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Living near hydraulic fracturing is associated with increased risk of hospitalization in people with heart failure (HF), a new study from Pennsylvania suggests.

The link was strongest among those with more severe heart failure but patients with either HF phenotype showed this association of increased risk with exposure to fracking activities, according to the investigators, led by Tara P. McAlexander, PhD, MPH, Drexel University Dornsife School of Public Health in Philadelphia.

“Our understanding has expanded well beyond the famous Harvard Six Cities study to know that it’s not just a short-term uptick in air pollution that›s going to send someone to the hospital a couple days later,” said Dr. McAlexander in an interview, referring to the study conducted from the mid-1970s through 1991. “We know that people who live in these environments and are exposed for long periods of time may have long-term detrimental effects.”

Although questions remain about specific mechanisms and how best to assess exposure, the evidence is mounting in a way that is consistent with the biologic hypotheses of how fracking would adversely affect health, Dr. McAlexander said. “We have many studies now on adverse pregnancy and birth outcomes, and that’s just the tip of the iceberg.”

Pennsylvania is a hot spot for fracking, also known as unconventional natural gas development (UNGD), with more than 12,000 wells drilled in the Marcellus shale since 2004. The shale extends from upstate New York in the north to northeastern Kentucky and Tennessee in the south and covers about 72,000 square miles. Last year, Pennsylvania pledged $3 million to study clusters of rare pediatric cancers and asthma near fracking operations. A recent grand jury report concluded government officials failed to protect residents from the health effects of fracking.

Fracking involves a cascade of activities that can trigger neural circuitry, sympathetic activation, and inflammation – all well-known pathways that potentiate heart failure, said Sanjay Rajagopalan, MD, who has researched the health effects of air pollution for two decades and was not involved with the study.

“If you think about it, it’s like environmental perturbation on steroids in some ways where they are pulling the trigger from a variety of different ways: noise, air pollution, social displacement, psychosocial impacts, economic disparities. So it’s not at all surprising that they saw an association,” said Dr. Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute and director of the Case Western Cardiovascular Research Institute, both in Cleveland, Ohio.

As reported in the Journal of the American College of Cardiology, Dr. McAlexander and colleagues at Johns Hopkins University, Baltimore, used electronic health data from the Geisinger Health System to identify 9,054 patients with heart failure seen between 2008 and 2015. Of these, 5,839 patients had an incident HF hospitalization and 3,215 served as controls. Geisinger operates 13 hospitals and two research centers in 45 of Pennsylvania’s 67 counties, serving more than 3 million of the state’s residents.

Patients’ residential addresses were used to identify latitude and longitude coordinates that were matched with 9,669 UNGD wells in Pennsylvania and the location of major and minor roadways. The researchers also calculated a measure of community socioeconomic deprivation.

The adjusted odds of hospitalization were higher for patients in the highest quartile of exposure for three of the four UNGD phases: pad preparation (odds ratio, 1.70; 95% confidence interval, 1.35-2.13), stimulation or the actual fracking (OR, 1.80; 95% CI, 1.35-2.40), and production (OR, 1.62; 95% CI, 1.07-2.45).

Dr. McAlexander said she initially thought the lack of association with drilling (OR, 0.97; 95% CI, 0.75-1.27) was a mistake but noted that the drilling metric reflects a shorter time period than, for example, 30 days needed to clear the well pad and bring in the necessary equipment.

Stronger associations between pad preparation, fracking, and production are also consistent with the known increases in air pollution, traffic, and noise associated with these phases.

Individuals with more severe HF had greater odds of hospitalization, but the effect sizes were generally comparable between HF with preserved versus reduced ejection fraction. For those with the highest exposure to fracking, the odds ratios for hospitalization reached 2.25 (95% CI, 1.56-3.25) and 2.09 (95% CI, 1.44-3.03), respectively.

Notably, patients who could be phenotyped versus those who could not were more likely to die, to be hospitalized for HF, and to have a higher Charlson Comorbidity Index and other relevant diagnoses like myocardial infarction.

“Clinicians need to be increasingly aware that the environments their patients are in are a huge factor in their disease progression and outlook,” McAlexander said. “We know that UNGD, specifically now, is something that could be impacting a heart failure patient’s survival.”

She also suggested that the findings may also spur more advocacy work and “across-silo” collaboration between clinicians and environmental researchers.

Dr. Rajagopalan said there is increasing recognition that physicians need to be aware of environmental health links as extreme events like the California and Oregon wildfires and coastal flooding become increasingly common. “Unfortunately, unconventional is becoming the new convention.”

The problem for many physicians, however, is just having enough bandwidth to get through the day and get enough learning to keep above water, he said. Artificial intelligence could be used to seed electronic medical records with other personalized information from a bevy of sources including smartphones and the internet of things, but fundamental changes are also needed in the educational process to emphasize the environment.

“It’s going to take a huge societal shift in the way we view commodities, what we consider healthy, etc, but it can happen very quickly because all it takes is a crisis like COVID-19 to bring people to their knees and make them understand how this is going to take over our lives over the next decade,” Dr. Rajagopalan said.

The scientific community has been calling for “good” epidemiologic studies on the health effects of fracking since the early 2010s, Barrak Alahmad, MBChB, MPH, Harvard T.H. Chan School of Public Health, and Haitham Khraishah, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, point out in an accompanying editorial.

The current study applied “extensive and rigorous methods” involving both the design and statistical approach, including use of a negative control analysis to assess for sources of spurious causal inference, several sensitivity analyses, and controlled for a wide range of covariates.

“Their results were consistent and robust across all these measures,” the editorialists wrote. “Most importantly, the effect size is probably too large to be explained away by an unmeasured confounder.”

Dr. Alahmad and Dr. Khraishah call for advancements in exposure assessment, citing a recent study reporting that ambient particle radioactivity near unconventional oil and gas sites could induce adverse health effects. Other unmet needs include a better understanding of racial disparities in the impacts of fracking and a fine-tuning of cause-specific cardiovascular morbidity and mortality.

The study was supported by training grants from the National Institute of Environmental Health Sciences to Dr. McAlexander and principal investigator Brian Schwartz, MD. The authors, Dr. Rajagopalan, Dr. Alahmad, and Dr. Khraishah have disclosed no relevant financial relationships.
 

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

Living near hydraulic fracturing is associated with increased risk of hospitalization in people with heart failure (HF), a new study from Pennsylvania suggests.

The link was strongest among those with more severe heart failure but patients with either HF phenotype showed this association of increased risk with exposure to fracking activities, according to the investigators, led by Tara P. McAlexander, PhD, MPH, Drexel University Dornsife School of Public Health in Philadelphia.

“Our understanding has expanded well beyond the famous Harvard Six Cities study to know that it’s not just a short-term uptick in air pollution that›s going to send someone to the hospital a couple days later,” said Dr. McAlexander in an interview, referring to the study conducted from the mid-1970s through 1991. “We know that people who live in these environments and are exposed for long periods of time may have long-term detrimental effects.”

Although questions remain about specific mechanisms and how best to assess exposure, the evidence is mounting in a way that is consistent with the biologic hypotheses of how fracking would adversely affect health, Dr. McAlexander said. “We have many studies now on adverse pregnancy and birth outcomes, and that’s just the tip of the iceberg.”

Pennsylvania is a hot spot for fracking, also known as unconventional natural gas development (UNGD), with more than 12,000 wells drilled in the Marcellus shale since 2004. The shale extends from upstate New York in the north to northeastern Kentucky and Tennessee in the south and covers about 72,000 square miles. Last year, Pennsylvania pledged $3 million to study clusters of rare pediatric cancers and asthma near fracking operations. A recent grand jury report concluded government officials failed to protect residents from the health effects of fracking.

Fracking involves a cascade of activities that can trigger neural circuitry, sympathetic activation, and inflammation – all well-known pathways that potentiate heart failure, said Sanjay Rajagopalan, MD, who has researched the health effects of air pollution for two decades and was not involved with the study.

“If you think about it, it’s like environmental perturbation on steroids in some ways where they are pulling the trigger from a variety of different ways: noise, air pollution, social displacement, psychosocial impacts, economic disparities. So it’s not at all surprising that they saw an association,” said Dr. Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute and director of the Case Western Cardiovascular Research Institute, both in Cleveland, Ohio.

As reported in the Journal of the American College of Cardiology, Dr. McAlexander and colleagues at Johns Hopkins University, Baltimore, used electronic health data from the Geisinger Health System to identify 9,054 patients with heart failure seen between 2008 and 2015. Of these, 5,839 patients had an incident HF hospitalization and 3,215 served as controls. Geisinger operates 13 hospitals and two research centers in 45 of Pennsylvania’s 67 counties, serving more than 3 million of the state’s residents.

Patients’ residential addresses were used to identify latitude and longitude coordinates that were matched with 9,669 UNGD wells in Pennsylvania and the location of major and minor roadways. The researchers also calculated a measure of community socioeconomic deprivation.

The adjusted odds of hospitalization were higher for patients in the highest quartile of exposure for three of the four UNGD phases: pad preparation (odds ratio, 1.70; 95% confidence interval, 1.35-2.13), stimulation or the actual fracking (OR, 1.80; 95% CI, 1.35-2.40), and production (OR, 1.62; 95% CI, 1.07-2.45).

Dr. McAlexander said she initially thought the lack of association with drilling (OR, 0.97; 95% CI, 0.75-1.27) was a mistake but noted that the drilling metric reflects a shorter time period than, for example, 30 days needed to clear the well pad and bring in the necessary equipment.

Stronger associations between pad preparation, fracking, and production are also consistent with the known increases in air pollution, traffic, and noise associated with these phases.

Individuals with more severe HF had greater odds of hospitalization, but the effect sizes were generally comparable between HF with preserved versus reduced ejection fraction. For those with the highest exposure to fracking, the odds ratios for hospitalization reached 2.25 (95% CI, 1.56-3.25) and 2.09 (95% CI, 1.44-3.03), respectively.

Notably, patients who could be phenotyped versus those who could not were more likely to die, to be hospitalized for HF, and to have a higher Charlson Comorbidity Index and other relevant diagnoses like myocardial infarction.

“Clinicians need to be increasingly aware that the environments their patients are in are a huge factor in their disease progression and outlook,” McAlexander said. “We know that UNGD, specifically now, is something that could be impacting a heart failure patient’s survival.”

She also suggested that the findings may also spur more advocacy work and “across-silo” collaboration between clinicians and environmental researchers.

Dr. Rajagopalan said there is increasing recognition that physicians need to be aware of environmental health links as extreme events like the California and Oregon wildfires and coastal flooding become increasingly common. “Unfortunately, unconventional is becoming the new convention.”

The problem for many physicians, however, is just having enough bandwidth to get through the day and get enough learning to keep above water, he said. Artificial intelligence could be used to seed electronic medical records with other personalized information from a bevy of sources including smartphones and the internet of things, but fundamental changes are also needed in the educational process to emphasize the environment.

“It’s going to take a huge societal shift in the way we view commodities, what we consider healthy, etc, but it can happen very quickly because all it takes is a crisis like COVID-19 to bring people to their knees and make them understand how this is going to take over our lives over the next decade,” Dr. Rajagopalan said.

The scientific community has been calling for “good” epidemiologic studies on the health effects of fracking since the early 2010s, Barrak Alahmad, MBChB, MPH, Harvard T.H. Chan School of Public Health, and Haitham Khraishah, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, point out in an accompanying editorial.

The current study applied “extensive and rigorous methods” involving both the design and statistical approach, including use of a negative control analysis to assess for sources of spurious causal inference, several sensitivity analyses, and controlled for a wide range of covariates.

“Their results were consistent and robust across all these measures,” the editorialists wrote. “Most importantly, the effect size is probably too large to be explained away by an unmeasured confounder.”

Dr. Alahmad and Dr. Khraishah call for advancements in exposure assessment, citing a recent study reporting that ambient particle radioactivity near unconventional oil and gas sites could induce adverse health effects. Other unmet needs include a better understanding of racial disparities in the impacts of fracking and a fine-tuning of cause-specific cardiovascular morbidity and mortality.

The study was supported by training grants from the National Institute of Environmental Health Sciences to Dr. McAlexander and principal investigator Brian Schwartz, MD. The authors, Dr. Rajagopalan, Dr. Alahmad, and Dr. Khraishah have disclosed no relevant financial relationships.
 

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

Living near hydraulic fracturing is associated with increased risk of hospitalization in people with heart failure (HF), a new study from Pennsylvania suggests.

The link was strongest among those with more severe heart failure but patients with either HF phenotype showed this association of increased risk with exposure to fracking activities, according to the investigators, led by Tara P. McAlexander, PhD, MPH, Drexel University Dornsife School of Public Health in Philadelphia.

“Our understanding has expanded well beyond the famous Harvard Six Cities study to know that it’s not just a short-term uptick in air pollution that›s going to send someone to the hospital a couple days later,” said Dr. McAlexander in an interview, referring to the study conducted from the mid-1970s through 1991. “We know that people who live in these environments and are exposed for long periods of time may have long-term detrimental effects.”

Although questions remain about specific mechanisms and how best to assess exposure, the evidence is mounting in a way that is consistent with the biologic hypotheses of how fracking would adversely affect health, Dr. McAlexander said. “We have many studies now on adverse pregnancy and birth outcomes, and that’s just the tip of the iceberg.”

Pennsylvania is a hot spot for fracking, also known as unconventional natural gas development (UNGD), with more than 12,000 wells drilled in the Marcellus shale since 2004. The shale extends from upstate New York in the north to northeastern Kentucky and Tennessee in the south and covers about 72,000 square miles. Last year, Pennsylvania pledged $3 million to study clusters of rare pediatric cancers and asthma near fracking operations. A recent grand jury report concluded government officials failed to protect residents from the health effects of fracking.

Fracking involves a cascade of activities that can trigger neural circuitry, sympathetic activation, and inflammation – all well-known pathways that potentiate heart failure, said Sanjay Rajagopalan, MD, who has researched the health effects of air pollution for two decades and was not involved with the study.

“If you think about it, it’s like environmental perturbation on steroids in some ways where they are pulling the trigger from a variety of different ways: noise, air pollution, social displacement, psychosocial impacts, economic disparities. So it’s not at all surprising that they saw an association,” said Dr. Rajagopalan, chief of cardiovascular medicine at University Hospitals Harrington Heart & Vascular Institute and director of the Case Western Cardiovascular Research Institute, both in Cleveland, Ohio.

As reported in the Journal of the American College of Cardiology, Dr. McAlexander and colleagues at Johns Hopkins University, Baltimore, used electronic health data from the Geisinger Health System to identify 9,054 patients with heart failure seen between 2008 and 2015. Of these, 5,839 patients had an incident HF hospitalization and 3,215 served as controls. Geisinger operates 13 hospitals and two research centers in 45 of Pennsylvania’s 67 counties, serving more than 3 million of the state’s residents.

Patients’ residential addresses were used to identify latitude and longitude coordinates that were matched with 9,669 UNGD wells in Pennsylvania and the location of major and minor roadways. The researchers also calculated a measure of community socioeconomic deprivation.

The adjusted odds of hospitalization were higher for patients in the highest quartile of exposure for three of the four UNGD phases: pad preparation (odds ratio, 1.70; 95% confidence interval, 1.35-2.13), stimulation or the actual fracking (OR, 1.80; 95% CI, 1.35-2.40), and production (OR, 1.62; 95% CI, 1.07-2.45).

Dr. McAlexander said she initially thought the lack of association with drilling (OR, 0.97; 95% CI, 0.75-1.27) was a mistake but noted that the drilling metric reflects a shorter time period than, for example, 30 days needed to clear the well pad and bring in the necessary equipment.

Stronger associations between pad preparation, fracking, and production are also consistent with the known increases in air pollution, traffic, and noise associated with these phases.

Individuals with more severe HF had greater odds of hospitalization, but the effect sizes were generally comparable between HF with preserved versus reduced ejection fraction. For those with the highest exposure to fracking, the odds ratios for hospitalization reached 2.25 (95% CI, 1.56-3.25) and 2.09 (95% CI, 1.44-3.03), respectively.

Notably, patients who could be phenotyped versus those who could not were more likely to die, to be hospitalized for HF, and to have a higher Charlson Comorbidity Index and other relevant diagnoses like myocardial infarction.

“Clinicians need to be increasingly aware that the environments their patients are in are a huge factor in their disease progression and outlook,” McAlexander said. “We know that UNGD, specifically now, is something that could be impacting a heart failure patient’s survival.”

She also suggested that the findings may also spur more advocacy work and “across-silo” collaboration between clinicians and environmental researchers.

Dr. Rajagopalan said there is increasing recognition that physicians need to be aware of environmental health links as extreme events like the California and Oregon wildfires and coastal flooding become increasingly common. “Unfortunately, unconventional is becoming the new convention.”

The problem for many physicians, however, is just having enough bandwidth to get through the day and get enough learning to keep above water, he said. Artificial intelligence could be used to seed electronic medical records with other personalized information from a bevy of sources including smartphones and the internet of things, but fundamental changes are also needed in the educational process to emphasize the environment.

“It’s going to take a huge societal shift in the way we view commodities, what we consider healthy, etc, but it can happen very quickly because all it takes is a crisis like COVID-19 to bring people to their knees and make them understand how this is going to take over our lives over the next decade,” Dr. Rajagopalan said.

The scientific community has been calling for “good” epidemiologic studies on the health effects of fracking since the early 2010s, Barrak Alahmad, MBChB, MPH, Harvard T.H. Chan School of Public Health, and Haitham Khraishah, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, point out in an accompanying editorial.

The current study applied “extensive and rigorous methods” involving both the design and statistical approach, including use of a negative control analysis to assess for sources of spurious causal inference, several sensitivity analyses, and controlled for a wide range of covariates.

“Their results were consistent and robust across all these measures,” the editorialists wrote. “Most importantly, the effect size is probably too large to be explained away by an unmeasured confounder.”

Dr. Alahmad and Dr. Khraishah call for advancements in exposure assessment, citing a recent study reporting that ambient particle radioactivity near unconventional oil and gas sites could induce adverse health effects. Other unmet needs include a better understanding of racial disparities in the impacts of fracking and a fine-tuning of cause-specific cardiovascular morbidity and mortality.

The study was supported by training grants from the National Institute of Environmental Health Sciences to Dr. McAlexander and principal investigator Brian Schwartz, MD. The authors, Dr. Rajagopalan, Dr. Alahmad, and Dr. Khraishah have disclosed no relevant financial relationships.
 

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

Coronary artery calcium (CAC) score as a measure of plaque burden more reliably predicts future cardiovascular (CV) risk in patients with suspected coronary disease (CAD) than whether or not the disease is obstructive, a large retrospective study suggests.

Indeed, CV risk went up in tandem with growing plaque burden regardless of whether there was obstructive disease in any coronary artery, defined as a 50% or greater stenosis by computed tomographic angiography (CTA).

The findings argue for plaque burden as measured by CAC score, rather than percent-stenosis severity, for guiding further treatment decisions in such patients, researchers say.

The research was based on more than 20,000 symptomatic patients referred to diagnostic CTA in the Western Denmark Heart Registry who were then followed for about 4 years for major CV events, including death, myocardial infarction, or stroke.

“What we show is that CAC is important for prognosis, and that patients with no stenosis have similar high risk as patients with stenosis when CAC burden is similar,” Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, said in an interview.

The guidelines “distinguish between primary and secondary prevention patients” based on the presence or absence of obstructive CAD, he said, but “our results challenge this long-held approach. We show that patients with nonobstructive CAD carry similar risk as patients with obstructive CAD.”

In practice, risk tends to be greater in patients with obstructive compared with nonobstructive CAD. But the reason “is simply that they normally have higher atherosclerosis burden,” Dr. Mortensen said. “When you stratify based on atherosclerosis burden, then patients with obstructive and nonobstructive CAD have similar risk.”

The analysis was published online Dec. 7 in the Journal of the American College of Cardiology with Mortensen as lead author.

Until recently, it had long been believed that CV-event risk was driven by ischemia – but “ischemia is just a surrogate for the extent of atherosclerotic disease,” Armin Arbab Zadeh, MD, PhD, MPH, who is not connected with the current study, said in an interview.

The finding that CV risk climbs with growing coronary plaque burden “essentially confirms” other recent studies, but with “added value in showing how well the calcium scores, compared to obstructive disease, track with risk. So it’s definitely a nice extension of the evidence,” said Dr. Zadeh, director of cardiac CT at Johns Hopkins University, Baltimore.

“This study clearly shows that there is no ischemia ‘threshold,’ that the risk starts from mild and goes up with the burden of atherosclerotic disease. We were essentially taught wrong for decades.”

Dr. Mortensen said that the new results “are in line with previous studies showing that atherosclerosis burden is very important for risk.” They also help explain why revascularization of patients with stable angina failed to cut the risk of MI or death in trials like COURAGE, FAME-2, and ISCHEMIA. It’s because “stenosis per se explains little of the risk compared to atherosclerosis burden.”

In the current analysis, for example, about 65% of events were in patients who did not show obstructive CAD at CTA. Its 23,759 patients with symptoms suggestive of CAD were referred for CTA from 2008 through 2017; 5,043 (21.2%) were found to have obstructive disease and 18,716 (78.8%) either had no CAD or nonobstructive disease.

About 4.4% of patients experienced a first major CV event over a median follow-up of 4.3 years. Only events occurring later than 90 days after CTA were counted in an effort to exclude any directly related to revascularization, Dr. Mortensen noted.

The risk of events went up proportionally with both CAC score and the number of coronaries with obstructive disease.

The number of major CV events per 1,000 person-years was 6.2 for patients with a CAC score of 0, of whom 87% had no CAD by CTA, 7% had nonobstructive CAD, and 6% had obstructive CAD.

The corresponding rate was 17.5 among patients with a CAC score >100-399 for a hazard ratio (HR) of 1.7 (95% confidence interval [CI] 1.4-2.1) vs. a CAC score of 0.

And it was 42.3 per 1,000 patient-years among patients with CAC score >1000, HR 3.4 (95% CI, 2.5-4.6) vs. a CAC score of 0. Among those with the highest-tier CAC score, none were without CAD by CTA, 17% had nonobstructive disease, and 83% had obstructive CAD.

The major CV event rate rose similarly by number of coronaries with obstructive disease. It was 6.1 per 1,000 person-years in patients with no CAD. But it was 12.3 in those with nonobstructive disease, HR 1.3 (95% CI 1.1-1.6), up to 34.7 in those with triple-vessel obstructive disease, HR 2.9 (95% CI 2.2-3.9), vs. no CAD.

However, in an analysis with stratification by CAC score tier (0, 1-99, 100-399, 400-1,000, and >1,000), obstructive CAD was not associated with increased major CV-event risk in any stratum. The findings were similar in each subgroup with 1-vessel, 2-vessel, or 3-vessel CAD when stratified by CAC score.

Nor did major CV event risk track with obstructive CAD in analyses by age or after excluding all patients who underwent coronary revascularization within 90 days of CTA, the group reported.

“I believe these results support the use of CTA as a first-line test in patients with symptoms suggestive of CAD, as it provides valuable information for both diagnosis and prognosis in symptomatic patients,” Dr. Mortensen said. Those found to have a higher burden of atherosclerosis, he added, should receive aggressive preventive therapy regardless of whether or not they have obstructive disease.

The evidence from this study and others “supports a CTA-based approach” in such patients, Dr. Zadeh said. “And I would go further to say that a stress test is really inadequate,” in that it “detects the disease at such a late stage, you’re missing the opportunity to identify these patients who have atherosclerotic disease while you can do something about it.”

Its continued use as a first-line test, Dr. Zadeh said, “is essentially, in my mind, dismissing the evidence.”

An accompanying editorial Todd C. Villines, MD, and Patricia Rodriguez Lozano, MD, of the University of Virginia, Charlottesville agreed that “it is time that the traditional definitions of primary and secondary prevention evolve to incorporate CAC and CTA measures of patient risk based on coronary artery plaque burden.”

But they pointed out some limitations of the current study.

“The authors compared CAC with ≥50% stenosis, not CAC to comprehensive, contemporary coronary CTA,” and so “did not assess numerous other well-validated measures of coronary plaque burden that are routinely obtained from coronary CTA that typically improve the prognostic accuracy of coronary CTA beyond stenosis alone.” Also not performed was “plaque quantification on coronary CTA, an emerging field of study.”

The editorialists noted that noncontrast CT as used in the study for CAC scoring “is generally not recommended as a standalone test in symptomatic patients. Most studies have shown that coronary CTA, a test that accurately detects stenosis and identifies all types of coronary atherosclerosis (calcified and noncalcified), has significantly higher diagnostic and prognostic accuracy than CAC when performed in symptomatic patients without known coronary artery disease.”

Dr. Mortensen has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Villines and Dr. Rodriguez Lozano have disclosed no relevant financial relationships. Dr. Zadeh disclosed receiving grant support from Canon Medical Systems.

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

Coronary artery calcium (CAC) score as a measure of plaque burden more reliably predicts future cardiovascular (CV) risk in patients with suspected coronary disease (CAD) than whether or not the disease is obstructive, a large retrospective study suggests.

Indeed, CV risk went up in tandem with growing plaque burden regardless of whether there was obstructive disease in any coronary artery, defined as a 50% or greater stenosis by computed tomographic angiography (CTA).

The findings argue for plaque burden as measured by CAC score, rather than percent-stenosis severity, for guiding further treatment decisions in such patients, researchers say.

The research was based on more than 20,000 symptomatic patients referred to diagnostic CTA in the Western Denmark Heart Registry who were then followed for about 4 years for major CV events, including death, myocardial infarction, or stroke.

“What we show is that CAC is important for prognosis, and that patients with no stenosis have similar high risk as patients with stenosis when CAC burden is similar,” Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, said in an interview.

The guidelines “distinguish between primary and secondary prevention patients” based on the presence or absence of obstructive CAD, he said, but “our results challenge this long-held approach. We show that patients with nonobstructive CAD carry similar risk as patients with obstructive CAD.”

In practice, risk tends to be greater in patients with obstructive compared with nonobstructive CAD. But the reason “is simply that they normally have higher atherosclerosis burden,” Dr. Mortensen said. “When you stratify based on atherosclerosis burden, then patients with obstructive and nonobstructive CAD have similar risk.”

The analysis was published online Dec. 7 in the Journal of the American College of Cardiology with Mortensen as lead author.

Until recently, it had long been believed that CV-event risk was driven by ischemia – but “ischemia is just a surrogate for the extent of atherosclerotic disease,” Armin Arbab Zadeh, MD, PhD, MPH, who is not connected with the current study, said in an interview.

The finding that CV risk climbs with growing coronary plaque burden “essentially confirms” other recent studies, but with “added value in showing how well the calcium scores, compared to obstructive disease, track with risk. So it’s definitely a nice extension of the evidence,” said Dr. Zadeh, director of cardiac CT at Johns Hopkins University, Baltimore.

“This study clearly shows that there is no ischemia ‘threshold,’ that the risk starts from mild and goes up with the burden of atherosclerotic disease. We were essentially taught wrong for decades.”

Dr. Mortensen said that the new results “are in line with previous studies showing that atherosclerosis burden is very important for risk.” They also help explain why revascularization of patients with stable angina failed to cut the risk of MI or death in trials like COURAGE, FAME-2, and ISCHEMIA. It’s because “stenosis per se explains little of the risk compared to atherosclerosis burden.”

In the current analysis, for example, about 65% of events were in patients who did not show obstructive CAD at CTA. Its 23,759 patients with symptoms suggestive of CAD were referred for CTA from 2008 through 2017; 5,043 (21.2%) were found to have obstructive disease and 18,716 (78.8%) either had no CAD or nonobstructive disease.

About 4.4% of patients experienced a first major CV event over a median follow-up of 4.3 years. Only events occurring later than 90 days after CTA were counted in an effort to exclude any directly related to revascularization, Dr. Mortensen noted.

The risk of events went up proportionally with both CAC score and the number of coronaries with obstructive disease.

The number of major CV events per 1,000 person-years was 6.2 for patients with a CAC score of 0, of whom 87% had no CAD by CTA, 7% had nonobstructive CAD, and 6% had obstructive CAD.

The corresponding rate was 17.5 among patients with a CAC score >100-399 for a hazard ratio (HR) of 1.7 (95% confidence interval [CI] 1.4-2.1) vs. a CAC score of 0.

And it was 42.3 per 1,000 patient-years among patients with CAC score >1000, HR 3.4 (95% CI, 2.5-4.6) vs. a CAC score of 0. Among those with the highest-tier CAC score, none were without CAD by CTA, 17% had nonobstructive disease, and 83% had obstructive CAD.

The major CV event rate rose similarly by number of coronaries with obstructive disease. It was 6.1 per 1,000 person-years in patients with no CAD. But it was 12.3 in those with nonobstructive disease, HR 1.3 (95% CI 1.1-1.6), up to 34.7 in those with triple-vessel obstructive disease, HR 2.9 (95% CI 2.2-3.9), vs. no CAD.

However, in an analysis with stratification by CAC score tier (0, 1-99, 100-399, 400-1,000, and >1,000), obstructive CAD was not associated with increased major CV-event risk in any stratum. The findings were similar in each subgroup with 1-vessel, 2-vessel, or 3-vessel CAD when stratified by CAC score.

Nor did major CV event risk track with obstructive CAD in analyses by age or after excluding all patients who underwent coronary revascularization within 90 days of CTA, the group reported.

“I believe these results support the use of CTA as a first-line test in patients with symptoms suggestive of CAD, as it provides valuable information for both diagnosis and prognosis in symptomatic patients,” Dr. Mortensen said. Those found to have a higher burden of atherosclerosis, he added, should receive aggressive preventive therapy regardless of whether or not they have obstructive disease.

The evidence from this study and others “supports a CTA-based approach” in such patients, Dr. Zadeh said. “And I would go further to say that a stress test is really inadequate,” in that it “detects the disease at such a late stage, you’re missing the opportunity to identify these patients who have atherosclerotic disease while you can do something about it.”

Its continued use as a first-line test, Dr. Zadeh said, “is essentially, in my mind, dismissing the evidence.”

An accompanying editorial Todd C. Villines, MD, and Patricia Rodriguez Lozano, MD, of the University of Virginia, Charlottesville agreed that “it is time that the traditional definitions of primary and secondary prevention evolve to incorporate CAC and CTA measures of patient risk based on coronary artery plaque burden.”

But they pointed out some limitations of the current study.

“The authors compared CAC with ≥50% stenosis, not CAC to comprehensive, contemporary coronary CTA,” and so “did not assess numerous other well-validated measures of coronary plaque burden that are routinely obtained from coronary CTA that typically improve the prognostic accuracy of coronary CTA beyond stenosis alone.” Also not performed was “plaque quantification on coronary CTA, an emerging field of study.”

The editorialists noted that noncontrast CT as used in the study for CAC scoring “is generally not recommended as a standalone test in symptomatic patients. Most studies have shown that coronary CTA, a test that accurately detects stenosis and identifies all types of coronary atherosclerosis (calcified and noncalcified), has significantly higher diagnostic and prognostic accuracy than CAC when performed in symptomatic patients without known coronary artery disease.”

Dr. Mortensen has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Villines and Dr. Rodriguez Lozano have disclosed no relevant financial relationships. Dr. Zadeh disclosed receiving grant support from Canon Medical Systems.

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

Coronary artery calcium (CAC) score as a measure of plaque burden more reliably predicts future cardiovascular (CV) risk in patients with suspected coronary disease (CAD) than whether or not the disease is obstructive, a large retrospective study suggests.

Indeed, CV risk went up in tandem with growing plaque burden regardless of whether there was obstructive disease in any coronary artery, defined as a 50% or greater stenosis by computed tomographic angiography (CTA).

The findings argue for plaque burden as measured by CAC score, rather than percent-stenosis severity, for guiding further treatment decisions in such patients, researchers say.

The research was based on more than 20,000 symptomatic patients referred to diagnostic CTA in the Western Denmark Heart Registry who were then followed for about 4 years for major CV events, including death, myocardial infarction, or stroke.

“What we show is that CAC is important for prognosis, and that patients with no stenosis have similar high risk as patients with stenosis when CAC burden is similar,” Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, said in an interview.

The guidelines “distinguish between primary and secondary prevention patients” based on the presence or absence of obstructive CAD, he said, but “our results challenge this long-held approach. We show that patients with nonobstructive CAD carry similar risk as patients with obstructive CAD.”

In practice, risk tends to be greater in patients with obstructive compared with nonobstructive CAD. But the reason “is simply that they normally have higher atherosclerosis burden,” Dr. Mortensen said. “When you stratify based on atherosclerosis burden, then patients with obstructive and nonobstructive CAD have similar risk.”

The analysis was published online Dec. 7 in the Journal of the American College of Cardiology with Mortensen as lead author.

Until recently, it had long been believed that CV-event risk was driven by ischemia – but “ischemia is just a surrogate for the extent of atherosclerotic disease,” Armin Arbab Zadeh, MD, PhD, MPH, who is not connected with the current study, said in an interview.

The finding that CV risk climbs with growing coronary plaque burden “essentially confirms” other recent studies, but with “added value in showing how well the calcium scores, compared to obstructive disease, track with risk. So it’s definitely a nice extension of the evidence,” said Dr. Zadeh, director of cardiac CT at Johns Hopkins University, Baltimore.

“This study clearly shows that there is no ischemia ‘threshold,’ that the risk starts from mild and goes up with the burden of atherosclerotic disease. We were essentially taught wrong for decades.”

Dr. Mortensen said that the new results “are in line with previous studies showing that atherosclerosis burden is very important for risk.” They also help explain why revascularization of patients with stable angina failed to cut the risk of MI or death in trials like COURAGE, FAME-2, and ISCHEMIA. It’s because “stenosis per se explains little of the risk compared to atherosclerosis burden.”

In the current analysis, for example, about 65% of events were in patients who did not show obstructive CAD at CTA. Its 23,759 patients with symptoms suggestive of CAD were referred for CTA from 2008 through 2017; 5,043 (21.2%) were found to have obstructive disease and 18,716 (78.8%) either had no CAD or nonobstructive disease.

About 4.4% of patients experienced a first major CV event over a median follow-up of 4.3 years. Only events occurring later than 90 days after CTA were counted in an effort to exclude any directly related to revascularization, Dr. Mortensen noted.

The risk of events went up proportionally with both CAC score and the number of coronaries with obstructive disease.

The number of major CV events per 1,000 person-years was 6.2 for patients with a CAC score of 0, of whom 87% had no CAD by CTA, 7% had nonobstructive CAD, and 6% had obstructive CAD.

The corresponding rate was 17.5 among patients with a CAC score >100-399 for a hazard ratio (HR) of 1.7 (95% confidence interval [CI] 1.4-2.1) vs. a CAC score of 0.

And it was 42.3 per 1,000 patient-years among patients with CAC score >1000, HR 3.4 (95% CI, 2.5-4.6) vs. a CAC score of 0. Among those with the highest-tier CAC score, none were without CAD by CTA, 17% had nonobstructive disease, and 83% had obstructive CAD.

The major CV event rate rose similarly by number of coronaries with obstructive disease. It was 6.1 per 1,000 person-years in patients with no CAD. But it was 12.3 in those with nonobstructive disease, HR 1.3 (95% CI 1.1-1.6), up to 34.7 in those with triple-vessel obstructive disease, HR 2.9 (95% CI 2.2-3.9), vs. no CAD.

However, in an analysis with stratification by CAC score tier (0, 1-99, 100-399, 400-1,000, and >1,000), obstructive CAD was not associated with increased major CV-event risk in any stratum. The findings were similar in each subgroup with 1-vessel, 2-vessel, or 3-vessel CAD when stratified by CAC score.

Nor did major CV event risk track with obstructive CAD in analyses by age or after excluding all patients who underwent coronary revascularization within 90 days of CTA, the group reported.

“I believe these results support the use of CTA as a first-line test in patients with symptoms suggestive of CAD, as it provides valuable information for both diagnosis and prognosis in symptomatic patients,” Dr. Mortensen said. Those found to have a higher burden of atherosclerosis, he added, should receive aggressive preventive therapy regardless of whether or not they have obstructive disease.

The evidence from this study and others “supports a CTA-based approach” in such patients, Dr. Zadeh said. “And I would go further to say that a stress test is really inadequate,” in that it “detects the disease at such a late stage, you’re missing the opportunity to identify these patients who have atherosclerotic disease while you can do something about it.”

Its continued use as a first-line test, Dr. Zadeh said, “is essentially, in my mind, dismissing the evidence.”

An accompanying editorial Todd C. Villines, MD, and Patricia Rodriguez Lozano, MD, of the University of Virginia, Charlottesville agreed that “it is time that the traditional definitions of primary and secondary prevention evolve to incorporate CAC and CTA measures of patient risk based on coronary artery plaque burden.”

But they pointed out some limitations of the current study.

“The authors compared CAC with ≥50% stenosis, not CAC to comprehensive, contemporary coronary CTA,” and so “did not assess numerous other well-validated measures of coronary plaque burden that are routinely obtained from coronary CTA that typically improve the prognostic accuracy of coronary CTA beyond stenosis alone.” Also not performed was “plaque quantification on coronary CTA, an emerging field of study.”

The editorialists noted that noncontrast CT as used in the study for CAC scoring “is generally not recommended as a standalone test in symptomatic patients. Most studies have shown that coronary CTA, a test that accurately detects stenosis and identifies all types of coronary atherosclerosis (calcified and noncalcified), has significantly higher diagnostic and prognostic accuracy than CAC when performed in symptomatic patients without known coronary artery disease.”

Dr. Mortensen has disclosed no relevant financial relationships. Disclosures for the other authors are in the report. Dr. Villines and Dr. Rodriguez Lozano have disclosed no relevant financial relationships. Dr. Zadeh disclosed receiving grant support from Canon Medical Systems.

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

Adults with rosacea had a significantly higher prevalence of multiple risk factors for cardiometabolic disease, according to the results of a meta-analysis of more than 50,000 patients.

To date, “mounting comorbidities of rosacea have been identified, suggesting that rosacea is not simply a skin disease but has links to multiple systemic illnesses,” wrote Qi Chen, MD, of Central South University, Changsha, China, and colleagues. The association with rosacea and cardiometabolic disease has been controversial, they added.

In a study published in the Journal of the American Academy of Dermatology, they identified 13 studies including 50,442 rosacea patients and 1,525,864 controls. Approximately 71% of the rosacea patients were women.

Overall, patients with rosacea showed a statistically significant association for hypertension (risk ratio, 1.20; 95% confidence interval, 1.08-1.34; P = .001) and dyslipidemia (RR, 1.32; 95% CI, 1.10-1.58; P = .002). Specifically, rosacea patients averaged higher standard mean differences of systolic and diastolic blood pressure, total cholesterol, HDL cholesterol and LDL cholesterol, and triglycerides, compared with controls.

Rosacea was not significantly associated with an increased risk for ischemic heart disease, stroke, or diabetes, although the rosacea patients showed significantly increased risk of higher fasting blood glucose, compared with controls.
 

Findings don’t show causality

The study findings were limited by several factors, including the observational nature of some of the studies and the inability to perform subgroup analyses based on subtype and disease severity, the researchers noted. In addition, most of the rosacea patients were outpatients. “Further investigations are warranted to identify the relationship between rosacea and [cardiometabolic disease] in general populations to further validate the significance of our findings.”

However, the results support the value of screening for cardiometabolic disease in rosacea patients to facilitate diagnosis and treatment of disease at an early stage, they concluded.

“Rosacea has been linked statistically to many comorbidities including depression, anxiety, hypertension, and diabetes mellitus,” Julie Harper, MD, of the Dermatology and Skin Care Center of Birmingham (Alabama), said in an interview.

“This study looked more specifically at cardiometabolic disease and found a statistically significant correlation between rosacea and hypertension, higher total cholesterol, higher triglycerides and higher fasting blood glucose,” she said. However, “while there is an association present in this meta-analysis, we cannot assume a cause-and-effect relationship.”

Although the analysis does not prove causality, the key message for clinicians is that cardiometabolic disease is quite common in rosacea patients, and risk factors should be identified and treated early, said Dr. Harper. “Our patients with and without rosacea will benefit from age-appropriate screening, physical examination, and laboratory evaluation with a primary care physician. For rosacea patients in particular, we can advise them that early research suggests that individuals with rosacea might have an increased risk of hypertension and/or high cholesterol and triglycerides. It never hurts to make an appointment with primary care and to be checked.”

“We need more confirmatory studies that minimize the influence of confounding,” Dr. Harper added. Rosacea also has also been linked to obesity, which is another risk factor for cardiometabolic disease.

The study was supported by multiple grants from the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose. Dr. Harper had no relevant financial conflicts to disclose.

SOURCE: Chen Q et al. J Am Acad Dermatol. 2020 Nov;83(5):1331-40.

Adults with rosacea had a significantly higher prevalence of multiple risk factors for cardiometabolic disease, according to the results of a meta-analysis of more than 50,000 patients.

To date, “mounting comorbidities of rosacea have been identified, suggesting that rosacea is not simply a skin disease but has links to multiple systemic illnesses,” wrote Qi Chen, MD, of Central South University, Changsha, China, and colleagues. The association with rosacea and cardiometabolic disease has been controversial, they added.

In a study published in the Journal of the American Academy of Dermatology, they identified 13 studies including 50,442 rosacea patients and 1,525,864 controls. Approximately 71% of the rosacea patients were women.

Overall, patients with rosacea showed a statistically significant association for hypertension (risk ratio, 1.20; 95% confidence interval, 1.08-1.34; P = .001) and dyslipidemia (RR, 1.32; 95% CI, 1.10-1.58; P = .002). Specifically, rosacea patients averaged higher standard mean differences of systolic and diastolic blood pressure, total cholesterol, HDL cholesterol and LDL cholesterol, and triglycerides, compared with controls.

Rosacea was not significantly associated with an increased risk for ischemic heart disease, stroke, or diabetes, although the rosacea patients showed significantly increased risk of higher fasting blood glucose, compared with controls.
 

Findings don’t show causality

The study findings were limited by several factors, including the observational nature of some of the studies and the inability to perform subgroup analyses based on subtype and disease severity, the researchers noted. In addition, most of the rosacea patients were outpatients. “Further investigations are warranted to identify the relationship between rosacea and [cardiometabolic disease] in general populations to further validate the significance of our findings.”

However, the results support the value of screening for cardiometabolic disease in rosacea patients to facilitate diagnosis and treatment of disease at an early stage, they concluded.

“Rosacea has been linked statistically to many comorbidities including depression, anxiety, hypertension, and diabetes mellitus,” Julie Harper, MD, of the Dermatology and Skin Care Center of Birmingham (Alabama), said in an interview.

“This study looked more specifically at cardiometabolic disease and found a statistically significant correlation between rosacea and hypertension, higher total cholesterol, higher triglycerides and higher fasting blood glucose,” she said. However, “while there is an association present in this meta-analysis, we cannot assume a cause-and-effect relationship.”

Although the analysis does not prove causality, the key message for clinicians is that cardiometabolic disease is quite common in rosacea patients, and risk factors should be identified and treated early, said Dr. Harper. “Our patients with and without rosacea will benefit from age-appropriate screening, physical examination, and laboratory evaluation with a primary care physician. For rosacea patients in particular, we can advise them that early research suggests that individuals with rosacea might have an increased risk of hypertension and/or high cholesterol and triglycerides. It never hurts to make an appointment with primary care and to be checked.”

“We need more confirmatory studies that minimize the influence of confounding,” Dr. Harper added. Rosacea also has also been linked to obesity, which is another risk factor for cardiometabolic disease.

The study was supported by multiple grants from the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose. Dr. Harper had no relevant financial conflicts to disclose.

SOURCE: Chen Q et al. J Am Acad Dermatol. 2020 Nov;83(5):1331-40.

Adults with rosacea had a significantly higher prevalence of multiple risk factors for cardiometabolic disease, according to the results of a meta-analysis of more than 50,000 patients.

To date, “mounting comorbidities of rosacea have been identified, suggesting that rosacea is not simply a skin disease but has links to multiple systemic illnesses,” wrote Qi Chen, MD, of Central South University, Changsha, China, and colleagues. The association with rosacea and cardiometabolic disease has been controversial, they added.

In a study published in the Journal of the American Academy of Dermatology, they identified 13 studies including 50,442 rosacea patients and 1,525,864 controls. Approximately 71% of the rosacea patients were women.

Overall, patients with rosacea showed a statistically significant association for hypertension (risk ratio, 1.20; 95% confidence interval, 1.08-1.34; P = .001) and dyslipidemia (RR, 1.32; 95% CI, 1.10-1.58; P = .002). Specifically, rosacea patients averaged higher standard mean differences of systolic and diastolic blood pressure, total cholesterol, HDL cholesterol and LDL cholesterol, and triglycerides, compared with controls.

Rosacea was not significantly associated with an increased risk for ischemic heart disease, stroke, or diabetes, although the rosacea patients showed significantly increased risk of higher fasting blood glucose, compared with controls.
 

Findings don’t show causality

The study findings were limited by several factors, including the observational nature of some of the studies and the inability to perform subgroup analyses based on subtype and disease severity, the researchers noted. In addition, most of the rosacea patients were outpatients. “Further investigations are warranted to identify the relationship between rosacea and [cardiometabolic disease] in general populations to further validate the significance of our findings.”

However, the results support the value of screening for cardiometabolic disease in rosacea patients to facilitate diagnosis and treatment of disease at an early stage, they concluded.

“Rosacea has been linked statistically to many comorbidities including depression, anxiety, hypertension, and diabetes mellitus,” Julie Harper, MD, of the Dermatology and Skin Care Center of Birmingham (Alabama), said in an interview.

“This study looked more specifically at cardiometabolic disease and found a statistically significant correlation between rosacea and hypertension, higher total cholesterol, higher triglycerides and higher fasting blood glucose,” she said. However, “while there is an association present in this meta-analysis, we cannot assume a cause-and-effect relationship.”

Although the analysis does not prove causality, the key message for clinicians is that cardiometabolic disease is quite common in rosacea patients, and risk factors should be identified and treated early, said Dr. Harper. “Our patients with and without rosacea will benefit from age-appropriate screening, physical examination, and laboratory evaluation with a primary care physician. For rosacea patients in particular, we can advise them that early research suggests that individuals with rosacea might have an increased risk of hypertension and/or high cholesterol and triglycerides. It never hurts to make an appointment with primary care and to be checked.”

“We need more confirmatory studies that minimize the influence of confounding,” Dr. Harper added. Rosacea also has also been linked to obesity, which is another risk factor for cardiometabolic disease.

The study was supported by multiple grants from the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose. Dr. Harper had no relevant financial conflicts to disclose.

SOURCE: Chen Q et al. J Am Acad Dermatol. 2020 Nov;83(5):1331-40.

Higher doses of vitamin D supplementation not only show no benefit in the prevention of falls in older adults at increased risk of falling, compared with the lowest doses, but they appear to increase the risk, new research shows.

Zbynek Pospisil/iStock/Getty Images

Based on the findings, supplemental vitamin D above the minimum dose of 200 IU/day likely has little benefit, lead author Lawrence J. Appel, MD, MPH, told this news organization.

“In the absence of any benefit of 1,000 IU/day versus 2,000 IU/day [of vitamin D supplementation] on falls, along with the potential for harm from doses above 1,000 IU/day, it is hard to recommend a dose above 200 IU/day in older-aged persons, unless there is a compelling reason,” asserted Dr. Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins Bloomberg School of Public Health in Baltimore.

“More is not always better – and it may even be worse,” when it comes to vitamin D’s role in the prevention of falls, he said.

The research, published in Annals of Internal Medicine, adds important evidence in the ongoing struggle to prevent falls, says Bruce R. Troen, MD, in an accompanying editorial.

“Falls and their deleterious consequences remain a substantial risk for older adults and a huge challenge for health care teams,” writes Dr. Troen, a physician-investigator with the Veterans Affairs Western New York Healthcare System.

However, commenting in an interview, Dr. Troen cautions: “There are many epidemiological studies that are correlative, not causative, that do show a likelihood for benefit [with vitamin D supplementation]. … Therefore, there’s no reason for clinicians to discontinue vitamin D in individuals because of this study.”

“If you’re monitoring an older adult who is frail and has multiple comorbidities, you want to know what their vitamin D level is [and] provide them an appropriate supplement if needed,” he emphasized.

Some guidelines already reflect the lack of evidence of any role of vitamin D supplementation in the prevention of falls, including those of the 2018 U.S. Preventive Services Task Force, which, in a reversal of its 2012 recommendation, now does not recommend vitamin D supplementation for fall prevention in older persons without osteoporosis or vitamin D deficiency, Dr. Appel and colleagues note.
 

No prevention of falls regardless of baseline vitamin D

As part of STURDY (Study to understand fall reduction and vitamin D in you), Dr. Appel and colleagues enrolled 688 community-dwelling participants who had an elevated risk of falling, defined as a serum 25-hydroxyvitamin D [25(OH)D] level of 25 to 72.5 nmol/L (10-29 ng/dL).

Participants were a mean age of 77.2 years and had a mean total 25(OH)D level of 55.3 nmol/L at enrollment.

They were randomized to one of four doses of vitamin D₃, including 200 IU/day (the control group), or 1,000, 2,000, or 4,000 IU/day.

The highest doses were found to be associated with worse – not better – outcomes including a shorter time to hospitalization or death, compared with the 1,000-IU/day group. The higher-dose groups were therefore switched to a dose of 1,000 IU/day or lower, and all participants were followed for up to 2 years.

Overall, 63% experienced falls over the course of the study, which, though high, was consistent with the study’s criteria of participants having an elevated fall risk.

Of the 667 participants who completed the trial, no benefit in prevention of falling was seen across any of the doses, compared with the control group dose of 200 IU/day, regardless of participants’ baseline vitamin D levels.

Safety analyses showed that even in the 1,000-IU/day group, a higher risk of first serious fall and first fall with hospitalization was seen compared with the 200-IU/day group.

A limitation is that the study did not have a placebo group, however, “200 IU/day is a very small dose, probably homeopathic,” Dr. Appel said. “It was likely close to a placebo,” he said.
 

Caveats: comorbidities, subgroups

In his editorial, Dr. Troen notes other studies, including VITAL (Vitamin D and Omega-3 Trial) also found no reduction in falls with higher vitamin D doses; however, that study did not show any significant risks with the higher doses.

He adds that the current study lacks information on subsets of participants.

“We don’t have enough information about the existing comorbidities and medications that these people are on to be able to pull back the layers. Maybe there is a subgroup that should not be getting 4,000 IU, whereas another subgroup may not be harmed and you may decide that patient can benefit,” he said.

Furthermore, the trial doesn’t address groups such as nursing home residents.

“I have, for instance, 85-year-olds with vitamin D levels of maybe 20 nmol/L with multiple medical issues, but levels that low were not included in the study, so this is a tricky business, but the bottom line is first, do no harm,” he said.

“We really need trials that factor in the multiple different aspects so we can come up, hopefully, with a holistic and interdisciplinary approach, which is usually the best way to optimize care for frail older adults,” he concluded.

The study received funding from the National Institute of Aging.
 

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

Higher doses of vitamin D supplementation not only show no benefit in the prevention of falls in older adults at increased risk of falling, compared with the lowest doses, but they appear to increase the risk, new research shows.

Zbynek Pospisil/iStock/Getty Images

Based on the findings, supplemental vitamin D above the minimum dose of 200 IU/day likely has little benefit, lead author Lawrence J. Appel, MD, MPH, told this news organization.

“In the absence of any benefit of 1,000 IU/day versus 2,000 IU/day [of vitamin D supplementation] on falls, along with the potential for harm from doses above 1,000 IU/day, it is hard to recommend a dose above 200 IU/day in older-aged persons, unless there is a compelling reason,” asserted Dr. Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins Bloomberg School of Public Health in Baltimore.

“More is not always better – and it may even be worse,” when it comes to vitamin D’s role in the prevention of falls, he said.

The research, published in Annals of Internal Medicine, adds important evidence in the ongoing struggle to prevent falls, says Bruce R. Troen, MD, in an accompanying editorial.

“Falls and their deleterious consequences remain a substantial risk for older adults and a huge challenge for health care teams,” writes Dr. Troen, a physician-investigator with the Veterans Affairs Western New York Healthcare System.

However, commenting in an interview, Dr. Troen cautions: “There are many epidemiological studies that are correlative, not causative, that do show a likelihood for benefit [with vitamin D supplementation]. … Therefore, there’s no reason for clinicians to discontinue vitamin D in individuals because of this study.”

“If you’re monitoring an older adult who is frail and has multiple comorbidities, you want to know what their vitamin D level is [and] provide them an appropriate supplement if needed,” he emphasized.

Some guidelines already reflect the lack of evidence of any role of vitamin D supplementation in the prevention of falls, including those of the 2018 U.S. Preventive Services Task Force, which, in a reversal of its 2012 recommendation, now does not recommend vitamin D supplementation for fall prevention in older persons without osteoporosis or vitamin D deficiency, Dr. Appel and colleagues note.
 

No prevention of falls regardless of baseline vitamin D

As part of STURDY (Study to understand fall reduction and vitamin D in you), Dr. Appel and colleagues enrolled 688 community-dwelling participants who had an elevated risk of falling, defined as a serum 25-hydroxyvitamin D [25(OH)D] level of 25 to 72.5 nmol/L (10-29 ng/dL).

Participants were a mean age of 77.2 years and had a mean total 25(OH)D level of 55.3 nmol/L at enrollment.

They were randomized to one of four doses of vitamin D₃, including 200 IU/day (the control group), or 1,000, 2,000, or 4,000 IU/day.

The highest doses were found to be associated with worse – not better – outcomes including a shorter time to hospitalization or death, compared with the 1,000-IU/day group. The higher-dose groups were therefore switched to a dose of 1,000 IU/day or lower, and all participants were followed for up to 2 years.

Overall, 63% experienced falls over the course of the study, which, though high, was consistent with the study’s criteria of participants having an elevated fall risk.

Of the 667 participants who completed the trial, no benefit in prevention of falling was seen across any of the doses, compared with the control group dose of 200 IU/day, regardless of participants’ baseline vitamin D levels.

Safety analyses showed that even in the 1,000-IU/day group, a higher risk of first serious fall and first fall with hospitalization was seen compared with the 200-IU/day group.

A limitation is that the study did not have a placebo group, however, “200 IU/day is a very small dose, probably homeopathic,” Dr. Appel said. “It was likely close to a placebo,” he said.
 

Caveats: comorbidities, subgroups

In his editorial, Dr. Troen notes other studies, including VITAL (Vitamin D and Omega-3 Trial) also found no reduction in falls with higher vitamin D doses; however, that study did not show any significant risks with the higher doses.

He adds that the current study lacks information on subsets of participants.

“We don’t have enough information about the existing comorbidities and medications that these people are on to be able to pull back the layers. Maybe there is a subgroup that should not be getting 4,000 IU, whereas another subgroup may not be harmed and you may decide that patient can benefit,” he said.

Furthermore, the trial doesn’t address groups such as nursing home residents.

“I have, for instance, 85-year-olds with vitamin D levels of maybe 20 nmol/L with multiple medical issues, but levels that low were not included in the study, so this is a tricky business, but the bottom line is first, do no harm,” he said.

“We really need trials that factor in the multiple different aspects so we can come up, hopefully, with a holistic and interdisciplinary approach, which is usually the best way to optimize care for frail older adults,” he concluded.

The study received funding from the National Institute of Aging.
 

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

Higher doses of vitamin D supplementation not only show no benefit in the prevention of falls in older adults at increased risk of falling, compared with the lowest doses, but they appear to increase the risk, new research shows.

Zbynek Pospisil/iStock/Getty Images

Based on the findings, supplemental vitamin D above the minimum dose of 200 IU/day likely has little benefit, lead author Lawrence J. Appel, MD, MPH, told this news organization.

“In the absence of any benefit of 1,000 IU/day versus 2,000 IU/day [of vitamin D supplementation] on falls, along with the potential for harm from doses above 1,000 IU/day, it is hard to recommend a dose above 200 IU/day in older-aged persons, unless there is a compelling reason,” asserted Dr. Appel, director of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins Bloomberg School of Public Health in Baltimore.

“More is not always better – and it may even be worse,” when it comes to vitamin D’s role in the prevention of falls, he said.

The research, published in Annals of Internal Medicine, adds important evidence in the ongoing struggle to prevent falls, says Bruce R. Troen, MD, in an accompanying editorial.

“Falls and their deleterious consequences remain a substantial risk for older adults and a huge challenge for health care teams,” writes Dr. Troen, a physician-investigator with the Veterans Affairs Western New York Healthcare System.

However, commenting in an interview, Dr. Troen cautions: “There are many epidemiological studies that are correlative, not causative, that do show a likelihood for benefit [with vitamin D supplementation]. … Therefore, there’s no reason for clinicians to discontinue vitamin D in individuals because of this study.”

“If you’re monitoring an older adult who is frail and has multiple comorbidities, you want to know what their vitamin D level is [and] provide them an appropriate supplement if needed,” he emphasized.

Some guidelines already reflect the lack of evidence of any role of vitamin D supplementation in the prevention of falls, including those of the 2018 U.S. Preventive Services Task Force, which, in a reversal of its 2012 recommendation, now does not recommend vitamin D supplementation for fall prevention in older persons without osteoporosis or vitamin D deficiency, Dr. Appel and colleagues note.
 

No prevention of falls regardless of baseline vitamin D

As part of STURDY (Study to understand fall reduction and vitamin D in you), Dr. Appel and colleagues enrolled 688 community-dwelling participants who had an elevated risk of falling, defined as a serum 25-hydroxyvitamin D [25(OH)D] level of 25 to 72.5 nmol/L (10-29 ng/dL).

Participants were a mean age of 77.2 years and had a mean total 25(OH)D level of 55.3 nmol/L at enrollment.

They were randomized to one of four doses of vitamin D₃, including 200 IU/day (the control group), or 1,000, 2,000, or 4,000 IU/day.

The highest doses were found to be associated with worse – not better – outcomes including a shorter time to hospitalization or death, compared with the 1,000-IU/day group. The higher-dose groups were therefore switched to a dose of 1,000 IU/day or lower, and all participants were followed for up to 2 years.

Overall, 63% experienced falls over the course of the study, which, though high, was consistent with the study’s criteria of participants having an elevated fall risk.

Of the 667 participants who completed the trial, no benefit in prevention of falling was seen across any of the doses, compared with the control group dose of 200 IU/day, regardless of participants’ baseline vitamin D levels.

Safety analyses showed that even in the 1,000-IU/day group, a higher risk of first serious fall and first fall with hospitalization was seen compared with the 200-IU/day group.

A limitation is that the study did not have a placebo group, however, “200 IU/day is a very small dose, probably homeopathic,” Dr. Appel said. “It was likely close to a placebo,” he said.
 

Caveats: comorbidities, subgroups

In his editorial, Dr. Troen notes other studies, including VITAL (Vitamin D and Omega-3 Trial) also found no reduction in falls with higher vitamin D doses; however, that study did not show any significant risks with the higher doses.

He adds that the current study lacks information on subsets of participants.

“We don’t have enough information about the existing comorbidities and medications that these people are on to be able to pull back the layers. Maybe there is a subgroup that should not be getting 4,000 IU, whereas another subgroup may not be harmed and you may decide that patient can benefit,” he said.

Furthermore, the trial doesn’t address groups such as nursing home residents.

“I have, for instance, 85-year-olds with vitamin D levels of maybe 20 nmol/L with multiple medical issues, but levels that low were not included in the study, so this is a tricky business, but the bottom line is first, do no harm,” he said.

“We really need trials that factor in the multiple different aspects so we can come up, hopefully, with a holistic and interdisciplinary approach, which is usually the best way to optimize care for frail older adults,” he concluded.

The study received funding from the National Institute of Aging.
 

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

COVID-19’s toll on member facilities pushed the American Academy of Sleep Medicine (AASM) recently to take a sizable gamble.

AASM announced in September that it would waive facility fees at all 2,648 AASM-accredited sleep facilities for 2021.

At $1,800-$2,600 for each facility, that will mean lost revenue of between $4.8 million and $6.9 million, but it’s a risk the academy felt it had to take.

AASM President Kannan Ramar, MBBS, MD, said in an interview that they are betting on the future of the field.

An internal survey of members, he said, found that nearly half (46%) of the 551 respondents thought they might have to close by the end of the year.

In addition, 66% reported a lower patient volume in the past month, and 36% reported that their practice or facility had to apply for loans or other financial assistance because of COVID-19, AASM said in its press release.

“We are hoping that if we help our members through this, they will be there for our patients,” Dr. Ramar said.

Other medical societies also are weighing options, straddling the line between needing income to provide resources for members but being acutely aware of the financial toll the pandemic is taking, according to one sampling.

As previously reported, primary care practices are projected to lose more than $68,000 in revenue per full-time physician in 2020, after steep drops in office visits and the collection of fees from March to May, according to a study led by researchers in the Blavatnik Institute at Harvard Medical School, Boston.

Those losses were calculated without considering a potential second wave of COVID-19 this year, the authors noted.
 

‘We can survive this’

Although AASM waived fees for its member facilities, individual physician fees have not been reduced so far. But the group is looking for more ways to help lower the economic burden on members, Dr. Ramar said.

“I don’t think we’ve ever been in this situation in the 45 years of the academy. This is a once-in-a-lifetime event for challenges we’re going through,” he said. “The board and the leadership realized that, if we’re going to do something, this is the time to do it.”

In addition to waiving the fees, AASM and the AASM Foundation are offering relief funding to state and regional sleep societies and research award recipients through programs created in response to COVID-19.

Some societies said they are not making changes to their dues or fees, some are forgoing cost-of-living fee increases, and some are waiving registration fees for annual meetings.

The American College of Allergy, Asthma and Immunology (ACAAI) waived most members’ registration fees for its annual meeting in November. Typically, that fee would be $500-$800 per member, plus charges for some premium sessions, Michael Blaiss, MD, ACAAI executive medical director, said.

Dr. Blaiss said in an interview that the college thought offering its 6,000 members essentially 25 free hours of CME would benefit them more than waiving annual membership dues, which are about $425 for physicians in the United States.

If the pandemic stretches through 2021, Dr. Blaiss said, “We can survive this. I’m not worried about that at all.”

But he acknowledged the painful effect on medical societies.

“I don’t think any organization would tell you it’s not having an effect on their income,” he said. “I know it is for us and for virtually any medical organization. A high percentage of income comes from the annual meeting.”

Waiving dues has not been a high priority among members in communications so far, Blaiss said.

American Academy of Dermatology President Bruce H. Thiers, MD, said in an interview that there will be no cost-of-living increase for 2021 dues, and AAD members can request a reduction in dues, which will be considered on a case-by-case basis.

“We understand that many members will have to make tough financial decisions,” he said.

In addition, AAD, which has more than 20,000 members, is exploring payment options to help members spread out the cost of membership.
 

ACP extends membership

The American College of Physicians, whose membership cycle starts in July, did not reduce dues but extended membership at no cost for 3 months through September to its 163,000 members, Phil Masters, MD, ACP’s vice president of membership, said in an interview.

It also expanded its educational offerings related to the pandemic, including webinars on physician wellness and issues regarding telemedicine.

He said expanding educational resources rather than waiving dues was an intentional decision after much discussion because “we’re primarily a services resource organization.”

Membership data are still being calculated, but early indications are that membership is not increasing this year, after seeing annual growth of about 2%-2.5%, Dr. Masters said. He noted that income is down “by several percent.” Annual membership dues average about $500 for physicians who have been practicing for 10 years.

“We’re well positioned to tolerate the ups and downs,” he said, but he acknowledged that “there’s no question the financial impact has been devastating on some practices.”

Like some other associations, ACP decided to cancel this year’s annual meeting, which had been planned for April. The 2021 annual meeting will be conducted online from April 29 to May 1.

Smaller organizations that rely heavily on income from the annual meeting will be severely challenged the longer the pandemic continues, Dr. Masters said.

The decision is not as simple as whether to reduce or eliminate dues, he noted. Organizations will have to reexamine their missions and structure their fees and offerings according to the needs of members.

“It’s a balance in doing things for the community at large and balancing the need to be sensitive to financial implications,” Dr. Masters said.

This article first appeared on Medscape.com.

COVID-19’s toll on member facilities pushed the American Academy of Sleep Medicine (AASM) recently to take a sizable gamble.

AASM announced in September that it would waive facility fees at all 2,648 AASM-accredited sleep facilities for 2021.

At $1,800-$2,600 for each facility, that will mean lost revenue of between $4.8 million and $6.9 million, but it’s a risk the academy felt it had to take.

AASM President Kannan Ramar, MBBS, MD, said in an interview that they are betting on the future of the field.

An internal survey of members, he said, found that nearly half (46%) of the 551 respondents thought they might have to close by the end of the year.

In addition, 66% reported a lower patient volume in the past month, and 36% reported that their practice or facility had to apply for loans or other financial assistance because of COVID-19, AASM said in its press release.

“We are hoping that if we help our members through this, they will be there for our patients,” Dr. Ramar said.

Other medical societies also are weighing options, straddling the line between needing income to provide resources for members but being acutely aware of the financial toll the pandemic is taking, according to one sampling.

As previously reported, primary care practices are projected to lose more than $68,000 in revenue per full-time physician in 2020, after steep drops in office visits and the collection of fees from March to May, according to a study led by researchers in the Blavatnik Institute at Harvard Medical School, Boston.

Those losses were calculated without considering a potential second wave of COVID-19 this year, the authors noted.
 

‘We can survive this’

Although AASM waived fees for its member facilities, individual physician fees have not been reduced so far. But the group is looking for more ways to help lower the economic burden on members, Dr. Ramar said.

“I don’t think we’ve ever been in this situation in the 45 years of the academy. This is a once-in-a-lifetime event for challenges we’re going through,” he said. “The board and the leadership realized that, if we’re going to do something, this is the time to do it.”

In addition to waiving the fees, AASM and the AASM Foundation are offering relief funding to state and regional sleep societies and research award recipients through programs created in response to COVID-19.

Some societies said they are not making changes to their dues or fees, some are forgoing cost-of-living fee increases, and some are waiving registration fees for annual meetings.

The American College of Allergy, Asthma and Immunology (ACAAI) waived most members’ registration fees for its annual meeting in November. Typically, that fee would be $500-$800 per member, plus charges for some premium sessions, Michael Blaiss, MD, ACAAI executive medical director, said.

Dr. Blaiss said in an interview that the college thought offering its 6,000 members essentially 25 free hours of CME would benefit them more than waiving annual membership dues, which are about $425 for physicians in the United States.

If the pandemic stretches through 2021, Dr. Blaiss said, “We can survive this. I’m not worried about that at all.”

But he acknowledged the painful effect on medical societies.

“I don’t think any organization would tell you it’s not having an effect on their income,” he said. “I know it is for us and for virtually any medical organization. A high percentage of income comes from the annual meeting.”

Waiving dues has not been a high priority among members in communications so far, Blaiss said.

American Academy of Dermatology President Bruce H. Thiers, MD, said in an interview that there will be no cost-of-living increase for 2021 dues, and AAD members can request a reduction in dues, which will be considered on a case-by-case basis.

“We understand that many members will have to make tough financial decisions,” he said.

In addition, AAD, which has more than 20,000 members, is exploring payment options to help members spread out the cost of membership.
 

ACP extends membership

The American College of Physicians, whose membership cycle starts in July, did not reduce dues but extended membership at no cost for 3 months through September to its 163,000 members, Phil Masters, MD, ACP’s vice president of membership, said in an interview.

It also expanded its educational offerings related to the pandemic, including webinars on physician wellness and issues regarding telemedicine.

He said expanding educational resources rather than waiving dues was an intentional decision after much discussion because “we’re primarily a services resource organization.”

Membership data are still being calculated, but early indications are that membership is not increasing this year, after seeing annual growth of about 2%-2.5%, Dr. Masters said. He noted that income is down “by several percent.” Annual membership dues average about $500 for physicians who have been practicing for 10 years.

“We’re well positioned to tolerate the ups and downs,” he said, but he acknowledged that “there’s no question the financial impact has been devastating on some practices.”

Like some other associations, ACP decided to cancel this year’s annual meeting, which had been planned for April. The 2021 annual meeting will be conducted online from April 29 to May 1.

Smaller organizations that rely heavily on income from the annual meeting will be severely challenged the longer the pandemic continues, Dr. Masters said.

The decision is not as simple as whether to reduce or eliminate dues, he noted. Organizations will have to reexamine their missions and structure their fees and offerings according to the needs of members.

“It’s a balance in doing things for the community at large and balancing the need to be sensitive to financial implications,” Dr. Masters said.

This article first appeared on Medscape.com.

COVID-19’s toll on member facilities pushed the American Academy of Sleep Medicine (AASM) recently to take a sizable gamble.

AASM announced in September that it would waive facility fees at all 2,648 AASM-accredited sleep facilities for 2021.

At $1,800-$2,600 for each facility, that will mean lost revenue of between $4.8 million and $6.9 million, but it’s a risk the academy felt it had to take.

AASM President Kannan Ramar, MBBS, MD, said in an interview that they are betting on the future of the field.

An internal survey of members, he said, found that nearly half (46%) of the 551 respondents thought they might have to close by the end of the year.

In addition, 66% reported a lower patient volume in the past month, and 36% reported that their practice or facility had to apply for loans or other financial assistance because of COVID-19, AASM said in its press release.

“We are hoping that if we help our members through this, they will be there for our patients,” Dr. Ramar said.

Other medical societies also are weighing options, straddling the line between needing income to provide resources for members but being acutely aware of the financial toll the pandemic is taking, according to one sampling.

As previously reported, primary care practices are projected to lose more than $68,000 in revenue per full-time physician in 2020, after steep drops in office visits and the collection of fees from March to May, according to a study led by researchers in the Blavatnik Institute at Harvard Medical School, Boston.

Those losses were calculated without considering a potential second wave of COVID-19 this year, the authors noted.
 

‘We can survive this’

Although AASM waived fees for its member facilities, individual physician fees have not been reduced so far. But the group is looking for more ways to help lower the economic burden on members, Dr. Ramar said.

“I don’t think we’ve ever been in this situation in the 45 years of the academy. This is a once-in-a-lifetime event for challenges we’re going through,” he said. “The board and the leadership realized that, if we’re going to do something, this is the time to do it.”

In addition to waiving the fees, AASM and the AASM Foundation are offering relief funding to state and regional sleep societies and research award recipients through programs created in response to COVID-19.

Some societies said they are not making changes to their dues or fees, some are forgoing cost-of-living fee increases, and some are waiving registration fees for annual meetings.

The American College of Allergy, Asthma and Immunology (ACAAI) waived most members’ registration fees for its annual meeting in November. Typically, that fee would be $500-$800 per member, plus charges for some premium sessions, Michael Blaiss, MD, ACAAI executive medical director, said.

Dr. Blaiss said in an interview that the college thought offering its 6,000 members essentially 25 free hours of CME would benefit them more than waiving annual membership dues, which are about $425 for physicians in the United States.

If the pandemic stretches through 2021, Dr. Blaiss said, “We can survive this. I’m not worried about that at all.”

But he acknowledged the painful effect on medical societies.

“I don’t think any organization would tell you it’s not having an effect on their income,” he said. “I know it is for us and for virtually any medical organization. A high percentage of income comes from the annual meeting.”

Waiving dues has not been a high priority among members in communications so far, Blaiss said.

American Academy of Dermatology President Bruce H. Thiers, MD, said in an interview that there will be no cost-of-living increase for 2021 dues, and AAD members can request a reduction in dues, which will be considered on a case-by-case basis.

“We understand that many members will have to make tough financial decisions,” he said.

In addition, AAD, which has more than 20,000 members, is exploring payment options to help members spread out the cost of membership.
 

ACP extends membership

The American College of Physicians, whose membership cycle starts in July, did not reduce dues but extended membership at no cost for 3 months through September to its 163,000 members, Phil Masters, MD, ACP’s vice president of membership, said in an interview.

It also expanded its educational offerings related to the pandemic, including webinars on physician wellness and issues regarding telemedicine.

He said expanding educational resources rather than waiving dues was an intentional decision after much discussion because “we’re primarily a services resource organization.”

Membership data are still being calculated, but early indications are that membership is not increasing this year, after seeing annual growth of about 2%-2.5%, Dr. Masters said. He noted that income is down “by several percent.” Annual membership dues average about $500 for physicians who have been practicing for 10 years.

“We’re well positioned to tolerate the ups and downs,” he said, but he acknowledged that “there’s no question the financial impact has been devastating on some practices.”

Like some other associations, ACP decided to cancel this year’s annual meeting, which had been planned for April. The 2021 annual meeting will be conducted online from April 29 to May 1.

Smaller organizations that rely heavily on income from the annual meeting will be severely challenged the longer the pandemic continues, Dr. Masters said.

The decision is not as simple as whether to reduce or eliminate dues, he noted. Organizations will have to reexamine their missions and structure their fees and offerings according to the needs of members.

“It’s a balance in doing things for the community at large and balancing the need to be sensitive to financial implications,” Dr. Masters said.

This article first appeared on Medscape.com.

Individuals experiencing a current episode of major depressive disorder (MDD) are significantly more likely to have insulin resistance (IR), research shows.

Investigators found patients with MDD were 51% more likely to have IR, compared with their counterparts without depressive disorder. In addition, in individuals experiencing current depression, IR was also associated with depression severity and depression chronicity.

“We learned two things from this study – first, that insulin resistance was associated with being in a depressive episode and with the severity of that episode,” Kathleen Watson, PhD, a postdoctoral research fellow in the department of psychiatry, Stanford (Calif.) University, told this news organization. “Second, we learned that we can estimate insulin resistance using a surrogate measure that is clinically accessible – the triglyceride/HDL ratio.”

The study was published online Dec. 2 in JAMA Psychiatry.
 

Targeted approach

Many studies have linked MDD and IR. However, said Dr. Watson, “We did not have much description of the nature of this relationship.” She added that her team wanted to gain a better understanding of how IR relates to depression characteristics, such as remission status, severity, and chronicity.

Characterizing these associations will “represent a critical step at better phenotyping, a prelude to longitudinal studies, and a more targeted approach to the treatment of MDD,” the authors note.

For the study, the researchers drew on data from the Netherlands Study of Depression and Anxiety, a longitudinal Dutch study of adults that “describes the course and consequences of depressive and anxiety disorders.”

The study included 1,269 study participants with current MDD (n = 536), remitted MDD (n = 394), and control participants without a history of MDD (n = 339).

In addition to investigating the association between MDD and IR, the researchers also wanted to understand “whether using different surrogate IR measures has consistent association with MDD.” IR was determined using two surrogate markers – the quantitative insulin sensitivity check index (QUICKI) and the triglyceride to high-density lipoprotein ratio. Participants in the bottom quartile of the QUICKI were categorized as IR, while all other participants were categorized as being “insulin sensitive.”

The second surrogate IR measure – the triglyceride-HDL ratio – is an index based on fasting blood sample measurements, in which the determination of IR was based on sex-specific cut points (female ratio, IR > 1.9; male ratio, IR > 2.8).

Depression was determined based on the Composite International Diagnostic Interview (version 2.1), while depression severity was based on the Inventory of Depression Symptomatology. “Chronicity” was defined as depression during the preceding 4 years and was measured using the life chart review.
 

State vs. trait

Insulin resistance was associated with current, but not with remitted, MDD (odds ratio, 1.51; 95% confidence interval, 1.08-2.12 and OR, 1.14; 95% CI, 0.79-1.64, respectively).

In a model adjusted for age, sex, education, partner status, smoking status, and alcohol consumption, IR, as assessed by both measures, was linked to depression severity – but only the triglyceride-HDL ratio yielded an association between IR and depression chronicity.

IR was not associated with depression severity or chronicity in remitted MDD on either measure.

The findings – specifically the association between current, but not remitted, MDD – suggest that “IR is a state, rather than a trait, biomarker of depression,” the authors note.

“There are many plausible mechanisms between IR and MDD,” said Dr. Watson. “Some hypotheses for the link include inflammations, alterations to the hypothalamic-pituitary-adrenal axis, and changes in health behavior.

“Understanding these nuances helped us to lay the foundation for future research, including asking whether IR can lead to the development of MDD,” she added.

Finally, Dr. Watson noted that her team is collaborating with neuroscientists to better identify the brain mechanisms at the genetic, molecular, and cellular level that link IR and MDD and ways to target them with potential treatments or interventions.
 

Shared biological mechanisms?

Commenting on the study in an interview, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto and head of the Mood Disorders Psychopharmacology Unit, said the results “suggest that a subpopulation of people with depression have what might be referred to as ‘metabolic syndrome type II’ – the depression is a consequence of abnormal metabolic processes.”

The results also suggest “maybe metabolic markers can be used as biomarkers of disease presence vs. absence,” said Dr. McIntyre, who is also the chairman and executive director of the Brain and Cognition Discovery Foundation, Toronto, and was not involved with the study.

Also commenting on the study, Andrea Fagiolini, MD, professor of psychiatry, University of Siena (Italy), said depression, metabolic, and inflammatory diseases “likely share some common biological mechanism, as they share risk factors such as unhealthy diet, unhealthy lifestyles, and frequent exposure to physical and psychological distress.”

It is “possible that treatment of depression improves IR; conversely, it is possible that lifestyle programs or medications that are able to improve IR may improve depressive symptoms,” suggested Dr. Fagiolini, who was not involved with the study. “It remains to be established which symptoms of depression are most involved in this correlation and whether their improvement precedes or follows the improvement in IR,” he noted.

The Netherlands Study of Depression and Anxiety is funded through the Geestkracht program of the Netherlands Organisation for Health Research and Development and is supported by several participating universities and mental health care organizations. Dr. Watson has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reported research grant support from CIHR/GACD/Chinese National Natural Research Foundation and speaker/consultation fees from multiple pharmaceutical companies. Dr. McIntyre is also CEO of AltMed. Dr. Fagiolini has served or is currently serving as consultant or speaker for or is a research grant recipient from multiple pharmaceutical companies.

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

Individuals experiencing a current episode of major depressive disorder (MDD) are significantly more likely to have insulin resistance (IR), research shows.

Investigators found patients with MDD were 51% more likely to have IR, compared with their counterparts without depressive disorder. In addition, in individuals experiencing current depression, IR was also associated with depression severity and depression chronicity.

“We learned two things from this study – first, that insulin resistance was associated with being in a depressive episode and with the severity of that episode,” Kathleen Watson, PhD, a postdoctoral research fellow in the department of psychiatry, Stanford (Calif.) University, told this news organization. “Second, we learned that we can estimate insulin resistance using a surrogate measure that is clinically accessible – the triglyceride/HDL ratio.”

The study was published online Dec. 2 in JAMA Psychiatry.
 

Targeted approach

Many studies have linked MDD and IR. However, said Dr. Watson, “We did not have much description of the nature of this relationship.” She added that her team wanted to gain a better understanding of how IR relates to depression characteristics, such as remission status, severity, and chronicity.

Characterizing these associations will “represent a critical step at better phenotyping, a prelude to longitudinal studies, and a more targeted approach to the treatment of MDD,” the authors note.

For the study, the researchers drew on data from the Netherlands Study of Depression and Anxiety, a longitudinal Dutch study of adults that “describes the course and consequences of depressive and anxiety disorders.”

The study included 1,269 study participants with current MDD (n = 536), remitted MDD (n = 394), and control participants without a history of MDD (n = 339).

In addition to investigating the association between MDD and IR, the researchers also wanted to understand “whether using different surrogate IR measures has consistent association with MDD.” IR was determined using two surrogate markers – the quantitative insulin sensitivity check index (QUICKI) and the triglyceride to high-density lipoprotein ratio. Participants in the bottom quartile of the QUICKI were categorized as IR, while all other participants were categorized as being “insulin sensitive.”

The second surrogate IR measure – the triglyceride-HDL ratio – is an index based on fasting blood sample measurements, in which the determination of IR was based on sex-specific cut points (female ratio, IR > 1.9; male ratio, IR > 2.8).

Depression was determined based on the Composite International Diagnostic Interview (version 2.1), while depression severity was based on the Inventory of Depression Symptomatology. “Chronicity” was defined as depression during the preceding 4 years and was measured using the life chart review.
 

State vs. trait

Insulin resistance was associated with current, but not with remitted, MDD (odds ratio, 1.51; 95% confidence interval, 1.08-2.12 and OR, 1.14; 95% CI, 0.79-1.64, respectively).

In a model adjusted for age, sex, education, partner status, smoking status, and alcohol consumption, IR, as assessed by both measures, was linked to depression severity – but only the triglyceride-HDL ratio yielded an association between IR and depression chronicity.

IR was not associated with depression severity or chronicity in remitted MDD on either measure.

The findings – specifically the association between current, but not remitted, MDD – suggest that “IR is a state, rather than a trait, biomarker of depression,” the authors note.

“There are many plausible mechanisms between IR and MDD,” said Dr. Watson. “Some hypotheses for the link include inflammations, alterations to the hypothalamic-pituitary-adrenal axis, and changes in health behavior.

“Understanding these nuances helped us to lay the foundation for future research, including asking whether IR can lead to the development of MDD,” she added.

Finally, Dr. Watson noted that her team is collaborating with neuroscientists to better identify the brain mechanisms at the genetic, molecular, and cellular level that link IR and MDD and ways to target them with potential treatments or interventions.
 

Shared biological mechanisms?

Commenting on the study in an interview, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto and head of the Mood Disorders Psychopharmacology Unit, said the results “suggest that a subpopulation of people with depression have what might be referred to as ‘metabolic syndrome type II’ – the depression is a consequence of abnormal metabolic processes.”

The results also suggest “maybe metabolic markers can be used as biomarkers of disease presence vs. absence,” said Dr. McIntyre, who is also the chairman and executive director of the Brain and Cognition Discovery Foundation, Toronto, and was not involved with the study.

Also commenting on the study, Andrea Fagiolini, MD, professor of psychiatry, University of Siena (Italy), said depression, metabolic, and inflammatory diseases “likely share some common biological mechanism, as they share risk factors such as unhealthy diet, unhealthy lifestyles, and frequent exposure to physical and psychological distress.”

It is “possible that treatment of depression improves IR; conversely, it is possible that lifestyle programs or medications that are able to improve IR may improve depressive symptoms,” suggested Dr. Fagiolini, who was not involved with the study. “It remains to be established which symptoms of depression are most involved in this correlation and whether their improvement precedes or follows the improvement in IR,” he noted.

The Netherlands Study of Depression and Anxiety is funded through the Geestkracht program of the Netherlands Organisation for Health Research and Development and is supported by several participating universities and mental health care organizations. Dr. Watson has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reported research grant support from CIHR/GACD/Chinese National Natural Research Foundation and speaker/consultation fees from multiple pharmaceutical companies. Dr. McIntyre is also CEO of AltMed. Dr. Fagiolini has served or is currently serving as consultant or speaker for or is a research grant recipient from multiple pharmaceutical companies.

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

Individuals experiencing a current episode of major depressive disorder (MDD) are significantly more likely to have insulin resistance (IR), research shows.

Investigators found patients with MDD were 51% more likely to have IR, compared with their counterparts without depressive disorder. In addition, in individuals experiencing current depression, IR was also associated with depression severity and depression chronicity.

“We learned two things from this study – first, that insulin resistance was associated with being in a depressive episode and with the severity of that episode,” Kathleen Watson, PhD, a postdoctoral research fellow in the department of psychiatry, Stanford (Calif.) University, told this news organization. “Second, we learned that we can estimate insulin resistance using a surrogate measure that is clinically accessible – the triglyceride/HDL ratio.”

The study was published online Dec. 2 in JAMA Psychiatry.
 

Targeted approach

Many studies have linked MDD and IR. However, said Dr. Watson, “We did not have much description of the nature of this relationship.” She added that her team wanted to gain a better understanding of how IR relates to depression characteristics, such as remission status, severity, and chronicity.

Characterizing these associations will “represent a critical step at better phenotyping, a prelude to longitudinal studies, and a more targeted approach to the treatment of MDD,” the authors note.

For the study, the researchers drew on data from the Netherlands Study of Depression and Anxiety, a longitudinal Dutch study of adults that “describes the course and consequences of depressive and anxiety disorders.”

The study included 1,269 study participants with current MDD (n = 536), remitted MDD (n = 394), and control participants without a history of MDD (n = 339).

In addition to investigating the association between MDD and IR, the researchers also wanted to understand “whether using different surrogate IR measures has consistent association with MDD.” IR was determined using two surrogate markers – the quantitative insulin sensitivity check index (QUICKI) and the triglyceride to high-density lipoprotein ratio. Participants in the bottom quartile of the QUICKI were categorized as IR, while all other participants were categorized as being “insulin sensitive.”

The second surrogate IR measure – the triglyceride-HDL ratio – is an index based on fasting blood sample measurements, in which the determination of IR was based on sex-specific cut points (female ratio, IR > 1.9; male ratio, IR > 2.8).

Depression was determined based on the Composite International Diagnostic Interview (version 2.1), while depression severity was based on the Inventory of Depression Symptomatology. “Chronicity” was defined as depression during the preceding 4 years and was measured using the life chart review.
 

State vs. trait

Insulin resistance was associated with current, but not with remitted, MDD (odds ratio, 1.51; 95% confidence interval, 1.08-2.12 and OR, 1.14; 95% CI, 0.79-1.64, respectively).

In a model adjusted for age, sex, education, partner status, smoking status, and alcohol consumption, IR, as assessed by both measures, was linked to depression severity – but only the triglyceride-HDL ratio yielded an association between IR and depression chronicity.

IR was not associated with depression severity or chronicity in remitted MDD on either measure.

The findings – specifically the association between current, but not remitted, MDD – suggest that “IR is a state, rather than a trait, biomarker of depression,” the authors note.

“There are many plausible mechanisms between IR and MDD,” said Dr. Watson. “Some hypotheses for the link include inflammations, alterations to the hypothalamic-pituitary-adrenal axis, and changes in health behavior.

“Understanding these nuances helped us to lay the foundation for future research, including asking whether IR can lead to the development of MDD,” she added.

Finally, Dr. Watson noted that her team is collaborating with neuroscientists to better identify the brain mechanisms at the genetic, molecular, and cellular level that link IR and MDD and ways to target them with potential treatments or interventions.
 

Shared biological mechanisms?

Commenting on the study in an interview, Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto and head of the Mood Disorders Psychopharmacology Unit, said the results “suggest that a subpopulation of people with depression have what might be referred to as ‘metabolic syndrome type II’ – the depression is a consequence of abnormal metabolic processes.”

The results also suggest “maybe metabolic markers can be used as biomarkers of disease presence vs. absence,” said Dr. McIntyre, who is also the chairman and executive director of the Brain and Cognition Discovery Foundation, Toronto, and was not involved with the study.

Also commenting on the study, Andrea Fagiolini, MD, professor of psychiatry, University of Siena (Italy), said depression, metabolic, and inflammatory diseases “likely share some common biological mechanism, as they share risk factors such as unhealthy diet, unhealthy lifestyles, and frequent exposure to physical and psychological distress.”

It is “possible that treatment of depression improves IR; conversely, it is possible that lifestyle programs or medications that are able to improve IR may improve depressive symptoms,” suggested Dr. Fagiolini, who was not involved with the study. “It remains to be established which symptoms of depression are most involved in this correlation and whether their improvement precedes or follows the improvement in IR,” he noted.

The Netherlands Study of Depression and Anxiety is funded through the Geestkracht program of the Netherlands Organisation for Health Research and Development and is supported by several participating universities and mental health care organizations. Dr. Watson has disclosed no relevant financial relationships. The other authors’ disclosures are listed on the original paper. Dr. McIntyre reported research grant support from CIHR/GACD/Chinese National Natural Research Foundation and speaker/consultation fees from multiple pharmaceutical companies. Dr. McIntyre is also CEO of AltMed. Dr. Fagiolini has served or is currently serving as consultant or speaker for or is a research grant recipient from multiple pharmaceutical companies.

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

Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.

Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.

Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”

In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m². At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.

Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.

Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”

Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.

SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
 

Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.

Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.

Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”

In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m². At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.

Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.

Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”

Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.

SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
 

Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.

Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.

Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”

In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m². At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.

Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.

Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”

Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.

SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
 

The risk for increased COVID-19 severity in people with type 1 diabetes appears similar to that of type 2 diabetes, contrary to some official advice from the Centers for Disease Control and Prevention. The new finding indicates that people with both types should be priority for receiving a vaccine, investigators say.

The study is the first to prospectively evaluate both inpatients and outpatients and to examine COVID-19 severity factors in addition to death in people with type 1 and type 2 diabetes separately, and was published online Dec. 2 in Diabetes Care. 

Among the patients, who were seen at Vanderbilt University Medical Center in Nashville, Tenn., between March and August of 2020, those with both type 1 and type 2 diabetes had between a three- and fourfold greater risk for COVID-19 hospitalization and greater illness severity compared with people without diabetes after adjustments for age, race, and a number of other risk factors.

This finding is important since as of Dec. 1, 2020, the CDC has classified the diabetes types differently in terms of underlying medical conditions that increase the risk for severe COVID-19.

Adults of any age with type 2 diabetes are considered “at increased risk of severe illness” from the virus that causes COVID-19 whereas the CDC says those with type 1 “might be at an increased risk.”

Lead author of the new paper Justin M. Gregory, MD, said in an interview: “I think this needs revision based on the current evidence. I think the data presented in our study and that of Barron et al. in Lancet Endocrinology 2020 indicate the need to place type 1 diabetes at parity with type 2 diabetes.

“These studies indicate both conditions carry an adjusted odds ratio of three to four when compared with people without diabetes for hospitalization, illness severity, and mortality,” he stressed.
 

Vaccines look promising for patients with diabetes

There were no phase 3 vaccine data available for the vaccine at the time that Dr. Gregory, of the Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Vanderbilt University, Nashville, Tenn., and colleagues were writing their manuscript in late summer, so the article does not mention this.

But now, Dr. Gregory said, “Based on the initial press releases from Pfizer and Moderna, I am now optimistic that these vaccines might mitigate the excess morbidity and mortality from COVID-19 experienced by patients with diabetes.

“I am eager to see what we learn on December 10 and 17 [the scheduled dates for the meetings of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee to review the Pfizer and Moderna vaccines, respectively].”

But with the winter pandemic surge in the meantime, “Our investigation suggests that as COVID-19 hospitalizations rise, patients with both type 1 and 2 diabetes will comprise a disproportionately higher number of those admissions and, once hospitalized, demonstrate a greater degree of illness severity,” he and his colleagues said.

“In light of these data, we call on our colleagues to emphasize the importance of social distancing measures and hand hygiene, with particular emphasis on patients with diabetes, including those in the most vulnerable communities whom our study affirms will face the most severe impact.”
 

After adjustments, excess severity risk similar for both diabetes types

The new study data came from electronic health records at Vanderbilt University Medical Center, comprising 137 primary care, urgent care, and hospital facilities where patients were tested for SARS-CoV-2 regardless of the reason for their visit.

Between March 17 and August 7, 2020, 6,451 patients tested positive for COVID-19. Of those, 273 had type 2 diabetes and 40 had type 1 diabetes.

Children younger than 18 years accounted for 20% of those with type 1 diabetes and 9.4% of those without diabetes, but none of the type 2 group. The group with type 2 diabetes was considerably older than the type 1 diabetes and no-diabetes groups, 58 years versus 37 and 33 years, respectively. 

Before adjustment for baseline characteristics that differed between groups, patients with type 1 diabetes appeared to have a risk for hospitalization and greater illness severity that was intermediate between the group with no diabetes and the group with type 2 diabetes, the researchers said.

But after adjustment for age, race, sex, hypertension, smoking, and body mass index, people with type 1 diabetes had odds ratios of 3.90 for hospitalization and 3.35 for greater illness severity, which was similar to risk in type 2 diabetes (3.36 and 3.42, respectively), compared to those without diabetes.
 

Deep dive explores COVID-19 severity risk factors in type 1 diabetes

The investigators then conducted a detailed chart review for 37 of the 40 patients with type 1 diabetes and phone surveys with 15 of them.

The majority (28) had not been hospitalized, and only one was hospitalized for diabetic ketoacidosis (DKA) within 14 days of positive SARS-CoV-2 testing.

This contrasts with a report from the T1D Exchange, in which nearly half of 33 patients with type 1 diabetes and COVID-19 had been hospitalized with DKA. The reason for the discrepancy may be that more severe patients would more likely be referred to the T1D Exchange Registry, Dr. Gregory and colleagues hypothesized.

Clinical factors associated with COVID-19 severity (P < .05) in their study included a prior hypertension diagnosis, higher hemoglobin A1c, at least one prior DKA admission in the past year, and not using a continuous glucose monitor (CGM). 

Hospitalizations were twice as likely and illness severity nearly twice as great among those with type 1 diabetes who were Black versus White. Just 8% of those with private insurance were hospitalized, compared with 60% of those with public insurance and 67% with no insurance (P = .001).

“Whereas previous reports have indicated proportionally higher rates of hospitalizations from COVID-19 among Black patients and those with public insurance, this study is the first to show a similar finding in the population with type 1 diabetes,” Dr. Gregory and colleagues wrote.

Only 9% of patients using a CGM were hospitalized versus 47% who used blood glucose meters (P < .016). Similarly, hospitalizations occurred in 6% using an insulin pump versus 33% using multiple daily injections (P < .085).

“Our analysis cannot exclude the possibility that greater amounts of diabetes technology use are a surrogate for higher socioeconomic status,” they noted.

This research was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, JDRF, and the Appleby Foundation. The authors have reported no relevant financial relationships.

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

The risk for increased COVID-19 severity in people with type 1 diabetes appears similar to that of type 2 diabetes, contrary to some official advice from the Centers for Disease Control and Prevention. The new finding indicates that people with both types should be priority for receiving a vaccine, investigators say.

The study is the first to prospectively evaluate both inpatients and outpatients and to examine COVID-19 severity factors in addition to death in people with type 1 and type 2 diabetes separately, and was published online Dec. 2 in Diabetes Care. 

Among the patients, who were seen at Vanderbilt University Medical Center in Nashville, Tenn., between March and August of 2020, those with both type 1 and type 2 diabetes had between a three- and fourfold greater risk for COVID-19 hospitalization and greater illness severity compared with people without diabetes after adjustments for age, race, and a number of other risk factors.

This finding is important since as of Dec. 1, 2020, the CDC has classified the diabetes types differently in terms of underlying medical conditions that increase the risk for severe COVID-19.

Adults of any age with type 2 diabetes are considered “at increased risk of severe illness” from the virus that causes COVID-19 whereas the CDC says those with type 1 “might be at an increased risk.”

Lead author of the new paper Justin M. Gregory, MD, said in an interview: “I think this needs revision based on the current evidence. I think the data presented in our study and that of Barron et al. in Lancet Endocrinology 2020 indicate the need to place type 1 diabetes at parity with type 2 diabetes.

“These studies indicate both conditions carry an adjusted odds ratio of three to four when compared with people without diabetes for hospitalization, illness severity, and mortality,” he stressed.
 

Vaccines look promising for patients with diabetes

There were no phase 3 vaccine data available for the vaccine at the time that Dr. Gregory, of the Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Vanderbilt University, Nashville, Tenn., and colleagues were writing their manuscript in late summer, so the article does not mention this.

But now, Dr. Gregory said, “Based on the initial press releases from Pfizer and Moderna, I am now optimistic that these vaccines might mitigate the excess morbidity and mortality from COVID-19 experienced by patients with diabetes.

“I am eager to see what we learn on December 10 and 17 [the scheduled dates for the meetings of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee to review the Pfizer and Moderna vaccines, respectively].”

But with the winter pandemic surge in the meantime, “Our investigation suggests that as COVID-19 hospitalizations rise, patients with both type 1 and 2 diabetes will comprise a disproportionately higher number of those admissions and, once hospitalized, demonstrate a greater degree of illness severity,” he and his colleagues said.

“In light of these data, we call on our colleagues to emphasize the importance of social distancing measures and hand hygiene, with particular emphasis on patients with diabetes, including those in the most vulnerable communities whom our study affirms will face the most severe impact.”
 

After adjustments, excess severity risk similar for both diabetes types

The new study data came from electronic health records at Vanderbilt University Medical Center, comprising 137 primary care, urgent care, and hospital facilities where patients were tested for SARS-CoV-2 regardless of the reason for their visit.

Between March 17 and August 7, 2020, 6,451 patients tested positive for COVID-19. Of those, 273 had type 2 diabetes and 40 had type 1 diabetes.

Children younger than 18 years accounted for 20% of those with type 1 diabetes and 9.4% of those without diabetes, but none of the type 2 group. The group with type 2 diabetes was considerably older than the type 1 diabetes and no-diabetes groups, 58 years versus 37 and 33 years, respectively. 

Before adjustment for baseline characteristics that differed between groups, patients with type 1 diabetes appeared to have a risk for hospitalization and greater illness severity that was intermediate between the group with no diabetes and the group with type 2 diabetes, the researchers said.

But after adjustment for age, race, sex, hypertension, smoking, and body mass index, people with type 1 diabetes had odds ratios of 3.90 for hospitalization and 3.35 for greater illness severity, which was similar to risk in type 2 diabetes (3.36 and 3.42, respectively), compared to those without diabetes.
 

Deep dive explores COVID-19 severity risk factors in type 1 diabetes

The investigators then conducted a detailed chart review for 37 of the 40 patients with type 1 diabetes and phone surveys with 15 of them.

The majority (28) had not been hospitalized, and only one was hospitalized for diabetic ketoacidosis (DKA) within 14 days of positive SARS-CoV-2 testing.

This contrasts with a report from the T1D Exchange, in which nearly half of 33 patients with type 1 diabetes and COVID-19 had been hospitalized with DKA. The reason for the discrepancy may be that more severe patients would more likely be referred to the T1D Exchange Registry, Dr. Gregory and colleagues hypothesized.

Clinical factors associated with COVID-19 severity (P < .05) in their study included a prior hypertension diagnosis, higher hemoglobin A1c, at least one prior DKA admission in the past year, and not using a continuous glucose monitor (CGM). 

Hospitalizations were twice as likely and illness severity nearly twice as great among those with type 1 diabetes who were Black versus White. Just 8% of those with private insurance were hospitalized, compared with 60% of those with public insurance and 67% with no insurance (P = .001).

“Whereas previous reports have indicated proportionally higher rates of hospitalizations from COVID-19 among Black patients and those with public insurance, this study is the first to show a similar finding in the population with type 1 diabetes,” Dr. Gregory and colleagues wrote.

Only 9% of patients using a CGM were hospitalized versus 47% who used blood glucose meters (P < .016). Similarly, hospitalizations occurred in 6% using an insulin pump versus 33% using multiple daily injections (P < .085).

“Our analysis cannot exclude the possibility that greater amounts of diabetes technology use are a surrogate for higher socioeconomic status,” they noted.

This research was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, JDRF, and the Appleby Foundation. The authors have reported no relevant financial relationships.

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

The risk for increased COVID-19 severity in people with type 1 diabetes appears similar to that of type 2 diabetes, contrary to some official advice from the Centers for Disease Control and Prevention. The new finding indicates that people with both types should be priority for receiving a vaccine, investigators say.

The study is the first to prospectively evaluate both inpatients and outpatients and to examine COVID-19 severity factors in addition to death in people with type 1 and type 2 diabetes separately, and was published online Dec. 2 in Diabetes Care. 

Among the patients, who were seen at Vanderbilt University Medical Center in Nashville, Tenn., between March and August of 2020, those with both type 1 and type 2 diabetes had between a three- and fourfold greater risk for COVID-19 hospitalization and greater illness severity compared with people without diabetes after adjustments for age, race, and a number of other risk factors.

This finding is important since as of Dec. 1, 2020, the CDC has classified the diabetes types differently in terms of underlying medical conditions that increase the risk for severe COVID-19.

Adults of any age with type 2 diabetes are considered “at increased risk of severe illness” from the virus that causes COVID-19 whereas the CDC says those with type 1 “might be at an increased risk.”

Lead author of the new paper Justin M. Gregory, MD, said in an interview: “I think this needs revision based on the current evidence. I think the data presented in our study and that of Barron et al. in Lancet Endocrinology 2020 indicate the need to place type 1 diabetes at parity with type 2 diabetes.

“These studies indicate both conditions carry an adjusted odds ratio of three to four when compared with people without diabetes for hospitalization, illness severity, and mortality,” he stressed.
 

Vaccines look promising for patients with diabetes

There were no phase 3 vaccine data available for the vaccine at the time that Dr. Gregory, of the Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Vanderbilt University, Nashville, Tenn., and colleagues were writing their manuscript in late summer, so the article does not mention this.

But now, Dr. Gregory said, “Based on the initial press releases from Pfizer and Moderna, I am now optimistic that these vaccines might mitigate the excess morbidity and mortality from COVID-19 experienced by patients with diabetes.

“I am eager to see what we learn on December 10 and 17 [the scheduled dates for the meetings of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee to review the Pfizer and Moderna vaccines, respectively].”

But with the winter pandemic surge in the meantime, “Our investigation suggests that as COVID-19 hospitalizations rise, patients with both type 1 and 2 diabetes will comprise a disproportionately higher number of those admissions and, once hospitalized, demonstrate a greater degree of illness severity,” he and his colleagues said.

“In light of these data, we call on our colleagues to emphasize the importance of social distancing measures and hand hygiene, with particular emphasis on patients with diabetes, including those in the most vulnerable communities whom our study affirms will face the most severe impact.”
 

After adjustments, excess severity risk similar for both diabetes types

The new study data came from electronic health records at Vanderbilt University Medical Center, comprising 137 primary care, urgent care, and hospital facilities where patients were tested for SARS-CoV-2 regardless of the reason for their visit.

Between March 17 and August 7, 2020, 6,451 patients tested positive for COVID-19. Of those, 273 had type 2 diabetes and 40 had type 1 diabetes.

Children younger than 18 years accounted for 20% of those with type 1 diabetes and 9.4% of those without diabetes, but none of the type 2 group. The group with type 2 diabetes was considerably older than the type 1 diabetes and no-diabetes groups, 58 years versus 37 and 33 years, respectively. 

Before adjustment for baseline characteristics that differed between groups, patients with type 1 diabetes appeared to have a risk for hospitalization and greater illness severity that was intermediate between the group with no diabetes and the group with type 2 diabetes, the researchers said.

But after adjustment for age, race, sex, hypertension, smoking, and body mass index, people with type 1 diabetes had odds ratios of 3.90 for hospitalization and 3.35 for greater illness severity, which was similar to risk in type 2 diabetes (3.36 and 3.42, respectively), compared to those without diabetes.
 

Deep dive explores COVID-19 severity risk factors in type 1 diabetes

The investigators then conducted a detailed chart review for 37 of the 40 patients with type 1 diabetes and phone surveys with 15 of them.

The majority (28) had not been hospitalized, and only one was hospitalized for diabetic ketoacidosis (DKA) within 14 days of positive SARS-CoV-2 testing.

This contrasts with a report from the T1D Exchange, in which nearly half of 33 patients with type 1 diabetes and COVID-19 had been hospitalized with DKA. The reason for the discrepancy may be that more severe patients would more likely be referred to the T1D Exchange Registry, Dr. Gregory and colleagues hypothesized.

Clinical factors associated with COVID-19 severity (P < .05) in their study included a prior hypertension diagnosis, higher hemoglobin A1c, at least one prior DKA admission in the past year, and not using a continuous glucose monitor (CGM). 

Hospitalizations were twice as likely and illness severity nearly twice as great among those with type 1 diabetes who were Black versus White. Just 8% of those with private insurance were hospitalized, compared with 60% of those with public insurance and 67% with no insurance (P = .001).

“Whereas previous reports have indicated proportionally higher rates of hospitalizations from COVID-19 among Black patients and those with public insurance, this study is the first to show a similar finding in the population with type 1 diabetes,” Dr. Gregory and colleagues wrote.

Only 9% of patients using a CGM were hospitalized versus 47% who used blood glucose meters (P < .016). Similarly, hospitalizations occurred in 6% using an insulin pump versus 33% using multiple daily injections (P < .085).

“Our analysis cannot exclude the possibility that greater amounts of diabetes technology use are a surrogate for higher socioeconomic status,” they noted.

This research was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, JDRF, and the Appleby Foundation. The authors have reported no relevant financial relationships.

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

A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.

Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.

Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.

In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.

All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).

Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.

SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.

A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.

Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.

Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.

In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.

All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).

Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.

SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.

A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.

Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.

Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.

In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.

All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).

Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.

SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.