Vitamin D supplementation significantly reduced the risk of relapse or death in a subgroup of patients with digestive tract cancer who were p53-immunoreactive, a recent analysis found.

In the p53-immunoreactive subgroup, daily vitamin D supplementation reduced the risk of relapse or death by 73%. Overall, the 5-year relapse-free survival (RFS) among those receiving vitamin D was 81% vs. almost 31% in the placebo group.

Vitamin D supplementation, however, had no effect on survival outcomes in the non–p53-immunoreactive subgroup.

©Kaspri/Fotolia.com

These findings represent a “game changer” for vitamin D and cancer, Michael Holick, PhD, MD, with Boston University, said in an editorial accompanying the study, published online in JAMA Network Open. The AMATERASU trial “provides an additional variable in our understanding of whether improving vitamin D status has any benefit for reducing risk of developing cancer as well as improving relapse-free and mortality outcomes.”

A growing body of research suggests that vitamin D supplementation may reduce the risk of cancer mortality, but the evidence remains mixed and efficacy may hinge on a patient’s tumor biology, specifically the p53 protein, the authors of the current analysis explained.

A 2019 randomized controlled trial from the research team found vitamin D supplements of 2000 IU/day did not improve RFS at 5 years in patients with digestive tract cancers. However, a post hoc analysis of the AMATERASU trial published in 2020 suggested that vitamin D supplementation improved RFS in a subgroup of patients with p53-positive digestive tract cancers, as seen using immunohistochemistry (IHC) staining (79% vs. 57% in the placebo group; hazard ratio, 0.52; P = .02).

In the current post hoc analysis of the AMATERASU trial, the research team explored whether vitamin D supplementation reduced the risk of relapse or death in the subgroup of patients who were p53 immunoreactive, defined as positivity for both nuclear accumulation of the p53 protein in more than 99% of cancer cells, as seen on IHC staining, as well as anti-p53 antibodies in serum.

In the trial, patients with stage I-III luminal gastrointestinal cancer who had undergone complete tumor resection were randomly assigned to receive placebo or oral vitamin D supplements of 2,000 IU/day from their first postoperative visit through the end of the trial, up to 8 years.

The current post hoc analysis by p53-immunoreactive status included 392 patients, of whom 47% had colorectal cancer, 43% had gastric cancer, 9% had esophageal cancer, and 0.5% had small-bowel cancer.

The post hoc analysis found that, among the p53-immunoreactive subgroup of 80 patients, relapse or death occurred in 9 of 54 patients (17%) in the vitamin D group and 14 of 26 patients (54%) in the placebo group. The 5-year RFS was significantly higher in the vitamin D group than the placebo group (81% vs. 31%; HR, 0.27; P = .002).

This was not the case in the 272 patients in the non–p53-immunoreactive subgroup. In this group, vitamin D supplementation had no apparent effect on 5-year RFS, compared with placebo (22% vs. 21%; HR, 1.09; 95% confidence interval, 0.65-1.84).

The main findings of this study were that daily supplementation of 2000 IU of vitamin D reduced the risk of relapse or death, compared with placebo, in the p53-immunoreactive subgroup, and they “suggest the importance of developing cancer immunotherapy targeting mutated p53 proteins,” study investigator Mitsuyoshi Urashima, MD, PhD, MPH, with Jikei University, Tokyo, and colleagues concluded.

Support for the study was provided by the Japan-Supported Program for the Strategic Research Foundation at Private Universities and a grant from the Japan Society for the Promotion of Science of the Ministry of Education, Culture, Sports, Science, and Technology. The authors report no relevant financial relationships. Dr. Holick reported grants from Carbogen Amcis and Solius; personal fees from Biogena, Sanofi, Faes Farma, Eric Anthony Nepute, and others; nonfinancial support from Ontometrics outside the submitted work; and had a patent for Novel Use of 25 hydroxy vitamin D pending for Carbogen Amcis BV and Aamanya AG.

A version of this article appeared on Medscape.com.

Vitamin D supplementation significantly reduced the risk of relapse or death in a subgroup of patients with digestive tract cancer who were p53-immunoreactive, a recent analysis found.

In the p53-immunoreactive subgroup, daily vitamin D supplementation reduced the risk of relapse or death by 73%. Overall, the 5-year relapse-free survival (RFS) among those receiving vitamin D was 81% vs. almost 31% in the placebo group.

Vitamin D supplementation, however, had no effect on survival outcomes in the non–p53-immunoreactive subgroup.

©Kaspri/Fotolia.com

These findings represent a “game changer” for vitamin D and cancer, Michael Holick, PhD, MD, with Boston University, said in an editorial accompanying the study, published online in JAMA Network Open. The AMATERASU trial “provides an additional variable in our understanding of whether improving vitamin D status has any benefit for reducing risk of developing cancer as well as improving relapse-free and mortality outcomes.”

A growing body of research suggests that vitamin D supplementation may reduce the risk of cancer mortality, but the evidence remains mixed and efficacy may hinge on a patient’s tumor biology, specifically the p53 protein, the authors of the current analysis explained.

A 2019 randomized controlled trial from the research team found vitamin D supplements of 2000 IU/day did not improve RFS at 5 years in patients with digestive tract cancers. However, a post hoc analysis of the AMATERASU trial published in 2020 suggested that vitamin D supplementation improved RFS in a subgroup of patients with p53-positive digestive tract cancers, as seen using immunohistochemistry (IHC) staining (79% vs. 57% in the placebo group; hazard ratio, 0.52; P = .02).

In the current post hoc analysis of the AMATERASU trial, the research team explored whether vitamin D supplementation reduced the risk of relapse or death in the subgroup of patients who were p53 immunoreactive, defined as positivity for both nuclear accumulation of the p53 protein in more than 99% of cancer cells, as seen on IHC staining, as well as anti-p53 antibodies in serum.

In the trial, patients with stage I-III luminal gastrointestinal cancer who had undergone complete tumor resection were randomly assigned to receive placebo or oral vitamin D supplements of 2,000 IU/day from their first postoperative visit through the end of the trial, up to 8 years.

The current post hoc analysis by p53-immunoreactive status included 392 patients, of whom 47% had colorectal cancer, 43% had gastric cancer, 9% had esophageal cancer, and 0.5% had small-bowel cancer.

The post hoc analysis found that, among the p53-immunoreactive subgroup of 80 patients, relapse or death occurred in 9 of 54 patients (17%) in the vitamin D group and 14 of 26 patients (54%) in the placebo group. The 5-year RFS was significantly higher in the vitamin D group than the placebo group (81% vs. 31%; HR, 0.27; P = .002).

This was not the case in the 272 patients in the non–p53-immunoreactive subgroup. In this group, vitamin D supplementation had no apparent effect on 5-year RFS, compared with placebo (22% vs. 21%; HR, 1.09; 95% confidence interval, 0.65-1.84).

The main findings of this study were that daily supplementation of 2000 IU of vitamin D reduced the risk of relapse or death, compared with placebo, in the p53-immunoreactive subgroup, and they “suggest the importance of developing cancer immunotherapy targeting mutated p53 proteins,” study investigator Mitsuyoshi Urashima, MD, PhD, MPH, with Jikei University, Tokyo, and colleagues concluded.

Support for the study was provided by the Japan-Supported Program for the Strategic Research Foundation at Private Universities and a grant from the Japan Society for the Promotion of Science of the Ministry of Education, Culture, Sports, Science, and Technology. The authors report no relevant financial relationships. Dr. Holick reported grants from Carbogen Amcis and Solius; personal fees from Biogena, Sanofi, Faes Farma, Eric Anthony Nepute, and others; nonfinancial support from Ontometrics outside the submitted work; and had a patent for Novel Use of 25 hydroxy vitamin D pending for Carbogen Amcis BV and Aamanya AG.

A version of this article appeared on Medscape.com.

Vitamin D supplementation significantly reduced the risk of relapse or death in a subgroup of patients with digestive tract cancer who were p53-immunoreactive, a recent analysis found.

In the p53-immunoreactive subgroup, daily vitamin D supplementation reduced the risk of relapse or death by 73%. Overall, the 5-year relapse-free survival (RFS) among those receiving vitamin D was 81% vs. almost 31% in the placebo group.

Vitamin D supplementation, however, had no effect on survival outcomes in the non–p53-immunoreactive subgroup.

©Kaspri/Fotolia.com

These findings represent a “game changer” for vitamin D and cancer, Michael Holick, PhD, MD, with Boston University, said in an editorial accompanying the study, published online in JAMA Network Open. The AMATERASU trial “provides an additional variable in our understanding of whether improving vitamin D status has any benefit for reducing risk of developing cancer as well as improving relapse-free and mortality outcomes.”

A growing body of research suggests that vitamin D supplementation may reduce the risk of cancer mortality, but the evidence remains mixed and efficacy may hinge on a patient’s tumor biology, specifically the p53 protein, the authors of the current analysis explained.

A 2019 randomized controlled trial from the research team found vitamin D supplements of 2000 IU/day did not improve RFS at 5 years in patients with digestive tract cancers. However, a post hoc analysis of the AMATERASU trial published in 2020 suggested that vitamin D supplementation improved RFS in a subgroup of patients with p53-positive digestive tract cancers, as seen using immunohistochemistry (IHC) staining (79% vs. 57% in the placebo group; hazard ratio, 0.52; P = .02).

In the current post hoc analysis of the AMATERASU trial, the research team explored whether vitamin D supplementation reduced the risk of relapse or death in the subgroup of patients who were p53 immunoreactive, defined as positivity for both nuclear accumulation of the p53 protein in more than 99% of cancer cells, as seen on IHC staining, as well as anti-p53 antibodies in serum.

In the trial, patients with stage I-III luminal gastrointestinal cancer who had undergone complete tumor resection were randomly assigned to receive placebo or oral vitamin D supplements of 2,000 IU/day from their first postoperative visit through the end of the trial, up to 8 years.

The current post hoc analysis by p53-immunoreactive status included 392 patients, of whom 47% had colorectal cancer, 43% had gastric cancer, 9% had esophageal cancer, and 0.5% had small-bowel cancer.

The post hoc analysis found that, among the p53-immunoreactive subgroup of 80 patients, relapse or death occurred in 9 of 54 patients (17%) in the vitamin D group and 14 of 26 patients (54%) in the placebo group. The 5-year RFS was significantly higher in the vitamin D group than the placebo group (81% vs. 31%; HR, 0.27; P = .002).

This was not the case in the 272 patients in the non–p53-immunoreactive subgroup. In this group, vitamin D supplementation had no apparent effect on 5-year RFS, compared with placebo (22% vs. 21%; HR, 1.09; 95% confidence interval, 0.65-1.84).

The main findings of this study were that daily supplementation of 2000 IU of vitamin D reduced the risk of relapse or death, compared with placebo, in the p53-immunoreactive subgroup, and they “suggest the importance of developing cancer immunotherapy targeting mutated p53 proteins,” study investigator Mitsuyoshi Urashima, MD, PhD, MPH, with Jikei University, Tokyo, and colleagues concluded.

Support for the study was provided by the Japan-Supported Program for the Strategic Research Foundation at Private Universities and a grant from the Japan Society for the Promotion of Science of the Ministry of Education, Culture, Sports, Science, and Technology. The authors report no relevant financial relationships. Dr. Holick reported grants from Carbogen Amcis and Solius; personal fees from Biogena, Sanofi, Faes Farma, Eric Anthony Nepute, and others; nonfinancial support from Ontometrics outside the submitted work; and had a patent for Novel Use of 25 hydroxy vitamin D pending for Carbogen Amcis BV and Aamanya AG.

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.

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.

There is amazing news for the world of obstetrics and for all pregnant women. The Food and Drug Administration recently approved a blood test that will predict, with 96% accuracy, if a pregnant woman will develop severe preeclampsia within 2 weeks. Severe preeclampsia is a critical obstetrical condition that can have serious outcomes for a mother and baby. It can lead to eclampsia, an obstetrical emergency, which often results in death of the mother and/or baby.

Based on research published in the Journal of the American Heart Association, the incidence of new‐onset hypertensive disorders of pregnancy (gestational hypertension and preeclampsia/eclampsia) have nearly doubled in the United States from 2007 to 2019. And they continue to climb.

According to the Preeclampsia Foundation, 5%-8% of all pregnancies in the United States will result in preeclampsia. Black women are at a 60% higher risk than white women, and according to various sources, other risk groups include those who became pregnant via in vitro fertilization, mothers of multiples (twins and triplets), women with gestational diabetes, women over age 35, women with chronic hypertension, obesity, polycystic ovary syndrome, sickle cell disease, rheumatoid arthritis, lupus, migraines, antiphospholipid syndrome, previous pregnancy with preeclampsia, family history, and scleroderma.
 

Screening and treatment

Preeclampsia is a multiorgan disease of pregnancy, and can be mild, but may quickly progress to severe, which can be life-threatening for mother and baby. It was previously referred to as toxemia or the high blood pressure disease of pregnancy. It primarily involves the cardiovascular, neurologic and renal systems, and the liver. Patients typically present with elevated blood pressures, but other symptoms may include headache, swelling of hands and feet, blurry/double vision or seeing spots, nausea/vomiting, and epigastric pain. It is diagnosed with elevated blood pressures, blood work, and protein in the urine.

Early screening for preeclampsia is done in the first trimester. Presently, a combination of prenatal blood work, blood pressure monitoring, and recognition of high-risk groups is used to determine a treatment plan going forward. The American Congress of Obstetricians and Gynecologists recommends women that fall into this group for potentially developing preeclampsia take daily aspirin as a preventative measure.

In its milder form, a pregnant woman can be observed as an outpatient – monitored with antepartum testing, lab work, and patient education to report significant symptoms as listed above. Teaching patients about fetal kick counts to monitor their baby’s movements is equally important. Women with mild preeclampsia usually can safely deliver at term, being induced between 37-39 weeks’ gestation.

On the other hand, if mild preeclampsia progresses to severe preeclampsia, delivery may be preterm for the safety of mother and baby. Severe preeclampsia can lead to maternal organ damage, seizures, and even death of mother and/or baby.

About 20% of women with severe preeclampsia will develop HELLP (Hemolysis, Elevated Liver enzymes, and Low Platelets) syndrome, a life-threatening disease that often warrants immediate delivery. According to the National Library of Medicine, the mortality rate of women with HELLP syndrome is up to 24% and the perinatal death rate is up as high as 37%. These serious conditions can cause ineffective maternal clotting, liver rupture, placental abruption, and postpartum hemorrhage. It is most prevalent in the third trimester but can occur within 48 hours of delivery.

The only cure for preeclampsia in any form is delivery.

Patients with severe preeclampsia are hospitalized until delivery – sometimes a few days to a couple of weeks. Mother and baby are closely watched for further progression, including signs of organ damage in the mother and changes to the well-being of the baby. If the mother’s health is severely compromised, then the baby will be compromised as well. A preterm delivery may be necessary.
 

Impact of the new test

The National Institute of Health states that preterm babies born from preeclamptic mothers can suffer many health problems including cerebral palsy, deafness, blindness, epilepsy, and a host of other respiratory, cardiovascular, and endocrine issues. But the biggest issue is preterm birth, defined as birth before 37 weeks gestation. Being born preterm can require a long stay in the intensive care nursery.

This is where the first-of-its-kind prognostic blood test comes into play. The test’s ability to predict severe preeclampsia within 2 weeks can help save lives. The test can offer health care providers the ability to administer steroids for fetal lung maturity before delivery and be more prepared to care for what could be a very compromised newborn.

The blood test, which is recommended between 23-35 weeks gestation, involves analyzing a ratio between two proteins from the placenta, sFlt1 and PIGF. The higher the ratio, the higher the risk that severe preeclampsia will develop. Results can be available within 30 minutes, which is critical when contemplating treatment.

An example of the use of this ratio is illustrated with chronic hypertension in pregnancy, which is defined as elevated blood pressure before 20 weeks or even before conception. Since chronic hypertension can be a primary precursor to preeclampsia, patients with this condition are at higher risk. The FDA-approved blood test would be helpful in determining the plan of care; that is, delivery versus hospitalization versus monitor as an outpatient.

With a positive test result, a pregnant woman can be immediately hospitalized where she can get the care she and baby need as they await delivery. Since health care providers already know the high-risk groups, surveillance can begin early, utilizing this blood test to predict the progression to severe preeclampsia. Conversely, if the test is negative, a treatment plan can be made as an outpatient and the pregnancy continues.

Not all hospitals are equipped to care for premature babies. If delivery is not imminent, providers can use this blood test to identify those that should be transferred to a tertiary center for observation and monitoring. Mother and baby would then not be separated after birth.

We really don’t know who will develop severe preeclampsia and who won’t. This new blood test will be a critical tool as pregnant patients go through their second and third trimesters. It will be especially pivotal for these women, but important for all pregnant women in reducing maternal and fetal mortality and morbidity.

Ms. Barnett is a registered nurse in the department of obstetrics, Mills-Peninsula Medical Center, Burlingame, Calif. She has disclosed no relevant financial relationships.

There is amazing news for the world of obstetrics and for all pregnant women. The Food and Drug Administration recently approved a blood test that will predict, with 96% accuracy, if a pregnant woman will develop severe preeclampsia within 2 weeks. Severe preeclampsia is a critical obstetrical condition that can have serious outcomes for a mother and baby. It can lead to eclampsia, an obstetrical emergency, which often results in death of the mother and/or baby.

Based on research published in the Journal of the American Heart Association, the incidence of new‐onset hypertensive disorders of pregnancy (gestational hypertension and preeclampsia/eclampsia) have nearly doubled in the United States from 2007 to 2019. And they continue to climb.

According to the Preeclampsia Foundation, 5%-8% of all pregnancies in the United States will result in preeclampsia. Black women are at a 60% higher risk than white women, and according to various sources, other risk groups include those who became pregnant via in vitro fertilization, mothers of multiples (twins and triplets), women with gestational diabetes, women over age 35, women with chronic hypertension, obesity, polycystic ovary syndrome, sickle cell disease, rheumatoid arthritis, lupus, migraines, antiphospholipid syndrome, previous pregnancy with preeclampsia, family history, and scleroderma.
 

Screening and treatment

Preeclampsia is a multiorgan disease of pregnancy, and can be mild, but may quickly progress to severe, which can be life-threatening for mother and baby. It was previously referred to as toxemia or the high blood pressure disease of pregnancy. It primarily involves the cardiovascular, neurologic and renal systems, and the liver. Patients typically present with elevated blood pressures, but other symptoms may include headache, swelling of hands and feet, blurry/double vision or seeing spots, nausea/vomiting, and epigastric pain. It is diagnosed with elevated blood pressures, blood work, and protein in the urine.

Early screening for preeclampsia is done in the first trimester. Presently, a combination of prenatal blood work, blood pressure monitoring, and recognition of high-risk groups is used to determine a treatment plan going forward. The American Congress of Obstetricians and Gynecologists recommends women that fall into this group for potentially developing preeclampsia take daily aspirin as a preventative measure.

In its milder form, a pregnant woman can be observed as an outpatient – monitored with antepartum testing, lab work, and patient education to report significant symptoms as listed above. Teaching patients about fetal kick counts to monitor their baby’s movements is equally important. Women with mild preeclampsia usually can safely deliver at term, being induced between 37-39 weeks’ gestation.

On the other hand, if mild preeclampsia progresses to severe preeclampsia, delivery may be preterm for the safety of mother and baby. Severe preeclampsia can lead to maternal organ damage, seizures, and even death of mother and/or baby.

About 20% of women with severe preeclampsia will develop HELLP (Hemolysis, Elevated Liver enzymes, and Low Platelets) syndrome, a life-threatening disease that often warrants immediate delivery. According to the National Library of Medicine, the mortality rate of women with HELLP syndrome is up to 24% and the perinatal death rate is up as high as 37%. These serious conditions can cause ineffective maternal clotting, liver rupture, placental abruption, and postpartum hemorrhage. It is most prevalent in the third trimester but can occur within 48 hours of delivery.

The only cure for preeclampsia in any form is delivery.

Patients with severe preeclampsia are hospitalized until delivery – sometimes a few days to a couple of weeks. Mother and baby are closely watched for further progression, including signs of organ damage in the mother and changes to the well-being of the baby. If the mother’s health is severely compromised, then the baby will be compromised as well. A preterm delivery may be necessary.
 

Impact of the new test

The National Institute of Health states that preterm babies born from preeclamptic mothers can suffer many health problems including cerebral palsy, deafness, blindness, epilepsy, and a host of other respiratory, cardiovascular, and endocrine issues. But the biggest issue is preterm birth, defined as birth before 37 weeks gestation. Being born preterm can require a long stay in the intensive care nursery.

This is where the first-of-its-kind prognostic blood test comes into play. The test’s ability to predict severe preeclampsia within 2 weeks can help save lives. The test can offer health care providers the ability to administer steroids for fetal lung maturity before delivery and be more prepared to care for what could be a very compromised newborn.

The blood test, which is recommended between 23-35 weeks gestation, involves analyzing a ratio between two proteins from the placenta, sFlt1 and PIGF. The higher the ratio, the higher the risk that severe preeclampsia will develop. Results can be available within 30 minutes, which is critical when contemplating treatment.

An example of the use of this ratio is illustrated with chronic hypertension in pregnancy, which is defined as elevated blood pressure before 20 weeks or even before conception. Since chronic hypertension can be a primary precursor to preeclampsia, patients with this condition are at higher risk. The FDA-approved blood test would be helpful in determining the plan of care; that is, delivery versus hospitalization versus monitor as an outpatient.

With a positive test result, a pregnant woman can be immediately hospitalized where she can get the care she and baby need as they await delivery. Since health care providers already know the high-risk groups, surveillance can begin early, utilizing this blood test to predict the progression to severe preeclampsia. Conversely, if the test is negative, a treatment plan can be made as an outpatient and the pregnancy continues.

Not all hospitals are equipped to care for premature babies. If delivery is not imminent, providers can use this blood test to identify those that should be transferred to a tertiary center for observation and monitoring. Mother and baby would then not be separated after birth.

We really don’t know who will develop severe preeclampsia and who won’t. This new blood test will be a critical tool as pregnant patients go through their second and third trimesters. It will be especially pivotal for these women, but important for all pregnant women in reducing maternal and fetal mortality and morbidity.

Ms. Barnett is a registered nurse in the department of obstetrics, Mills-Peninsula Medical Center, Burlingame, Calif. She has disclosed no relevant financial relationships.

There is amazing news for the world of obstetrics and for all pregnant women. The Food and Drug Administration recently approved a blood test that will predict, with 96% accuracy, if a pregnant woman will develop severe preeclampsia within 2 weeks. Severe preeclampsia is a critical obstetrical condition that can have serious outcomes for a mother and baby. It can lead to eclampsia, an obstetrical emergency, which often results in death of the mother and/or baby.

Based on research published in the Journal of the American Heart Association, the incidence of new‐onset hypertensive disorders of pregnancy (gestational hypertension and preeclampsia/eclampsia) have nearly doubled in the United States from 2007 to 2019. And they continue to climb.

According to the Preeclampsia Foundation, 5%-8% of all pregnancies in the United States will result in preeclampsia. Black women are at a 60% higher risk than white women, and according to various sources, other risk groups include those who became pregnant via in vitro fertilization, mothers of multiples (twins and triplets), women with gestational diabetes, women over age 35, women with chronic hypertension, obesity, polycystic ovary syndrome, sickle cell disease, rheumatoid arthritis, lupus, migraines, antiphospholipid syndrome, previous pregnancy with preeclampsia, family history, and scleroderma.
 

Screening and treatment

Preeclampsia is a multiorgan disease of pregnancy, and can be mild, but may quickly progress to severe, which can be life-threatening for mother and baby. It was previously referred to as toxemia or the high blood pressure disease of pregnancy. It primarily involves the cardiovascular, neurologic and renal systems, and the liver. Patients typically present with elevated blood pressures, but other symptoms may include headache, swelling of hands and feet, blurry/double vision or seeing spots, nausea/vomiting, and epigastric pain. It is diagnosed with elevated blood pressures, blood work, and protein in the urine.

Early screening for preeclampsia is done in the first trimester. Presently, a combination of prenatal blood work, blood pressure monitoring, and recognition of high-risk groups is used to determine a treatment plan going forward. The American Congress of Obstetricians and Gynecologists recommends women that fall into this group for potentially developing preeclampsia take daily aspirin as a preventative measure.

In its milder form, a pregnant woman can be observed as an outpatient – monitored with antepartum testing, lab work, and patient education to report significant symptoms as listed above. Teaching patients about fetal kick counts to monitor their baby’s movements is equally important. Women with mild preeclampsia usually can safely deliver at term, being induced between 37-39 weeks’ gestation.

On the other hand, if mild preeclampsia progresses to severe preeclampsia, delivery may be preterm for the safety of mother and baby. Severe preeclampsia can lead to maternal organ damage, seizures, and even death of mother and/or baby.

About 20% of women with severe preeclampsia will develop HELLP (Hemolysis, Elevated Liver enzymes, and Low Platelets) syndrome, a life-threatening disease that often warrants immediate delivery. According to the National Library of Medicine, the mortality rate of women with HELLP syndrome is up to 24% and the perinatal death rate is up as high as 37%. These serious conditions can cause ineffective maternal clotting, liver rupture, placental abruption, and postpartum hemorrhage. It is most prevalent in the third trimester but can occur within 48 hours of delivery.

The only cure for preeclampsia in any form is delivery.

Patients with severe preeclampsia are hospitalized until delivery – sometimes a few days to a couple of weeks. Mother and baby are closely watched for further progression, including signs of organ damage in the mother and changes to the well-being of the baby. If the mother’s health is severely compromised, then the baby will be compromised as well. A preterm delivery may be necessary.
 

Impact of the new test

The National Institute of Health states that preterm babies born from preeclamptic mothers can suffer many health problems including cerebral palsy, deafness, blindness, epilepsy, and a host of other respiratory, cardiovascular, and endocrine issues. But the biggest issue is preterm birth, defined as birth before 37 weeks gestation. Being born preterm can require a long stay in the intensive care nursery.

This is where the first-of-its-kind prognostic blood test comes into play. The test’s ability to predict severe preeclampsia within 2 weeks can help save lives. The test can offer health care providers the ability to administer steroids for fetal lung maturity before delivery and be more prepared to care for what could be a very compromised newborn.

The blood test, which is recommended between 23-35 weeks gestation, involves analyzing a ratio between two proteins from the placenta, sFlt1 and PIGF. The higher the ratio, the higher the risk that severe preeclampsia will develop. Results can be available within 30 minutes, which is critical when contemplating treatment.

An example of the use of this ratio is illustrated with chronic hypertension in pregnancy, which is defined as elevated blood pressure before 20 weeks or even before conception. Since chronic hypertension can be a primary precursor to preeclampsia, patients with this condition are at higher risk. The FDA-approved blood test would be helpful in determining the plan of care; that is, delivery versus hospitalization versus monitor as an outpatient.

With a positive test result, a pregnant woman can be immediately hospitalized where she can get the care she and baby need as they await delivery. Since health care providers already know the high-risk groups, surveillance can begin early, utilizing this blood test to predict the progression to severe preeclampsia. Conversely, if the test is negative, a treatment plan can be made as an outpatient and the pregnancy continues.

Not all hospitals are equipped to care for premature babies. If delivery is not imminent, providers can use this blood test to identify those that should be transferred to a tertiary center for observation and monitoring. Mother and baby would then not be separated after birth.

We really don’t know who will develop severe preeclampsia and who won’t. This new blood test will be a critical tool as pregnant patients go through their second and third trimesters. It will be especially pivotal for these women, but important for all pregnant women in reducing maternal and fetal mortality and morbidity.

Ms. Barnett is a registered nurse in the department of obstetrics, Mills-Peninsula Medical Center, Burlingame, Calif. She has disclosed no relevant financial relationships.

Patients with pregestational diabetes may benefit from use of a continuous subcutaneous insulin infusion pump paired with a continuous glucose monitor. Use of the tools has been associated with a reduction in maternal and neonatal morbidity, a recent study found.

“We were seeing an unacceptable burden of both maternal and fetal disease in our diabetic population,” said Neil Hamill, MD, a maternal-fetal medicine specialist at Methodist Women’s Hospital, Omaha, Neb., and an author of the study. “We thought the success with this technology in the nonpregnant population would and should translate into the pregnant population.”

Dr. Hamill and his colleagues analyzed data from 55 pregnant patients who received care at the Women’s Hospital Perinatal Center at the Nebraska Methodist Health System between October 2019 and October 2022. Everyone in the cohort had pregestational diabetes and required insulin prior to week 20 of pregnancy. They used CGMs for more than 2 weeks. The study set blood glucose levels of less than 140 mg/dL as a healthy benchmark.

Participants who had severe preeclampsia, who had delivered preterm, who had delivered a neonate with respiratory distress syndrome, and/or who had given birth to a larger-than-expected infant spent less time in the safe zone – having a blood glucose level below 140 mg/dL – than women who did not have those risk factors.

“When blood sugar control is better, maternal and fetal outcomes are improved,” Dr. Hamill said.

Neetu Sodhi, MD, an ob.gyn. at Providence Cedars-Sinai Tarzana Medical Center, Los Angeles, expressed optimism that use of blood glucose monitors and insulin pumps can improve outcomes for pregnant patients with pregestational diabetes.

“This is just another case for why it’s so important for patients to have access to these types of devices that really, really improve their outcomes and their health, and now it’s proven in the case of pregnancy outcomes too – or at least suggested strongly with this data,” Dr. Sodhi said.

Mark Ebell, MD, a professor of epidemiology at the University of Georgia, Athens, was more skeptical, pointing out that study participants might have used other methods in addition to the technology to lower their blood sugar levels.

The findings suggest that insulin pumps are more manageable than multiple, daily self-injections. About 1 in 9 women have diabetes in the United States, and 35% of people newly diagnosed with the condition are women of reproductive age.

Dr. Hamill said that in future research, use of a stricter criterion for baseline blood sugar levels (< 140 mg/dL) would be helpful, as would exploring how much time patients need to spend below that level for optimal outcomes.

“Those questions are really absent in the literature,” Dr. Hamill said. “Most of our obstetrical literature is comparing treatment types. All those things are secondary. It’s the blood sugar that confers the risk, and if we get the blood sugar better, risk is reduced.”

Dr. Hamill added that the benefits of these technologies for patients with gestational diabetes are unclear in consideration of the limited duration of the disease and the time required to implant or install a monitor and pump, as well as associated risks and the cost of the devices.

Dr. Sodhi said clinicians who see patients during family planning visits should review morbidities and medical problems related to diabetes.

“I think this is a study that’s maybe too early,” Dr. Sodhi said. “They did ‘guesstimates’ on what target blood glucose ranges to be looking at, but I think over time, we might, with more studies like this, be building a case to try to put these types of monitors in for patients who are young for the purpose of optimizing pregnancy outcomes.”

The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with pregestational diabetes may benefit from use of a continuous subcutaneous insulin infusion pump paired with a continuous glucose monitor. Use of the tools has been associated with a reduction in maternal and neonatal morbidity, a recent study found.

“We were seeing an unacceptable burden of both maternal and fetal disease in our diabetic population,” said Neil Hamill, MD, a maternal-fetal medicine specialist at Methodist Women’s Hospital, Omaha, Neb., and an author of the study. “We thought the success with this technology in the nonpregnant population would and should translate into the pregnant population.”

Dr. Hamill and his colleagues analyzed data from 55 pregnant patients who received care at the Women’s Hospital Perinatal Center at the Nebraska Methodist Health System between October 2019 and October 2022. Everyone in the cohort had pregestational diabetes and required insulin prior to week 20 of pregnancy. They used CGMs for more than 2 weeks. The study set blood glucose levels of less than 140 mg/dL as a healthy benchmark.

Participants who had severe preeclampsia, who had delivered preterm, who had delivered a neonate with respiratory distress syndrome, and/or who had given birth to a larger-than-expected infant spent less time in the safe zone – having a blood glucose level below 140 mg/dL – than women who did not have those risk factors.

“When blood sugar control is better, maternal and fetal outcomes are improved,” Dr. Hamill said.

Neetu Sodhi, MD, an ob.gyn. at Providence Cedars-Sinai Tarzana Medical Center, Los Angeles, expressed optimism that use of blood glucose monitors and insulin pumps can improve outcomes for pregnant patients with pregestational diabetes.

“This is just another case for why it’s so important for patients to have access to these types of devices that really, really improve their outcomes and their health, and now it’s proven in the case of pregnancy outcomes too – or at least suggested strongly with this data,” Dr. Sodhi said.

Mark Ebell, MD, a professor of epidemiology at the University of Georgia, Athens, was more skeptical, pointing out that study participants might have used other methods in addition to the technology to lower their blood sugar levels.

The findings suggest that insulin pumps are more manageable than multiple, daily self-injections. About 1 in 9 women have diabetes in the United States, and 35% of people newly diagnosed with the condition are women of reproductive age.

Dr. Hamill said that in future research, use of a stricter criterion for baseline blood sugar levels (< 140 mg/dL) would be helpful, as would exploring how much time patients need to spend below that level for optimal outcomes.

“Those questions are really absent in the literature,” Dr. Hamill said. “Most of our obstetrical literature is comparing treatment types. All those things are secondary. It’s the blood sugar that confers the risk, and if we get the blood sugar better, risk is reduced.”

Dr. Hamill added that the benefits of these technologies for patients with gestational diabetes are unclear in consideration of the limited duration of the disease and the time required to implant or install a monitor and pump, as well as associated risks and the cost of the devices.

Dr. Sodhi said clinicians who see patients during family planning visits should review morbidities and medical problems related to diabetes.

“I think this is a study that’s maybe too early,” Dr. Sodhi said. “They did ‘guesstimates’ on what target blood glucose ranges to be looking at, but I think over time, we might, with more studies like this, be building a case to try to put these types of monitors in for patients who are young for the purpose of optimizing pregnancy outcomes.”

The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients with pregestational diabetes may benefit from use of a continuous subcutaneous insulin infusion pump paired with a continuous glucose monitor. Use of the tools has been associated with a reduction in maternal and neonatal morbidity, a recent study found.

“We were seeing an unacceptable burden of both maternal and fetal disease in our diabetic population,” said Neil Hamill, MD, a maternal-fetal medicine specialist at Methodist Women’s Hospital, Omaha, Neb., and an author of the study. “We thought the success with this technology in the nonpregnant population would and should translate into the pregnant population.”

Dr. Hamill and his colleagues analyzed data from 55 pregnant patients who received care at the Women’s Hospital Perinatal Center at the Nebraska Methodist Health System between October 2019 and October 2022. Everyone in the cohort had pregestational diabetes and required insulin prior to week 20 of pregnancy. They used CGMs for more than 2 weeks. The study set blood glucose levels of less than 140 mg/dL as a healthy benchmark.

Participants who had severe preeclampsia, who had delivered preterm, who had delivered a neonate with respiratory distress syndrome, and/or who had given birth to a larger-than-expected infant spent less time in the safe zone – having a blood glucose level below 140 mg/dL – than women who did not have those risk factors.

“When blood sugar control is better, maternal and fetal outcomes are improved,” Dr. Hamill said.

Neetu Sodhi, MD, an ob.gyn. at Providence Cedars-Sinai Tarzana Medical Center, Los Angeles, expressed optimism that use of blood glucose monitors and insulin pumps can improve outcomes for pregnant patients with pregestational diabetes.

“This is just another case for why it’s so important for patients to have access to these types of devices that really, really improve their outcomes and their health, and now it’s proven in the case of pregnancy outcomes too – or at least suggested strongly with this data,” Dr. Sodhi said.

Mark Ebell, MD, a professor of epidemiology at the University of Georgia, Athens, was more skeptical, pointing out that study participants might have used other methods in addition to the technology to lower their blood sugar levels.

The findings suggest that insulin pumps are more manageable than multiple, daily self-injections. About 1 in 9 women have diabetes in the United States, and 35% of people newly diagnosed with the condition are women of reproductive age.

Dr. Hamill said that in future research, use of a stricter criterion for baseline blood sugar levels (< 140 mg/dL) would be helpful, as would exploring how much time patients need to spend below that level for optimal outcomes.

“Those questions are really absent in the literature,” Dr. Hamill said. “Most of our obstetrical literature is comparing treatment types. All those things are secondary. It’s the blood sugar that confers the risk, and if we get the blood sugar better, risk is reduced.”

Dr. Hamill added that the benefits of these technologies for patients with gestational diabetes are unclear in consideration of the limited duration of the disease and the time required to implant or install a monitor and pump, as well as associated risks and the cost of the devices.

Dr. Sodhi said clinicians who see patients during family planning visits should review morbidities and medical problems related to diabetes.

“I think this is a study that’s maybe too early,” Dr. Sodhi said. “They did ‘guesstimates’ on what target blood glucose ranges to be looking at, but I think over time, we might, with more studies like this, be building a case to try to put these types of monitors in for patients who are young for the purpose of optimizing pregnancy outcomes.”

The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Changes in retinal tissues known to be associated with Parkinson’s disease (PD) may occur up to 7 years before clinical symptoms of the disease appear, a new study suggests. 

Researchers used artificial intelligence (AI) to analyze data from two population-level data sets and the world’s largest database of retinal images and associated clinical data to detect the retinal changes in patients with PD and in healthy individuals who developed the disease years later. 

Prior research had shown that PD is associated with a thinning of the ganglion cell-inner plexiform layer (GCIPL) in the retina, something that investigators confirmed in this new study. But they also identified changes in the inner nuclear layer (INL), which is a new finding. 

The study is the largest to date on retinal markers in PD and the first to show these changes in living patients.

“I think we are still several years away from converting these findings into individual level prediction for patients,” lead author, Siegfried Wagner, MD, MsC, Honorary Clinical Senior Research Fellow at Moorfields Eye Hospital and University College of London Institute of Ophthalmology in London, told this news organization. “The most important takeaway is that there are observable differences in the retina of individuals who go on to develop Parkinson’s disease.”

The findings were published online in Neurology. 
 

Another look at OCT

Researchers used data from retinal eye scans taken by optical coherence tomography (OCT), a noninvasive three-dimensional imaging technology that is widely used by opticians. 

Other studies have used OCT to detect retinal changes in multiple sclerosis and cognitive decline. 

For this research, investigators identified markers in people with PD using ophthalmic imaging data from 700 patients and 105,770 controls who participated in the retrospective AlzEye study. 

After adjustment for age, sex, ethnicity, hypertension, and diabetes, individuals with PD had significantly thinner GCIPL and reduced thickness of the INL.

To evaluate retinal changes in patients before a PD diagnosis, researchers then turned to 50,405 participants in the UK Biobank with no history of PD who received a retinal scan as part of their baseline visit. Of that group, 53 were diagnosed with PD during the study period. 

Researchers found an association between new diagnoses of PD and reduced thickness of the GCIPL (hazard ratio [HR], 0.62; P = .002) and thinner INL, especially at the inferior subfield (HR, 0.66; P = .002). That association persisted even in people whose clinical symptoms developed within 2 years of the retinal scan. 

“We wonder if the reduced INL thickness is indicating a direct dopaminergic impairment occurring within the inner retina,” Dr. Wagner said. “Dopaminergic amacrine cells only account for a small proportion of the cells in this layer but previous work in the laboratory shows observable abnormalities in Parkinson’s disease.”
 

Too early for diagnostics?

Commenting on the findings, Rebecca Gilbert, MD, PhD, chief scientific officer, American Parkinson Disease Association, noted that the changes in the retinal thickness identified in the study were too small to be useful in the clinic as a screening tool for early PD. 

“In order for that to happen, the specificity and sensitivity needs to be established,” she said. “Both specificity and sensitivity need to be high enough so that the test can be used to give clinically meaningful results – and reliably tell an individual with PD that he or she does have the disease and individual without PD that he or she doesn’t have the disease.”

Authors of an accompanying editorial agreed. Valeria Koska, MD, and Philipp Albrecht, MD, both of Heinrich Heine University Düsseldorf in Germany, noted that though the effect sizes of retinal changes were small, the study “sets new standards for the role of retinal morphology as potential biomarker in neurodegenerative disease.”

The study was funded by Fight for Sight UK, Medical Research Council, UK Research & Innovation, Basque Health Department, and the Wellcome Trust Study. Dr. Wagner reported funding from the Medical Research Council and the Rank Prize. Dr. Gilbert is employed by the American Parkinson Disease Association. Dr. Albrecht has received grant and personal fees and nonfinancial support from Allergan, Biogen, Celgene, Ipsen, Janssen Cilag, Merck, Merz Pharmaceuticals, Novartis, Roche, and Teva, outside the submitted work. Dr. Koska reported no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

Changes in retinal tissues known to be associated with Parkinson’s disease (PD) may occur up to 7 years before clinical symptoms of the disease appear, a new study suggests. 

Researchers used artificial intelligence (AI) to analyze data from two population-level data sets and the world’s largest database of retinal images and associated clinical data to detect the retinal changes in patients with PD and in healthy individuals who developed the disease years later. 

Prior research had shown that PD is associated with a thinning of the ganglion cell-inner plexiform layer (GCIPL) in the retina, something that investigators confirmed in this new study. But they also identified changes in the inner nuclear layer (INL), which is a new finding. 

The study is the largest to date on retinal markers in PD and the first to show these changes in living patients.

“I think we are still several years away from converting these findings into individual level prediction for patients,” lead author, Siegfried Wagner, MD, MsC, Honorary Clinical Senior Research Fellow at Moorfields Eye Hospital and University College of London Institute of Ophthalmology in London, told this news organization. “The most important takeaway is that there are observable differences in the retina of individuals who go on to develop Parkinson’s disease.”

The findings were published online in Neurology. 
 

Another look at OCT

Researchers used data from retinal eye scans taken by optical coherence tomography (OCT), a noninvasive three-dimensional imaging technology that is widely used by opticians. 

Other studies have used OCT to detect retinal changes in multiple sclerosis and cognitive decline. 

For this research, investigators identified markers in people with PD using ophthalmic imaging data from 700 patients and 105,770 controls who participated in the retrospective AlzEye study. 

After adjustment for age, sex, ethnicity, hypertension, and diabetes, individuals with PD had significantly thinner GCIPL and reduced thickness of the INL.

To evaluate retinal changes in patients before a PD diagnosis, researchers then turned to 50,405 participants in the UK Biobank with no history of PD who received a retinal scan as part of their baseline visit. Of that group, 53 were diagnosed with PD during the study period. 

Researchers found an association between new diagnoses of PD and reduced thickness of the GCIPL (hazard ratio [HR], 0.62; P = .002) and thinner INL, especially at the inferior subfield (HR, 0.66; P = .002). That association persisted even in people whose clinical symptoms developed within 2 years of the retinal scan. 

“We wonder if the reduced INL thickness is indicating a direct dopaminergic impairment occurring within the inner retina,” Dr. Wagner said. “Dopaminergic amacrine cells only account for a small proportion of the cells in this layer but previous work in the laboratory shows observable abnormalities in Parkinson’s disease.”
 

Too early for diagnostics?

Commenting on the findings, Rebecca Gilbert, MD, PhD, chief scientific officer, American Parkinson Disease Association, noted that the changes in the retinal thickness identified in the study were too small to be useful in the clinic as a screening tool for early PD. 

“In order for that to happen, the specificity and sensitivity needs to be established,” she said. “Both specificity and sensitivity need to be high enough so that the test can be used to give clinically meaningful results – and reliably tell an individual with PD that he or she does have the disease and individual without PD that he or she doesn’t have the disease.”

Authors of an accompanying editorial agreed. Valeria Koska, MD, and Philipp Albrecht, MD, both of Heinrich Heine University Düsseldorf in Germany, noted that though the effect sizes of retinal changes were small, the study “sets new standards for the role of retinal morphology as potential biomarker in neurodegenerative disease.”

The study was funded by Fight for Sight UK, Medical Research Council, UK Research & Innovation, Basque Health Department, and the Wellcome Trust Study. Dr. Wagner reported funding from the Medical Research Council and the Rank Prize. Dr. Gilbert is employed by the American Parkinson Disease Association. Dr. Albrecht has received grant and personal fees and nonfinancial support from Allergan, Biogen, Celgene, Ipsen, Janssen Cilag, Merck, Merz Pharmaceuticals, Novartis, Roche, and Teva, outside the submitted work. Dr. Koska reported no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

Changes in retinal tissues known to be associated with Parkinson’s disease (PD) may occur up to 7 years before clinical symptoms of the disease appear, a new study suggests. 

Researchers used artificial intelligence (AI) to analyze data from two population-level data sets and the world’s largest database of retinal images and associated clinical data to detect the retinal changes in patients with PD and in healthy individuals who developed the disease years later. 

Prior research had shown that PD is associated with a thinning of the ganglion cell-inner plexiform layer (GCIPL) in the retina, something that investigators confirmed in this new study. But they also identified changes in the inner nuclear layer (INL), which is a new finding. 

The study is the largest to date on retinal markers in PD and the first to show these changes in living patients.

“I think we are still several years away from converting these findings into individual level prediction for patients,” lead author, Siegfried Wagner, MD, MsC, Honorary Clinical Senior Research Fellow at Moorfields Eye Hospital and University College of London Institute of Ophthalmology in London, told this news organization. “The most important takeaway is that there are observable differences in the retina of individuals who go on to develop Parkinson’s disease.”

The findings were published online in Neurology. 
 

Another look at OCT

Researchers used data from retinal eye scans taken by optical coherence tomography (OCT), a noninvasive three-dimensional imaging technology that is widely used by opticians. 

Other studies have used OCT to detect retinal changes in multiple sclerosis and cognitive decline. 

For this research, investigators identified markers in people with PD using ophthalmic imaging data from 700 patients and 105,770 controls who participated in the retrospective AlzEye study. 

After adjustment for age, sex, ethnicity, hypertension, and diabetes, individuals with PD had significantly thinner GCIPL and reduced thickness of the INL.

To evaluate retinal changes in patients before a PD diagnosis, researchers then turned to 50,405 participants in the UK Biobank with no history of PD who received a retinal scan as part of their baseline visit. Of that group, 53 were diagnosed with PD during the study period. 

Researchers found an association between new diagnoses of PD and reduced thickness of the GCIPL (hazard ratio [HR], 0.62; P = .002) and thinner INL, especially at the inferior subfield (HR, 0.66; P = .002). That association persisted even in people whose clinical symptoms developed within 2 years of the retinal scan. 

“We wonder if the reduced INL thickness is indicating a direct dopaminergic impairment occurring within the inner retina,” Dr. Wagner said. “Dopaminergic amacrine cells only account for a small proportion of the cells in this layer but previous work in the laboratory shows observable abnormalities in Parkinson’s disease.”
 

Too early for diagnostics?

Commenting on the findings, Rebecca Gilbert, MD, PhD, chief scientific officer, American Parkinson Disease Association, noted that the changes in the retinal thickness identified in the study were too small to be useful in the clinic as a screening tool for early PD. 

“In order for that to happen, the specificity and sensitivity needs to be established,” she said. “Both specificity and sensitivity need to be high enough so that the test can be used to give clinically meaningful results – and reliably tell an individual with PD that he or she does have the disease and individual without PD that he or she doesn’t have the disease.”

Authors of an accompanying editorial agreed. Valeria Koska, MD, and Philipp Albrecht, MD, both of Heinrich Heine University Düsseldorf in Germany, noted that though the effect sizes of retinal changes were small, the study “sets new standards for the role of retinal morphology as potential biomarker in neurodegenerative disease.”

The study was funded by Fight for Sight UK, Medical Research Council, UK Research & Innovation, Basque Health Department, and the Wellcome Trust Study. Dr. Wagner reported funding from the Medical Research Council and the Rank Prize. Dr. Gilbert is employed by the American Parkinson Disease Association. Dr. Albrecht has received grant and personal fees and nonfinancial support from Allergan, Biogen, Celgene, Ipsen, Janssen Cilag, Merck, Merz Pharmaceuticals, Novartis, Roche, and Teva, outside the submitted work. Dr. Koska reported no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

Science supports the use of a whole food, predominantly plant-based dietary pattern for optimal health, including reduced risk for chronic disease, and best practice in treatment of leading chronic disease.

But clinicians who prescribe such eating patterns encounter a common concern from patients whose health may benefit.

“Where will I get my protein?”

We’ve all heard it, and it’s understandable. Patients know that protein is essential for their health and strength, and animal foods have developed a reputation for being the premier protein sources that humans should prioritize through diet. But widespread misconceptions about human needs for protein have inaccurately equated animal food as the best and only sources of protein, augmented by fad diets and modern food marketing. All of this leads to confusion about how much protein people should actually consume and the quality of protein found in plant foods, making many patients reluctant to fully embrace a whole food, predominately plant-based diet.

margouillatphotos/Thinkstock

To ensure that patients have all the facts when making dietary decisions, clinicians need to be prepared to respond to concerns about protein adequacy and quality with evidence-based information. A good starting point for these conversations is to assess how much protein patients are already consuming. A review of the 2015-2016 National Health and Nutrition Examination Survey found that women normally consume an average of 69 g and men an average of 97 g of protein daily.

As a general point of reference, the recommended dietary allowance for protein is about 0.8 g/kg of bodyweight (or 0.36 g/lb), which equates to about 52 g of protein per day for a 145-lb woman and 65 g for a 180-lb man. But for many patients, it may be best to get a more precise recommendation based upon age, gender and physical activity level by using a handy Department of Agriculture tool for health care professionals to calculate daily protein and other nutrient needs. Patients can also use one of countless apps to track their protein and other nutrient intake. By using the tool and a tracking app, both clinician and patients can be fully informed whether protein needs are being met.

The recommended daily allowances for protein are easily met by consuming a variety of whole plant foods, including a variety of minimally processed vegetables, fruits, whole grains, legumes, nuts, and seeds. One cup of cooked red lentils or black beans, for example, contains between 15 g and 18 g of protein. A quarter cup of almonds contains about 7 g of protein and one cup of cooked oats has 5 g.
 

What about those amino acids?

An area of contention around plant food protein is “complete versus incomplete protein,” terms used to describe whether a protein contains all nine essential amino acids that our bodies require from a single source. Animal food sources usually contain all the essential amino acids, whereas plant sources of protein may contain varying amounts of these amino acids or may even be missing some.

This leads to a misconception that someone adopting a diet of predominately plant food may have to stack or combine specific plant foods in a meal to ensure their protein intake includes an appropriate proportion of amino acids. But the process of protein breakdown turnover solves this problem. The body continuously breaks down protein and recombines it with amino acids stored in tissue for use when needed. Once absorbed by the small intestine, it doesn’t matter whether the protein or amino acids came from the same meal. As long as a person is eating a variety of plant-based protein sources, they will consume adequate amounts of all essential amino acids.

This is true even for athletes, older adults and pregnant women. It is also the position of the Academy of Nutrition and Dietetics that a whole-food, predominately plant-based eating pattern is appropriate for athletes and “all stages of the life cycle, including pregnancy, lactation, infancy, childhood, adolescence, older adulthood.”
 

The plant-based diet

For examples of healthy plant-based eating plans, The American College of Lifestyle Medicine offers a complimentary guide for a whole food, predominantly plant-based diet that demonstrates how easily the recommended dietary allowance of protein is satisfied. A breakfast of rolled oats, a lunch of bean burritos, and a dinner of mashed potatoes, with chickpeas with a couple snacks throughout the day, adds up to 71 g of protein. Other plant-based meal plans top 100 g or 90 g, with all meal plans meeting or surpassing recommended allowances.

Along with the protein, plant food delivers other beneficial nutrients and dietary components like fiber, antioxidants, anti-inflammatory properties, various vitamins and nutrients, and phytochemicals and vitamin D, without the saturated fats and sodium in meat. But U.S. adults get approximately two-thirds of their protein from animal sources, which lack fiber and have higher levels of saturated fats or sodium that can raise cholesterol and increase the risks for heart disease and stroke.

For clinicians, ACLM published a 10-part series of research white papers on the benefits of a whole food, plant-predominant dietary lifestyle and offers a catalogue of food as medicine continuing medical education and continuing education courses.

Patients hunger for knowledge about health-promoting nutrition but may have difficulty sorting myths from evidence-based facts. Each healthcare professional has an important and powerful opportunity to steer patients in a healthier direction through their diet.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development; President, American College of Lifestyle Medicine, Mountain View, Calif. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Science supports the use of a whole food, predominantly plant-based dietary pattern for optimal health, including reduced risk for chronic disease, and best practice in treatment of leading chronic disease.

But clinicians who prescribe such eating patterns encounter a common concern from patients whose health may benefit.

“Where will I get my protein?”

We’ve all heard it, and it’s understandable. Patients know that protein is essential for their health and strength, and animal foods have developed a reputation for being the premier protein sources that humans should prioritize through diet. But widespread misconceptions about human needs for protein have inaccurately equated animal food as the best and only sources of protein, augmented by fad diets and modern food marketing. All of this leads to confusion about how much protein people should actually consume and the quality of protein found in plant foods, making many patients reluctant to fully embrace a whole food, predominately plant-based diet.

margouillatphotos/Thinkstock

To ensure that patients have all the facts when making dietary decisions, clinicians need to be prepared to respond to concerns about protein adequacy and quality with evidence-based information. A good starting point for these conversations is to assess how much protein patients are already consuming. A review of the 2015-2016 National Health and Nutrition Examination Survey found that women normally consume an average of 69 g and men an average of 97 g of protein daily.

As a general point of reference, the recommended dietary allowance for protein is about 0.8 g/kg of bodyweight (or 0.36 g/lb), which equates to about 52 g of protein per day for a 145-lb woman and 65 g for a 180-lb man. But for many patients, it may be best to get a more precise recommendation based upon age, gender and physical activity level by using a handy Department of Agriculture tool for health care professionals to calculate daily protein and other nutrient needs. Patients can also use one of countless apps to track their protein and other nutrient intake. By using the tool and a tracking app, both clinician and patients can be fully informed whether protein needs are being met.

The recommended daily allowances for protein are easily met by consuming a variety of whole plant foods, including a variety of minimally processed vegetables, fruits, whole grains, legumes, nuts, and seeds. One cup of cooked red lentils or black beans, for example, contains between 15 g and 18 g of protein. A quarter cup of almonds contains about 7 g of protein and one cup of cooked oats has 5 g.
 

What about those amino acids?

An area of contention around plant food protein is “complete versus incomplete protein,” terms used to describe whether a protein contains all nine essential amino acids that our bodies require from a single source. Animal food sources usually contain all the essential amino acids, whereas plant sources of protein may contain varying amounts of these amino acids or may even be missing some.

This leads to a misconception that someone adopting a diet of predominately plant food may have to stack or combine specific plant foods in a meal to ensure their protein intake includes an appropriate proportion of amino acids. But the process of protein breakdown turnover solves this problem. The body continuously breaks down protein and recombines it with amino acids stored in tissue for use when needed. Once absorbed by the small intestine, it doesn’t matter whether the protein or amino acids came from the same meal. As long as a person is eating a variety of plant-based protein sources, they will consume adequate amounts of all essential amino acids.

This is true even for athletes, older adults and pregnant women. It is also the position of the Academy of Nutrition and Dietetics that a whole-food, predominately plant-based eating pattern is appropriate for athletes and “all stages of the life cycle, including pregnancy, lactation, infancy, childhood, adolescence, older adulthood.”
 

The plant-based diet

For examples of healthy plant-based eating plans, The American College of Lifestyle Medicine offers a complimentary guide for a whole food, predominantly plant-based diet that demonstrates how easily the recommended dietary allowance of protein is satisfied. A breakfast of rolled oats, a lunch of bean burritos, and a dinner of mashed potatoes, with chickpeas with a couple snacks throughout the day, adds up to 71 g of protein. Other plant-based meal plans top 100 g or 90 g, with all meal plans meeting or surpassing recommended allowances.

Along with the protein, plant food delivers other beneficial nutrients and dietary components like fiber, antioxidants, anti-inflammatory properties, various vitamins and nutrients, and phytochemicals and vitamin D, without the saturated fats and sodium in meat. But U.S. adults get approximately two-thirds of their protein from animal sources, which lack fiber and have higher levels of saturated fats or sodium that can raise cholesterol and increase the risks for heart disease and stroke.

For clinicians, ACLM published a 10-part series of research white papers on the benefits of a whole food, plant-predominant dietary lifestyle and offers a catalogue of food as medicine continuing medical education and continuing education courses.

Patients hunger for knowledge about health-promoting nutrition but may have difficulty sorting myths from evidence-based facts. Each healthcare professional has an important and powerful opportunity to steer patients in a healthier direction through their diet.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development; President, American College of Lifestyle Medicine, Mountain View, Calif. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Science supports the use of a whole food, predominantly plant-based dietary pattern for optimal health, including reduced risk for chronic disease, and best practice in treatment of leading chronic disease.

But clinicians who prescribe such eating patterns encounter a common concern from patients whose health may benefit.

“Where will I get my protein?”

We’ve all heard it, and it’s understandable. Patients know that protein is essential for their health and strength, and animal foods have developed a reputation for being the premier protein sources that humans should prioritize through diet. But widespread misconceptions about human needs for protein have inaccurately equated animal food as the best and only sources of protein, augmented by fad diets and modern food marketing. All of this leads to confusion about how much protein people should actually consume and the quality of protein found in plant foods, making many patients reluctant to fully embrace a whole food, predominately plant-based diet.

margouillatphotos/Thinkstock

To ensure that patients have all the facts when making dietary decisions, clinicians need to be prepared to respond to concerns about protein adequacy and quality with evidence-based information. A good starting point for these conversations is to assess how much protein patients are already consuming. A review of the 2015-2016 National Health and Nutrition Examination Survey found that women normally consume an average of 69 g and men an average of 97 g of protein daily.

As a general point of reference, the recommended dietary allowance for protein is about 0.8 g/kg of bodyweight (or 0.36 g/lb), which equates to about 52 g of protein per day for a 145-lb woman and 65 g for a 180-lb man. But for many patients, it may be best to get a more precise recommendation based upon age, gender and physical activity level by using a handy Department of Agriculture tool for health care professionals to calculate daily protein and other nutrient needs. Patients can also use one of countless apps to track their protein and other nutrient intake. By using the tool and a tracking app, both clinician and patients can be fully informed whether protein needs are being met.

The recommended daily allowances for protein are easily met by consuming a variety of whole plant foods, including a variety of minimally processed vegetables, fruits, whole grains, legumes, nuts, and seeds. One cup of cooked red lentils or black beans, for example, contains between 15 g and 18 g of protein. A quarter cup of almonds contains about 7 g of protein and one cup of cooked oats has 5 g.
 

What about those amino acids?

An area of contention around plant food protein is “complete versus incomplete protein,” terms used to describe whether a protein contains all nine essential amino acids that our bodies require from a single source. Animal food sources usually contain all the essential amino acids, whereas plant sources of protein may contain varying amounts of these amino acids or may even be missing some.

This leads to a misconception that someone adopting a diet of predominately plant food may have to stack or combine specific plant foods in a meal to ensure their protein intake includes an appropriate proportion of amino acids. But the process of protein breakdown turnover solves this problem. The body continuously breaks down protein and recombines it with amino acids stored in tissue for use when needed. Once absorbed by the small intestine, it doesn’t matter whether the protein or amino acids came from the same meal. As long as a person is eating a variety of plant-based protein sources, they will consume adequate amounts of all essential amino acids.

This is true even for athletes, older adults and pregnant women. It is also the position of the Academy of Nutrition and Dietetics that a whole-food, predominately plant-based eating pattern is appropriate for athletes and “all stages of the life cycle, including pregnancy, lactation, infancy, childhood, adolescence, older adulthood.”
 

The plant-based diet

For examples of healthy plant-based eating plans, The American College of Lifestyle Medicine offers a complimentary guide for a whole food, predominantly plant-based diet that demonstrates how easily the recommended dietary allowance of protein is satisfied. A breakfast of rolled oats, a lunch of bean burritos, and a dinner of mashed potatoes, with chickpeas with a couple snacks throughout the day, adds up to 71 g of protein. Other plant-based meal plans top 100 g or 90 g, with all meal plans meeting or surpassing recommended allowances.

Along with the protein, plant food delivers other beneficial nutrients and dietary components like fiber, antioxidants, anti-inflammatory properties, various vitamins and nutrients, and phytochemicals and vitamin D, without the saturated fats and sodium in meat. But U.S. adults get approximately two-thirds of their protein from animal sources, which lack fiber and have higher levels of saturated fats or sodium that can raise cholesterol and increase the risks for heart disease and stroke.

For clinicians, ACLM published a 10-part series of research white papers on the benefits of a whole food, plant-predominant dietary lifestyle and offers a catalogue of food as medicine continuing medical education and continuing education courses.

Patients hunger for knowledge about health-promoting nutrition but may have difficulty sorting myths from evidence-based facts. Each healthcare professional has an important and powerful opportunity to steer patients in a healthier direction through their diet.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development; President, American College of Lifestyle Medicine, Mountain View, Calif. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Although the usual age at onset of PsA is in the fourth or fifth decade of life, children may develop juvenile-onset PsA (JPsA). Less attention has been paid to this form of juvenile idiopathic arthritis (JIA), and the impact of JPsA vis-à-vis other forms of JIA is not well known. In addition, only about half of the patients with JPsA have cutaneous psoriasis. The impact of psoriasis on children with JPsA is not known. In order to evaluate differences in disease outcomes in patients with JPsA, Low and colleagues evaluated 1653 children and young people with JIA who were recruited to the Childhood Arthritis Prospective Study, of whom 111 had JPsA at diagnosis. They demonstrated that there were no significant differences in patient-reported outcomes between children with JPsA and other JIA categories. However, children with JPsA and psoriasis at JPsA diagnosis had more depressive symptoms compared with those without psoriasis. Moreover, children with JPsA vs other JIA categories had 2.35 times higher odds of having persistently poor well-being scores despite improvements in joint counts and physician global scores. Thus, children with JPsA have poorer well-being scores and a higher prevalence of depression, which requires multidisciplinary care.

Apart from immunomodulatory therapies, weight loss leads to improvement in disease activity in patients with obesity and PsA. However, the mechanisms by which weight loss improves PsA is currently not known, but is likely to be due to changes in adipokines and inflammation-related cytokines. In a recent study¹that included patients with PsA and obesity, it was demonstrated that weight loss through a Very Low Energy Diet (VLED) resulted in significant improvements in PsA disease activity. Landgren and colleagues now aimed to determine the effects of VLED on cytokines and adipokines. They obtained blood samples from patients with PsA and obesity (n = 41) and matched control individuals without rheumatic disease or psoriasis (n = 39) who were on VLED. At month 6, along with significant weight loss, serum levels of interleukin-23 and leptin decreased significantly, while those of total adiponectin and high-molecular-weight adiponectin increased significantly in patients with PsA and control individuals. The change in body mass index correlated positively with a reduction in serum interleukin-23 (r_S = 0.671, P < .001) and improvement in PsA disease activity (P = .003). This study highlights the anti-inflammatory effect of weight loss in patients with PsA. Weight loss can complement immunomodulatory therapy in PsA patients with obesity.

Additional Reference

1. Klingberg E, Bilberg A, Björkman S, et al. Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study. Arthritis Res Ther. 2019;21:17. doi: 10.1186/s13075-019-1810-5

Although the usual age at onset of PsA is in the fourth or fifth decade of life, children may develop juvenile-onset PsA (JPsA). Less attention has been paid to this form of juvenile idiopathic arthritis (JIA), and the impact of JPsA vis-à-vis other forms of JIA is not well known. In addition, only about half of the patients with JPsA have cutaneous psoriasis. The impact of psoriasis on children with JPsA is not known. In order to evaluate differences in disease outcomes in patients with JPsA, Low and colleagues evaluated 1653 children and young people with JIA who were recruited to the Childhood Arthritis Prospective Study, of whom 111 had JPsA at diagnosis. They demonstrated that there were no significant differences in patient-reported outcomes between children with JPsA and other JIA categories. However, children with JPsA and psoriasis at JPsA diagnosis had more depressive symptoms compared with those without psoriasis. Moreover, children with JPsA vs other JIA categories had 2.35 times higher odds of having persistently poor well-being scores despite improvements in joint counts and physician global scores. Thus, children with JPsA have poorer well-being scores and a higher prevalence of depression, which requires multidisciplinary care.

Apart from immunomodulatory therapies, weight loss leads to improvement in disease activity in patients with obesity and PsA. However, the mechanisms by which weight loss improves PsA is currently not known, but is likely to be due to changes in adipokines and inflammation-related cytokines. In a recent study¹that included patients with PsA and obesity, it was demonstrated that weight loss through a Very Low Energy Diet (VLED) resulted in significant improvements in PsA disease activity. Landgren and colleagues now aimed to determine the effects of VLED on cytokines and adipokines. They obtained blood samples from patients with PsA and obesity (n = 41) and matched control individuals without rheumatic disease or psoriasis (n = 39) who were on VLED. At month 6, along with significant weight loss, serum levels of interleukin-23 and leptin decreased significantly, while those of total adiponectin and high-molecular-weight adiponectin increased significantly in patients with PsA and control individuals. The change in body mass index correlated positively with a reduction in serum interleukin-23 (r_S = 0.671, P < .001) and improvement in PsA disease activity (P = .003). This study highlights the anti-inflammatory effect of weight loss in patients with PsA. Weight loss can complement immunomodulatory therapy in PsA patients with obesity.

Additional Reference

1. Klingberg E, Bilberg A, Björkman S, et al. Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study. Arthritis Res Ther. 2019;21:17. doi: 10.1186/s13075-019-1810-5

Although the usual age at onset of PsA is in the fourth or fifth decade of life, children may develop juvenile-onset PsA (JPsA). Less attention has been paid to this form of juvenile idiopathic arthritis (JIA), and the impact of JPsA vis-à-vis other forms of JIA is not well known. In addition, only about half of the patients with JPsA have cutaneous psoriasis. The impact of psoriasis on children with JPsA is not known. In order to evaluate differences in disease outcomes in patients with JPsA, Low and colleagues evaluated 1653 children and young people with JIA who were recruited to the Childhood Arthritis Prospective Study, of whom 111 had JPsA at diagnosis. They demonstrated that there were no significant differences in patient-reported outcomes between children with JPsA and other JIA categories. However, children with JPsA and psoriasis at JPsA diagnosis had more depressive symptoms compared with those without psoriasis. Moreover, children with JPsA vs other JIA categories had 2.35 times higher odds of having persistently poor well-being scores despite improvements in joint counts and physician global scores. Thus, children with JPsA have poorer well-being scores and a higher prevalence of depression, which requires multidisciplinary care.

Apart from immunomodulatory therapies, weight loss leads to improvement in disease activity in patients with obesity and PsA. However, the mechanisms by which weight loss improves PsA is currently not known, but is likely to be due to changes in adipokines and inflammation-related cytokines. In a recent study¹that included patients with PsA and obesity, it was demonstrated that weight loss through a Very Low Energy Diet (VLED) resulted in significant improvements in PsA disease activity. Landgren and colleagues now aimed to determine the effects of VLED on cytokines and adipokines. They obtained blood samples from patients with PsA and obesity (n = 41) and matched control individuals without rheumatic disease or psoriasis (n = 39) who were on VLED. At month 6, along with significant weight loss, serum levels of interleukin-23 and leptin decreased significantly, while those of total adiponectin and high-molecular-weight adiponectin increased significantly in patients with PsA and control individuals. The change in body mass index correlated positively with a reduction in serum interleukin-23 (r_S = 0.671, P < .001) and improvement in PsA disease activity (P = .003). This study highlights the anti-inflammatory effect of weight loss in patients with PsA. Weight loss can complement immunomodulatory therapy in PsA patients with obesity.

Additional Reference

1. Klingberg E, Bilberg A, Björkman S, et al. Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study. Arthritis Res Ther. 2019;21:17. doi: 10.1186/s13075-019-1810-5

AMSTERDAM – Adults with heart failure with preserved ejection fraction (HFpEF) but without diabetes showed significant improvements in their heart failure-related symptoms and physical limitations, exercise function, and weight loss when treated with a weight-reducing dose of semaglutide for 52 weeks, compared with placebo, in the randomized STEP-HFpEF trial.

The results, which also showed the treatment’s safety in these patients, “indicate that treatment with semaglutide is a valuable therapeutic approach in the management of patients with HFpEF and obesity,” Mikhail Kosiborod, MD, said at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge News

The findings establish semaglutide, a glucagonlike peptide–1 (GLP-1) receptor agonist, as a second class of medication with proven efficacy and safety for people with HFpEF, joining two agents also proven beneficial for people with HFpEF, dapagliflozin (Farxiga) and empagliflozin (Jardiance), both from the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors.

When administered at the approved dose for weight loss of 2.4 mg, injected subcutaneously weekly for 52 weeks, semaglutide (Wegovy) produced an average 7.8-point incremental improvement in patients’ scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated measure of symptoms and functional limitations, compared with controls who received placebo injections, as well as an average incremental weight loss from baseline, compared with placebo, of 10.7%. Both were significant effects, compared with placebo, and clinically meaningful benefits for the study’s two primary endpoints.

Simultaneously with Kosiborod’s report the results also appeared in a report posted online in the New England Journal of Medicine.
 

A ‘paradigm shift’ for medical weight loss in cardiology

The findings from this study with 529 randomized patients immediately propelled the weight loss formulation of semaglutide into the ranks of agents used to treat and prevent cardiovascular disease events. This evolution in the indications for semaglutide will be driven not only by the STEP-HFpEF results but also by findings from the SELECT trial, which tested the same semaglutide weight-loss dose in people with obesity, established cardiovascular disease, and had positive top-line results for prevention of major cardiovascular adverse events, according to a press release from Novo Nordisk on Aug. 8.

The STEP-HFpEF and SELECT results will trigger “a paradigm shift” for cardiologists, who will now need to consider prescribing a weight-loss medication to many of their patients, agents that until now were not part of the usual pharmacologic toolbox for cardiologists, said Dr. Kosiborod, a cardiologist and codirector of the Haverty Cardiometabolic Center of Excellence at Saint Luke’s Mid America Heart Institute in Kansas City, Mo. This shift will require education to bring the clinical cardiology community on board, he added in an interview.

Given that semaglutide administered at this dose already has a Food and Drug Administration–approved indication for weight loss in people with obesity or overweight plus at least one comorbidity, clinicians could immediately start using the treatment in people with obesity and HFpEF, said Dr. Kosiborod and other cardiologists.

Weekly semaglutide injections “could be considered a treatment option right now” for people with obesity and HFpEF, Dr. Kosiborod said during a press briefing.

Other experts agreed, especially because the STEP-HFpEF results confirmed that weight loss treatment with semaglutide was safe in this population.
 

‘A terrific win for patients’

The new findings are “a terrific win and game changer for patients with HFpEF,” commented Gregg C. Fonarow, MD, professor and cochief of cardiology at the University of California, Los Angeles, who was not involved with the study.

“The magnitude of improvement in the patient-reported health status scores are large and impressive. These data support clinical use of this agent for individuals with HFpEF with a body mass index of 30 kg/m², patients who already fall within existing indications,” Dr. Fonarow said in an interview.

“Given the improvements in clinical outcomes in the STEP-HFpEF and SELECT trials, cardiologists should be prescribing these medications to eligible patients without conditions,” he added. “The perception of [semaglutide] needs to shift and be viewed as a component of the comprehensive medical therapies provided to individuals with established cardiovascular disease or HFpEF who also have elevated body mass index to improve their clinical outcomes.”

Mitchel L. Zoler/MDedge News

Historically, cardiologists have had a concern that weight loss was potentially harmful in people with heart failure and that obesity was protective, a phenomenon known as the “obesity paradox,” but the STEP-HFpEF data help disprove that notion, commented Nancy K. Sweitzer, MD, PhD, a heart failure specialist and vice chair of clinical research in the department of medicine at Washington University in St. Louis, who also was not involved in the study.
 

No signal of an obesity paradox

“There’s been a concern in the heart failure community to use weight-loss strategies in people with heart failure because of this, but this evidence provides a lot of confidence that it’s safe to use this weight loss treatment. The results show that patients feel better and lose weight with no signal of harm,” Dr. Sweitzer said in an interview.

The “encouraging findings” for semaglutide in patients with HFpEF “potentially add a much needed extra option for these patients and provide another upstream treatment for patients with signs of this condition plus a high body mass index,” commented Yigal M. Pinto, MD, PhD, in an editorial that accompanied the published report.

“How these findings translate to hard end points remains to be established and will be important in determining the role of GLP-1 agonism,” wrote Dr. Pinto, a professor and heart failure specialist at Amsterdam University Medical Center.

But Dr. Kosiborod said that the improvement seen in the KCCQ score was itself an important benefit for patients. “Heart failure is defined clinically based on symptoms,” he noted, and results in prior studies documented that patients value improvements in symptoms and physical limitations even more than they value “hard endpoints” such as survival.

The new findings, which indicate that two different and expensive classes of medications are now standard of care for many people with HFpEF and obesity – the SGLT2 inhibitors and the GLP-1 receptor agonist semaglutide – also raise concerns over patient access and affordability, as many U.S. insurers have a history of requiring prior authorization, high copays, or coverage denials for these two medical classes.

But Dr. Sweitzer and Dr. Kosiborod both said that the insurance-coverage climate seems, in just the past couple of years or so, to have dramatically improved, although it’s still not ideal.
 

Prior authorization hoops have decreased

“We still have prior-authorization hoops to jump through, but I expect these will continue to decrease over time as evidence for clinical benefits [from weight loss] continues to accumulate,” said Dr. Sweitzer.

And “the SELECT data mean that cardiologists will need to become comfortable prescribing GLP-1 receptor agonists,” she added.

“It’s not okay for insurers to say we are not going to cover weight loss medications because it’s a cosmetic indication,” said Dr. Kosiborod. “Obesity appears to be very important in the pathogenesis and progression of heart failure, and if patients derive substantial benefit, they should have access to this treatment.”

The improvements in KCCQ score, as well as in several secondary and exploratory endpoints including a significant reduction in C-reactive protein (an indication of a potent anti-inflammatory effect), an average 20 m increase in 6-minute walk distance, a significant average drop in N-terminal pro-brain natriuretic peptide, and a drop in heart failure hospitalizations or urgent heart failure visits (although the trial was not powered to show differences in clinical events), “were the largest benefits in these outcomes we’ve seen,” compared with any other medical intervention in people with HFpEF, he noted.

“About 80% of U.S. patients with HFpEF have obesity or overweight,” Dr. Kosiborod noted. Using semaglutide on these patients “is an issue of access and insurance coverage. My hope is that these and other data will favorably change this.”

A related trial with a similar design, STEP-HFpEF DM, is still in progress and testing the same semaglutide treatment in adults with HFpEF, obesity, and type 2 diabetes, noted Dr. Kosiborod, who is also lead investigator for that study. He said those results will likely become available before the end of 2023.

The study was funded by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Kosiborod has been a consultant and adviser to and has received honoraria from Novo Nordisk. He has also been a consultant to numerous other companies, received research grants from AstraZeneca, Boehringer Ingelheim, and Pfizer, honoraria from AstraZeneca, and is a stockholder in Artera Health and Saghmos Therapeutics. Dr. Fonarow has been a consultant to Abbott, Amgen, AstraZeneca, CHF Solutions, Cytokinetics, Edwards, Janssen, Medtronic, Merck, Novartis, and Regeneron. Dr. Sweitzer reported no relevant financial relationships.

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

AMSTERDAM – Adults with heart failure with preserved ejection fraction (HFpEF) but without diabetes showed significant improvements in their heart failure-related symptoms and physical limitations, exercise function, and weight loss when treated with a weight-reducing dose of semaglutide for 52 weeks, compared with placebo, in the randomized STEP-HFpEF trial.

The results, which also showed the treatment’s safety in these patients, “indicate that treatment with semaglutide is a valuable therapeutic approach in the management of patients with HFpEF and obesity,” Mikhail Kosiborod, MD, said at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge News

The findings establish semaglutide, a glucagonlike peptide–1 (GLP-1) receptor agonist, as a second class of medication with proven efficacy and safety for people with HFpEF, joining two agents also proven beneficial for people with HFpEF, dapagliflozin (Farxiga) and empagliflozin (Jardiance), both from the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors.

When administered at the approved dose for weight loss of 2.4 mg, injected subcutaneously weekly for 52 weeks, semaglutide (Wegovy) produced an average 7.8-point incremental improvement in patients’ scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated measure of symptoms and functional limitations, compared with controls who received placebo injections, as well as an average incremental weight loss from baseline, compared with placebo, of 10.7%. Both were significant effects, compared with placebo, and clinically meaningful benefits for the study’s two primary endpoints.

Simultaneously with Kosiborod’s report the results also appeared in a report posted online in the New England Journal of Medicine.
 

A ‘paradigm shift’ for medical weight loss in cardiology

The findings from this study with 529 randomized patients immediately propelled the weight loss formulation of semaglutide into the ranks of agents used to treat and prevent cardiovascular disease events. This evolution in the indications for semaglutide will be driven not only by the STEP-HFpEF results but also by findings from the SELECT trial, which tested the same semaglutide weight-loss dose in people with obesity, established cardiovascular disease, and had positive top-line results for prevention of major cardiovascular adverse events, according to a press release from Novo Nordisk on Aug. 8.

The STEP-HFpEF and SELECT results will trigger “a paradigm shift” for cardiologists, who will now need to consider prescribing a weight-loss medication to many of their patients, agents that until now were not part of the usual pharmacologic toolbox for cardiologists, said Dr. Kosiborod, a cardiologist and codirector of the Haverty Cardiometabolic Center of Excellence at Saint Luke’s Mid America Heart Institute in Kansas City, Mo. This shift will require education to bring the clinical cardiology community on board, he added in an interview.

Given that semaglutide administered at this dose already has a Food and Drug Administration–approved indication for weight loss in people with obesity or overweight plus at least one comorbidity, clinicians could immediately start using the treatment in people with obesity and HFpEF, said Dr. Kosiborod and other cardiologists.

Weekly semaglutide injections “could be considered a treatment option right now” for people with obesity and HFpEF, Dr. Kosiborod said during a press briefing.

Other experts agreed, especially because the STEP-HFpEF results confirmed that weight loss treatment with semaglutide was safe in this population.
 

‘A terrific win for patients’

The new findings are “a terrific win and game changer for patients with HFpEF,” commented Gregg C. Fonarow, MD, professor and cochief of cardiology at the University of California, Los Angeles, who was not involved with the study.

“The magnitude of improvement in the patient-reported health status scores are large and impressive. These data support clinical use of this agent for individuals with HFpEF with a body mass index of 30 kg/m², patients who already fall within existing indications,” Dr. Fonarow said in an interview.

“Given the improvements in clinical outcomes in the STEP-HFpEF and SELECT trials, cardiologists should be prescribing these medications to eligible patients without conditions,” he added. “The perception of [semaglutide] needs to shift and be viewed as a component of the comprehensive medical therapies provided to individuals with established cardiovascular disease or HFpEF who also have elevated body mass index to improve their clinical outcomes.”

Mitchel L. Zoler/MDedge News

Historically, cardiologists have had a concern that weight loss was potentially harmful in people with heart failure and that obesity was protective, a phenomenon known as the “obesity paradox,” but the STEP-HFpEF data help disprove that notion, commented Nancy K. Sweitzer, MD, PhD, a heart failure specialist and vice chair of clinical research in the department of medicine at Washington University in St. Louis, who also was not involved in the study.
 

No signal of an obesity paradox

“There’s been a concern in the heart failure community to use weight-loss strategies in people with heart failure because of this, but this evidence provides a lot of confidence that it’s safe to use this weight loss treatment. The results show that patients feel better and lose weight with no signal of harm,” Dr. Sweitzer said in an interview.

The “encouraging findings” for semaglutide in patients with HFpEF “potentially add a much needed extra option for these patients and provide another upstream treatment for patients with signs of this condition plus a high body mass index,” commented Yigal M. Pinto, MD, PhD, in an editorial that accompanied the published report.

“How these findings translate to hard end points remains to be established and will be important in determining the role of GLP-1 agonism,” wrote Dr. Pinto, a professor and heart failure specialist at Amsterdam University Medical Center.

But Dr. Kosiborod said that the improvement seen in the KCCQ score was itself an important benefit for patients. “Heart failure is defined clinically based on symptoms,” he noted, and results in prior studies documented that patients value improvements in symptoms and physical limitations even more than they value “hard endpoints” such as survival.

The new findings, which indicate that two different and expensive classes of medications are now standard of care for many people with HFpEF and obesity – the SGLT2 inhibitors and the GLP-1 receptor agonist semaglutide – also raise concerns over patient access and affordability, as many U.S. insurers have a history of requiring prior authorization, high copays, or coverage denials for these two medical classes.

But Dr. Sweitzer and Dr. Kosiborod both said that the insurance-coverage climate seems, in just the past couple of years or so, to have dramatically improved, although it’s still not ideal.
 

Prior authorization hoops have decreased

“We still have prior-authorization hoops to jump through, but I expect these will continue to decrease over time as evidence for clinical benefits [from weight loss] continues to accumulate,” said Dr. Sweitzer.

And “the SELECT data mean that cardiologists will need to become comfortable prescribing GLP-1 receptor agonists,” she added.

“It’s not okay for insurers to say we are not going to cover weight loss medications because it’s a cosmetic indication,” said Dr. Kosiborod. “Obesity appears to be very important in the pathogenesis and progression of heart failure, and if patients derive substantial benefit, they should have access to this treatment.”

The improvements in KCCQ score, as well as in several secondary and exploratory endpoints including a significant reduction in C-reactive protein (an indication of a potent anti-inflammatory effect), an average 20 m increase in 6-minute walk distance, a significant average drop in N-terminal pro-brain natriuretic peptide, and a drop in heart failure hospitalizations or urgent heart failure visits (although the trial was not powered to show differences in clinical events), “were the largest benefits in these outcomes we’ve seen,” compared with any other medical intervention in people with HFpEF, he noted.

“About 80% of U.S. patients with HFpEF have obesity or overweight,” Dr. Kosiborod noted. Using semaglutide on these patients “is an issue of access and insurance coverage. My hope is that these and other data will favorably change this.”

A related trial with a similar design, STEP-HFpEF DM, is still in progress and testing the same semaglutide treatment in adults with HFpEF, obesity, and type 2 diabetes, noted Dr. Kosiborod, who is also lead investigator for that study. He said those results will likely become available before the end of 2023.

The study was funded by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Kosiborod has been a consultant and adviser to and has received honoraria from Novo Nordisk. He has also been a consultant to numerous other companies, received research grants from AstraZeneca, Boehringer Ingelheim, and Pfizer, honoraria from AstraZeneca, and is a stockholder in Artera Health and Saghmos Therapeutics. Dr. Fonarow has been a consultant to Abbott, Amgen, AstraZeneca, CHF Solutions, Cytokinetics, Edwards, Janssen, Medtronic, Merck, Novartis, and Regeneron. Dr. Sweitzer reported no relevant financial relationships.

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

AMSTERDAM – Adults with heart failure with preserved ejection fraction (HFpEF) but without diabetes showed significant improvements in their heart failure-related symptoms and physical limitations, exercise function, and weight loss when treated with a weight-reducing dose of semaglutide for 52 weeks, compared with placebo, in the randomized STEP-HFpEF trial.

The results, which also showed the treatment’s safety in these patients, “indicate that treatment with semaglutide is a valuable therapeutic approach in the management of patients with HFpEF and obesity,” Mikhail Kosiborod, MD, said at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge News

The findings establish semaglutide, a glucagonlike peptide–1 (GLP-1) receptor agonist, as a second class of medication with proven efficacy and safety for people with HFpEF, joining two agents also proven beneficial for people with HFpEF, dapagliflozin (Farxiga) and empagliflozin (Jardiance), both from the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors.

When administered at the approved dose for weight loss of 2.4 mg, injected subcutaneously weekly for 52 weeks, semaglutide (Wegovy) produced an average 7.8-point incremental improvement in patients’ scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated measure of symptoms and functional limitations, compared with controls who received placebo injections, as well as an average incremental weight loss from baseline, compared with placebo, of 10.7%. Both were significant effects, compared with placebo, and clinically meaningful benefits for the study’s two primary endpoints.

Simultaneously with Kosiborod’s report the results also appeared in a report posted online in the New England Journal of Medicine.
 

A ‘paradigm shift’ for medical weight loss in cardiology

The findings from this study with 529 randomized patients immediately propelled the weight loss formulation of semaglutide into the ranks of agents used to treat and prevent cardiovascular disease events. This evolution in the indications for semaglutide will be driven not only by the STEP-HFpEF results but also by findings from the SELECT trial, which tested the same semaglutide weight-loss dose in people with obesity, established cardiovascular disease, and had positive top-line results for prevention of major cardiovascular adverse events, according to a press release from Novo Nordisk on Aug. 8.

The STEP-HFpEF and SELECT results will trigger “a paradigm shift” for cardiologists, who will now need to consider prescribing a weight-loss medication to many of their patients, agents that until now were not part of the usual pharmacologic toolbox for cardiologists, said Dr. Kosiborod, a cardiologist and codirector of the Haverty Cardiometabolic Center of Excellence at Saint Luke’s Mid America Heart Institute in Kansas City, Mo. This shift will require education to bring the clinical cardiology community on board, he added in an interview.

Given that semaglutide administered at this dose already has a Food and Drug Administration–approved indication for weight loss in people with obesity or overweight plus at least one comorbidity, clinicians could immediately start using the treatment in people with obesity and HFpEF, said Dr. Kosiborod and other cardiologists.

Weekly semaglutide injections “could be considered a treatment option right now” for people with obesity and HFpEF, Dr. Kosiborod said during a press briefing.

Other experts agreed, especially because the STEP-HFpEF results confirmed that weight loss treatment with semaglutide was safe in this population.
 

‘A terrific win for patients’

The new findings are “a terrific win and game changer for patients with HFpEF,” commented Gregg C. Fonarow, MD, professor and cochief of cardiology at the University of California, Los Angeles, who was not involved with the study.

“The magnitude of improvement in the patient-reported health status scores are large and impressive. These data support clinical use of this agent for individuals with HFpEF with a body mass index of 30 kg/m², patients who already fall within existing indications,” Dr. Fonarow said in an interview.

“Given the improvements in clinical outcomes in the STEP-HFpEF and SELECT trials, cardiologists should be prescribing these medications to eligible patients without conditions,” he added. “The perception of [semaglutide] needs to shift and be viewed as a component of the comprehensive medical therapies provided to individuals with established cardiovascular disease or HFpEF who also have elevated body mass index to improve their clinical outcomes.”

Mitchel L. Zoler/MDedge News

Historically, cardiologists have had a concern that weight loss was potentially harmful in people with heart failure and that obesity was protective, a phenomenon known as the “obesity paradox,” but the STEP-HFpEF data help disprove that notion, commented Nancy K. Sweitzer, MD, PhD, a heart failure specialist and vice chair of clinical research in the department of medicine at Washington University in St. Louis, who also was not involved in the study.
 

No signal of an obesity paradox

“There’s been a concern in the heart failure community to use weight-loss strategies in people with heart failure because of this, but this evidence provides a lot of confidence that it’s safe to use this weight loss treatment. The results show that patients feel better and lose weight with no signal of harm,” Dr. Sweitzer said in an interview.

The “encouraging findings” for semaglutide in patients with HFpEF “potentially add a much needed extra option for these patients and provide another upstream treatment for patients with signs of this condition plus a high body mass index,” commented Yigal M. Pinto, MD, PhD, in an editorial that accompanied the published report.

“How these findings translate to hard end points remains to be established and will be important in determining the role of GLP-1 agonism,” wrote Dr. Pinto, a professor and heart failure specialist at Amsterdam University Medical Center.

But Dr. Kosiborod said that the improvement seen in the KCCQ score was itself an important benefit for patients. “Heart failure is defined clinically based on symptoms,” he noted, and results in prior studies documented that patients value improvements in symptoms and physical limitations even more than they value “hard endpoints” such as survival.

The new findings, which indicate that two different and expensive classes of medications are now standard of care for many people with HFpEF and obesity – the SGLT2 inhibitors and the GLP-1 receptor agonist semaglutide – also raise concerns over patient access and affordability, as many U.S. insurers have a history of requiring prior authorization, high copays, or coverage denials for these two medical classes.

But Dr. Sweitzer and Dr. Kosiborod both said that the insurance-coverage climate seems, in just the past couple of years or so, to have dramatically improved, although it’s still not ideal.
 

Prior authorization hoops have decreased

“We still have prior-authorization hoops to jump through, but I expect these will continue to decrease over time as evidence for clinical benefits [from weight loss] continues to accumulate,” said Dr. Sweitzer.

And “the SELECT data mean that cardiologists will need to become comfortable prescribing GLP-1 receptor agonists,” she added.

“It’s not okay for insurers to say we are not going to cover weight loss medications because it’s a cosmetic indication,” said Dr. Kosiborod. “Obesity appears to be very important in the pathogenesis and progression of heart failure, and if patients derive substantial benefit, they should have access to this treatment.”

The improvements in KCCQ score, as well as in several secondary and exploratory endpoints including a significant reduction in C-reactive protein (an indication of a potent anti-inflammatory effect), an average 20 m increase in 6-minute walk distance, a significant average drop in N-terminal pro-brain natriuretic peptide, and a drop in heart failure hospitalizations or urgent heart failure visits (although the trial was not powered to show differences in clinical events), “were the largest benefits in these outcomes we’ve seen,” compared with any other medical intervention in people with HFpEF, he noted.

“About 80% of U.S. patients with HFpEF have obesity or overweight,” Dr. Kosiborod noted. Using semaglutide on these patients “is an issue of access and insurance coverage. My hope is that these and other data will favorably change this.”

A related trial with a similar design, STEP-HFpEF DM, is still in progress and testing the same semaglutide treatment in adults with HFpEF, obesity, and type 2 diabetes, noted Dr. Kosiborod, who is also lead investigator for that study. He said those results will likely become available before the end of 2023.

The study was funded by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Kosiborod has been a consultant and adviser to and has received honoraria from Novo Nordisk. He has also been a consultant to numerous other companies, received research grants from AstraZeneca, Boehringer Ingelheim, and Pfizer, honoraria from AstraZeneca, and is a stockholder in Artera Health and Saghmos Therapeutics. Dr. Fonarow has been a consultant to Abbott, Amgen, AstraZeneca, CHF Solutions, Cytokinetics, Edwards, Janssen, Medtronic, Merck, Novartis, and Regeneron. Dr. Sweitzer reported no relevant financial relationships.

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

A stylish 40-something-year-old walks into my office looking mildly sheepish. She is a well-known actress who was recently panned by the paparazzi for having “too much cellulite” after they illegally photographed her playing with her child on a private beach.

Without a doubt, she will request semaglutide (Ozempic) before long, but first we will need to wade through the morass of social condemnation out there about Ozempic to assure her that she is being neither immoral nor reckless for considering it.

After nearly 20 years of practicing medicine with a focus on weight loss and preventive care, here is how I see the situation:

Ozempic is nothing new, people! Endocrinologists have been using this class of medication since Byetta hit the market in 2005. We have had 18 years to make informed risk-benefit analyses.

People are obsessed with the risk for pancreatitis. Any type of weight loss can cause gallstones, and this is what can trigger pancreatitis. Unless you’re the type of person who worries that your balanced Weight Watchers diet is going to cause pancreatitis, you should probably remove this risk from your calculations.

Glucagonlike peptide–1 (GLP-1) receptor agonists are naturally occurring gut hormones that reduce inflammatory cascades and clotting risk. We are not giving a dangerous treatment (e.g., fen-phen) that increases cardiovascular risk – quite the contrary, in fact.

Just because influencers are promoting a product doesn’t mean the product is inherently worthless. One of my patients accused me of prescribing a medication that is the “laughingstock of America.” Try telling that to the scores of cardiologists who send patients to my colleagues and me to start Ozempic to help lower their patients’ risk for stroke and heart attack. Or tell this to my patient who survived an episode of rapid atrial fibrillation and was told by his cardiologist that he definitely would have died if he had not lost 30 pounds from Ozempic in the preceding year.

Sometimes it seems like society has become more judgmental about Ozempic than about plastic surgery for weight loss. If we have to choose between liposuction (which doesn’t reduce visceral fat – the dangerous type of fat) or Ozempic, the latter clearly wins because of its real health benefits.

How does it make any sense to say that this medication should be reserved for patients who already have obesity and type 2 diabetes? Why should we penalize patients who have not yet reached those thresholds by denying access to preventive care? Don’t we constantly hear about how our health care system would be much more efficient if we focused on preventive care and not just treatment?

Some people claim that we have to limit access to this medication because of drug shortages. Thankfully, the United States responds to supply and demand economics and will quickly adjust. 

I’ve had more patients than I can possibly number with severe binge eating disorders (resistant to years of therapy and medication) who finally developed healthy relationships with food while taking these types of medications. Mounjaro, I’m talking about you…

I always hear the argument that it is immoral to give these medications to patients with a history of restrictive eating patterns. Although every patient needs to be carefully evaluated, often these medications remove food as both the enemy and primary focus of every waking thought. They allow patients to refocus on other aspects of their lives – such as family, friends, hobbies, work – and regain a sense of purpose. If anyone wants to run a trial on this little hypothesis of mine, please reach out to me. 

Okay, I agree you might get a little constipated (most often described by patients as the “rabbit pellet phenomenon”), but it’s a small price to pay, no? I’ll throw in a few prunes with the prescription.

Suffice it to say, I did give my 40-something-year-old patient the medication she desired, and she has a new lease on life (as well as better blood pressure and cholesterol).

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

A stylish 40-something-year-old walks into my office looking mildly sheepish. She is a well-known actress who was recently panned by the paparazzi for having “too much cellulite” after they illegally photographed her playing with her child on a private beach.

Without a doubt, she will request semaglutide (Ozempic) before long, but first we will need to wade through the morass of social condemnation out there about Ozempic to assure her that she is being neither immoral nor reckless for considering it.

After nearly 20 years of practicing medicine with a focus on weight loss and preventive care, here is how I see the situation:

Ozempic is nothing new, people! Endocrinologists have been using this class of medication since Byetta hit the market in 2005. We have had 18 years to make informed risk-benefit analyses.

People are obsessed with the risk for pancreatitis. Any type of weight loss can cause gallstones, and this is what can trigger pancreatitis. Unless you’re the type of person who worries that your balanced Weight Watchers diet is going to cause pancreatitis, you should probably remove this risk from your calculations.

Glucagonlike peptide–1 (GLP-1) receptor agonists are naturally occurring gut hormones that reduce inflammatory cascades and clotting risk. We are not giving a dangerous treatment (e.g., fen-phen) that increases cardiovascular risk – quite the contrary, in fact.

Just because influencers are promoting a product doesn’t mean the product is inherently worthless. One of my patients accused me of prescribing a medication that is the “laughingstock of America.” Try telling that to the scores of cardiologists who send patients to my colleagues and me to start Ozempic to help lower their patients’ risk for stroke and heart attack. Or tell this to my patient who survived an episode of rapid atrial fibrillation and was told by his cardiologist that he definitely would have died if he had not lost 30 pounds from Ozempic in the preceding year.

Sometimes it seems like society has become more judgmental about Ozempic than about plastic surgery for weight loss. If we have to choose between liposuction (which doesn’t reduce visceral fat – the dangerous type of fat) or Ozempic, the latter clearly wins because of its real health benefits.

How does it make any sense to say that this medication should be reserved for patients who already have obesity and type 2 diabetes? Why should we penalize patients who have not yet reached those thresholds by denying access to preventive care? Don’t we constantly hear about how our health care system would be much more efficient if we focused on preventive care and not just treatment?

Some people claim that we have to limit access to this medication because of drug shortages. Thankfully, the United States responds to supply and demand economics and will quickly adjust. 

I’ve had more patients than I can possibly number with severe binge eating disorders (resistant to years of therapy and medication) who finally developed healthy relationships with food while taking these types of medications. Mounjaro, I’m talking about you…

I always hear the argument that it is immoral to give these medications to patients with a history of restrictive eating patterns. Although every patient needs to be carefully evaluated, often these medications remove food as both the enemy and primary focus of every waking thought. They allow patients to refocus on other aspects of their lives – such as family, friends, hobbies, work – and regain a sense of purpose. If anyone wants to run a trial on this little hypothesis of mine, please reach out to me. 

Okay, I agree you might get a little constipated (most often described by patients as the “rabbit pellet phenomenon”), but it’s a small price to pay, no? I’ll throw in a few prunes with the prescription.

Suffice it to say, I did give my 40-something-year-old patient the medication she desired, and she has a new lease on life (as well as better blood pressure and cholesterol).

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

A stylish 40-something-year-old walks into my office looking mildly sheepish. She is a well-known actress who was recently panned by the paparazzi for having “too much cellulite” after they illegally photographed her playing with her child on a private beach.

Without a doubt, she will request semaglutide (Ozempic) before long, but first we will need to wade through the morass of social condemnation out there about Ozempic to assure her that she is being neither immoral nor reckless for considering it.

After nearly 20 years of practicing medicine with a focus on weight loss and preventive care, here is how I see the situation:

Ozempic is nothing new, people! Endocrinologists have been using this class of medication since Byetta hit the market in 2005. We have had 18 years to make informed risk-benefit analyses.

People are obsessed with the risk for pancreatitis. Any type of weight loss can cause gallstones, and this is what can trigger pancreatitis. Unless you’re the type of person who worries that your balanced Weight Watchers diet is going to cause pancreatitis, you should probably remove this risk from your calculations.

Glucagonlike peptide–1 (GLP-1) receptor agonists are naturally occurring gut hormones that reduce inflammatory cascades and clotting risk. We are not giving a dangerous treatment (e.g., fen-phen) that increases cardiovascular risk – quite the contrary, in fact.

Just because influencers are promoting a product doesn’t mean the product is inherently worthless. One of my patients accused me of prescribing a medication that is the “laughingstock of America.” Try telling that to the scores of cardiologists who send patients to my colleagues and me to start Ozempic to help lower their patients’ risk for stroke and heart attack. Or tell this to my patient who survived an episode of rapid atrial fibrillation and was told by his cardiologist that he definitely would have died if he had not lost 30 pounds from Ozempic in the preceding year.

Sometimes it seems like society has become more judgmental about Ozempic than about plastic surgery for weight loss. If we have to choose between liposuction (which doesn’t reduce visceral fat – the dangerous type of fat) or Ozempic, the latter clearly wins because of its real health benefits.

How does it make any sense to say that this medication should be reserved for patients who already have obesity and type 2 diabetes? Why should we penalize patients who have not yet reached those thresholds by denying access to preventive care? Don’t we constantly hear about how our health care system would be much more efficient if we focused on preventive care and not just treatment?

Some people claim that we have to limit access to this medication because of drug shortages. Thankfully, the United States responds to supply and demand economics and will quickly adjust. 

I’ve had more patients than I can possibly number with severe binge eating disorders (resistant to years of therapy and medication) who finally developed healthy relationships with food while taking these types of medications. Mounjaro, I’m talking about you…

I always hear the argument that it is immoral to give these medications to patients with a history of restrictive eating patterns. Although every patient needs to be carefully evaluated, often these medications remove food as both the enemy and primary focus of every waking thought. They allow patients to refocus on other aspects of their lives – such as family, friends, hobbies, work – and regain a sense of purpose. If anyone wants to run a trial on this little hypothesis of mine, please reach out to me. 

Okay, I agree you might get a little constipated (most often described by patients as the “rabbit pellet phenomenon”), but it’s a small price to pay, no? I’ll throw in a few prunes with the prescription.

Suffice it to say, I did give my 40-something-year-old patient the medication she desired, and she has a new lease on life (as well as better blood pressure and cholesterol).

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

The Food and Drug Administration has approved natalizumab-sztn injection (Tyruko, Sandoz), the first biosimilar to Biogen’s Tysabri (natalizumab), to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting MS, and active secondary progressive disease.

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis. [This] approval could have a meaningful impact for patients managing their disease,” Paul R. Lee, MD, PhD, director of the division of neurology II, FDA Center for Drug Evaluation and Research, said in a statement.

Olivier Le Moal/Getty Images

The natalizumab biosimilar is given using the same dosing and administration schedule. Like the reference product, it is indicated for adults with moderately to severely active Crohn’s disease unresponsive to other medications.

The approval of the natalizumab biosimilar is based on results of the phase 3 Antelope trial, which showed no clinically meaningful differences between it and the reference product.

The trial included 264 adults (mean age, 36 years; 61% women) with relapsing remitting MS from 48 centers in seven Eastern European countries.

All were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of the natalizumab biosimilar or the reference product for a total of 12 infusions.

At 24 and 48 weeks, there were no between-group differences in annualized relapse rates or Expanded Disability Status Scale scores, which were similar between treatment groups at baseline. There were also no significant differences in safety, tolerability, or immunogenicity.

The prescribing information for both natalizumab products includes a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability.

Risk factors for the development of PML include the presence of antibodies to the JC virus, longer duration of therapy, and prior use of immunosuppressants.

“These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab products, and health care providers should monitor patients and withhold treatment immediately at the first sign or symptom suggestive of PML,” the FDA advises.

Because of the risks of PML, natalizumab products are available only through a restricted drug distribution program under a risk evaluation and mitigation strategy.

In a statement, Sandoz said it’s committed to having the product available in the United States “as soon as possible.”

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved natalizumab-sztn injection (Tyruko, Sandoz), the first biosimilar to Biogen’s Tysabri (natalizumab), to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting MS, and active secondary progressive disease.

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis. [This] approval could have a meaningful impact for patients managing their disease,” Paul R. Lee, MD, PhD, director of the division of neurology II, FDA Center for Drug Evaluation and Research, said in a statement.

Olivier Le Moal/Getty Images

The natalizumab biosimilar is given using the same dosing and administration schedule. Like the reference product, it is indicated for adults with moderately to severely active Crohn’s disease unresponsive to other medications.

The approval of the natalizumab biosimilar is based on results of the phase 3 Antelope trial, which showed no clinically meaningful differences between it and the reference product.

The trial included 264 adults (mean age, 36 years; 61% women) with relapsing remitting MS from 48 centers in seven Eastern European countries.

All were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of the natalizumab biosimilar or the reference product for a total of 12 infusions.

At 24 and 48 weeks, there were no between-group differences in annualized relapse rates or Expanded Disability Status Scale scores, which were similar between treatment groups at baseline. There were also no significant differences in safety, tolerability, or immunogenicity.

The prescribing information for both natalizumab products includes a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability.

Risk factors for the development of PML include the presence of antibodies to the JC virus, longer duration of therapy, and prior use of immunosuppressants.

“These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab products, and health care providers should monitor patients and withhold treatment immediately at the first sign or symptom suggestive of PML,” the FDA advises.

Because of the risks of PML, natalizumab products are available only through a restricted drug distribution program under a risk evaluation and mitigation strategy.

In a statement, Sandoz said it’s committed to having the product available in the United States “as soon as possible.”

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved natalizumab-sztn injection (Tyruko, Sandoz), the first biosimilar to Biogen’s Tysabri (natalizumab), to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting MS, and active secondary progressive disease.

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis. [This] approval could have a meaningful impact for patients managing their disease,” Paul R. Lee, MD, PhD, director of the division of neurology II, FDA Center for Drug Evaluation and Research, said in a statement.

Olivier Le Moal/Getty Images

The natalizumab biosimilar is given using the same dosing and administration schedule. Like the reference product, it is indicated for adults with moderately to severely active Crohn’s disease unresponsive to other medications.

The approval of the natalizumab biosimilar is based on results of the phase 3 Antelope trial, which showed no clinically meaningful differences between it and the reference product.

The trial included 264 adults (mean age, 36 years; 61% women) with relapsing remitting MS from 48 centers in seven Eastern European countries.

All were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of the natalizumab biosimilar or the reference product for a total of 12 infusions.

At 24 and 48 weeks, there were no between-group differences in annualized relapse rates or Expanded Disability Status Scale scores, which were similar between treatment groups at baseline. There were also no significant differences in safety, tolerability, or immunogenicity.

The prescribing information for both natalizumab products includes a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability.

Risk factors for the development of PML include the presence of antibodies to the JC virus, longer duration of therapy, and prior use of immunosuppressants.

“These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab products, and health care providers should monitor patients and withhold treatment immediately at the first sign or symptom suggestive of PML,” the FDA advises.

Because of the risks of PML, natalizumab products are available only through a restricted drug distribution program under a risk evaluation and mitigation strategy.

In a statement, Sandoz said it’s committed to having the product available in the United States “as soon as possible.”

A version of this article appeared on Medscape.com.