MDedge Endocrinology

LAS VEGAS – People with obesity may be able to reduce their risk of colorectal cancer with weight loss surgery or medication, researchers say.

“We need to have conversations with our patients in the clinic and educate them that they have these resources available,” said Aakash Desai, MD, a hospitalist at MetroHealth Medical Center, Cleveland, in an interview with this news organization.

Dr. Desai and colleagues found that sleeve gastrectomy and four medications were associated with a reduced risk of colorectal cancer but Roux-en-Y gastrojejunostomy and orlistat were not.

Coauthor Zryan Shwani, MD, a gastroenterology fellow at Sibley Memorial Hospital, Washington, D.C., presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.

Working with an underserved population with high rates of obesity in northeastern Ohio, the researchers wondered how surgery and medication could affect these patients.

They analyzed data from the IBM Explorys clinical database, which compiles and standardizes data from electronic medical records on about 74 million patients from more than 300 U.S. hospitals. Consistent with previous studies, they determined that patients with obesity in the database were 2.5 times more likely than people with a healthy weight to be diagnosed with colorectal cancer (odds ratio, 2.48; 95% CI, 2.45-2.51).

Zeroing in on people who had weight loss interventions, they included adults aged 18-75 years who had undergone either Roux-en-Y gastrojejunostomy or sleeve gastrectomy, or had taken the medications liraglutide, orlistat, phentermine/topiramate, bupropion/naltrexone, or lorcaserin.

They excluded patients with Lynch syndrome, intestinal polyposis syndrome, a family history of gastrointestinal malignancy, inflammatory bowel disease, or tobacco or alcohol abuse. Patients who had taken one of the weight loss medications and also had type 2 diabetes were excluded. They did not include patients who had undergone gastric banding because it has become less popular.

For the weight loss medication group, they found 117,730 patients who met their criteria. For the surgery group, 43,050 patients met the criteria.

In analyzing the colorectal cancer rates, they included only diagnoses of malignant neoplasms made 2 years after the interventions.

They compared these patients to a control group of 52,540 people matched in age, with a body mass index (BMI) greater than 30 kg/m² who did not undergo weight loss surgery or take weight loss medication.

Among the 9,370 patients who underwent Roux-en-Y gastrojejunostomy, 50 were diagnosed with colorectal cancer and 400 had benign polyps. Their rate of colorectal cancer was not statistically different from people who didn’t have surgery (OR, 1.09; 95% CI, 0.82-1.43). The rate of benign polyps after Roux-en-Y gastrojejunostomy was greater (OR, 1.72; 95% CI, 1.55-1.90).

On the other hand, among the 33,680 patients who underwent sleeve gastrectomy, 50 were diagnosed with colorectal cancer, a lower rate than in the population who didn’t have surgery (OR, 0.30; 95% CI, 0.22-0.39). Their risk of benign polyps was also reduced (OR, 0.45; 95% CI, 0.40-0.50).

All of the medications were significantly associated with a lower risk of colorectal cancer, except orlistat (OR, 0.94; 95% CI, 0.72-1.25).

The finding on Roux-en-Y gastrojejunostomy agreed with studies from England and Nordic countries showing double the risk of colorectal cancer in those patients but conflicted with a French study showing decreased risk, Dr. Shwani said.

While the study doesn’t establish a reason why Roux-en-Y gastrojejunostomy was less beneficial, other researchers have associated the procedure with biomarkers of inflammation, Dr. Shwani said. “It’s inconsistent, and I don’t think we have a clear answer why.”

As a retrospective analysis, the study could not establish a cause-and-effect relationship between surgery or medication and cancer, or adjust for such factors as diet, exercise, or genes, he acknowledged.

Colorectal cancer is just one outcome to consider when deciding whether to undergo weight loss surgery or take weight loss drugs, said session moderator Mohammad Yaghoobi, MD, an associate professor of medicine at McMaster University, Hamilton, Ont.

“The most important outcome that should be investigated is the survival of the patients after obesity surgery,” he told this news organization. “The second would be the quality of life of those patients. Colon cancer is preventable if you are having regular colonoscopies.”

Other studies have not shown much difference between patients who have weight loss surgery and those who don’t, he added.

The study was funded by Merck. Dr. Desai and Dr. Shwani have reported receiving grant funding from Merck. Dr. Yaghoobi has reported no relevant financial relationships.

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

LAS VEGAS – People with obesity may be able to reduce their risk of colorectal cancer with weight loss surgery or medication, researchers say.

“We need to have conversations with our patients in the clinic and educate them that they have these resources available,” said Aakash Desai, MD, a hospitalist at MetroHealth Medical Center, Cleveland, in an interview with this news organization.

Dr. Desai and colleagues found that sleeve gastrectomy and four medications were associated with a reduced risk of colorectal cancer but Roux-en-Y gastrojejunostomy and orlistat were not.

Coauthor Zryan Shwani, MD, a gastroenterology fellow at Sibley Memorial Hospital, Washington, D.C., presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.

Working with an underserved population with high rates of obesity in northeastern Ohio, the researchers wondered how surgery and medication could affect these patients.

They analyzed data from the IBM Explorys clinical database, which compiles and standardizes data from electronic medical records on about 74 million patients from more than 300 U.S. hospitals. Consistent with previous studies, they determined that patients with obesity in the database were 2.5 times more likely than people with a healthy weight to be diagnosed with colorectal cancer (odds ratio, 2.48; 95% CI, 2.45-2.51).

Zeroing in on people who had weight loss interventions, they included adults aged 18-75 years who had undergone either Roux-en-Y gastrojejunostomy or sleeve gastrectomy, or had taken the medications liraglutide, orlistat, phentermine/topiramate, bupropion/naltrexone, or lorcaserin.

They excluded patients with Lynch syndrome, intestinal polyposis syndrome, a family history of gastrointestinal malignancy, inflammatory bowel disease, or tobacco or alcohol abuse. Patients who had taken one of the weight loss medications and also had type 2 diabetes were excluded. They did not include patients who had undergone gastric banding because it has become less popular.

For the weight loss medication group, they found 117,730 patients who met their criteria. For the surgery group, 43,050 patients met the criteria.

In analyzing the colorectal cancer rates, they included only diagnoses of malignant neoplasms made 2 years after the interventions.

They compared these patients to a control group of 52,540 people matched in age, with a body mass index (BMI) greater than 30 kg/m² who did not undergo weight loss surgery or take weight loss medication.

Among the 9,370 patients who underwent Roux-en-Y gastrojejunostomy, 50 were diagnosed with colorectal cancer and 400 had benign polyps. Their rate of colorectal cancer was not statistically different from people who didn’t have surgery (OR, 1.09; 95% CI, 0.82-1.43). The rate of benign polyps after Roux-en-Y gastrojejunostomy was greater (OR, 1.72; 95% CI, 1.55-1.90).

On the other hand, among the 33,680 patients who underwent sleeve gastrectomy, 50 were diagnosed with colorectal cancer, a lower rate than in the population who didn’t have surgery (OR, 0.30; 95% CI, 0.22-0.39). Their risk of benign polyps was also reduced (OR, 0.45; 95% CI, 0.40-0.50).

All of the medications were significantly associated with a lower risk of colorectal cancer, except orlistat (OR, 0.94; 95% CI, 0.72-1.25).

The finding on Roux-en-Y gastrojejunostomy agreed with studies from England and Nordic countries showing double the risk of colorectal cancer in those patients but conflicted with a French study showing decreased risk, Dr. Shwani said.

While the study doesn’t establish a reason why Roux-en-Y gastrojejunostomy was less beneficial, other researchers have associated the procedure with biomarkers of inflammation, Dr. Shwani said. “It’s inconsistent, and I don’t think we have a clear answer why.”

As a retrospective analysis, the study could not establish a cause-and-effect relationship between surgery or medication and cancer, or adjust for such factors as diet, exercise, or genes, he acknowledged.

Colorectal cancer is just one outcome to consider when deciding whether to undergo weight loss surgery or take weight loss drugs, said session moderator Mohammad Yaghoobi, MD, an associate professor of medicine at McMaster University, Hamilton, Ont.

“The most important outcome that should be investigated is the survival of the patients after obesity surgery,” he told this news organization. “The second would be the quality of life of those patients. Colon cancer is preventable if you are having regular colonoscopies.”

Other studies have not shown much difference between patients who have weight loss surgery and those who don’t, he added.

The study was funded by Merck. Dr. Desai and Dr. Shwani have reported receiving grant funding from Merck. Dr. Yaghoobi has reported no relevant financial relationships.

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

LAS VEGAS – People with obesity may be able to reduce their risk of colorectal cancer with weight loss surgery or medication, researchers say.

“We need to have conversations with our patients in the clinic and educate them that they have these resources available,” said Aakash Desai, MD, a hospitalist at MetroHealth Medical Center, Cleveland, in an interview with this news organization.

Dr. Desai and colleagues found that sleeve gastrectomy and four medications were associated with a reduced risk of colorectal cancer but Roux-en-Y gastrojejunostomy and orlistat were not.

Coauthor Zryan Shwani, MD, a gastroenterology fellow at Sibley Memorial Hospital, Washington, D.C., presented the findings here at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting.

Working with an underserved population with high rates of obesity in northeastern Ohio, the researchers wondered how surgery and medication could affect these patients.

They analyzed data from the IBM Explorys clinical database, which compiles and standardizes data from electronic medical records on about 74 million patients from more than 300 U.S. hospitals. Consistent with previous studies, they determined that patients with obesity in the database were 2.5 times more likely than people with a healthy weight to be diagnosed with colorectal cancer (odds ratio, 2.48; 95% CI, 2.45-2.51).

Zeroing in on people who had weight loss interventions, they included adults aged 18-75 years who had undergone either Roux-en-Y gastrojejunostomy or sleeve gastrectomy, or had taken the medications liraglutide, orlistat, phentermine/topiramate, bupropion/naltrexone, or lorcaserin.

They excluded patients with Lynch syndrome, intestinal polyposis syndrome, a family history of gastrointestinal malignancy, inflammatory bowel disease, or tobacco or alcohol abuse. Patients who had taken one of the weight loss medications and also had type 2 diabetes were excluded. They did not include patients who had undergone gastric banding because it has become less popular.

For the weight loss medication group, they found 117,730 patients who met their criteria. For the surgery group, 43,050 patients met the criteria.

In analyzing the colorectal cancer rates, they included only diagnoses of malignant neoplasms made 2 years after the interventions.

They compared these patients to a control group of 52,540 people matched in age, with a body mass index (BMI) greater than 30 kg/m² who did not undergo weight loss surgery or take weight loss medication.

Among the 9,370 patients who underwent Roux-en-Y gastrojejunostomy, 50 were diagnosed with colorectal cancer and 400 had benign polyps. Their rate of colorectal cancer was not statistically different from people who didn’t have surgery (OR, 1.09; 95% CI, 0.82-1.43). The rate of benign polyps after Roux-en-Y gastrojejunostomy was greater (OR, 1.72; 95% CI, 1.55-1.90).

On the other hand, among the 33,680 patients who underwent sleeve gastrectomy, 50 were diagnosed with colorectal cancer, a lower rate than in the population who didn’t have surgery (OR, 0.30; 95% CI, 0.22-0.39). Their risk of benign polyps was also reduced (OR, 0.45; 95% CI, 0.40-0.50).

All of the medications were significantly associated with a lower risk of colorectal cancer, except orlistat (OR, 0.94; 95% CI, 0.72-1.25).

The finding on Roux-en-Y gastrojejunostomy agreed with studies from England and Nordic countries showing double the risk of colorectal cancer in those patients but conflicted with a French study showing decreased risk, Dr. Shwani said.

While the study doesn’t establish a reason why Roux-en-Y gastrojejunostomy was less beneficial, other researchers have associated the procedure with biomarkers of inflammation, Dr. Shwani said. “It’s inconsistent, and I don’t think we have a clear answer why.”

As a retrospective analysis, the study could not establish a cause-and-effect relationship between surgery or medication and cancer, or adjust for such factors as diet, exercise, or genes, he acknowledged.

Colorectal cancer is just one outcome to consider when deciding whether to undergo weight loss surgery or take weight loss drugs, said session moderator Mohammad Yaghoobi, MD, an associate professor of medicine at McMaster University, Hamilton, Ont.

“The most important outcome that should be investigated is the survival of the patients after obesity surgery,” he told this news organization. “The second would be the quality of life of those patients. Colon cancer is preventable if you are having regular colonoscopies.”

Other studies have not shown much difference between patients who have weight loss surgery and those who don’t, he added.

The study was funded by Merck. Dr. Desai and Dr. Shwani have reported receiving grant funding from Merck. Dr. Yaghoobi has reported no relevant financial relationships.

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

For those of us who cannot sit in the sun and fish all day, the next best thing for preventing autoimmune diseases may be supplementation with vitamin D and fish oil-derived omega-3 fatty acids, results of a large prospective randomized trial suggest.

Ziga Plahutar

Among nearly 26,000 adults enrolled in a randomized trial designed primarily to study the effects of vitamin D and omega-3 supplementation on incident cancer and cardiovascular disease, 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of omega-3 fatty acid supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases, reported Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston.

“The clinical importance of these results is very high, given that these are nontoxic, well-tolerated supplements, and that there are no other known effective therapies to reduce the incidence of autoimmune diseases,” she said during the virtual annual meeting of the American College of Rheumatology.

“People do have to take the supplements a long time to start to see the reduction in risk, especially for vitamin D, but they make biological sense, and autoimmune diseases develop slowly over time, so taking it today isn’t going to reduce risk of developing something tomorrow,” Dr. Costenbader said in an interview.

“These supplements have other health benefits. Obviously, fish oil is anti-inflammatory, and vitamin D is good for osteoporosis prevention, especially in our patients who take glucocorticoids. People who are otherwise healthy and have a family history of autoimmune disease might also consider starting to take these supplements,” she said.

After watching her presentation, session co-moderator Gregg Silverman, MD, from the NYU Langone School of Medicine in New York, who was not involved in the study, commented “I’m going to [nutrition store] GNC to get some vitamins.”

When asked for comment, the other session moderator, Tracy Frech, MD, of Vanderbilt University, Nashville, said, “I think Dr. Costenbader’s work is very important and her presentation excellent. My current practice is replacement of vitamin D in all autoimmune disease patients with low levels and per bone health guidelines. Additionally, I discuss omega-3 supplementation with Sjögren’s [syndrome] patients as a consideration.”

Evidence base

Dr. Costenbader noted that in a 2013 observational study from France, vitamin D derived through ultraviolet (UV) light exposure was associated with a lower risk for incident Crohn’s disease but not ulcerative colitis, and in two analyses of data in 2014 from the Nurses’ Health Study, both high plasma levels of 25-OH vitamin D and geographic residence in areas of high UV exposure were associated with a decreased incidence of rheumatoid arthritis (RA).

Other observational studies have supported omega-3 fatty acids for their anti-inflammatory properties, including a 2005 Danish prospective cohort study showing a lower risk for RA in participants who reported higher levels of fatty fish intake. In a separate study conducted in 2017, healthy volunteers with higher omega-3 fatty acid/total lipid proportions in red blood cell membranes had a lower prevalence of anti-cyclic citrullinated peptide (anti-CCP) antibodies and rheumatoid factor and a lower incidence of progression to inflammatory arthritis, she said.

Ancillary study

Despite the evidence, however, there have been no prospective randomized trials to test the effects of either vitamin D or omega-3 fatty acid supplementation on the incidence of autoimmune disease over time.

To rectify this, Dr. Costenbader and colleagues piggybacked an ancillary study onto the Vitamin D and Omega-3 Trial (VITAL), which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older, and 13,085 women aged 55 and older.

The study had a 2 x 2 factorial design, with patients randomly assigned to vitamin D 2,000 IU/day or placebo, and then further randomized to either 1 g/day omega-3 fatty acids or placebo in both the vitamin D and placebo primary randomization arms.

At baseline 16,956 participants were assayed for 25-OH vitamin D and plasma omega 3 index, the ratio of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to total fatty acids. Participants self-reported baseline and all incident autoimmune diseases annually, with the reports confirmed by medical record review and disease criteria whenever possible.

Results

At 5 years of follow-up, confirmed incident autoimmune diseases had occurred in 123 patients in the active vitamin D group, compared with 155 in the placebo vitamin D group, translating into a hazard ratio (HR) for vitamin D of 0.78 (P = .045).

In the active omega-3 arm, 130 participants developed an autoimmune disease, compared with 148 in the placebo omega-3 arm, which translated into a nonsignificant HR of 0.85.

There was no statistical interaction between the two supplements. The investigators did observe an interaction between vitamin D and body mass index, with the effect stronger among participants with low BMI (P = .02). There also was an interaction between omega-3 fatty acids with a family history of autoimmune disease (P = .03).

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with an HR for incident autoimmune disease of 0.68 (P = .02), omega-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03).

Dr. Costenbader and colleagues acknowledged that the study was limited by the lack of a high-risk or nutritionally-deficient population, where the effects of supplementation might be larger; the restriction of the sample to older adults; and to the difficulty of confirming incident autoimmune thyroid disease from patient reports.

Cheryl Koehn, an arthritis patient advocate from Vancouver, Canada, who was not involved in the study, commented in the “chat” section of the presentation that her rheumatologist “has recommended vitamin D for years now. Says basically everyone north of Boston is vitamin D deficient. I take 1,000 IU per day. Been taking it for years.” Ms. Koehn is the founder and president of Arthritis Consumer Experts, a website that provides education to those with arthritis.

“Agreed. I tell every patient to take vitamin D supplement,” commented Fatma Dedeoglu, MD, a rheumatologist at Boston Children’s Hospital.



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

For those of us who cannot sit in the sun and fish all day, the next best thing for preventing autoimmune diseases may be supplementation with vitamin D and fish oil-derived omega-3 fatty acids, results of a large prospective randomized trial suggest.

Ziga Plahutar

Among nearly 26,000 adults enrolled in a randomized trial designed primarily to study the effects of vitamin D and omega-3 supplementation on incident cancer and cardiovascular disease, 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of omega-3 fatty acid supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases, reported Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston.

“The clinical importance of these results is very high, given that these are nontoxic, well-tolerated supplements, and that there are no other known effective therapies to reduce the incidence of autoimmune diseases,” she said during the virtual annual meeting of the American College of Rheumatology.

“People do have to take the supplements a long time to start to see the reduction in risk, especially for vitamin D, but they make biological sense, and autoimmune diseases develop slowly over time, so taking it today isn’t going to reduce risk of developing something tomorrow,” Dr. Costenbader said in an interview.

“These supplements have other health benefits. Obviously, fish oil is anti-inflammatory, and vitamin D is good for osteoporosis prevention, especially in our patients who take glucocorticoids. People who are otherwise healthy and have a family history of autoimmune disease might also consider starting to take these supplements,” she said.

After watching her presentation, session co-moderator Gregg Silverman, MD, from the NYU Langone School of Medicine in New York, who was not involved in the study, commented “I’m going to [nutrition store] GNC to get some vitamins.”

When asked for comment, the other session moderator, Tracy Frech, MD, of Vanderbilt University, Nashville, said, “I think Dr. Costenbader’s work is very important and her presentation excellent. My current practice is replacement of vitamin D in all autoimmune disease patients with low levels and per bone health guidelines. Additionally, I discuss omega-3 supplementation with Sjögren’s [syndrome] patients as a consideration.”

Evidence base

Dr. Costenbader noted that in a 2013 observational study from France, vitamin D derived through ultraviolet (UV) light exposure was associated with a lower risk for incident Crohn’s disease but not ulcerative colitis, and in two analyses of data in 2014 from the Nurses’ Health Study, both high plasma levels of 25-OH vitamin D and geographic residence in areas of high UV exposure were associated with a decreased incidence of rheumatoid arthritis (RA).

Other observational studies have supported omega-3 fatty acids for their anti-inflammatory properties, including a 2005 Danish prospective cohort study showing a lower risk for RA in participants who reported higher levels of fatty fish intake. In a separate study conducted in 2017, healthy volunteers with higher omega-3 fatty acid/total lipid proportions in red blood cell membranes had a lower prevalence of anti-cyclic citrullinated peptide (anti-CCP) antibodies and rheumatoid factor and a lower incidence of progression to inflammatory arthritis, she said.

Ancillary study

Despite the evidence, however, there have been no prospective randomized trials to test the effects of either vitamin D or omega-3 fatty acid supplementation on the incidence of autoimmune disease over time.

To rectify this, Dr. Costenbader and colleagues piggybacked an ancillary study onto the Vitamin D and Omega-3 Trial (VITAL), which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older, and 13,085 women aged 55 and older.

The study had a 2 x 2 factorial design, with patients randomly assigned to vitamin D 2,000 IU/day or placebo, and then further randomized to either 1 g/day omega-3 fatty acids or placebo in both the vitamin D and placebo primary randomization arms.

At baseline 16,956 participants were assayed for 25-OH vitamin D and plasma omega 3 index, the ratio of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to total fatty acids. Participants self-reported baseline and all incident autoimmune diseases annually, with the reports confirmed by medical record review and disease criteria whenever possible.

Results

At 5 years of follow-up, confirmed incident autoimmune diseases had occurred in 123 patients in the active vitamin D group, compared with 155 in the placebo vitamin D group, translating into a hazard ratio (HR) for vitamin D of 0.78 (P = .045).

In the active omega-3 arm, 130 participants developed an autoimmune disease, compared with 148 in the placebo omega-3 arm, which translated into a nonsignificant HR of 0.85.

There was no statistical interaction between the two supplements. The investigators did observe an interaction between vitamin D and body mass index, with the effect stronger among participants with low BMI (P = .02). There also was an interaction between omega-3 fatty acids with a family history of autoimmune disease (P = .03).

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with an HR for incident autoimmune disease of 0.68 (P = .02), omega-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03).

Dr. Costenbader and colleagues acknowledged that the study was limited by the lack of a high-risk or nutritionally-deficient population, where the effects of supplementation might be larger; the restriction of the sample to older adults; and to the difficulty of confirming incident autoimmune thyroid disease from patient reports.

Cheryl Koehn, an arthritis patient advocate from Vancouver, Canada, who was not involved in the study, commented in the “chat” section of the presentation that her rheumatologist “has recommended vitamin D for years now. Says basically everyone north of Boston is vitamin D deficient. I take 1,000 IU per day. Been taking it for years.” Ms. Koehn is the founder and president of Arthritis Consumer Experts, a website that provides education to those with arthritis.

“Agreed. I tell every patient to take vitamin D supplement,” commented Fatma Dedeoglu, MD, a rheumatologist at Boston Children’s Hospital.



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

For those of us who cannot sit in the sun and fish all day, the next best thing for preventing autoimmune diseases may be supplementation with vitamin D and fish oil-derived omega-3 fatty acids, results of a large prospective randomized trial suggest.

Ziga Plahutar

Among nearly 26,000 adults enrolled in a randomized trial designed primarily to study the effects of vitamin D and omega-3 supplementation on incident cancer and cardiovascular disease, 5 years of vitamin D supplementation was associated with a 22% reduction in risk for confirmed autoimmune diseases, and 5 years of omega-3 fatty acid supplementation was associated with an 18% reduction in confirmed and probable incident autoimmune diseases, reported Karen H. Costenbader, MD, MPH, of Brigham & Women’s Hospital in Boston.

“The clinical importance of these results is very high, given that these are nontoxic, well-tolerated supplements, and that there are no other known effective therapies to reduce the incidence of autoimmune diseases,” she said during the virtual annual meeting of the American College of Rheumatology.

“People do have to take the supplements a long time to start to see the reduction in risk, especially for vitamin D, but they make biological sense, and autoimmune diseases develop slowly over time, so taking it today isn’t going to reduce risk of developing something tomorrow,” Dr. Costenbader said in an interview.

“These supplements have other health benefits. Obviously, fish oil is anti-inflammatory, and vitamin D is good for osteoporosis prevention, especially in our patients who take glucocorticoids. People who are otherwise healthy and have a family history of autoimmune disease might also consider starting to take these supplements,” she said.

After watching her presentation, session co-moderator Gregg Silverman, MD, from the NYU Langone School of Medicine in New York, who was not involved in the study, commented “I’m going to [nutrition store] GNC to get some vitamins.”

When asked for comment, the other session moderator, Tracy Frech, MD, of Vanderbilt University, Nashville, said, “I think Dr. Costenbader’s work is very important and her presentation excellent. My current practice is replacement of vitamin D in all autoimmune disease patients with low levels and per bone health guidelines. Additionally, I discuss omega-3 supplementation with Sjögren’s [syndrome] patients as a consideration.”

Evidence base

Dr. Costenbader noted that in a 2013 observational study from France, vitamin D derived through ultraviolet (UV) light exposure was associated with a lower risk for incident Crohn’s disease but not ulcerative colitis, and in two analyses of data in 2014 from the Nurses’ Health Study, both high plasma levels of 25-OH vitamin D and geographic residence in areas of high UV exposure were associated with a decreased incidence of rheumatoid arthritis (RA).

Other observational studies have supported omega-3 fatty acids for their anti-inflammatory properties, including a 2005 Danish prospective cohort study showing a lower risk for RA in participants who reported higher levels of fatty fish intake. In a separate study conducted in 2017, healthy volunteers with higher omega-3 fatty acid/total lipid proportions in red blood cell membranes had a lower prevalence of anti-cyclic citrullinated peptide (anti-CCP) antibodies and rheumatoid factor and a lower incidence of progression to inflammatory arthritis, she said.

Ancillary study

Despite the evidence, however, there have been no prospective randomized trials to test the effects of either vitamin D or omega-3 fatty acid supplementation on the incidence of autoimmune disease over time.

To rectify this, Dr. Costenbader and colleagues piggybacked an ancillary study onto the Vitamin D and Omega-3 Trial (VITAL), which had primary outcomes of cancer and cardiovascular disease incidence.

A total of 25,871 participants were enrolled, including 12,786 men aged 50 and older, and 13,085 women aged 55 and older.

The study had a 2 x 2 factorial design, with patients randomly assigned to vitamin D 2,000 IU/day or placebo, and then further randomized to either 1 g/day omega-3 fatty acids or placebo in both the vitamin D and placebo primary randomization arms.

At baseline 16,956 participants were assayed for 25-OH vitamin D and plasma omega 3 index, the ratio of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to total fatty acids. Participants self-reported baseline and all incident autoimmune diseases annually, with the reports confirmed by medical record review and disease criteria whenever possible.

Results

At 5 years of follow-up, confirmed incident autoimmune diseases had occurred in 123 patients in the active vitamin D group, compared with 155 in the placebo vitamin D group, translating into a hazard ratio (HR) for vitamin D of 0.78 (P = .045).

In the active omega-3 arm, 130 participants developed an autoimmune disease, compared with 148 in the placebo omega-3 arm, which translated into a nonsignificant HR of 0.85.

There was no statistical interaction between the two supplements. The investigators did observe an interaction between vitamin D and body mass index, with the effect stronger among participants with low BMI (P = .02). There also was an interaction between omega-3 fatty acids with a family history of autoimmune disease (P = .03).

In multivariate analysis adjusted for age, sex, race, and other supplement arm, vitamin D alone was associated with an HR for incident autoimmune disease of 0.68 (P = .02), omega-3 alone was associated with a nonsignificant HR of 0.74, and the combination was associated with an HR of 0.69 (P = .03).

Dr. Costenbader and colleagues acknowledged that the study was limited by the lack of a high-risk or nutritionally-deficient population, where the effects of supplementation might be larger; the restriction of the sample to older adults; and to the difficulty of confirming incident autoimmune thyroid disease from patient reports.

Cheryl Koehn, an arthritis patient advocate from Vancouver, Canada, who was not involved in the study, commented in the “chat” section of the presentation that her rheumatologist “has recommended vitamin D for years now. Says basically everyone north of Boston is vitamin D deficient. I take 1,000 IU per day. Been taking it for years.” Ms. Koehn is the founder and president of Arthritis Consumer Experts, a website that provides education to those with arthritis.

“Agreed. I tell every patient to take vitamin D supplement,” commented Fatma Dedeoglu, MD, a rheumatologist at Boston Children’s Hospital.



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

Over half of people who believed they were transgender, transitioned to the opposite sex, but then regretted it and transitioned back – known as detransitioners – felt they did not receive adequate evaluation from a doctor or mental health professional before starting transition, new research indicates.

In what is thought to be the first study to ask whether detransitioners informed their original clinicians of their regret at transitioning, only 24 of the 100 surveyed said they had done so.

This strongly suggests that records on detransition may understate the real numbers, said Lisa Littman, MD, MPH, president of The Institute for Comprehensive Gender Dysphoria Research (ICGDR), who is the sole author of the study, published in Archives of Sexual Behavior.

She stressed that the findings illustrate the complexity surrounding gender dysphoria. “We need to recognize that there are many different types of experiences around gender dysphoria, transition, and detransition,” she told this news organization.

She said there is some resistance among certain health care professionals, and in society in general, to the idea that transitioning is not always successful.
 

‘We need to understand why this is happening’

“Detransition exists and we need to understand why this is happening,” Dr. Littman emphasized.

She observed that some supporters of “rapid transition” do not want to accept that transitioning helps some individuals but harms others.

“In the end, our goals should be providing the right treatment for the right patient, and without a thorough evaluation, clinicians are at serious risk of giving patients the wrong treatment,” she urged.

She noted that, despite some individuals feeling better after transition, these people still felt inclined to detransition because of discrimination and pressure.

“Individuals should not be pressured to detransition, nor should they be pressured to transition. Both types of pressure were reported by respondents.” 

The recently recognized shift from mostly natal males to natal females seeking to transition was borne out by her study data, with the proportion of natal girls who detransitioned at 69%.
 

‘Shedding light’ on often ignored population

Asked to comment on the study, Laura Edwards-Leeper, PhD, a clinical psychologist from Beaverton, Ore., who specializes in gender-diverse and transgender children, welcomed Dr. Littman’s study.

It is, said Dr. Edwards-Leeper, a “critical preliminary step toward shedding light on this often-ignored and dismissed population of individuals who deserve support, compassion, and sometimes medical intervention from health care providers.”

She added that multiple online reports attest to detransitioners feeling they had not received adequate evaluation prior to medically transitioning, as well as many who expressed feeling too ashamed or angry to return to their same clinicians to detransition.

“Littman’s study provides quantitative support for both of these reported experiences, further emphasizing the importance of the field taking a closer look at the processes currently in place for those experiencing gender dysphoria,” said Dr. Edwards-Leeper.

And Miroslav L. Djordjevic, MD, PhD, professor of surgery/urology, University of Belgrade (Serbia), who is a specialist in urogenital reconstructive surgery and has performed over 2,000 gender-reassignment surgeries in transgender individuals, has recently seen many cases of regret after such surgeries, with requests for reversal operations.

“Despite the fact that medical detransition is relatively safe and without severe consequences, surgical detransition presents one of the most difficult issues in transgender medicine,” Dr. Djordjevic told this news organization.

Commending Dr. Littman on her study, he drew attention to some of the bioethical questions that arise relating to those who detransition.

“I ask what happened in the period before medical transitioning? Was there proper psychological care during medical transitioning? Who confirmed their desire for detransition – the same professionals who did the transition?” or someone else, he continued. “And who accepted these individuals for gender-affirming surgery and what were the criteria for this decision?”
 

Substantial study of reasons for both transitioning and detransitioning 

In her article, Dr. Littman describes a 100-strong population of individuals (66 Americans, 9 British, 9 Canadian, 4 Australians, and 12 from “other” nations), ranging in age from 18 years to over 60 years with a mean age of 29.2 years, who had experienced gender dysphoria, chosen to undergo medical and/or surgical transition, and then detransitioned by discontinuing medications, having reversal surgery, or both.

Participants completed a 115-question survey providing data including age at first experience of gender dysphoria, when participants first sought transitioning care and from whom, and whether they felt pressured to do so. Friendship group dynamics were also explored.

Various narratives of participants’ transitioning-detransitioning experiences were gathered and grouped, for example, those related to discrimination pressures, experiences of trauma or mental health conditions prior to transition, and reports of internalized homophobia.

Dr. Edwards-Leeper observed that the study offers a more extensive assessment of reasons for detransitioning than any other prior research in the field, which has been sparse.

A survey published in April found that detransitioners report significant unmet medical and psychological needs, and a lack of compassion and help from medical and mental health practitioners.

But another 2021 study concluded most detransitioners only reverted to their birth sex because of societal or family pressure, discrimination, or shift to a nonbinary identity.

“However, [Dr.] Littman’s study found that only a small percentage actually detransitioned for that reason [23%], whereas the majority detransitioned because of a change in how the individual understood being a male or female, resulting in becoming comfortable in their assigned gender [60%],” noted Dr. Edwards-Leeper.
 

Reasons for detransitioning

Asked to expand upon the motives for detransition identified in her study, Dr. Littman told this news organization: “We found remarkable breadth in the reasons given for detransitioning.” 

“I believe that we were able to capture the diversity of experiences around detransition because we reached out to communities that were strongly ‘protransition’ – like the World Professional Association for Transgender Health – and communities where individuals might be more skeptical about transition being universally beneficial, like detransition forums,” she said.

Speaking to the complexity of the experiences, 87% selected more than one reason for detransitioning.

The most common reason (60%) was becoming more comfortable identifying with their birth sex, followed by having concerns about potential medical complications from transitioning (49.0%).

Regarding those who became more comfortable with their natal sex, Dr. Littman noted that the finding adds “further support that gender dysphoria is not always permanent.”

She added that, “because most gender-dysphoric youth who are allowed to go through puberty grow up to be lesbian, gay, or bisexual (LGB) nontransgender adults, intervening too soon with medical treatments risks derailing their development as LGB individuals.”

Internalized homophobia or difficulty accepting themselves as lesbian, gay, or bisexual was reported by 23% of participants as a reason for transition and subsequent detransition. 

“For these people, transitioning could be interpreted as an attempt to escape the reality of being same-sex attracted and detransitioning was part of accepting themselves as homosexual or bisexual,” explained Dr. Littman.

“Exploring their distress and discomfort around sexual orientation issues may have been more helpful to them than medical and surgical transition or at least an important part of exploration,” she added in the article.
 

Societal pressure, friends, and social media also play a role

The latest first-hand reports also support prior work by Dr. Littman when she first identified the concept she termed rapid-onset gender dysphoria (ROGD) to describe a sudden transgender identification, usually in the early teenage years, and with no prior indication of any gender questioning.

ROGD, Dr. Littman believes, is strongly related to psychosocial factors, such as trauma, mental health problems, or social influence contributing to the development of gender dysphoria.

The current study found that 58% of respondents expressed the belief that the cause of their gender dysphoria was something specific, such as trauma, abuse, or a mental health condition, with respondents suggesting that transitioning prevented, or delayed, them from addressing their underlying mental health conditions. 

One participant is quoted as saying: “I was deeply uncomfortable with my secondary sex characteristics, which I now understand was a result of childhood trauma and associating my secondary sex characteristics with those events.”

Reflecting on their previous identification as transgender, more than a third of respondents reported that someone else told them their feelings meant they were transgender, and they believed them.

“This speaks to the effect social influence can have on people’s interpretation of their own feelings and their development of a transgender identity,” Dr. Littman remarked.

“Participants also listed several social media sources that encouraged them to believe that transitioning would help them,” she added.

Several friendship group dynamics suggestive of social influence were reported by a subset of respondents, including the fact that their friendship groups mocked people who were not transgender and their popularity increased when they announced they were going to transition. 
 

Pendulum has swung too far the other way

Natal females, who in recent years have made up most referrals, were younger than natal males when they sought transition and decided to detransition; and they stayed “transitioned” for a shorter period than natal males. They were also more likely to have experienced a trauma less than 1 year before the onset of gender dysphoria and were more likely to have felt pressured to transition. 

“Because the females in the study transitioned more recently than the males, they may have experienced a culture where there is more of a ‘push’ to transition,” Dr. Littman pointed out.

She added that, “20 years ago, gender-dysphoric patients were most likely to be underdiagnosed and undertreated. Now, the pendulum has swung the other way and patients are, in my opinion, more likely to be overdiagnosed and overtreated. I think we need to aim for somewhere between these two extremes and prioritize people getting the right treatment for the right reason for their distress.”

Dr. Djordjevic added that, with colleagues from Belgrade and the Netherlands, he has published accounts of the experiences of seven individuals who showed regret after gender-affirming surgery.

All of them were born male, “and we confirmed the very poor evaluation and transition process they underwent. We conclude that clinicians should be aware that not everyone with gender identity disorders need or want all elements of hormonal or surgical therapy,” he told this news organization.

Dr. Edwards-Leeper said that more long-term longitudinal studies are needed that follow individuals who undergo transition under different models of care.

“My prediction is that those who first engage in supportive, gender exploratory therapy, followed by comprehensive assessment, will have the best outcomes, perhaps even if they ultimately detransition, as these individuals will know that they did not jump into irreversible interventions too quickly and had time to make the best decision for themselves at the time,” she concluded.

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

Over half of people who believed they were transgender, transitioned to the opposite sex, but then regretted it and transitioned back – known as detransitioners – felt they did not receive adequate evaluation from a doctor or mental health professional before starting transition, new research indicates.

In what is thought to be the first study to ask whether detransitioners informed their original clinicians of their regret at transitioning, only 24 of the 100 surveyed said they had done so.

This strongly suggests that records on detransition may understate the real numbers, said Lisa Littman, MD, MPH, president of The Institute for Comprehensive Gender Dysphoria Research (ICGDR), who is the sole author of the study, published in Archives of Sexual Behavior.

She stressed that the findings illustrate the complexity surrounding gender dysphoria. “We need to recognize that there are many different types of experiences around gender dysphoria, transition, and detransition,” she told this news organization.

She said there is some resistance among certain health care professionals, and in society in general, to the idea that transitioning is not always successful.
 

‘We need to understand why this is happening’

“Detransition exists and we need to understand why this is happening,” Dr. Littman emphasized.

She observed that some supporters of “rapid transition” do not want to accept that transitioning helps some individuals but harms others.

“In the end, our goals should be providing the right treatment for the right patient, and without a thorough evaluation, clinicians are at serious risk of giving patients the wrong treatment,” she urged.

She noted that, despite some individuals feeling better after transition, these people still felt inclined to detransition because of discrimination and pressure.

“Individuals should not be pressured to detransition, nor should they be pressured to transition. Both types of pressure were reported by respondents.” 

The recently recognized shift from mostly natal males to natal females seeking to transition was borne out by her study data, with the proportion of natal girls who detransitioned at 69%.
 

‘Shedding light’ on often ignored population

Asked to comment on the study, Laura Edwards-Leeper, PhD, a clinical psychologist from Beaverton, Ore., who specializes in gender-diverse and transgender children, welcomed Dr. Littman’s study.

It is, said Dr. Edwards-Leeper, a “critical preliminary step toward shedding light on this often-ignored and dismissed population of individuals who deserve support, compassion, and sometimes medical intervention from health care providers.”

She added that multiple online reports attest to detransitioners feeling they had not received adequate evaluation prior to medically transitioning, as well as many who expressed feeling too ashamed or angry to return to their same clinicians to detransition.

“Littman’s study provides quantitative support for both of these reported experiences, further emphasizing the importance of the field taking a closer look at the processes currently in place for those experiencing gender dysphoria,” said Dr. Edwards-Leeper.

And Miroslav L. Djordjevic, MD, PhD, professor of surgery/urology, University of Belgrade (Serbia), who is a specialist in urogenital reconstructive surgery and has performed over 2,000 gender-reassignment surgeries in transgender individuals, has recently seen many cases of regret after such surgeries, with requests for reversal operations.

“Despite the fact that medical detransition is relatively safe and without severe consequences, surgical detransition presents one of the most difficult issues in transgender medicine,” Dr. Djordjevic told this news organization.

Commending Dr. Littman on her study, he drew attention to some of the bioethical questions that arise relating to those who detransition.

“I ask what happened in the period before medical transitioning? Was there proper psychological care during medical transitioning? Who confirmed their desire for detransition – the same professionals who did the transition?” or someone else, he continued. “And who accepted these individuals for gender-affirming surgery and what were the criteria for this decision?”
 

Substantial study of reasons for both transitioning and detransitioning 

In her article, Dr. Littman describes a 100-strong population of individuals (66 Americans, 9 British, 9 Canadian, 4 Australians, and 12 from “other” nations), ranging in age from 18 years to over 60 years with a mean age of 29.2 years, who had experienced gender dysphoria, chosen to undergo medical and/or surgical transition, and then detransitioned by discontinuing medications, having reversal surgery, or both.

Participants completed a 115-question survey providing data including age at first experience of gender dysphoria, when participants first sought transitioning care and from whom, and whether they felt pressured to do so. Friendship group dynamics were also explored.

Various narratives of participants’ transitioning-detransitioning experiences were gathered and grouped, for example, those related to discrimination pressures, experiences of trauma or mental health conditions prior to transition, and reports of internalized homophobia.

Dr. Edwards-Leeper observed that the study offers a more extensive assessment of reasons for detransitioning than any other prior research in the field, which has been sparse.

A survey published in April found that detransitioners report significant unmet medical and psychological needs, and a lack of compassion and help from medical and mental health practitioners.

But another 2021 study concluded most detransitioners only reverted to their birth sex because of societal or family pressure, discrimination, or shift to a nonbinary identity.

“However, [Dr.] Littman’s study found that only a small percentage actually detransitioned for that reason [23%], whereas the majority detransitioned because of a change in how the individual understood being a male or female, resulting in becoming comfortable in their assigned gender [60%],” noted Dr. Edwards-Leeper.
 

Reasons for detransitioning

Asked to expand upon the motives for detransition identified in her study, Dr. Littman told this news organization: “We found remarkable breadth in the reasons given for detransitioning.” 

“I believe that we were able to capture the diversity of experiences around detransition because we reached out to communities that were strongly ‘protransition’ – like the World Professional Association for Transgender Health – and communities where individuals might be more skeptical about transition being universally beneficial, like detransition forums,” she said.

Speaking to the complexity of the experiences, 87% selected more than one reason for detransitioning.

The most common reason (60%) was becoming more comfortable identifying with their birth sex, followed by having concerns about potential medical complications from transitioning (49.0%).

Regarding those who became more comfortable with their natal sex, Dr. Littman noted that the finding adds “further support that gender dysphoria is not always permanent.”

She added that, “because most gender-dysphoric youth who are allowed to go through puberty grow up to be lesbian, gay, or bisexual (LGB) nontransgender adults, intervening too soon with medical treatments risks derailing their development as LGB individuals.”

Internalized homophobia or difficulty accepting themselves as lesbian, gay, or bisexual was reported by 23% of participants as a reason for transition and subsequent detransition. 

“For these people, transitioning could be interpreted as an attempt to escape the reality of being same-sex attracted and detransitioning was part of accepting themselves as homosexual or bisexual,” explained Dr. Littman.

“Exploring their distress and discomfort around sexual orientation issues may have been more helpful to them than medical and surgical transition or at least an important part of exploration,” she added in the article.
 

Societal pressure, friends, and social media also play a role

The latest first-hand reports also support prior work by Dr. Littman when she first identified the concept she termed rapid-onset gender dysphoria (ROGD) to describe a sudden transgender identification, usually in the early teenage years, and with no prior indication of any gender questioning.

ROGD, Dr. Littman believes, is strongly related to psychosocial factors, such as trauma, mental health problems, or social influence contributing to the development of gender dysphoria.

The current study found that 58% of respondents expressed the belief that the cause of their gender dysphoria was something specific, such as trauma, abuse, or a mental health condition, with respondents suggesting that transitioning prevented, or delayed, them from addressing their underlying mental health conditions. 

One participant is quoted as saying: “I was deeply uncomfortable with my secondary sex characteristics, which I now understand was a result of childhood trauma and associating my secondary sex characteristics with those events.”

Reflecting on their previous identification as transgender, more than a third of respondents reported that someone else told them their feelings meant they were transgender, and they believed them.

“This speaks to the effect social influence can have on people’s interpretation of their own feelings and their development of a transgender identity,” Dr. Littman remarked.

“Participants also listed several social media sources that encouraged them to believe that transitioning would help them,” she added.

Several friendship group dynamics suggestive of social influence were reported by a subset of respondents, including the fact that their friendship groups mocked people who were not transgender and their popularity increased when they announced they were going to transition. 
 

Pendulum has swung too far the other way

Natal females, who in recent years have made up most referrals, were younger than natal males when they sought transition and decided to detransition; and they stayed “transitioned” for a shorter period than natal males. They were also more likely to have experienced a trauma less than 1 year before the onset of gender dysphoria and were more likely to have felt pressured to transition. 

“Because the females in the study transitioned more recently than the males, they may have experienced a culture where there is more of a ‘push’ to transition,” Dr. Littman pointed out.

She added that, “20 years ago, gender-dysphoric patients were most likely to be underdiagnosed and undertreated. Now, the pendulum has swung the other way and patients are, in my opinion, more likely to be overdiagnosed and overtreated. I think we need to aim for somewhere between these two extremes and prioritize people getting the right treatment for the right reason for their distress.”

Dr. Djordjevic added that, with colleagues from Belgrade and the Netherlands, he has published accounts of the experiences of seven individuals who showed regret after gender-affirming surgery.

All of them were born male, “and we confirmed the very poor evaluation and transition process they underwent. We conclude that clinicians should be aware that not everyone with gender identity disorders need or want all elements of hormonal or surgical therapy,” he told this news organization.

Dr. Edwards-Leeper said that more long-term longitudinal studies are needed that follow individuals who undergo transition under different models of care.

“My prediction is that those who first engage in supportive, gender exploratory therapy, followed by comprehensive assessment, will have the best outcomes, perhaps even if they ultimately detransition, as these individuals will know that they did not jump into irreversible interventions too quickly and had time to make the best decision for themselves at the time,” she concluded.

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

Over half of people who believed they were transgender, transitioned to the opposite sex, but then regretted it and transitioned back – known as detransitioners – felt they did not receive adequate evaluation from a doctor or mental health professional before starting transition, new research indicates.

In what is thought to be the first study to ask whether detransitioners informed their original clinicians of their regret at transitioning, only 24 of the 100 surveyed said they had done so.

This strongly suggests that records on detransition may understate the real numbers, said Lisa Littman, MD, MPH, president of The Institute for Comprehensive Gender Dysphoria Research (ICGDR), who is the sole author of the study, published in Archives of Sexual Behavior.

She stressed that the findings illustrate the complexity surrounding gender dysphoria. “We need to recognize that there are many different types of experiences around gender dysphoria, transition, and detransition,” she told this news organization.

She said there is some resistance among certain health care professionals, and in society in general, to the idea that transitioning is not always successful.
 

‘We need to understand why this is happening’

“Detransition exists and we need to understand why this is happening,” Dr. Littman emphasized.

She observed that some supporters of “rapid transition” do not want to accept that transitioning helps some individuals but harms others.

“In the end, our goals should be providing the right treatment for the right patient, and without a thorough evaluation, clinicians are at serious risk of giving patients the wrong treatment,” she urged.

She noted that, despite some individuals feeling better after transition, these people still felt inclined to detransition because of discrimination and pressure.

“Individuals should not be pressured to detransition, nor should they be pressured to transition. Both types of pressure were reported by respondents.” 

The recently recognized shift from mostly natal males to natal females seeking to transition was borne out by her study data, with the proportion of natal girls who detransitioned at 69%.
 

‘Shedding light’ on often ignored population

Asked to comment on the study, Laura Edwards-Leeper, PhD, a clinical psychologist from Beaverton, Ore., who specializes in gender-diverse and transgender children, welcomed Dr. Littman’s study.

It is, said Dr. Edwards-Leeper, a “critical preliminary step toward shedding light on this often-ignored and dismissed population of individuals who deserve support, compassion, and sometimes medical intervention from health care providers.”

She added that multiple online reports attest to detransitioners feeling they had not received adequate evaluation prior to medically transitioning, as well as many who expressed feeling too ashamed or angry to return to their same clinicians to detransition.

“Littman’s study provides quantitative support for both of these reported experiences, further emphasizing the importance of the field taking a closer look at the processes currently in place for those experiencing gender dysphoria,” said Dr. Edwards-Leeper.

And Miroslav L. Djordjevic, MD, PhD, professor of surgery/urology, University of Belgrade (Serbia), who is a specialist in urogenital reconstructive surgery and has performed over 2,000 gender-reassignment surgeries in transgender individuals, has recently seen many cases of regret after such surgeries, with requests for reversal operations.

“Despite the fact that medical detransition is relatively safe and without severe consequences, surgical detransition presents one of the most difficult issues in transgender medicine,” Dr. Djordjevic told this news organization.

Commending Dr. Littman on her study, he drew attention to some of the bioethical questions that arise relating to those who detransition.

“I ask what happened in the period before medical transitioning? Was there proper psychological care during medical transitioning? Who confirmed their desire for detransition – the same professionals who did the transition?” or someone else, he continued. “And who accepted these individuals for gender-affirming surgery and what were the criteria for this decision?”
 

Substantial study of reasons for both transitioning and detransitioning 

In her article, Dr. Littman describes a 100-strong population of individuals (66 Americans, 9 British, 9 Canadian, 4 Australians, and 12 from “other” nations), ranging in age from 18 years to over 60 years with a mean age of 29.2 years, who had experienced gender dysphoria, chosen to undergo medical and/or surgical transition, and then detransitioned by discontinuing medications, having reversal surgery, or both.

Participants completed a 115-question survey providing data including age at first experience of gender dysphoria, when participants first sought transitioning care and from whom, and whether they felt pressured to do so. Friendship group dynamics were also explored.

Various narratives of participants’ transitioning-detransitioning experiences were gathered and grouped, for example, those related to discrimination pressures, experiences of trauma or mental health conditions prior to transition, and reports of internalized homophobia.

Dr. Edwards-Leeper observed that the study offers a more extensive assessment of reasons for detransitioning than any other prior research in the field, which has been sparse.

A survey published in April found that detransitioners report significant unmet medical and psychological needs, and a lack of compassion and help from medical and mental health practitioners.

But another 2021 study concluded most detransitioners only reverted to their birth sex because of societal or family pressure, discrimination, or shift to a nonbinary identity.

“However, [Dr.] Littman’s study found that only a small percentage actually detransitioned for that reason [23%], whereas the majority detransitioned because of a change in how the individual understood being a male or female, resulting in becoming comfortable in their assigned gender [60%],” noted Dr. Edwards-Leeper.
 

Reasons for detransitioning

Asked to expand upon the motives for detransition identified in her study, Dr. Littman told this news organization: “We found remarkable breadth in the reasons given for detransitioning.” 

“I believe that we were able to capture the diversity of experiences around detransition because we reached out to communities that were strongly ‘protransition’ – like the World Professional Association for Transgender Health – and communities where individuals might be more skeptical about transition being universally beneficial, like detransition forums,” she said.

Speaking to the complexity of the experiences, 87% selected more than one reason for detransitioning.

The most common reason (60%) was becoming more comfortable identifying with their birth sex, followed by having concerns about potential medical complications from transitioning (49.0%).

Regarding those who became more comfortable with their natal sex, Dr. Littman noted that the finding adds “further support that gender dysphoria is not always permanent.”

She added that, “because most gender-dysphoric youth who are allowed to go through puberty grow up to be lesbian, gay, or bisexual (LGB) nontransgender adults, intervening too soon with medical treatments risks derailing their development as LGB individuals.”

Internalized homophobia or difficulty accepting themselves as lesbian, gay, or bisexual was reported by 23% of participants as a reason for transition and subsequent detransition. 

“For these people, transitioning could be interpreted as an attempt to escape the reality of being same-sex attracted and detransitioning was part of accepting themselves as homosexual or bisexual,” explained Dr. Littman.

“Exploring their distress and discomfort around sexual orientation issues may have been more helpful to them than medical and surgical transition or at least an important part of exploration,” she added in the article.
 

Societal pressure, friends, and social media also play a role

The latest first-hand reports also support prior work by Dr. Littman when she first identified the concept she termed rapid-onset gender dysphoria (ROGD) to describe a sudden transgender identification, usually in the early teenage years, and with no prior indication of any gender questioning.

ROGD, Dr. Littman believes, is strongly related to psychosocial factors, such as trauma, mental health problems, or social influence contributing to the development of gender dysphoria.

The current study found that 58% of respondents expressed the belief that the cause of their gender dysphoria was something specific, such as trauma, abuse, or a mental health condition, with respondents suggesting that transitioning prevented, or delayed, them from addressing their underlying mental health conditions. 

One participant is quoted as saying: “I was deeply uncomfortable with my secondary sex characteristics, which I now understand was a result of childhood trauma and associating my secondary sex characteristics with those events.”

Reflecting on their previous identification as transgender, more than a third of respondents reported that someone else told them their feelings meant they were transgender, and they believed them.

“This speaks to the effect social influence can have on people’s interpretation of their own feelings and their development of a transgender identity,” Dr. Littman remarked.

“Participants also listed several social media sources that encouraged them to believe that transitioning would help them,” she added.

Several friendship group dynamics suggestive of social influence were reported by a subset of respondents, including the fact that their friendship groups mocked people who were not transgender and their popularity increased when they announced they were going to transition. 
 

Pendulum has swung too far the other way

Natal females, who in recent years have made up most referrals, were younger than natal males when they sought transition and decided to detransition; and they stayed “transitioned” for a shorter period than natal males. They were also more likely to have experienced a trauma less than 1 year before the onset of gender dysphoria and were more likely to have felt pressured to transition. 

“Because the females in the study transitioned more recently than the males, they may have experienced a culture where there is more of a ‘push’ to transition,” Dr. Littman pointed out.

She added that, “20 years ago, gender-dysphoric patients were most likely to be underdiagnosed and undertreated. Now, the pendulum has swung the other way and patients are, in my opinion, more likely to be overdiagnosed and overtreated. I think we need to aim for somewhere between these two extremes and prioritize people getting the right treatment for the right reason for their distress.”

Dr. Djordjevic added that, with colleagues from Belgrade and the Netherlands, he has published accounts of the experiences of seven individuals who showed regret after gender-affirming surgery.

All of them were born male, “and we confirmed the very poor evaluation and transition process they underwent. We conclude that clinicians should be aware that not everyone with gender identity disorders need or want all elements of hormonal or surgical therapy,” he told this news organization.

Dr. Edwards-Leeper said that more long-term longitudinal studies are needed that follow individuals who undergo transition under different models of care.

“My prediction is that those who first engage in supportive, gender exploratory therapy, followed by comprehensive assessment, will have the best outcomes, perhaps even if they ultimately detransition, as these individuals will know that they did not jump into irreversible interventions too quickly and had time to make the best decision for themselves at the time,” she concluded.

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

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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

An experimental antiviral pill appears to work very well at keeping people who are at high risk of severe COVID-19 from being admitted to the hospital and dying, according to the drug’s maker, Pfizer.

The drug -- called Paxlovid -- was 89% effective, compared to a placebo, at preventing hospitalization or death in patients with COVID-19 who were at high risk of severe complications. The company says it plans to ask the FDA to authorize the drug for emergency use.

The medication appears to work so well that Pfizer has stopped enrollment in the trial of the drug, which works by blocking an enzyme called a protease that the new coronavirus needs to make more copies of itself.

Stopping a clinical trial is a rare action that’s typically taken when a therapy appears to be very effective or clearly dangerous. In both those cases, it’s considered unethical to continue a clinical trial where people are randomly assigned either an active drug or a placebo, when safer or more effective options are available to them.

In this case, the company said in a news release that the move was recommended by an independent panel of advisers who are overseeing the trial, called a data safety monitoring committee, and done in consultation with the FDA.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Albert Bourla, PhD, Pfizer chairman and chief executive officer. “These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In a randomized clinical trial that included more than 1,900 patients who tested positive for COVID-19 and were at risk for having severe complications for their infections, those who received Paxlovid within 3 days of the start of their symptoms were 89% less likely to be hospitalized than those who got a placebo pill -- three patients out of 389 who got the drug were hospitalized, compared with 27 out of 385 who got the placebo. Among patients who got the drug within 5 days of the start of their symptoms, six out of 607 were hospitalized within 28 days, compared to 41 out of 612 who got the placebo.

There were no deaths over the course of a month in patients who took Paxlovid, but 10 deaths in the group that got the placebo.

The news comes on the heels of an announcement in October by the drug company Merck that its experimental antiviral pill, molnupiravir, reduced the risk of hospitalization or death by 50% in patients with mild to moderate COVID, compared to a placebo.

The United Kingdom became the first country to authorize the use of molnupiravir, which is brand-named Lagevrio.

Stephen Griffin, PhD, an associate professor of medicine at the University of Leeds, hailed the success of both new antiviral pills.

“They both demonstrate that, with appropriate investment, the development of bespoke direct-acting antiviral drugs targeting SARS-CoV2 was eminently feasible and has ultimately proven far more successful than repurposing other drugs with questionable antiviral effects,” said Dr. Griffin, who was not involved in the development of either drug.

“The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection, and is also a vital element for the care of clinically vulnerable people who may be unable to either receive or respond to vaccines,” he said.

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

Designed to show noninferiority for treatment of coronary artery disease (CAD) in patients with diabetes, a head-to-head comparison of contemporary stents ended up showing that one was superior to the for the primary endpoint of target lesion failure (TLF).

HandmadePictures/Thinkstock

In the superiority analysis, the 35% relative reduction in the risk of TLF at 1 year for the Cre8 EVO (Alvimedica) stent relative to the Resolute Onyx (Medtronic) device reached significance, according to Rafael Romaguera, MD, PhD, an interventional cardiologist at the Bellvitge University Hospital, Barcelona.

At 1 year, the rates of TLF were 7.2% and 10.5% for the Cre8 EVO and Resolute Onyx stents, respectively. On the basis of noninferiority, the 3.73% reduction in TLF at 1 year among those receiving the Cre8 EVO device provided a highly significant confirmation of noninferiority (P < .001) and triggered the preplanned superiority analysis.

When the significant advantage on the TLF endpoint (P = .03) was broken down into its components, the Cre8 EVO stent was linked to numerically lower rates of cardiac death (2.1% vs. 2.7%), target vessel MI (5.3% vs. 7.2%), and target lesion revascularization (2.4% vs. 3.9%), according to the SUGAR (Second-Generation Drug-Eluting Stents in Diabetes) trial results presented at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

In a previous study comparing these devices, called the ReCre8 trial, the rates of TLF in an all-comer CAD population were similar at 1 year. When an updated 3-year analysis was presented earlier in 2021 at the Cardiovascular Research Technologies meeting, they remained similar.
 

Diabetes-centered trial was unmet need

The rationale for conducting a new trial limited to patients with diabetes was based on the greater risk in this population, according to Dr. Romaguera. He cited data that indicate the risk of major adverse cardiac events are about two times higher 2 years after stent implantation in patients with diabetes relative to those without, even when contemporary drug-eluting stents are used.

Both the Cre8 EVO and Resolute Onyx stent are drug eluting and employ contemporary architecture that provides the basis for marketing claims that they are suitable for complex patients; but they have differences.

“There are three features that I think differentiate the Cre8 EVO stent,” Dr. Romaguera reported at the meeting, sponsored by the Cardiovascular Research Foundation.

One is the absence of polymer, which contrasts with the permanent polymer of the Resolute device. This feature affects the dissolution of the anti-inflammatory drug and might be one explanation for the greater protection from ischemic events, according to Dr. Romaguera.

Another is the thickness of the struts, which range from 70 to 80 mm for the Cre8 EVO device and from 92 to 102 mm for the Resolute Onyx device. In experimental studies, strut thickness has been associated with greater risk of thrombus formation, although it is unclear if this modest difference is clinically significant.

Also important, the Cre8 EVO device employs sirolimus for an anti-inflammatory effect, while the Resolute Onyx elutes zotarolimus. Again, experimental evidence suggests a greater anti-inflammatory effect reduces the need for dual-antiplatelet therapy (DAPT); that might offer a relative advantage in patients with an elevated risk of bleeding.

It is not clear whether all of these features contribute to the better results observed in this trial in diabetes patients, but Dr. Romaguera indicated that the lower risk of TLF with Cre8 EVO is not just statistically significant but also clinically meaningful.

In SUGAR, which included 23 centers in Spain, 1,175 patients with confirmed diabetes scheduled for percutaneous intervention (PCI) were randomized to one of the two stents. The study was purposely designed with very few exclusion criteria.
 

SUGAR trial employed all-comer design

“This was an all-comer design and there was no limitation in regard to clinical presentation, complexity, number of lesions, or other disease features,” said Dr. Romaguera. The major exclusions were a life expectancy of less than 2 years and a contraindication to taking DAPT for at least 1 month,

The patients were almost equally divided between those who had a non–ST-segment elevation MI) and those with chronic coronary artery disease, but patients with a STEMI, representing about 12% of the population, were included. Almost all of the patients (about 95%) had type 2 diabetes; nearly one-third were on insulin at the time of randomization.

According to Dr. Romaguera, “SUGAR is the first powered trial to compare new-generation drug-eluting stents in patients with diabetes,” and he emphasized the all-comer design in supporting its clinical relevance.

Several of those participating in discussion of the trial during the late-breaker session agreed. Although the moderator, Gregg Stone, MD, of the Icahn School of Medicine at Mount Sinai, New York, expressed surprise that the trial “actually demonstrated superiority” given the difficulty of showing a difference between modern stents, he called the findings “remarkable.”

Others seemed to suggest that it would alter their practice.

“This study is sweet like sugar for us, because now we have a stent that is dedicated and fitted for the diabetic population,” said Gennaro Sardella, MD, of Sapienza University of Rome.

For Marc Etienne Jolicoeur, MD, an interventional cardiologist associated with Duke University, Durham, N.C., one of the impressive findings was the early separation of the curves in favor of Cre8 EVO. Calling SUGAR a “fantastic trial,” he indicated that the progressive advantage over time reinforced his impression that the difference is real.

However, David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta, was more circumspect. He did not express any criticisms of the trial, but he called for “a larger evidence base” before declaring the Cre8 EVO device a standard of care for patients with diabetes undergoing PCI.

The SUGAR results were published in the European Heart Journal at the time of presentation at the meeting.

The trial was funded by the Spanish Society of Cardiology. Dr. Romaguera reported financial relationships with Biotronik and Boston Scientific. Dr. Stone, has financial relationships with more than 10 pharmaceutical companies, including those developing devices used in PCI. Dr. Sardella and Dr. Jolicoeur reported no financial relationships relevant to this topic. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

Designed to show noninferiority for treatment of coronary artery disease (CAD) in patients with diabetes, a head-to-head comparison of contemporary stents ended up showing that one was superior to the for the primary endpoint of target lesion failure (TLF).

HandmadePictures/Thinkstock

In the superiority analysis, the 35% relative reduction in the risk of TLF at 1 year for the Cre8 EVO (Alvimedica) stent relative to the Resolute Onyx (Medtronic) device reached significance, according to Rafael Romaguera, MD, PhD, an interventional cardiologist at the Bellvitge University Hospital, Barcelona.

At 1 year, the rates of TLF were 7.2% and 10.5% for the Cre8 EVO and Resolute Onyx stents, respectively. On the basis of noninferiority, the 3.73% reduction in TLF at 1 year among those receiving the Cre8 EVO device provided a highly significant confirmation of noninferiority (P < .001) and triggered the preplanned superiority analysis.

When the significant advantage on the TLF endpoint (P = .03) was broken down into its components, the Cre8 EVO stent was linked to numerically lower rates of cardiac death (2.1% vs. 2.7%), target vessel MI (5.3% vs. 7.2%), and target lesion revascularization (2.4% vs. 3.9%), according to the SUGAR (Second-Generation Drug-Eluting Stents in Diabetes) trial results presented at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

In a previous study comparing these devices, called the ReCre8 trial, the rates of TLF in an all-comer CAD population were similar at 1 year. When an updated 3-year analysis was presented earlier in 2021 at the Cardiovascular Research Technologies meeting, they remained similar.
 

Diabetes-centered trial was unmet need

The rationale for conducting a new trial limited to patients with diabetes was based on the greater risk in this population, according to Dr. Romaguera. He cited data that indicate the risk of major adverse cardiac events are about two times higher 2 years after stent implantation in patients with diabetes relative to those without, even when contemporary drug-eluting stents are used.

Both the Cre8 EVO and Resolute Onyx stent are drug eluting and employ contemporary architecture that provides the basis for marketing claims that they are suitable for complex patients; but they have differences.

“There are three features that I think differentiate the Cre8 EVO stent,” Dr. Romaguera reported at the meeting, sponsored by the Cardiovascular Research Foundation.

One is the absence of polymer, which contrasts with the permanent polymer of the Resolute device. This feature affects the dissolution of the anti-inflammatory drug and might be one explanation for the greater protection from ischemic events, according to Dr. Romaguera.

Another is the thickness of the struts, which range from 70 to 80 mm for the Cre8 EVO device and from 92 to 102 mm for the Resolute Onyx device. In experimental studies, strut thickness has been associated with greater risk of thrombus formation, although it is unclear if this modest difference is clinically significant.

Also important, the Cre8 EVO device employs sirolimus for an anti-inflammatory effect, while the Resolute Onyx elutes zotarolimus. Again, experimental evidence suggests a greater anti-inflammatory effect reduces the need for dual-antiplatelet therapy (DAPT); that might offer a relative advantage in patients with an elevated risk of bleeding.

It is not clear whether all of these features contribute to the better results observed in this trial in diabetes patients, but Dr. Romaguera indicated that the lower risk of TLF with Cre8 EVO is not just statistically significant but also clinically meaningful.

In SUGAR, which included 23 centers in Spain, 1,175 patients with confirmed diabetes scheduled for percutaneous intervention (PCI) were randomized to one of the two stents. The study was purposely designed with very few exclusion criteria.
 

SUGAR trial employed all-comer design

“This was an all-comer design and there was no limitation in regard to clinical presentation, complexity, number of lesions, or other disease features,” said Dr. Romaguera. The major exclusions were a life expectancy of less than 2 years and a contraindication to taking DAPT for at least 1 month,

The patients were almost equally divided between those who had a non–ST-segment elevation MI) and those with chronic coronary artery disease, but patients with a STEMI, representing about 12% of the population, were included. Almost all of the patients (about 95%) had type 2 diabetes; nearly one-third were on insulin at the time of randomization.

According to Dr. Romaguera, “SUGAR is the first powered trial to compare new-generation drug-eluting stents in patients with diabetes,” and he emphasized the all-comer design in supporting its clinical relevance.

Several of those participating in discussion of the trial during the late-breaker session agreed. Although the moderator, Gregg Stone, MD, of the Icahn School of Medicine at Mount Sinai, New York, expressed surprise that the trial “actually demonstrated superiority” given the difficulty of showing a difference between modern stents, he called the findings “remarkable.”

Others seemed to suggest that it would alter their practice.

“This study is sweet like sugar for us, because now we have a stent that is dedicated and fitted for the diabetic population,” said Gennaro Sardella, MD, of Sapienza University of Rome.

For Marc Etienne Jolicoeur, MD, an interventional cardiologist associated with Duke University, Durham, N.C., one of the impressive findings was the early separation of the curves in favor of Cre8 EVO. Calling SUGAR a “fantastic trial,” he indicated that the progressive advantage over time reinforced his impression that the difference is real.

However, David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta, was more circumspect. He did not express any criticisms of the trial, but he called for “a larger evidence base” before declaring the Cre8 EVO device a standard of care for patients with diabetes undergoing PCI.

The SUGAR results were published in the European Heart Journal at the time of presentation at the meeting.

The trial was funded by the Spanish Society of Cardiology. Dr. Romaguera reported financial relationships with Biotronik and Boston Scientific. Dr. Stone, has financial relationships with more than 10 pharmaceutical companies, including those developing devices used in PCI. Dr. Sardella and Dr. Jolicoeur reported no financial relationships relevant to this topic. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

Designed to show noninferiority for treatment of coronary artery disease (CAD) in patients with diabetes, a head-to-head comparison of contemporary stents ended up showing that one was superior to the for the primary endpoint of target lesion failure (TLF).

HandmadePictures/Thinkstock

In the superiority analysis, the 35% relative reduction in the risk of TLF at 1 year for the Cre8 EVO (Alvimedica) stent relative to the Resolute Onyx (Medtronic) device reached significance, according to Rafael Romaguera, MD, PhD, an interventional cardiologist at the Bellvitge University Hospital, Barcelona.

At 1 year, the rates of TLF were 7.2% and 10.5% for the Cre8 EVO and Resolute Onyx stents, respectively. On the basis of noninferiority, the 3.73% reduction in TLF at 1 year among those receiving the Cre8 EVO device provided a highly significant confirmation of noninferiority (P < .001) and triggered the preplanned superiority analysis.

When the significant advantage on the TLF endpoint (P = .03) was broken down into its components, the Cre8 EVO stent was linked to numerically lower rates of cardiac death (2.1% vs. 2.7%), target vessel MI (5.3% vs. 7.2%), and target lesion revascularization (2.4% vs. 3.9%), according to the SUGAR (Second-Generation Drug-Eluting Stents in Diabetes) trial results presented at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando and sponsored by the Cardiovascular Research Foundation.

In a previous study comparing these devices, called the ReCre8 trial, the rates of TLF in an all-comer CAD population were similar at 1 year. When an updated 3-year analysis was presented earlier in 2021 at the Cardiovascular Research Technologies meeting, they remained similar.
 

Diabetes-centered trial was unmet need

The rationale for conducting a new trial limited to patients with diabetes was based on the greater risk in this population, according to Dr. Romaguera. He cited data that indicate the risk of major adverse cardiac events are about two times higher 2 years after stent implantation in patients with diabetes relative to those without, even when contemporary drug-eluting stents are used.

Both the Cre8 EVO and Resolute Onyx stent are drug eluting and employ contemporary architecture that provides the basis for marketing claims that they are suitable for complex patients; but they have differences.

“There are three features that I think differentiate the Cre8 EVO stent,” Dr. Romaguera reported at the meeting, sponsored by the Cardiovascular Research Foundation.

One is the absence of polymer, which contrasts with the permanent polymer of the Resolute device. This feature affects the dissolution of the anti-inflammatory drug and might be one explanation for the greater protection from ischemic events, according to Dr. Romaguera.

Another is the thickness of the struts, which range from 70 to 80 mm for the Cre8 EVO device and from 92 to 102 mm for the Resolute Onyx device. In experimental studies, strut thickness has been associated with greater risk of thrombus formation, although it is unclear if this modest difference is clinically significant.

Also important, the Cre8 EVO device employs sirolimus for an anti-inflammatory effect, while the Resolute Onyx elutes zotarolimus. Again, experimental evidence suggests a greater anti-inflammatory effect reduces the need for dual-antiplatelet therapy (DAPT); that might offer a relative advantage in patients with an elevated risk of bleeding.

It is not clear whether all of these features contribute to the better results observed in this trial in diabetes patients, but Dr. Romaguera indicated that the lower risk of TLF with Cre8 EVO is not just statistically significant but also clinically meaningful.

In SUGAR, which included 23 centers in Spain, 1,175 patients with confirmed diabetes scheduled for percutaneous intervention (PCI) were randomized to one of the two stents. The study was purposely designed with very few exclusion criteria.
 

SUGAR trial employed all-comer design

“This was an all-comer design and there was no limitation in regard to clinical presentation, complexity, number of lesions, or other disease features,” said Dr. Romaguera. The major exclusions were a life expectancy of less than 2 years and a contraindication to taking DAPT for at least 1 month,

The patients were almost equally divided between those who had a non–ST-segment elevation MI) and those with chronic coronary artery disease, but patients with a STEMI, representing about 12% of the population, were included. Almost all of the patients (about 95%) had type 2 diabetes; nearly one-third were on insulin at the time of randomization.

According to Dr. Romaguera, “SUGAR is the first powered trial to compare new-generation drug-eluting stents in patients with diabetes,” and he emphasized the all-comer design in supporting its clinical relevance.

Several of those participating in discussion of the trial during the late-breaker session agreed. Although the moderator, Gregg Stone, MD, of the Icahn School of Medicine at Mount Sinai, New York, expressed surprise that the trial “actually demonstrated superiority” given the difficulty of showing a difference between modern stents, he called the findings “remarkable.”

Others seemed to suggest that it would alter their practice.

“This study is sweet like sugar for us, because now we have a stent that is dedicated and fitted for the diabetic population,” said Gennaro Sardella, MD, of Sapienza University of Rome.

For Marc Etienne Jolicoeur, MD, an interventional cardiologist associated with Duke University, Durham, N.C., one of the impressive findings was the early separation of the curves in favor of Cre8 EVO. Calling SUGAR a “fantastic trial,” he indicated that the progressive advantage over time reinforced his impression that the difference is real.

However, David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta, was more circumspect. He did not express any criticisms of the trial, but he called for “a larger evidence base” before declaring the Cre8 EVO device a standard of care for patients with diabetes undergoing PCI.

The SUGAR results were published in the European Heart Journal at the time of presentation at the meeting.

The trial was funded by the Spanish Society of Cardiology. Dr. Romaguera reported financial relationships with Biotronik and Boston Scientific. Dr. Stone, has financial relationships with more than 10 pharmaceutical companies, including those developing devices used in PCI. Dr. Sardella and Dr. Jolicoeur reported no financial relationships relevant to this topic. Dr. Kandzari reported financial relationships with Ablative Solutions and Medtronic.

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

Increased mental health needs, higher acuity from delayed appointments, and added questions and conversations surrounding COVID-19 are forcing primary care offices to rethink priorities in office visits.

Evidence of this came from the latest Primary Care Collaborative (PCC) survey, which found that primary care clinicians are seeing more complex patients requiring longer appointments in the wake of COVID-19.

The PCC with the Larry A. Green Center regularly surveys primary care clinicians. This round of questions came August 14-17 and included 1,263 respondents from 49 states, the District of Columbia, and two territories.

More than 7 in 10 (71%) respondents said their patients are more complex and nearly the same percentage said appointments are taking more time.

Ann Greiner, president and CEO of the PCC, said in an interview that 55% of respondents reported that clinicians are struggling to keep up with pent-up demand after patients have delayed or canceled care. Sixty-five percent in the survey said they had seen a rise in children’s mental health issues, and 58% said they were unsure how to help their patients with long COVID.

In addition, primary care clinicians are having repeated conversations with patients on why they should get a vaccine and which one.

“I think that’s adding to the complexity. There is a lot going on here with patient trust,” Ms. Greiner said.
 

‘We’re going to be playing catch-up’

Jacqueline Fincher, MD, an internist in Thompson, Ga., said in an interview that appointments have gotten longer and more complex in the wake of the pandemic – “no question.”

The immediate past president of the American College of Physicians is seeing patients with chronic disease that has gone untreated for sometimes a year or more, she said.

“Their blood pressure was not under good control, they were under more stress, their sugars were up and weren’t being followed as closely for conditions such as congestive heart failure,” she said.

Dr. Fincher, who works in a rural practice 40 miles from Augusta, Ga., with her physician husband and two other physicians, said patients are ready to come back in, “but I don’t have enough slots for them.”

She said she prioritizes what to help patients with first and schedules the next tier for the next appointment, but added, “honestly, over the next 2 years we’re going to be playing catch-up.”

At the same time, the CDC has estimated that 45% of U.S. adults are at increased risk for complications from COVID-19 because of cardiovascular disease, diabetes, respiratory disease, hypertension, or cancer. Rates ranged from 19.8% for people 18-29 years old to 80.7% for people over 80 years of age.
 

Long COVID could overwhelm existing health care capacity

Primary care physicians are also having to diagnose sometimes “invisible” symptoms after people have recovered from acute COVID-19 infection. Diagnosing takes intent listening to patients who describe symptoms that tests can’t confirm.

As this news organization has previously reported, half of COVID-19 survivors report postacute sequelae of COVID-19 (PASC) lasting longer than 6 months.

“These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries,” the authors wrote.
 

Anxiety, depression ‘have gone off the charts’

Danielle Loeb, MD, MPH, associate professor of internal medicine at the University of Colorado in Denver, who studies complexity in primary care, said in the wake of COVID-19, more patients have developed “new, serious anxiety.”

Courtesy Dr. Danielle Loeb

“That got extremely exacerbated during the pandemic. Anxiety and depression have gone off the charts,” said Dr. Loeb, who prefers the pronoun “they.”

Dr. Loeb cares for a large number of transgender patients. As offices reopen, some patients are having trouble reintegrating into the workplace and resuming social contacts. The primary care doctor says appointments can get longer because of the need to complete tasks, such as filling out forms for Family Medical Leave Act for those not yet ready to return to work.

COVID-19–related fears are keeping many patients from coming into the office, Dr. Loeb said, either from fear of exposure or because they have mental health issues that keep them from feeling safe leaving the house.

“That really affects my ability to care for them,” they said.

Loss of employment in the pandemic or fear of job loss and subsequent changing of insurance has complicated primary care in terms of treatment and administrative tasks, according to Dr. Loeb.

To help treat patients with acute mental health issues and manage other patients, Dr. Loeb’s practice has brought in a social worker and a therapist.

Team-based care is key in the survival of primary care practices, though providing that is difficult in the smaller clinics because of the critical mass of patients needed to make it viable, they said.

“It’s the only answer. It’s the only way you don’t drown,” Dr. Loeb added. “I’m not drowning, and I credit that to my clinic having the help to support the mental health piece of things.”
 

Rethinking workflow

Tricia McGinnis, MPP, MPH, executive vice president of the nonprofit Center for Health Care Strategies (CHCS) says complexity has forced rethinking workflow.

“A lot of the trends we’re seeing in primary care were there pre-COVID, but COVID has exacerbated those trends,” she said in an interview.

“The good news ... is that it was already becoming clear that primary care needed to provide basic mental health services and integrate with behavioral health. It had also become clear that effective primary care needed to address social issues that keep patients from accessing health care,” she said.

Expanding care teams, as Dr. Loeb mentioned, is a key strategy, according to Ms. McGinnis. Potential teams would include the clinical staff, but also social workers and community health workers – people who come from the community primary care is serving who can help build trust with patients and connect the patient to the primary care team.

“There’s a lot that needs to happen that the clinician doesn’t need to do,” she said.

Telehealth can be a big factor in coordinating the team, Ms. McGinnis added.

“It’s thinking less about who’s doing the work, but more about the work that needs to be done to keep people healthy. Then let’s think about the type of workers best suited to perform those tasks,” she said.

As for reimbursing more complex care, population-based, up-front capitated payments linked to high-quality care and better outcomes will need to replace fee-for-service models, according to Ms. McGinnis.

That will provide reliable incomes for primary care offices, but also flexibility in how each patient with different levels of complexity is managed, she said.

Ms. Greiner, Dr. Fincher, Dr. Loeb, and Ms. McGinnis have no relevant financial relationships.

A new type of blood glucose monitoring system now available in the United States allows users to test with a single button-push instead of finger-sticking or inserting test strips into a meter.

The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.

It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.

An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.  

“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.

“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
 

How does POGO compare with CGM?

Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.

Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”

“Patients also need to obtain a prescription in order to use CGM.”

“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.

The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.

The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.  

The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.

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

A new type of blood glucose monitoring system now available in the United States allows users to test with a single button-push instead of finger-sticking or inserting test strips into a meter.

The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.

It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.

An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.  

“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.

“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
 

How does POGO compare with CGM?

Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.

Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”

“Patients also need to obtain a prescription in order to use CGM.”

“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.

The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.

The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.  

The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.

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

A new type of blood glucose monitoring system now available in the United States allows users to test with a single button-push instead of finger-sticking or inserting test strips into a meter.

The POGO Automatic Blood Glucose Monitoring System (Intuity Medical) has been cleared by the U.S. Food and Drug Administration for people with diabetes aged 13 years and older.

It contains a 10-test cartridge, and once loaded and the monitor is turned on, the user only has to press their finger on a button to activate POGO Automatic, which then does all the work of lancing and blood collection, followed by a 4-second countdown and a result. Users only need to carry the monitor and not separate lancets or strips.

An app called Patterns is available for iOS and Android that allows the results from the device to automatically sync via Bluetooth. It visually presents glucose trends and enables data sharing with health care providers.  

“We know that people with diabetes are more effective at managing their diabetes when they regularly check their blood glucose and use the information to take action,” said Daniel Einhorn, MD, medical director of Scripps Whittier Diabetes Institute, president of Diabetes and Endocrine Associates, and chairperson of the Intuity Medical Scientific Advisory Board, in a company statement.

“My patients and millions of others with diabetes have struggled for decades with the burden of checking their glucose because it’s complicated, there’s a lot to carry around, and it’s intrusive,” he added. “What they’ve needed is a simple, quick, and truly discreet way to check their blood glucose, so they’ll actually do it.”
 

How does POGO compare with CGM?

Continuous glucose monitors (CGMs), such as the Abbott FreeStyle Libre, Dexcom G6, and Eversense implant, are increasingly employed by people with type 1 diabetes, and some with type 2 diabetes, to keep a close eye on their blood glucose levels.

Asked how the POGO device compares with CGM systems, Intuity Chief Commercial Officer Dean Zikria said: “While [CGM] is certainly an important option for a subset of people with diabetes, CGM is a very different technology, requiring a user to wear a sensor and transmitter on their body.”

“Patients also need to obtain a prescription in order to use CGM.”

“Conversely, POGO Automatic is available with or without a prescription. POGO Automatic also gives people who do not want to wear a device on their body a new choice other than traditional blood glucose monitoring,” Mr. Zikria added.

The POGO system is available at U.S. pharmacies, including CVS and Walgreens, and can also be purchased online.

The device costs $68 from the company website and a pack of 5 cartridges (each containing 10 tests, with an aim of people performing 1-2 tests per day) costs a further $32 as a one-off, or $32 per month as a subscription.  

The product is also eligible for purchase using Flexible Spending Accounts and Health Savings Accounts.

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

The authors of a study purportedly showing that ivermectin could treat patients with SARS-CoV-2 have retracted their paper after acknowledging that their data were garbled.

The paper, “Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon,” appeared in the journal Viruses in May. According to the abstract: “A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received.”

Results results results … and: “Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.”

However, in early October, the BBC reported — in a larger piece about the concerns about ivermectin-Covid-19 research — that the study “was found to have blocks of details of 11 patients that had been copied and pasted repeatedly – suggesting many of the trial’s apparent patients didn’t really exist.”

The study’s authors told the BBC that the ‘original set of data was rigged, sabotaged or mistakenly entered in the final file’ and that they have submitted a retraction to the scientific journal which published it.

That’s not quite what the retraction notice states: “The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [ 1 ], cited above. Following publication, the authors contacted the editorial office regarding an error between files used for the statistical analysis. Adhering to our complaints procedure, an investigation was conducted that confirmed the error reported by the authors.

This retraction was approved by the Editor in Chief of the journal. The authors agreed to this retraction.”

Ali Samaha, of Lebanese University in Beirut, and the lead author of the study, told us: “It was brought to our attention that we have used wrong file for our paper. We informed immediately the journal and we have run investigations. After revising the raw data we realised that a file that was used to train a research assistant was sent by mistake for analysis. Re-analysing the original data , the conclusions of the paper remained valid. For our transparency we asked for retraction.”

About that BBC report? Samaha said: “The BBC article was generated before the report of independent reviewers who confirmed an innocent mistake by using wrong file.”

Samaha added that he and his colleagues are now considering whether to resubmit the paper.

The article has been cited four times, according to Clarivate Analytics’ Web of Science — including in this meta-analysis published in June in the American Journal of Therapeutics , which concluded that: “Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

That article was a social media darling, receiving more than 45,000 tweets and pickups in 90 news outlets, according to Altmetrics, which ranks it No. 7 among all papers published at that time.

A version of this article first appeared on Retraction Watch.

The authors of a study purportedly showing that ivermectin could treat patients with SARS-CoV-2 have retracted their paper after acknowledging that their data were garbled.

The paper, “Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon,” appeared in the journal Viruses in May. According to the abstract: “A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received.”

Results results results … and: “Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.”

However, in early October, the BBC reported — in a larger piece about the concerns about ivermectin-Covid-19 research — that the study “was found to have blocks of details of 11 patients that had been copied and pasted repeatedly – suggesting many of the trial’s apparent patients didn’t really exist.”

The study’s authors told the BBC that the ‘original set of data was rigged, sabotaged or mistakenly entered in the final file’ and that they have submitted a retraction to the scientific journal which published it.

That’s not quite what the retraction notice states: “The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [ 1 ], cited above. Following publication, the authors contacted the editorial office regarding an error between files used for the statistical analysis. Adhering to our complaints procedure, an investigation was conducted that confirmed the error reported by the authors.

This retraction was approved by the Editor in Chief of the journal. The authors agreed to this retraction.”

Ali Samaha, of Lebanese University in Beirut, and the lead author of the study, told us: “It was brought to our attention that we have used wrong file for our paper. We informed immediately the journal and we have run investigations. After revising the raw data we realised that a file that was used to train a research assistant was sent by mistake for analysis. Re-analysing the original data , the conclusions of the paper remained valid. For our transparency we asked for retraction.”

About that BBC report? Samaha said: “The BBC article was generated before the report of independent reviewers who confirmed an innocent mistake by using wrong file.”

Samaha added that he and his colleagues are now considering whether to resubmit the paper.

The article has been cited four times, according to Clarivate Analytics’ Web of Science — including in this meta-analysis published in June in the American Journal of Therapeutics , which concluded that: “Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

That article was a social media darling, receiving more than 45,000 tweets and pickups in 90 news outlets, according to Altmetrics, which ranks it No. 7 among all papers published at that time.

A version of this article first appeared on Retraction Watch.

The authors of a study purportedly showing that ivermectin could treat patients with SARS-CoV-2 have retracted their paper after acknowledging that their data were garbled.

The paper, “Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon,” appeared in the journal Viruses in May. According to the abstract: “A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received.”

Results results results … and: “Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.”

However, in early October, the BBC reported — in a larger piece about the concerns about ivermectin-Covid-19 research — that the study “was found to have blocks of details of 11 patients that had been copied and pasted repeatedly – suggesting many of the trial’s apparent patients didn’t really exist.”

The study’s authors told the BBC that the ‘original set of data was rigged, sabotaged or mistakenly entered in the final file’ and that they have submitted a retraction to the scientific journal which published it.

That’s not quite what the retraction notice states: “The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [ 1 ], cited above. Following publication, the authors contacted the editorial office regarding an error between files used for the statistical analysis. Adhering to our complaints procedure, an investigation was conducted that confirmed the error reported by the authors.

This retraction was approved by the Editor in Chief of the journal. The authors agreed to this retraction.”

Ali Samaha, of Lebanese University in Beirut, and the lead author of the study, told us: “It was brought to our attention that we have used wrong file for our paper. We informed immediately the journal and we have run investigations. After revising the raw data we realised that a file that was used to train a research assistant was sent by mistake for analysis. Re-analysing the original data , the conclusions of the paper remained valid. For our transparency we asked for retraction.”

About that BBC report? Samaha said: “The BBC article was generated before the report of independent reviewers who confirmed an innocent mistake by using wrong file.”

Samaha added that he and his colleagues are now considering whether to resubmit the paper.

The article has been cited four times, according to Clarivate Analytics’ Web of Science — including in this meta-analysis published in June in the American Journal of Therapeutics , which concluded that: “Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

That article was a social media darling, receiving more than 45,000 tweets and pickups in 90 news outlets, according to Altmetrics, which ranks it No. 7 among all papers published at that time.

A version of this article first appeared on Retraction Watch.

In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

• Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
• Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
• Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
• Choose healthy sources of protein, mostly from plants (legumes and nuts).
• Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
• Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
• Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
• Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
• Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
• If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
• While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
• Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

• Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
• Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
• Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
• Choose healthy sources of protein, mostly from plants (legumes and nuts).
• Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
• Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
• Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
• Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
• Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
• If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
• While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
• Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

In a new scientific statement on diet and lifestyle recommendations, the American Heart Association is highlighting, for the first time, structural challenges that impede the adoption of heart-healthy dietary patterns.

American Heart Association

This is in addition to stressing aspects of diet that improve cardiovascular health and reduce cardiovascular risk, with an emphasis on dietary patterns and food-based guidance beyond naming individual foods or nutrients.

The 2021 Dietary Guidance to Improve Cardiovascular Health scientific statement, developed under Alice H. Lichtenstein, DSc, chair of the AHA writing group, provides 10 evidence-based guidance recommendations to promote cardiometabolic health.

“The way to make heart-healthy choices every day,” said Dr. Lichtenstein, of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, in a statement, “is to step back, look at the environment in which you eat, whether it be at home, at work, during social interaction, and then identify what the best choices are. And if there are no good choices, then think about how you can modify your environment so that there are good choices.”

The statement, published in Circulation, underscores growing evidence that nutrition-related chronic diseases have maternal-nutritional origins, and that prevention of pediatric obesity is a key to preserving and prolonging ideal cardiovascular health.

The features are as follows:

• Adjust energy intake and expenditure to achieve and maintain a healthy body weight. To counter the shift toward higher energy intake and more sedentary lifestyles over the past 3 decades, the statement recommends at least 150 minutes of moderate physical activity per week, adjusted for individual’s age, activity level, sex, and size.
• Eat plenty of fruits and vegetables; choose a wide variety. Observational and intervention studies document that dietary patterns rich in varied fruits and vegetables, with the exception of white potatoes, are linked to a lower risk of cardiovascular disease (CVD). Also, whole fruits and vegetables, which more readily provide fiber and satiety, are preferred over juices.
• Choose whole grain foods and products made mostly with whole grains rather than refined grains. Evidence from observational, interventional, and clinical studies confirm the benefits of frequent consumption of whole grains over infrequent consumption or over refined grains in terms of CVD risk, coronary heart disease (CHD), stroke, metabolic syndrome, cardiometabolic risk factors, laxation, and gut microbiota.
• Choose healthy sources of protein, mostly from plants (legumes and nuts).
• Higher intake of legumes, which are rich in protein and fiber, is associated with lower CVD risk, while higher nut intake is associated with lower risks of CVD, CHD, and stroke mortality/incidence. Replacing animal-source foods with plant-source whole foods, beyond health benefits, lowers the diet’s carbon footprint. Meat alternatives are often ultraprocessed and evidence on their short- and long-term health effects is limited. Unsaturated fats are preferred, as are lean, nonprocessed meats.
• Use liquid plant oils rather than tropical oils (coconut, palm, and palm kernel), animal fats (butter and lard), and partially hydrogenated fats. Saturated and trans fats (animal and dairy fats, and partially hydrogenated fat) should be replaced with nontropical liquid plant oils. Evidence supports cardiovascular benefits of dietary unsaturated fats, especially polyunsaturated fats primarily from plant oils (e.g. soybean, corn, safflower and sunflower oils, walnuts, and flax seeds).
• Choose minimally processed foods instead of ultraprocessed foods. Because of their proven association with adverse health outcomes, including overweight and obesity, cardiometabolic disorders (type 2 diabetes, CVD), and all-cause mortality, the consumption of many ultraprocessed foods is of concern. Ultraprocessed foods include artificial colors and flavors and preservatives that promote shelf stability, preserve texture, and increase palatability. A general principle is to emphasize unprocessed or minimally processed foods.
• Minimize intake of beverages and foods with added sugars. Added sugars (commonly glucose, dextrose, sucrose, corn syrup, honey, maple syrup, and concentrated fruit juice) are tied to elevated risk for type 2 diabetes, high cholesterol, and excess body weight. Findings from meta-analyses on body weight and metabolic outcomes for replacing added sugars with low-energy sweeteners are mixed, and the possibility of reverse causality has been raised.
• Choose and prepare foods with little or no salt. In general, the effects of sodium reduction on blood pressure tend to be higher in Black people, middle-aged and older people, and those with hypertension. In the United States, the main combined sources of sodium intake are processed foods, those prepared outside the home, packaged foods, and restaurant foods. Potassium-enriched salts are a promising alternative.
• If you don’t drink alcohol, don’t start; if you choose to drink, limit intake.
• While relationships between alcohol intake and cardiovascular outcomes are complex, the 2020 Dietary Guidelines Advisory Committee recently concluded that those who do drink should consume no more than one drink per day and should not drink alcohol in binges; the 2020 Dietary Guidelines for Americans con­tinues to recommend no more than one drink per day for women and two drinks per day for men.
• Adhere to the guidance regardless in all settings. Food-based dietary guidance applies to all foods and beverages, regardless of where prepared, procured, and consumed. Policies should be enacted that encourage healthier default options (for example, whole grains, minimized sodium and sugar content).

Recognizing impediments

The AHA/ASA scientific statement closes with the declaration: “Creating an environment that facilitates, rather than impedes, adherence to heart-healthy dietary patterns among all individuals is a public health imperative.” It points to the National Institutes of Health’s 2020-2030 Strategic Plan for National Institutes of Health Nutrition Research, which focuses on precision nutrition as a means “to determine the impact on health of not only what individuals eat, but also of why, when, and how they eat throughout the life course.”

Ultimately, precision nutrition may provide personalized diets for CVD prevention. But the “food environment,” often conditioned by “rampant nutrition misinformation” through local, state, and federal practices and policies, may impede the adoption of heart-healthy dietary patterns. Factors such as targeted food marketing (for example, of processed food and beverages in minority neighborhoods), structural racism, neighborhood segregation, unhealthy built environments, and food insecurity create environments in which unhealthy foods are the default option.”

These factors compound adverse dietary and health effects, and underscore a need to “directly combat nutrition misinformation among the public and health care professionals.” They also explain why, despite widespread knowledge of heart-healthy dietary pattern components, little progress has been made in achieving dietary goals in the United States.

Dr. Lichtenstein’s office, in response to a request regarding AHA advocacy and consumer programs, provided the following links: Voices for Healthy Kids initiative site and choosing healthier processed foods and one on fresh, frozen, and canned fruits and vegetables.

Dr. Lichtenstein had no disclosures. Disclosures for the writing group members are included in the statement.

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

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

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

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

The Biden administration on Nov. 4 unveiled its rule to require most of the country’s larger employers to mandate workers be fully vaccinated against COVID-19, but set a Jan. 4 deadline, avoiding the busy holiday season.

The White House also shifted the time lines for earlier mandates applying to federal workers and contractors to Jan. 4. And the same deadline applies to a new separate rule for health care workers.

The new rules are meant to preempt “any inconsistent state or local laws,” including bans and limits on employers’ authority to require vaccination, masks, or testing, the White House said in a statement.

The rule on employers from the Occupational Safety and Health Administration will apply to organizations with 100 or more employees. These employers will need to make sure each worker is fully vaccinated or tests for COVID-19 on at least a weekly basis. The OSHA rule will also require that employers provide paid time for employees to get vaccinated and ensure that all unvaccinated workers wear a face mask in the workplace. This rule will cover 84 million employees. The OSHA rule will not apply to workplaces covered by either the Centers for Medicare & Medicaid Services rule or the federal contractor vaccination requirement

“The virus will not go away by itself, or because we wish it away: We have to act,” President Joe Biden said in a statement. “Vaccination is the single best pathway out of this pandemic.”

Mandates were not the preferred route to managing the pandemic, he said.

“Too many people remain unvaccinated for us to get out of this pandemic for good,” he said. “So I instituted requirements – and they are working.”

The White House said 70% percent of U.S. adults are now fully vaccinated – up from less than 1% when Mr. Biden took office in January.

The CMS vaccine rule is meant to cover more than 17 million workers and about 76,000 medical care sites, including hospitals, ambulatory surgery centers, nursing homes, dialysis facilities, home health agencies, and long-term care facilities. The rule will apply to employees whether their positions involve patient care or not.

Unlike the OSHA mandate, the one for health care workers will not offer the option of frequent COVID-19 testing instead of vaccination. There is a “higher bar” for health care workers, given their role in treating patients, so the mandate allows only for vaccination or limited exemptions, a senior administration official said on Nov. 3 during a call with reporters.

The CMS rule includes a “range of remedies,” including penalties and denial of payment for health care facilities that fail to meet the vaccine mandate. CMS could theoretically cut off hospitals and other medical organizations for failure to comply, but that would be a “last resort,” a senior administration official said. CMS will instead work with health care facilities to help them comply with the federal rule on vaccination of medical workers.

The new CMS rules apply only to Medicare- and Medicaid-certified centers and organizations. The rule does not directly apply to other health care entities, such as doctor’s offices, that are not regulated by CMS.

“Most states have separate licensing requirements for health care staff and health care providers that would be applicable to physician office staff and other staff in small health care entities that are not subject to vaccination requirements under this IFC,” CMS said in the rule.

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