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Election gift for Florida? Trump poised to approve drug imports from Canada
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states – Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont – have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida – the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan – something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a health consultant who has worked with Colorado on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the Internet, or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import lower-cost medicines for personal use each year, and about 20 million say they or someone in their household have done so because the prices are much lower in other countries, according to surveys.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation – approved in 2019 – would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs – including injectable and biologic medicines – were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Md., said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story also ran on Miami Herald.
Many Americans still concerned about access to health care
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
according to the results of a survey conducted Aug. 7-26.
Nationally, 23.8% of respondents said that they were very concerned about being able to receive care during the pandemic, and another 27.4% said that they were somewhat concerned. Just under a quarter, 24.3%, said they were not very concerned, while 20.4% were not at all concerned, the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States reported after surveying 21,196 adults.
At the state level, Mississippi had the most adults (35.5%) who were very concerned about their access to care, followed by Texas (32.7%) and Nevada (32.4%). The residents of Montana were least likely (10.5%) to be very concerned, with Vermont next at 11.6% and Wyoming slightly higher at 13.8%. Montana also had the highest proportion of adults, 30.2%, who were not at all concerned, the consortium’s data show.
When asked about getting the coronavirus themselves, 67.8% of U.S. adults came down on the concerned side (33.3% somewhat and 34.5% very concerned) versus 30.8% who were not concerned (18.6% were not very concerned; 12.2% were not concerned at all.). Respondents’ concern was higher for their family members’ risk of getting coronavirus: 30.2% were somewhat concerned and 47.6% were very concerned, the consortium said.
Among many other topics, respondents were asked how closely they had followed recommended health guidelines in the last week, with the two extremes shown here:
- Avoiding contact with other people: 49.3% very closely, 4.8% not at all closely.
- Frequently washing hands: 74.7% very, 1.6% not at all.
- Disinfecting often-touched surfaces: 54.4% very, 4.3% not at all.
- Wearing a face mask in public: 75.7% very, 3.5% not at all.
The consortium is a joint project of the Network Science Institute of Northeastern University; the Shorenstein Center on Media, Politics, and Public Policy of Harvard University; Harvard Medical School; the School of Communication and Information at Rutgers University; and the department of political science at Northwestern University. The project is supported by grants from the National Science Foundation.
Type 2 diabetes drugs and their use are top of EASD agenda
This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.
The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.
In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”
Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.
“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.
EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
More cardiovascular and renal outcomes for SGLT2 inhibitors
The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.
Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).
Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”
A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.
The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”
Del Prato also named that symposium as a meeting highlight.
“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
Who’s “right” – diabetologists or cardiologists?
Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.
Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”
Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”
“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
Other big trial results: CGM after MI, semaglutide for obesity
Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).
LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.
The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.
Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
Personalized medicine, COVID-19, intermittent fasting, and much more
Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.
Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”
This field, he predicted, “will grow enormously in the next 10 years.”
Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”
Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.
There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”
“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.
Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda.
This article first appeared on Medscape.com.
This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.
The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.
In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”
Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.
“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.
EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
More cardiovascular and renal outcomes for SGLT2 inhibitors
The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.
Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).
Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”
A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.
The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”
Del Prato also named that symposium as a meeting highlight.
“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
Who’s “right” – diabetologists or cardiologists?
Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.
Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”
Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”
“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
Other big trial results: CGM after MI, semaglutide for obesity
Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).
LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.
The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.
Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
Personalized medicine, COVID-19, intermittent fasting, and much more
Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.
Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”
This field, he predicted, “will grow enormously in the next 10 years.”
Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”
Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.
There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”
“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.
Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda.
This article first appeared on Medscape.com.
This year’s virtual meeting of the European Association for the Study of Diabetes (EASD) offers new data and insights regarding the use of newer glucose-lowering agents for treating people with, and without, diabetes, as well as updates on diabetes technology, a symposium on COVID-19, and much more.
The meeting takes place live online September 22-25, Central European time, because it was to have been located in Vienna before the COVID-19 pandemic, which forced nearly all medical meetings to go virtual. However, as in years past, videos of all the sessions will be available to registrants for later viewing and to the public a month after the meeting ends. The registration fee is less than half the cost for previous years.
In fact, EASD was better prepared to go virtual than many other medical societies, and not just because they had more time to plan since the pandemic began, EASD president Stefano Del Prato, MD, told Medscape Medical News. “Starting in 2013 we already had a virtual congress in parallel to the face-to-face meeting. Everything at the congress was simultaneously available on streaming. That made us more confident in what we could achieve with a virtual meeting.”
Last year, the EASD meeting held in Barcelona was the first for which the number of virtual attendees equaled the number who attended in person, about 15,000 each. Another 80,000 people have accessed the video content in the year since.
“Maybe this is a unique occasion for reaching out to a really global audience,” said Del Prato, professor of endocrinology and metabolism and chief of the section of diabetes at the University of Pisa School of Medicine, Italy.
EASD Honorary Secretary Mikael Rydén, MD, PhD, the meeting’s program chair, told Medscape Medical News, “I’m really looking forward to this meeting because of the interactivity. I hope that, lacking the possibility of having a physical meeting, this is absolutely the best one can do.”
More cardiovascular and renal outcomes for SGLT2 inhibitors
The impact of the sodium-glucose cotransporter 2 (SGLT2) inhibitor drug class beyond glucose-lowering has dominated the agenda of diabetes meetings for the past 5 years, and this EASD is no exception.
Here, new data will be presented for the previously reported EMPEROR-Reduced trial of empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) for patients with heart failure with or without diabetes; DAPA-CKD, on renal outcomes for dapagliflozin (Farxiga, AstraZeneca); and renal results from the VERTIS CV outcome trial of ertugliflozin (Steglatro, Merck).
Regarding DAPA-CKD, Del Prato noted, “We will have a greater opportunity ... to go deeper into the results during a 1-hour session.”
A related session, a joint EASD/European Society of Cardiology (ESC) symposium on the “dawn of cardiovascular risk reduction in type 2 diabetes” will review the development of SGLT2 inhibitors and the data accumulated for the drug class over the past 5 years since the landmark EMPA-REG OUTCOME trial was first reported at EASD in 2015.
The joint symposium, Rydénsaid, will be “extremely important for clinicians. It’s a revolution in type 2 diabetes treatment, and perhaps in those without diabetes who have heart failure...It’s not about a single company, but experts involved in all the different trials of the different SGLT2 inhibitors...We’re still seeing the huge impact that the SGLT2 inhibitors have made, and the incretins as well. We’re still living in these rumbling years after these huge trials.”
Del Prato also named that symposium as a meeting highlight.
“From a clinical point of view, I think the EMPA-REG 5-year session will be of great interest. That was really a turning point not only in the field of diabetes, but also in cardiology and nephrology. I think that will be a great opportunity to see how quickly and how importantly SGLT2 inhibition has turned into a great opportunity for many people.”
Who’s “right” – diabetologists or cardiologists?
Another session likely to draw a crowd of clinicians is a debate about which guidelines are “right”: the ESC’s, which advise first-line use of an SGLT2 inhibitor or glucagon-like peptide-1 (GLP-1) agonist for patients with established CVD or those at high risk, or the more conservative EASD/American Diabetes Association’s, which still advise metformin as first-line therapy for type 2 diabetes.
Rydén, who is professor and senior consultant in endocrinology at the Karolinska University Hospital and Karolinska Institute, Sweden, commented, “The difference is in how aggressive to be in treatment and when adding drugs...I think we have slightly different ways of seeing things and how we implement them.”
Del Prato noted, “We need to clear the fog about what are the current indications for people with diabetes. There is definitely a point of contact between cardiology and diabetology. ... We like to split [the disciplines] up, but discussion is a good way to get people thinking.”
“It will be very important to address the importance of glucose control but yet also leverage a new form of treatment that will have properties above and beyond glucose-lowering capacity.”
Other big trial results: CGM after MI, semaglutide for obesity
Other major new trial results to be presented in dedicated sessions include LIBERATES (Improving Glucose Control in Patients With Diabetes Following Myocardial Infarction: The Role of a Novel Glycaemic Monitoring), and STEP program (Semaglutide for the Treatment of Obesity).
LIBERATES will compare glycemic control with the Abbott FreeStyle Libre 14-day sensor and standard fingerstick glucose monitoring versus blinded continuous glucose monitoring (CGM) for 90 days after a heart attack. It was a late addition to the meeting program, Rydén noted.
The semaglutide study is looking at weight loss associated with a higher dose of the GLP-1 agonist than is currently approved for diabetes, similar to the way in which liraglutide was developed as an obesity agent after first gaining approval for type 2 diabetes.
Regarding semaglutide, Rydén said, “I’ve heard this one is quite efficient. It will be interesting.”
Personalized medicine, COVID-19, intermittent fasting, and much more
Both Rydén and Del Prato also said they were looking forward to a joint EASD/American Diabetes Association symposium on a newly launched precision medicine initiative. The session will include talks on subclassifications of diabetes, genetics, and precision diabetes medicine in practice, as well as lessons on the latter from Greenland.
Rydén noted, “I think it’s interesting for everyone, from the primary healthcare physician to the basic scientist. We’re trying to understand why we have this huge diabetic panorama and how do we identify the subject who should have a specific treatment, or perhaps [will] develop a specific complication of diabetes.”
This field, he predicted, “will grow enormously in the next 10 years.”
Del Prato pointed out, “Diabetes is more heterogeneous than we tend to believe for both types. Better guidance for individualization of treatments could be a great opportunity. ... Ways to better genotype and phenotype the population are becoming less expensive and easier to access. It will be a different way to treat diabetes in the future.”
Other noteworthy conference sessions will address COVID-19 and diabetes, intermittent fasting, new technologies, diabetes and cancer, the role of liver surveillance in patients with diabetes, medicines that can cause diabetes, exercise in type 1 diabetes, and the burden of hypoglycemia.
There will also be opportunities for networking, Del Prato said. “You’ll be able to walk around with your own avatar. You’ll be assisted by [artificial intelligence] to build your own program based on what you’ve been following. You can participate in discussion rooms. You can walk in and out.”
“We hope people will appreciate the science and the spirit of the congress – mingling, interacting, chatting to start discussion and maybe collaboration. It will be lots of fun. I would like to invite all Medscape readers to come and register.
Rydén has reported being a consultant, speaker, and/or advisory board member for Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Novartis, and AstraZeneca. Del Prato has reported being a speaker, advisory board member, and/or receiving research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Novo Nordisk, Sanofi, Servier, and Takeda.
This article first appeared on Medscape.com.
For BP screening, shorter rest time yields similar results
Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.
In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.
“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.
“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
A challenging recommendation
The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.
They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).
They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.
Overall, there was no significant difference in the average BP obtained at any of the rest periods.
After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.
When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.
However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
More efficient, economic
“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.
“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.
Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”
“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.
“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.
She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.
The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.
In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.
“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.
“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
A challenging recommendation
The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.
They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).
They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.
Overall, there was no significant difference in the average BP obtained at any of the rest periods.
After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.
When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.
However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
More efficient, economic
“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.
“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.
Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”
“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.
“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.
She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.
The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Current guidelines recommend a 5-minute rest period before a blood pressure screening measurement, but that might not be necessary for all patients.
In a prospective crossover study, average differences in blood pressure measurements obtained after 0 or 2 minutes of rest were not significantly different than readings obtained after the recommended 5 minutes of rest in adults with systolic blood pressure below 140 mm Hg.
“The average differences in BP by rest period were small, and BPs obtained after shorter rest periods were noninferior to those obtained after 5 minutes when SBP is below 140,” Tammy M. Brady, MD, PhD, Johns Hopkins University, Baltimore, said in an interview.
“This suggests shorter rest times, even 0 minutes, may be reasonable for screening when the initial SBP is below 140,” said Brady.
She presented her research at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension..
A challenging recommendation
The 5-minute rest period is “challenging” to implement in busy clinical settings, Dr. Brady said. The researchers therefore set out to determine the effect of no rest and the effect of a shorter rest period (2 minutes) on blood pressure screening.
They recruited 113 adults (mean age, 55; 64% women, 74% Black) with SBP that ranged from below 115 mm Hg to above 145 mm Hg and with diastolic BP that ranged from below 75 mm Hg to above 105 mm Hg. About one-quarter (28%) had SBP in the stage 2 hypertension range (at least 140 mm Hg).
They obtained four sets of automated BP measurements after 5, 2, or 0 minutes of rest. All participants had their BP measured after a second 5-minute rest period as their last measurement to estimate repeatability.
Overall, there was no significant difference in the average BP obtained at any of the rest periods.
After the first and second 5-minute rest period, BPs were 127.5/74.7 mm Hg and 127.0/75.6 mm Hg, respectively. After 2 and 0 minutes of rest, BPs were 126.8/73.7 mm Hg and 126.5/74.0 mm Hg.
When looking just at adults with SBP below 140 mm Hg, there was no more than an average difference of ±2 mm Hg between BPs obtained at the 5-minute resting periods, compared with the shorter resting periods.
However, in those with SBP below 140 mm Hg, BP values were significantly different (defined as more than ±2 mm Hg) with shorter rest periods, “suggesting that shorter rest periods were in fact inferior to resting for 5 minutes in these patients,” Dr. Brady said.
More efficient, economic
“Economics play a significant role in blood pressure screenings, as clinics not as well-funded may find it especially challenging to implement a uniform, 5-minute rest period before testing, which could ultimately reduce the number of patients able to be screened,” Dr. Brady added in a conference statement.
“While our study sample was small, a reasonable approach based on these findings would be to measure blood pressure after minimal to no rest, and then repeat the measurements after 5 minutes only if a patient is found to have elevated blood pressure,” she said.
Weighing in on the results, Karen A. Griffin, MD, who chairs the AHA council on hypertension, said that “reducing the rest period to screen an individual for hypertension may result in faster throughput in the clinic and confer a cost savings.”
“At the present time, in order to maintain the clinic flow, some clinics use a single, often times ‘nonrested’ BP measurement as a screen, reserving the 5-minute rest automated-office BP measurement for patients found to have an elevated screening BP,” noted Dr. Griffin, professor of medicine, Loyola University Medical Center, Maywood, Ill.
“Nevertheless, even if limiting the use of automated-office BP to those who fail the initial screening BP, a cost savings would still be realized by reducing the currently recommended 5-minute rest to 2 minutes and have the most impact in very busy, less well-funded clinics,” said Dr. Griffin.
She cautioned, however, that further studies in a larger population will be needed before making a change to current clinical practice guidelines.
The study had no specific funding. Dr. Brady and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
FROM JOINT HYPERTENSION 2020
2020-2021 respiratory viral season: Onset, presentations, and testing likely to differ in pandemic
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.
Respiratory virus seasons usually follow a fairly well-known pattern. Enterovirus 68 (EV-D68) is a summer-to-early fall virus with biennial peak years. Rhinovirus (HRv) and adenovirus (Adv) occur nearly year-round but may have small upticks in the first month or so that children return to school. Early in the school year, upper respiratory infections from both HRv and Adv and viral sore throats from Adv are common, with conjunctivitis from Adv outbreaks in some years. October to November is human parainfluenza (HPiV) 1 and 2 season, often presenting as croup. Human metapneumovirus infections span October through April. In late November to December, influenza begins, usually with an A type, later transitioning to a B type in February through April. Also in December, respiratory syncytial virus (RSV) starts, characteristically with bronchiolitis presentations, peaking in February to March and tapering off in May. In late March to April, HPiV 3 also appears for 4-6 weeks.
Will 2020-2021 be different?
Summer was remarkably free of expected enterovirus activity, suggesting that the seasonal parade may differ this year. Remember that the 2019-2020 respiratory season suddenly and nearly completely stopped in March because of social distancing and lockdowns needed to address the SARS-CoV-2 pandemic.
The mild influenza season in the southern hemisphere suggests that our influenza season also could be mild. But perhaps not – most southern hemisphere countries that are surveyed for influenza activities had the most intense SARS-CoV-2 mitigations, making the observed mildness potentially related more to social mitigation than less virulent influenza strains. If so, southern hemisphere influenza data may not apply to the United States, where social distancing and masks are ignored or used inconsistently by almost half the population.
Further, the stop-and-go pattern of in-person school/college attendance adds to uncertainties for the usual orderly virus-specific seasonality. The result may be multiple stop-and-go “pop-up” or “mini” outbreaks for any given virus potentially reflected as exaggerated local or regional differences in circulation of various viruses. The erratic seasonality also would increase coinfections, which could present with more severe or different symptoms.
SARS-CoV-2’s potential interaction
Will the relatively mild presentations for most children with SARS-CoV-2 hold up in the setting of coinfections or sequential respiratory viral infections? Could SARS-CoV-2 cause worse/more prolonged symptoms or more sequelae if paired simultaneously or in tandem with a traditional respiratory virus? To date, data on the frequency and severity of SARS-CoV-2 coinfections are conflicting and sparse, but it appears that non-SARS-CoV-2 viruses can be involved in 15%-50% pediatric acute respiratory infections.1,2
However, it may not be important to know about coinfecting viruses other than influenza (can be treated) or SARS-CoV-2 (needs quarantine and contact tracing), unless symptoms are atypical or more severe than usual. For example, a young child with bronchiolitis is most likely infected with RSV, but HPiV, influenza, metapneumovirus, HRv, and even SARS-CoV-2 can cause bronchiolitis. Even so, testing outpatients for RSV or non-influenza is not routine or even clinically helpful. Supportive treatment and restriction from daycare attendance are sufficient management for outpatient ARIs whether presenting as bronchiolitis or not.
Considerations for SARS-CoV-2 testing: Outpatient bronchiolitis
If a child presents with classic bronchiolitis but has above moderate to severe symptoms, is SARS-CoV-2 a consideration? Perhaps, if SARS-CoV-2 acts similarly to non-SARS-CoV-2s.
A recent report from the 30th Multicenter Airway Research Collaboration (MARC-30) surveillance study (2007-2014) of children hospitalized with clinical bronchiolitis evaluated respiratory viruses, including RSV and the four common non-SARS coronaviruses using molecular testing.3 Among 1,880 subjects, a CoV (alpha CoV: NL63 or 229E, or beta CoV: KKU1 or OC43) was detected in 12%. Yet most had only RSV (n = 1,661); 32 had only CoV (n = 32). But note that 219 had both.
Bronchiolitis subjects with CoV were older – median 3.7 (1.4-5.8) vs. 2.8 (1.9-7.2) years – and more likely male than were RSV subjects (68% vs. 58%). OC43 was most frequent followed by equal numbers of HKU1 and NL63, while 229E was the least frequent. Medical utilization and severity did not differ among the CoVs, or between RSV+CoV vs. RSV alone, unless one considered CoV viral load as a variable. ICU use increased when the polymerase chain reaction cycle threshold result indicated a high CoV viral load.
These data suggest CoVs are not infrequent coinfectors with RSV in bronchiolitis – and that SARS-CoV-2 is the same. Therefore, a bronchiolitis presentation doesn’t necessarily take us off the hook for the need to consider SARS-CoV-2 testing, particularly in the somewhat older bronchiolitis patient with more than mild symptoms.
Considerations for SARS-CoV-2 testing: Outpatient influenza-like illness
In 2020-2021, the Centers for Disease Control and Prevention recommends considering empiric antiviral treatment for ILIs (fever plus either cough or sore throat) based upon our clinical judgement, even in non-high-risk children.4
While pediatric COVID-19 illnesses are predominantly asymptomatic or mild, a febrile ARI is also a SARS-CoV-2 compatible presentation. So, if all we use is our clinical judgment, how do we know if the febrile ARI is due to influenza or SARS-CoV-2 or both? At least one study used a highly sensitive and specific molecular influenza test to show that the accuracy of clinically diagnosing influenza in children is not much better than flipping a coin and would lead to potential antiviral overuse.5
So, it seems ideal to test for influenza when possible. Point-of-care (POC) tests are frequently used for outpatients. Eight POC Clinical Laboratory Improvement Amendments (CLIA)–waived kits, some also detecting RSV, are available but most have modest sensitivity (60%-80%) compared with lab-based molecular tests.6 That said, if supplies and kits for one of the POC tests are available to us during these SARS-CoV-2 stressed times (back orders seem more common this year), a positive influenza test in the first 48 hours of symptoms confirms the option to prescribe an antiviral. Yet how will we have confidence that the febrile ARI is not also partly due to SARS-CoV-2? Currently febrile ARIs usually are considered SARS-CoV-2 and the children are sent for SARS-CoV-2 testing. During influenza season, it seems we will need to continue to send febrile outpatients for SARS-CoV-2 testing, even if POC influenza positive, via whatever mechanisms are available as time goes on.
We expect more rapid pediatric testing modalities for SARS-CoV-2 (maybe even saliva tests) to become available over the next months. Indeed, rapid antigen tests and rapid molecular tests are being evaluated in adults and seem destined for CLIA waivers as POC tests, and even home testing kits. Pediatric approvals hopefully also will occur. So, the pathways for SARS-CoV-2 testing available now will likely change over this winter. But be aware that supplies/kits will be prioritized to locations within high need areas and bulk purchase contracts. So POC kits may remain scarce for practices, meaning a reference laboratory still could be the way to go for SARS-CoV-2 for at least the rest of 2020. Reference labs are becoming creative as well; one combined detection of influenza A, influenza B, RSV, and SARS-CoV-2 into one test, and hopes to get approval for swab collection that can be done by families at home and mailed in.
Summary
Expect variations on the traditional parade of seasonal respiratory viruses, with increased numbers of coinfections. Choosing the outpatient who needs influenza testing is the same as in past years, although we have CDC permissive recommendations to prescribe antivirals for any outpatient ILI within the first 48 hours of symptoms. Still, POC testing for influenza remains potentially valuable in the ILI patient. The choice of whether and how to test for SARS-CoV-2 given its potential to be a primary or coinfecting agent in presentations linked more closely to a traditional virus (e.g. RSV bronchiolitis) will be a test of our clinical judgement until more data and easier testing are available. Further complicating coinfection recognition is the fact that many sick visits occur by telehealth and much testing is done at drive-through SARS-CoV-2 testing facilities with no clinician exam. Unless we are liberal in SARS-CoV-2 testing, detecting SARS-CoV-2 coinfections is easier said than done given its usually mild presentation being overshadowed by any coinfecting virus.
But understanding who has SARS-CoV-2, even as a coinfection, still is essential in controlling the pandemic. We will need to be vigilant for evolving approaches to SARS-CoV-2 testing in the context of symptomatic ARI presentations, knowing this will likely remain a moving target for the foreseeable future.
Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospital-Kansas City, Mo. Children’s Mercy Hospital receives grant funding to study two candidate RSV vaccines. The hospital also receives CDC funding under the New Vaccine Surveillance Network for multicenter surveillance of acute respiratory infections, including influenza, RSV, and parainfluenza virus. Email Dr. Harrison at [email protected].
References
1. Pediatrics. 2020;146(1):e20200961.
2. JAMA. 2020 May 26;323(20):2085-6.
3. Pediatrics. 2020. doi: 10.1542/peds.2020-1267.
4. www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.
5. J. Pediatr. 2020. doi: 10.1016/j.jpeds.2020.08.007.
6. www.cdc.gov/flu/professionals/diagnosis/table-nucleic-acid-detection.html.
Dr. Fauci: ‘About 40%-45% of infections are asymptomatic’
Anthony Fauci, MD, highlighting the latest COVID-19 developments on Friday, said, “It is now clear that about 40%-45% of infections are asymptomatic.”
Asymptomatic carriers can account for a large proportion — up to 50% — of virus transmissions, Fauci, director of the National Institute of Allergy and Infectious Diseases, told a virtual crowd of critical care clinicians gathered by the Society of Critical Care Medicine.
Such transmissions have made response strategies, such as contact tracing, extremely difficult, he said.
Lew Kaplan, MD, president of SCCM, told Medscape Medical News after the presentation: “That really supports the universal wearing of masks and the capstone message from that – you should protect one another.
“That kind of social responsibility that sits within the public health domain to me is as important as the vaccine candidates and the science behind the receptors. It underpins the necessary relationship and the interdependence of the medical community with the public,” Kaplan added.
Fauci’s plenary led the SCCM’s conference, “COVID-19: What’s Next/Preparing for the Second Wave,” running today and Saturday.
Why U.S. response lags behind Spain and Italy
“This virus has literally exploded upon the planet in a pandemic manner which is unparalleled to anything we’ve seen in the last 102 years since the pandemic of 1918,” Fauci said.
“Unfortunately, the United States has been hit harder than any other country in the world, with 6 million reported cases.”
He explained that in the European Union countries the disease spiked early on and returned to a low baseline. “Unfortunately for them,” Fauci said, “as they’re trying to open up their economy, it’s coming back up.”
The United States, he explained, plateaued at about 20,000 cases a day, then a surge of cases in Florida, California, Texas, and Arizona brought the cases to 70,000 a day. Now cases have returned to 35,000-40,000 a day.
The difference in the trajectory of the response, he said, is that, compared with Spain and Italy for example, the United States has not shut down mobility in parks, outdoor spaces, and grocery stores nearly as much as some European countries did.
He pointed to numerous clusters of cases, spread from social or work gatherings, including the well-known Skagit County Washington state choir practice in March, in which a symptomatic choir member infected 87% of the 61 people rehearsing.
Vaccine by end of the year
As for a vaccine timeline, Fauci told SCCM members, “We project that by the end of this year, namely November/December, we will know if we have a safe and effective vaccine and we are cautiously optimistic that we will be successful, based on promising data in the animal model as well as good immunological data that we see from the phase 1 and phase 2 trials.”
However, also on Friday, Fauci told MSNBC’s Andrea Mitchell that a sense of normalcy is not likely before the middle of next year.
“By the time you mobilize the distribution of the vaccinations, and you get the majority, or more, of the population vaccinated and protected, that’s likely not going to happen [until] the mid- or end of 2021,” he said.
According to the Centers for Disease Control and Prevention (CDC) case tracker, as of Thursday, COVID-19 had resulted in more than 190,000 deaths overall and more than 256,000 new cases in the United States in the past 7 days.
Fauci has warned that the next few months will be critical in the virus’ trajectory, with the double onslaught of COVID-19 and the flu season.
On Thursday, Fauci said, “We need to hunker down and get through this fall and winter because it’s not going to be easy.”
Fauci remains a top trusted source in COVID-19 information, poll numbers show.
A Kaiser Family Foundation poll released Thursday found that 68% of US adults had a fair amount or a great deal of trust that Fauci would provide reliable information on COVID-19, just slightly more that the 67% who said they trust the CDC information. About half (53%) say they trust Deborah Birx, MD, the coordinator for the White House Coronavirus Task Force, as a reliable source of information.
The poll also found that 54% of Americans said they would not get a COVID-19 vaccine if one was approved by the US Food and Drug Administration before the November election and was made available and free to all who wanted it.
Kaplan and Fauci report no relevant financial relationships.
This article first appeared on Medscape.com.
Anthony Fauci, MD, highlighting the latest COVID-19 developments on Friday, said, “It is now clear that about 40%-45% of infections are asymptomatic.”
Asymptomatic carriers can account for a large proportion — up to 50% — of virus transmissions, Fauci, director of the National Institute of Allergy and Infectious Diseases, told a virtual crowd of critical care clinicians gathered by the Society of Critical Care Medicine.
Such transmissions have made response strategies, such as contact tracing, extremely difficult, he said.
Lew Kaplan, MD, president of SCCM, told Medscape Medical News after the presentation: “That really supports the universal wearing of masks and the capstone message from that – you should protect one another.
“That kind of social responsibility that sits within the public health domain to me is as important as the vaccine candidates and the science behind the receptors. It underpins the necessary relationship and the interdependence of the medical community with the public,” Kaplan added.
Fauci’s plenary led the SCCM’s conference, “COVID-19: What’s Next/Preparing for the Second Wave,” running today and Saturday.
Why U.S. response lags behind Spain and Italy
“This virus has literally exploded upon the planet in a pandemic manner which is unparalleled to anything we’ve seen in the last 102 years since the pandemic of 1918,” Fauci said.
“Unfortunately, the United States has been hit harder than any other country in the world, with 6 million reported cases.”
He explained that in the European Union countries the disease spiked early on and returned to a low baseline. “Unfortunately for them,” Fauci said, “as they’re trying to open up their economy, it’s coming back up.”
The United States, he explained, plateaued at about 20,000 cases a day, then a surge of cases in Florida, California, Texas, and Arizona brought the cases to 70,000 a day. Now cases have returned to 35,000-40,000 a day.
The difference in the trajectory of the response, he said, is that, compared with Spain and Italy for example, the United States has not shut down mobility in parks, outdoor spaces, and grocery stores nearly as much as some European countries did.
He pointed to numerous clusters of cases, spread from social or work gatherings, including the well-known Skagit County Washington state choir practice in March, in which a symptomatic choir member infected 87% of the 61 people rehearsing.
Vaccine by end of the year
As for a vaccine timeline, Fauci told SCCM members, “We project that by the end of this year, namely November/December, we will know if we have a safe and effective vaccine and we are cautiously optimistic that we will be successful, based on promising data in the animal model as well as good immunological data that we see from the phase 1 and phase 2 trials.”
However, also on Friday, Fauci told MSNBC’s Andrea Mitchell that a sense of normalcy is not likely before the middle of next year.
“By the time you mobilize the distribution of the vaccinations, and you get the majority, or more, of the population vaccinated and protected, that’s likely not going to happen [until] the mid- or end of 2021,” he said.
According to the Centers for Disease Control and Prevention (CDC) case tracker, as of Thursday, COVID-19 had resulted in more than 190,000 deaths overall and more than 256,000 new cases in the United States in the past 7 days.
Fauci has warned that the next few months will be critical in the virus’ trajectory, with the double onslaught of COVID-19 and the flu season.
On Thursday, Fauci said, “We need to hunker down and get through this fall and winter because it’s not going to be easy.”
Fauci remains a top trusted source in COVID-19 information, poll numbers show.
A Kaiser Family Foundation poll released Thursday found that 68% of US adults had a fair amount or a great deal of trust that Fauci would provide reliable information on COVID-19, just slightly more that the 67% who said they trust the CDC information. About half (53%) say they trust Deborah Birx, MD, the coordinator for the White House Coronavirus Task Force, as a reliable source of information.
The poll also found that 54% of Americans said they would not get a COVID-19 vaccine if one was approved by the US Food and Drug Administration before the November election and was made available and free to all who wanted it.
Kaplan and Fauci report no relevant financial relationships.
This article first appeared on Medscape.com.
Anthony Fauci, MD, highlighting the latest COVID-19 developments on Friday, said, “It is now clear that about 40%-45% of infections are asymptomatic.”
Asymptomatic carriers can account for a large proportion — up to 50% — of virus transmissions, Fauci, director of the National Institute of Allergy and Infectious Diseases, told a virtual crowd of critical care clinicians gathered by the Society of Critical Care Medicine.
Such transmissions have made response strategies, such as contact tracing, extremely difficult, he said.
Lew Kaplan, MD, president of SCCM, told Medscape Medical News after the presentation: “That really supports the universal wearing of masks and the capstone message from that – you should protect one another.
“That kind of social responsibility that sits within the public health domain to me is as important as the vaccine candidates and the science behind the receptors. It underpins the necessary relationship and the interdependence of the medical community with the public,” Kaplan added.
Fauci’s plenary led the SCCM’s conference, “COVID-19: What’s Next/Preparing for the Second Wave,” running today and Saturday.
Why U.S. response lags behind Spain and Italy
“This virus has literally exploded upon the planet in a pandemic manner which is unparalleled to anything we’ve seen in the last 102 years since the pandemic of 1918,” Fauci said.
“Unfortunately, the United States has been hit harder than any other country in the world, with 6 million reported cases.”
He explained that in the European Union countries the disease spiked early on and returned to a low baseline. “Unfortunately for them,” Fauci said, “as they’re trying to open up their economy, it’s coming back up.”
The United States, he explained, plateaued at about 20,000 cases a day, then a surge of cases in Florida, California, Texas, and Arizona brought the cases to 70,000 a day. Now cases have returned to 35,000-40,000 a day.
The difference in the trajectory of the response, he said, is that, compared with Spain and Italy for example, the United States has not shut down mobility in parks, outdoor spaces, and grocery stores nearly as much as some European countries did.
He pointed to numerous clusters of cases, spread from social or work gatherings, including the well-known Skagit County Washington state choir practice in March, in which a symptomatic choir member infected 87% of the 61 people rehearsing.
Vaccine by end of the year
As for a vaccine timeline, Fauci told SCCM members, “We project that by the end of this year, namely November/December, we will know if we have a safe and effective vaccine and we are cautiously optimistic that we will be successful, based on promising data in the animal model as well as good immunological data that we see from the phase 1 and phase 2 trials.”
However, also on Friday, Fauci told MSNBC’s Andrea Mitchell that a sense of normalcy is not likely before the middle of next year.
“By the time you mobilize the distribution of the vaccinations, and you get the majority, or more, of the population vaccinated and protected, that’s likely not going to happen [until] the mid- or end of 2021,” he said.
According to the Centers for Disease Control and Prevention (CDC) case tracker, as of Thursday, COVID-19 had resulted in more than 190,000 deaths overall and more than 256,000 new cases in the United States in the past 7 days.
Fauci has warned that the next few months will be critical in the virus’ trajectory, with the double onslaught of COVID-19 and the flu season.
On Thursday, Fauci said, “We need to hunker down and get through this fall and winter because it’s not going to be easy.”
Fauci remains a top trusted source in COVID-19 information, poll numbers show.
A Kaiser Family Foundation poll released Thursday found that 68% of US adults had a fair amount or a great deal of trust that Fauci would provide reliable information on COVID-19, just slightly more that the 67% who said they trust the CDC information. About half (53%) say they trust Deborah Birx, MD, the coordinator for the White House Coronavirus Task Force, as a reliable source of information.
The poll also found that 54% of Americans said they would not get a COVID-19 vaccine if one was approved by the US Food and Drug Administration before the November election and was made available and free to all who wanted it.
Kaplan and Fauci report no relevant financial relationships.
This article first appeared on Medscape.com.
Liberalized European sports cardiology guidelines break new ground
New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.
These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.
The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.
In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”
Dr. Pelliccia put this new recommendation into context.
“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.
The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.
“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.
The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.
“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.
Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
Exercise and heart failure
Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.
However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.
“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.
Valvular heart disease and exercise
Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.
“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.
The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.
Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.
The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.
SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.
New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.
These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.
The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.
In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”
Dr. Pelliccia put this new recommendation into context.
“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.
The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.
“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.
The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.
“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.
Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
Exercise and heart failure
Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.
However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.
“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.
Valvular heart disease and exercise
Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.
“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.
The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.
Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.
The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.
SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.
New guidelines on sports cardiology from the European Society of Cardiology break fresh ground by green-lighting participation in vigorous competitive sports by selected patients with stable coronary artery disease, heart failure, or mild arrhythmias.
These liberalized guidelines, released at the virtual annual congress of the European Society of Cardiology, thus move well beyond the standard exercise advice to engage in about 150 minutes per week of moderate physical activity, typically defined as brisk walking or its equivalent.
The guidelines reflect a conviction that exercise is powerful medicine for patients with cardiovascular disease and also affords a means to help curb the epidemics of diabetes and obesity that drive cardiovascular risk, according to Antonio Pelliccia, MD, who cochaired the 24-member task force of European and American experts that developed the guidelines.
In a session highlighting the new sports cardiology guidelines, Mats Borjesson, MD, head of the Center for Health and Performance at Gothenburg (Sweden) University, summarized the section devoted to patients with stable coronary artery disease: “If you have established CAD and a low risk of adverse events during exercise, you are eligible for high-intensity exercise and competitive sports. But if you have persistent ischemia despite medical treatment, or symptoms, then you’re only eligible for leisure-time subthreshold activity.”
Dr. Pelliccia put this new recommendation into context.
“We are not talking anymore in this particular disease just about cardiac rehabilitation or leisure-time activity, but we are also opening the border and talking about competitive sports activity in selected patients where you have the evidence for low risk of exercise-induced adverse events. This is a major achievement now for what is the major disease in our adult population,” said Dr. Pelliccia, chief of cardiology at the Institute of Sports Medicine and Science at the Italian National Olympic Committee and professor of sports cardiology at La Sapienza University of Rome.
The recommendation for individualized consideration of all types of exercise, even including vigorous competitive sports, in low-risk patients with CAD gets a class IIa, level of evidence (LOE) C recommendation in the new guidelines. That’s a big step down from a ringing class Ia endorsement, but since sports cardiology is a relatively young field with little evidence that’s based on randomized trials, the guidelines are rife with many other class IIa, LOE C recommendations as well.
“The level of evidence is rather low, so these guidelines are very much the personal perspective of the expert panel,” explained Martin Halle, MD, professor and head of the department of prevention, rehabilitation, and sports cardiology at Technical University of Munich.
The high-risk features for exercise-induced cardiac adverse events in patients with longstanding stable CAD, as cited in the guidelines, include a critical coronary stenosis, defined as a more than 70% lesion in a major coronary artery or a greater than 50% stenosis in the left main, and/or a fractional flow reserve score of less than 0.8; a left ventricular ejection fraction of 50% or less with wall-motion abnormalities; inducible myocardial ischemia on maximal exercise testing; nonsustained ventricular tachycardia; polymorphic or very frequent ventricular premature beats at rest and during maximum stress; and a recent acute coronary syndrome (ACS). These features call for an exercise prescription tailored to remain below the patient’s angina and ischemia thresholds.
“It’s important for cardiologists out there to understand that we definitely need a maximal exercise test. In somebody who is running and has an ACS and then wants to start running again, 200 watts on an ergometer is too low. We have to push them up to the end, and then if everything is okay – left ventricular function is okay, no ischemia, no arrhythmias under exercise testing – then it’s fine,” Dr. Halle said.
Dr. Pelliccia added that close follow-up is needed, because this is an evolving disease.”
Exercise and heart failure
Massimo F. Piepoli, MD, PhD, noted that the guidelines give a class IIb, LOE C recommendation for consideration of high-intensity recreational endurance and power sports in patients with heart failure with either midrange or preserved ejection fraction, provided they are stable, asymptomatic, on optimal guideline-directed medical therapy, and without abnormalities on a maximal exercise stress test.
However, such intense physical activity is not recommended in patients with heart failure with reduced ejection fraction, regardless of their symptom status, added Dr. Piepoli of Guglielmo da Saliceto Hospital in Placenza, Italy.
“We’re talking here, I think for the first time, about possible competitive sports participation in individuals with heart failure, depending on their clinical condition. We are really opening the barriers to sports participation, even in these patients in whom we never thought of it before,” Dr. Pelliccia observed.
Valvular heart disease and exercise
Guidelines panelist Sabiha Gati, MRCP, PhD, said asymptomatic individuals with mild valvular abnormalities can participate in all recreational and competitive sports; that’s a class I, LOE C recommendation.
“Moderate regurgitant lesions are better tolerated than stenotic lesions, and those with preserved systolic function, good functional capacity, without any exercise-induced arrhythmias or ischemia or abnormal hemodynamic response are considered to be low risk and can participate in all sports,” added Dr. Gati, a cardiologist at Royal Brompton Hospital, London.
The two most common valvular abnormalities encountered in clinical practice are bicuspid aortic valve and mitral valve prolapse. Dr. Gati noted that, while mitral valve prolapse has a benign prognosis in the great majority of affected individuals, the presence of specific features indicative of increased risk for sudden cardiac death precludes participation in strenuous exercise. These include T-wave inversion in the inferior leads on a 12-lead ECG, long QT, bileaflet mitral valve prolapse, basal inferolateral wall fibrosis, severe mitral regurgitation, or a family history of sudden cardiac death.
Bicuspid aortic valve has a prevalence of 1%-2% in the general population. It can be associated with aortic stenosis, aortic regurgitation, and increased risk of ascending aortic aneurysm and dissection. Since it remains unclear whether intensive exercise accelerates aortic dilatation, a cautious approach to sports participation is recommended in patients with an ascending aorta above the normal limit of 40 mm, she said.
The 80-page ESC sports cardiology guidelines, published online simultaneously with their presentation, cover a broad range of additional topics, including exercise recommendations for the general public, for the elderly, as well as for patients with cardiomyopathies, adult congenital heart disease, arrhythmias, and channelopathies. Gaps in evidence are also highlighted.
SOURCE: Pelliccia A. ESC 2020 and Eur Heart J. 2020 Aug 29. doi: 10.1093/eurheartj/ehaa605.
FROM ESC CONGRESS 2020
Biologics for psoriasis may also reduce coronary plaque
Biologics used as treatment for psoriasis may also help reduce lipid-rich necrotic core (LRNC), a high-risk plaque associated with cardiovascular events, recent research from a prospective, observational study suggests.
Cardiac CT scans performed on patients with psoriasis 1 year after starting biologic therapy revealed a reduction in LRNC, compared with patients who were not receiving biologics, according to Harry Choi, MD, of the National Heart, Lung, and Blood Institute at the National Institutes of Health and colleagues. The association with reduction in LRNC and biologic therapy remained significant when adjusted for type of biologic. “These findings demonstrate that LRNC may be modulated by the control of systemic inflammation,” the researchers wrote in their study, published Sept. 15 in Circulation: Cardiovascular Imaging.
Dr. Choi and colleagues evaluated 289 patients with psoriasis within the Psoriasis Atherosclerosis and Cardiometabolic Disease Initiative cohort. The patients had a mean age of 50 years and a mean body mass index of 29.4 kg/m2, as well as a mean Psoriasis Area and Severity Index (PASI) score of 6.0. At baseline, 29% of patients had hypertension, 41% had hyperlipidemia, their mean Framingham risk score was 1.9, and a three-quarters (212 of 289) had mild to moderate psoriasis.
Changes in LRNC were observed at 1 year, compared with baseline prior to and after receiving biologic therapy (124 patients) in comparison with patients who did not undergo biologic therapy (85 patients). Biologic therapies were grouped by type, which included anti–tumor necrosis factor (anti-TNF), anti–interleukin (IL)–12/23, and anti–IL-17 biologics.
There were a significant associations between LRNC and Framingham risk score (standardized beta coefficient, 0.12; 95% confidence interval, 0.00-0.15; P = .045) and severity of psoriasis (beta, 0.13; 95% CI, 0.01-0.26; P = .029) at baseline.
Key findings
The researchers found a significant reduction in LRNC 1 year after patients began biologic therapy (median, 2.97 mm2; interquartile range, 1.99-4.66), compared with baseline (median, 3.12 mm2; IQR, 1.84-4.35) (P = .028), while patients who did not receive biologic therapy had nonsignificantly higher LRNC after 1 year (median, 3.12 mm2; IQR, 1.82-4.60), compared with baseline measurements (median, 3.34 mm2; IQR, 2.04–4.74) (P = .06).
The results remained significant after the researchers adjusted for psoriasis severity, Framingham risk score, BMI, use of statins (beta, −0.09; 95% CI, −0.01 to −0.18; P = .033). Significant reductions in LRNC also remained when analyzing patients receiving anti-TNF, anti–IL-12/23, and anti–IL-17 biologics independently, and there were no significant between-group differences in reduction of LRNC.
The potential of biologics for improving vascular health
Discussing the study results in a press release from the American Heart Association, senior author Nehal N. Mehta, MD, MSCE, FAHA, chief of the Lab of Inflammation and Cardiometabolic Diseases at the NHLBI at NIH, compared the effect biologic therapy had on coronary plaque reduction with that of statins.
“There is approximately 6%-8% reduction in coronary plaque following therapy with statins. Similarly, our treatment with biologic therapy reduced coronary plaque by the same amount after one year. These findings suggest that biologic therapy to treat psoriasis may be just as beneficial as statin therapy on heart arteries,” Dr. Mehta said in the release.
In an interview, Nieca Goldberg, MD, medical director of NYU Women’s Heart Program at NYU Langone Health, echoed Dr. Mehta’s commments and said psoriasis carries the “potential to treat two conditions with the same drug.”
“We know conditions such as psoriatic arthritis and rheumatoid arthritis cause chronic inflammation. Chronic inflammation causes injury to blood vessels and high-risk coronary plaque. Individuals with these inflammatory conditions are at high risk for heart attack,” she said. “This study shows that biologic treatment for psoriatic arthritis can reduce the presence of high-risk plaque. It shows the potential to treat chronic inflammation and high-risk coronary plaque.”
While the results show an association between use of biologics and LRNC reduction, the study design was observational and patients had a short follow-up period. Dr. Goldberg noted more studies are needed to evaluate the effect of biologics on reducing cardiovascular events such as a myocardial infarction.
“We have never before been able to show healing of an inflamed plaque like this in humans. Biologic therapy reduces systemic inflammation and immune activation, and it has a favorable impact on improving overall vascular health,” Dr. Mehta said in the press release. “Imagine if we can treat both psoriasis and coronary heart disease with one therapy – that is the question to be asked in future studies.”
This study was funded with support from the NHLBI Intramural Research Program and the NIH Medical Research Scholars Program at the National Institutes of Health. One investigator reports financial relationships with numerous pharmaceutical companies. The other authors report no relevant conflicts of interest. Dr. Mehta also reports numerous such relationships. Dr. Goldberg reports no relevant conflicts of interest.
SOURCE: Choi H et al. Circ Cardiovasc Imaging. 2020 Sep;13(9):e011199.
Biologics used as treatment for psoriasis may also help reduce lipid-rich necrotic core (LRNC), a high-risk plaque associated with cardiovascular events, recent research from a prospective, observational study suggests.
Cardiac CT scans performed on patients with psoriasis 1 year after starting biologic therapy revealed a reduction in LRNC, compared with patients who were not receiving biologics, according to Harry Choi, MD, of the National Heart, Lung, and Blood Institute at the National Institutes of Health and colleagues. The association with reduction in LRNC and biologic therapy remained significant when adjusted for type of biologic. “These findings demonstrate that LRNC may be modulated by the control of systemic inflammation,” the researchers wrote in their study, published Sept. 15 in Circulation: Cardiovascular Imaging.
Dr. Choi and colleagues evaluated 289 patients with psoriasis within the Psoriasis Atherosclerosis and Cardiometabolic Disease Initiative cohort. The patients had a mean age of 50 years and a mean body mass index of 29.4 kg/m2, as well as a mean Psoriasis Area and Severity Index (PASI) score of 6.0. At baseline, 29% of patients had hypertension, 41% had hyperlipidemia, their mean Framingham risk score was 1.9, and a three-quarters (212 of 289) had mild to moderate psoriasis.
Changes in LRNC were observed at 1 year, compared with baseline prior to and after receiving biologic therapy (124 patients) in comparison with patients who did not undergo biologic therapy (85 patients). Biologic therapies were grouped by type, which included anti–tumor necrosis factor (anti-TNF), anti–interleukin (IL)–12/23, and anti–IL-17 biologics.
There were a significant associations between LRNC and Framingham risk score (standardized beta coefficient, 0.12; 95% confidence interval, 0.00-0.15; P = .045) and severity of psoriasis (beta, 0.13; 95% CI, 0.01-0.26; P = .029) at baseline.
Key findings
The researchers found a significant reduction in LRNC 1 year after patients began biologic therapy (median, 2.97 mm2; interquartile range, 1.99-4.66), compared with baseline (median, 3.12 mm2; IQR, 1.84-4.35) (P = .028), while patients who did not receive biologic therapy had nonsignificantly higher LRNC after 1 year (median, 3.12 mm2; IQR, 1.82-4.60), compared with baseline measurements (median, 3.34 mm2; IQR, 2.04–4.74) (P = .06).
The results remained significant after the researchers adjusted for psoriasis severity, Framingham risk score, BMI, use of statins (beta, −0.09; 95% CI, −0.01 to −0.18; P = .033). Significant reductions in LRNC also remained when analyzing patients receiving anti-TNF, anti–IL-12/23, and anti–IL-17 biologics independently, and there were no significant between-group differences in reduction of LRNC.
The potential of biologics for improving vascular health
Discussing the study results in a press release from the American Heart Association, senior author Nehal N. Mehta, MD, MSCE, FAHA, chief of the Lab of Inflammation and Cardiometabolic Diseases at the NHLBI at NIH, compared the effect biologic therapy had on coronary plaque reduction with that of statins.
“There is approximately 6%-8% reduction in coronary plaque following therapy with statins. Similarly, our treatment with biologic therapy reduced coronary plaque by the same amount after one year. These findings suggest that biologic therapy to treat psoriasis may be just as beneficial as statin therapy on heart arteries,” Dr. Mehta said in the release.
In an interview, Nieca Goldberg, MD, medical director of NYU Women’s Heart Program at NYU Langone Health, echoed Dr. Mehta’s commments and said psoriasis carries the “potential to treat two conditions with the same drug.”
“We know conditions such as psoriatic arthritis and rheumatoid arthritis cause chronic inflammation. Chronic inflammation causes injury to blood vessels and high-risk coronary plaque. Individuals with these inflammatory conditions are at high risk for heart attack,” she said. “This study shows that biologic treatment for psoriatic arthritis can reduce the presence of high-risk plaque. It shows the potential to treat chronic inflammation and high-risk coronary plaque.”
While the results show an association between use of biologics and LRNC reduction, the study design was observational and patients had a short follow-up period. Dr. Goldberg noted more studies are needed to evaluate the effect of biologics on reducing cardiovascular events such as a myocardial infarction.
“We have never before been able to show healing of an inflamed plaque like this in humans. Biologic therapy reduces systemic inflammation and immune activation, and it has a favorable impact on improving overall vascular health,” Dr. Mehta said in the press release. “Imagine if we can treat both psoriasis and coronary heart disease with one therapy – that is the question to be asked in future studies.”
This study was funded with support from the NHLBI Intramural Research Program and the NIH Medical Research Scholars Program at the National Institutes of Health. One investigator reports financial relationships with numerous pharmaceutical companies. The other authors report no relevant conflicts of interest. Dr. Mehta also reports numerous such relationships. Dr. Goldberg reports no relevant conflicts of interest.
SOURCE: Choi H et al. Circ Cardiovasc Imaging. 2020 Sep;13(9):e011199.
Biologics used as treatment for psoriasis may also help reduce lipid-rich necrotic core (LRNC), a high-risk plaque associated with cardiovascular events, recent research from a prospective, observational study suggests.
Cardiac CT scans performed on patients with psoriasis 1 year after starting biologic therapy revealed a reduction in LRNC, compared with patients who were not receiving biologics, according to Harry Choi, MD, of the National Heart, Lung, and Blood Institute at the National Institutes of Health and colleagues. The association with reduction in LRNC and biologic therapy remained significant when adjusted for type of biologic. “These findings demonstrate that LRNC may be modulated by the control of systemic inflammation,” the researchers wrote in their study, published Sept. 15 in Circulation: Cardiovascular Imaging.
Dr. Choi and colleagues evaluated 289 patients with psoriasis within the Psoriasis Atherosclerosis and Cardiometabolic Disease Initiative cohort. The patients had a mean age of 50 years and a mean body mass index of 29.4 kg/m2, as well as a mean Psoriasis Area and Severity Index (PASI) score of 6.0. At baseline, 29% of patients had hypertension, 41% had hyperlipidemia, their mean Framingham risk score was 1.9, and a three-quarters (212 of 289) had mild to moderate psoriasis.
Changes in LRNC were observed at 1 year, compared with baseline prior to and after receiving biologic therapy (124 patients) in comparison with patients who did not undergo biologic therapy (85 patients). Biologic therapies were grouped by type, which included anti–tumor necrosis factor (anti-TNF), anti–interleukin (IL)–12/23, and anti–IL-17 biologics.
There were a significant associations between LRNC and Framingham risk score (standardized beta coefficient, 0.12; 95% confidence interval, 0.00-0.15; P = .045) and severity of psoriasis (beta, 0.13; 95% CI, 0.01-0.26; P = .029) at baseline.
Key findings
The researchers found a significant reduction in LRNC 1 year after patients began biologic therapy (median, 2.97 mm2; interquartile range, 1.99-4.66), compared with baseline (median, 3.12 mm2; IQR, 1.84-4.35) (P = .028), while patients who did not receive biologic therapy had nonsignificantly higher LRNC after 1 year (median, 3.12 mm2; IQR, 1.82-4.60), compared with baseline measurements (median, 3.34 mm2; IQR, 2.04–4.74) (P = .06).
The results remained significant after the researchers adjusted for psoriasis severity, Framingham risk score, BMI, use of statins (beta, −0.09; 95% CI, −0.01 to −0.18; P = .033). Significant reductions in LRNC also remained when analyzing patients receiving anti-TNF, anti–IL-12/23, and anti–IL-17 biologics independently, and there were no significant between-group differences in reduction of LRNC.
The potential of biologics for improving vascular health
Discussing the study results in a press release from the American Heart Association, senior author Nehal N. Mehta, MD, MSCE, FAHA, chief of the Lab of Inflammation and Cardiometabolic Diseases at the NHLBI at NIH, compared the effect biologic therapy had on coronary plaque reduction with that of statins.
“There is approximately 6%-8% reduction in coronary plaque following therapy with statins. Similarly, our treatment with biologic therapy reduced coronary plaque by the same amount after one year. These findings suggest that biologic therapy to treat psoriasis may be just as beneficial as statin therapy on heart arteries,” Dr. Mehta said in the release.
In an interview, Nieca Goldberg, MD, medical director of NYU Women’s Heart Program at NYU Langone Health, echoed Dr. Mehta’s commments and said psoriasis carries the “potential to treat two conditions with the same drug.”
“We know conditions such as psoriatic arthritis and rheumatoid arthritis cause chronic inflammation. Chronic inflammation causes injury to blood vessels and high-risk coronary plaque. Individuals with these inflammatory conditions are at high risk for heart attack,” she said. “This study shows that biologic treatment for psoriatic arthritis can reduce the presence of high-risk plaque. It shows the potential to treat chronic inflammation and high-risk coronary plaque.”
While the results show an association between use of biologics and LRNC reduction, the study design was observational and patients had a short follow-up period. Dr. Goldberg noted more studies are needed to evaluate the effect of biologics on reducing cardiovascular events such as a myocardial infarction.
“We have never before been able to show healing of an inflamed plaque like this in humans. Biologic therapy reduces systemic inflammation and immune activation, and it has a favorable impact on improving overall vascular health,” Dr. Mehta said in the press release. “Imagine if we can treat both psoriasis and coronary heart disease with one therapy – that is the question to be asked in future studies.”
This study was funded with support from the NHLBI Intramural Research Program and the NIH Medical Research Scholars Program at the National Institutes of Health. One investigator reports financial relationships with numerous pharmaceutical companies. The other authors report no relevant conflicts of interest. Dr. Mehta also reports numerous such relationships. Dr. Goldberg reports no relevant conflicts of interest.
SOURCE: Choi H et al. Circ Cardiovasc Imaging. 2020 Sep;13(9):e011199.
FROM CIRCULATION: CARDIOVASCULAR IMAGING
Many providers don’t follow hypertension guidelines
Many health care professionals are not following current, evidence-based guidelines to screen for and diagnose hypertension, and appear to have substantial gaps in knowledge, beliefs, and use of recommended practices, results from a large survey suggest.
“One surprising finding was that there was so much trust in the stethoscope, because the automated monitors are a better way to take blood pressure,” lead author Beverly Green, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, said in an interview.
The results of the survey were presented Sept. 10 at the virtual joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The U.S. Preventive Services Task Force (USPSTF) and the American Heart Association/American College of Cardiology recommend out-of-office blood pressure measurements – via ambulatory blood pressure monitoring (ABPM) or home BP monitoring – before making a new diagnosis of hypertension.
To gauge provider knowledge, beliefs, and practices related to BP diagnostic tests, the researchers surveyed 282 providers: 102 medical assistants (MA), 28 licensed practical nurses (LPNs), 33 registered nurses (RNs), 86 primary care physicians, and 33 advanced practitioners (APs).
More than three-quarters of providers (79%) felt that BP measured manually with a stethoscope and ABPM were “very or highly” accurate ways to measure BP when making a new diagnosis of hypertension.
Most did not think that automated clinic BPs, home BP, or kiosk BP measurements were very or highly accurate.
Nearly all providers surveyed (96%) reported that they “always or almost always” rely on clinic BP measurements when diagnosing hypertension, but the majority of physicians/APs would prefer using ABPM (61%) if available.
The problem with ABPM, said Dr. Green, is “it’s just not very available or convenient for patients, and a lot of providers think that patients won’t tolerate it.” Yet, without it, there is a risk for misclassification, she said.
Karen A. Griffin, MD, who chairs the AHA Council on Hypertension, said it became “customary to use clinic BP since ABPM was not previously reimbursed for the routine diagnosis of hypertension.
“Now that the payment for ABPM has been expanded, the number of machines at most institutions is not adequate for the need. Consequently, it will take some time to catch up with the current guidelines for diagnosing hypertension,” she said in an interview.
The provider survey by Dr. Green and colleagues also shows slow uptake of updated thresholds for high blood pressure.
Eighty-four percent of physicians/APs and 68% of MA/LPN/RNs said they used a clinic BP threshold of at least 140/90 mm Hg for making a new diagnosis of hypertension.
Only 3.5% and 9.0%, respectively, reported using the updated threshold of at least 130/80 mm Hg put forth in 2017.
Dr. Griffin said part of this stems from the fact that the survey began before the updated guidelines were released in 2017, “not to mention the fact that some societies have opposed the new threshold of 130/80 mm Hg.”
“I think, with time, the data on morbidity and mortality associated with the goal of 130/80 mm Hg will hopefully convince those who have not yet implemented these new guidelines that it is a safe and effective BP goal,” Dr. Griffin said.
This research had no specific funding. Dr. Green and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Many health care professionals are not following current, evidence-based guidelines to screen for and diagnose hypertension, and appear to have substantial gaps in knowledge, beliefs, and use of recommended practices, results from a large survey suggest.
“One surprising finding was that there was so much trust in the stethoscope, because the automated monitors are a better way to take blood pressure,” lead author Beverly Green, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, said in an interview.
The results of the survey were presented Sept. 10 at the virtual joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The U.S. Preventive Services Task Force (USPSTF) and the American Heart Association/American College of Cardiology recommend out-of-office blood pressure measurements – via ambulatory blood pressure monitoring (ABPM) or home BP monitoring – before making a new diagnosis of hypertension.
To gauge provider knowledge, beliefs, and practices related to BP diagnostic tests, the researchers surveyed 282 providers: 102 medical assistants (MA), 28 licensed practical nurses (LPNs), 33 registered nurses (RNs), 86 primary care physicians, and 33 advanced practitioners (APs).
More than three-quarters of providers (79%) felt that BP measured manually with a stethoscope and ABPM were “very or highly” accurate ways to measure BP when making a new diagnosis of hypertension.
Most did not think that automated clinic BPs, home BP, or kiosk BP measurements were very or highly accurate.
Nearly all providers surveyed (96%) reported that they “always or almost always” rely on clinic BP measurements when diagnosing hypertension, but the majority of physicians/APs would prefer using ABPM (61%) if available.
The problem with ABPM, said Dr. Green, is “it’s just not very available or convenient for patients, and a lot of providers think that patients won’t tolerate it.” Yet, without it, there is a risk for misclassification, she said.
Karen A. Griffin, MD, who chairs the AHA Council on Hypertension, said it became “customary to use clinic BP since ABPM was not previously reimbursed for the routine diagnosis of hypertension.
“Now that the payment for ABPM has been expanded, the number of machines at most institutions is not adequate for the need. Consequently, it will take some time to catch up with the current guidelines for diagnosing hypertension,” she said in an interview.
The provider survey by Dr. Green and colleagues also shows slow uptake of updated thresholds for high blood pressure.
Eighty-four percent of physicians/APs and 68% of MA/LPN/RNs said they used a clinic BP threshold of at least 140/90 mm Hg for making a new diagnosis of hypertension.
Only 3.5% and 9.0%, respectively, reported using the updated threshold of at least 130/80 mm Hg put forth in 2017.
Dr. Griffin said part of this stems from the fact that the survey began before the updated guidelines were released in 2017, “not to mention the fact that some societies have opposed the new threshold of 130/80 mm Hg.”
“I think, with time, the data on morbidity and mortality associated with the goal of 130/80 mm Hg will hopefully convince those who have not yet implemented these new guidelines that it is a safe and effective BP goal,” Dr. Griffin said.
This research had no specific funding. Dr. Green and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
Many health care professionals are not following current, evidence-based guidelines to screen for and diagnose hypertension, and appear to have substantial gaps in knowledge, beliefs, and use of recommended practices, results from a large survey suggest.
“One surprising finding was that there was so much trust in the stethoscope, because the automated monitors are a better way to take blood pressure,” lead author Beverly Green, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, said in an interview.
The results of the survey were presented Sept. 10 at the virtual joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
The U.S. Preventive Services Task Force (USPSTF) and the American Heart Association/American College of Cardiology recommend out-of-office blood pressure measurements – via ambulatory blood pressure monitoring (ABPM) or home BP monitoring – before making a new diagnosis of hypertension.
To gauge provider knowledge, beliefs, and practices related to BP diagnostic tests, the researchers surveyed 282 providers: 102 medical assistants (MA), 28 licensed practical nurses (LPNs), 33 registered nurses (RNs), 86 primary care physicians, and 33 advanced practitioners (APs).
More than three-quarters of providers (79%) felt that BP measured manually with a stethoscope and ABPM were “very or highly” accurate ways to measure BP when making a new diagnosis of hypertension.
Most did not think that automated clinic BPs, home BP, or kiosk BP measurements were very or highly accurate.
Nearly all providers surveyed (96%) reported that they “always or almost always” rely on clinic BP measurements when diagnosing hypertension, but the majority of physicians/APs would prefer using ABPM (61%) if available.
The problem with ABPM, said Dr. Green, is “it’s just not very available or convenient for patients, and a lot of providers think that patients won’t tolerate it.” Yet, without it, there is a risk for misclassification, she said.
Karen A. Griffin, MD, who chairs the AHA Council on Hypertension, said it became “customary to use clinic BP since ABPM was not previously reimbursed for the routine diagnosis of hypertension.
“Now that the payment for ABPM has been expanded, the number of machines at most institutions is not adequate for the need. Consequently, it will take some time to catch up with the current guidelines for diagnosing hypertension,” she said in an interview.
The provider survey by Dr. Green and colleagues also shows slow uptake of updated thresholds for high blood pressure.
Eighty-four percent of physicians/APs and 68% of MA/LPN/RNs said they used a clinic BP threshold of at least 140/90 mm Hg for making a new diagnosis of hypertension.
Only 3.5% and 9.0%, respectively, reported using the updated threshold of at least 130/80 mm Hg put forth in 2017.
Dr. Griffin said part of this stems from the fact that the survey began before the updated guidelines were released in 2017, “not to mention the fact that some societies have opposed the new threshold of 130/80 mm Hg.”
“I think, with time, the data on morbidity and mortality associated with the goal of 130/80 mm Hg will hopefully convince those who have not yet implemented these new guidelines that it is a safe and effective BP goal,” Dr. Griffin said.
This research had no specific funding. Dr. Green and Dr. Griffin have no relevant disclosures.
A version of this article originally appeared on Medscape.com.
COVID-19 and the psychological side effects of PPE
A few months ago, I published a short thought piece on the use of “sitters” with patients who were COVID-19 positive, or patients under investigation. In it, I recommended the use of telesitters for those who normally would warrant a human sitter, to decrease the discomfort of sitting in full personal protective equipment (PPE) (gown, mask, gloves, etc.) while monitoring a suicidal patient.
I received several queries, which I want to address here. In addition, I want to draw from my Army days in terms of the claustrophobia often experienced with PPE.
The first of the questions was about evidence-based practices. The second was about the discomfort of having sitters sit for many hours in the full gear.
I do not know of any evidence-based practices, but I hope we will develop them.
I agree that spending many hours in full PPE can be discomforting, which is why I wrote the essay.
As far as lessons learned from the Army time, I briefly learned how to wear a “gas mask” or Mission-Oriented Protective Posture (MOPP gear) while at Fort Bragg. We were run through the “gas chamber,” where sergeants released tear gas while we had the mask on. We were then asked to lift it up, and then tearing and sputtering, we could leave the small wooden building.
We wore the mask as part of our Army gear, usually on the right leg. After that, I mainly used the protective mask in its bag as a pillow when I was in the field.
Fast forward to August 1990. I arrived at Camp Casey, near the Korean demilitarized zone. Four days later, Saddam Hussein invaded Kuwait. The gas mask moved from a pillow to something we had to wear while doing 12-mile road marches in “full ruck.” In full ruck, you have your uniform on, with TA-50, knapsack, and weapon. No, I do not remember any more what TA-50 stands for, but essentially it is the webbing that holds your bullets and bandages.
Many could not tolerate it. They developed claustrophobia – sweating, air hunger, and panic. If stationed in the Gulf for Operation Desert Storm, they were evacuated home.
I wrote a couple of short articles on treatment of gas mask phobia.1,2 I basically advised desensitization. Start by watching TV in it for 5 minutes. Graduate to ironing your uniform in the mask. Go then to shorter runs. Work up to the 12-mile road march.
In my second tour in Korea, we had exercises where we simulated being hit by nerve agents and had to operate the hospital for days at a time in partial or full PPE. It was tough but we did it, and felt more confident about surviving attacks from North Korea.
So back to the pandemic present. I have gotten more used to my constant wearing of a surgical mask. I get anxious when I see others with masks below their noses.
The pandemic is not going away anytime soon, in my opinion. Furthermore, there are other viruses that are worse, such as Ebola. It is only a matter of time.
So, let us train with our PPE. If health care workers cannot tolerate them, use desensitization- and anxiety-reducing techniques to help them.
There are no easy answers here, in the time of the COVID pandemic. However, we owe it to ourselves, our patients, and society to do the best we can.
References
1. Ritchie EC. Milit Med. 1992 Feb;157(2):104-6.
2. Ritchie EC. Milit Med. 2001 Dec;166. Suppl. 2(1)83-4.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].
A few months ago, I published a short thought piece on the use of “sitters” with patients who were COVID-19 positive, or patients under investigation. In it, I recommended the use of telesitters for those who normally would warrant a human sitter, to decrease the discomfort of sitting in full personal protective equipment (PPE) (gown, mask, gloves, etc.) while monitoring a suicidal patient.
I received several queries, which I want to address here. In addition, I want to draw from my Army days in terms of the claustrophobia often experienced with PPE.
The first of the questions was about evidence-based practices. The second was about the discomfort of having sitters sit for many hours in the full gear.
I do not know of any evidence-based practices, but I hope we will develop them.
I agree that spending many hours in full PPE can be discomforting, which is why I wrote the essay.
As far as lessons learned from the Army time, I briefly learned how to wear a “gas mask” or Mission-Oriented Protective Posture (MOPP gear) while at Fort Bragg. We were run through the “gas chamber,” where sergeants released tear gas while we had the mask on. We were then asked to lift it up, and then tearing and sputtering, we could leave the small wooden building.
We wore the mask as part of our Army gear, usually on the right leg. After that, I mainly used the protective mask in its bag as a pillow when I was in the field.
Fast forward to August 1990. I arrived at Camp Casey, near the Korean demilitarized zone. Four days later, Saddam Hussein invaded Kuwait. The gas mask moved from a pillow to something we had to wear while doing 12-mile road marches in “full ruck.” In full ruck, you have your uniform on, with TA-50, knapsack, and weapon. No, I do not remember any more what TA-50 stands for, but essentially it is the webbing that holds your bullets and bandages.
Many could not tolerate it. They developed claustrophobia – sweating, air hunger, and panic. If stationed in the Gulf for Operation Desert Storm, they were evacuated home.
I wrote a couple of short articles on treatment of gas mask phobia.1,2 I basically advised desensitization. Start by watching TV in it for 5 minutes. Graduate to ironing your uniform in the mask. Go then to shorter runs. Work up to the 12-mile road march.
In my second tour in Korea, we had exercises where we simulated being hit by nerve agents and had to operate the hospital for days at a time in partial or full PPE. It was tough but we did it, and felt more confident about surviving attacks from North Korea.
So back to the pandemic present. I have gotten more used to my constant wearing of a surgical mask. I get anxious when I see others with masks below their noses.
The pandemic is not going away anytime soon, in my opinion. Furthermore, there are other viruses that are worse, such as Ebola. It is only a matter of time.
So, let us train with our PPE. If health care workers cannot tolerate them, use desensitization- and anxiety-reducing techniques to help them.
There are no easy answers here, in the time of the COVID pandemic. However, we owe it to ourselves, our patients, and society to do the best we can.
References
1. Ritchie EC. Milit Med. 1992 Feb;157(2):104-6.
2. Ritchie EC. Milit Med. 2001 Dec;166. Suppl. 2(1)83-4.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].
A few months ago, I published a short thought piece on the use of “sitters” with patients who were COVID-19 positive, or patients under investigation. In it, I recommended the use of telesitters for those who normally would warrant a human sitter, to decrease the discomfort of sitting in full personal protective equipment (PPE) (gown, mask, gloves, etc.) while monitoring a suicidal patient.
I received several queries, which I want to address here. In addition, I want to draw from my Army days in terms of the claustrophobia often experienced with PPE.
The first of the questions was about evidence-based practices. The second was about the discomfort of having sitters sit for many hours in the full gear.
I do not know of any evidence-based practices, but I hope we will develop them.
I agree that spending many hours in full PPE can be discomforting, which is why I wrote the essay.
As far as lessons learned from the Army time, I briefly learned how to wear a “gas mask” or Mission-Oriented Protective Posture (MOPP gear) while at Fort Bragg. We were run through the “gas chamber,” where sergeants released tear gas while we had the mask on. We were then asked to lift it up, and then tearing and sputtering, we could leave the small wooden building.
We wore the mask as part of our Army gear, usually on the right leg. After that, I mainly used the protective mask in its bag as a pillow when I was in the field.
Fast forward to August 1990. I arrived at Camp Casey, near the Korean demilitarized zone. Four days later, Saddam Hussein invaded Kuwait. The gas mask moved from a pillow to something we had to wear while doing 12-mile road marches in “full ruck.” In full ruck, you have your uniform on, with TA-50, knapsack, and weapon. No, I do not remember any more what TA-50 stands for, but essentially it is the webbing that holds your bullets and bandages.
Many could not tolerate it. They developed claustrophobia – sweating, air hunger, and panic. If stationed in the Gulf for Operation Desert Storm, they were evacuated home.
I wrote a couple of short articles on treatment of gas mask phobia.1,2 I basically advised desensitization. Start by watching TV in it for 5 minutes. Graduate to ironing your uniform in the mask. Go then to shorter runs. Work up to the 12-mile road march.
In my second tour in Korea, we had exercises where we simulated being hit by nerve agents and had to operate the hospital for days at a time in partial or full PPE. It was tough but we did it, and felt more confident about surviving attacks from North Korea.
So back to the pandemic present. I have gotten more used to my constant wearing of a surgical mask. I get anxious when I see others with masks below their noses.
The pandemic is not going away anytime soon, in my opinion. Furthermore, there are other viruses that are worse, such as Ebola. It is only a matter of time.
So, let us train with our PPE. If health care workers cannot tolerate them, use desensitization- and anxiety-reducing techniques to help them.
There are no easy answers here, in the time of the COVID pandemic. However, we owe it to ourselves, our patients, and society to do the best we can.
References
1. Ritchie EC. Milit Med. 1992 Feb;157(2):104-6.
2. Ritchie EC. Milit Med. 2001 Dec;166. Suppl. 2(1)83-4.
Dr. Ritchie is chair of psychiatry at Medstar Washington Hospital Center and professor of psychiatry at Georgetown University, Washington. She has no disclosures and can be reached at [email protected].