MDedge Cardiology

Current American and European guidelines recommending long-term beta-blocker therapy following an acute MI appear to be obsolete in the modern reperfusion era, suggests an analysis of Danish registry data.

Those guidelines are based on old randomized trials of beta-blocker therapy conducted prior to introduction of routine percutaneous coronary intervention and modern multidrug optimal medical therapy for acute MI. There have been no prospective controlled studies in the reperfusion era. And a new Danish national observational study strongly suggests it’s time to reexamine the beta-blocker recommendation, Anders Holt, MD, said at the virtual annual congress of the European Society of Cardiology.

“Stable, optimally treated MI patients do not seem to benefit from beta-blocker treatment exceeding 3 months post hospitalization – bearing in mind this doesn’t apply to patients with other indications for beta-blockers, like heart failure or atrial fibrillation,” said Dr. Holt of Copenhagen University Hospital.

His analysis of Danish national registry data on more than 30,000 patients hospitalized for acute MI during 2003-2018 earned him the annual ESC Young Investigator Award in Population Science.

Frontline Medical News

“This was a crisp and clear presentation of a very creative use of observational epidemiology to try to understand the length of therapy that may or may not be appropriate,” commented award session cochair Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

Dr. Holt reported on 30,177 patients optimally treated for a first MI in Danish hospitals during 2003-2018, none of whom had a prior indication or contraindication for beta-blocker therapy. “Optimally treated” meant they underwent percutaneous coronary revascularization and were discharged on a statin and aspirin. As a study requirement, all had to be stable 90 days post hospitalization, at which point 24,770 of the patients were on long-term beta-blocker therapy, and 5,407 (18%) were not. The two groups were comparable in terms of age, sex, comorbidities, and baseline medications. All patients were followed through the registries for a maximum of 3 years, the duration of beta-blocker therapy post MI recommended in American Heart Association/American College of Cardiology guidelines. (The Danish Society of Cardiology recommends 2 years.)

At 3 years post MI, there was no between-group difference in a composite outcome comprising cardiovascular death, recurrent MI, heart failure, stroke, angina, or a cardiac procedure, with a rate of 22.9% in the beta-blocker group and 21.6% in patients not on long-term beta-blocker therapy. The rate of recurrent MI was identical at 6.7% in both groups. Cardiovascular death occurred during 3 years of follow-up in 1.4% of patients on beta-blocker therapy and 1.7% who weren’t, a nonsignificant difference.

“We saw no evidence of any cardioprotective effect, but no increased risk of adverse events resulting in hospitalization, either,” Dr. Holt observed. “I would like to acknowledge that no evidence of effect does not necessarily equal evidence of no effect, but even if there was an effect we can with fair certainty say that it’s probably quite minimal.”

He noted that the Danish registry data indicates that each year since 2012 has shown a growing trend for Danish patients to dispense with long-term beta-blocker therapy after an acute MI.

“This might indicate we are nudging toward a change in practice, where more physicians are thinking that long-term beta-blocker therapy might not be indicated for all MI patients in the reperfusion era,” according to Dr. Holt.

Asked by the four-judge award panel about the possibility of unmeasured confounding in this observational study, Dr Holt responded: “I would be very cautious about asking patients to stop beta-blocker therapy after 3 months just based on this observational data. We can’t speak to causality in an observational study.” But he added that “well-designed observational studies provide valuable data regarding this topic and should not be ignored. They should possibly influence the guidelines and the designs for upcoming randomized trials.”

He conducted several supplementary analyses designed to address the possibility of unevenly distributed unmeasured confounding in the registry study. These analyses proved reassuring. A positive exposure control analysis compared 3-year outcomes in patients who remained on long-term statin therapy and those who didn’t. As expected, outcomes were significantly better in those who did: a 3-year composite outcome rate of 22.1%, compared with 32.1% in patients not on a statin; a cardiovascular death rate of 1.3% with and 2.1% without statin therapy; a recurrent MI rate of 6.6%, compared with 10.1% without a statin; and a 2.8% all-cause mortality with and 5.4% without statin therapy.

In contrast, all-cause mortality was unaffected by whether or not patients were on long-term beta-blocker therapy. And in a negative exposure outcome analysis, no association was found between beta-blocker therapy and the risk of hospitalization for pneumonia, as to be expected if the beta-blocker and no-beta-blocker groups were comparable in key respects.

Dr. Holt reported having no financial conflicts regarding his study.

[email protected]

Current American and European guidelines recommending long-term beta-blocker therapy following an acute MI appear to be obsolete in the modern reperfusion era, suggests an analysis of Danish registry data.

Those guidelines are based on old randomized trials of beta-blocker therapy conducted prior to introduction of routine percutaneous coronary intervention and modern multidrug optimal medical therapy for acute MI. There have been no prospective controlled studies in the reperfusion era. And a new Danish national observational study strongly suggests it’s time to reexamine the beta-blocker recommendation, Anders Holt, MD, said at the virtual annual congress of the European Society of Cardiology.

“Stable, optimally treated MI patients do not seem to benefit from beta-blocker treatment exceeding 3 months post hospitalization – bearing in mind this doesn’t apply to patients with other indications for beta-blockers, like heart failure or atrial fibrillation,” said Dr. Holt of Copenhagen University Hospital.

His analysis of Danish national registry data on more than 30,000 patients hospitalized for acute MI during 2003-2018 earned him the annual ESC Young Investigator Award in Population Science.

Frontline Medical News

“This was a crisp and clear presentation of a very creative use of observational epidemiology to try to understand the length of therapy that may or may not be appropriate,” commented award session cochair Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

Dr. Holt reported on 30,177 patients optimally treated for a first MI in Danish hospitals during 2003-2018, none of whom had a prior indication or contraindication for beta-blocker therapy. “Optimally treated” meant they underwent percutaneous coronary revascularization and were discharged on a statin and aspirin. As a study requirement, all had to be stable 90 days post hospitalization, at which point 24,770 of the patients were on long-term beta-blocker therapy, and 5,407 (18%) were not. The two groups were comparable in terms of age, sex, comorbidities, and baseline medications. All patients were followed through the registries for a maximum of 3 years, the duration of beta-blocker therapy post MI recommended in American Heart Association/American College of Cardiology guidelines. (The Danish Society of Cardiology recommends 2 years.)

At 3 years post MI, there was no between-group difference in a composite outcome comprising cardiovascular death, recurrent MI, heart failure, stroke, angina, or a cardiac procedure, with a rate of 22.9% in the beta-blocker group and 21.6% in patients not on long-term beta-blocker therapy. The rate of recurrent MI was identical at 6.7% in both groups. Cardiovascular death occurred during 3 years of follow-up in 1.4% of patients on beta-blocker therapy and 1.7% who weren’t, a nonsignificant difference.

“We saw no evidence of any cardioprotective effect, but no increased risk of adverse events resulting in hospitalization, either,” Dr. Holt observed. “I would like to acknowledge that no evidence of effect does not necessarily equal evidence of no effect, but even if there was an effect we can with fair certainty say that it’s probably quite minimal.”

He noted that the Danish registry data indicates that each year since 2012 has shown a growing trend for Danish patients to dispense with long-term beta-blocker therapy after an acute MI.

“This might indicate we are nudging toward a change in practice, where more physicians are thinking that long-term beta-blocker therapy might not be indicated for all MI patients in the reperfusion era,” according to Dr. Holt.

Asked by the four-judge award panel about the possibility of unmeasured confounding in this observational study, Dr Holt responded: “I would be very cautious about asking patients to stop beta-blocker therapy after 3 months just based on this observational data. We can’t speak to causality in an observational study.” But he added that “well-designed observational studies provide valuable data regarding this topic and should not be ignored. They should possibly influence the guidelines and the designs for upcoming randomized trials.”

He conducted several supplementary analyses designed to address the possibility of unevenly distributed unmeasured confounding in the registry study. These analyses proved reassuring. A positive exposure control analysis compared 3-year outcomes in patients who remained on long-term statin therapy and those who didn’t. As expected, outcomes were significantly better in those who did: a 3-year composite outcome rate of 22.1%, compared with 32.1% in patients not on a statin; a cardiovascular death rate of 1.3% with and 2.1% without statin therapy; a recurrent MI rate of 6.6%, compared with 10.1% without a statin; and a 2.8% all-cause mortality with and 5.4% without statin therapy.

In contrast, all-cause mortality was unaffected by whether or not patients were on long-term beta-blocker therapy. And in a negative exposure outcome analysis, no association was found between beta-blocker therapy and the risk of hospitalization for pneumonia, as to be expected if the beta-blocker and no-beta-blocker groups were comparable in key respects.

Dr. Holt reported having no financial conflicts regarding his study.

[email protected]

Current American and European guidelines recommending long-term beta-blocker therapy following an acute MI appear to be obsolete in the modern reperfusion era, suggests an analysis of Danish registry data.

Those guidelines are based on old randomized trials of beta-blocker therapy conducted prior to introduction of routine percutaneous coronary intervention and modern multidrug optimal medical therapy for acute MI. There have been no prospective controlled studies in the reperfusion era. And a new Danish national observational study strongly suggests it’s time to reexamine the beta-blocker recommendation, Anders Holt, MD, said at the virtual annual congress of the European Society of Cardiology.

“Stable, optimally treated MI patients do not seem to benefit from beta-blocker treatment exceeding 3 months post hospitalization – bearing in mind this doesn’t apply to patients with other indications for beta-blockers, like heart failure or atrial fibrillation,” said Dr. Holt of Copenhagen University Hospital.

His analysis of Danish national registry data on more than 30,000 patients hospitalized for acute MI during 2003-2018 earned him the annual ESC Young Investigator Award in Population Science.

Frontline Medical News

“This was a crisp and clear presentation of a very creative use of observational epidemiology to try to understand the length of therapy that may or may not be appropriate,” commented award session cochair Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.

Dr. Holt reported on 30,177 patients optimally treated for a first MI in Danish hospitals during 2003-2018, none of whom had a prior indication or contraindication for beta-blocker therapy. “Optimally treated” meant they underwent percutaneous coronary revascularization and were discharged on a statin and aspirin. As a study requirement, all had to be stable 90 days post hospitalization, at which point 24,770 of the patients were on long-term beta-blocker therapy, and 5,407 (18%) were not. The two groups were comparable in terms of age, sex, comorbidities, and baseline medications. All patients were followed through the registries for a maximum of 3 years, the duration of beta-blocker therapy post MI recommended in American Heart Association/American College of Cardiology guidelines. (The Danish Society of Cardiology recommends 2 years.)

At 3 years post MI, there was no between-group difference in a composite outcome comprising cardiovascular death, recurrent MI, heart failure, stroke, angina, or a cardiac procedure, with a rate of 22.9% in the beta-blocker group and 21.6% in patients not on long-term beta-blocker therapy. The rate of recurrent MI was identical at 6.7% in both groups. Cardiovascular death occurred during 3 years of follow-up in 1.4% of patients on beta-blocker therapy and 1.7% who weren’t, a nonsignificant difference.

“We saw no evidence of any cardioprotective effect, but no increased risk of adverse events resulting in hospitalization, either,” Dr. Holt observed. “I would like to acknowledge that no evidence of effect does not necessarily equal evidence of no effect, but even if there was an effect we can with fair certainty say that it’s probably quite minimal.”

He noted that the Danish registry data indicates that each year since 2012 has shown a growing trend for Danish patients to dispense with long-term beta-blocker therapy after an acute MI.

“This might indicate we are nudging toward a change in practice, where more physicians are thinking that long-term beta-blocker therapy might not be indicated for all MI patients in the reperfusion era,” according to Dr. Holt.

Asked by the four-judge award panel about the possibility of unmeasured confounding in this observational study, Dr Holt responded: “I would be very cautious about asking patients to stop beta-blocker therapy after 3 months just based on this observational data. We can’t speak to causality in an observational study.” But he added that “well-designed observational studies provide valuable data regarding this topic and should not be ignored. They should possibly influence the guidelines and the designs for upcoming randomized trials.”

He conducted several supplementary analyses designed to address the possibility of unevenly distributed unmeasured confounding in the registry study. These analyses proved reassuring. A positive exposure control analysis compared 3-year outcomes in patients who remained on long-term statin therapy and those who didn’t. As expected, outcomes were significantly better in those who did: a 3-year composite outcome rate of 22.1%, compared with 32.1% in patients not on a statin; a cardiovascular death rate of 1.3% with and 2.1% without statin therapy; a recurrent MI rate of 6.6%, compared with 10.1% without a statin; and a 2.8% all-cause mortality with and 5.4% without statin therapy.

In contrast, all-cause mortality was unaffected by whether or not patients were on long-term beta-blocker therapy. And in a negative exposure outcome analysis, no association was found between beta-blocker therapy and the risk of hospitalization for pneumonia, as to be expected if the beta-blocker and no-beta-blocker groups were comparable in key respects.

Dr. Holt reported having no financial conflicts regarding his study.

[email protected]

Atrial fibrillation has been known to confer an increased risk for poor outcomes after transcatheter aortic valve replacement, but there’s been no evidence of how the etiology of AFib can influence post-TAVR outcomes.

enot-poloskun/Getty Images

Now, a group of researchers from Bern (Switzerland) University are reporting that valvular AFib almost triples the risk of death or debilitating stroke, compared with patients with no AFib, and significantly increases the risk over nonvalvular AFib.*

“The present findings may have implications for risk stratification in patients undergoing TAVR,” wrote Taishi Okuno, MD, and colleagues in what they said is the first study “to appreciate the combined effect” of AFib and mitral stenosis in TAVR. “The identification of valvular AFib may refine the estimated risk for adverse clinical outcomes in patients undergoing TAVR,” they wrote in JACC: Cardiovascular Interventions.

“The fact that valvular AFib seems to confer a higher risk is an interesting finding,” Fred Welt, MD, professor of cardiology at the University of Utah, Salt Lake City, said in an interview. “I think it helps to a certain extent in prognostication because we can say to patients who have concomitant mitral valve disease that they are at higher risk.” Dr. Welt is also chair of the American College of Cardiology Interventional Council.

The analysis included 1,472 patients with aortic stenosis who had TAVR at Bern University Hospital between August 2007 and June 2018, 32% of whom (465) had atrial fibrillation, subcategorized as nonvalvular (26%, 376) and valvular (6%, 89). The primary endpoint, a composite of cardiovascular death or disabling stroke 1 year after TAVR, occurred in 9.3% of patients with no AFib, 14.5% of those with nonvalvular AFib and 24.2% of patients with valvular AFib.

In terms of hazard ratios, patients with nonvalvular AFib had a 57% greater risk of poor outcomes (P = .009) and those with valvular AFib had a 275% greater risk (P < .001), compared with patients with no AFib. Patients with valvular AFib had a 77% higher rate of cardiovascular death or stroke than those with nonvalvular AFib (P = .027).**

In their analysis, Dr. Okuno and colleagues acknowledged that the definition of valvular AFib used in guidelines and clinical trials isn’t uniform. Valvular atrial fibrillation was defined as AFib with mitral stenosis or a mitral valve prosthesis.

To account for the varying definitions of valvular and nonvalvular AFib, the researchers performed a sensitivity analysis of AFib patients with significant valve disease other than mitral stenosis; 42% of patients in the nonvalvular group fit this definition. Patients with AFib and valvular disease other than mitral stenosis had almost twice the risk of cardiovascular death or disabling stroke at 1 year, compared with patients who had AFib but no significant disease of any valve (20.1% vs. 10.9%, P = .03).

Furthermore, when they excluded patients with mild mitral stenosis from the valvular AFib group, “the effect of an increased risk for cardiovascular death or disabling stroke was no longer statistically significant.”

When the researchers separated out the two elements of the composite endpoint, they found valvular AFib carried a significantly higher risk of cardiovascular death – 21.1% (P < .002) vs. 7% for no AFib and 12.3% (P = .003) for nonvalvular AFib. However, the incidence of cardiovascular events – disabling stroke, nondisabling stroke and transient ischemic attack – showed no significant difference across the three groups, Dr. Okuno and colleagues noted. Specifically, the rates of disabling stroke were 3.8%, 3.7% and 5.7% in the no-AFib, nonvalvular-AFib, and valvular-AFib groups, respectively

In an invited editorial, Bernard Iung, MD, and Vincent Algalarrondo, MD, PhD, noted the problems with the definitions for valvular and nonvalvular AFib. “The term valvular AFib now frequently refers to patients with AFib associated with moderate or severe mitral stenosis or a mechanical heart valve,” they wrote. The definition is justified, they noted, because there’s little evidence on the use of non–vitamin K antagonist oral anticoagulants (NOACs) in patients with mitral stenosis.

They noted the term nonvalvular is “ambiguous” because it doesn’t exclude valvular disease but rather only a subset defined by the restrictive use of a class of anticoagulants. Hence, the definition of valvular AFib “is subject to criticisms and remains not standardized.”

“The individualization of valvular AFib in patients undergoing TAVR is debatable, and the definition used in the present study also included mild mitral stenosis and bioprostheses, thereby highlighting again the lack of a clear and uniform definition of the concept of valvular AFib,” they wrote.

While Dr. Welt said the findings may help in stratifying risk in patients with valvular AFib, he’s not certain how that would influence treatment decisions. “In most cases when we’re considering TAVR in these patients it’s because they have severe symptomatic aortic stenosis,” he said.

Surgery as an alternative is fraught with consequences, he said. “Would it be because you would want to repair the mitral valve as well?” he said. “And once you get into that territory, you’re talking about double-valve surgery, which is a much riskier operation than isolated aortic valve replacement.”

The study raises important questions about patients with valvular AFib, Dr. Welt added. “Why are these patients dying at higher rate? Is it some other arrhythmia or some other hemodynamic problem? Are there other things we can learn about these patients that would help us to better treat patients?”

But exploring these findings further with a randomized clinical trial may not be practical, he added. “The number of patients in whom this is an issue is in the scheme of things rather low: 6%,” he said.

Dr. Okuno has no relevant financial disclosures. Dr. Iung is a consultant for Edwards Lifesciences. Dr. Algalarrondo has been a consultant for Pfizer and Alnylam. Dr. Welt disclosed a relationship with Medtronic.

SOURCE: Okuno T et al. JACC Cardiovasc Interv. 2020 Sep 21. doi: 10.1016/j.jcin.2020.05.049.

Corrections, 9/29/20: An earlier version of this article misstated the increase in risk of (*) death or debilitating stroke and of (**) a poor outcome in those with valvular Afib.

Atrial fibrillation has been known to confer an increased risk for poor outcomes after transcatheter aortic valve replacement, but there’s been no evidence of how the etiology of AFib can influence post-TAVR outcomes.

enot-poloskun/Getty Images

Now, a group of researchers from Bern (Switzerland) University are reporting that valvular AFib almost triples the risk of death or debilitating stroke, compared with patients with no AFib, and significantly increases the risk over nonvalvular AFib.*

“The present findings may have implications for risk stratification in patients undergoing TAVR,” wrote Taishi Okuno, MD, and colleagues in what they said is the first study “to appreciate the combined effect” of AFib and mitral stenosis in TAVR. “The identification of valvular AFib may refine the estimated risk for adverse clinical outcomes in patients undergoing TAVR,” they wrote in JACC: Cardiovascular Interventions.

“The fact that valvular AFib seems to confer a higher risk is an interesting finding,” Fred Welt, MD, professor of cardiology at the University of Utah, Salt Lake City, said in an interview. “I think it helps to a certain extent in prognostication because we can say to patients who have concomitant mitral valve disease that they are at higher risk.” Dr. Welt is also chair of the American College of Cardiology Interventional Council.

The analysis included 1,472 patients with aortic stenosis who had TAVR at Bern University Hospital between August 2007 and June 2018, 32% of whom (465) had atrial fibrillation, subcategorized as nonvalvular (26%, 376) and valvular (6%, 89). The primary endpoint, a composite of cardiovascular death or disabling stroke 1 year after TAVR, occurred in 9.3% of patients with no AFib, 14.5% of those with nonvalvular AFib and 24.2% of patients with valvular AFib.

In terms of hazard ratios, patients with nonvalvular AFib had a 57% greater risk of poor outcomes (P = .009) and those with valvular AFib had a 275% greater risk (P < .001), compared with patients with no AFib. Patients with valvular AFib had a 77% higher rate of cardiovascular death or stroke than those with nonvalvular AFib (P = .027).**

In their analysis, Dr. Okuno and colleagues acknowledged that the definition of valvular AFib used in guidelines and clinical trials isn’t uniform. Valvular atrial fibrillation was defined as AFib with mitral stenosis or a mitral valve prosthesis.

To account for the varying definitions of valvular and nonvalvular AFib, the researchers performed a sensitivity analysis of AFib patients with significant valve disease other than mitral stenosis; 42% of patients in the nonvalvular group fit this definition. Patients with AFib and valvular disease other than mitral stenosis had almost twice the risk of cardiovascular death or disabling stroke at 1 year, compared with patients who had AFib but no significant disease of any valve (20.1% vs. 10.9%, P = .03).

Furthermore, when they excluded patients with mild mitral stenosis from the valvular AFib group, “the effect of an increased risk for cardiovascular death or disabling stroke was no longer statistically significant.”

When the researchers separated out the two elements of the composite endpoint, they found valvular AFib carried a significantly higher risk of cardiovascular death – 21.1% (P < .002) vs. 7% for no AFib and 12.3% (P = .003) for nonvalvular AFib. However, the incidence of cardiovascular events – disabling stroke, nondisabling stroke and transient ischemic attack – showed no significant difference across the three groups, Dr. Okuno and colleagues noted. Specifically, the rates of disabling stroke were 3.8%, 3.7% and 5.7% in the no-AFib, nonvalvular-AFib, and valvular-AFib groups, respectively

In an invited editorial, Bernard Iung, MD, and Vincent Algalarrondo, MD, PhD, noted the problems with the definitions for valvular and nonvalvular AFib. “The term valvular AFib now frequently refers to patients with AFib associated with moderate or severe mitral stenosis or a mechanical heart valve,” they wrote. The definition is justified, they noted, because there’s little evidence on the use of non–vitamin K antagonist oral anticoagulants (NOACs) in patients with mitral stenosis.

They noted the term nonvalvular is “ambiguous” because it doesn’t exclude valvular disease but rather only a subset defined by the restrictive use of a class of anticoagulants. Hence, the definition of valvular AFib “is subject to criticisms and remains not standardized.”

“The individualization of valvular AFib in patients undergoing TAVR is debatable, and the definition used in the present study also included mild mitral stenosis and bioprostheses, thereby highlighting again the lack of a clear and uniform definition of the concept of valvular AFib,” they wrote.

While Dr. Welt said the findings may help in stratifying risk in patients with valvular AFib, he’s not certain how that would influence treatment decisions. “In most cases when we’re considering TAVR in these patients it’s because they have severe symptomatic aortic stenosis,” he said.

Surgery as an alternative is fraught with consequences, he said. “Would it be because you would want to repair the mitral valve as well?” he said. “And once you get into that territory, you’re talking about double-valve surgery, which is a much riskier operation than isolated aortic valve replacement.”

The study raises important questions about patients with valvular AFib, Dr. Welt added. “Why are these patients dying at higher rate? Is it some other arrhythmia or some other hemodynamic problem? Are there other things we can learn about these patients that would help us to better treat patients?”

But exploring these findings further with a randomized clinical trial may not be practical, he added. “The number of patients in whom this is an issue is in the scheme of things rather low: 6%,” he said.

Dr. Okuno has no relevant financial disclosures. Dr. Iung is a consultant for Edwards Lifesciences. Dr. Algalarrondo has been a consultant for Pfizer and Alnylam. Dr. Welt disclosed a relationship with Medtronic.

SOURCE: Okuno T et al. JACC Cardiovasc Interv. 2020 Sep 21. doi: 10.1016/j.jcin.2020.05.049.

Corrections, 9/29/20: An earlier version of this article misstated the increase in risk of (*) death or debilitating stroke and of (**) a poor outcome in those with valvular Afib.

Atrial fibrillation has been known to confer an increased risk for poor outcomes after transcatheter aortic valve replacement, but there’s been no evidence of how the etiology of AFib can influence post-TAVR outcomes.

enot-poloskun/Getty Images

Now, a group of researchers from Bern (Switzerland) University are reporting that valvular AFib almost triples the risk of death or debilitating stroke, compared with patients with no AFib, and significantly increases the risk over nonvalvular AFib.*

“The present findings may have implications for risk stratification in patients undergoing TAVR,” wrote Taishi Okuno, MD, and colleagues in what they said is the first study “to appreciate the combined effect” of AFib and mitral stenosis in TAVR. “The identification of valvular AFib may refine the estimated risk for adverse clinical outcomes in patients undergoing TAVR,” they wrote in JACC: Cardiovascular Interventions.

“The fact that valvular AFib seems to confer a higher risk is an interesting finding,” Fred Welt, MD, professor of cardiology at the University of Utah, Salt Lake City, said in an interview. “I think it helps to a certain extent in prognostication because we can say to patients who have concomitant mitral valve disease that they are at higher risk.” Dr. Welt is also chair of the American College of Cardiology Interventional Council.

The analysis included 1,472 patients with aortic stenosis who had TAVR at Bern University Hospital between August 2007 and June 2018, 32% of whom (465) had atrial fibrillation, subcategorized as nonvalvular (26%, 376) and valvular (6%, 89). The primary endpoint, a composite of cardiovascular death or disabling stroke 1 year after TAVR, occurred in 9.3% of patients with no AFib, 14.5% of those with nonvalvular AFib and 24.2% of patients with valvular AFib.

In terms of hazard ratios, patients with nonvalvular AFib had a 57% greater risk of poor outcomes (P = .009) and those with valvular AFib had a 275% greater risk (P < .001), compared with patients with no AFib. Patients with valvular AFib had a 77% higher rate of cardiovascular death or stroke than those with nonvalvular AFib (P = .027).**

In their analysis, Dr. Okuno and colleagues acknowledged that the definition of valvular AFib used in guidelines and clinical trials isn’t uniform. Valvular atrial fibrillation was defined as AFib with mitral stenosis or a mitral valve prosthesis.

To account for the varying definitions of valvular and nonvalvular AFib, the researchers performed a sensitivity analysis of AFib patients with significant valve disease other than mitral stenosis; 42% of patients in the nonvalvular group fit this definition. Patients with AFib and valvular disease other than mitral stenosis had almost twice the risk of cardiovascular death or disabling stroke at 1 year, compared with patients who had AFib but no significant disease of any valve (20.1% vs. 10.9%, P = .03).

Furthermore, when they excluded patients with mild mitral stenosis from the valvular AFib group, “the effect of an increased risk for cardiovascular death or disabling stroke was no longer statistically significant.”

When the researchers separated out the two elements of the composite endpoint, they found valvular AFib carried a significantly higher risk of cardiovascular death – 21.1% (P < .002) vs. 7% for no AFib and 12.3% (P = .003) for nonvalvular AFib. However, the incidence of cardiovascular events – disabling stroke, nondisabling stroke and transient ischemic attack – showed no significant difference across the three groups, Dr. Okuno and colleagues noted. Specifically, the rates of disabling stroke were 3.8%, 3.7% and 5.7% in the no-AFib, nonvalvular-AFib, and valvular-AFib groups, respectively

In an invited editorial, Bernard Iung, MD, and Vincent Algalarrondo, MD, PhD, noted the problems with the definitions for valvular and nonvalvular AFib. “The term valvular AFib now frequently refers to patients with AFib associated with moderate or severe mitral stenosis or a mechanical heart valve,” they wrote. The definition is justified, they noted, because there’s little evidence on the use of non–vitamin K antagonist oral anticoagulants (NOACs) in patients with mitral stenosis.

They noted the term nonvalvular is “ambiguous” because it doesn’t exclude valvular disease but rather only a subset defined by the restrictive use of a class of anticoagulants. Hence, the definition of valvular AFib “is subject to criticisms and remains not standardized.”

“The individualization of valvular AFib in patients undergoing TAVR is debatable, and the definition used in the present study also included mild mitral stenosis and bioprostheses, thereby highlighting again the lack of a clear and uniform definition of the concept of valvular AFib,” they wrote.

While Dr. Welt said the findings may help in stratifying risk in patients with valvular AFib, he’s not certain how that would influence treatment decisions. “In most cases when we’re considering TAVR in these patients it’s because they have severe symptomatic aortic stenosis,” he said.

Surgery as an alternative is fraught with consequences, he said. “Would it be because you would want to repair the mitral valve as well?” he said. “And once you get into that territory, you’re talking about double-valve surgery, which is a much riskier operation than isolated aortic valve replacement.”

The study raises important questions about patients with valvular AFib, Dr. Welt added. “Why are these patients dying at higher rate? Is it some other arrhythmia or some other hemodynamic problem? Are there other things we can learn about these patients that would help us to better treat patients?”

But exploring these findings further with a randomized clinical trial may not be practical, he added. “The number of patients in whom this is an issue is in the scheme of things rather low: 6%,” he said.

Dr. Okuno has no relevant financial disclosures. Dr. Iung is a consultant for Edwards Lifesciences. Dr. Algalarrondo has been a consultant for Pfizer and Alnylam. Dr. Welt disclosed a relationship with Medtronic.

SOURCE: Okuno T et al. JACC Cardiovasc Interv. 2020 Sep 21. doi: 10.1016/j.jcin.2020.05.049.

Corrections, 9/29/20: An earlier version of this article misstated the increase in risk of (*) death or debilitating stroke and of (**) a poor outcome in those with valvular Afib.

As may be expected, lifestyle risk factors, including physical activity and diet, are found to be more influential in determining type 2 diabetes risk within a married couple than physiologic factors such as glucose tolerance or insulin sensitivity, researchers have shown.

“Essentially, these data suggest that couple-based interventions targeting spouses’ similarities might be [an] efficient way of delivering lifestyle interventions,” said study lead Omar Silverman-Retana, MD, PhD.

“We identified that spousal concordance was strongest for behavioral risk factors, in particular physical activity and diet,” he told Medscape Medical News in an interview.

Silverman-Retana, of Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark, reported the findings in a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), held online because of the coronavirus pandemic.

Effectively, concordance was found to be weaker in the pathophysiologic markers because these are more biologically determined compared with lifestyle factors.

Janice Kiecolt-Glaser, PhD, is a marital biobehavioral researcher who is interested in spousal concordance for many chronic health conditions.

This “research is part of a growing body of evidence that carries a clear message: Be careful whom you marry, your life may depend on it!” she explained.

“Your partner’s behavior definitely influences your own, and in the case of diabetes, the researchers have found clear behavioral links, and those make sense,” she told Medscape Medical News.

“In addition, data from our lab and others show that the gut microbiomes of cohabiting couples are more similar than those of unrelated pairs,” noted Kiecolt-Glaser, who is professor of psychiatry and behavioral Health at Ohio State University College of Medicine in Columbus.

“Diet and exercise both have substantial influences on the gut microbiome, and there is growing evidence that the gut microbiome contributes to risk for diabetes. This research fits with, and extends, what we know.”
 

A comprehensive picture of mechanisms leading to diabetes

The research led by Silverman-Retana and colleagues comprised a cross-sectional analysis of couples who participated in The Maastricht Study, an extensive phenotyping trial that focuses on the causes of type 2 diabetes, its classic complications, and its emerging comorbidities.

The researchers measured a comprehensive list of lifestyle and physiologic indicators, and using the social network aspect of the study, identified 172 couples with complete information for the final analysis.

Spousal concordance in lifestyle factors and pathophysiologic mechanisms of type 2 diabetes, including beta cell function and insulin sensitivity, were determined using regression analysis. Risk factors included waist circumference, percentage body fat, physical activity, sedentary time, the Dutch Healthy Diet Index (DHDI), and total energy consumption.

In addition, the researchers assessed glucose metabolism status using fasting and 2-hour plasma glucose, as well as HbA1c, and they also derived beta cell function indices using a seven-time point glucose tolerance test, and insulin sensitivity.

“Most importantly, we measured risk factors and pathophysiologic factors in the same study, and to the same level of detail in both partners, providing a more comprehensive picture of the mechanisms that lead to type 2 diabetes,” Silverman-Retana highlighted.

There have been previous studies addressing disease risk and couples’ concordance. A prior study, also by Silverman-Retana and colleagues at Aarhus University, found a link between the weight of one spouse and the chances of a diagnosis of type 2 diabetes in the other spouse.

Another study, reported by Medscape Medical News  in 2018, showed that when one spouse tried to lose weight with a weight management program, the other ‘untreated’ spouse was also likely to drop some weight.

Silverman-Retana noted that other research examining the similarities and differences within couples has investigated physical activity using self-reported questionnaires, but the current study used accelerometer data.  “These provide a more precise measure of physical activity,” he said, in pointing out one way in which the new study differs from previous ones. 

The findings suggest that for men, the strongest spousal concordance was for the Dutch Healthy Diet Index (DHDI), meaning that a one unit increase in wives’ DHDI was associated with a 0.53 unit difference in the men’s DHDI.

For women, the strongest concordance was for the time spent in high intensity physical activity, such that a one unit increase in husbands’ time spent in high intensity physical activity was associated with a 0.36 unit difference in women’s time spent in high intensity physical activity.

“If we compare the concordance, it weakens as we move downstream to the immediate causal risk factors of type 2 diabetes,” explained Silverman-Retana. “The weakest concordance was found in beta cell function indices and glucose metabolism indicators because these are more biologically determined.”

Concordance is mainly explained by the fact that we tend to choose a partner who has similar characteristics to our own, in terms of social class and/or educational level, smoking status, exercise habits and diet, explained the researcher.

“It would be interesting to know how behavioral similarity depends on the length of marriage or time as a couple. Future studies will need to look into this,” he concluded.   

Silverman-Retana and Kiecolt-Glaser have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

As may be expected, lifestyle risk factors, including physical activity and diet, are found to be more influential in determining type 2 diabetes risk within a married couple than physiologic factors such as glucose tolerance or insulin sensitivity, researchers have shown.

“Essentially, these data suggest that couple-based interventions targeting spouses’ similarities might be [an] efficient way of delivering lifestyle interventions,” said study lead Omar Silverman-Retana, MD, PhD.

“We identified that spousal concordance was strongest for behavioral risk factors, in particular physical activity and diet,” he told Medscape Medical News in an interview.

Silverman-Retana, of Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark, reported the findings in a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), held online because of the coronavirus pandemic.

Effectively, concordance was found to be weaker in the pathophysiologic markers because these are more biologically determined compared with lifestyle factors.

Janice Kiecolt-Glaser, PhD, is a marital biobehavioral researcher who is interested in spousal concordance for many chronic health conditions.

This “research is part of a growing body of evidence that carries a clear message: Be careful whom you marry, your life may depend on it!” she explained.

“Your partner’s behavior definitely influences your own, and in the case of diabetes, the researchers have found clear behavioral links, and those make sense,” she told Medscape Medical News.

“In addition, data from our lab and others show that the gut microbiomes of cohabiting couples are more similar than those of unrelated pairs,” noted Kiecolt-Glaser, who is professor of psychiatry and behavioral Health at Ohio State University College of Medicine in Columbus.

“Diet and exercise both have substantial influences on the gut microbiome, and there is growing evidence that the gut microbiome contributes to risk for diabetes. This research fits with, and extends, what we know.”
 

A comprehensive picture of mechanisms leading to diabetes

The research led by Silverman-Retana and colleagues comprised a cross-sectional analysis of couples who participated in The Maastricht Study, an extensive phenotyping trial that focuses on the causes of type 2 diabetes, its classic complications, and its emerging comorbidities.

The researchers measured a comprehensive list of lifestyle and physiologic indicators, and using the social network aspect of the study, identified 172 couples with complete information for the final analysis.

Spousal concordance in lifestyle factors and pathophysiologic mechanisms of type 2 diabetes, including beta cell function and insulin sensitivity, were determined using regression analysis. Risk factors included waist circumference, percentage body fat, physical activity, sedentary time, the Dutch Healthy Diet Index (DHDI), and total energy consumption.

In addition, the researchers assessed glucose metabolism status using fasting and 2-hour plasma glucose, as well as HbA1c, and they also derived beta cell function indices using a seven-time point glucose tolerance test, and insulin sensitivity.

“Most importantly, we measured risk factors and pathophysiologic factors in the same study, and to the same level of detail in both partners, providing a more comprehensive picture of the mechanisms that lead to type 2 diabetes,” Silverman-Retana highlighted.

There have been previous studies addressing disease risk and couples’ concordance. A prior study, also by Silverman-Retana and colleagues at Aarhus University, found a link between the weight of one spouse and the chances of a diagnosis of type 2 diabetes in the other spouse.

Another study, reported by Medscape Medical News  in 2018, showed that when one spouse tried to lose weight with a weight management program, the other ‘untreated’ spouse was also likely to drop some weight.

Silverman-Retana noted that other research examining the similarities and differences within couples has investigated physical activity using self-reported questionnaires, but the current study used accelerometer data.  “These provide a more precise measure of physical activity,” he said, in pointing out one way in which the new study differs from previous ones. 

The findings suggest that for men, the strongest spousal concordance was for the Dutch Healthy Diet Index (DHDI), meaning that a one unit increase in wives’ DHDI was associated with a 0.53 unit difference in the men’s DHDI.

For women, the strongest concordance was for the time spent in high intensity physical activity, such that a one unit increase in husbands’ time spent in high intensity physical activity was associated with a 0.36 unit difference in women’s time spent in high intensity physical activity.

“If we compare the concordance, it weakens as we move downstream to the immediate causal risk factors of type 2 diabetes,” explained Silverman-Retana. “The weakest concordance was found in beta cell function indices and glucose metabolism indicators because these are more biologically determined.”

Concordance is mainly explained by the fact that we tend to choose a partner who has similar characteristics to our own, in terms of social class and/or educational level, smoking status, exercise habits and diet, explained the researcher.

“It would be interesting to know how behavioral similarity depends on the length of marriage or time as a couple. Future studies will need to look into this,” he concluded.   

Silverman-Retana and Kiecolt-Glaser have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

As may be expected, lifestyle risk factors, including physical activity and diet, are found to be more influential in determining type 2 diabetes risk within a married couple than physiologic factors such as glucose tolerance or insulin sensitivity, researchers have shown.

“Essentially, these data suggest that couple-based interventions targeting spouses’ similarities might be [an] efficient way of delivering lifestyle interventions,” said study lead Omar Silverman-Retana, MD, PhD.

“We identified that spousal concordance was strongest for behavioral risk factors, in particular physical activity and diet,” he told Medscape Medical News in an interview.

Silverman-Retana, of Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark, reported the findings in a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), held online because of the coronavirus pandemic.

Effectively, concordance was found to be weaker in the pathophysiologic markers because these are more biologically determined compared with lifestyle factors.

Janice Kiecolt-Glaser, PhD, is a marital biobehavioral researcher who is interested in spousal concordance for many chronic health conditions.

This “research is part of a growing body of evidence that carries a clear message: Be careful whom you marry, your life may depend on it!” she explained.

“Your partner’s behavior definitely influences your own, and in the case of diabetes, the researchers have found clear behavioral links, and those make sense,” she told Medscape Medical News.

“In addition, data from our lab and others show that the gut microbiomes of cohabiting couples are more similar than those of unrelated pairs,” noted Kiecolt-Glaser, who is professor of psychiatry and behavioral Health at Ohio State University College of Medicine in Columbus.

“Diet and exercise both have substantial influences on the gut microbiome, and there is growing evidence that the gut microbiome contributes to risk for diabetes. This research fits with, and extends, what we know.”
 

A comprehensive picture of mechanisms leading to diabetes

The research led by Silverman-Retana and colleagues comprised a cross-sectional analysis of couples who participated in The Maastricht Study, an extensive phenotyping trial that focuses on the causes of type 2 diabetes, its classic complications, and its emerging comorbidities.

The researchers measured a comprehensive list of lifestyle and physiologic indicators, and using the social network aspect of the study, identified 172 couples with complete information for the final analysis.

Spousal concordance in lifestyle factors and pathophysiologic mechanisms of type 2 diabetes, including beta cell function and insulin sensitivity, were determined using regression analysis. Risk factors included waist circumference, percentage body fat, physical activity, sedentary time, the Dutch Healthy Diet Index (DHDI), and total energy consumption.

In addition, the researchers assessed glucose metabolism status using fasting and 2-hour plasma glucose, as well as HbA1c, and they also derived beta cell function indices using a seven-time point glucose tolerance test, and insulin sensitivity.

“Most importantly, we measured risk factors and pathophysiologic factors in the same study, and to the same level of detail in both partners, providing a more comprehensive picture of the mechanisms that lead to type 2 diabetes,” Silverman-Retana highlighted.

There have been previous studies addressing disease risk and couples’ concordance. A prior study, also by Silverman-Retana and colleagues at Aarhus University, found a link between the weight of one spouse and the chances of a diagnosis of type 2 diabetes in the other spouse.

Another study, reported by Medscape Medical News  in 2018, showed that when one spouse tried to lose weight with a weight management program, the other ‘untreated’ spouse was also likely to drop some weight.

Silverman-Retana noted that other research examining the similarities and differences within couples has investigated physical activity using self-reported questionnaires, but the current study used accelerometer data.  “These provide a more precise measure of physical activity,” he said, in pointing out one way in which the new study differs from previous ones. 

The findings suggest that for men, the strongest spousal concordance was for the Dutch Healthy Diet Index (DHDI), meaning that a one unit increase in wives’ DHDI was associated with a 0.53 unit difference in the men’s DHDI.

For women, the strongest concordance was for the time spent in high intensity physical activity, such that a one unit increase in husbands’ time spent in high intensity physical activity was associated with a 0.36 unit difference in women’s time spent in high intensity physical activity.

“If we compare the concordance, it weakens as we move downstream to the immediate causal risk factors of type 2 diabetes,” explained Silverman-Retana. “The weakest concordance was found in beta cell function indices and glucose metabolism indicators because these are more biologically determined.”

Concordance is mainly explained by the fact that we tend to choose a partner who has similar characteristics to our own, in terms of social class and/or educational level, smoking status, exercise habits and diet, explained the researcher.

“It would be interesting to know how behavioral similarity depends on the length of marriage or time as a couple. Future studies will need to look into this,” he concluded.   

Silverman-Retana and Kiecolt-Glaser have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Survival of U.S. patients who received a kidney transplant improved during 2000-2018, but the extent of improvement among patients whose end-stage kidney disease linked with diabetes lagged behind patients with renal disease unrelated to diabetes, based on a review of more than 250,000 U.S. renal transplant recipients from that period.

Mohammed Haneefa Nizamudeen/Getty Images

After adjustment for several demographic and clinical baseline differences, as well as for several characteristics of the organ donor, the analysis showed that patients with type 2 diabetes (T2D) had a significant 64% higher mortality rate following kidney transplant compared with patients without diabetes, while patients with type 1 diabetes (T1D) had a significant 94% increased relative rate of death, Jessica Harding, PhD, said at the virtual annual meeting of the European Association for the Study of Diabetes.

The analyses that Dr. Harding reported also showed that, throughout the period examined, mortality rates following kidney transplant remained several times greater than the death rate of similar Americans who did not undergo renal replacement. By 2017, the standardized mortality ratio for patients with T2D following a kidney transplant was roughly fourfold greater than in similarly aged Americans in the general population who did undergo a transplant, while for patients with T1D the standardized mortality ratio compared with the general population was about sevenfold higher.

“Important disparities” for survival following kidney transplantation based on a specific diabetes etiology exist among U.S. patients, and further research should examine ways to better reduce posttransplant mortality in patients with diabetes, especially those with T1D, concluded Dr. Harding, an epidemiologist in the division of transplantation, department of surgery, at Emory University, Atlanta.

Issues surrounding kidney transplantation and postsurgical survival among patients with diabetes are important because these patients remain very susceptible to developing end-stage kidney disease and need for renal replacement. Adequate management of hyperglycemia, hypertension, and the adverse cardiovascular effects of immunosuppressive drugs might provide effective strategies for further mortality reductions among patients with diabetes following kidney transplant, she suggested.

The study used data collected in the United States Renal Data System during January 2000–August 2018, and included 258,188 adults who underwent a first-time, single kidney transplant at a U.S. center. About 20,000 patients had T1D (8%), about 59,000 (23%) had T2D, and the remaining 69% had no diabetes diagnosis. The data allowed for survival monitoring during a median follow-up of just over 6 years, during which more than 72,000 of the tracked patients (28%) died. The Renal Data System entries for 2017 also showed that 47% of U.S. patients with new end-stage renal disease had a diabetes etiology, Dr. Harding said.

The study received no commercial funding. Dr. Harding had no disclosures.

[email protected]

SOURCE: Harding J. EASD 2020. Oral presentation 66.

Survival of U.S. patients who received a kidney transplant improved during 2000-2018, but the extent of improvement among patients whose end-stage kidney disease linked with diabetes lagged behind patients with renal disease unrelated to diabetes, based on a review of more than 250,000 U.S. renal transplant recipients from that period.

Mohammed Haneefa Nizamudeen/Getty Images

After adjustment for several demographic and clinical baseline differences, as well as for several characteristics of the organ donor, the analysis showed that patients with type 2 diabetes (T2D) had a significant 64% higher mortality rate following kidney transplant compared with patients without diabetes, while patients with type 1 diabetes (T1D) had a significant 94% increased relative rate of death, Jessica Harding, PhD, said at the virtual annual meeting of the European Association for the Study of Diabetes.

The analyses that Dr. Harding reported also showed that, throughout the period examined, mortality rates following kidney transplant remained several times greater than the death rate of similar Americans who did not undergo renal replacement. By 2017, the standardized mortality ratio for patients with T2D following a kidney transplant was roughly fourfold greater than in similarly aged Americans in the general population who did undergo a transplant, while for patients with T1D the standardized mortality ratio compared with the general population was about sevenfold higher.

“Important disparities” for survival following kidney transplantation based on a specific diabetes etiology exist among U.S. patients, and further research should examine ways to better reduce posttransplant mortality in patients with diabetes, especially those with T1D, concluded Dr. Harding, an epidemiologist in the division of transplantation, department of surgery, at Emory University, Atlanta.

Issues surrounding kidney transplantation and postsurgical survival among patients with diabetes are important because these patients remain very susceptible to developing end-stage kidney disease and need for renal replacement. Adequate management of hyperglycemia, hypertension, and the adverse cardiovascular effects of immunosuppressive drugs might provide effective strategies for further mortality reductions among patients with diabetes following kidney transplant, she suggested.

The study used data collected in the United States Renal Data System during January 2000–August 2018, and included 258,188 adults who underwent a first-time, single kidney transplant at a U.S. center. About 20,000 patients had T1D (8%), about 59,000 (23%) had T2D, and the remaining 69% had no diabetes diagnosis. The data allowed for survival monitoring during a median follow-up of just over 6 years, during which more than 72,000 of the tracked patients (28%) died. The Renal Data System entries for 2017 also showed that 47% of U.S. patients with new end-stage renal disease had a diabetes etiology, Dr. Harding said.

The study received no commercial funding. Dr. Harding had no disclosures.

[email protected]

SOURCE: Harding J. EASD 2020. Oral presentation 66.

Survival of U.S. patients who received a kidney transplant improved during 2000-2018, but the extent of improvement among patients whose end-stage kidney disease linked with diabetes lagged behind patients with renal disease unrelated to diabetes, based on a review of more than 250,000 U.S. renal transplant recipients from that period.

Mohammed Haneefa Nizamudeen/Getty Images

After adjustment for several demographic and clinical baseline differences, as well as for several characteristics of the organ donor, the analysis showed that patients with type 2 diabetes (T2D) had a significant 64% higher mortality rate following kidney transplant compared with patients without diabetes, while patients with type 1 diabetes (T1D) had a significant 94% increased relative rate of death, Jessica Harding, PhD, said at the virtual annual meeting of the European Association for the Study of Diabetes.

The analyses that Dr. Harding reported also showed that, throughout the period examined, mortality rates following kidney transplant remained several times greater than the death rate of similar Americans who did not undergo renal replacement. By 2017, the standardized mortality ratio for patients with T2D following a kidney transplant was roughly fourfold greater than in similarly aged Americans in the general population who did undergo a transplant, while for patients with T1D the standardized mortality ratio compared with the general population was about sevenfold higher.

“Important disparities” for survival following kidney transplantation based on a specific diabetes etiology exist among U.S. patients, and further research should examine ways to better reduce posttransplant mortality in patients with diabetes, especially those with T1D, concluded Dr. Harding, an epidemiologist in the division of transplantation, department of surgery, at Emory University, Atlanta.

Issues surrounding kidney transplantation and postsurgical survival among patients with diabetes are important because these patients remain very susceptible to developing end-stage kidney disease and need for renal replacement. Adequate management of hyperglycemia, hypertension, and the adverse cardiovascular effects of immunosuppressive drugs might provide effective strategies for further mortality reductions among patients with diabetes following kidney transplant, she suggested.

The study used data collected in the United States Renal Data System during January 2000–August 2018, and included 258,188 adults who underwent a first-time, single kidney transplant at a U.S. center. About 20,000 patients had T1D (8%), about 59,000 (23%) had T2D, and the remaining 69% had no diabetes diagnosis. The data allowed for survival monitoring during a median follow-up of just over 6 years, during which more than 72,000 of the tracked patients (28%) died. The Renal Data System entries for 2017 also showed that 47% of U.S. patients with new end-stage renal disease had a diabetes etiology, Dr. Harding said.

The study received no commercial funding. Dr. Harding had no disclosures.

[email protected]

SOURCE: Harding J. EASD 2020. Oral presentation 66.

More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.

kate_sept2004/E+

Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.

Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
 

Specialist pay gap narrows slightly

As in the past 10 years of the survey, female physicians continue to make less than their male colleagues. The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).

The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.

The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).

“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.

“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.

Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.

The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.

An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.

Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
 

Women more likely than men to live above their means

More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).

Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.

Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.

Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).

Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.

This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).

Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.

Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).

Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
 

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

More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.

kate_sept2004/E+

Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.

Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
 

Specialist pay gap narrows slightly

As in the past 10 years of the survey, female physicians continue to make less than their male colleagues. The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).

The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.

The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).

“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.

“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.

Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.

The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.

An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.

Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
 

Women more likely than men to live above their means

More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).

Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.

Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.

Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).

Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.

This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).

Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.

Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).

Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
 

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

More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.

kate_sept2004/E+

Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.

Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
 

Specialist pay gap narrows slightly

As in the past 10 years of the survey, female physicians continue to make less than their male colleagues. The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).

The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.

The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).

“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.

“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.

Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.

The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.

An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.

Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
 

Women more likely than men to live above their means

More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).

Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.

Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.

Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).

Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.

This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).

Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.

Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).

Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
 

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

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.

If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.

Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.

AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.

A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

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.

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.

If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.

Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.

AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.

A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

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.

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.

If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.

Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.

AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.

A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

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.

The Centers for Disease Control and Prevention (CDC) today abruptly deleted information from its website that it had updated Friday on how COVID-19 is spread.

The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.

CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.

However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”

Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”

Previous information

Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.

Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”

The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”

On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.

The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).

The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.

WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.

The CDC update was made Friday without announcement.

“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”

Again Monday, there was no announcement that information had changed.

Update added air purifiers for prevention

The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.

The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention (CDC) today abruptly deleted information from its website that it had updated Friday on how COVID-19 is spread.

The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.

CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.

However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”

Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”

Previous information

Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.

Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”

The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”

On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.

The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).

The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.

WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.

The CDC update was made Friday without announcement.

“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”

Again Monday, there was no announcement that information had changed.

Update added air purifiers for prevention

The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.

The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention (CDC) today abruptly deleted information from its website that it had updated Friday on how COVID-19 is spread.

The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.

CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.

However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”

Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”

Previous information

Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.

Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”

The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”

On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.

The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).

The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.

WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.

The CDC update was made Friday without announcement.

“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”

Again Monday, there was no announcement that information had changed.

Update added air purifiers for prevention

The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.

The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick

This article first appeared on Medscape.com.

On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”

Supreme Court of the United States

I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”

Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.

Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.

“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”

Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

Let’s take them one at a time.
 

The ACA under fire – again

The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.

Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.

Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.

Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.

While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.

But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.

At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.

Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.

But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.

A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.

As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
 

Reproductive rights

A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.

Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.

Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.

But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.

And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.

For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.

“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”

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.

On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”

Supreme Court of the United States

I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”

Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.

Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.

“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”

Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

Let’s take them one at a time.
 

The ACA under fire – again

The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.

Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.

Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.

Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.

While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.

But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.

At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.

Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.

But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.

A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.

As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
 

Reproductive rights

A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.

Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.

Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.

But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.

And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.

For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.

“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”

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.

On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”

Supreme Court of the United States

I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”

Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.

Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.

“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”

Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.

Let’s take them one at a time.
 

The ACA under fire – again

The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.

Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.

Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.

Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.

While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.

But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.

At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.

Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.

But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.

A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.

As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
 

Reproductive rights

A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.

Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.

Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.

But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.

And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.

For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.

“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”

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.

The more patients with type 2 diabetes exercise, the greater their drop in A1c, according to a new post hoc analysis of data collected during 6 months of supervised exercise.

This “dose-response” relationship between exercise and reductions in A1c held firm for those who did aerobic training or a mixture of aerobic and resistance exercises (combined), but not for those who did only resistance exercises, say Ronald J. Sigal, MD, and colleagues in their article published in the September issue of Medicine & Science in Sports & Exercise.

The findings “suggest that an increased volume of aerobic or combined aerobic and resistance exercise is associated with greater improvement in glycemic control,” say Dr. Sigal, a professor in the division of endocrinology and metabolism at the University of Calgary (Alta.) and colleagues.

In addition, the results “support aerobic and combined exercise prescriptions outlined in clinical practice guidelines … such as those published by the American Diabetes Association (Diabetes Care. 2016;39:2065-79),” they note.

Dr. Sigal was also a coauthor of the ADA position statement on exercise, physical activity, and diabetes.
 

Those who exercised the most saw biggest drop in A1c

In the new report, Dr. Sigal and coauthors note they are “unaware of previous studies exploring the relationship between adherence to prescribed exercise and change in glycemic control in patients with type 2 diabetes.”

The analysis used data collected from the DARE (Diabetes Aerobic and Resistance Exercise) trial, which randomized 251 patients with type 2 diabetes to a 6-month supervised exercise program or their usual habits (the latter were used as sedentary controls). The original DARE results showed that each of the three tested modes of supervised exercise – exclusively aerobic, exclusively resistance training, or a combination of both – resulted in a significant drop in average A1c level, compared with controls (Ann Int Med. 2007;147:357-69).  

This original study did not subdivide patients in the intervention groups by level of adherence to their exercise prescription.

The new analysis focused on the 185 patients randomized to one of the three exercise arms and tracked adherence by both self-recorded logs from patients and reports from the trainers who ran the exercise sessions.

The patients were an average of 54 years old, and slightly more than a third were women. Median A1c at baseline was about 7.7%. Median overall adherence to their exercise regimen was about 86% and was roughly similar in the three exercise subgroups.

The exercise prescription consisted of a 60-minute session (including warm-up and cool-down) three times weekly.

Those who did the most exercise saw the biggest improvements in A1c: a 20% increase in adherence (which correlated with an additional two sessions per month) was associated with a 0.15% decrease in A1c (P = .021)

When analyzed by type of exercise, both the subgroup that performed aerobic exercise only and the subgroup that did both aerobic and resistance exercise showed significant correlations with reductions in A1c. There was no significant association with A1c for the patients who did only resistance training.

Further subgroup analyses showed that significant relationships between exercise adherence and reduced glycemia were seen in only patients younger than 55 years old, men, and those with a baseline A1c ≥ 7.5%.

The researchers caution that the low number of patients in their analysis limits the statistical power and thereby interpretation of the findings, as does the post-hoc nature of the analysis.

DARE received no commercial funding. The authors have reported no relevant financial relationships.

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

The more patients with type 2 diabetes exercise, the greater their drop in A1c, according to a new post hoc analysis of data collected during 6 months of supervised exercise.

This “dose-response” relationship between exercise and reductions in A1c held firm for those who did aerobic training or a mixture of aerobic and resistance exercises (combined), but not for those who did only resistance exercises, say Ronald J. Sigal, MD, and colleagues in their article published in the September issue of Medicine & Science in Sports & Exercise.

The findings “suggest that an increased volume of aerobic or combined aerobic and resistance exercise is associated with greater improvement in glycemic control,” say Dr. Sigal, a professor in the division of endocrinology and metabolism at the University of Calgary (Alta.) and colleagues.

In addition, the results “support aerobic and combined exercise prescriptions outlined in clinical practice guidelines … such as those published by the American Diabetes Association (Diabetes Care. 2016;39:2065-79),” they note.

Dr. Sigal was also a coauthor of the ADA position statement on exercise, physical activity, and diabetes.
 

Those who exercised the most saw biggest drop in A1c

In the new report, Dr. Sigal and coauthors note they are “unaware of previous studies exploring the relationship between adherence to prescribed exercise and change in glycemic control in patients with type 2 diabetes.”

The analysis used data collected from the DARE (Diabetes Aerobic and Resistance Exercise) trial, which randomized 251 patients with type 2 diabetes to a 6-month supervised exercise program or their usual habits (the latter were used as sedentary controls). The original DARE results showed that each of the three tested modes of supervised exercise – exclusively aerobic, exclusively resistance training, or a combination of both – resulted in a significant drop in average A1c level, compared with controls (Ann Int Med. 2007;147:357-69).  

This original study did not subdivide patients in the intervention groups by level of adherence to their exercise prescription.

The new analysis focused on the 185 patients randomized to one of the three exercise arms and tracked adherence by both self-recorded logs from patients and reports from the trainers who ran the exercise sessions.

The patients were an average of 54 years old, and slightly more than a third were women. Median A1c at baseline was about 7.7%. Median overall adherence to their exercise regimen was about 86% and was roughly similar in the three exercise subgroups.

The exercise prescription consisted of a 60-minute session (including warm-up and cool-down) three times weekly.

Those who did the most exercise saw the biggest improvements in A1c: a 20% increase in adherence (which correlated with an additional two sessions per month) was associated with a 0.15% decrease in A1c (P = .021)

When analyzed by type of exercise, both the subgroup that performed aerobic exercise only and the subgroup that did both aerobic and resistance exercise showed significant correlations with reductions in A1c. There was no significant association with A1c for the patients who did only resistance training.

Further subgroup analyses showed that significant relationships between exercise adherence and reduced glycemia were seen in only patients younger than 55 years old, men, and those with a baseline A1c ≥ 7.5%.

The researchers caution that the low number of patients in their analysis limits the statistical power and thereby interpretation of the findings, as does the post-hoc nature of the analysis.

DARE received no commercial funding. The authors have reported no relevant financial relationships.

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

The more patients with type 2 diabetes exercise, the greater their drop in A1c, according to a new post hoc analysis of data collected during 6 months of supervised exercise.

This “dose-response” relationship between exercise and reductions in A1c held firm for those who did aerobic training or a mixture of aerobic and resistance exercises (combined), but not for those who did only resistance exercises, say Ronald J. Sigal, MD, and colleagues in their article published in the September issue of Medicine & Science in Sports & Exercise.

The findings “suggest that an increased volume of aerobic or combined aerobic and resistance exercise is associated with greater improvement in glycemic control,” say Dr. Sigal, a professor in the division of endocrinology and metabolism at the University of Calgary (Alta.) and colleagues.

In addition, the results “support aerobic and combined exercise prescriptions outlined in clinical practice guidelines … such as those published by the American Diabetes Association (Diabetes Care. 2016;39:2065-79),” they note.

Dr. Sigal was also a coauthor of the ADA position statement on exercise, physical activity, and diabetes.
 

Those who exercised the most saw biggest drop in A1c

In the new report, Dr. Sigal and coauthors note they are “unaware of previous studies exploring the relationship between adherence to prescribed exercise and change in glycemic control in patients with type 2 diabetes.”

The analysis used data collected from the DARE (Diabetes Aerobic and Resistance Exercise) trial, which randomized 251 patients with type 2 diabetes to a 6-month supervised exercise program or their usual habits (the latter were used as sedentary controls). The original DARE results showed that each of the three tested modes of supervised exercise – exclusively aerobic, exclusively resistance training, or a combination of both – resulted in a significant drop in average A1c level, compared with controls (Ann Int Med. 2007;147:357-69).  

This original study did not subdivide patients in the intervention groups by level of adherence to their exercise prescription.

The new analysis focused on the 185 patients randomized to one of the three exercise arms and tracked adherence by both self-recorded logs from patients and reports from the trainers who ran the exercise sessions.

The patients were an average of 54 years old, and slightly more than a third were women. Median A1c at baseline was about 7.7%. Median overall adherence to their exercise regimen was about 86% and was roughly similar in the three exercise subgroups.

The exercise prescription consisted of a 60-minute session (including warm-up and cool-down) three times weekly.

Those who did the most exercise saw the biggest improvements in A1c: a 20% increase in adherence (which correlated with an additional two sessions per month) was associated with a 0.15% decrease in A1c (P = .021)

When analyzed by type of exercise, both the subgroup that performed aerobic exercise only and the subgroup that did both aerobic and resistance exercise showed significant correlations with reductions in A1c. There was no significant association with A1c for the patients who did only resistance training.

Further subgroup analyses showed that significant relationships between exercise adherence and reduced glycemia were seen in only patients younger than 55 years old, men, and those with a baseline A1c ≥ 7.5%.

The researchers caution that the low number of patients in their analysis limits the statistical power and thereby interpretation of the findings, as does the post-hoc nature of the analysis.

DARE received no commercial funding. The authors have reported no relevant financial relationships.

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