Lori Youmshajekian

TOPLINE:

Nearly one in five adolescents are living with prediabetes, a condition where blood glucose levels are elevated, but are not high enough for a type 2 diabetes (T2D) diagnosis. According to a new study, higher levels of nonfasting glucose and hemoglobin A1c, and worsening obesity are important predictors of progression to T2D. In addition, metformin and weight stabilization may prove to be important interventions for preventing T2D in kids.

METHODOLOGY:

• Researchers did a retrospective chart review of patient data from Vanderbilt University Medical Center Pediatric Prediabetes Clinic, Nashville, Tenn., from May 2015 to August 2022.
• The study included 552 children with prediabetes, defined as abnormal blood glucose (fasting plasma glucose [FPG] ≥ 100 mg/dL, random glucose ≥ 150 mg/dL), or hemoglobin A1c equal to or greater than 5.9%.
• Based on follow-up visits, patients were classified as having progressed to T2D, or nonprogression.
• Researchers analyzed the patients’ initial visit A1c, fasting C-peptide, 2-hour glucose, fasting glucose, and body mass index (BMI), among other baseline characteristics.

TAKEAWAY:

• Thirty-six children (6.5%) progressed to T2D during the duration of the study period.
• The average time to T2D diagnosis was much longer in patients taking metformin (43 months), compared with those not taking the prescribed medication (28 months).
• Worsening obesity was strongly associated with T2D progression – patients who progressed to T2D had a higher BMI at baseline and had continued weight gain.
• A higher baseline A1c, fasting C-peptide, and 2-hour glucose were also associated with progression to T2D.
• In the multivariable analysis, both A1c and 2-hour glucose were strong independent predictors of progression.
• Fasting plasma glucose was not associated with progression to T2D.

IN PRACTICE:

“Weight stabilization and metformin therapy could be important interventions for diabetes prevention in children,” study author Ashley H. Shoemaker, MD, MSci, a pediatric endocrinologist at Vanderbilt University Medical Center in Nashville, Tenn., said in a press release.

In addition, A1c plus a nonfasting glucose may be a feasible way to identify high-risk pediatric patients in a clinical setting.
 

SOURCE:

This study was performed by Natasha Belsky, Jaclyn Tamaroff, and Ashley H. Shoemaker of the Vanderbilt University Medical Center and the Vanderbilt University School of Medicine in Nashville, Tenn. It was published October 12, 2023, in the Journal of the Endocrine Society

LIMITATIONS:

Additional patients who developed T2D may have been lost to follow-up, since the authors did not contact patients to confirm their disease status. The authors were also unable to establish racial differences in the progression to T2D because of missing data.

DISCLOSURES:

Funding for this study was provided by the National Center for Advancing Translational Sciences. One author has research contracts with Novo Nordisk and Boehringer Ingelheim.

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

TOPLINE:

Nearly one in five adolescents are living with prediabetes, a condition where blood glucose levels are elevated, but are not high enough for a type 2 diabetes (T2D) diagnosis. According to a new study, higher levels of nonfasting glucose and hemoglobin A1c, and worsening obesity are important predictors of progression to T2D. In addition, metformin and weight stabilization may prove to be important interventions for preventing T2D in kids.

METHODOLOGY:

• Researchers did a retrospective chart review of patient data from Vanderbilt University Medical Center Pediatric Prediabetes Clinic, Nashville, Tenn., from May 2015 to August 2022.
• The study included 552 children with prediabetes, defined as abnormal blood glucose (fasting plasma glucose [FPG] ≥ 100 mg/dL, random glucose ≥ 150 mg/dL), or hemoglobin A1c equal to or greater than 5.9%.
• Based on follow-up visits, patients were classified as having progressed to T2D, or nonprogression.
• Researchers analyzed the patients’ initial visit A1c, fasting C-peptide, 2-hour glucose, fasting glucose, and body mass index (BMI), among other baseline characteristics.

TAKEAWAY:

• Thirty-six children (6.5%) progressed to T2D during the duration of the study period.
• The average time to T2D diagnosis was much longer in patients taking metformin (43 months), compared with those not taking the prescribed medication (28 months).
• Worsening obesity was strongly associated with T2D progression – patients who progressed to T2D had a higher BMI at baseline and had continued weight gain.
• A higher baseline A1c, fasting C-peptide, and 2-hour glucose were also associated with progression to T2D.
• In the multivariable analysis, both A1c and 2-hour glucose were strong independent predictors of progression.
• Fasting plasma glucose was not associated with progression to T2D.

IN PRACTICE:

“Weight stabilization and metformin therapy could be important interventions for diabetes prevention in children,” study author Ashley H. Shoemaker, MD, MSci, a pediatric endocrinologist at Vanderbilt University Medical Center in Nashville, Tenn., said in a press release.

In addition, A1c plus a nonfasting glucose may be a feasible way to identify high-risk pediatric patients in a clinical setting.
 

SOURCE:

This study was performed by Natasha Belsky, Jaclyn Tamaroff, and Ashley H. Shoemaker of the Vanderbilt University Medical Center and the Vanderbilt University School of Medicine in Nashville, Tenn. It was published October 12, 2023, in the Journal of the Endocrine Society

LIMITATIONS:

Additional patients who developed T2D may have been lost to follow-up, since the authors did not contact patients to confirm their disease status. The authors were also unable to establish racial differences in the progression to T2D because of missing data.

DISCLOSURES:

Funding for this study was provided by the National Center for Advancing Translational Sciences. One author has research contracts with Novo Nordisk and Boehringer Ingelheim.

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

TOPLINE:

Nearly one in five adolescents are living with prediabetes, a condition where blood glucose levels are elevated, but are not high enough for a type 2 diabetes (T2D) diagnosis. According to a new study, higher levels of nonfasting glucose and hemoglobin A1c, and worsening obesity are important predictors of progression to T2D. In addition, metformin and weight stabilization may prove to be important interventions for preventing T2D in kids.

METHODOLOGY:

• Researchers did a retrospective chart review of patient data from Vanderbilt University Medical Center Pediatric Prediabetes Clinic, Nashville, Tenn., from May 2015 to August 2022.
• The study included 552 children with prediabetes, defined as abnormal blood glucose (fasting plasma glucose [FPG] ≥ 100 mg/dL, random glucose ≥ 150 mg/dL), or hemoglobin A1c equal to or greater than 5.9%.
• Based on follow-up visits, patients were classified as having progressed to T2D, or nonprogression.
• Researchers analyzed the patients’ initial visit A1c, fasting C-peptide, 2-hour glucose, fasting glucose, and body mass index (BMI), among other baseline characteristics.

TAKEAWAY:

• Thirty-six children (6.5%) progressed to T2D during the duration of the study period.
• The average time to T2D diagnosis was much longer in patients taking metformin (43 months), compared with those not taking the prescribed medication (28 months).
• Worsening obesity was strongly associated with T2D progression – patients who progressed to T2D had a higher BMI at baseline and had continued weight gain.
• A higher baseline A1c, fasting C-peptide, and 2-hour glucose were also associated with progression to T2D.
• In the multivariable analysis, both A1c and 2-hour glucose were strong independent predictors of progression.
• Fasting plasma glucose was not associated with progression to T2D.

IN PRACTICE:

“Weight stabilization and metformin therapy could be important interventions for diabetes prevention in children,” study author Ashley H. Shoemaker, MD, MSci, a pediatric endocrinologist at Vanderbilt University Medical Center in Nashville, Tenn., said in a press release.

In addition, A1c plus a nonfasting glucose may be a feasible way to identify high-risk pediatric patients in a clinical setting.
 

SOURCE:

This study was performed by Natasha Belsky, Jaclyn Tamaroff, and Ashley H. Shoemaker of the Vanderbilt University Medical Center and the Vanderbilt University School of Medicine in Nashville, Tenn. It was published October 12, 2023, in the Journal of the Endocrine Society

LIMITATIONS:

Additional patients who developed T2D may have been lost to follow-up, since the authors did not contact patients to confirm their disease status. The authors were also unable to establish racial differences in the progression to T2D because of missing data.

DISCLOSURES:

Funding for this study was provided by the National Center for Advancing Translational Sciences. One author has research contracts with Novo Nordisk and Boehringer Ingelheim.

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

“Night owls” have an increased risk for developing type 2 diabetes and are more likely to smoke more, exercise less, and have poor sleep habits, compared with their “early bird” counterparts, according to a new study, published in Annals of Internal Medicine.

The work focused on participants’ self-assessed chronotype – an individuals’ circadian preference, or natural preference to sleep and wake up earlier or later, commonly known as being an early bird or a night owl.

Analyzing the self-reported lifestyle behaviors and sleeping habits of more than 60,000 middle-aged female nurses, researchers from Brigham and Women’s Hospital and Harvard Medical School, both in Boston, found that those with a preference for waking up later had a 72% higher risk for diabetes and were 54% more likely to have unhealthy lifestyle behaviors, compared with participants who tended to wake up earlier.

After adjustment for six lifestyle factors – diet, alcohol use, body mass index (BMI), physical activity, smoking status, and sleep duration – the association between diabetes risk and evening chronotype weakened to a 19% higher risk of developing type 2 diabetes.

In a subgroup analysis, this association was stronger among women who either had had no night shifts over the previous 2 years or had worked night shifts for less than 10 years in their careers. For nurses who had worked night shifts recently, the study found no association between evening chronotype and diabetes risk.

The participants, drawn from the Nurses’ Health Study II, were between 45 and 62 years age, with no history of cancer, cardiovascular disease, or diabetes. Researchers followed the group from 2009 until 2017.
 

Is there a mismatch between natural circadian rhythm and work schedule?

The authors, led by Sina Kianersi, DVM, PhD, of Harvard Medical School, Boston, suggest that their results may be linked to a mismatch between a person’s circadian rhythm and their physical and social environment – for example, if someone lives on a schedule opposite to their circadian preference.

In one 2015 study, female nurses who had worked daytime shifts for more than 10 years but had an evening chronotype had the highest diabetes risk, compared with early chronotypes (51% more likely to develop type 2 diabetes).

In a 2022 study, an evening chronotype was associated with a 30% elevated risk for type 2 diabetes. The authors speculated that circadian misalignment could be to blame – for example, being a night owl but working early morning – which can disrupt glycemic and lipid metabolism.

Previous studies have found that shorter or irregular sleep habits are associated with a higher risk of type 2 diabetes. Other studies have also found that people with an evening chronotype are more likely than early birds to have unhealthy eating habits, have lower levels of physical activity, and smoke and drink.

This new study did not find that an evening chronotype was associated with unhealthy drinking, which the authors defined as having one or more drinks per day.

In an accompanying editorial, two physicians from the Harvard T.H. Chan School of Public Health in Boston caution that the statistical design of the study limits its ability to establish causation.

“Chronotype could change later, which might correlate with lifestyle changes,” write Kehuan Lin, MS, Mingyang Song, MBBS, and Edward Giovannucci, MD. “Experimental trials are required to determine whether chronotype is a marker of unhealthy lifestyle or an independent determinant.”

They also suggest that psychological factors and the type of work being performed by the participants could be potential confounders.

The authors of the study note that their findings might not be generalizable to groups other than middle-aged White female nurses. The study population also had a relatively high level of education and were socioeconomically advantaged.

Self-reporting chronotypes with a single question could also result in misclassification and measurement error, the authors acknowledge.

The findings underscore the value of assessing an individuals’ chronotype for scheduling shift work – for example, assigning night owls to night shifts may improve their metabolic health and sleeping habits, according to the authors of the study.

“Given the importance of lifestyle modification in diabetes prevention, future research is warranted to investigate whether improving lifestyle behaviors could effectively reduce diabetes risk in persons with an evening chronotype,” the authors conclude.

The study was supported by grants from the National Institutes of Health and the European Research Council.

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

“Night owls” have an increased risk for developing type 2 diabetes and are more likely to smoke more, exercise less, and have poor sleep habits, compared with their “early bird” counterparts, according to a new study, published in Annals of Internal Medicine.

The work focused on participants’ self-assessed chronotype – an individuals’ circadian preference, or natural preference to sleep and wake up earlier or later, commonly known as being an early bird or a night owl.

Analyzing the self-reported lifestyle behaviors and sleeping habits of more than 60,000 middle-aged female nurses, researchers from Brigham and Women’s Hospital and Harvard Medical School, both in Boston, found that those with a preference for waking up later had a 72% higher risk for diabetes and were 54% more likely to have unhealthy lifestyle behaviors, compared with participants who tended to wake up earlier.

After adjustment for six lifestyle factors – diet, alcohol use, body mass index (BMI), physical activity, smoking status, and sleep duration – the association between diabetes risk and evening chronotype weakened to a 19% higher risk of developing type 2 diabetes.

In a subgroup analysis, this association was stronger among women who either had had no night shifts over the previous 2 years or had worked night shifts for less than 10 years in their careers. For nurses who had worked night shifts recently, the study found no association between evening chronotype and diabetes risk.

The participants, drawn from the Nurses’ Health Study II, were between 45 and 62 years age, with no history of cancer, cardiovascular disease, or diabetes. Researchers followed the group from 2009 until 2017.
 

Is there a mismatch between natural circadian rhythm and work schedule?

The authors, led by Sina Kianersi, DVM, PhD, of Harvard Medical School, Boston, suggest that their results may be linked to a mismatch between a person’s circadian rhythm and their physical and social environment – for example, if someone lives on a schedule opposite to their circadian preference.

In one 2015 study, female nurses who had worked daytime shifts for more than 10 years but had an evening chronotype had the highest diabetes risk, compared with early chronotypes (51% more likely to develop type 2 diabetes).

In a 2022 study, an evening chronotype was associated with a 30% elevated risk for type 2 diabetes. The authors speculated that circadian misalignment could be to blame – for example, being a night owl but working early morning – which can disrupt glycemic and lipid metabolism.

Previous studies have found that shorter or irregular sleep habits are associated with a higher risk of type 2 diabetes. Other studies have also found that people with an evening chronotype are more likely than early birds to have unhealthy eating habits, have lower levels of physical activity, and smoke and drink.

This new study did not find that an evening chronotype was associated with unhealthy drinking, which the authors defined as having one or more drinks per day.

In an accompanying editorial, two physicians from the Harvard T.H. Chan School of Public Health in Boston caution that the statistical design of the study limits its ability to establish causation.

“Chronotype could change later, which might correlate with lifestyle changes,” write Kehuan Lin, MS, Mingyang Song, MBBS, and Edward Giovannucci, MD. “Experimental trials are required to determine whether chronotype is a marker of unhealthy lifestyle or an independent determinant.”

They also suggest that psychological factors and the type of work being performed by the participants could be potential confounders.

The authors of the study note that their findings might not be generalizable to groups other than middle-aged White female nurses. The study population also had a relatively high level of education and were socioeconomically advantaged.

Self-reporting chronotypes with a single question could also result in misclassification and measurement error, the authors acknowledge.

The findings underscore the value of assessing an individuals’ chronotype for scheduling shift work – for example, assigning night owls to night shifts may improve their metabolic health and sleeping habits, according to the authors of the study.

“Given the importance of lifestyle modification in diabetes prevention, future research is warranted to investigate whether improving lifestyle behaviors could effectively reduce diabetes risk in persons with an evening chronotype,” the authors conclude.

The study was supported by grants from the National Institutes of Health and the European Research Council.

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

“Night owls” have an increased risk for developing type 2 diabetes and are more likely to smoke more, exercise less, and have poor sleep habits, compared with their “early bird” counterparts, according to a new study, published in Annals of Internal Medicine.

The work focused on participants’ self-assessed chronotype – an individuals’ circadian preference, or natural preference to sleep and wake up earlier or later, commonly known as being an early bird or a night owl.

Analyzing the self-reported lifestyle behaviors and sleeping habits of more than 60,000 middle-aged female nurses, researchers from Brigham and Women’s Hospital and Harvard Medical School, both in Boston, found that those with a preference for waking up later had a 72% higher risk for diabetes and were 54% more likely to have unhealthy lifestyle behaviors, compared with participants who tended to wake up earlier.

After adjustment for six lifestyle factors – diet, alcohol use, body mass index (BMI), physical activity, smoking status, and sleep duration – the association between diabetes risk and evening chronotype weakened to a 19% higher risk of developing type 2 diabetes.

In a subgroup analysis, this association was stronger among women who either had had no night shifts over the previous 2 years or had worked night shifts for less than 10 years in their careers. For nurses who had worked night shifts recently, the study found no association between evening chronotype and diabetes risk.

The participants, drawn from the Nurses’ Health Study II, were between 45 and 62 years age, with no history of cancer, cardiovascular disease, or diabetes. Researchers followed the group from 2009 until 2017.
 

Is there a mismatch between natural circadian rhythm and work schedule?

The authors, led by Sina Kianersi, DVM, PhD, of Harvard Medical School, Boston, suggest that their results may be linked to a mismatch between a person’s circadian rhythm and their physical and social environment – for example, if someone lives on a schedule opposite to their circadian preference.

In one 2015 study, female nurses who had worked daytime shifts for more than 10 years but had an evening chronotype had the highest diabetes risk, compared with early chronotypes (51% more likely to develop type 2 diabetes).

In a 2022 study, an evening chronotype was associated with a 30% elevated risk for type 2 diabetes. The authors speculated that circadian misalignment could be to blame – for example, being a night owl but working early morning – which can disrupt glycemic and lipid metabolism.

Previous studies have found that shorter or irregular sleep habits are associated with a higher risk of type 2 diabetes. Other studies have also found that people with an evening chronotype are more likely than early birds to have unhealthy eating habits, have lower levels of physical activity, and smoke and drink.

This new study did not find that an evening chronotype was associated with unhealthy drinking, which the authors defined as having one or more drinks per day.

In an accompanying editorial, two physicians from the Harvard T.H. Chan School of Public Health in Boston caution that the statistical design of the study limits its ability to establish causation.

“Chronotype could change later, which might correlate with lifestyle changes,” write Kehuan Lin, MS, Mingyang Song, MBBS, and Edward Giovannucci, MD. “Experimental trials are required to determine whether chronotype is a marker of unhealthy lifestyle or an independent determinant.”

They also suggest that psychological factors and the type of work being performed by the participants could be potential confounders.

The authors of the study note that their findings might not be generalizable to groups other than middle-aged White female nurses. The study population also had a relatively high level of education and were socioeconomically advantaged.

Self-reporting chronotypes with a single question could also result in misclassification and measurement error, the authors acknowledge.

The findings underscore the value of assessing an individuals’ chronotype for scheduling shift work – for example, assigning night owls to night shifts may improve their metabolic health and sleeping habits, according to the authors of the study.

“Given the importance of lifestyle modification in diabetes prevention, future research is warranted to investigate whether improving lifestyle behaviors could effectively reduce diabetes risk in persons with an evening chronotype,” the authors conclude.

The study was supported by grants from the National Institutes of Health and the European Research Council.

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

Apple cider vinegar and fenugreek seeds are the most effective at reducing fasting blood glucose and hemoglobin A1c levels, compared with four other popular herbal remedies for type 2 diabetes, a recent systematic review found.

The review included 44 randomized clinical trials with more than 3,000 participants using six herbal remedies: apple cider vinegar, cinnamon, curcumin, fenugreek seeds, ginger, and saffron.

Apple cider vinegar, fenugreek seeds, curcumin (turmeric), and cinnamon resulted in statistically significant reductions in fasting blood glucose, compared with the control groups in the clinical trials. Out of all the remedies, the authors found apple cider vinegar to be the most effective for lowering fasting blood glucose levels.

The review also found that apple cider vinegar and fenugreek seeds had a statistically significant effect on reducing A1c, compared with the control groups. The authors found the herbal remedies made no difference to insulin level or homeostatic model assessment for insulin resistance (HOMA-IR).

The results are published online in Diabetes & Metabolic Syndrome: Clinical Research & Reviews. The authors said they hoped the review would help medical professionals and people with type 2 diabetes understand the effectiveness of different herbal remedies and consider incorporating these remedies into standard care.

“Some people use curcumin, some use ginger, some use apple cider [vinegar], but it’s not clear which is better,” said Shiv Mudgal, PhD, corresponding author of the paper and an associate professor in nursing at the All India Institute of Medical Sciences in Deoghar, India.

“We thought it would be nice to get some idea about how they work and how they compete with each other,” said Subodh Kumar, MD, the first author and an associate professor in pharmacology at the All India Institute of Medical Sciences in Deoghar, India.

They wanted to understand how the herbal remedies worked by including insulin level and HOMA-IR as measurable outcomes but found nothing conclusive. Instead, they speculated that the effect of apple cider vinegar and fenugreek seeds on blood glucose and A1c could be related to delayed gastric emptying, among other mechanisms.

However, the results should be interpreted with caution, said Dr. Kumar.

Apple cider vinegar had three clinical trials to back the finding, and fenugreek seeds had four studies supporting the results – fewer than the other included remedies. The authors also identified risks of bias from the randomization process and the allocation concealment process in several of the included trials.

Most of the studies included only short follow-up periods, meaning that the long-term effects of using these herbal remedies to help manage type 2 diabetes remain unclear.

The six herbal remedies included in the study were chosen out of dozens of popular complementary medicines for the strength and number of clinical trials backing their use.

The limited number included in the review is a drawback, according to Merlin Willcox, DPhil, a clinical lecturer in general practice at the University of Southampton, England, who was not involved in the research.

“It means they’ve left out stuff that’s potentially effective,” Dr. Willcox said in an interview.

Dr. Willcox, who has coauthored a review of herbal remedies for glycemic control in type 2 diabetes, said he was surprised that apple cider vinegar came out on top in this analysis.

His review concluded that aloe vera leaf gel, psyllium fiber, and fenugreek seeds appeared to be the most effective at reducing A1c, compared with the control groups of the included trials, out of 18 plant-based remedies.

There were no adverse effects associated with the herbal remedies, according to Dr. Mudgal. However, the evidence for the herbal remedies included in their review also lacked substantial follow-up periods assessing their long-term effects.

“You need to look at the evidence for each individual remedy; it’s not just about what plant it is, but it’s about what preparation, what dose. All of that comes into play,” Dr. Willcox said.

Up to 3.6 million people use herbal remedies to manage type 2 diabetes in the United States, according to a 2014 study cited by the review authors. The number is much higher elsewhere: As many as two-thirds of patients with diabetes in India and Saudi Arabia incorporate herbal remedies to help manage symptoms, whereas about half of patients with diabetes in the United Kingdom use herbal medicines.

Experts warn of the risks associated with using herbal medicines to complement traditional therapies.

“I caution my patients about dietary supplements and herbals because of the lack of high-quality data demonstrating efficacy and safety,” Katherine H. Saunders, MD, DABOM, cofounder of Intellihealth and clinical assistant professor of medicine at Weill Cornell Medicine, New York, said in an interview.

For Dr. Willcox, the risks relate to where patients get their information from. Many patients with type 2 diabetes are too scared to talk to their doctor about herbal medicines. 

“They think their doctor is going to be negative or dismissive,” Dr. Willcox said. “So patients are getting their information from family and friends or from the Internet, which is not necessarily the most reliable, evidence-based source of information.”

The authors have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Apple cider vinegar and fenugreek seeds are the most effective at reducing fasting blood glucose and hemoglobin A1c levels, compared with four other popular herbal remedies for type 2 diabetes, a recent systematic review found.

The review included 44 randomized clinical trials with more than 3,000 participants using six herbal remedies: apple cider vinegar, cinnamon, curcumin, fenugreek seeds, ginger, and saffron.

Apple cider vinegar, fenugreek seeds, curcumin (turmeric), and cinnamon resulted in statistically significant reductions in fasting blood glucose, compared with the control groups in the clinical trials. Out of all the remedies, the authors found apple cider vinegar to be the most effective for lowering fasting blood glucose levels.

The review also found that apple cider vinegar and fenugreek seeds had a statistically significant effect on reducing A1c, compared with the control groups. The authors found the herbal remedies made no difference to insulin level or homeostatic model assessment for insulin resistance (HOMA-IR).

The results are published online in Diabetes & Metabolic Syndrome: Clinical Research & Reviews. The authors said they hoped the review would help medical professionals and people with type 2 diabetes understand the effectiveness of different herbal remedies and consider incorporating these remedies into standard care.

“Some people use curcumin, some use ginger, some use apple cider [vinegar], but it’s not clear which is better,” said Shiv Mudgal, PhD, corresponding author of the paper and an associate professor in nursing at the All India Institute of Medical Sciences in Deoghar, India.

“We thought it would be nice to get some idea about how they work and how they compete with each other,” said Subodh Kumar, MD, the first author and an associate professor in pharmacology at the All India Institute of Medical Sciences in Deoghar, India.

They wanted to understand how the herbal remedies worked by including insulin level and HOMA-IR as measurable outcomes but found nothing conclusive. Instead, they speculated that the effect of apple cider vinegar and fenugreek seeds on blood glucose and A1c could be related to delayed gastric emptying, among other mechanisms.

However, the results should be interpreted with caution, said Dr. Kumar.

Apple cider vinegar had three clinical trials to back the finding, and fenugreek seeds had four studies supporting the results – fewer than the other included remedies. The authors also identified risks of bias from the randomization process and the allocation concealment process in several of the included trials.

Most of the studies included only short follow-up periods, meaning that the long-term effects of using these herbal remedies to help manage type 2 diabetes remain unclear.

The six herbal remedies included in the study were chosen out of dozens of popular complementary medicines for the strength and number of clinical trials backing their use.

The limited number included in the review is a drawback, according to Merlin Willcox, DPhil, a clinical lecturer in general practice at the University of Southampton, England, who was not involved in the research.

“It means they’ve left out stuff that’s potentially effective,” Dr. Willcox said in an interview.

Dr. Willcox, who has coauthored a review of herbal remedies for glycemic control in type 2 diabetes, said he was surprised that apple cider vinegar came out on top in this analysis.

His review concluded that aloe vera leaf gel, psyllium fiber, and fenugreek seeds appeared to be the most effective at reducing A1c, compared with the control groups of the included trials, out of 18 plant-based remedies.

There were no adverse effects associated with the herbal remedies, according to Dr. Mudgal. However, the evidence for the herbal remedies included in their review also lacked substantial follow-up periods assessing their long-term effects.

“You need to look at the evidence for each individual remedy; it’s not just about what plant it is, but it’s about what preparation, what dose. All of that comes into play,” Dr. Willcox said.

Up to 3.6 million people use herbal remedies to manage type 2 diabetes in the United States, according to a 2014 study cited by the review authors. The number is much higher elsewhere: As many as two-thirds of patients with diabetes in India and Saudi Arabia incorporate herbal remedies to help manage symptoms, whereas about half of patients with diabetes in the United Kingdom use herbal medicines.

Experts warn of the risks associated with using herbal medicines to complement traditional therapies.

“I caution my patients about dietary supplements and herbals because of the lack of high-quality data demonstrating efficacy and safety,” Katherine H. Saunders, MD, DABOM, cofounder of Intellihealth and clinical assistant professor of medicine at Weill Cornell Medicine, New York, said in an interview.

For Dr. Willcox, the risks relate to where patients get their information from. Many patients with type 2 diabetes are too scared to talk to their doctor about herbal medicines. 

“They think their doctor is going to be negative or dismissive,” Dr. Willcox said. “So patients are getting their information from family and friends or from the Internet, which is not necessarily the most reliable, evidence-based source of information.”

The authors have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Apple cider vinegar and fenugreek seeds are the most effective at reducing fasting blood glucose and hemoglobin A1c levels, compared with four other popular herbal remedies for type 2 diabetes, a recent systematic review found.

The review included 44 randomized clinical trials with more than 3,000 participants using six herbal remedies: apple cider vinegar, cinnamon, curcumin, fenugreek seeds, ginger, and saffron.

Apple cider vinegar, fenugreek seeds, curcumin (turmeric), and cinnamon resulted in statistically significant reductions in fasting blood glucose, compared with the control groups in the clinical trials. Out of all the remedies, the authors found apple cider vinegar to be the most effective for lowering fasting blood glucose levels.

The review also found that apple cider vinegar and fenugreek seeds had a statistically significant effect on reducing A1c, compared with the control groups. The authors found the herbal remedies made no difference to insulin level or homeostatic model assessment for insulin resistance (HOMA-IR).

The results are published online in Diabetes & Metabolic Syndrome: Clinical Research & Reviews. The authors said they hoped the review would help medical professionals and people with type 2 diabetes understand the effectiveness of different herbal remedies and consider incorporating these remedies into standard care.

“Some people use curcumin, some use ginger, some use apple cider [vinegar], but it’s not clear which is better,” said Shiv Mudgal, PhD, corresponding author of the paper and an associate professor in nursing at the All India Institute of Medical Sciences in Deoghar, India.

“We thought it would be nice to get some idea about how they work and how they compete with each other,” said Subodh Kumar, MD, the first author and an associate professor in pharmacology at the All India Institute of Medical Sciences in Deoghar, India.

They wanted to understand how the herbal remedies worked by including insulin level and HOMA-IR as measurable outcomes but found nothing conclusive. Instead, they speculated that the effect of apple cider vinegar and fenugreek seeds on blood glucose and A1c could be related to delayed gastric emptying, among other mechanisms.

However, the results should be interpreted with caution, said Dr. Kumar.

Apple cider vinegar had three clinical trials to back the finding, and fenugreek seeds had four studies supporting the results – fewer than the other included remedies. The authors also identified risks of bias from the randomization process and the allocation concealment process in several of the included trials.

Most of the studies included only short follow-up periods, meaning that the long-term effects of using these herbal remedies to help manage type 2 diabetes remain unclear.

The six herbal remedies included in the study were chosen out of dozens of popular complementary medicines for the strength and number of clinical trials backing their use.

The limited number included in the review is a drawback, according to Merlin Willcox, DPhil, a clinical lecturer in general practice at the University of Southampton, England, who was not involved in the research.

“It means they’ve left out stuff that’s potentially effective,” Dr. Willcox said in an interview.

Dr. Willcox, who has coauthored a review of herbal remedies for glycemic control in type 2 diabetes, said he was surprised that apple cider vinegar came out on top in this analysis.

His review concluded that aloe vera leaf gel, psyllium fiber, and fenugreek seeds appeared to be the most effective at reducing A1c, compared with the control groups of the included trials, out of 18 plant-based remedies.

There were no adverse effects associated with the herbal remedies, according to Dr. Mudgal. However, the evidence for the herbal remedies included in their review also lacked substantial follow-up periods assessing their long-term effects.

“You need to look at the evidence for each individual remedy; it’s not just about what plant it is, but it’s about what preparation, what dose. All of that comes into play,” Dr. Willcox said.

Up to 3.6 million people use herbal remedies to manage type 2 diabetes in the United States, according to a 2014 study cited by the review authors. The number is much higher elsewhere: As many as two-thirds of patients with diabetes in India and Saudi Arabia incorporate herbal remedies to help manage symptoms, whereas about half of patients with diabetes in the United Kingdom use herbal medicines.

Experts warn of the risks associated with using herbal medicines to complement traditional therapies.

“I caution my patients about dietary supplements and herbals because of the lack of high-quality data demonstrating efficacy and safety,” Katherine H. Saunders, MD, DABOM, cofounder of Intellihealth and clinical assistant professor of medicine at Weill Cornell Medicine, New York, said in an interview.

For Dr. Willcox, the risks relate to where patients get their information from. Many patients with type 2 diabetes are too scared to talk to their doctor about herbal medicines. 

“They think their doctor is going to be negative or dismissive,” Dr. Willcox said. “So patients are getting their information from family and friends or from the Internet, which is not necessarily the most reliable, evidence-based source of information.”

The authors have reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

A pair of genetically modified pig kidneys filtered blood and produced urine for 7 days after being transplanted into a brain-dead patient – marking another important step toward opening up a new supply of much-needed organs for those with end-stage kidney disease.

A team of researchers in Alabama removed a brain-dead person’s kidneys and transplanted two kidneys that had been taken from a genetically modified pig. The researchers monitored the patient’s response to the organs and tracked the kidneys’ function over a 7-day period. The findings were published in JAMA Surgery.

During the first 24 hours after transplantation, the pig kidneys made more than 37 liters of urine. “It was really a remarkable thing to see,” lead investigator Jayme Locke, MD, professor of surgery and the Arnold G. Diethelm Endowed Chair in Transplantation Surgery, University of Alabama at Birmingham, said in a press release.

The recipient was given standard maintenance immunosuppression - tacrolimus, mycophenolate mofetil, and prednisone. The target tacrolimus level (8-10 ng/dL) was reached by postoperative day 2 and was maintained through study completion.

At the end of the study, the serum creatinine level was 0.9 mg/dL, and creatinine clearance was 200 mL/min. Creatinine levels are an indicator of kidney function and demonstrate the organ’s ability to filter waste from blood, according to Roger Lord, PhD, senior lecturer (medical sciences) in the School of Behavioural and Health Sciences, Australian Catholic University, who was not involved in the research.

This is the first time that it has been demonstrated that a standard immunosuppression regimen may be sufficient to support xenotransplantation with pig kidneys and in which creatinine clearance was achieved.

The finding comes less than 2 years after the same team published results from a similar experiment. In that transplant, the investigators didn’t observe significant creatinine excretion into the urine.

In the team’s previous attempts, kidney function was delayed because the brain-dead recipients had deteriorated physiologically. This time, the subject was stable, and the team was able to observe urine production within 4 minutes of restoration of blood flow to the transplanted pig organs.

“This new work firmly establishes that the xenografts not only make urine but provide life-sustaining kidney function by clearing serum creatinine,” Locke said in an interview. “This is the first time in history this has been shown.”

The investigators are hoping animal-sourced organs could become an alternative for human transplantations, potentially solving the serious shortage of human organs available for patients on transplant waiting lists.

Organ transplantation can treat patients with advanced kidney disease and kidney failure, but there are not enough human organs available to meet the need. More than 92,000 people in the United States are waiting for a kidney, according to the American Kidney Fund.

Organ rejection is a risk with xenotransplants – animal-to-human organ transplants. Investigators in this study used kidneys from pigs with 10 gene modifications. The modifications were intended to decrease the likelihood of the organs being rejected by a human host.

The kidneys were still viable at the end of the 7-day period. In addition, there was no microscopic blood clot formation, another indicator of normal kidney function, according to Dr. Lord, who provided comments to the UK Science Media Centre.

The long-term outcomes of animal-to-human organ transplantation remain unclear. Dr. Lord describes the operation as a “first step” to demonstrate that genetically modified, transplanted pig kidneys can function normally so as to remove creatinine over a 7-day period.

Dr. Locke and colleagues said: “Future research in living human recipients is necessary to determine long-term xenograft kidney function and whether xenografts could serve as a bridge or destination therapy for end-stage kidney disease.

“Because our study represents a single case, generalizability of the findings is limited. This study showcases xenotransplant as a viable potential solution to an organ shortage crisis responsible for thousands of preventable deaths annually,” they concluded.

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

A pair of genetically modified pig kidneys filtered blood and produced urine for 7 days after being transplanted into a brain-dead patient – marking another important step toward opening up a new supply of much-needed organs for those with end-stage kidney disease.

A team of researchers in Alabama removed a brain-dead person’s kidneys and transplanted two kidneys that had been taken from a genetically modified pig. The researchers monitored the patient’s response to the organs and tracked the kidneys’ function over a 7-day period. The findings were published in JAMA Surgery.

During the first 24 hours after transplantation, the pig kidneys made more than 37 liters of urine. “It was really a remarkable thing to see,” lead investigator Jayme Locke, MD, professor of surgery and the Arnold G. Diethelm Endowed Chair in Transplantation Surgery, University of Alabama at Birmingham, said in a press release.

The recipient was given standard maintenance immunosuppression - tacrolimus, mycophenolate mofetil, and prednisone. The target tacrolimus level (8-10 ng/dL) was reached by postoperative day 2 and was maintained through study completion.

At the end of the study, the serum creatinine level was 0.9 mg/dL, and creatinine clearance was 200 mL/min. Creatinine levels are an indicator of kidney function and demonstrate the organ’s ability to filter waste from blood, according to Roger Lord, PhD, senior lecturer (medical sciences) in the School of Behavioural and Health Sciences, Australian Catholic University, who was not involved in the research.

This is the first time that it has been demonstrated that a standard immunosuppression regimen may be sufficient to support xenotransplantation with pig kidneys and in which creatinine clearance was achieved.

The finding comes less than 2 years after the same team published results from a similar experiment. In that transplant, the investigators didn’t observe significant creatinine excretion into the urine.

In the team’s previous attempts, kidney function was delayed because the brain-dead recipients had deteriorated physiologically. This time, the subject was stable, and the team was able to observe urine production within 4 minutes of restoration of blood flow to the transplanted pig organs.

“This new work firmly establishes that the xenografts not only make urine but provide life-sustaining kidney function by clearing serum creatinine,” Locke said in an interview. “This is the first time in history this has been shown.”

The investigators are hoping animal-sourced organs could become an alternative for human transplantations, potentially solving the serious shortage of human organs available for patients on transplant waiting lists.

Organ transplantation can treat patients with advanced kidney disease and kidney failure, but there are not enough human organs available to meet the need. More than 92,000 people in the United States are waiting for a kidney, according to the American Kidney Fund.

Organ rejection is a risk with xenotransplants – animal-to-human organ transplants. Investigators in this study used kidneys from pigs with 10 gene modifications. The modifications were intended to decrease the likelihood of the organs being rejected by a human host.

The kidneys were still viable at the end of the 7-day period. In addition, there was no microscopic blood clot formation, another indicator of normal kidney function, according to Dr. Lord, who provided comments to the UK Science Media Centre.

The long-term outcomes of animal-to-human organ transplantation remain unclear. Dr. Lord describes the operation as a “first step” to demonstrate that genetically modified, transplanted pig kidneys can function normally so as to remove creatinine over a 7-day period.

Dr. Locke and colleagues said: “Future research in living human recipients is necessary to determine long-term xenograft kidney function and whether xenografts could serve as a bridge or destination therapy for end-stage kidney disease.

“Because our study represents a single case, generalizability of the findings is limited. This study showcases xenotransplant as a viable potential solution to an organ shortage crisis responsible for thousands of preventable deaths annually,” they concluded.

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

A pair of genetically modified pig kidneys filtered blood and produced urine for 7 days after being transplanted into a brain-dead patient – marking another important step toward opening up a new supply of much-needed organs for those with end-stage kidney disease.

A team of researchers in Alabama removed a brain-dead person’s kidneys and transplanted two kidneys that had been taken from a genetically modified pig. The researchers monitored the patient’s response to the organs and tracked the kidneys’ function over a 7-day period. The findings were published in JAMA Surgery.

During the first 24 hours after transplantation, the pig kidneys made more than 37 liters of urine. “It was really a remarkable thing to see,” lead investigator Jayme Locke, MD, professor of surgery and the Arnold G. Diethelm Endowed Chair in Transplantation Surgery, University of Alabama at Birmingham, said in a press release.

The recipient was given standard maintenance immunosuppression - tacrolimus, mycophenolate mofetil, and prednisone. The target tacrolimus level (8-10 ng/dL) was reached by postoperative day 2 and was maintained through study completion.

At the end of the study, the serum creatinine level was 0.9 mg/dL, and creatinine clearance was 200 mL/min. Creatinine levels are an indicator of kidney function and demonstrate the organ’s ability to filter waste from blood, according to Roger Lord, PhD, senior lecturer (medical sciences) in the School of Behavioural and Health Sciences, Australian Catholic University, who was not involved in the research.

This is the first time that it has been demonstrated that a standard immunosuppression regimen may be sufficient to support xenotransplantation with pig kidneys and in which creatinine clearance was achieved.

The finding comes less than 2 years after the same team published results from a similar experiment. In that transplant, the investigators didn’t observe significant creatinine excretion into the urine.

In the team’s previous attempts, kidney function was delayed because the brain-dead recipients had deteriorated physiologically. This time, the subject was stable, and the team was able to observe urine production within 4 minutes of restoration of blood flow to the transplanted pig organs.

“This new work firmly establishes that the xenografts not only make urine but provide life-sustaining kidney function by clearing serum creatinine,” Locke said in an interview. “This is the first time in history this has been shown.”

The investigators are hoping animal-sourced organs could become an alternative for human transplantations, potentially solving the serious shortage of human organs available for patients on transplant waiting lists.

Organ transplantation can treat patients with advanced kidney disease and kidney failure, but there are not enough human organs available to meet the need. More than 92,000 people in the United States are waiting for a kidney, according to the American Kidney Fund.

Organ rejection is a risk with xenotransplants – animal-to-human organ transplants. Investigators in this study used kidneys from pigs with 10 gene modifications. The modifications were intended to decrease the likelihood of the organs being rejected by a human host.

The kidneys were still viable at the end of the 7-day period. In addition, there was no microscopic blood clot formation, another indicator of normal kidney function, according to Dr. Lord, who provided comments to the UK Science Media Centre.

The long-term outcomes of animal-to-human organ transplantation remain unclear. Dr. Lord describes the operation as a “first step” to demonstrate that genetically modified, transplanted pig kidneys can function normally so as to remove creatinine over a 7-day period.

Dr. Locke and colleagues said: “Future research in living human recipients is necessary to determine long-term xenograft kidney function and whether xenografts could serve as a bridge or destination therapy for end-stage kidney disease.

“Because our study represents a single case, generalizability of the findings is limited. This study showcases xenotransplant as a viable potential solution to an organ shortage crisis responsible for thousands of preventable deaths annually,” they concluded.

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

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

[embed:render:related:node:228422]

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

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

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

[embed:render:related:node:228422]

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

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

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

[embed:render:related:node:228422]

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

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

On July 13, the Food and Drug Administration approved the first over-the-counter (OTC) norgestrel birth control pill (Opill). The daily oral contraceptive was approved for prescription use 5 decades ago, providing regulators with a half-century of data to show that the progestin-only drug can be used safely without a prescription. 

The drug is the latest in a series of medications that have made the switch from behind the pharmacy counter to retail shelves. 

Experts say several more classes of drugs to treat high cholesterol, asthma, and other common health problems could be next.
 

Why switch?

When a drug manufacturer submits a proposal for a switch to OTC, the key question that the FDA considers is patient safety. Some risks can be mitigated by approving OTC drugs at lower doses than what is available as the prescription version. 

“There is no drug that doesn’t have risks,” said Almut G. Winterstein, RPh, PhD, a distinguished professor in pharmaceutical outcomes and policy and director of the Center for Drug Evaluation and Safety at the University of Florida, Gainesville. “Risks are mitigated by putting specific constraints around access to those medications.”

Dr. Winterstein, a former chair of the FDA’s Drug Safety and Risk Management Advisory Committee, said that nonprescription drugs are unnecessary in a functional health care system. 

Many patients may struggle with accessing health clinicians, so making medications available OTC fills gaps left by not being able to get a prescription, according to Dr. Winterstein. 

A 2012 paper funded by the Consumer Healthcare Products Association (CHPA), the organization representing manufacturers and distributors of OTC medications, estimated that one quarter of people who bought OTC drugs would not otherwise seek treatment if these treatments were available only via prescription. The CHPA notes that the number of those who experience allergies who use nonprescription antihistamines and allergy-relief drugs increased by about 10% between 2009 and 2015. 
 

Cholesterol drugs

Approximately 80 million U.S. adults are eligible for cholesterol-lowering medications, particularly statins, but nearly half don’t take them, according to the Centers for Disease Control and Prevention. 

Fear of side effects is the most common reason people might avoid taking these drugs. But eliminating the need for a refill may encourage uptake of the statins. 

“It’s refill, refill, refill,” said Allen J. Taylor, MD, chairman of cardiology at MedStar Heart and Vascular Institute, in Washington. “We spend a ton of time refilling statins and it’s a headache for patients, too.” 

The need to secure regular prescriptions for the drug, “doesn’t put enough trust and faith in pharmacists and doesn’t put enough trust and faith in patients,” Dr. Taylor said. 

Moving statins to the front end of a pharmacy might not be the best move given the potential for drug interactions, but a nonprescription behind-the-counter approach could work, according to Dr. Taylor. 

“The concerns are modest at most, to where they can be monitored by a pharmacist,” he said. “There’s probably more people that would take a statin if they had that kind of access.” 

Many statin manufacturers have attempted to make the prescription-to-OTC switch. In 2005, an FDA advisory panel rejected Merck’s proposal for OTC sales of lovastatin after reviewing a study that found only 55% of OTC purchases would have been medically appropriate. 

In 2015, Pfizer pulled its application to make the cholesterol drug atorvastatin available to patients OTC because patients were not using the drug correctly. AstraZeneca is investigating an online platform that would allow patients to self-assess their eligibility for rosuvastatin. 
 

Asthma inhalers 

Inhalers are the main rescue therapy for asthma aside from a visit to the ED. 

The only inhaler available OTC is epinephrine sold under the brand name Primatene Mist, but this type of medicine device is not recommended as a first-line therapy for acute asthma symptoms, according to the American Medical Association. 

“It’s been around for a long time and has stayed over the counter even though newer, safer agents have come onto the market which aren’t available over the counter,” said William B. Feldman, MD, DPhil, MPH, a pulmonologist at Brigham and Women’s Hospital, Boston. 

Patients who have a hard time getting to a doctor or patients who lack insurance often face barriers accessing albuterol inhalers and beta agonist–corticosteroid combinations, according to Dr. Feldman. A switch to OTC distribution would widen access. 

“What we’re advocating is, if they’re going to have access to Primatene Mist, wouldn’t it be sensible to have access to a safer and more effective therapy?” Dr. Feldman said. 
 

Triptans

Migraines affect an estimated 39 million people in the United States, according to the American Migraine Foundation. Several drugs to treat migraine are available OTC, including nonsteroidal anti-inflammatory drugs, aspirin, and acetaminophen. Triptans, drugs used for the short-term treatment of acute symptoms, are prescription-only in the United States. 

But in the United Kingdom, triptans first became available in retail stores in 2006, leading to reduced costs for patients, employers, and the government. One study found that government health expenditures would be reduced by $84 million annually if the OTC switch were made in six European countries. 

However, overuse of the drug and potential contraindications have been cited as concerns with OTC access. 

For Dr. Winterstein, the decision to switch isn’t just about the freedom to buy a drug; it comes down to weighing potential risks and benefits. 

“Drugs are only as good as if they’re used in the context of how they should be used,” Dr. Winterstein said. “It’s not candy.”
 

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

On July 13, the Food and Drug Administration approved the first over-the-counter (OTC) norgestrel birth control pill (Opill). The daily oral contraceptive was approved for prescription use 5 decades ago, providing regulators with a half-century of data to show that the progestin-only drug can be used safely without a prescription. 

The drug is the latest in a series of medications that have made the switch from behind the pharmacy counter to retail shelves. 

Experts say several more classes of drugs to treat high cholesterol, asthma, and other common health problems could be next.
 

Why switch?

When a drug manufacturer submits a proposal for a switch to OTC, the key question that the FDA considers is patient safety. Some risks can be mitigated by approving OTC drugs at lower doses than what is available as the prescription version. 

“There is no drug that doesn’t have risks,” said Almut G. Winterstein, RPh, PhD, a distinguished professor in pharmaceutical outcomes and policy and director of the Center for Drug Evaluation and Safety at the University of Florida, Gainesville. “Risks are mitigated by putting specific constraints around access to those medications.”

Dr. Winterstein, a former chair of the FDA’s Drug Safety and Risk Management Advisory Committee, said that nonprescription drugs are unnecessary in a functional health care system. 

Many patients may struggle with accessing health clinicians, so making medications available OTC fills gaps left by not being able to get a prescription, according to Dr. Winterstein. 

A 2012 paper funded by the Consumer Healthcare Products Association (CHPA), the organization representing manufacturers and distributors of OTC medications, estimated that one quarter of people who bought OTC drugs would not otherwise seek treatment if these treatments were available only via prescription. The CHPA notes that the number of those who experience allergies who use nonprescription antihistamines and allergy-relief drugs increased by about 10% between 2009 and 2015. 
 

Cholesterol drugs

Approximately 80 million U.S. adults are eligible for cholesterol-lowering medications, particularly statins, but nearly half don’t take them, according to the Centers for Disease Control and Prevention. 

Fear of side effects is the most common reason people might avoid taking these drugs. But eliminating the need for a refill may encourage uptake of the statins. 

“It’s refill, refill, refill,” said Allen J. Taylor, MD, chairman of cardiology at MedStar Heart and Vascular Institute, in Washington. “We spend a ton of time refilling statins and it’s a headache for patients, too.” 

The need to secure regular prescriptions for the drug, “doesn’t put enough trust and faith in pharmacists and doesn’t put enough trust and faith in patients,” Dr. Taylor said. 

Moving statins to the front end of a pharmacy might not be the best move given the potential for drug interactions, but a nonprescription behind-the-counter approach could work, according to Dr. Taylor. 

“The concerns are modest at most, to where they can be monitored by a pharmacist,” he said. “There’s probably more people that would take a statin if they had that kind of access.” 

Many statin manufacturers have attempted to make the prescription-to-OTC switch. In 2005, an FDA advisory panel rejected Merck’s proposal for OTC sales of lovastatin after reviewing a study that found only 55% of OTC purchases would have been medically appropriate. 

In 2015, Pfizer pulled its application to make the cholesterol drug atorvastatin available to patients OTC because patients were not using the drug correctly. AstraZeneca is investigating an online platform that would allow patients to self-assess their eligibility for rosuvastatin. 
 

Asthma inhalers 

Inhalers are the main rescue therapy for asthma aside from a visit to the ED. 

The only inhaler available OTC is epinephrine sold under the brand name Primatene Mist, but this type of medicine device is not recommended as a first-line therapy for acute asthma symptoms, according to the American Medical Association. 

“It’s been around for a long time and has stayed over the counter even though newer, safer agents have come onto the market which aren’t available over the counter,” said William B. Feldman, MD, DPhil, MPH, a pulmonologist at Brigham and Women’s Hospital, Boston. 

Patients who have a hard time getting to a doctor or patients who lack insurance often face barriers accessing albuterol inhalers and beta agonist–corticosteroid combinations, according to Dr. Feldman. A switch to OTC distribution would widen access. 

“What we’re advocating is, if they’re going to have access to Primatene Mist, wouldn’t it be sensible to have access to a safer and more effective therapy?” Dr. Feldman said. 
 

Triptans

Migraines affect an estimated 39 million people in the United States, according to the American Migraine Foundation. Several drugs to treat migraine are available OTC, including nonsteroidal anti-inflammatory drugs, aspirin, and acetaminophen. Triptans, drugs used for the short-term treatment of acute symptoms, are prescription-only in the United States. 

But in the United Kingdom, triptans first became available in retail stores in 2006, leading to reduced costs for patients, employers, and the government. One study found that government health expenditures would be reduced by $84 million annually if the OTC switch were made in six European countries. 

However, overuse of the drug and potential contraindications have been cited as concerns with OTC access. 

For Dr. Winterstein, the decision to switch isn’t just about the freedom to buy a drug; it comes down to weighing potential risks and benefits. 

“Drugs are only as good as if they’re used in the context of how they should be used,” Dr. Winterstein said. “It’s not candy.”
 

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

On July 13, the Food and Drug Administration approved the first over-the-counter (OTC) norgestrel birth control pill (Opill). The daily oral contraceptive was approved for prescription use 5 decades ago, providing regulators with a half-century of data to show that the progestin-only drug can be used safely without a prescription. 

The drug is the latest in a series of medications that have made the switch from behind the pharmacy counter to retail shelves. 

Experts say several more classes of drugs to treat high cholesterol, asthma, and other common health problems could be next.
 

Why switch?

When a drug manufacturer submits a proposal for a switch to OTC, the key question that the FDA considers is patient safety. Some risks can be mitigated by approving OTC drugs at lower doses than what is available as the prescription version. 

“There is no drug that doesn’t have risks,” said Almut G. Winterstein, RPh, PhD, a distinguished professor in pharmaceutical outcomes and policy and director of the Center for Drug Evaluation and Safety at the University of Florida, Gainesville. “Risks are mitigated by putting specific constraints around access to those medications.”

Dr. Winterstein, a former chair of the FDA’s Drug Safety and Risk Management Advisory Committee, said that nonprescription drugs are unnecessary in a functional health care system. 

Many patients may struggle with accessing health clinicians, so making medications available OTC fills gaps left by not being able to get a prescription, according to Dr. Winterstein. 

A 2012 paper funded by the Consumer Healthcare Products Association (CHPA), the organization representing manufacturers and distributors of OTC medications, estimated that one quarter of people who bought OTC drugs would not otherwise seek treatment if these treatments were available only via prescription. The CHPA notes that the number of those who experience allergies who use nonprescription antihistamines and allergy-relief drugs increased by about 10% between 2009 and 2015. 
 

Cholesterol drugs

Approximately 80 million U.S. adults are eligible for cholesterol-lowering medications, particularly statins, but nearly half don’t take them, according to the Centers for Disease Control and Prevention. 

Fear of side effects is the most common reason people might avoid taking these drugs. But eliminating the need for a refill may encourage uptake of the statins. 

“It’s refill, refill, refill,” said Allen J. Taylor, MD, chairman of cardiology at MedStar Heart and Vascular Institute, in Washington. “We spend a ton of time refilling statins and it’s a headache for patients, too.” 

The need to secure regular prescriptions for the drug, “doesn’t put enough trust and faith in pharmacists and doesn’t put enough trust and faith in patients,” Dr. Taylor said. 

Moving statins to the front end of a pharmacy might not be the best move given the potential for drug interactions, but a nonprescription behind-the-counter approach could work, according to Dr. Taylor. 

“The concerns are modest at most, to where they can be monitored by a pharmacist,” he said. “There’s probably more people that would take a statin if they had that kind of access.” 

Many statin manufacturers have attempted to make the prescription-to-OTC switch. In 2005, an FDA advisory panel rejected Merck’s proposal for OTC sales of lovastatin after reviewing a study that found only 55% of OTC purchases would have been medically appropriate. 

In 2015, Pfizer pulled its application to make the cholesterol drug atorvastatin available to patients OTC because patients were not using the drug correctly. AstraZeneca is investigating an online platform that would allow patients to self-assess their eligibility for rosuvastatin. 
 

Asthma inhalers 

Inhalers are the main rescue therapy for asthma aside from a visit to the ED. 

The only inhaler available OTC is epinephrine sold under the brand name Primatene Mist, but this type of medicine device is not recommended as a first-line therapy for acute asthma symptoms, according to the American Medical Association. 

“It’s been around for a long time and has stayed over the counter even though newer, safer agents have come onto the market which aren’t available over the counter,” said William B. Feldman, MD, DPhil, MPH, a pulmonologist at Brigham and Women’s Hospital, Boston. 

Patients who have a hard time getting to a doctor or patients who lack insurance often face barriers accessing albuterol inhalers and beta agonist–corticosteroid combinations, according to Dr. Feldman. A switch to OTC distribution would widen access. 

“What we’re advocating is, if they’re going to have access to Primatene Mist, wouldn’t it be sensible to have access to a safer and more effective therapy?” Dr. Feldman said. 
 

Triptans

Migraines affect an estimated 39 million people in the United States, according to the American Migraine Foundation. Several drugs to treat migraine are available OTC, including nonsteroidal anti-inflammatory drugs, aspirin, and acetaminophen. Triptans, drugs used for the short-term treatment of acute symptoms, are prescription-only in the United States. 

But in the United Kingdom, triptans first became available in retail stores in 2006, leading to reduced costs for patients, employers, and the government. One study found that government health expenditures would be reduced by $84 million annually if the OTC switch were made in six European countries. 

However, overuse of the drug and potential contraindications have been cited as concerns with OTC access. 

For Dr. Winterstein, the decision to switch isn’t just about the freedom to buy a drug; it comes down to weighing potential risks and benefits. 

“Drugs are only as good as if they’re used in the context of how they should be used,” Dr. Winterstein said. “It’s not candy.”
 

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

BOSTON – Intermittent fasting is an effective alternative to calorie restriction for shedding extra pounds, according to a new study of people with type 2 diabetes.

For the study, 57 overweight and obese participants with type 2 diabetes were randomly assigned to three different groups: The first group ate between noon and 8 p.m., the second was asked to reduce caloric intake by 25% of maintenance calories, and the third, a control group, continued eating normally.

The calorie-restriction group tracked intake on MyFitnessPal, an app that logs the calorie content of different foods. Both the intermittent-fasting and calorie-restriction groups were assigned a dietitian to help with adherence.

After 6 months, participants in the intermittent-fasting group lost about 4.3% of body weight – the equivalent of 10 pounds of weight loss for a person weighing 230 pounds – whereas participants in the calorie-restriction group lost about 2.5% of body weight.

The difference between the two groups was not significant, so one approach isn’t necessarily better than the other for weight loss.

“Let’s not think of this as an approach that’s better than calorie restriction,” William Yancy, MD, MHS, an internist and weight management specialist at Duke Lifestyle and Weight Management Center, Durham, N.C., said in an interview. “It’s an alternative approach to calorie restriction.”

Participants’ willingness to adhere to the diet likely accounted for the percentage difference between the groups, study author Vasiliki Pavlou, RDN, told this news organization. Ms. Pavlou presented the findings at the Nutrition 2023 conference.

“People that have type 2 diabetes, they’ve already been to the doctor, they’ve already been told to count calories,” said Ms. Pavlou, a doctoral student at the University of Illinois at Chicago. “There were many weeks where they came to us with nothing on MyFitnessPal and we’d have to encourage them to start tracking again.”

The intermittent-fasting group adhered to the eating time window 6 out of 7 days of the week, with a 1-hour grace period for the noon-to-8-p.m. window. In comparison, one-third of the calorie-restriction group didn’t stay within 200 calories of the goal, according to Ms. Pavlou.

That meant the fasting group cut about 100 calories more per day than the calorie-restriction group, which was reflected in their weight loss, Ms. Pavlou said.

A1c levels dropped by about 1% in both the intermittent-fasting and calorie-restriction groups – a meaningful decrease, said Dr. Yancy. “I think a 0.5% difference would have some clinical significance in terms of complications from diabetes,” he said. “So 1% would be even more clinically meaningful.”

However, fewer participants taking insulin in the calorie-restriction group could explain the difference, according to Ms. Pavlou. “Usually, when someone goes on insulin, their pancreas is already not functioning as well,” she said. “And it’s way harder to see improvements in their A1c and glycemic control.”

Up to 90% of people with type 2 diabetes are overweight or obese. Weight loss is one of the major components of type 2 diabetes care, according to the American Diabetes Association, and studies have shown that even a 5% reduction in body weight can reduce blood glucose concentration and A1c. Some studies suggest diabetes remission can occur after a 10% loss in body weight, but Dr. Yancy said it depends on the person.

“It depends on the individual, their metabolic situation, how long they’ve had diabetes, what kind of approach they’re following, maybe what medicines they’re taking,” Dr. Yancy said. “There’s a lot of different factors involved in remission.”

The study cohort generally had advanced diabetes and was taking a mix of medications, so the results might not be applicable to people with a more recent diabetes diagnosis, according to Ms. Pavlou.

Dr. Yancy said intermittent fasting could work well for the right person. The success of the approach could depend on a person’s eating habits and whether their meals usually fall outside the time-restricted window, or it could depend on how well a person follows rules, according to Dr. Yancy.

“Some people might not eat much after 8 o’clock, and some people might skip breakfast,” Dr. Yancy said. “And if that’s the case, then it’s not going to make a big impact on their weight probably.”

Medication is also an important consideration. Not eating can be dangerous for patients taking short-acting insulin or sulfonylureas, according to Dr. Yancy.

Ms. Pavlou said these findings show intermittent fasting is another option for patients with type 2 diabetes trying to lose weight. “If you’ve tried calorie counting, that’s not working for you or if you’re kind of burnt out, this is something else that you could try,” she said.

“We have a lot of patients that need to lose weight, and we have patients who respond differently to different approaches,” said Dr. Yancy. “So having various approaches is really valuable.”

The manuscript is currently under review at JAMA Internal Medicine, said Ms. Pavlou.
 

A version of this article appeared on Medscape.com.

BOSTON – Intermittent fasting is an effective alternative to calorie restriction for shedding extra pounds, according to a new study of people with type 2 diabetes.

For the study, 57 overweight and obese participants with type 2 diabetes were randomly assigned to three different groups: The first group ate between noon and 8 p.m., the second was asked to reduce caloric intake by 25% of maintenance calories, and the third, a control group, continued eating normally.

The calorie-restriction group tracked intake on MyFitnessPal, an app that logs the calorie content of different foods. Both the intermittent-fasting and calorie-restriction groups were assigned a dietitian to help with adherence.

After 6 months, participants in the intermittent-fasting group lost about 4.3% of body weight – the equivalent of 10 pounds of weight loss for a person weighing 230 pounds – whereas participants in the calorie-restriction group lost about 2.5% of body weight.

The difference between the two groups was not significant, so one approach isn’t necessarily better than the other for weight loss.

“Let’s not think of this as an approach that’s better than calorie restriction,” William Yancy, MD, MHS, an internist and weight management specialist at Duke Lifestyle and Weight Management Center, Durham, N.C., said in an interview. “It’s an alternative approach to calorie restriction.”

Participants’ willingness to adhere to the diet likely accounted for the percentage difference between the groups, study author Vasiliki Pavlou, RDN, told this news organization. Ms. Pavlou presented the findings at the Nutrition 2023 conference.

“People that have type 2 diabetes, they’ve already been to the doctor, they’ve already been told to count calories,” said Ms. Pavlou, a doctoral student at the University of Illinois at Chicago. “There were many weeks where they came to us with nothing on MyFitnessPal and we’d have to encourage them to start tracking again.”

The intermittent-fasting group adhered to the eating time window 6 out of 7 days of the week, with a 1-hour grace period for the noon-to-8-p.m. window. In comparison, one-third of the calorie-restriction group didn’t stay within 200 calories of the goal, according to Ms. Pavlou.

That meant the fasting group cut about 100 calories more per day than the calorie-restriction group, which was reflected in their weight loss, Ms. Pavlou said.

A1c levels dropped by about 1% in both the intermittent-fasting and calorie-restriction groups – a meaningful decrease, said Dr. Yancy. “I think a 0.5% difference would have some clinical significance in terms of complications from diabetes,” he said. “So 1% would be even more clinically meaningful.”

However, fewer participants taking insulin in the calorie-restriction group could explain the difference, according to Ms. Pavlou. “Usually, when someone goes on insulin, their pancreas is already not functioning as well,” she said. “And it’s way harder to see improvements in their A1c and glycemic control.”

Up to 90% of people with type 2 diabetes are overweight or obese. Weight loss is one of the major components of type 2 diabetes care, according to the American Diabetes Association, and studies have shown that even a 5% reduction in body weight can reduce blood glucose concentration and A1c. Some studies suggest diabetes remission can occur after a 10% loss in body weight, but Dr. Yancy said it depends on the person.

“It depends on the individual, their metabolic situation, how long they’ve had diabetes, what kind of approach they’re following, maybe what medicines they’re taking,” Dr. Yancy said. “There’s a lot of different factors involved in remission.”

The study cohort generally had advanced diabetes and was taking a mix of medications, so the results might not be applicable to people with a more recent diabetes diagnosis, according to Ms. Pavlou.

Dr. Yancy said intermittent fasting could work well for the right person. The success of the approach could depend on a person’s eating habits and whether their meals usually fall outside the time-restricted window, or it could depend on how well a person follows rules, according to Dr. Yancy.

“Some people might not eat much after 8 o’clock, and some people might skip breakfast,” Dr. Yancy said. “And if that’s the case, then it’s not going to make a big impact on their weight probably.”

Medication is also an important consideration. Not eating can be dangerous for patients taking short-acting insulin or sulfonylureas, according to Dr. Yancy.

Ms. Pavlou said these findings show intermittent fasting is another option for patients with type 2 diabetes trying to lose weight. “If you’ve tried calorie counting, that’s not working for you or if you’re kind of burnt out, this is something else that you could try,” she said.

“We have a lot of patients that need to lose weight, and we have patients who respond differently to different approaches,” said Dr. Yancy. “So having various approaches is really valuable.”

The manuscript is currently under review at JAMA Internal Medicine, said Ms. Pavlou.
 

A version of this article appeared on Medscape.com.

BOSTON – Intermittent fasting is an effective alternative to calorie restriction for shedding extra pounds, according to a new study of people with type 2 diabetes.

For the study, 57 overweight and obese participants with type 2 diabetes were randomly assigned to three different groups: The first group ate between noon and 8 p.m., the second was asked to reduce caloric intake by 25% of maintenance calories, and the third, a control group, continued eating normally.

The calorie-restriction group tracked intake on MyFitnessPal, an app that logs the calorie content of different foods. Both the intermittent-fasting and calorie-restriction groups were assigned a dietitian to help with adherence.

After 6 months, participants in the intermittent-fasting group lost about 4.3% of body weight – the equivalent of 10 pounds of weight loss for a person weighing 230 pounds – whereas participants in the calorie-restriction group lost about 2.5% of body weight.

The difference between the two groups was not significant, so one approach isn’t necessarily better than the other for weight loss.

“Let’s not think of this as an approach that’s better than calorie restriction,” William Yancy, MD, MHS, an internist and weight management specialist at Duke Lifestyle and Weight Management Center, Durham, N.C., said in an interview. “It’s an alternative approach to calorie restriction.”

Participants’ willingness to adhere to the diet likely accounted for the percentage difference between the groups, study author Vasiliki Pavlou, RDN, told this news organization. Ms. Pavlou presented the findings at the Nutrition 2023 conference.

“People that have type 2 diabetes, they’ve already been to the doctor, they’ve already been told to count calories,” said Ms. Pavlou, a doctoral student at the University of Illinois at Chicago. “There were many weeks where they came to us with nothing on MyFitnessPal and we’d have to encourage them to start tracking again.”

The intermittent-fasting group adhered to the eating time window 6 out of 7 days of the week, with a 1-hour grace period for the noon-to-8-p.m. window. In comparison, one-third of the calorie-restriction group didn’t stay within 200 calories of the goal, according to Ms. Pavlou.

That meant the fasting group cut about 100 calories more per day than the calorie-restriction group, which was reflected in their weight loss, Ms. Pavlou said.

A1c levels dropped by about 1% in both the intermittent-fasting and calorie-restriction groups – a meaningful decrease, said Dr. Yancy. “I think a 0.5% difference would have some clinical significance in terms of complications from diabetes,” he said. “So 1% would be even more clinically meaningful.”

However, fewer participants taking insulin in the calorie-restriction group could explain the difference, according to Ms. Pavlou. “Usually, when someone goes on insulin, their pancreas is already not functioning as well,” she said. “And it’s way harder to see improvements in their A1c and glycemic control.”

Up to 90% of people with type 2 diabetes are overweight or obese. Weight loss is one of the major components of type 2 diabetes care, according to the American Diabetes Association, and studies have shown that even a 5% reduction in body weight can reduce blood glucose concentration and A1c. Some studies suggest diabetes remission can occur after a 10% loss in body weight, but Dr. Yancy said it depends on the person.

“It depends on the individual, their metabolic situation, how long they’ve had diabetes, what kind of approach they’re following, maybe what medicines they’re taking,” Dr. Yancy said. “There’s a lot of different factors involved in remission.”

The study cohort generally had advanced diabetes and was taking a mix of medications, so the results might not be applicable to people with a more recent diabetes diagnosis, according to Ms. Pavlou.

Dr. Yancy said intermittent fasting could work well for the right person. The success of the approach could depend on a person’s eating habits and whether their meals usually fall outside the time-restricted window, or it could depend on how well a person follows rules, according to Dr. Yancy.

“Some people might not eat much after 8 o’clock, and some people might skip breakfast,” Dr. Yancy said. “And if that’s the case, then it’s not going to make a big impact on their weight probably.”

Medication is also an important consideration. Not eating can be dangerous for patients taking short-acting insulin or sulfonylureas, according to Dr. Yancy.

Ms. Pavlou said these findings show intermittent fasting is another option for patients with type 2 diabetes trying to lose weight. “If you’ve tried calorie counting, that’s not working for you or if you’re kind of burnt out, this is something else that you could try,” she said.

“We have a lot of patients that need to lose weight, and we have patients who respond differently to different approaches,” said Dr. Yancy. “So having various approaches is really valuable.”

The manuscript is currently under review at JAMA Internal Medicine, said Ms. Pavlou.
 

A version of this article appeared on Medscape.com.

Berberine, a plant-derived compound historically used in traditional Chinese medicine, is experiencing increased popularity thanks to social media, especially TikTok, where the hashtag #berberine has more than 75 million views at the time of this writing. Social media influencers are promoting the compound, calling it “nature’s Ozempic,” saying they lost weight taking the supplement.

Off-the-shelf berberine comes as a yellow-orange powder usually encased in a capsule or mixed into tablet form. It’s extracted from the roots, stems, and leaves of various plants, including goldenseal and barberry.

Its use is additionally promoted for insulin resistance, polycystic ovary syndrome, and even cancer, but medical experts are warning potential users that it lacks robust evidence to support its use.

“There’s not that much data on it,” says Reshmi Srinath, MD, director of the Mount Sinai weight and metabolism management program, New York. “It’s sort of shocking now that it’s popped up into the media, to be frank.”

In response to berberine’s online popularity, the National Center for Complementary and Integrative Health issued a warning, stating that “there isn’t enough rigorous scientific evidence to determine whether it is effective.”
 

Overstated claims, lack of scientific research?

Other endocrinologists and weight management experts agree. “The claims are pretty overstated when it comes to the impact on weight loss, based on the evidence in the literature that’s currently available,” says Jaime Almandoz, MD, medical director of the UT Southwestern Medical Center, Dallas, weight wellness program.

A review of 12 randomized controlled trials evaluating berberine’s effects on obesity concluded that the treatment moderately decreased body weight. The trials included were conducted over only a few months and had small numbers of participants, and weight loss was not the primary outcome measure.

“There are few randomized controlled trials,” says Ivania Rizo, MD, an endocrinologist at Boston University. “It appears that they all have some low quality of methods which essentially can lead to an increased risk of bias.”

Another review, of 35 studies – most of them on animals and human cells and similarly underpowered – concluded that berberine showed promise for reducing blood glucose. A separate study found that berberine treatment actually increased the body weight and appetite of rats.

How exactly berberine elicits these effects is not entirely clear. Several studies point to its activation of AMP-activated protein kinase, which improves glucose tolerance in rats, as the mechanism for weight loss. Metformin, a drug used to improve glycemic control in people with type 2 diabetes, works in a similar way. Other researchers have hypothesized a link between berberine and the gut microbiome to explain its effect on type 2 diabetes and weight loss, though the clinical data to substantiate this link are shaky.

“I caution my patients about dietary supplements for weight management because we do not have high-quality data demonstrating efficacy,” Katherine Saunders, MD, DABOM, an obesity expert and cofounder of Intellihealth, a platform for obesity management, said in an email.
 

Experimenting with berberine

Despite the lack of substantial evidence supporting berberine’s use for weight management and obesity, interest in the supplement seems to be increasing. One reason could be that lifestyle interventions aren’t sufficient for most people with obesity to lose a significant amount of weight, with many requiring medical intervention, according to Dr. Saunders.

But access to treatment providers is limited. “As a result, it is not uncommon for individuals with obesity to experiment with dietary supplements like berberine,” she observed.

Dr. Srinath, the Mount Sinai doctor, says many patients have asked for her thoughts on berberine as a weight loss supplement. “I say, you know, it’s something you’re welcome to try, but we don’t have enough data at this time to recommend it.”

The hype surrounding the supplement isn’t all that surprising. About 42% of adults in the United States have obesity, according to 2019-2023 National Health and Nutrition Examination Survey data, pointing to a serious need for accessible drugs to address the condition. Berberine is available over the counter and is far cheaper than most of the newer U.S. Food and Drug Administration–approved drugs for weight loss.

Wegovy, semaglutide approved to treat obesity, can cost as much as $1,300 per package; and Ozempic, semaglutide approved to treat type 2 diabetes, can cost more than $1,000 per month. “That’s a very steep price to pay,” says Dr. Srinath.

Many insurance companies won’t cover the drugs, curbing access to Americans who need them, says Dr. Almandoz. Federally sponsored programs such as Medicare and Medicaid also don’t cover the drugs, which are approved for obesity and weight management. “That’s been a huge hole in our health care system,” says Dr. Srinath. “That’s sort of what’s been driving interest in supplements and things like that.”

Among adults trying to lose weight, only about 3% said they took prescription medication for weight loss, according to a report from the U.S. Government Accountability Office. This report includes 2013-2016 data, predating Wegovy’s approval for chronic weight management.

“These classes are notorious for being quite pricey and not well covered by insurance,” says Dr. Almandoz. “It’s easy to see why someone would promote something that someone may have more access to.”

Comparing Ozempic or Wegovy with berberine can be misleading. Those drugs work by mimicking the effect of the hormone GLP-1 to help reduce appetite.

A clinical trial assessing the efficacy of semaglutide found that adults with obesity who took the drug for 68 weeks lost approximately 15% of their body weight in combination with lifestyle changes. The FDA approval was based on this trial and three others that showed similarly substantial reductions in weight.

The trials also document the many side effects of taking the drugs, primarily gastrointestinal in nature. The short- and long-term effects of berberine, on the other hand, are less clear. Some of the clinical trials reported diarrhea and stomach upset as the most common adverse effects.

Its perception as a naturally derived option for weight loss, though, might encourage people to overlook the potential interactions that berberine could have with other drugs, according to Dr. Almandoz.

He says clinicians considering natural products or nutraceuticals for patients should check for potential side effects and find reliable database sources to determine any potential medication interactions for patients. But the unregulated nature of berberine makes this challenging, Dr. Almandoz adds.

The dosage, formulations, and quality of berberine vary in each study and each product because supplements don’t need to pass through the checks and balances of the FDA to land on shelves.

The lack of regulation could incentivize some companies to add stimulants to enhance any weight loss effect that the supplement may have. Those additives might interact with other health conditions or cause side effects like anxiety, says Dr. Almandoz.

Berberine should also not be taken during pregnancy or while breastfeeding, and it is unsafe for young children; in newborns and children, the supplement can cause higher levels of bilirubin in the blood, worsening any jaundice at birth and posing a greater risk for kernicterus.

Dr. Rizo urges patients, before they ask for berberine, to first ask for safe and effective interventions they can access. “I don’t want to have people not use effective interventions that are currently available to them, and instead use something that needs to be better studied and needs to be better regulated,” she says.

While the “nature’s Ozempic” catchphrase could be drawing in potential users with its dubious comparison, berberine’s escalating popularity might also be a symptom of people seeking a quick fix, the experts worry.

“That’s my fear,” says Dr. Srinath. “ ‘Let me get this medicine, let me lose the weight fast,’ but at the end of the day, weight management is a long-term journey. It takes time, it takes effort, it is not easy, and there is no quick fix.”

This is another concern for doctors; for people who’ve struggled with losing weight for years, not seeing results from berberine could feel like another failure.

“It will give them another opportunity to feel like they are being unsuccessful or that they are failing at weight loss again,” says Dr. Almandoz. “It feeds into the hopelessness that many people with obesity have around their weight management.”

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

Berberine, a plant-derived compound historically used in traditional Chinese medicine, is experiencing increased popularity thanks to social media, especially TikTok, where the hashtag #berberine has more than 75 million views at the time of this writing. Social media influencers are promoting the compound, calling it “nature’s Ozempic,” saying they lost weight taking the supplement.

Off-the-shelf berberine comes as a yellow-orange powder usually encased in a capsule or mixed into tablet form. It’s extracted from the roots, stems, and leaves of various plants, including goldenseal and barberry.

Its use is additionally promoted for insulin resistance, polycystic ovary syndrome, and even cancer, but medical experts are warning potential users that it lacks robust evidence to support its use.

“There’s not that much data on it,” says Reshmi Srinath, MD, director of the Mount Sinai weight and metabolism management program, New York. “It’s sort of shocking now that it’s popped up into the media, to be frank.”

In response to berberine’s online popularity, the National Center for Complementary and Integrative Health issued a warning, stating that “there isn’t enough rigorous scientific evidence to determine whether it is effective.”
 

Overstated claims, lack of scientific research?

Other endocrinologists and weight management experts agree. “The claims are pretty overstated when it comes to the impact on weight loss, based on the evidence in the literature that’s currently available,” says Jaime Almandoz, MD, medical director of the UT Southwestern Medical Center, Dallas, weight wellness program.

A review of 12 randomized controlled trials evaluating berberine’s effects on obesity concluded that the treatment moderately decreased body weight. The trials included were conducted over only a few months and had small numbers of participants, and weight loss was not the primary outcome measure.

“There are few randomized controlled trials,” says Ivania Rizo, MD, an endocrinologist at Boston University. “It appears that they all have some low quality of methods which essentially can lead to an increased risk of bias.”

Another review, of 35 studies – most of them on animals and human cells and similarly underpowered – concluded that berberine showed promise for reducing blood glucose. A separate study found that berberine treatment actually increased the body weight and appetite of rats.

How exactly berberine elicits these effects is not entirely clear. Several studies point to its activation of AMP-activated protein kinase, which improves glucose tolerance in rats, as the mechanism for weight loss. Metformin, a drug used to improve glycemic control in people with type 2 diabetes, works in a similar way. Other researchers have hypothesized a link between berberine and the gut microbiome to explain its effect on type 2 diabetes and weight loss, though the clinical data to substantiate this link are shaky.

“I caution my patients about dietary supplements for weight management because we do not have high-quality data demonstrating efficacy,” Katherine Saunders, MD, DABOM, an obesity expert and cofounder of Intellihealth, a platform for obesity management, said in an email.
 

Experimenting with berberine

Despite the lack of substantial evidence supporting berberine’s use for weight management and obesity, interest in the supplement seems to be increasing. One reason could be that lifestyle interventions aren’t sufficient for most people with obesity to lose a significant amount of weight, with many requiring medical intervention, according to Dr. Saunders.

But access to treatment providers is limited. “As a result, it is not uncommon for individuals with obesity to experiment with dietary supplements like berberine,” she observed.

Dr. Srinath, the Mount Sinai doctor, says many patients have asked for her thoughts on berberine as a weight loss supplement. “I say, you know, it’s something you’re welcome to try, but we don’t have enough data at this time to recommend it.”

The hype surrounding the supplement isn’t all that surprising. About 42% of adults in the United States have obesity, according to 2019-2023 National Health and Nutrition Examination Survey data, pointing to a serious need for accessible drugs to address the condition. Berberine is available over the counter and is far cheaper than most of the newer U.S. Food and Drug Administration–approved drugs for weight loss.

Wegovy, semaglutide approved to treat obesity, can cost as much as $1,300 per package; and Ozempic, semaglutide approved to treat type 2 diabetes, can cost more than $1,000 per month. “That’s a very steep price to pay,” says Dr. Srinath.

Many insurance companies won’t cover the drugs, curbing access to Americans who need them, says Dr. Almandoz. Federally sponsored programs such as Medicare and Medicaid also don’t cover the drugs, which are approved for obesity and weight management. “That’s been a huge hole in our health care system,” says Dr. Srinath. “That’s sort of what’s been driving interest in supplements and things like that.”

Among adults trying to lose weight, only about 3% said they took prescription medication for weight loss, according to a report from the U.S. Government Accountability Office. This report includes 2013-2016 data, predating Wegovy’s approval for chronic weight management.

“These classes are notorious for being quite pricey and not well covered by insurance,” says Dr. Almandoz. “It’s easy to see why someone would promote something that someone may have more access to.”

Comparing Ozempic or Wegovy with berberine can be misleading. Those drugs work by mimicking the effect of the hormone GLP-1 to help reduce appetite.

A clinical trial assessing the efficacy of semaglutide found that adults with obesity who took the drug for 68 weeks lost approximately 15% of their body weight in combination with lifestyle changes. The FDA approval was based on this trial and three others that showed similarly substantial reductions in weight.

The trials also document the many side effects of taking the drugs, primarily gastrointestinal in nature. The short- and long-term effects of berberine, on the other hand, are less clear. Some of the clinical trials reported diarrhea and stomach upset as the most common adverse effects.

Its perception as a naturally derived option for weight loss, though, might encourage people to overlook the potential interactions that berberine could have with other drugs, according to Dr. Almandoz.

He says clinicians considering natural products or nutraceuticals for patients should check for potential side effects and find reliable database sources to determine any potential medication interactions for patients. But the unregulated nature of berberine makes this challenging, Dr. Almandoz adds.

The dosage, formulations, and quality of berberine vary in each study and each product because supplements don’t need to pass through the checks and balances of the FDA to land on shelves.

The lack of regulation could incentivize some companies to add stimulants to enhance any weight loss effect that the supplement may have. Those additives might interact with other health conditions or cause side effects like anxiety, says Dr. Almandoz.

Berberine should also not be taken during pregnancy or while breastfeeding, and it is unsafe for young children; in newborns and children, the supplement can cause higher levels of bilirubin in the blood, worsening any jaundice at birth and posing a greater risk for kernicterus.

Dr. Rizo urges patients, before they ask for berberine, to first ask for safe and effective interventions they can access. “I don’t want to have people not use effective interventions that are currently available to them, and instead use something that needs to be better studied and needs to be better regulated,” she says.

While the “nature’s Ozempic” catchphrase could be drawing in potential users with its dubious comparison, berberine’s escalating popularity might also be a symptom of people seeking a quick fix, the experts worry.

“That’s my fear,” says Dr. Srinath. “ ‘Let me get this medicine, let me lose the weight fast,’ but at the end of the day, weight management is a long-term journey. It takes time, it takes effort, it is not easy, and there is no quick fix.”

This is another concern for doctors; for people who’ve struggled with losing weight for years, not seeing results from berberine could feel like another failure.

“It will give them another opportunity to feel like they are being unsuccessful or that they are failing at weight loss again,” says Dr. Almandoz. “It feeds into the hopelessness that many people with obesity have around their weight management.”

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

Berberine, a plant-derived compound historically used in traditional Chinese medicine, is experiencing increased popularity thanks to social media, especially TikTok, where the hashtag #berberine has more than 75 million views at the time of this writing. Social media influencers are promoting the compound, calling it “nature’s Ozempic,” saying they lost weight taking the supplement.

Off-the-shelf berberine comes as a yellow-orange powder usually encased in a capsule or mixed into tablet form. It’s extracted from the roots, stems, and leaves of various plants, including goldenseal and barberry.

Its use is additionally promoted for insulin resistance, polycystic ovary syndrome, and even cancer, but medical experts are warning potential users that it lacks robust evidence to support its use.

“There’s not that much data on it,” says Reshmi Srinath, MD, director of the Mount Sinai weight and metabolism management program, New York. “It’s sort of shocking now that it’s popped up into the media, to be frank.”

In response to berberine’s online popularity, the National Center for Complementary and Integrative Health issued a warning, stating that “there isn’t enough rigorous scientific evidence to determine whether it is effective.”
 

Overstated claims, lack of scientific research?

Other endocrinologists and weight management experts agree. “The claims are pretty overstated when it comes to the impact on weight loss, based on the evidence in the literature that’s currently available,” says Jaime Almandoz, MD, medical director of the UT Southwestern Medical Center, Dallas, weight wellness program.

A review of 12 randomized controlled trials evaluating berberine’s effects on obesity concluded that the treatment moderately decreased body weight. The trials included were conducted over only a few months and had small numbers of participants, and weight loss was not the primary outcome measure.

“There are few randomized controlled trials,” says Ivania Rizo, MD, an endocrinologist at Boston University. “It appears that they all have some low quality of methods which essentially can lead to an increased risk of bias.”

Another review, of 35 studies – most of them on animals and human cells and similarly underpowered – concluded that berberine showed promise for reducing blood glucose. A separate study found that berberine treatment actually increased the body weight and appetite of rats.

How exactly berberine elicits these effects is not entirely clear. Several studies point to its activation of AMP-activated protein kinase, which improves glucose tolerance in rats, as the mechanism for weight loss. Metformin, a drug used to improve glycemic control in people with type 2 diabetes, works in a similar way. Other researchers have hypothesized a link between berberine and the gut microbiome to explain its effect on type 2 diabetes and weight loss, though the clinical data to substantiate this link are shaky.

“I caution my patients about dietary supplements for weight management because we do not have high-quality data demonstrating efficacy,” Katherine Saunders, MD, DABOM, an obesity expert and cofounder of Intellihealth, a platform for obesity management, said in an email.
 

Experimenting with berberine

Despite the lack of substantial evidence supporting berberine’s use for weight management and obesity, interest in the supplement seems to be increasing. One reason could be that lifestyle interventions aren’t sufficient for most people with obesity to lose a significant amount of weight, with many requiring medical intervention, according to Dr. Saunders.

But access to treatment providers is limited. “As a result, it is not uncommon for individuals with obesity to experiment with dietary supplements like berberine,” she observed.

Dr. Srinath, the Mount Sinai doctor, says many patients have asked for her thoughts on berberine as a weight loss supplement. “I say, you know, it’s something you’re welcome to try, but we don’t have enough data at this time to recommend it.”

The hype surrounding the supplement isn’t all that surprising. About 42% of adults in the United States have obesity, according to 2019-2023 National Health and Nutrition Examination Survey data, pointing to a serious need for accessible drugs to address the condition. Berberine is available over the counter and is far cheaper than most of the newer U.S. Food and Drug Administration–approved drugs for weight loss.

Wegovy, semaglutide approved to treat obesity, can cost as much as $1,300 per package; and Ozempic, semaglutide approved to treat type 2 diabetes, can cost more than $1,000 per month. “That’s a very steep price to pay,” says Dr. Srinath.

Many insurance companies won’t cover the drugs, curbing access to Americans who need them, says Dr. Almandoz. Federally sponsored programs such as Medicare and Medicaid also don’t cover the drugs, which are approved for obesity and weight management. “That’s been a huge hole in our health care system,” says Dr. Srinath. “That’s sort of what’s been driving interest in supplements and things like that.”

Among adults trying to lose weight, only about 3% said they took prescription medication for weight loss, according to a report from the U.S. Government Accountability Office. This report includes 2013-2016 data, predating Wegovy’s approval for chronic weight management.

“These classes are notorious for being quite pricey and not well covered by insurance,” says Dr. Almandoz. “It’s easy to see why someone would promote something that someone may have more access to.”

Comparing Ozempic or Wegovy with berberine can be misleading. Those drugs work by mimicking the effect of the hormone GLP-1 to help reduce appetite.

A clinical trial assessing the efficacy of semaglutide found that adults with obesity who took the drug for 68 weeks lost approximately 15% of their body weight in combination with lifestyle changes. The FDA approval was based on this trial and three others that showed similarly substantial reductions in weight.

The trials also document the many side effects of taking the drugs, primarily gastrointestinal in nature. The short- and long-term effects of berberine, on the other hand, are less clear. Some of the clinical trials reported diarrhea and stomach upset as the most common adverse effects.

Its perception as a naturally derived option for weight loss, though, might encourage people to overlook the potential interactions that berberine could have with other drugs, according to Dr. Almandoz.

He says clinicians considering natural products or nutraceuticals for patients should check for potential side effects and find reliable database sources to determine any potential medication interactions for patients. But the unregulated nature of berberine makes this challenging, Dr. Almandoz adds.

The dosage, formulations, and quality of berberine vary in each study and each product because supplements don’t need to pass through the checks and balances of the FDA to land on shelves.

The lack of regulation could incentivize some companies to add stimulants to enhance any weight loss effect that the supplement may have. Those additives might interact with other health conditions or cause side effects like anxiety, says Dr. Almandoz.

Berberine should also not be taken during pregnancy or while breastfeeding, and it is unsafe for young children; in newborns and children, the supplement can cause higher levels of bilirubin in the blood, worsening any jaundice at birth and posing a greater risk for kernicterus.

Dr. Rizo urges patients, before they ask for berberine, to first ask for safe and effective interventions they can access. “I don’t want to have people not use effective interventions that are currently available to them, and instead use something that needs to be better studied and needs to be better regulated,” she says.

While the “nature’s Ozempic” catchphrase could be drawing in potential users with its dubious comparison, berberine’s escalating popularity might also be a symptom of people seeking a quick fix, the experts worry.

“That’s my fear,” says Dr. Srinath. “ ‘Let me get this medicine, let me lose the weight fast,’ but at the end of the day, weight management is a long-term journey. It takes time, it takes effort, it is not easy, and there is no quick fix.”

This is another concern for doctors; for people who’ve struggled with losing weight for years, not seeing results from berberine could feel like another failure.

“It will give them another opportunity to feel like they are being unsuccessful or that they are failing at weight loss again,” says Dr. Almandoz. “It feeds into the hopelessness that many people with obesity have around their weight management.”

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

Following reports that the European Medicines Agency is looking into instances of suicide or self-harm after patients took the weight loss drugs semaglutide or liraglutide, the manufacturer, Novo Nordisk, issued a statement to this news organization in which it says it “remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”

U.S. experts say they haven’t personally seen this adverse effect in any patients except for one isolated case. An increase in suicidal ideation, particularly among younger people, has been reported following bariatric surgery for weight loss.

In the United States, the two drugs – both GLP-1 agonists – already come with a warning about the potential for these adverse effects on the branded versions approved for weight loss, Wegovy and Saxenda. (Years earlier, both drugs, marketed as Ozempic and Victoza, were also approved for treatment of type 2 diabetes.)

Of more than 1,200 reports of adverse reactions with semaglutide, 60 cases of suicidal ideation and 7 suicide attempts have been reported since 2018, according to the Food and Drug Administration’s Adverse Event Reporting System (FAERS) public database. For liraglutide, there were 71 cases of suicidal ideation, 28 suicide attempts, and 25 completed suicides out of more than 35,000 reports of adverse reactions.

The FAERS website cautions users that the data may be duplicated or incomplete, that rates of occurrence cannot be established using the data, that reports have not been verified, and that the existence of a report cannot establish causation.

The EMA is looking into about 150 reports of possible cases of self-injury and suicidal thoughts, according to a press release from the agency.

“It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors,” it says. The medicines are widely used in the European Union, according to the press release.

The review of Ozempic, Saxenda, and Wegovy, which started on July 3, 2023, has been extended to include other GLP-1 receptor agonists, which include dulaglutide, exenatide, and lixisenatide. This review is expected to conclude in November 2023.

In a statement, Novo Nordisk did not directly dispute a potential link between the drugs and suicidal ideation.

“In the U.S., FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation,” the statement indicates. “This event had been reported in clinical trials with other weight management products.”

It adds: “Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.”
 

Important to know the denominator

“What’s important to know is the denominator,” said Holly Lofton, MD, a clinical associate professor of surgery and medicine and the director of the medical weight management program at NYU Langone, New York. “It needs a denominator with the total population on the medication so we can determine if that’s really a significant risk.”

Dr. Lofton described an isolated, anecdotal case of a patient who had no history of depression or mental health problems but developed suicidal thoughts after taking Saxenda for several months. In that case, the 25-year-old was experiencing problems in a personal relationship and with social media.

Two other weight loss specialists contacted by this news organization had not had patients who had experienced suicidal ideation with the drugs. “These are not very common in practice,” Dr. Lofton said in an interview.

The U.S. prescribing information for Saxenda, which contains liraglutide and has been approved as an adjunct to diet and exercise for chronic weight management, recommends monitoring for the emergence of depression and suicidal thoughts. In the clinical trials, 6 of the 3,384 patients who took the drug reported suicidal ideation; none of the 1,941 patients who received placebo did so, according to the FDA.

Similarly, the U.S. prescribing information for Wegovy, which contains semaglutide, recommends monitoring for the emergence of suicidal thoughts or depression, but this recommendation was based on clinical trials of other weight management products. The prescribing information for Ozempic, the brand name for semaglutide for type 2 diabetes, does not include this recommendation.
 

Is it the weight loss, rather than the meds? Seen with bariatric surgery too

Speculating what the link, if any, might be, Dr. Lofton suggested dopamine release could be playing a role. Small trials in humans as well as animal studies hint at a blunting of dopamine responses to usual triggers – including addictive substances and possibly food – that may also affect mood.

Young people (aged 18-34) who undergo bariatric surgery are at an increased risk of suicide during follow-up compared to their peers who don’t have surgery. And a study found an increase in events involving self-harm after bariatric surgery, especially among patients who already had a mental health disorder.

For a patient who derives comfort from food, not being able to eat in response to a stressful event may lead that patient to act out in more serious ways, according to Dr. Lofton. “That’s why, again, surgical follow-up is so important and their presurgical psychiatric evaluation is so important.”

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

Following reports that the European Medicines Agency is looking into instances of suicide or self-harm after patients took the weight loss drugs semaglutide or liraglutide, the manufacturer, Novo Nordisk, issued a statement to this news organization in which it says it “remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”

U.S. experts say they haven’t personally seen this adverse effect in any patients except for one isolated case. An increase in suicidal ideation, particularly among younger people, has been reported following bariatric surgery for weight loss.

In the United States, the two drugs – both GLP-1 agonists – already come with a warning about the potential for these adverse effects on the branded versions approved for weight loss, Wegovy and Saxenda. (Years earlier, both drugs, marketed as Ozempic and Victoza, were also approved for treatment of type 2 diabetes.)

Of more than 1,200 reports of adverse reactions with semaglutide, 60 cases of suicidal ideation and 7 suicide attempts have been reported since 2018, according to the Food and Drug Administration’s Adverse Event Reporting System (FAERS) public database. For liraglutide, there were 71 cases of suicidal ideation, 28 suicide attempts, and 25 completed suicides out of more than 35,000 reports of adverse reactions.

The FAERS website cautions users that the data may be duplicated or incomplete, that rates of occurrence cannot be established using the data, that reports have not been verified, and that the existence of a report cannot establish causation.

The EMA is looking into about 150 reports of possible cases of self-injury and suicidal thoughts, according to a press release from the agency.

“It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors,” it says. The medicines are widely used in the European Union, according to the press release.

The review of Ozempic, Saxenda, and Wegovy, which started on July 3, 2023, has been extended to include other GLP-1 receptor agonists, which include dulaglutide, exenatide, and lixisenatide. This review is expected to conclude in November 2023.

In a statement, Novo Nordisk did not directly dispute a potential link between the drugs and suicidal ideation.

“In the U.S., FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation,” the statement indicates. “This event had been reported in clinical trials with other weight management products.”

It adds: “Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.”
 

Important to know the denominator

“What’s important to know is the denominator,” said Holly Lofton, MD, a clinical associate professor of surgery and medicine and the director of the medical weight management program at NYU Langone, New York. “It needs a denominator with the total population on the medication so we can determine if that’s really a significant risk.”

Dr. Lofton described an isolated, anecdotal case of a patient who had no history of depression or mental health problems but developed suicidal thoughts after taking Saxenda for several months. In that case, the 25-year-old was experiencing problems in a personal relationship and with social media.

Two other weight loss specialists contacted by this news organization had not had patients who had experienced suicidal ideation with the drugs. “These are not very common in practice,” Dr. Lofton said in an interview.

The U.S. prescribing information for Saxenda, which contains liraglutide and has been approved as an adjunct to diet and exercise for chronic weight management, recommends monitoring for the emergence of depression and suicidal thoughts. In the clinical trials, 6 of the 3,384 patients who took the drug reported suicidal ideation; none of the 1,941 patients who received placebo did so, according to the FDA.

Similarly, the U.S. prescribing information for Wegovy, which contains semaglutide, recommends monitoring for the emergence of suicidal thoughts or depression, but this recommendation was based on clinical trials of other weight management products. The prescribing information for Ozempic, the brand name for semaglutide for type 2 diabetes, does not include this recommendation.
 

Is it the weight loss, rather than the meds? Seen with bariatric surgery too

Speculating what the link, if any, might be, Dr. Lofton suggested dopamine release could be playing a role. Small trials in humans as well as animal studies hint at a blunting of dopamine responses to usual triggers – including addictive substances and possibly food – that may also affect mood.

Young people (aged 18-34) who undergo bariatric surgery are at an increased risk of suicide during follow-up compared to their peers who don’t have surgery. And a study found an increase in events involving self-harm after bariatric surgery, especially among patients who already had a mental health disorder.

For a patient who derives comfort from food, not being able to eat in response to a stressful event may lead that patient to act out in more serious ways, according to Dr. Lofton. “That’s why, again, surgical follow-up is so important and their presurgical psychiatric evaluation is so important.”

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

Following reports that the European Medicines Agency is looking into instances of suicide or self-harm after patients took the weight loss drugs semaglutide or liraglutide, the manufacturer, Novo Nordisk, issued a statement to this news organization in which it says it “remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”

U.S. experts say they haven’t personally seen this adverse effect in any patients except for one isolated case. An increase in suicidal ideation, particularly among younger people, has been reported following bariatric surgery for weight loss.

In the United States, the two drugs – both GLP-1 agonists – already come with a warning about the potential for these adverse effects on the branded versions approved for weight loss, Wegovy and Saxenda. (Years earlier, both drugs, marketed as Ozempic and Victoza, were also approved for treatment of type 2 diabetes.)

Of more than 1,200 reports of adverse reactions with semaglutide, 60 cases of suicidal ideation and 7 suicide attempts have been reported since 2018, according to the Food and Drug Administration’s Adverse Event Reporting System (FAERS) public database. For liraglutide, there were 71 cases of suicidal ideation, 28 suicide attempts, and 25 completed suicides out of more than 35,000 reports of adverse reactions.

The FAERS website cautions users that the data may be duplicated or incomplete, that rates of occurrence cannot be established using the data, that reports have not been verified, and that the existence of a report cannot establish causation.

The EMA is looking into about 150 reports of possible cases of self-injury and suicidal thoughts, according to a press release from the agency.

“It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors,” it says. The medicines are widely used in the European Union, according to the press release.

The review of Ozempic, Saxenda, and Wegovy, which started on July 3, 2023, has been extended to include other GLP-1 receptor agonists, which include dulaglutide, exenatide, and lixisenatide. This review is expected to conclude in November 2023.

In a statement, Novo Nordisk did not directly dispute a potential link between the drugs and suicidal ideation.

“In the U.S., FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation,” the statement indicates. “This event had been reported in clinical trials with other weight management products.”

It adds: “Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.”
 

Important to know the denominator

“What’s important to know is the denominator,” said Holly Lofton, MD, a clinical associate professor of surgery and medicine and the director of the medical weight management program at NYU Langone, New York. “It needs a denominator with the total population on the medication so we can determine if that’s really a significant risk.”

Dr. Lofton described an isolated, anecdotal case of a patient who had no history of depression or mental health problems but developed suicidal thoughts after taking Saxenda for several months. In that case, the 25-year-old was experiencing problems in a personal relationship and with social media.

Two other weight loss specialists contacted by this news organization had not had patients who had experienced suicidal ideation with the drugs. “These are not very common in practice,” Dr. Lofton said in an interview.

The U.S. prescribing information for Saxenda, which contains liraglutide and has been approved as an adjunct to diet and exercise for chronic weight management, recommends monitoring for the emergence of depression and suicidal thoughts. In the clinical trials, 6 of the 3,384 patients who took the drug reported suicidal ideation; none of the 1,941 patients who received placebo did so, according to the FDA.

Similarly, the U.S. prescribing information for Wegovy, which contains semaglutide, recommends monitoring for the emergence of suicidal thoughts or depression, but this recommendation was based on clinical trials of other weight management products. The prescribing information for Ozempic, the brand name for semaglutide for type 2 diabetes, does not include this recommendation.
 

Is it the weight loss, rather than the meds? Seen with bariatric surgery too

Speculating what the link, if any, might be, Dr. Lofton suggested dopamine release could be playing a role. Small trials in humans as well as animal studies hint at a blunting of dopamine responses to usual triggers – including addictive substances and possibly food – that may also affect mood.

Young people (aged 18-34) who undergo bariatric surgery are at an increased risk of suicide during follow-up compared to their peers who don’t have surgery. And a study found an increase in events involving self-harm after bariatric surgery, especially among patients who already had a mental health disorder.

For a patient who derives comfort from food, not being able to eat in response to a stressful event may lead that patient to act out in more serious ways, according to Dr. Lofton. “That’s why, again, surgical follow-up is so important and their presurgical psychiatric evaluation is so important.”

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

Madeline Sterling, MD, knew something was wrong when she heard her patient’s voice on the phone. The patient was breathing too fast and sounded fatigued. Like many people with heart failure, this patient had several comorbidities: diabetes, high blood pressure, and cancer, which was in remission.

The patient had been in and out of the hospital several times and was afraid of going back, but Dr. Sterling, a primary care physician, advised her that it was the safe thing to do.

During the woman’s stay, the inpatient cardiology team called Dr. Sterling to provide status updates and ask for input. When the patient was discharged, Dr. Sterling received information on what medicines had been changed and scheduled follow-up care within 10 days. Dr. Sterling, who’d cared for the woman for many years, called her family, her home health aide, and another caregiver to discuss the plan.

“When you know these patients really well, it’s helpful,” Dr. Sterling, a professor of medicine at Weill Cornell Medicine, New York, said. Primary care clinicians have “an appreciation for how all these conditions fit together, how the medicines fit together, and how to put that patient’s priorities at the front of the equation.”

Research has shown that follow-up care within 7-10 days after discharge, especially for patients with heart failure, can prevent hospital readmissions. Patients’ health can change rapidly following discharge: They may start retaining fluid or may not know how to maintain a low-sodium diet, or they might have trouble obtaining medication. Primary care clinicians spot these early warning signs in follow-up visits.

Heart failure affects more than 6 million adults in the United States, according to the Centers for Disease Control and Prevention. The condition is a common cause of hospital readmissions within 30 days of discharge, according to research published by the American Heart Association.

Patients with heart failure are particularly challenging to care for because of comorbidities.

“They’re a very, very sick group of patients that are very difficult to manage,” said Noah Moss, MD, an advanced heart failure and transplant cardiologist at Mount Sinai Hospital, New York.

But patients do not always receive the follow-up care they need, some studies have found.
 

Right drugs at the right time

Kelly Axsom, MD, a cardiologist at the Columbia University Medical Center, New York, and director of the centralized heart failure management program at the New York–Presbyterian Hospital System, called the primary care clinician the “captain of the ship,” ensuring that medications are reconciled and providing education about what to eat after discharge.

“It’s actually pretty complicated to go from being in the hospital to being at home,” Dr. Axsom said. “There are often many medication changes, there are lots of instructions that are told to you as a patient that are hard to remember.”

A patient’s weight might fluctuate in the days following discharge because the dose of diuretics might be too low or too high and need to be adjusted, according to Ishani Ganguli, MD, MPH, an assistant professor of medicine and a general internist in the Division of General Internal Medicine and Primary Care at Harvard Medical School and Brigham and Women’s Hospital, Boston.

K. Melissa Hayes, DNP, ANP-BC, CHFN, an assistant professor in the adult gerontology primary care program at the Vanderbilt University School of Nursing, Nashville, Tenn., recalled one patient who was given a months’ worth of medications following his discharge from the hospital.

“He was given expensive medications he couldn’t afford and not any refills or how to get those medications,” Dr. Hayes said.

Sometimes patients have no way to get to the pharmacy, or their pharmacy doesn’t have the medication they need, or their insurance doesn’t cover the drugs.

“The average patient is on at least six medications for heart failure, maybe even seven, and then that’s not including all their other medications,” Dr. Hayes said. “That can be a lot for people to keep up with.”

Dr. Hayes talks to her patients with heart failure about what drugs they have been prescribed and what medications they require more of, and she deprescribes any that are duplicative.

Helping patients understand why they are taking each drug encourages them to stick to the regimen. Diuretics, for example, can lead to frequent urination. If patients are unable to take regular bathroom breaks, they may be tempted to stop using the medication – a potentially catastrophic mistake.

“Often I have patients say, ‘Nobody ever explained it to me that way,’ ” Dr. Hayes said. “Someone can have a PhD but not understand their medications.”

Clinicians also can alert patients to commonly used medications that can worsen heart failure, such as diabetes drugs and over-the-counter medications such as ibuprofen.

Patients should be prescribed a combination of four recommended medications. But several studies have found that clinicians often fail to achieve the target doses for those medications. The use of guideline-directed medications reduces mortality and hospitalization rates, according to multiple clinical trials.
 

Eyes and ears on the patient

Once home, patients must stick to the right diet, weigh themselves every day, and monitor their blood pressure. But changing behaviors can be a struggle.

“Being seen quickly within a couple of days of discharge, you can catch things,” said Dr. Hayes, who has edited a book on managing patients with heart failure in primary care.

“It’s an opportunity to see how they’re doing at home, make sure they have their medications, make sure there’s been no misunderstanding or miscommunication about what they’re supposed to be doing at home,” says Marc Itskowitz, MD, a primary care physician affiliated with Allegheny General Hospital, Pittsburgh.

Ideally, a record that readily integrates information from wearables – such as blood pressure and weight – would make it easier to spot abnormalities, Dr. Itskowtiz said. “I think we’re still in the infancy of the electronic health record,” he said.

Ensuring that follow-up visits are as accessible as possible for patients is also important. Telehealth makes it easier for patients after they return home from the hospital, Dr. Itskowitz said.
 

More infrastructure

Another challenge of providing follow-up care for patients with heart failure is completing all the tasks a clinician must do within a 20-minute visit: an examination; education on the condition and medications; counseling on diet and exercise; coordination of medical equipment, such as a blood pressure cuff for home use; and making appointments with specialists.

“In the current system, additional support for primary care is needed so we can do all this,” Dr. Sterling said.

Staff at primary care clinics should be trained to answer calls from patients when they experience changes in their weight or are worried about other potential problems. “A lot of primary care practices are bare bones,” Dr. Hayes said, meaning they might not have the staff to field those calls. Educating patients as to when they should call their physician, especially after experiencing worsening symptoms, is also important.

Dr. Hayes suggests setting aside time in the schedule each week to see patients who have been recently discharged from the hospital. In the Cardiology and Vascular Clinic at Nashville General Hospital, Tenn., where she spends half a day each week, Dr. Hayes requests 30 minutes to see patients who have recently been discharged from hospital.

Even when the process goes smoothly, some patients will return to the hospital because of the progressive nature of heart failure, according to Dr. Hayes. Improving care following their hospitalization can keep these people from rapidly declining.

“Most patients with heart failure want to be taking care of the grandchildren or be able to enjoy family dinners together,” Dr. Axsom said. “I think anything we can do to help improve their quality of life is really important.”
 

Take-home

• See heart failure patients early after their discharge from hospital, ideally within 7-10 days.
• Make sure patients have access to the right medications at the right dosages and that they know why they’re taking them.
• Educate patients about the diet they should be following.
• Have a system to monitor patients’ symptoms and let them know when they should call.

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

Madeline Sterling, MD, knew something was wrong when she heard her patient’s voice on the phone. The patient was breathing too fast and sounded fatigued. Like many people with heart failure, this patient had several comorbidities: diabetes, high blood pressure, and cancer, which was in remission.

The patient had been in and out of the hospital several times and was afraid of going back, but Dr. Sterling, a primary care physician, advised her that it was the safe thing to do.

During the woman’s stay, the inpatient cardiology team called Dr. Sterling to provide status updates and ask for input. When the patient was discharged, Dr. Sterling received information on what medicines had been changed and scheduled follow-up care within 10 days. Dr. Sterling, who’d cared for the woman for many years, called her family, her home health aide, and another caregiver to discuss the plan.

“When you know these patients really well, it’s helpful,” Dr. Sterling, a professor of medicine at Weill Cornell Medicine, New York, said. Primary care clinicians have “an appreciation for how all these conditions fit together, how the medicines fit together, and how to put that patient’s priorities at the front of the equation.”

Research has shown that follow-up care within 7-10 days after discharge, especially for patients with heart failure, can prevent hospital readmissions. Patients’ health can change rapidly following discharge: They may start retaining fluid or may not know how to maintain a low-sodium diet, or they might have trouble obtaining medication. Primary care clinicians spot these early warning signs in follow-up visits.

Heart failure affects more than 6 million adults in the United States, according to the Centers for Disease Control and Prevention. The condition is a common cause of hospital readmissions within 30 days of discharge, according to research published by the American Heart Association.

Patients with heart failure are particularly challenging to care for because of comorbidities.

“They’re a very, very sick group of patients that are very difficult to manage,” said Noah Moss, MD, an advanced heart failure and transplant cardiologist at Mount Sinai Hospital, New York.

But patients do not always receive the follow-up care they need, some studies have found.
 

Right drugs at the right time

Kelly Axsom, MD, a cardiologist at the Columbia University Medical Center, New York, and director of the centralized heart failure management program at the New York–Presbyterian Hospital System, called the primary care clinician the “captain of the ship,” ensuring that medications are reconciled and providing education about what to eat after discharge.

“It’s actually pretty complicated to go from being in the hospital to being at home,” Dr. Axsom said. “There are often many medication changes, there are lots of instructions that are told to you as a patient that are hard to remember.”

A patient’s weight might fluctuate in the days following discharge because the dose of diuretics might be too low or too high and need to be adjusted, according to Ishani Ganguli, MD, MPH, an assistant professor of medicine and a general internist in the Division of General Internal Medicine and Primary Care at Harvard Medical School and Brigham and Women’s Hospital, Boston.

K. Melissa Hayes, DNP, ANP-BC, CHFN, an assistant professor in the adult gerontology primary care program at the Vanderbilt University School of Nursing, Nashville, Tenn., recalled one patient who was given a months’ worth of medications following his discharge from the hospital.

“He was given expensive medications he couldn’t afford and not any refills or how to get those medications,” Dr. Hayes said.

Sometimes patients have no way to get to the pharmacy, or their pharmacy doesn’t have the medication they need, or their insurance doesn’t cover the drugs.

“The average patient is on at least six medications for heart failure, maybe even seven, and then that’s not including all their other medications,” Dr. Hayes said. “That can be a lot for people to keep up with.”

Dr. Hayes talks to her patients with heart failure about what drugs they have been prescribed and what medications they require more of, and she deprescribes any that are duplicative.

Helping patients understand why they are taking each drug encourages them to stick to the regimen. Diuretics, for example, can lead to frequent urination. If patients are unable to take regular bathroom breaks, they may be tempted to stop using the medication – a potentially catastrophic mistake.

“Often I have patients say, ‘Nobody ever explained it to me that way,’ ” Dr. Hayes said. “Someone can have a PhD but not understand their medications.”

Clinicians also can alert patients to commonly used medications that can worsen heart failure, such as diabetes drugs and over-the-counter medications such as ibuprofen.

Patients should be prescribed a combination of four recommended medications. But several studies have found that clinicians often fail to achieve the target doses for those medications. The use of guideline-directed medications reduces mortality and hospitalization rates, according to multiple clinical trials.
 

Eyes and ears on the patient

Once home, patients must stick to the right diet, weigh themselves every day, and monitor their blood pressure. But changing behaviors can be a struggle.

“Being seen quickly within a couple of days of discharge, you can catch things,” said Dr. Hayes, who has edited a book on managing patients with heart failure in primary care.

“It’s an opportunity to see how they’re doing at home, make sure they have their medications, make sure there’s been no misunderstanding or miscommunication about what they’re supposed to be doing at home,” says Marc Itskowitz, MD, a primary care physician affiliated with Allegheny General Hospital, Pittsburgh.

Ideally, a record that readily integrates information from wearables – such as blood pressure and weight – would make it easier to spot abnormalities, Dr. Itskowtiz said. “I think we’re still in the infancy of the electronic health record,” he said.

Ensuring that follow-up visits are as accessible as possible for patients is also important. Telehealth makes it easier for patients after they return home from the hospital, Dr. Itskowitz said.
 

More infrastructure

Another challenge of providing follow-up care for patients with heart failure is completing all the tasks a clinician must do within a 20-minute visit: an examination; education on the condition and medications; counseling on diet and exercise; coordination of medical equipment, such as a blood pressure cuff for home use; and making appointments with specialists.

“In the current system, additional support for primary care is needed so we can do all this,” Dr. Sterling said.

Staff at primary care clinics should be trained to answer calls from patients when they experience changes in their weight or are worried about other potential problems. “A lot of primary care practices are bare bones,” Dr. Hayes said, meaning they might not have the staff to field those calls. Educating patients as to when they should call their physician, especially after experiencing worsening symptoms, is also important.

Dr. Hayes suggests setting aside time in the schedule each week to see patients who have been recently discharged from the hospital. In the Cardiology and Vascular Clinic at Nashville General Hospital, Tenn., where she spends half a day each week, Dr. Hayes requests 30 minutes to see patients who have recently been discharged from hospital.

Even when the process goes smoothly, some patients will return to the hospital because of the progressive nature of heart failure, according to Dr. Hayes. Improving care following their hospitalization can keep these people from rapidly declining.

“Most patients with heart failure want to be taking care of the grandchildren or be able to enjoy family dinners together,” Dr. Axsom said. “I think anything we can do to help improve their quality of life is really important.”
 

Take-home

• See heart failure patients early after their discharge from hospital, ideally within 7-10 days.
• Make sure patients have access to the right medications at the right dosages and that they know why they’re taking them.
• Educate patients about the diet they should be following.
• Have a system to monitor patients’ symptoms and let them know when they should call.

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

Madeline Sterling, MD, knew something was wrong when she heard her patient’s voice on the phone. The patient was breathing too fast and sounded fatigued. Like many people with heart failure, this patient had several comorbidities: diabetes, high blood pressure, and cancer, which was in remission.

The patient had been in and out of the hospital several times and was afraid of going back, but Dr. Sterling, a primary care physician, advised her that it was the safe thing to do.

During the woman’s stay, the inpatient cardiology team called Dr. Sterling to provide status updates and ask for input. When the patient was discharged, Dr. Sterling received information on what medicines had been changed and scheduled follow-up care within 10 days. Dr. Sterling, who’d cared for the woman for many years, called her family, her home health aide, and another caregiver to discuss the plan.

“When you know these patients really well, it’s helpful,” Dr. Sterling, a professor of medicine at Weill Cornell Medicine, New York, said. Primary care clinicians have “an appreciation for how all these conditions fit together, how the medicines fit together, and how to put that patient’s priorities at the front of the equation.”

Research has shown that follow-up care within 7-10 days after discharge, especially for patients with heart failure, can prevent hospital readmissions. Patients’ health can change rapidly following discharge: They may start retaining fluid or may not know how to maintain a low-sodium diet, or they might have trouble obtaining medication. Primary care clinicians spot these early warning signs in follow-up visits.

Heart failure affects more than 6 million adults in the United States, according to the Centers for Disease Control and Prevention. The condition is a common cause of hospital readmissions within 30 days of discharge, according to research published by the American Heart Association.

Patients with heart failure are particularly challenging to care for because of comorbidities.

“They’re a very, very sick group of patients that are very difficult to manage,” said Noah Moss, MD, an advanced heart failure and transplant cardiologist at Mount Sinai Hospital, New York.

But patients do not always receive the follow-up care they need, some studies have found.
 

Right drugs at the right time

Kelly Axsom, MD, a cardiologist at the Columbia University Medical Center, New York, and director of the centralized heart failure management program at the New York–Presbyterian Hospital System, called the primary care clinician the “captain of the ship,” ensuring that medications are reconciled and providing education about what to eat after discharge.

“It’s actually pretty complicated to go from being in the hospital to being at home,” Dr. Axsom said. “There are often many medication changes, there are lots of instructions that are told to you as a patient that are hard to remember.”

A patient’s weight might fluctuate in the days following discharge because the dose of diuretics might be too low or too high and need to be adjusted, according to Ishani Ganguli, MD, MPH, an assistant professor of medicine and a general internist in the Division of General Internal Medicine and Primary Care at Harvard Medical School and Brigham and Women’s Hospital, Boston.

K. Melissa Hayes, DNP, ANP-BC, CHFN, an assistant professor in the adult gerontology primary care program at the Vanderbilt University School of Nursing, Nashville, Tenn., recalled one patient who was given a months’ worth of medications following his discharge from the hospital.

“He was given expensive medications he couldn’t afford and not any refills or how to get those medications,” Dr. Hayes said.

Sometimes patients have no way to get to the pharmacy, or their pharmacy doesn’t have the medication they need, or their insurance doesn’t cover the drugs.

“The average patient is on at least six medications for heart failure, maybe even seven, and then that’s not including all their other medications,” Dr. Hayes said. “That can be a lot for people to keep up with.”

Dr. Hayes talks to her patients with heart failure about what drugs they have been prescribed and what medications they require more of, and she deprescribes any that are duplicative.

Helping patients understand why they are taking each drug encourages them to stick to the regimen. Diuretics, for example, can lead to frequent urination. If patients are unable to take regular bathroom breaks, they may be tempted to stop using the medication – a potentially catastrophic mistake.

“Often I have patients say, ‘Nobody ever explained it to me that way,’ ” Dr. Hayes said. “Someone can have a PhD but not understand their medications.”

Clinicians also can alert patients to commonly used medications that can worsen heart failure, such as diabetes drugs and over-the-counter medications such as ibuprofen.

Patients should be prescribed a combination of four recommended medications. But several studies have found that clinicians often fail to achieve the target doses for those medications. The use of guideline-directed medications reduces mortality and hospitalization rates, according to multiple clinical trials.
 

Eyes and ears on the patient

Once home, patients must stick to the right diet, weigh themselves every day, and monitor their blood pressure. But changing behaviors can be a struggle.

“Being seen quickly within a couple of days of discharge, you can catch things,” said Dr. Hayes, who has edited a book on managing patients with heart failure in primary care.

“It’s an opportunity to see how they’re doing at home, make sure they have their medications, make sure there’s been no misunderstanding or miscommunication about what they’re supposed to be doing at home,” says Marc Itskowitz, MD, a primary care physician affiliated with Allegheny General Hospital, Pittsburgh.

Ideally, a record that readily integrates information from wearables – such as blood pressure and weight – would make it easier to spot abnormalities, Dr. Itskowtiz said. “I think we’re still in the infancy of the electronic health record,” he said.

Ensuring that follow-up visits are as accessible as possible for patients is also important. Telehealth makes it easier for patients after they return home from the hospital, Dr. Itskowitz said.
 

More infrastructure

Another challenge of providing follow-up care for patients with heart failure is completing all the tasks a clinician must do within a 20-minute visit: an examination; education on the condition and medications; counseling on diet and exercise; coordination of medical equipment, such as a blood pressure cuff for home use; and making appointments with specialists.

“In the current system, additional support for primary care is needed so we can do all this,” Dr. Sterling said.

Staff at primary care clinics should be trained to answer calls from patients when they experience changes in their weight or are worried about other potential problems. “A lot of primary care practices are bare bones,” Dr. Hayes said, meaning they might not have the staff to field those calls. Educating patients as to when they should call their physician, especially after experiencing worsening symptoms, is also important.

Dr. Hayes suggests setting aside time in the schedule each week to see patients who have been recently discharged from the hospital. In the Cardiology and Vascular Clinic at Nashville General Hospital, Tenn., where she spends half a day each week, Dr. Hayes requests 30 minutes to see patients who have recently been discharged from hospital.

Even when the process goes smoothly, some patients will return to the hospital because of the progressive nature of heart failure, according to Dr. Hayes. Improving care following their hospitalization can keep these people from rapidly declining.

“Most patients with heart failure want to be taking care of the grandchildren or be able to enjoy family dinners together,” Dr. Axsom said. “I think anything we can do to help improve their quality of life is really important.”
 

Take-home

• See heart failure patients early after their discharge from hospital, ideally within 7-10 days.
• Make sure patients have access to the right medications at the right dosages and that they know why they’re taking them.
• Educate patients about the diet they should be following.
• Have a system to monitor patients’ symptoms and let them know when they should call.

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