentrations.
• The participants were followed for a median duration of 115 months, during which 503 died.

TAKEAWAY:

• Patients with CKD who died during the follow-up period had a significantly higher TFQI (P < .001) than those who survived.
• The rates of all-cause mortality increased from 26.61% in the lowest TFQI tertile to 40.89% in the highest tertile (P = .001).
• A per unit increase in the TFQI was associated with a 40% increased risk for all-cause mortality (hazard ratio, 1.40; 95% CI, 1.10-1.79).
• This association between TFQI level and all-cause mortality persisted in all subgroups stratified by age, gender, race, body mass index, hypertension, diabetes, cardiovascular diseases, and CKD stages.

IN PRACTICE:

“Our study demonstrates that impaired sensitivity to thyroid hormone might be associated with all-cause mortality in CKD patients with normal thyroid function, independent of other traditional risk factors and comorbidities,” the authors wrote.

SOURCE:

This study was led by Qichao Yang and Ru Dong, Department of Endocrinology, Affiliated Wujin Hospital of Jiangsu University, Changzhou, China, and was published online on August 6, 2024, in BMC Public Health.

LIMITATIONS:

Thyroid function was measured only at baseline, and the changes in thyroid function over time were not measured. The study excluded people on thyroid hormone replacement therapy but did not consider other medication use that might have affected thyroid function, such as beta-blockers, steroids, and amiodarone. Thyroid-related antibodies, metabolic syndrome, and nonalcoholic fatty liver disease were not included in the analysis as possible confounding factors. The US-based sample requires further validation.

DISCLOSURES:

The study was supported by the Changzhou Health Commission. The authors declared no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An impaired central sensitivity to thyroid hormone may be associated with an increased risk for death in patients with chronic kidney disease (CKD) and normal thyroid function.

METHODOLOGY:

• Previous studies have shown that abnormal levels of thyroid-stimulating hormone (TSH) are associated with a higher mortality risk in patients with CKD, but whether the risk extends to those with normal thyroid function remains controversial.
• Researchers investigated the association between central sensitivity to thyroid hormone and the risk for all-cause mortality in 1303 euthyroid patients with CKD (mean age, 60 years; 59% women) from the National Health and Nutrition Examination Survey database (2007-2012).
• All participants had CKD stages I-IV, defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m² and/or a urinary albumin to urinary creatinine ratio ≥ 30 mg/g.
• The central sensitivity to thyroid hormone was primarily evaluated using a new central thyroid hormone resistance index, the Thyroid Feedback Quantile–based Index (TFQI), using free thyroxine and TSH concentrations.
• The participants were followed for a median duration of 115 months, during which 503 died.

TAKEAWAY:

• Patients with CKD who died during the follow-up period had a significantly higher TFQI (P < .001) than those who survived.
• The rates of all-cause mortality increased from 26.61% in the lowest TFQI tertile to 40.89% in the highest tertile (P = .001).
• A per unit increase in the TFQI was associated with a 40% increased risk for all-cause mortality (hazard ratio, 1.40; 95% CI, 1.10-1.79).
• This association between TFQI level and all-cause mortality persisted in all subgroups stratified by age, gender, race, body mass index, hypertension, diabetes, cardiovascular diseases, and CKD stages.

IN PRACTICE:

“Our study demonstrates that impaired sensitivity to thyroid hormone might be associated with all-cause mortality in CKD patients with normal thyroid function, independent of other traditional risk factors and comorbidities,” the authors wrote.

SOURCE:

This study was led by Qichao Yang and Ru Dong, Department of Endocrinology, Affiliated Wujin Hospital of Jiangsu University, Changzhou, China, and was published online on August 6, 2024, in BMC Public Health.

LIMITATIONS:

Thyroid function was measured only at baseline, and the changes in thyroid function over time were not measured. The study excluded people on thyroid hormone replacement therapy but did not consider other medication use that might have affected thyroid function, such as beta-blockers, steroids, and amiodarone. Thyroid-related antibodies, metabolic syndrome, and nonalcoholic fatty liver disease were not included in the analysis as possible confounding factors. The US-based sample requires further validation.

DISCLOSURES:

The study was supported by the Changzhou Health Commission. The authors declared no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An impaired central sensitivity to thyroid hormone may be associated with an increased risk for death in patients with chronic kidney disease (CKD) and normal thyroid function.

METHODOLOGY:

• Previous studies have shown that abnormal levels of thyroid-stimulating hormone (TSH) are associated with a higher mortality risk in patients with CKD, but whether the risk extends to those with normal thyroid function remains controversial.
• Researchers investigated the association between central sensitivity to thyroid hormone and the risk for all-cause mortality in 1303 euthyroid patients with CKD (mean age, 60 years; 59% women) from the National Health and Nutrition Examination Survey database (2007-2012).
• All participants had CKD stages I-IV, defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m² and/or a urinary albumin to urinary creatinine ratio ≥ 30 mg/g.
• The central sensitivity to thyroid hormone was primarily evaluated using a new central thyroid hormone resistance index, the Thyroid Feedback Quantile–based Index (TFQI), using free thyroxine and TSH concentrations.
• The participants were followed for a median duration of 115 months, during which 503 died.

TAKEAWAY:

• Patients with CKD who died during the follow-up period had a significantly higher TFQI (P < .001) than those who survived.
• The rates of all-cause mortality increased from 26.61% in the lowest TFQI tertile to 40.89% in the highest tertile (P = .001).
• A per unit increase in the TFQI was associated with a 40% increased risk for all-cause mortality (hazard ratio, 1.40; 95% CI, 1.10-1.79).
• This association between TFQI level and all-cause mortality persisted in all subgroups stratified by age, gender, race, body mass index, hypertension, diabetes, cardiovascular diseases, and CKD stages.

IN PRACTICE:

“Our study demonstrates that impaired sensitivity to thyroid hormone might be associated with all-cause mortality in CKD patients with normal thyroid function, independent of other traditional risk factors and comorbidities,” the authors wrote.

SOURCE:

This study was led by Qichao Yang and Ru Dong, Department of Endocrinology, Affiliated Wujin Hospital of Jiangsu University, Changzhou, China, and was published online on August 6, 2024, in BMC Public Health.

LIMITATIONS:

Thyroid function was measured only at baseline, and the changes in thyroid function over time were not measured. The study excluded people on thyroid hormone replacement therapy but did not consider other medication use that might have affected thyroid function, such as beta-blockers, steroids, and amiodarone. Thyroid-related antibodies, metabolic syndrome, and nonalcoholic fatty liver disease were not included in the analysis as possible confounding factors. The US-based sample requires further validation.

DISCLOSURES:

The study was supported by the Changzhou Health Commission. The authors declared no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.