Clinical Neurology News

We are months into the COVID-19 crisis, and mental health issues are proving to be rampant. In every crisis, there is opportunity, and this one is no different. The opportunity is clear. For Mental Health Awareness Month and beyond, we must convey a powerful message that mental health is key to our well-being and must be actively addressed. Because almost everyone has felt excess anxiety these last months, we have a unique chance to engage a wider audience.

To address the urgent need, the Mental Health Coalition was formed with the understanding that the mental health crisis is fueled by a pervasive and devastating stigma, preventing millions of individuals from being able to seek the critical treatment they need. Spearheaded by social activist and fashion designer, Kenneth Cole, it is a coalition of leading mental health organizations, brands, celebrities, and advocates who have joined forces to end the stigma surrounding mental health and to change the way people talk about, and care for, mental illness. The group’s mission listed on its website states: “We must increase the conversation around mental health. We must act to end silence, reduce stigma, and engage our community to inspire hope at this essential moment.”

As most of the United States has been under stay-at-home orders, our traditional relationships have been radically disrupted. New types of relationships are forming as we are relying even more on technology to connect us. Social media seems to be on the only “social” we can now safely engage in.

The coalition’s campaign, “#howareyoureally?” is harnessing the power of social media and creating a storytelling platform to allow users to more genuinely share their feelings in these unprecedented times. Celebrities include Whoopi Goldberg, Kendall Jenner, Chris Cuomo, Deepak Chopra, Kesha, and many more have already shared their stories.

“How Are You, Really?” challenges people to answer this question using social media in an open and honest fashion while still providing hope.

The second component of the initiative is to increase access to care, and they have a long list of collaborators, including leading mental health organizations such as the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, Child Mind Institute, Depression and Bipolar Support Alliance, Didi Hirsch Mental Health Services, National Alliance on Mental Illness, and many more.

We have a unique opportunity this Mental Health Awareness Month, and I hope we will see more and more people sharing their stories and reaching out for help. As a community, we must be prepared to meet the escalating needs of our population.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach, Fla. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

We are months into the COVID-19 crisis, and mental health issues are proving to be rampant. In every crisis, there is opportunity, and this one is no different. The opportunity is clear. For Mental Health Awareness Month and beyond, we must convey a powerful message that mental health is key to our well-being and must be actively addressed. Because almost everyone has felt excess anxiety these last months, we have a unique chance to engage a wider audience.

To address the urgent need, the Mental Health Coalition was formed with the understanding that the mental health crisis is fueled by a pervasive and devastating stigma, preventing millions of individuals from being able to seek the critical treatment they need. Spearheaded by social activist and fashion designer, Kenneth Cole, it is a coalition of leading mental health organizations, brands, celebrities, and advocates who have joined forces to end the stigma surrounding mental health and to change the way people talk about, and care for, mental illness. The group’s mission listed on its website states: “We must increase the conversation around mental health. We must act to end silence, reduce stigma, and engage our community to inspire hope at this essential moment.”

As most of the United States has been under stay-at-home orders, our traditional relationships have been radically disrupted. New types of relationships are forming as we are relying even more on technology to connect us. Social media seems to be on the only “social” we can now safely engage in.

The coalition’s campaign, “#howareyoureally?” is harnessing the power of social media and creating a storytelling platform to allow users to more genuinely share their feelings in these unprecedented times. Celebrities include Whoopi Goldberg, Kendall Jenner, Chris Cuomo, Deepak Chopra, Kesha, and many more have already shared their stories.

“How Are You, Really?” challenges people to answer this question using social media in an open and honest fashion while still providing hope.

The second component of the initiative is to increase access to care, and they have a long list of collaborators, including leading mental health organizations such as the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, Child Mind Institute, Depression and Bipolar Support Alliance, Didi Hirsch Mental Health Services, National Alliance on Mental Illness, and many more.

We have a unique opportunity this Mental Health Awareness Month, and I hope we will see more and more people sharing their stories and reaching out for help. As a community, we must be prepared to meet the escalating needs of our population.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach, Fla. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

We are months into the COVID-19 crisis, and mental health issues are proving to be rampant. In every crisis, there is opportunity, and this one is no different. The opportunity is clear. For Mental Health Awareness Month and beyond, we must convey a powerful message that mental health is key to our well-being and must be actively addressed. Because almost everyone has felt excess anxiety these last months, we have a unique chance to engage a wider audience.

To address the urgent need, the Mental Health Coalition was formed with the understanding that the mental health crisis is fueled by a pervasive and devastating stigma, preventing millions of individuals from being able to seek the critical treatment they need. Spearheaded by social activist and fashion designer, Kenneth Cole, it is a coalition of leading mental health organizations, brands, celebrities, and advocates who have joined forces to end the stigma surrounding mental health and to change the way people talk about, and care for, mental illness. The group’s mission listed on its website states: “We must increase the conversation around mental health. We must act to end silence, reduce stigma, and engage our community to inspire hope at this essential moment.”

As most of the United States has been under stay-at-home orders, our traditional relationships have been radically disrupted. New types of relationships are forming as we are relying even more on technology to connect us. Social media seems to be on the only “social” we can now safely engage in.

The coalition’s campaign, “#howareyoureally?” is harnessing the power of social media and creating a storytelling platform to allow users to more genuinely share their feelings in these unprecedented times. Celebrities include Whoopi Goldberg, Kendall Jenner, Chris Cuomo, Deepak Chopra, Kesha, and many more have already shared their stories.

“How Are You, Really?” challenges people to answer this question using social media in an open and honest fashion while still providing hope.

The second component of the initiative is to increase access to care, and they have a long list of collaborators, including leading mental health organizations such as the American Foundation for Suicide Prevention, Anxiety and Depression Association of America, Child Mind Institute, Depression and Bipolar Support Alliance, Didi Hirsch Mental Health Services, National Alliance on Mental Illness, and many more.

We have a unique opportunity this Mental Health Awareness Month, and I hope we will see more and more people sharing their stories and reaching out for help. As a community, we must be prepared to meet the escalating needs of our population.
 

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach, Fla. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018) and is the founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world. Dr. Ritvo also is the cofounder of the Bold Beauty Project, a nonprofit group that pairs women with disabilities with photographers who create art exhibitions to raise awareness.

A new nationwide U.S. observational study suggests that ACE inhibitors may protect against severe illness in older people with COVID-19, prompting the start of a randomized clinical trial to test the strategy.

In addition, a new meta-analysis of all the available data on the use of ACE inhibitors and angiotensin-receptor blockers (ARBs) in COVID-19–infected patients has concluded that these drugs are not associated with more severe disease and do not increase susceptibility to infection.

The observational study, which was published on the MedRxiv preprint server on May 19 and has not yet been peer reviewed, was conducted by the health insurance company United Heath Group and by Yale University, New Haven, Conn.

The investigators analyzed data from 10,000 patients from across the United States who had tested positive for COVID-19, who were enrolled in Medicare Advantage insurance plans or were commercially insured, and who had received a prescription for one or more antihypertensive medications.

Results showed that the use of ACE inhibitors was associated with an almost 40% lower risk for COVID-19 hospitalization for older people enrolled in Medicare Advantage plans. No such benefit was seen in the younger commercially insured patients or in either group with ARBs.

Courtesy Yale University

At a telephone media briefing on the study, senior investigator Harlan M. Krumholz, MD, said: “We don’t believe this is enough info to change practice, but we do think this is an interesting and intriguing result.

“These findings merit a clinical trial to formally test whether ACE inhibitors – which are cheap, widely available, and well-tolerated drugs – can reduce hospitalization of patients infected with COVID-19,” added Dr. Krumholz, professor of medicine at Yale and director of the Yale New Haven Hospital Center for Outcomes Research.

A pragmatic clinical trial is now being planned. In this trial, 10,000 older people who test positive for COVID-19 will be randomly assigned to receive either a low dose of an ACE inhibitor or placebo. It is hoped that recruitment for the trial will begin in June of 2020. It is open to all eligible Americans who are older than 50 years, who test negative for COVID-19, and who are not taking medications for hypertension. Prospective patients can sign up at a dedicated website.

The randomized trial, also conducted by United Health Group and Yale, is said to be “one of the first virtual COVID-19 clinical trials to be launched at scale.”

For the observational study, the researchers identified 2,263 people who were receiving medication for hypertension and who tested positive for COVID-19. Of these, approximately two-thirds were older, Medicare Advantage enrollees; one-third were younger, commercially insured individuals.

In a propensity score–matched analysis, the investigators matched 441 patients who were taking ACE inhibitors to 441 patients who were taking other antihypertensive agents; and 412 patients who were receiving an ARB to 412 patients who were receiving other antihypertensive agents.

Results showed that during a median of 30 days after testing positive, 12.7% of the cohort were hospitalized for COVID-19. In propensity score–matched analyses, neither ACE inhibitors (hazard ratio [HR], 0.77; P = .18) nor ARBs (HR, 0.88; P =.48) were significantly associated with risk for hospitalization.

However, in analyses stratified by the insurance group, ACE inhibitors (but not ARBs) were associated with a significant lower risk for hospitalization among the Medicare group (HR, 0.61; P = .02) but not among the commercially insured group (HR, 2.14; P = .12).

A second study examined outcomes of 7,933 individuals with hypertension who were hospitalized with COVID-19 (92% of these patients were Medicare Advantage enrollees). Of these, 14.2% died, 59.5% survived to discharge, and 26.3% underwent ongoing hospitalization. In propensity score–matched analyses, use of neither an ACE inhibitor (HR, 0.97; P = .74) nor an ARB (HR, 1.15; P = .15) was associated with risk of in-hospital mortality.

The researchers said their findings are consistent with prior evidence from randomized clinical trials suggesting a reduced risk for pneumonia with ACE inhibitors that is not observed with ARBs.

They also cited some preclinical evidence that they said suggests a possible protective role for ACE inhibitors in COVID-19: that ACE inhibitors, but not ARBs, are associated with the upregulation of ACE2 receptors, which modulate the local interactions of the renin-angiotensin-aldosterone system in the lung tissue.

“The presence of ACE2 receptors, therefore, exerts a protective effect against the development of acute lung injury in infections with SARS coronaviruses, which lead to dysregulation of these mechanisms and endothelial damage,” they added. “Further, our observations do not support theoretical concerns of adverse outcomes due to enhanced virulence of SARS coronaviruses due to overexpression of ACE2 receptors in cell cultures – an indirect binding site for these viruses.”

The authors also noted that their findings have “important implications” for four ongoing randomized trials of ACE inhibitors/ARBs in COVID-19, “as none of them align with the observations of our study.”

They pointed out that of the four ongoing trials, three are testing the use of ACE inhibitors or ARBs in the treatment of hospitalized COVID-19 patients, and one is testing the use of a 10-day course of ARBs after a positive SARS-CoV-2 test to prevent hospitalization.
 

Experts cautious

However, two cardiovascular experts who were asked to comment on this latest study were not overly optimistic about the data.

Michael A. Weber, MD, professor of medicine at the State University of New York, Brooklyn, said: “This report adds to the growing number of observational studies that show varying effects of ACE inhibitors and ARBs in increasing or decreasing hospitalizations for COVID-19 and the likelihood of in-hospital mortality. Overall, this new report differs from others in the remarkable effects of insurance coverage: In particular, for ACE inhibitors, there was a 40% reduction in fatal events in Medicare patients but a twofold increase in patients using commercial insurance – albeit the test for heterogeneity when comparing the two groups did not quite reach statistical significance.

“In essence, these authors are saying that ACE inhibitors are highly protective in patients aged 65 or older but bordering on harmful in patients aged below 65. I agree that it’s worthwhile to check this finding in a prospective trial ... but this hypothesis does seem to be a reach.”

Dr. Weber noted that both ACE inhibitors and ARBs increase the level of the ACE2 enzyme to which the COVID-19 virus binds in the lungs.

“The ACE inhibitors do so by inhibiting the enzyme’s action and thus stimulate further enzyme production; the ARBs block the effects of angiotensin II, which results in high angiotensin II levels that also upregulate ACE2 production,” he said. “Perhaps the ACE inhibitors, by binding to the ACE enzyme, can in some way interfere with the enzyme’s uptake of the COVID virus and thus provide some measure of clinical protection. This is possible, but why would this effect be apparent only in older people?”

Catherine Hackett/MDedge News

John McMurray, MD, professor of medical cardiology at the University of Glasgow, Scotland, added: “This looks like a subgroup of a subgroup type analysis based on small numbers of events – I think there were only 77 hospitalizations among the 722 patients treated with an ACE inhibitor, and the Medicare Advantage subgroup was only 581 of those 722 patients.

“The hazard ratio had wide 95% CI [confidence interval] and a modest P value,” Dr. McMurray added. “So yes, interesting and hypothesis-generating, but not definitive.”
 

New meta-analysis

The new meta-analysis of all data so far available on ACE inhibitor and ARB use for patients with COVID-19 was published online in Annals of Internal Medicine on May 15.

The analysis is a living, systematic review with ongoing literature surveillance and critical appraisal, which will be updated as new data become available. It included 14 observational studies.

The authors, led by Katherine M. Mackey, MD, VA Portland Health Care System, Oregon, concluded: “High-certainty evidence suggests that ACE-inhibitor or ARB use is not associated with more severe COVID-19 disease, and moderate certainty evidence suggested no association between use of these medications and positive SARS-CoV-2 test results among symptomatic patients. Whether these medications increase the risk for mild or asymptomatic disease or are beneficial in COVID-19 treatment remains uncertain.”

In an accompanying editorial, William G. Kussmaul III, MD, Drexel University, Philadelphia, said that initial fears that these drugs may be harmful for patients with COVID-19 now seem to have been unfounded.

“We now have reasonable reassurance that drugs that alter the renin-angiotensin system do not pose substantial threats as either COVID-19 risk factors or severity multipliers,” he wrote.
 

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

A new nationwide U.S. observational study suggests that ACE inhibitors may protect against severe illness in older people with COVID-19, prompting the start of a randomized clinical trial to test the strategy.

In addition, a new meta-analysis of all the available data on the use of ACE inhibitors and angiotensin-receptor blockers (ARBs) in COVID-19–infected patients has concluded that these drugs are not associated with more severe disease and do not increase susceptibility to infection.

The observational study, which was published on the MedRxiv preprint server on May 19 and has not yet been peer reviewed, was conducted by the health insurance company United Heath Group and by Yale University, New Haven, Conn.

The investigators analyzed data from 10,000 patients from across the United States who had tested positive for COVID-19, who were enrolled in Medicare Advantage insurance plans or were commercially insured, and who had received a prescription for one or more antihypertensive medications.

Results showed that the use of ACE inhibitors was associated with an almost 40% lower risk for COVID-19 hospitalization for older people enrolled in Medicare Advantage plans. No such benefit was seen in the younger commercially insured patients or in either group with ARBs.

Courtesy Yale University

At a telephone media briefing on the study, senior investigator Harlan M. Krumholz, MD, said: “We don’t believe this is enough info to change practice, but we do think this is an interesting and intriguing result.

“These findings merit a clinical trial to formally test whether ACE inhibitors – which are cheap, widely available, and well-tolerated drugs – can reduce hospitalization of patients infected with COVID-19,” added Dr. Krumholz, professor of medicine at Yale and director of the Yale New Haven Hospital Center for Outcomes Research.

A pragmatic clinical trial is now being planned. In this trial, 10,000 older people who test positive for COVID-19 will be randomly assigned to receive either a low dose of an ACE inhibitor or placebo. It is hoped that recruitment for the trial will begin in June of 2020. It is open to all eligible Americans who are older than 50 years, who test negative for COVID-19, and who are not taking medications for hypertension. Prospective patients can sign up at a dedicated website.

The randomized trial, also conducted by United Health Group and Yale, is said to be “one of the first virtual COVID-19 clinical trials to be launched at scale.”

For the observational study, the researchers identified 2,263 people who were receiving medication for hypertension and who tested positive for COVID-19. Of these, approximately two-thirds were older, Medicare Advantage enrollees; one-third were younger, commercially insured individuals.

In a propensity score–matched analysis, the investigators matched 441 patients who were taking ACE inhibitors to 441 patients who were taking other antihypertensive agents; and 412 patients who were receiving an ARB to 412 patients who were receiving other antihypertensive agents.

Results showed that during a median of 30 days after testing positive, 12.7% of the cohort were hospitalized for COVID-19. In propensity score–matched analyses, neither ACE inhibitors (hazard ratio [HR], 0.77; P = .18) nor ARBs (HR, 0.88; P =.48) were significantly associated with risk for hospitalization.

However, in analyses stratified by the insurance group, ACE inhibitors (but not ARBs) were associated with a significant lower risk for hospitalization among the Medicare group (HR, 0.61; P = .02) but not among the commercially insured group (HR, 2.14; P = .12).

A second study examined outcomes of 7,933 individuals with hypertension who were hospitalized with COVID-19 (92% of these patients were Medicare Advantage enrollees). Of these, 14.2% died, 59.5% survived to discharge, and 26.3% underwent ongoing hospitalization. In propensity score–matched analyses, use of neither an ACE inhibitor (HR, 0.97; P = .74) nor an ARB (HR, 1.15; P = .15) was associated with risk of in-hospital mortality.

The researchers said their findings are consistent with prior evidence from randomized clinical trials suggesting a reduced risk for pneumonia with ACE inhibitors that is not observed with ARBs.

They also cited some preclinical evidence that they said suggests a possible protective role for ACE inhibitors in COVID-19: that ACE inhibitors, but not ARBs, are associated with the upregulation of ACE2 receptors, which modulate the local interactions of the renin-angiotensin-aldosterone system in the lung tissue.

“The presence of ACE2 receptors, therefore, exerts a protective effect against the development of acute lung injury in infections with SARS coronaviruses, which lead to dysregulation of these mechanisms and endothelial damage,” they added. “Further, our observations do not support theoretical concerns of adverse outcomes due to enhanced virulence of SARS coronaviruses due to overexpression of ACE2 receptors in cell cultures – an indirect binding site for these viruses.”

The authors also noted that their findings have “important implications” for four ongoing randomized trials of ACE inhibitors/ARBs in COVID-19, “as none of them align with the observations of our study.”

They pointed out that of the four ongoing trials, three are testing the use of ACE inhibitors or ARBs in the treatment of hospitalized COVID-19 patients, and one is testing the use of a 10-day course of ARBs after a positive SARS-CoV-2 test to prevent hospitalization.
 

Experts cautious

However, two cardiovascular experts who were asked to comment on this latest study were not overly optimistic about the data.

Michael A. Weber, MD, professor of medicine at the State University of New York, Brooklyn, said: “This report adds to the growing number of observational studies that show varying effects of ACE inhibitors and ARBs in increasing or decreasing hospitalizations for COVID-19 and the likelihood of in-hospital mortality. Overall, this new report differs from others in the remarkable effects of insurance coverage: In particular, for ACE inhibitors, there was a 40% reduction in fatal events in Medicare patients but a twofold increase in patients using commercial insurance – albeit the test for heterogeneity when comparing the two groups did not quite reach statistical significance.

“In essence, these authors are saying that ACE inhibitors are highly protective in patients aged 65 or older but bordering on harmful in patients aged below 65. I agree that it’s worthwhile to check this finding in a prospective trial ... but this hypothesis does seem to be a reach.”

Dr. Weber noted that both ACE inhibitors and ARBs increase the level of the ACE2 enzyme to which the COVID-19 virus binds in the lungs.

“The ACE inhibitors do so by inhibiting the enzyme’s action and thus stimulate further enzyme production; the ARBs block the effects of angiotensin II, which results in high angiotensin II levels that also upregulate ACE2 production,” he said. “Perhaps the ACE inhibitors, by binding to the ACE enzyme, can in some way interfere with the enzyme’s uptake of the COVID virus and thus provide some measure of clinical protection. This is possible, but why would this effect be apparent only in older people?”

Catherine Hackett/MDedge News

John McMurray, MD, professor of medical cardiology at the University of Glasgow, Scotland, added: “This looks like a subgroup of a subgroup type analysis based on small numbers of events – I think there were only 77 hospitalizations among the 722 patients treated with an ACE inhibitor, and the Medicare Advantage subgroup was only 581 of those 722 patients.

“The hazard ratio had wide 95% CI [confidence interval] and a modest P value,” Dr. McMurray added. “So yes, interesting and hypothesis-generating, but not definitive.”
 

New meta-analysis

The new meta-analysis of all data so far available on ACE inhibitor and ARB use for patients with COVID-19 was published online in Annals of Internal Medicine on May 15.

The analysis is a living, systematic review with ongoing literature surveillance and critical appraisal, which will be updated as new data become available. It included 14 observational studies.

The authors, led by Katherine M. Mackey, MD, VA Portland Health Care System, Oregon, concluded: “High-certainty evidence suggests that ACE-inhibitor or ARB use is not associated with more severe COVID-19 disease, and moderate certainty evidence suggested no association between use of these medications and positive SARS-CoV-2 test results among symptomatic patients. Whether these medications increase the risk for mild or asymptomatic disease or are beneficial in COVID-19 treatment remains uncertain.”

In an accompanying editorial, William G. Kussmaul III, MD, Drexel University, Philadelphia, said that initial fears that these drugs may be harmful for patients with COVID-19 now seem to have been unfounded.

“We now have reasonable reassurance that drugs that alter the renin-angiotensin system do not pose substantial threats as either COVID-19 risk factors or severity multipliers,” he wrote.
 

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

A new nationwide U.S. observational study suggests that ACE inhibitors may protect against severe illness in older people with COVID-19, prompting the start of a randomized clinical trial to test the strategy.

In addition, a new meta-analysis of all the available data on the use of ACE inhibitors and angiotensin-receptor blockers (ARBs) in COVID-19–infected patients has concluded that these drugs are not associated with more severe disease and do not increase susceptibility to infection.

The observational study, which was published on the MedRxiv preprint server on May 19 and has not yet been peer reviewed, was conducted by the health insurance company United Heath Group and by Yale University, New Haven, Conn.

The investigators analyzed data from 10,000 patients from across the United States who had tested positive for COVID-19, who were enrolled in Medicare Advantage insurance plans or were commercially insured, and who had received a prescription for one or more antihypertensive medications.

Results showed that the use of ACE inhibitors was associated with an almost 40% lower risk for COVID-19 hospitalization for older people enrolled in Medicare Advantage plans. No such benefit was seen in the younger commercially insured patients or in either group with ARBs.

Courtesy Yale University

At a telephone media briefing on the study, senior investigator Harlan M. Krumholz, MD, said: “We don’t believe this is enough info to change practice, but we do think this is an interesting and intriguing result.

“These findings merit a clinical trial to formally test whether ACE inhibitors – which are cheap, widely available, and well-tolerated drugs – can reduce hospitalization of patients infected with COVID-19,” added Dr. Krumholz, professor of medicine at Yale and director of the Yale New Haven Hospital Center for Outcomes Research.

A pragmatic clinical trial is now being planned. In this trial, 10,000 older people who test positive for COVID-19 will be randomly assigned to receive either a low dose of an ACE inhibitor or placebo. It is hoped that recruitment for the trial will begin in June of 2020. It is open to all eligible Americans who are older than 50 years, who test negative for COVID-19, and who are not taking medications for hypertension. Prospective patients can sign up at a dedicated website.

The randomized trial, also conducted by United Health Group and Yale, is said to be “one of the first virtual COVID-19 clinical trials to be launched at scale.”

For the observational study, the researchers identified 2,263 people who were receiving medication for hypertension and who tested positive for COVID-19. Of these, approximately two-thirds were older, Medicare Advantage enrollees; one-third were younger, commercially insured individuals.

In a propensity score–matched analysis, the investigators matched 441 patients who were taking ACE inhibitors to 441 patients who were taking other antihypertensive agents; and 412 patients who were receiving an ARB to 412 patients who were receiving other antihypertensive agents.

Results showed that during a median of 30 days after testing positive, 12.7% of the cohort were hospitalized for COVID-19. In propensity score–matched analyses, neither ACE inhibitors (hazard ratio [HR], 0.77; P = .18) nor ARBs (HR, 0.88; P =.48) were significantly associated with risk for hospitalization.

However, in analyses stratified by the insurance group, ACE inhibitors (but not ARBs) were associated with a significant lower risk for hospitalization among the Medicare group (HR, 0.61; P = .02) but not among the commercially insured group (HR, 2.14; P = .12).

A second study examined outcomes of 7,933 individuals with hypertension who were hospitalized with COVID-19 (92% of these patients were Medicare Advantage enrollees). Of these, 14.2% died, 59.5% survived to discharge, and 26.3% underwent ongoing hospitalization. In propensity score–matched analyses, use of neither an ACE inhibitor (HR, 0.97; P = .74) nor an ARB (HR, 1.15; P = .15) was associated with risk of in-hospital mortality.

The researchers said their findings are consistent with prior evidence from randomized clinical trials suggesting a reduced risk for pneumonia with ACE inhibitors that is not observed with ARBs.

They also cited some preclinical evidence that they said suggests a possible protective role for ACE inhibitors in COVID-19: that ACE inhibitors, but not ARBs, are associated with the upregulation of ACE2 receptors, which modulate the local interactions of the renin-angiotensin-aldosterone system in the lung tissue.

“The presence of ACE2 receptors, therefore, exerts a protective effect against the development of acute lung injury in infections with SARS coronaviruses, which lead to dysregulation of these mechanisms and endothelial damage,” they added. “Further, our observations do not support theoretical concerns of adverse outcomes due to enhanced virulence of SARS coronaviruses due to overexpression of ACE2 receptors in cell cultures – an indirect binding site for these viruses.”

The authors also noted that their findings have “important implications” for four ongoing randomized trials of ACE inhibitors/ARBs in COVID-19, “as none of them align with the observations of our study.”

They pointed out that of the four ongoing trials, three are testing the use of ACE inhibitors or ARBs in the treatment of hospitalized COVID-19 patients, and one is testing the use of a 10-day course of ARBs after a positive SARS-CoV-2 test to prevent hospitalization.
 

Experts cautious

However, two cardiovascular experts who were asked to comment on this latest study were not overly optimistic about the data.

Michael A. Weber, MD, professor of medicine at the State University of New York, Brooklyn, said: “This report adds to the growing number of observational studies that show varying effects of ACE inhibitors and ARBs in increasing or decreasing hospitalizations for COVID-19 and the likelihood of in-hospital mortality. Overall, this new report differs from others in the remarkable effects of insurance coverage: In particular, for ACE inhibitors, there was a 40% reduction in fatal events in Medicare patients but a twofold increase in patients using commercial insurance – albeit the test for heterogeneity when comparing the two groups did not quite reach statistical significance.

“In essence, these authors are saying that ACE inhibitors are highly protective in patients aged 65 or older but bordering on harmful in patients aged below 65. I agree that it’s worthwhile to check this finding in a prospective trial ... but this hypothesis does seem to be a reach.”

Dr. Weber noted that both ACE inhibitors and ARBs increase the level of the ACE2 enzyme to which the COVID-19 virus binds in the lungs.

“The ACE inhibitors do so by inhibiting the enzyme’s action and thus stimulate further enzyme production; the ARBs block the effects of angiotensin II, which results in high angiotensin II levels that also upregulate ACE2 production,” he said. “Perhaps the ACE inhibitors, by binding to the ACE enzyme, can in some way interfere with the enzyme’s uptake of the COVID virus and thus provide some measure of clinical protection. This is possible, but why would this effect be apparent only in older people?”

Catherine Hackett/MDedge News

John McMurray, MD, professor of medical cardiology at the University of Glasgow, Scotland, added: “This looks like a subgroup of a subgroup type analysis based on small numbers of events – I think there were only 77 hospitalizations among the 722 patients treated with an ACE inhibitor, and the Medicare Advantage subgroup was only 581 of those 722 patients.

“The hazard ratio had wide 95% CI [confidence interval] and a modest P value,” Dr. McMurray added. “So yes, interesting and hypothesis-generating, but not definitive.”
 

New meta-analysis

The new meta-analysis of all data so far available on ACE inhibitor and ARB use for patients with COVID-19 was published online in Annals of Internal Medicine on May 15.

The analysis is a living, systematic review with ongoing literature surveillance and critical appraisal, which will be updated as new data become available. It included 14 observational studies.

The authors, led by Katherine M. Mackey, MD, VA Portland Health Care System, Oregon, concluded: “High-certainty evidence suggests that ACE-inhibitor or ARB use is not associated with more severe COVID-19 disease, and moderate certainty evidence suggested no association between use of these medications and positive SARS-CoV-2 test results among symptomatic patients. Whether these medications increase the risk for mild or asymptomatic disease or are beneficial in COVID-19 treatment remains uncertain.”

In an accompanying editorial, William G. Kussmaul III, MD, Drexel University, Philadelphia, said that initial fears that these drugs may be harmful for patients with COVID-19 now seem to have been unfounded.

“We now have reasonable reassurance that drugs that alter the renin-angiotensin system do not pose substantial threats as either COVID-19 risk factors or severity multipliers,” he wrote.
 

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

The drastic drop in admissions for acute myocardial infarctions (AMI) during the COVID-19 pandemic in Italy has seen a parallel rise in MI fatality rates in those who do present to hospitals, according to a new report. This gives credence to suggestions that people have avoided hospitals during the pandemic despite life-threatening emergencies.

Salvatore De Rosa, MD, PhD, and colleagues reported their results in the European Heart Journal.

“These data return a frightening picture of about half of AMI patients not reaching out to the hospital at all, which will probably significantly increase mortality for AMI and bring with it a number of patients with post-MI heart failure, despite the fact that acute coronary syndrome management protocols were promptly implemented,” Dr. De Rosa, of Magna Graecia University in Catanzaro, Italy, and associates wrote.
 

Hospitalizations down

The study counted AMIs at 54 hospital coronary care units nationwide for the week of March 12-19, 2020, at the height of the coronavirus outbreak in northern Italy, and compared that with an equivalent week in 2019. The researchers reported 319 AMIs during the week in 2020, compared with 618 in the equivalent 2019 week, a 48% reduction (P < .001). Although the outbreak was worst in northern Italy, the decline in admissions occurred throughout the country.

An analysis of subtype determined the decline in the incidence of ST-segment elevation MI lagged significantly behind that of non-STEMI. STEMI declined from 268 in 2019 to 197 in 2020, a 27% reduction, while hospitalizations for non-STEMI went from 350 to 122, a 65% reduction.

The researchers also found substantial reductions in hospitalizations for heart failure, by 47%, and atrial fibrillation, by 53%. Incidentally, the mean age of atrial fibrillation patients was considerably younger in 2020: 64.6 vs. 70 years.
 

Death, complications up

AMI patients who managed to get to the hospital during the pandemic also had worse outcomes. Mortality for STEMI cases more than tripled, to 14% during the outbreak, compared with 4% in 2019 (P < .001) and complication rates increased by 80% to 19% (P = .025). Twenty-one STEMI patients were positive for COVID-19 and more than a quarter (29%) died, which was more than two and a half times the 12% death rate in non–COVID-19 STEMI patients.

Analysis of the STEMI group also found that the care gap for women with heart disease worsened significantly during the pandemic, as they comprised 20.3% of cases this year, compared with 25.4% before the pandemic. Also, the reduction in admissions for STEMI during the pandemic was statistically significant at 41% for women, but not for men at 18%.

Non-STEMI patients fared better overall than STEMI patients, but their outcomes also worsened during the pandemic. Non-STEMI patients were significantly less likely to have percutaneous coronary intervention during the pandemic than previously; the rate declined by 13%, from 77% to 66%. The non-STEMI mortality rate nearly doubled, although not statistically significantly, from 1.7% to 3.3%, whereas complication rates actually more than doubled, from 5.1% to 10.7%, a significant difference. Twelve (9.8%) of the non-STEMI patients were COVID-19 positive, but none died.
 

Trend extends beyond borders

Dr. De Rosa and colleagues noted that their findings are in line with studies that reported similar declines for STEMI interventions in the United States and Spain during the pandemic (J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.011; REC Interv Cardiol. 2020. doi: 10.24875/RECIC.M20000120).

Additionally, a group at Kaiser Permanente in Northern California also reported a 50% decline in the incidence of AMI hospitalizations during the pandemic (N Engl J Med. 2020 May 19. doi: 10.1056/NEJMc2015630). Likewise, a study of aortic dissections in New York reported a sharp decline in procedures during the pandemic in the city, from 13 to 3 a month (J Am Coll Cardiol. 2020 May 15. doi: 10.1016/j.jacc.2020.05.022)

The researchers in Italy didn’t aim to determine the reasons for the decline in AMI hospitalizations, but Dr. De Rosa and colleagues speculated on the following explanations: Fear of contagion in response to media reports, concentration of resources to address COVID-19 may have engendered a sense to defer less urgent care among patients and health care systems, and a true reduction in acute cardiovascular disease because people under stay-at-home orders had low physical stress.

“The concern is fewer MIs most likely means people are dying at home or presenting later as this study suggests,” said Martha Gulati, MD, chief of cardiology at the University of Arizona, Phoenix, in interpreting the results of the Italian study.

That could be a result of a mixed message from the media about accessing health care during the pandemic. “What it suggests to a lot of us is that the media has transmitted this notion that hospitals are busy taking care of COVID-19 patients, but we never said don’t come to hospital if you’re having a heart attack,” Dr. Gulati said. “I think we created some sort of fear that patients if they didn’t have COVID-19 they didn’t want to bother physicians.”

Dr. Gulati, whose practice focuses on women with CVD, said the study’s findings that interventions in women dropped more precipitously than men were concerning. “We know already that women don’t do as well after a heart attack, compared to men, and now we see it worsen it even further when women aren’t presenting,” she said. “We’re worried that this is going to increase the gap.”

Dr. DeRosa and colleagues have no relevant financial relationships to disclose.

SOURCE: De Rosa S et al. Euro Heart J. 2020 May 15. doi: 10.1093/eurheartj/ehaa409.

The drastic drop in admissions for acute myocardial infarctions (AMI) during the COVID-19 pandemic in Italy has seen a parallel rise in MI fatality rates in those who do present to hospitals, according to a new report. This gives credence to suggestions that people have avoided hospitals during the pandemic despite life-threatening emergencies.

Salvatore De Rosa, MD, PhD, and colleagues reported their results in the European Heart Journal.

“These data return a frightening picture of about half of AMI patients not reaching out to the hospital at all, which will probably significantly increase mortality for AMI and bring with it a number of patients with post-MI heart failure, despite the fact that acute coronary syndrome management protocols were promptly implemented,” Dr. De Rosa, of Magna Graecia University in Catanzaro, Italy, and associates wrote.
 

Hospitalizations down

The study counted AMIs at 54 hospital coronary care units nationwide for the week of March 12-19, 2020, at the height of the coronavirus outbreak in northern Italy, and compared that with an equivalent week in 2019. The researchers reported 319 AMIs during the week in 2020, compared with 618 in the equivalent 2019 week, a 48% reduction (P < .001). Although the outbreak was worst in northern Italy, the decline in admissions occurred throughout the country.

An analysis of subtype determined the decline in the incidence of ST-segment elevation MI lagged significantly behind that of non-STEMI. STEMI declined from 268 in 2019 to 197 in 2020, a 27% reduction, while hospitalizations for non-STEMI went from 350 to 122, a 65% reduction.

The researchers also found substantial reductions in hospitalizations for heart failure, by 47%, and atrial fibrillation, by 53%. Incidentally, the mean age of atrial fibrillation patients was considerably younger in 2020: 64.6 vs. 70 years.
 

Death, complications up

AMI patients who managed to get to the hospital during the pandemic also had worse outcomes. Mortality for STEMI cases more than tripled, to 14% during the outbreak, compared with 4% in 2019 (P < .001) and complication rates increased by 80% to 19% (P = .025). Twenty-one STEMI patients were positive for COVID-19 and more than a quarter (29%) died, which was more than two and a half times the 12% death rate in non–COVID-19 STEMI patients.

Analysis of the STEMI group also found that the care gap for women with heart disease worsened significantly during the pandemic, as they comprised 20.3% of cases this year, compared with 25.4% before the pandemic. Also, the reduction in admissions for STEMI during the pandemic was statistically significant at 41% for women, but not for men at 18%.

Non-STEMI patients fared better overall than STEMI patients, but their outcomes also worsened during the pandemic. Non-STEMI patients were significantly less likely to have percutaneous coronary intervention during the pandemic than previously; the rate declined by 13%, from 77% to 66%. The non-STEMI mortality rate nearly doubled, although not statistically significantly, from 1.7% to 3.3%, whereas complication rates actually more than doubled, from 5.1% to 10.7%, a significant difference. Twelve (9.8%) of the non-STEMI patients were COVID-19 positive, but none died.
 

Trend extends beyond borders

Dr. De Rosa and colleagues noted that their findings are in line with studies that reported similar declines for STEMI interventions in the United States and Spain during the pandemic (J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.011; REC Interv Cardiol. 2020. doi: 10.24875/RECIC.M20000120).

Additionally, a group at Kaiser Permanente in Northern California also reported a 50% decline in the incidence of AMI hospitalizations during the pandemic (N Engl J Med. 2020 May 19. doi: 10.1056/NEJMc2015630). Likewise, a study of aortic dissections in New York reported a sharp decline in procedures during the pandemic in the city, from 13 to 3 a month (J Am Coll Cardiol. 2020 May 15. doi: 10.1016/j.jacc.2020.05.022)

The researchers in Italy didn’t aim to determine the reasons for the decline in AMI hospitalizations, but Dr. De Rosa and colleagues speculated on the following explanations: Fear of contagion in response to media reports, concentration of resources to address COVID-19 may have engendered a sense to defer less urgent care among patients and health care systems, and a true reduction in acute cardiovascular disease because people under stay-at-home orders had low physical stress.

“The concern is fewer MIs most likely means people are dying at home or presenting later as this study suggests,” said Martha Gulati, MD, chief of cardiology at the University of Arizona, Phoenix, in interpreting the results of the Italian study.

That could be a result of a mixed message from the media about accessing health care during the pandemic. “What it suggests to a lot of us is that the media has transmitted this notion that hospitals are busy taking care of COVID-19 patients, but we never said don’t come to hospital if you’re having a heart attack,” Dr. Gulati said. “I think we created some sort of fear that patients if they didn’t have COVID-19 they didn’t want to bother physicians.”

Dr. Gulati, whose practice focuses on women with CVD, said the study’s findings that interventions in women dropped more precipitously than men were concerning. “We know already that women don’t do as well after a heart attack, compared to men, and now we see it worsen it even further when women aren’t presenting,” she said. “We’re worried that this is going to increase the gap.”

Dr. DeRosa and colleagues have no relevant financial relationships to disclose.

SOURCE: De Rosa S et al. Euro Heart J. 2020 May 15. doi: 10.1093/eurheartj/ehaa409.

The drastic drop in admissions for acute myocardial infarctions (AMI) during the COVID-19 pandemic in Italy has seen a parallel rise in MI fatality rates in those who do present to hospitals, according to a new report. This gives credence to suggestions that people have avoided hospitals during the pandemic despite life-threatening emergencies.

Salvatore De Rosa, MD, PhD, and colleagues reported their results in the European Heart Journal.

“These data return a frightening picture of about half of AMI patients not reaching out to the hospital at all, which will probably significantly increase mortality for AMI and bring with it a number of patients with post-MI heart failure, despite the fact that acute coronary syndrome management protocols were promptly implemented,” Dr. De Rosa, of Magna Graecia University in Catanzaro, Italy, and associates wrote.
 

Hospitalizations down

The study counted AMIs at 54 hospital coronary care units nationwide for the week of March 12-19, 2020, at the height of the coronavirus outbreak in northern Italy, and compared that with an equivalent week in 2019. The researchers reported 319 AMIs during the week in 2020, compared with 618 in the equivalent 2019 week, a 48% reduction (P < .001). Although the outbreak was worst in northern Italy, the decline in admissions occurred throughout the country.

An analysis of subtype determined the decline in the incidence of ST-segment elevation MI lagged significantly behind that of non-STEMI. STEMI declined from 268 in 2019 to 197 in 2020, a 27% reduction, while hospitalizations for non-STEMI went from 350 to 122, a 65% reduction.

The researchers also found substantial reductions in hospitalizations for heart failure, by 47%, and atrial fibrillation, by 53%. Incidentally, the mean age of atrial fibrillation patients was considerably younger in 2020: 64.6 vs. 70 years.
 

Death, complications up

AMI patients who managed to get to the hospital during the pandemic also had worse outcomes. Mortality for STEMI cases more than tripled, to 14% during the outbreak, compared with 4% in 2019 (P < .001) and complication rates increased by 80% to 19% (P = .025). Twenty-one STEMI patients were positive for COVID-19 and more than a quarter (29%) died, which was more than two and a half times the 12% death rate in non–COVID-19 STEMI patients.

Analysis of the STEMI group also found that the care gap for women with heart disease worsened significantly during the pandemic, as they comprised 20.3% of cases this year, compared with 25.4% before the pandemic. Also, the reduction in admissions for STEMI during the pandemic was statistically significant at 41% for women, but not for men at 18%.

Non-STEMI patients fared better overall than STEMI patients, but their outcomes also worsened during the pandemic. Non-STEMI patients were significantly less likely to have percutaneous coronary intervention during the pandemic than previously; the rate declined by 13%, from 77% to 66%. The non-STEMI mortality rate nearly doubled, although not statistically significantly, from 1.7% to 3.3%, whereas complication rates actually more than doubled, from 5.1% to 10.7%, a significant difference. Twelve (9.8%) of the non-STEMI patients were COVID-19 positive, but none died.
 

Trend extends beyond borders

Dr. De Rosa and colleagues noted that their findings are in line with studies that reported similar declines for STEMI interventions in the United States and Spain during the pandemic (J Am Coll Cardiol. 2020. doi: 10.1016/j.jacc.2020.04.011; REC Interv Cardiol. 2020. doi: 10.24875/RECIC.M20000120).

Additionally, a group at Kaiser Permanente in Northern California also reported a 50% decline in the incidence of AMI hospitalizations during the pandemic (N Engl J Med. 2020 May 19. doi: 10.1056/NEJMc2015630). Likewise, a study of aortic dissections in New York reported a sharp decline in procedures during the pandemic in the city, from 13 to 3 a month (J Am Coll Cardiol. 2020 May 15. doi: 10.1016/j.jacc.2020.05.022)

The researchers in Italy didn’t aim to determine the reasons for the decline in AMI hospitalizations, but Dr. De Rosa and colleagues speculated on the following explanations: Fear of contagion in response to media reports, concentration of resources to address COVID-19 may have engendered a sense to defer less urgent care among patients and health care systems, and a true reduction in acute cardiovascular disease because people under stay-at-home orders had low physical stress.

“The concern is fewer MIs most likely means people are dying at home or presenting later as this study suggests,” said Martha Gulati, MD, chief of cardiology at the University of Arizona, Phoenix, in interpreting the results of the Italian study.

That could be a result of a mixed message from the media about accessing health care during the pandemic. “What it suggests to a lot of us is that the media has transmitted this notion that hospitals are busy taking care of COVID-19 patients, but we never said don’t come to hospital if you’re having a heart attack,” Dr. Gulati said. “I think we created some sort of fear that patients if they didn’t have COVID-19 they didn’t want to bother physicians.”

Dr. Gulati, whose practice focuses on women with CVD, said the study’s findings that interventions in women dropped more precipitously than men were concerning. “We know already that women don’t do as well after a heart attack, compared to men, and now we see it worsen it even further when women aren’t presenting,” she said. “We’re worried that this is going to increase the gap.”

Dr. DeRosa and colleagues have no relevant financial relationships to disclose.

SOURCE: De Rosa S et al. Euro Heart J. 2020 May 15. doi: 10.1093/eurheartj/ehaa409.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

COVID-19 vaccines face tough road

Vaccine-induced neutralizing antibodies may not be sufficient to reliably provide sustained protection against SARS-CoV-2 infection. Rather, a successful vaccine against coronavirus will likely need to incorporate T-cell epitopes to induce a long-term memory T-cell immune response to the virus, Mehrdad Matloubian, MD, PhD, predicted at the virtual edition of the American College of Rheumatology’s 2020 State-of-the-Art Clinical Symposium. “In one study, 20 of 26 patients with SARS had lost their antibody response by 6 years post infection. And they had no B-cell immunity against the SARS antigens. The good news is they did have T-cell memory against SARS virus, and people with more severe disease tended to have more T-cell memory against SARS. All of this has really important implications for vaccine development,” observed Dr. Matloubian, a rheumatologist at the University of California, San Francisco. READ MORE
 

Chilblain-like lesions in children with suspected COVID-19

Reports are growing of cases of children with suspected COVID-19 and chilblain-like lesions. Most recently, there were two reports in Spain and Italy. These symptoms should be considered a sign of infection with the virus, but the symptoms themselves typically don’t require treatment, according to the authors of the two new reports, which were published in Pediatric Dermatology. READ MORE

FDA approves olaparib in metastatic prostate cancer

The Food and Drug Administration approved olaparib (Lynparza) for deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The drug is limited to use in men who have progressed following prior treatment with enzalutamide or abiraterone. The agency also recently approved rucaparib (Rubraca) for use in patients with mCRPC that harbor deleterious BRCA mutations (germline and/or somatic). READ MORE

Drugs, alcohol, suicide

Deaths from drugs, alcohol, and suicide are on the rise, despite recent decreases in opioid overdose deaths. A report released May 21 by the Trust for America’s Health (TFAH) and the Well Being Trust shows that 151,964 Americans died in 2018 from alcohol, drugs, and suicide. Experts warn that these deaths may increase in the wake of COVID-19. “We know what works to address deaths of despair but progress has been uneven and death rates continue to climb, with communities of color experiencing higher rates of increases in drug-induced and alcohol deaths,” said TFAH President and CEO John Auerbach. READ MORE

Guidance on managing suspected stroke during COVID-19

The American Heart Association/American Stroke Association has developed a “conceptual framework” to assist emergency medical service providers and in-hospital triage teams handle suspected cases of acute stroke during the ongoing COVID-19 crisis and future pandemics. The main factors to guide the triage decision are the likelihood of a large vessel occlusion; the magnitude of additional delays because of inter-hospital transfer and work flow efficiency at the primary stroke center or acute stroke ready hospital; the need for advanced critical care resources; and the availability of bed, staff, and PPE resources at the hospitals. READ MORE

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Severe COVID-19 may cause delirium in the acute stage of illness, followed by the possibility of depression, anxiety, fatigue, insomnia, and posttraumatic stress disorder (PTSD) over the longer term, new research suggests.

Results from “the first systematic review and meta-analysis of the psychiatric consequences of coronavirus infection” showed that previous coronavirus epidemics were associated with a significant psychiatric burden in both the acute and post-illness stages.

“Most people with COVID-19 will not develop any mental health problems, even among those with severe cases requiring hospitalization, but given the huge numbers of people getting sick, the global impact on mental health could be considerable,” co–lead investigator Jonathan Rogers, MRCPsych, Department of Psychiatry, University College London, United Kingdom, said in a news release.

The study was published online May 18 in Lancet Psychiatry.

Need for Monitoring, Support

The researchers analyzed 65 peer-reviewed studies and seven preprint articles with data on acute and post-illness psychiatric and neuropsychiatric features of patients who had been hospitalized with COVID-19, as well as two other diseases caused by coronaviruses – severe acute respiratory syndrome (SARS), in 2002–2004, and Middle East respiratory syndrome (MERS), in 2012.

“Our main findings are that signs suggestive of delirium are common in the acute stage of SARS, MERS, and COVID-19; there is evidence of depression, anxiety, fatigue, and post-traumatic stress disorder in the post-illness stage of previous coronavirus epidemics, but there are few data yet on COVID-19,” the investigators write.

The data show that among patients acutely ill with SARS and MERS, 28% experienced confusion, 33% had depressed mood, 36% had anxiety, 34% suffered from impaired memory, and 42% had insomnia.

After recovery from SARS and MERS, sleep disorder, frequent recall of traumatic memories, emotional lability, impaired concentration, fatigue, and impaired memory were reported in more than 15% of patients during a follow-up period that ranged from 6 weeks to 39 months.

In a meta-analysis, the point prevalence in the post-illness stage was 32% for PTSD and about 15% for depression and anxiety.

In patients acutely ill with severe COVID-19, available data suggest that 65% experience delirium, 69% have agitation after withdrawal of sedation, and 21% have altered consciousness.

In one study, 33% of patients had a dysexecutive syndrome at discharge, characterized by symptoms such as inattention, disorientation, or poorly organized movements in response to command. Currently, data are very limited regarding patients who have recovered from COVID-19, the investigators caution.

“To avoid a large-scale mental health crisis, we hope that people who have been hospitalized with COVID-19 will be offered support, and monitored after they recover to ensure they do not develop mental illnesses, and are able to access treatment if needed,” senior author Anthony David, FMedSci, from UCL Institute of Mental Health, said in a news release.

“While most people with COVID-19 will recover without experiencing mental illness, we need to research which factors may contribute to enduring mental health problems, and develop interventions to prevent and treat them,” he added.

Be Prepared

The coauthors of a linked commentary say it makes sense, from a biological perspective, to merge data on these three coronavirus diseases, given the degree to which they resemble each other.

They caution, however, that treatment of COVID-19 seems to be different from treatment of SARS and MERS. In addition, the social and economic situation of COVID-19 survivors’ return is completely different from that of SARS and MERS survivors.

Findings from previous coronavirus outbreaks are “useful, but might not be exact predictors of prevalences of psychiatric complications for patients with COVID-19,” write Iris Sommer, MD, PhD, from University Medical Center Groningen, the Netherlands, and P. Roberto Bakker, MD, PhD, from Maastricht University Medical Center, the Netherlands.

“The warning from [this study] that we should prepare to treat large numbers of patients with COVID-19 who go on to develop delirium, post-traumatic stress disorder, anxiety, and depression is an important message for the psychiatric community,” they add.

Sommer and Bakker also say the reported estimates of prevalence in this study should be interpreted with caution, “as true numbers of both acute and long-term psychiatric disorders for patients with COVID-19 might be considerably higher.”

Funding for the study was provided by the Wellcome Trust, the UK National Institute for Health Research (NIHR), the UK Medical Research Council, the NIHR Biomedical Research Center at the University College London Hospitals NHS Foundation Trust, and the University College London. The authors of the study and the commentary have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

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The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

[email protected]

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.

The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

[email protected]

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.

The American Geriatrics Society has issued policy recommendations aimed at protecting seniors from ageism when it comes to resource allocation in the current context of treating patients infected with COVID-19.

“The AGS is deeply concerned about potentially negative long-term consequences of COVID-19 emergency rationing strategies that disfavor older adults,” Timothy W. Farrell, MD, University of Utah, Salt Lake City, and colleagues wrote in an AGS position statement published online in the Journal of the American Geriatrics Society.

“In particular, rationing strategies that are solely, or predominantly, based on age cutoffs could lead to persistent beliefs that older adults’ lives are less valuable than others or are even expendable, and contribute to already rampant ageism,” the authors continued. “Unless the injustice in these strategies is corrected, this will be a persistent issue if there is a resurgence of COVID-19 cases, a pandemic caused by a different virus in the future, or a different type of disaster where resources are scarce.”

To counter a potential bias against the elderly population should scarce resources force rationing decisions, AGS has made recommendations and strategies that health care systems should incorporate into a policy framework.

One principle in the AGS statement is clear: “Age per se should never be used as a means for a categorical exclusion from therapeutic interventions that represent the standard of care. ... Likewise, specific age-based cutoffs should not be used in resource allocation strategies.”

Peter Angelos, MD, chief of endocrine surgery at the University of Chicago, applauded the position statement.

“It is a well-written statement and I do think that it appropriately suggests that age in and of itself is not a good predictor of who is at greatest risk if infected with coronavirus,” Dr. Angelos, who also serves as the associate director of the MacLean Center for Clinical Medical Ethics, said in an interview.

He suggested a scenario in which a younger person could have multiple comorbidities that could put that individual at a higher risk of death because of complications from COVID-19 (or another pandemic in the future), compared with an older patient who is otherwise a healthy individual with a lower risk of death.

“For that reason, I agree with the authors that there should not be an arbitrary cutoff of age for which we don’t treat people or we limit treatment.”

Rather, the authors state that the primary allocation method in emergency circumstances that require rationing because of lack of resources should “equally weigh in-hospital survival and severe comorbidities contributing to short-term (<6 months) mortality.”

When assessing comorbidities, “the disparate impact of social determinants of health including culture, ethnicity, socioeconomic status, and other factors should be considered.”

AGS’s position statement adds that criteria such as “life-years saved” and “long-term predicted life expectancy” should not be used as they tend to disadvantage older adults.

The organization noted that institutions “should develop resource allocation strategies that are transparent, applied uniformly, and developed with forethought and input from multiple disciplines including ethics, medicine, law, and nursing. These strategies should be used consistently when making emergency decisions.” The AGS called for institutions to frequently review these strategies to ensure they are updated with the most recent evidence and to identify any issues of bias that may emerge.

Dr. Angelos stressed that these guidelines should be developed in a transparent and open fashion. He also highlighted the AGS recommendation of the use of triage officers or triage committees to make the determination about resource allocation should those decisions need to be made.

“We don’t want caregivers who are at the bedside taking care of patients to have the responsibility to say ‘We are going to treat one person as opposed to another person,’ ” he said. “You want to have those decisions made by a team that is separate from the bedside caregivers.”

He agreed with the statement authors that the goal of the triage committee decisions should be to maximize lives saved as opposed to life-years saved. Dr. Angelos noted that his institution’s plan focuses on lives saved should the need for resource rationing come to pass.

In addition to institutional strategies, AGS also emphasized in the position statement that older adults should develop individual care plans that include lists of medical conditions, medications, health care providers, and advance directives. The statement also noted that about only 50% of adults over age 60 years have complete advance directives, a rate Dr. Farrell and colleagues state is “unacceptably low.”

“Advance care planning should not be limited to the purview of only the primary care, geriatrics, or palliative care health professional, and urgent efforts should be made to discuss patient preferences before an emergent need arises,” the paper states, noting that specialists need to be a part of the conversation.

However, the position statement is clear that, while AGS is encouraging providers to talk about advance care planning with their patients, “providers should not pressure, even subtly, patients to engage in advance care planning or change to Do Not Resuscitate/Do Not Intubate (DNR/DNI) status with the intent to conserve health resources.”

Dr. Angelos reiterated this point and suggested that advance directive conversations need to be happening and happening more often.

“This current pandemic has forced us all to realize that, even in well-resourced societies like the United States, we may be faced with situations of absolute scarcity, so we ought to have these conversations up front so that we are not put in a position where we have to make decisions, and those decisions may not be well thought out and may not be ethically justifiable,” he said.

[email protected]

SOURCE: Farrell TW et al. J Am Geriat Soc. 2020 May 6; doi: 10.1111/jgs.16537.

Mainstream media outlets have been flooded recently with reports speculating on what role, if any, vitamin D may play in reducing the severity of COVID-19 infection.

Observational data comparing outcomes from various countries suggest inverse links between vitamin D levels and the severity of COVID-19 responses, as well as mortality, with the further suggestion of an effect of vitamin D on the immune response to infection.

But other studies question such a link, including any association between vitamin D concentration and differences in COVID-19 severity by ethnic group.

And while some researchers and clinicians believe people should get tested to see if they have adequate vitamin D levels during this pandemic – in particular frontline health care workers – most doctors say the best way to ensure that people have adequate levels of vitamin D during COVID-19 is to simply take supplements at currently recommended levels.

This is especially important given the fact that, during “lockdown” scenarios, many people are spending more time than usual indoors.

Clifford Rosen, MD, senior scientist at Maine Medical Center’s Research Institute in Scarborough, has been researching vitamin D for 25 years.

“There’s no randomized, controlled trial for sure, and that’s the gold standard,” he said in an interview, and “the observational data are so confounded, it’s difficult to know.”

Whether from diet or supplementation, having adequate vitamin D is important, especially for those at the highest risk of COVID-19, he said. Still, robust data supporting a role of vitamin D in prevention of COVID-19, or as any kind of “therapy” for the infection, are currently lacking.

Rose Anne Kenny, MD, professor of medical gerontology at Trinity College Dublin, recently coauthored an article detailing an inverse association between vitamin D levels and mortality from COVID-19 across countries in Europe.

“At no stage are any of us saying this is a given, but there’s a probability that [vitamin D] – a low-hanging fruit – is a contributory factor and we can do something about it now,” she said in an interview.

Dr. Kenny is calling for the Irish government to formally change their recommendations. “We call on the Irish government to update guidelines as a matter of urgency and encourage all adults to take [vitamin D] supplements during the COVID-19 crisis.” Northern Ireland, part of the United Kingdom, also has not yet made this recommendation, she said.

Meanwhile, Harpreet S. Bajaj, MD, MPH, a practicing endocrinologist from Mount Sinai Hospital, Toronto, said: “Vitamin D could have any of three potential roles in risk for COVID-19 and/or its severity: no role, simply a marker, or a causal factor.”

Dr. Bajaj said – as did Dr. Rosen and Dr. Kenny – that randomized, controlled trials (RCTs) are sorely needed to help ascertain whether there is a specific role of vitamin D.

“Until then, we should continue to follow established public health recommendations for vitamin D supplementation, in addition to following COVID-19 prevention guidance and evolving guidelines for COVID-19 treatment.”
 

What is the role of vitamin D fortification?

In their study in the Irish Medical Journal, Dr. Kenny and colleagues noted that, in Europe, despite being sunny, Spain and Northern Italy had high rates of vitamin D deficiency and have experienced some of the highest COVID-19 infection and mortality rates in the world.

But these countries do not formally fortify foods or recommend supplementation with vitamin D.

Conversely, the northern countries of Norway, Finland, and Sweden had higher vitamin D levels despite less UVB sunlight exposure, as a result of common supplementation and formal fortification of foods. These Nordic countries also had lower levels of COVID-19 infection and mortality.

Overall, the correlation between low vitamin D levels and mortality from COVID-19 was statistically significant (P = .046), the investigators reported.

“Optimizing vitamin D status to recommendations by national and international public health agencies will certainly have ... potential benefits for COVID-19,” they concluded.

“We’re not saying there aren’t any confounders. This can absolutely be the case, but this [finding] needs to be in the mix of evidence,” Dr. Kenny said.

Dr. Kenny also noted that countries in the Southern Hemisphere have been seeing a relatively low mortality from COVID-19, although she acknowledged the explanation could be that the virus spread later to those countries.

Dr. Rosen has doubts on this issue, too.

“Sure, vitamin D supplementation may have worked for [Nordic countries], their COVID-19 has been better controlled, but there’s no causality here; there’s another step to actually prove this. Other factors might be at play,” he said.

“Look at Brazil, it’s at the equator but the disease is devastating the country. Right now, I just don’t believe it.”

Does vitamin D have a role to play in immune modulation?

One theory currently circulating is that, if vitamin D does have any role to play in modulating response to COVID-19, this may be via a blunting of the immune system reaction to the virus.

In a recent preprint study, Ali Daneshkhah, PhD, and colleagues from Northwestern University, Chicago, interrogated hospital data from China, France, Germany, Italy, Iran, South Korea, Spain, Switzerland, the United Kingdom, and the United States.

Specifically, the risk of severe COVID-19 cases among patients with severe vitamin D deficiency was 17.3%, whereas the equivalent figure for patients with normal vitamin D levels was 14.6% (a reduction of 15.6%).

“This potential effect may be attributed to vitamin D’s ability to suppress the adaptive immune system, regulating cytokine levels and thereby reducing the risk of developing severe COVID-19,” said the researchers.

Likewise, JoAnn E. Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital in Boston, in a recent commentary, noted evidence from an observational study from three South Asian hospitals, in which the prevalence of vitamin D deficiency was much higher among those with severe COVID-19 illness compared with those with mild illness.

“We also know that vitamin D has an immune-modulating effect and can lower inflammation, and this may be relevant to the respiratory response during COVID-19 and the cytokine storm that’s been demonstrated,” she noted.

Dr. Rosen said he is willing to listen on the issue of a potential role of vitamin D in immune modulation.

“I’ve been a huge skeptic from the get-go, and loudly criticized the data for doing nothing. I am surprised at myself for saying there might be some effect,” he said.

“Clearly most people don’t get this [cytokine storm] but of those that do, it’s unclear why they do. Maybe if you are vitamin D sufficient, it might have some impact down the road on your response to an infection,” Dr. Rosen said. “Vitamin D may induce proteins important in modulating the function of macrophages of the immune system.”

Ethnic minorities disproportionately affected

It is also well recognized that COVID-19 disproportionately affects black and Asian minority ethnic individuals.

But on the issue of vitamin D in this context, one recent peer-reviewed study using UK Biobank data found no evidence to support a potential role for vitamin D concentration to explain susceptibility to COVID-19 infection either overall or in explaining differences between ethnic groups.

“Vitamin D is unlikely to be the underlying mechanism for the higher risk observed in black and minority ethnic individuals, and vitamin D supplements are unlikely to provide an effective intervention,” Claire Hastie, PhD, of the University of Glasgow and colleagues concluded.

But this hasn’t stopped two endocrinologists from appealing to members of the British Association of Physicians of Indian Origin (BAPIO) to get their vitamin D levels tested.

The black and Asian minority ethnic population, “especially frontline staff, should get their Vitamin D₃ levels checked and get appropriate replacement as required,” said Parag Singhal, MD, of Weston General Hospital, Weston-Super-Mare, England, and David C. Anderson, a retired endocrinologist, said in a letter to BAPIO members.

Indeed, they suggested a booster dose of 100,000 IU as a one-off for black and Asian minority ethnic health care staff that should raise vitamin D levels for 2-3 months. They referred to a systematic review that concludes that “single vitamin D₃ doses ≥300,000 IU are most effective at improving vitamin D status ... for up to 3 months”.

Commenting on the idea, Dr. Rosen remarked that, in general, the high-dose 50,000-500,000 IU given as a one-off does not confer any greater benefit than a single dose of 1,000 IU per day, except that the blood levels go up quicker and higher.

“Really there is no evidence that getting to super-high levels of vitamin D confer a greater benefit than normal levels,” he said. “So if health care workers suspect vitamin D deficiency, daily doses of 1,000 IU seem reasonable; even if they miss doses, the blood levels are relatively stable.”

On the specific question of vitamin D needs in ethnic minorities, Dr. Rosen said while such individuals do have lower serum levels of vitamin D, the issue is whether there are meaningful clinical implications related to this.

“The real question is whether [ethnic minority individuals] have physiologically adapted for this in other ways because these low levels have been so for thousands of years. In fact, African Americans have lower vitamin D levels but they absolutely have better bones than [whites],” he pointed out. 
 

Testing and governmental recommendations during COVID-19

The U.S. National Institutes of Health in general advises 400 IU to 800 IU per day intake of vitamin D, depending on age, with those over 70 years requiring the highest daily dose. This will result in blood levels that are sufficient to maintain bone health and normal calcium metabolism in healthy people. There are no additional recommendations specific to vitamin D intake during the COVID-19 pandemic, however.

And Dr. Rosen pointed out that there is no evidence for mass screening of vitamin D levels among the U.S. population.

“U.S. public health guidance was pre-COVID, and I think high-risk individuals might want to think about their levels; for example, someone with inflammatory bowel disease or liver or pancreatic disease. These people are at higher risk anyway, and it could be because their vitamin D is low,” he said.

“Skip the test and ensure you are getting adequate levels of vitamin D whether via diet or supplement [400-800 IU per day],” he suggested. “It won’t harm.”

The U.K.’s Public Health England (PHE) clarified its advice on vitamin D supplementation during COVID-19. Alison Tedstone, PhD, chief nutritionist at PHE, said: “Many people are spending more time indoors and may not get all the vitamin D they need from sunlight. To protect their bone and muscle health, they should consider taking a daily supplement containing 10 micrograms [400 IU] of vitamin D.”

However, “there is no sufficient evidence to support recommending Vitamin D for reducing the risk of COVID-19,” she stressed.

Dr. Bajaj is on the advisory board of Medscape Diabetes & Endocrinology. He has ties with Amgen, AstraZeneca Boehringer Ingelheim, Janssen, Merck, Novo Nordisk, Sanofi, Eli Lilly,Valeant, Canadian Collaborative Research Network, CMS Knowledge Translation, Diabetes Canada Scientific Group, LMC Healthcare,mdBriefCase,Medscape, andMeducom. Dr. Kenny, Dr. Rosen, and Dr. Singhal have disclosed no relevant financial relationships.

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

Mainstream media outlets have been flooded recently with reports speculating on what role, if any, vitamin D may play in reducing the severity of COVID-19 infection.

Observational data comparing outcomes from various countries suggest inverse links between vitamin D levels and the severity of COVID-19 responses, as well as mortality, with the further suggestion of an effect of vitamin D on the immune response to infection.

But other studies question such a link, including any association between vitamin D concentration and differences in COVID-19 severity by ethnic group.

And while some researchers and clinicians believe people should get tested to see if they have adequate vitamin D levels during this pandemic – in particular frontline health care workers – most doctors say the best way to ensure that people have adequate levels of vitamin D during COVID-19 is to simply take supplements at currently recommended levels.

This is especially important given the fact that, during “lockdown” scenarios, many people are spending more time than usual indoors.

Clifford Rosen, MD, senior scientist at Maine Medical Center’s Research Institute in Scarborough, has been researching vitamin D for 25 years.

“There’s no randomized, controlled trial for sure, and that’s the gold standard,” he said in an interview, and “the observational data are so confounded, it’s difficult to know.”

Whether from diet or supplementation, having adequate vitamin D is important, especially for those at the highest risk of COVID-19, he said. Still, robust data supporting a role of vitamin D in prevention of COVID-19, or as any kind of “therapy” for the infection, are currently lacking.

Rose Anne Kenny, MD, professor of medical gerontology at Trinity College Dublin, recently coauthored an article detailing an inverse association between vitamin D levels and mortality from COVID-19 across countries in Europe.

“At no stage are any of us saying this is a given, but there’s a probability that [vitamin D] – a low-hanging fruit – is a contributory factor and we can do something about it now,” she said in an interview.

Dr. Kenny is calling for the Irish government to formally change their recommendations. “We call on the Irish government to update guidelines as a matter of urgency and encourage all adults to take [vitamin D] supplements during the COVID-19 crisis.” Northern Ireland, part of the United Kingdom, also has not yet made this recommendation, she said.

Meanwhile, Harpreet S. Bajaj, MD, MPH, a practicing endocrinologist from Mount Sinai Hospital, Toronto, said: “Vitamin D could have any of three potential roles in risk for COVID-19 and/or its severity: no role, simply a marker, or a causal factor.”

Dr. Bajaj said – as did Dr. Rosen and Dr. Kenny – that randomized, controlled trials (RCTs) are sorely needed to help ascertain whether there is a specific role of vitamin D.

“Until then, we should continue to follow established public health recommendations for vitamin D supplementation, in addition to following COVID-19 prevention guidance and evolving guidelines for COVID-19 treatment.”
 

What is the role of vitamin D fortification?

In their study in the Irish Medical Journal, Dr. Kenny and colleagues noted that, in Europe, despite being sunny, Spain and Northern Italy had high rates of vitamin D deficiency and have experienced some of the highest COVID-19 infection and mortality rates in the world.

But these countries do not formally fortify foods or recommend supplementation with vitamin D.

Conversely, the northern countries of Norway, Finland, and Sweden had higher vitamin D levels despite less UVB sunlight exposure, as a result of common supplementation and formal fortification of foods. These Nordic countries also had lower levels of COVID-19 infection and mortality.

Overall, the correlation between low vitamin D levels and mortality from COVID-19 was statistically significant (P = .046), the investigators reported.

“Optimizing vitamin D status to recommendations by national and international public health agencies will certainly have ... potential benefits for COVID-19,” they concluded.

“We’re not saying there aren’t any confounders. This can absolutely be the case, but this [finding] needs to be in the mix of evidence,” Dr. Kenny said.

Dr. Kenny also noted that countries in the Southern Hemisphere have been seeing a relatively low mortality from COVID-19, although she acknowledged the explanation could be that the virus spread later to those countries.

Dr. Rosen has doubts on this issue, too.

“Sure, vitamin D supplementation may have worked for [Nordic countries], their COVID-19 has been better controlled, but there’s no causality here; there’s another step to actually prove this. Other factors might be at play,” he said.

“Look at Brazil, it’s at the equator but the disease is devastating the country. Right now, I just don’t believe it.”

Does vitamin D have a role to play in immune modulation?

One theory currently circulating is that, if vitamin D does have any role to play in modulating response to COVID-19, this may be via a blunting of the immune system reaction to the virus.

In a recent preprint study, Ali Daneshkhah, PhD, and colleagues from Northwestern University, Chicago, interrogated hospital data from China, France, Germany, Italy, Iran, South Korea, Spain, Switzerland, the United Kingdom, and the United States.

Specifically, the risk of severe COVID-19 cases among patients with severe vitamin D deficiency was 17.3%, whereas the equivalent figure for patients with normal vitamin D levels was 14.6% (a reduction of 15.6%).

“This potential effect may be attributed to vitamin D’s ability to suppress the adaptive immune system, regulating cytokine levels and thereby reducing the risk of developing severe COVID-19,” said the researchers.

Likewise, JoAnn E. Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital in Boston, in a recent commentary, noted evidence from an observational study from three South Asian hospitals, in which the prevalence of vitamin D deficiency was much higher among those with severe COVID-19 illness compared with those with mild illness.

“We also know that vitamin D has an immune-modulating effect and can lower inflammation, and this may be relevant to the respiratory response during COVID-19 and the cytokine storm that’s been demonstrated,” she noted.

Dr. Rosen said he is willing to listen on the issue of a potential role of vitamin D in immune modulation.

“I’ve been a huge skeptic from the get-go, and loudly criticized the data for doing nothing. I am surprised at myself for saying there might be some effect,” he said.

“Clearly most people don’t get this [cytokine storm] but of those that do, it’s unclear why they do. Maybe if you are vitamin D sufficient, it might have some impact down the road on your response to an infection,” Dr. Rosen said. “Vitamin D may induce proteins important in modulating the function of macrophages of the immune system.”

Ethnic minorities disproportionately affected

It is also well recognized that COVID-19 disproportionately affects black and Asian minority ethnic individuals.

But on the issue of vitamin D in this context, one recent peer-reviewed study using UK Biobank data found no evidence to support a potential role for vitamin D concentration to explain susceptibility to COVID-19 infection either overall or in explaining differences between ethnic groups.

“Vitamin D is unlikely to be the underlying mechanism for the higher risk observed in black and minority ethnic individuals, and vitamin D supplements are unlikely to provide an effective intervention,” Claire Hastie, PhD, of the University of Glasgow and colleagues concluded.

But this hasn’t stopped two endocrinologists from appealing to members of the British Association of Physicians of Indian Origin (BAPIO) to get their vitamin D levels tested.

The black and Asian minority ethnic population, “especially frontline staff, should get their Vitamin D₃ levels checked and get appropriate replacement as required,” said Parag Singhal, MD, of Weston General Hospital, Weston-Super-Mare, England, and David C. Anderson, a retired endocrinologist, said in a letter to BAPIO members.

Indeed, they suggested a booster dose of 100,000 IU as a one-off for black and Asian minority ethnic health care staff that should raise vitamin D levels for 2-3 months. They referred to a systematic review that concludes that “single vitamin D₃ doses ≥300,000 IU are most effective at improving vitamin D status ... for up to 3 months”.

Commenting on the idea, Dr. Rosen remarked that, in general, the high-dose 50,000-500,000 IU given as a one-off does not confer any greater benefit than a single dose of 1,000 IU per day, except that the blood levels go up quicker and higher.

“Really there is no evidence that getting to super-high levels of vitamin D confer a greater benefit than normal levels,” he said. “So if health care workers suspect vitamin D deficiency, daily doses of 1,000 IU seem reasonable; even if they miss doses, the blood levels are relatively stable.”

On the specific question of vitamin D needs in ethnic minorities, Dr. Rosen said while such individuals do have lower serum levels of vitamin D, the issue is whether there are meaningful clinical implications related to this.

“The real question is whether [ethnic minority individuals] have physiologically adapted for this in other ways because these low levels have been so for thousands of years. In fact, African Americans have lower vitamin D levels but they absolutely have better bones than [whites],” he pointed out. 
 

Testing and governmental recommendations during COVID-19

The U.S. National Institutes of Health in general advises 400 IU to 800 IU per day intake of vitamin D, depending on age, with those over 70 years requiring the highest daily dose. This will result in blood levels that are sufficient to maintain bone health and normal calcium metabolism in healthy people. There are no additional recommendations specific to vitamin D intake during the COVID-19 pandemic, however.

And Dr. Rosen pointed out that there is no evidence for mass screening of vitamin D levels among the U.S. population.

“U.S. public health guidance was pre-COVID, and I think high-risk individuals might want to think about their levels; for example, someone with inflammatory bowel disease or liver or pancreatic disease. These people are at higher risk anyway, and it could be because their vitamin D is low,” he said.

“Skip the test and ensure you are getting adequate levels of vitamin D whether via diet or supplement [400-800 IU per day],” he suggested. “It won’t harm.”

The U.K.’s Public Health England (PHE) clarified its advice on vitamin D supplementation during COVID-19. Alison Tedstone, PhD, chief nutritionist at PHE, said: “Many people are spending more time indoors and may not get all the vitamin D they need from sunlight. To protect their bone and muscle health, they should consider taking a daily supplement containing 10 micrograms [400 IU] of vitamin D.”

However, “there is no sufficient evidence to support recommending Vitamin D for reducing the risk of COVID-19,” she stressed.

Dr. Bajaj is on the advisory board of Medscape Diabetes & Endocrinology. He has ties with Amgen, AstraZeneca Boehringer Ingelheim, Janssen, Merck, Novo Nordisk, Sanofi, Eli Lilly,Valeant, Canadian Collaborative Research Network, CMS Knowledge Translation, Diabetes Canada Scientific Group, LMC Healthcare,mdBriefCase,Medscape, andMeducom. Dr. Kenny, Dr. Rosen, and Dr. Singhal have disclosed no relevant financial relationships.

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

Mainstream media outlets have been flooded recently with reports speculating on what role, if any, vitamin D may play in reducing the severity of COVID-19 infection.

Observational data comparing outcomes from various countries suggest inverse links between vitamin D levels and the severity of COVID-19 responses, as well as mortality, with the further suggestion of an effect of vitamin D on the immune response to infection.

But other studies question such a link, including any association between vitamin D concentration and differences in COVID-19 severity by ethnic group.

And while some researchers and clinicians believe people should get tested to see if they have adequate vitamin D levels during this pandemic – in particular frontline health care workers – most doctors say the best way to ensure that people have adequate levels of vitamin D during COVID-19 is to simply take supplements at currently recommended levels.

This is especially important given the fact that, during “lockdown” scenarios, many people are spending more time than usual indoors.

Clifford Rosen, MD, senior scientist at Maine Medical Center’s Research Institute in Scarborough, has been researching vitamin D for 25 years.

“There’s no randomized, controlled trial for sure, and that’s the gold standard,” he said in an interview, and “the observational data are so confounded, it’s difficult to know.”

Whether from diet or supplementation, having adequate vitamin D is important, especially for those at the highest risk of COVID-19, he said. Still, robust data supporting a role of vitamin D in prevention of COVID-19, or as any kind of “therapy” for the infection, are currently lacking.

Rose Anne Kenny, MD, professor of medical gerontology at Trinity College Dublin, recently coauthored an article detailing an inverse association between vitamin D levels and mortality from COVID-19 across countries in Europe.

“At no stage are any of us saying this is a given, but there’s a probability that [vitamin D] – a low-hanging fruit – is a contributory factor and we can do something about it now,” she said in an interview.

Dr. Kenny is calling for the Irish government to formally change their recommendations. “We call on the Irish government to update guidelines as a matter of urgency and encourage all adults to take [vitamin D] supplements during the COVID-19 crisis.” Northern Ireland, part of the United Kingdom, also has not yet made this recommendation, she said.

Meanwhile, Harpreet S. Bajaj, MD, MPH, a practicing endocrinologist from Mount Sinai Hospital, Toronto, said: “Vitamin D could have any of three potential roles in risk for COVID-19 and/or its severity: no role, simply a marker, or a causal factor.”

Dr. Bajaj said – as did Dr. Rosen and Dr. Kenny – that randomized, controlled trials (RCTs) are sorely needed to help ascertain whether there is a specific role of vitamin D.

“Until then, we should continue to follow established public health recommendations for vitamin D supplementation, in addition to following COVID-19 prevention guidance and evolving guidelines for COVID-19 treatment.”
 

What is the role of vitamin D fortification?

In their study in the Irish Medical Journal, Dr. Kenny and colleagues noted that, in Europe, despite being sunny, Spain and Northern Italy had high rates of vitamin D deficiency and have experienced some of the highest COVID-19 infection and mortality rates in the world.

But these countries do not formally fortify foods or recommend supplementation with vitamin D.

Conversely, the northern countries of Norway, Finland, and Sweden had higher vitamin D levels despite less UVB sunlight exposure, as a result of common supplementation and formal fortification of foods. These Nordic countries also had lower levels of COVID-19 infection and mortality.

Overall, the correlation between low vitamin D levels and mortality from COVID-19 was statistically significant (P = .046), the investigators reported.

“Optimizing vitamin D status to recommendations by national and international public health agencies will certainly have ... potential benefits for COVID-19,” they concluded.

“We’re not saying there aren’t any confounders. This can absolutely be the case, but this [finding] needs to be in the mix of evidence,” Dr. Kenny said.

Dr. Kenny also noted that countries in the Southern Hemisphere have been seeing a relatively low mortality from COVID-19, although she acknowledged the explanation could be that the virus spread later to those countries.

Dr. Rosen has doubts on this issue, too.

“Sure, vitamin D supplementation may have worked for [Nordic countries], their COVID-19 has been better controlled, but there’s no causality here; there’s another step to actually prove this. Other factors might be at play,” he said.

“Look at Brazil, it’s at the equator but the disease is devastating the country. Right now, I just don’t believe it.”

Does vitamin D have a role to play in immune modulation?

One theory currently circulating is that, if vitamin D does have any role to play in modulating response to COVID-19, this may be via a blunting of the immune system reaction to the virus.

In a recent preprint study, Ali Daneshkhah, PhD, and colleagues from Northwestern University, Chicago, interrogated hospital data from China, France, Germany, Italy, Iran, South Korea, Spain, Switzerland, the United Kingdom, and the United States.

Specifically, the risk of severe COVID-19 cases among patients with severe vitamin D deficiency was 17.3%, whereas the equivalent figure for patients with normal vitamin D levels was 14.6% (a reduction of 15.6%).

“This potential effect may be attributed to vitamin D’s ability to suppress the adaptive immune system, regulating cytokine levels and thereby reducing the risk of developing severe COVID-19,” said the researchers.

Likewise, JoAnn E. Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital in Boston, in a recent commentary, noted evidence from an observational study from three South Asian hospitals, in which the prevalence of vitamin D deficiency was much higher among those with severe COVID-19 illness compared with those with mild illness.

“We also know that vitamin D has an immune-modulating effect and can lower inflammation, and this may be relevant to the respiratory response during COVID-19 and the cytokine storm that’s been demonstrated,” she noted.

Dr. Rosen said he is willing to listen on the issue of a potential role of vitamin D in immune modulation.

“I’ve been a huge skeptic from the get-go, and loudly criticized the data for doing nothing. I am surprised at myself for saying there might be some effect,” he said.

“Clearly most people don’t get this [cytokine storm] but of those that do, it’s unclear why they do. Maybe if you are vitamin D sufficient, it might have some impact down the road on your response to an infection,” Dr. Rosen said. “Vitamin D may induce proteins important in modulating the function of macrophages of the immune system.”

Ethnic minorities disproportionately affected

It is also well recognized that COVID-19 disproportionately affects black and Asian minority ethnic individuals.

But on the issue of vitamin D in this context, one recent peer-reviewed study using UK Biobank data found no evidence to support a potential role for vitamin D concentration to explain susceptibility to COVID-19 infection either overall or in explaining differences between ethnic groups.

“Vitamin D is unlikely to be the underlying mechanism for the higher risk observed in black and minority ethnic individuals, and vitamin D supplements are unlikely to provide an effective intervention,” Claire Hastie, PhD, of the University of Glasgow and colleagues concluded.

But this hasn’t stopped two endocrinologists from appealing to members of the British Association of Physicians of Indian Origin (BAPIO) to get their vitamin D levels tested.

The black and Asian minority ethnic population, “especially frontline staff, should get their Vitamin D₃ levels checked and get appropriate replacement as required,” said Parag Singhal, MD, of Weston General Hospital, Weston-Super-Mare, England, and David C. Anderson, a retired endocrinologist, said in a letter to BAPIO members.

Indeed, they suggested a booster dose of 100,000 IU as a one-off for black and Asian minority ethnic health care staff that should raise vitamin D levels for 2-3 months. They referred to a systematic review that concludes that “single vitamin D₃ doses ≥300,000 IU are most effective at improving vitamin D status ... for up to 3 months”.

Commenting on the idea, Dr. Rosen remarked that, in general, the high-dose 50,000-500,000 IU given as a one-off does not confer any greater benefit than a single dose of 1,000 IU per day, except that the blood levels go up quicker and higher.

“Really there is no evidence that getting to super-high levels of vitamin D confer a greater benefit than normal levels,” he said. “So if health care workers suspect vitamin D deficiency, daily doses of 1,000 IU seem reasonable; even if they miss doses, the blood levels are relatively stable.”

On the specific question of vitamin D needs in ethnic minorities, Dr. Rosen said while such individuals do have lower serum levels of vitamin D, the issue is whether there are meaningful clinical implications related to this.

“The real question is whether [ethnic minority individuals] have physiologically adapted for this in other ways because these low levels have been so for thousands of years. In fact, African Americans have lower vitamin D levels but they absolutely have better bones than [whites],” he pointed out. 
 

Testing and governmental recommendations during COVID-19

The U.S. National Institutes of Health in general advises 400 IU to 800 IU per day intake of vitamin D, depending on age, with those over 70 years requiring the highest daily dose. This will result in blood levels that are sufficient to maintain bone health and normal calcium metabolism in healthy people. There are no additional recommendations specific to vitamin D intake during the COVID-19 pandemic, however.

And Dr. Rosen pointed out that there is no evidence for mass screening of vitamin D levels among the U.S. population.

“U.S. public health guidance was pre-COVID, and I think high-risk individuals might want to think about their levels; for example, someone with inflammatory bowel disease or liver or pancreatic disease. These people are at higher risk anyway, and it could be because their vitamin D is low,” he said.

“Skip the test and ensure you are getting adequate levels of vitamin D whether via diet or supplement [400-800 IU per day],” he suggested. “It won’t harm.”

The U.K.’s Public Health England (PHE) clarified its advice on vitamin D supplementation during COVID-19. Alison Tedstone, PhD, chief nutritionist at PHE, said: “Many people are spending more time indoors and may not get all the vitamin D they need from sunlight. To protect their bone and muscle health, they should consider taking a daily supplement containing 10 micrograms [400 IU] of vitamin D.”

However, “there is no sufficient evidence to support recommending Vitamin D for reducing the risk of COVID-19,” she stressed.

Dr. Bajaj is on the advisory board of Medscape Diabetes & Endocrinology. He has ties with Amgen, AstraZeneca Boehringer Ingelheim, Janssen, Merck, Novo Nordisk, Sanofi, Eli Lilly,Valeant, Canadian Collaborative Research Network, CMS Knowledge Translation, Diabetes Canada Scientific Group, LMC Healthcare,mdBriefCase,Medscape, andMeducom. Dr. Kenny, Dr. Rosen, and Dr. Singhal have disclosed no relevant financial relationships.

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

Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.

“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.

In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.

Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).

Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.

About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.

Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.

Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.

“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.

The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.

The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”

“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.

Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.

SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.

This article was updated 5/19/20.

Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.

“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.

In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.

Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).

Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.

About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.

Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.

Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.

“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.

The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.

The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”

“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.

Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.

SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.

This article was updated 5/19/20.

Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.

“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.

In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.

Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).

Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.

About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.

Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.

Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.

“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.

The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.

The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”

“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.

Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.

SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.

This article was updated 5/19/20.