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Drinking your way to heart failure, and the fringe benefits of COVID-19 vaccination

Article Type
Changed

 

Energy drink doom

Who doesn’t need some caffeine to get going in the morning and keep moving throughout the day? Whether it’s tea, coffee, or energy drinks, people can get addicted to caffeinated beverages when there are only so many hours in a day and way too much work to get done.

Alexander Mirokhin/Fotolia.com

That’s what happened to a 21-year-old college student who powered down four 16-ounce cans of energy drink – each with double the amount of caffeine in an ordinary cup of coffee – every day for 2 years. Now, if you’ve ever overdone it with caffeine, you know there are some uncomfortable side effects, like shaking and anxiety. In this case, the student reported migraines, tremors, and heart palpitations. Instead of being able to focus better on his work, he had trouble concentrating.

Over time, after these side effects took a turn for the worse and became shortness of breath and weight loss, he visited St. Thomas’ Hospital in London, where physicians diagnosed him with both heart and renal failure.

Excessive consumption of energy drinks is known to cause issues such as high blood pressure and irregular heart beat, so if that’s your fuel of choice, it might be worth cutting down. Maybe take a morning run to get the blood pumping – in a good way – instead?
 

Loneliness may be hazardous to your health

Sometimes loneliness can feel like it affects your physical health, but according to a study there’s a possibility that it actually does.

@paolitta/Unsplash

Back in the 1980s, researchers from the University of Eastern Finland started monitoring almost 3,000 middle-aged men. They’ve kept up with the participants until the present day, and the results have been staggering. After an average follow-up of over 20 years, 25% of participants developed cancer and 11% died from cancer, and the increase in risk from loneliness was about 10%, regardless of age, lifestyle, and BMI.

What does that say about preventive care? The researchers think these data are cause enough to pay attention to loneliness as a health issue along with smoking and weight.

Social interactions and relationships play important roles in human mental health, of course, but this is pretty solid evidence that they play a role in physical health too. As the researchers said, “Awareness of the health effects of loneliness is constantly increasing. Therefore, it is important to examine, in more detail, the mechanisms by which loneliness causes adverse health effects.”

So, as we progress through this pandemic, maybe you should join that social group on Facebook? Who knows what kind of effect it could have on your health?
 

An ounce of prevention is worth 12 ounces of lager

COVID-19 vaccine refusal is now a thing, and there’s no law that says people have to be immunized against our newest, bestest buddy, SARS-CoV-2, but the folks who skip it are missing out. And no, we’re not talking about immunity against disease.

Governor Jim Justice

We’re talking … FREE STUFF!

Corporate America has stepped up and is now rewarding those who get the COVID-19 vaccine:

  • Budweiser will give a free beer to anyone – anyone over age 21, that is – with proof of vaccination until May 16.
  • Show a vaccination card at a Krispy Kreme and you can get a free glazed doughnut, every day. You don’t even need to buy anything.
  • White Castle will give you a free dessert-on-a-stick just for showing proof of vaccination. No purchase is required, but the offer ends May 31.

But wait, there’s more!

Even the public sector is getting in on the giveaway action. Gov. Jim Justice announced April 26 that West Virginia will give a $100 savings bond to any resident aged 16-35 years who receives a COVID-19 vaccine. It must make sense, because the governor broke out a white board to show residents he’s done the math.

One closing thought: How cool would it be if he was named to the Supreme Court, so he could be Justice Justice?


 

Where no shirt has gone before

Space. The final frontier, for both humanity and for shirts. Specifically, it’s a new frontier for the Bio-Monitor smart shirt, a tank-top filled with sensors that monitor the wearer’s stats, such as heart and breathing rate, oxygen saturation, skin temperature, and blood pressure. And you thought space was just for finding a new human habitat and growing steak.

Canadian Space Agency/NASA

This shirt is already used by athletes to assess performance and by people with limited mobility to monitor health, so its potential impending usage by astronauts makes sense. Space is a pretty extreme environment, to put it mildly, and there’s a lot we still don’t know about how the human body reacts to it. Traditionally, astronauts hook themselves up to separate devices so their stats can be measured, a method which captures only snapshots of their bodies. By wearing the shirt constantly, the astronauts can be measured constantly, so scientists and doctors can see how the body deals with microgravity during normal activities and sleep. It also reduces stress, as there is no psychological impact of having to report in for constant health checks.

For the test, astronauts wore the shirt for 72 hours before flight and for 72 hours during flight. The shirts passed this first test with flying colors; in addition to providing accurate and more consistent stats monitoring than traditional methods, scientists on the ground determined that the astronauts recorded far less physical activity during flight than preflight, a finding in line with previous studies.

And before you question whether or not a tank top is really appropriate for space, just remember, Picard pulled it off at the end of “First Contact,” and that’s arguably the best Star Trek movie. So there’s certainly precedent.
 

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Energy drink doom

Who doesn’t need some caffeine to get going in the morning and keep moving throughout the day? Whether it’s tea, coffee, or energy drinks, people can get addicted to caffeinated beverages when there are only so many hours in a day and way too much work to get done.

Alexander Mirokhin/Fotolia.com

That’s what happened to a 21-year-old college student who powered down four 16-ounce cans of energy drink – each with double the amount of caffeine in an ordinary cup of coffee – every day for 2 years. Now, if you’ve ever overdone it with caffeine, you know there are some uncomfortable side effects, like shaking and anxiety. In this case, the student reported migraines, tremors, and heart palpitations. Instead of being able to focus better on his work, he had trouble concentrating.

Over time, after these side effects took a turn for the worse and became shortness of breath and weight loss, he visited St. Thomas’ Hospital in London, where physicians diagnosed him with both heart and renal failure.

Excessive consumption of energy drinks is known to cause issues such as high blood pressure and irregular heart beat, so if that’s your fuel of choice, it might be worth cutting down. Maybe take a morning run to get the blood pumping – in a good way – instead?
 

Loneliness may be hazardous to your health

Sometimes loneliness can feel like it affects your physical health, but according to a study there’s a possibility that it actually does.

@paolitta/Unsplash

Back in the 1980s, researchers from the University of Eastern Finland started monitoring almost 3,000 middle-aged men. They’ve kept up with the participants until the present day, and the results have been staggering. After an average follow-up of over 20 years, 25% of participants developed cancer and 11% died from cancer, and the increase in risk from loneliness was about 10%, regardless of age, lifestyle, and BMI.

What does that say about preventive care? The researchers think these data are cause enough to pay attention to loneliness as a health issue along with smoking and weight.

Social interactions and relationships play important roles in human mental health, of course, but this is pretty solid evidence that they play a role in physical health too. As the researchers said, “Awareness of the health effects of loneliness is constantly increasing. Therefore, it is important to examine, in more detail, the mechanisms by which loneliness causes adverse health effects.”

So, as we progress through this pandemic, maybe you should join that social group on Facebook? Who knows what kind of effect it could have on your health?
 

An ounce of prevention is worth 12 ounces of lager

COVID-19 vaccine refusal is now a thing, and there’s no law that says people have to be immunized against our newest, bestest buddy, SARS-CoV-2, but the folks who skip it are missing out. And no, we’re not talking about immunity against disease.

Governor Jim Justice

We’re talking … FREE STUFF!

Corporate America has stepped up and is now rewarding those who get the COVID-19 vaccine:

  • Budweiser will give a free beer to anyone – anyone over age 21, that is – with proof of vaccination until May 16.
  • Show a vaccination card at a Krispy Kreme and you can get a free glazed doughnut, every day. You don’t even need to buy anything.
  • White Castle will give you a free dessert-on-a-stick just for showing proof of vaccination. No purchase is required, but the offer ends May 31.

But wait, there’s more!

Even the public sector is getting in on the giveaway action. Gov. Jim Justice announced April 26 that West Virginia will give a $100 savings bond to any resident aged 16-35 years who receives a COVID-19 vaccine. It must make sense, because the governor broke out a white board to show residents he’s done the math.

One closing thought: How cool would it be if he was named to the Supreme Court, so he could be Justice Justice?


 

Where no shirt has gone before

Space. The final frontier, for both humanity and for shirts. Specifically, it’s a new frontier for the Bio-Monitor smart shirt, a tank-top filled with sensors that monitor the wearer’s stats, such as heart and breathing rate, oxygen saturation, skin temperature, and blood pressure. And you thought space was just for finding a new human habitat and growing steak.

Canadian Space Agency/NASA

This shirt is already used by athletes to assess performance and by people with limited mobility to monitor health, so its potential impending usage by astronauts makes sense. Space is a pretty extreme environment, to put it mildly, and there’s a lot we still don’t know about how the human body reacts to it. Traditionally, astronauts hook themselves up to separate devices so their stats can be measured, a method which captures only snapshots of their bodies. By wearing the shirt constantly, the astronauts can be measured constantly, so scientists and doctors can see how the body deals with microgravity during normal activities and sleep. It also reduces stress, as there is no psychological impact of having to report in for constant health checks.

For the test, astronauts wore the shirt for 72 hours before flight and for 72 hours during flight. The shirts passed this first test with flying colors; in addition to providing accurate and more consistent stats monitoring than traditional methods, scientists on the ground determined that the astronauts recorded far less physical activity during flight than preflight, a finding in line with previous studies.

And before you question whether or not a tank top is really appropriate for space, just remember, Picard pulled it off at the end of “First Contact,” and that’s arguably the best Star Trek movie. So there’s certainly precedent.
 

 

Energy drink doom

Who doesn’t need some caffeine to get going in the morning and keep moving throughout the day? Whether it’s tea, coffee, or energy drinks, people can get addicted to caffeinated beverages when there are only so many hours in a day and way too much work to get done.

Alexander Mirokhin/Fotolia.com

That’s what happened to a 21-year-old college student who powered down four 16-ounce cans of energy drink – each with double the amount of caffeine in an ordinary cup of coffee – every day for 2 years. Now, if you’ve ever overdone it with caffeine, you know there are some uncomfortable side effects, like shaking and anxiety. In this case, the student reported migraines, tremors, and heart palpitations. Instead of being able to focus better on his work, he had trouble concentrating.

Over time, after these side effects took a turn for the worse and became shortness of breath and weight loss, he visited St. Thomas’ Hospital in London, where physicians diagnosed him with both heart and renal failure.

Excessive consumption of energy drinks is known to cause issues such as high blood pressure and irregular heart beat, so if that’s your fuel of choice, it might be worth cutting down. Maybe take a morning run to get the blood pumping – in a good way – instead?
 

Loneliness may be hazardous to your health

Sometimes loneliness can feel like it affects your physical health, but according to a study there’s a possibility that it actually does.

@paolitta/Unsplash

Back in the 1980s, researchers from the University of Eastern Finland started monitoring almost 3,000 middle-aged men. They’ve kept up with the participants until the present day, and the results have been staggering. After an average follow-up of over 20 years, 25% of participants developed cancer and 11% died from cancer, and the increase in risk from loneliness was about 10%, regardless of age, lifestyle, and BMI.

What does that say about preventive care? The researchers think these data are cause enough to pay attention to loneliness as a health issue along with smoking and weight.

Social interactions and relationships play important roles in human mental health, of course, but this is pretty solid evidence that they play a role in physical health too. As the researchers said, “Awareness of the health effects of loneliness is constantly increasing. Therefore, it is important to examine, in more detail, the mechanisms by which loneliness causes adverse health effects.”

So, as we progress through this pandemic, maybe you should join that social group on Facebook? Who knows what kind of effect it could have on your health?
 

An ounce of prevention is worth 12 ounces of lager

COVID-19 vaccine refusal is now a thing, and there’s no law that says people have to be immunized against our newest, bestest buddy, SARS-CoV-2, but the folks who skip it are missing out. And no, we’re not talking about immunity against disease.

Governor Jim Justice

We’re talking … FREE STUFF!

Corporate America has stepped up and is now rewarding those who get the COVID-19 vaccine:

  • Budweiser will give a free beer to anyone – anyone over age 21, that is – with proof of vaccination until May 16.
  • Show a vaccination card at a Krispy Kreme and you can get a free glazed doughnut, every day. You don’t even need to buy anything.
  • White Castle will give you a free dessert-on-a-stick just for showing proof of vaccination. No purchase is required, but the offer ends May 31.

But wait, there’s more!

Even the public sector is getting in on the giveaway action. Gov. Jim Justice announced April 26 that West Virginia will give a $100 savings bond to any resident aged 16-35 years who receives a COVID-19 vaccine. It must make sense, because the governor broke out a white board to show residents he’s done the math.

One closing thought: How cool would it be if he was named to the Supreme Court, so he could be Justice Justice?


 

Where no shirt has gone before

Space. The final frontier, for both humanity and for shirts. Specifically, it’s a new frontier for the Bio-Monitor smart shirt, a tank-top filled with sensors that monitor the wearer’s stats, such as heart and breathing rate, oxygen saturation, skin temperature, and blood pressure. And you thought space was just for finding a new human habitat and growing steak.

Canadian Space Agency/NASA

This shirt is already used by athletes to assess performance and by people with limited mobility to monitor health, so its potential impending usage by astronauts makes sense. Space is a pretty extreme environment, to put it mildly, and there’s a lot we still don’t know about how the human body reacts to it. Traditionally, astronauts hook themselves up to separate devices so their stats can be measured, a method which captures only snapshots of their bodies. By wearing the shirt constantly, the astronauts can be measured constantly, so scientists and doctors can see how the body deals with microgravity during normal activities and sleep. It also reduces stress, as there is no psychological impact of having to report in for constant health checks.

For the test, astronauts wore the shirt for 72 hours before flight and for 72 hours during flight. The shirts passed this first test with flying colors; in addition to providing accurate and more consistent stats monitoring than traditional methods, scientists on the ground determined that the astronauts recorded far less physical activity during flight than preflight, a finding in line with previous studies.

And before you question whether or not a tank top is really appropriate for space, just remember, Picard pulled it off at the end of “First Contact,” and that’s arguably the best Star Trek movie. So there’s certainly precedent.
 

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Consider risk for Barrett’s esophagus after bariatric surgery

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Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

ChrisPole/thinkstock
endoscope

Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

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Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

ChrisPole/thinkstock
endoscope

Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

Barrett’s esophagus occurred in nearly 12% of patients who underwent esophagogastroduodenoscopy after sleeve gastrectomy, but it was not associated with postoperative gastroesophageal reflux disease (GERD), based on data from 10 studies that totaled 680 adult patients.

ChrisPole/thinkstock
endoscope

Sleeve gastrectomy has become more popular in recent years as an effective strategy for patients with severe obesity, wrote Bashar J. Qumseya, MD, of the University of Florida, Gainesville, and colleagues. However, GERD is a common concern for patients undergoing sleeve gastrectomy and is the major risk factor for Barrett’s esophagus. However, the prevalence of Barrett’s esophagus in the sleeve gastrectomy population has not been examined.

In a meta-analysis published in Gastrointestinal Endoscopy, the researchers reviewed 10 studies that totaled 680 patients who underwent esophagogastroduodenoscopy 6 months to 10 years after a sleeve gastrectomy procedure. The primary outcome was Barrett’s esophagus prevalence in sleeve gastrectomy patients, with the prevalence of erosive esophagitis and GERD at follow-up as secondary outcomes.

Overall, 54 patients developed Barrett’s esophagus, for a pooled prevalence of 11.6%, and all cases were nondysplastic and de novo. There was no significant association between Barrett’s esophagus and the presence of postoperative GERD, the researchers said (odds ratio, 1.74; P = .37).

However, the rate of erosive esophagitis increased by 86% in five studies with long-term follow-up and by 35% in two studies with short-term follow-up, which suggests an increased risk of 13% each year after sleeve gastrectomy, the researchers noted.

Besides the risk of Barrett’s esophagus after sleeve gastrectomy, “the risk of [erosive esophagitis] is also of significant interest and shares the same pathophysiology with [Barrett’s esophagus] and GERD,” they emphasized.

The study findings were limited by several factors including the small sample size and the focus on Barrett’s esophagus rather than erosive esophagitis or GERD as the primary outcome, the researchers noted. However, the results indicate that sleeve gastrectomy patients are at increased risk for Barrett’s esophagus, and larger studies are needed to better understand the pathophysiology. Furthermore, although there is some debate regarding the risk of GERD and erosive esophagitis after sleeve gastrectomy, the authors wrote that the data from their study showed a “consistent and substantial trend” toward more erosive esophagitis after sleeve gastrectomy.

“Gastroenterologists, primary care providers, and bariatric surgeons should be aware” of the data and should discuss the risks of sleeve gastrectomy with patients before the procedure, including the risks and benefits of postprocedure screening for Barrett’s esophagus, they concluded.
 

Consider surveillance for Barrett’s

The study is important because of the increased rates of GERD and potentially Barrett’s esophagus that have been noted after sleeve gastrectomy, Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, said in an interview.

“Many of these studies have been small, and the findings of meta-analyses have been limited by high heterogeneity,” he noted. “With the rise in popularity of sleeve gastrectomy, it is important to accurately assess potential long-term complications.”

Dr. Ketwaroo said he was not surprised by the study findings given several reports of increased GERD after sleeve gastrectomy. “Given the accepted pathophysiology of Barrett’s esophagus, I anticipated increased risk of Barrett’s esophagus after sleeve gastrectomy as well.

“Clinicians should consider surveillance for Barrett’s esophagus after sleeve gastrectomy, and possible early proton pump inhibitor use for both GERD/erosive esophagitis and Barrett’s esophagus chemoprophylaxis. Patients with longer-segment or dysplastic Barrett’s esophagus prior to sleeve gastrectomy may have to be monitored more closely after surgery,” he said.

Dr. Ketwaroo noted that the study was limited by the small sample size, “with only approximately 50 patients with Barrett’s esophagus after surgery among 680 overall.” He emphasized that “we will need a much larger prospective study to confirm this finding. Additionally, I would want to explore if sleeve gastrectomy increases rate of progression of dysplasia in those who develop Barrett’s esophagus.”

The study received no outside funding. Lead author Dr. Qumseya had no financial conflicts to disclose. Dr. Ketwaroo serves on the GI & Hepatology News editorial advisory board.

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Pfizer developing pill to treat COVID-19 symptoms

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Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

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Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

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Psoriasis associated with an increased risk of COVID-19 in real-world study

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People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

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People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

 

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

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CDC: Vaccinated people can mostly drop masks outdoors

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After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

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After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

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Promising data on once-weekly insulin, phase 3 study ongoing

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Two new phase 2 studies show encouraging findings with the investigational once-weekly basal insulin analogue icodec (Novo Nordisk) for people with type 2 diabetes who require insulin.

Sara Freeman/MDedge News
Dr. Ildiko Lingvay

Insulin icodec works by reversibly binding to albumin, which slows the release of the active insulin analogue. It has a half-life of about 1 week. The glucose-lowering effect is distributed nearly evenly over the course of that week.

Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center, Dallas, who is an author of both new articles, said: “A weekly insulin is a game changer that will decrease the treatment burden for patients while also improving compliance.”

She noted that these studies demonstrate optimal approaches to initiating treatment with icodec and serve “as the steppingstones for a large phase 3 clinical trial program that is currently ongoing ... which is designed to evaluate the efficacy of once-weekly insulin administration in patients with either type 1 or type 2 diabetes.”

Another advantage of the formulation, Dr. Lingvay pointed out in a press release from her institution, is that it could decrease the burden on caregivers of patients with diabetes who require insulin.

“For example, for patients who need help injecting, those living in long-term care facilities, and those with memory problems, a once-weekly insulin will facilitate treatment and decrease the burden on the care providers,” she explained.
 

Titration balances glycemic control with hypoglycemic risk reduction

The first phase 2 trial, published online April 19, 2021, in Diabetes Care, was an open-label, 16-week, treat-to-target study that involved 205 insulin-naive adults with type 2 diabetes whose hemoglobin A1c levels were 7%-10% while using oral glucose-lowering medications.

They were randomly assigned to one of three once-weekly icodec titration groups:

  • Group A – Fasting glucose target of 80-130 mg/dL with adjustments ±21 units/wk
  • Group B – Fasting glucose target of 80-130 mg/dL with ±28 units/wk
  • Group C – Fasting glucose target of 70-108 mg/dL, adjusting by ±28 units/wk or to once-daily glargine U100 with a fasting glucose target of 80-130 mg/dL with adjustments of ±4 units/d

The percentage of time in the ideal glucose range of 70-180 mg/dL, assessed by continuous glucose monitoring during weeks 15-16, improved from baseline levels of 57.0%, 55.2%, 51.0% for groups A, B, and C, respectively, and from 55.3% for glargine to 76.6%, 83.0%, 80.9%, and 75.9%, respectively.

There were no unexpected safety problems. Hypoglycemia episodes of glucose levels <54 mg/dL occurred in 0.05, 0.15, 0.38, and 0.00 per patient-year for the four groups, respectively. None were severe (i.e., required assistance).

The titration for patients in group A (80-130 mg/dL, ±21 units/wk) yielded the best balance between glycemic control and risk for hypoglycemia, Dr. Lingvay and colleagues said.
 

Use of loading dose when switching to icodec improves time in range

In the other phase 2 trial, also published online April 19 in Diabetes Care, Harpreet S. Bajaj, MD, of Mount Sinai Hospital, Toronto, and colleagues, with Dr. Lingvay as a coauthor, examined two methods of switching to icodec. This multicenter, open-label, treat-to-target study included 154 patients with A1c levels of 7-10% who were already receiving basal insulin daily and at least one oral glucose-lowering medication.

Patients were randomly assigned to one of three treatment approaches: a 100% loading dose of icodec (only the first dose was doubled), no loading dose, or once-daily glargine.

The primary endpoint was time in range (70-180 mg/dL) during weeks 15 and 16. This was achieved with 72.9% of patients receiving the icodec loading dose, 66.0% of patients receiving icodec without the loading dose, and 65.0% of patients receiving daily glargine. The difference between the icodec loading-dose method and glargine was significant, Dr. Bajaj and colleagues reported.

The mean A1c level was reduced from an overall average of 7.9% at baseline to 7.1% in the icodec loading dose group and to 7.4% in both the no-loading-dose and glargine groups.

Rates of adverse events and hypoglycemic episodes did not differ significantly among the groups.

Previous phase 2 data showing that the efficacy and safety of icodec were comparable with that of once-daily insulin glargine U100 in 247 insulin-naive patients with type 2 diabetes were published in November 2020 in the New England Journal of Medicine and were presented at the European Association for the Study of Diabetes (EASD) 2020 Annual Meeting, as reported by this news organization.

Both studies were funded by Novo Nordisk. Dr. Lingvey has received research funding, advisory/consulting fees, or other support from Novo Nordisk, Eli Lilly, Sanofi, AstraZeneca, Boehringer Ingelheim, Janssen, Intercept, Intarcia, Target RWE, Merck, Pfizer, Novartis, GI Dynamics, Mylan, Mannkind, Valeritas, Bayer, and Zealand Pharma. Dr. Bajaj has received speaking fees from AstraZeneca, Eli Lilly, Janssen Pharmaceuticals, Merck, and Novo Nordisk and research funding paid to LMC Healthcare for serving as principal investigator on clinical trials from Amgen, AstraZeneca Boehringer Ingelheim, Ceapro Inc, Eli Lilly, Gilead Sciences, Janssen Pharmaceuticals, Kowa Pharmaceuticals, Madrigal Pharmaceuticals, Merck, Novo Nordisk, Sanofi, and Tricida.

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

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Two new phase 2 studies show encouraging findings with the investigational once-weekly basal insulin analogue icodec (Novo Nordisk) for people with type 2 diabetes who require insulin.

Sara Freeman/MDedge News
Dr. Ildiko Lingvay

Insulin icodec works by reversibly binding to albumin, which slows the release of the active insulin analogue. It has a half-life of about 1 week. The glucose-lowering effect is distributed nearly evenly over the course of that week.

Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center, Dallas, who is an author of both new articles, said: “A weekly insulin is a game changer that will decrease the treatment burden for patients while also improving compliance.”

She noted that these studies demonstrate optimal approaches to initiating treatment with icodec and serve “as the steppingstones for a large phase 3 clinical trial program that is currently ongoing ... which is designed to evaluate the efficacy of once-weekly insulin administration in patients with either type 1 or type 2 diabetes.”

Another advantage of the formulation, Dr. Lingvay pointed out in a press release from her institution, is that it could decrease the burden on caregivers of patients with diabetes who require insulin.

“For example, for patients who need help injecting, those living in long-term care facilities, and those with memory problems, a once-weekly insulin will facilitate treatment and decrease the burden on the care providers,” she explained.
 

Titration balances glycemic control with hypoglycemic risk reduction

The first phase 2 trial, published online April 19, 2021, in Diabetes Care, was an open-label, 16-week, treat-to-target study that involved 205 insulin-naive adults with type 2 diabetes whose hemoglobin A1c levels were 7%-10% while using oral glucose-lowering medications.

They were randomly assigned to one of three once-weekly icodec titration groups:

  • Group A – Fasting glucose target of 80-130 mg/dL with adjustments ±21 units/wk
  • Group B – Fasting glucose target of 80-130 mg/dL with ±28 units/wk
  • Group C – Fasting glucose target of 70-108 mg/dL, adjusting by ±28 units/wk or to once-daily glargine U100 with a fasting glucose target of 80-130 mg/dL with adjustments of ±4 units/d

The percentage of time in the ideal glucose range of 70-180 mg/dL, assessed by continuous glucose monitoring during weeks 15-16, improved from baseline levels of 57.0%, 55.2%, 51.0% for groups A, B, and C, respectively, and from 55.3% for glargine to 76.6%, 83.0%, 80.9%, and 75.9%, respectively.

There were no unexpected safety problems. Hypoglycemia episodes of glucose levels <54 mg/dL occurred in 0.05, 0.15, 0.38, and 0.00 per patient-year for the four groups, respectively. None were severe (i.e., required assistance).

The titration for patients in group A (80-130 mg/dL, ±21 units/wk) yielded the best balance between glycemic control and risk for hypoglycemia, Dr. Lingvay and colleagues said.
 

Use of loading dose when switching to icodec improves time in range

In the other phase 2 trial, also published online April 19 in Diabetes Care, Harpreet S. Bajaj, MD, of Mount Sinai Hospital, Toronto, and colleagues, with Dr. Lingvay as a coauthor, examined two methods of switching to icodec. This multicenter, open-label, treat-to-target study included 154 patients with A1c levels of 7-10% who were already receiving basal insulin daily and at least one oral glucose-lowering medication.

Patients were randomly assigned to one of three treatment approaches: a 100% loading dose of icodec (only the first dose was doubled), no loading dose, or once-daily glargine.

The primary endpoint was time in range (70-180 mg/dL) during weeks 15 and 16. This was achieved with 72.9% of patients receiving the icodec loading dose, 66.0% of patients receiving icodec without the loading dose, and 65.0% of patients receiving daily glargine. The difference between the icodec loading-dose method and glargine was significant, Dr. Bajaj and colleagues reported.

The mean A1c level was reduced from an overall average of 7.9% at baseline to 7.1% in the icodec loading dose group and to 7.4% in both the no-loading-dose and glargine groups.

Rates of adverse events and hypoglycemic episodes did not differ significantly among the groups.

Previous phase 2 data showing that the efficacy and safety of icodec were comparable with that of once-daily insulin glargine U100 in 247 insulin-naive patients with type 2 diabetes were published in November 2020 in the New England Journal of Medicine and were presented at the European Association for the Study of Diabetes (EASD) 2020 Annual Meeting, as reported by this news organization.

Both studies were funded by Novo Nordisk. Dr. Lingvey has received research funding, advisory/consulting fees, or other support from Novo Nordisk, Eli Lilly, Sanofi, AstraZeneca, Boehringer Ingelheim, Janssen, Intercept, Intarcia, Target RWE, Merck, Pfizer, Novartis, GI Dynamics, Mylan, Mannkind, Valeritas, Bayer, and Zealand Pharma. Dr. Bajaj has received speaking fees from AstraZeneca, Eli Lilly, Janssen Pharmaceuticals, Merck, and Novo Nordisk and research funding paid to LMC Healthcare for serving as principal investigator on clinical trials from Amgen, AstraZeneca Boehringer Ingelheim, Ceapro Inc, Eli Lilly, Gilead Sciences, Janssen Pharmaceuticals, Kowa Pharmaceuticals, Madrigal Pharmaceuticals, Merck, Novo Nordisk, Sanofi, and Tricida.

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

Two new phase 2 studies show encouraging findings with the investigational once-weekly basal insulin analogue icodec (Novo Nordisk) for people with type 2 diabetes who require insulin.

Sara Freeman/MDedge News
Dr. Ildiko Lingvay

Insulin icodec works by reversibly binding to albumin, which slows the release of the active insulin analogue. It has a half-life of about 1 week. The glucose-lowering effect is distributed nearly evenly over the course of that week.

Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center, Dallas, who is an author of both new articles, said: “A weekly insulin is a game changer that will decrease the treatment burden for patients while also improving compliance.”

She noted that these studies demonstrate optimal approaches to initiating treatment with icodec and serve “as the steppingstones for a large phase 3 clinical trial program that is currently ongoing ... which is designed to evaluate the efficacy of once-weekly insulin administration in patients with either type 1 or type 2 diabetes.”

Another advantage of the formulation, Dr. Lingvay pointed out in a press release from her institution, is that it could decrease the burden on caregivers of patients with diabetes who require insulin.

“For example, for patients who need help injecting, those living in long-term care facilities, and those with memory problems, a once-weekly insulin will facilitate treatment and decrease the burden on the care providers,” she explained.
 

Titration balances glycemic control with hypoglycemic risk reduction

The first phase 2 trial, published online April 19, 2021, in Diabetes Care, was an open-label, 16-week, treat-to-target study that involved 205 insulin-naive adults with type 2 diabetes whose hemoglobin A1c levels were 7%-10% while using oral glucose-lowering medications.

They were randomly assigned to one of three once-weekly icodec titration groups:

  • Group A – Fasting glucose target of 80-130 mg/dL with adjustments ±21 units/wk
  • Group B – Fasting glucose target of 80-130 mg/dL with ±28 units/wk
  • Group C – Fasting glucose target of 70-108 mg/dL, adjusting by ±28 units/wk or to once-daily glargine U100 with a fasting glucose target of 80-130 mg/dL with adjustments of ±4 units/d

The percentage of time in the ideal glucose range of 70-180 mg/dL, assessed by continuous glucose monitoring during weeks 15-16, improved from baseline levels of 57.0%, 55.2%, 51.0% for groups A, B, and C, respectively, and from 55.3% for glargine to 76.6%, 83.0%, 80.9%, and 75.9%, respectively.

There were no unexpected safety problems. Hypoglycemia episodes of glucose levels <54 mg/dL occurred in 0.05, 0.15, 0.38, and 0.00 per patient-year for the four groups, respectively. None were severe (i.e., required assistance).

The titration for patients in group A (80-130 mg/dL, ±21 units/wk) yielded the best balance between glycemic control and risk for hypoglycemia, Dr. Lingvay and colleagues said.
 

Use of loading dose when switching to icodec improves time in range

In the other phase 2 trial, also published online April 19 in Diabetes Care, Harpreet S. Bajaj, MD, of Mount Sinai Hospital, Toronto, and colleagues, with Dr. Lingvay as a coauthor, examined two methods of switching to icodec. This multicenter, open-label, treat-to-target study included 154 patients with A1c levels of 7-10% who were already receiving basal insulin daily and at least one oral glucose-lowering medication.

Patients were randomly assigned to one of three treatment approaches: a 100% loading dose of icodec (only the first dose was doubled), no loading dose, or once-daily glargine.

The primary endpoint was time in range (70-180 mg/dL) during weeks 15 and 16. This was achieved with 72.9% of patients receiving the icodec loading dose, 66.0% of patients receiving icodec without the loading dose, and 65.0% of patients receiving daily glargine. The difference between the icodec loading-dose method and glargine was significant, Dr. Bajaj and colleagues reported.

The mean A1c level was reduced from an overall average of 7.9% at baseline to 7.1% in the icodec loading dose group and to 7.4% in both the no-loading-dose and glargine groups.

Rates of adverse events and hypoglycemic episodes did not differ significantly among the groups.

Previous phase 2 data showing that the efficacy and safety of icodec were comparable with that of once-daily insulin glargine U100 in 247 insulin-naive patients with type 2 diabetes were published in November 2020 in the New England Journal of Medicine and were presented at the European Association for the Study of Diabetes (EASD) 2020 Annual Meeting, as reported by this news organization.

Both studies were funded by Novo Nordisk. Dr. Lingvey has received research funding, advisory/consulting fees, or other support from Novo Nordisk, Eli Lilly, Sanofi, AstraZeneca, Boehringer Ingelheim, Janssen, Intercept, Intarcia, Target RWE, Merck, Pfizer, Novartis, GI Dynamics, Mylan, Mannkind, Valeritas, Bayer, and Zealand Pharma. Dr. Bajaj has received speaking fees from AstraZeneca, Eli Lilly, Janssen Pharmaceuticals, Merck, and Novo Nordisk and research funding paid to LMC Healthcare for serving as principal investigator on clinical trials from Amgen, AstraZeneca Boehringer Ingelheim, Ceapro Inc, Eli Lilly, Gilead Sciences, Janssen Pharmaceuticals, Kowa Pharmaceuticals, Madrigal Pharmaceuticals, Merck, Novo Nordisk, Sanofi, and Tricida.

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

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Feds lift pause of J&J COVID vaccine, add new warning

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Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson &amp; Johnson


“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.

In the end, the potential benefits of the vaccine far outweighed its risks.

“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.

“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.

The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.

The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).

As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.

The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.

William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.

He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”

As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.

“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.

ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.

In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.

As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.

She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.

Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.

Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.


This article was updated April 24, 2021, and first appeared on WebMD.com.

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Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson &amp; Johnson


“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.

In the end, the potential benefits of the vaccine far outweighed its risks.

“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.

“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.

The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.

The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).

As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.

The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.

William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.

He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”

As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.

“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.

ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.

In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.

As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.

She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.

Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.

Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.


This article was updated April 24, 2021, and first appeared on WebMD.com.

Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.

Johnson &amp; Johnson


“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.

In the end, the potential benefits of the vaccine far outweighed its risks.

“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.

“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.

The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.

The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).

As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.

The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.

William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.

He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”

As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.

“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.

ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.

In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.

As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.

She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.

Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.

Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.


This article was updated April 24, 2021, and first appeared on WebMD.com.

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Nurses or physicians: Who are at highest suicide risk?

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Female nurses are at significantly greater risk of dying by suicide than physicians in findings that contradict previous research suggesting doctors are at greatest risk.

pondsaksit/Getty Images

Results of a large retrospective cohort study show that nurses of both sexes were 18% more likely to die by suicide, compared with individuals in the general population. In addition, compared with female physicians, the suicide risk among female nurses was 70% higher.

“The main takeaway is that the risk of suicide among nurses is twice that of the general population and even higher than that among physicians, a population known to be at high risk,” lead author Matthew Davis, MPH, PhD, associate professor, department of systems, populations, and leadership, University of Michigan, Ann Arbor, said in an interview.

The study was published online April 14, 2021, in JAMA Psychiatry.
 

Focus on physicians

Compared with the general public, health care workers are at higher risk for suicide, but most studies of suicide have focused on physicians, Dr. Davis said.

Although “there were several older studies hinting that there might be a difference in suicide risk among nurses,” the data were insufficient to “make an overall conclusion,” he noted.

For that reason, his group “set out to make the best estimates possible” by using a large dataset from the National Violent Death Reporting System of the Centers for Disease Control and Prevention spanning the years 2007-2018 and focusing on suicides by individuals aged 30 years and older (n = 159,372 suicides).

Additional workforce data were acquired from the Bureau of Labor Statistics and the Association of Medical Colleges State Physician Workforce Data.

An important area of focus was method of suicide.

The reason we looked at this is because people who work in healthcare have easier access to medications and know how to use them to overdose, which also increases their risk,” Dr. Davis said in a press release.
 

Enormous job strain

The researchers identified 2,374 suicides among nurses, 857 suicides among physicians, and 156,141 suicides in the general population.

Compared with the general population, nurses who died by suicide were more likely to be women, less racially diverse (non-Hispanic White), and more likely to have been married.

pondsaksit/Getty Images

Rates of suicide were higher among nurses than among the general population, with a sex-adjusted incidence for 2017-2018 of 23.8 per 100,000 versus 20.1 per 100,000 (relative risk, 1.18; 95% confidence interval, 1.03-1.36).

The difference between suicide rates among female nurses and among women in the general population was even more striking: In 2017-2018, the suicide incidence among nurses was 17.1 per 100,000 versus 8.6 per 100,000 in the population at large (RR, 1.99; 95% CI, 1.82-2.18).

“In absolute terms, being a female nurse was associated with an additional 8.5 suicides per 100,000 (7.0-10.0), compared with the general population,” the authors reported.

In contrast, overall physician suicide rates were not statistically different from those of the general population (RR, 1.01; 95% CI, 0.79-1.30) except during the period 2011-2012 (11.7 per 100,000; 95% CI, 6.6-16.8 vs. 7.5 per 100,000; 95% CI, 7.2-7.7).

Clinicians of both sexes were more likely to use poisoning and less likely to use a firearm, compared with individuals in the general population who died by suicide. For example, 24.9% (23.5%-26.4%) of nurse suicides involved poisoning, compared to 16.8% (16.6%-17.0%) of suicides in the general population.

Toxicology reports showed that the presence of antidepressants, benzodiazepines, barbiturates, and opiates was more common in clinician suicides than suicides in the general population.

Dr. Davis suggested the higher risk for suicide among nurses, compared with physicians, might be attributed to “high job demands – for example, nurses provide the majority of bedside care, work long shifts in stressful environments, and have less autonomy.

“Health care workers and friends and family of health care workers need to be aware of mental health issues and suicide risk that can be associated with the job and, most importantly, recognize those who may be struggling and encourage them to get help by calling the National Suicide Prevention Lifeline,” he said.

Other potential contributors include “avoidance of mental health services due to stigma and greater access to the means to commit suicide via medication,” Dr. Davis noted.
 

 

 

Benchmark research

Commenting on the study, Constance Guille, MD, MSCR, professor in the department of psychiatry and behavioral science, Medical University of South Carolina, Charleston, noted that nurses are “predominantly female” and that women tend to be twice as likely as men to experience depression, which is a major risk factor for suicide. Thus, this population is particularly vulnerable.

One reason the investigators did not find that suicide rates were higher among physicians is that the health care professionals whom the researchers studied were older than 30 years. Thus, the study “excludes younger physicians in early practice or training, who likely do have higher suicide rates than the general population,” she suggested.

Dr. Guille, who is the author of an accompanying editorial and was not involved with the study, recommended “taking a public health approach, implementing preventative interventions, identifying people at high risk, providing treatment for health care professionals struggling with mental health problems, and destigmatizing help seeking.”

She encouraged clinicians to “reach out to colleagues who are struggling in a way to help them seek services and check in with them because it’s helpful when peers reach out.”

Dr. Davis noted that these disturbing trends will likely increase in the aftermath of the COVID-19 pandemic. “The pandemic has placed enormous strain on the health care workforce, and we fear this may have made the situation even worse.”

The current findings “will serve as a benchmark for future comparisons,” he said.

No source of funding for the study was reported. Dr. Davis has received consulting fees as a statistical reviewer for the journal Regional Anesthesia and Pain Medicine. His coauthors disclosed no relevant financial relationships. Dr. Guille has received grants from the National Institute on Drug Abuse, the American Foundation on Suicide Prevention, and the Duke Endowment and serves on the advisory board and speakers bureau of Sage Therapeutics.

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

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Female nurses are at significantly greater risk of dying by suicide than physicians in findings that contradict previous research suggesting doctors are at greatest risk.

pondsaksit/Getty Images

Results of a large retrospective cohort study show that nurses of both sexes were 18% more likely to die by suicide, compared with individuals in the general population. In addition, compared with female physicians, the suicide risk among female nurses was 70% higher.

“The main takeaway is that the risk of suicide among nurses is twice that of the general population and even higher than that among physicians, a population known to be at high risk,” lead author Matthew Davis, MPH, PhD, associate professor, department of systems, populations, and leadership, University of Michigan, Ann Arbor, said in an interview.

The study was published online April 14, 2021, in JAMA Psychiatry.
 

Focus on physicians

Compared with the general public, health care workers are at higher risk for suicide, but most studies of suicide have focused on physicians, Dr. Davis said.

Although “there were several older studies hinting that there might be a difference in suicide risk among nurses,” the data were insufficient to “make an overall conclusion,” he noted.

For that reason, his group “set out to make the best estimates possible” by using a large dataset from the National Violent Death Reporting System of the Centers for Disease Control and Prevention spanning the years 2007-2018 and focusing on suicides by individuals aged 30 years and older (n = 159,372 suicides).

Additional workforce data were acquired from the Bureau of Labor Statistics and the Association of Medical Colleges State Physician Workforce Data.

An important area of focus was method of suicide.

The reason we looked at this is because people who work in healthcare have easier access to medications and know how to use them to overdose, which also increases their risk,” Dr. Davis said in a press release.
 

Enormous job strain

The researchers identified 2,374 suicides among nurses, 857 suicides among physicians, and 156,141 suicides in the general population.

Compared with the general population, nurses who died by suicide were more likely to be women, less racially diverse (non-Hispanic White), and more likely to have been married.

pondsaksit/Getty Images

Rates of suicide were higher among nurses than among the general population, with a sex-adjusted incidence for 2017-2018 of 23.8 per 100,000 versus 20.1 per 100,000 (relative risk, 1.18; 95% confidence interval, 1.03-1.36).

The difference between suicide rates among female nurses and among women in the general population was even more striking: In 2017-2018, the suicide incidence among nurses was 17.1 per 100,000 versus 8.6 per 100,000 in the population at large (RR, 1.99; 95% CI, 1.82-2.18).

“In absolute terms, being a female nurse was associated with an additional 8.5 suicides per 100,000 (7.0-10.0), compared with the general population,” the authors reported.

In contrast, overall physician suicide rates were not statistically different from those of the general population (RR, 1.01; 95% CI, 0.79-1.30) except during the period 2011-2012 (11.7 per 100,000; 95% CI, 6.6-16.8 vs. 7.5 per 100,000; 95% CI, 7.2-7.7).

Clinicians of both sexes were more likely to use poisoning and less likely to use a firearm, compared with individuals in the general population who died by suicide. For example, 24.9% (23.5%-26.4%) of nurse suicides involved poisoning, compared to 16.8% (16.6%-17.0%) of suicides in the general population.

Toxicology reports showed that the presence of antidepressants, benzodiazepines, barbiturates, and opiates was more common in clinician suicides than suicides in the general population.

Dr. Davis suggested the higher risk for suicide among nurses, compared with physicians, might be attributed to “high job demands – for example, nurses provide the majority of bedside care, work long shifts in stressful environments, and have less autonomy.

“Health care workers and friends and family of health care workers need to be aware of mental health issues and suicide risk that can be associated with the job and, most importantly, recognize those who may be struggling and encourage them to get help by calling the National Suicide Prevention Lifeline,” he said.

Other potential contributors include “avoidance of mental health services due to stigma and greater access to the means to commit suicide via medication,” Dr. Davis noted.
 

 

 

Benchmark research

Commenting on the study, Constance Guille, MD, MSCR, professor in the department of psychiatry and behavioral science, Medical University of South Carolina, Charleston, noted that nurses are “predominantly female” and that women tend to be twice as likely as men to experience depression, which is a major risk factor for suicide. Thus, this population is particularly vulnerable.

One reason the investigators did not find that suicide rates were higher among physicians is that the health care professionals whom the researchers studied were older than 30 years. Thus, the study “excludes younger physicians in early practice or training, who likely do have higher suicide rates than the general population,” she suggested.

Dr. Guille, who is the author of an accompanying editorial and was not involved with the study, recommended “taking a public health approach, implementing preventative interventions, identifying people at high risk, providing treatment for health care professionals struggling with mental health problems, and destigmatizing help seeking.”

She encouraged clinicians to “reach out to colleagues who are struggling in a way to help them seek services and check in with them because it’s helpful when peers reach out.”

Dr. Davis noted that these disturbing trends will likely increase in the aftermath of the COVID-19 pandemic. “The pandemic has placed enormous strain on the health care workforce, and we fear this may have made the situation even worse.”

The current findings “will serve as a benchmark for future comparisons,” he said.

No source of funding for the study was reported. Dr. Davis has received consulting fees as a statistical reviewer for the journal Regional Anesthesia and Pain Medicine. His coauthors disclosed no relevant financial relationships. Dr. Guille has received grants from the National Institute on Drug Abuse, the American Foundation on Suicide Prevention, and the Duke Endowment and serves on the advisory board and speakers bureau of Sage Therapeutics.

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

Female nurses are at significantly greater risk of dying by suicide than physicians in findings that contradict previous research suggesting doctors are at greatest risk.

pondsaksit/Getty Images

Results of a large retrospective cohort study show that nurses of both sexes were 18% more likely to die by suicide, compared with individuals in the general population. In addition, compared with female physicians, the suicide risk among female nurses was 70% higher.

“The main takeaway is that the risk of suicide among nurses is twice that of the general population and even higher than that among physicians, a population known to be at high risk,” lead author Matthew Davis, MPH, PhD, associate professor, department of systems, populations, and leadership, University of Michigan, Ann Arbor, said in an interview.

The study was published online April 14, 2021, in JAMA Psychiatry.
 

Focus on physicians

Compared with the general public, health care workers are at higher risk for suicide, but most studies of suicide have focused on physicians, Dr. Davis said.

Although “there were several older studies hinting that there might be a difference in suicide risk among nurses,” the data were insufficient to “make an overall conclusion,” he noted.

For that reason, his group “set out to make the best estimates possible” by using a large dataset from the National Violent Death Reporting System of the Centers for Disease Control and Prevention spanning the years 2007-2018 and focusing on suicides by individuals aged 30 years and older (n = 159,372 suicides).

Additional workforce data were acquired from the Bureau of Labor Statistics and the Association of Medical Colleges State Physician Workforce Data.

An important area of focus was method of suicide.

The reason we looked at this is because people who work in healthcare have easier access to medications and know how to use them to overdose, which also increases their risk,” Dr. Davis said in a press release.
 

Enormous job strain

The researchers identified 2,374 suicides among nurses, 857 suicides among physicians, and 156,141 suicides in the general population.

Compared with the general population, nurses who died by suicide were more likely to be women, less racially diverse (non-Hispanic White), and more likely to have been married.

pondsaksit/Getty Images

Rates of suicide were higher among nurses than among the general population, with a sex-adjusted incidence for 2017-2018 of 23.8 per 100,000 versus 20.1 per 100,000 (relative risk, 1.18; 95% confidence interval, 1.03-1.36).

The difference between suicide rates among female nurses and among women in the general population was even more striking: In 2017-2018, the suicide incidence among nurses was 17.1 per 100,000 versus 8.6 per 100,000 in the population at large (RR, 1.99; 95% CI, 1.82-2.18).

“In absolute terms, being a female nurse was associated with an additional 8.5 suicides per 100,000 (7.0-10.0), compared with the general population,” the authors reported.

In contrast, overall physician suicide rates were not statistically different from those of the general population (RR, 1.01; 95% CI, 0.79-1.30) except during the period 2011-2012 (11.7 per 100,000; 95% CI, 6.6-16.8 vs. 7.5 per 100,000; 95% CI, 7.2-7.7).

Clinicians of both sexes were more likely to use poisoning and less likely to use a firearm, compared with individuals in the general population who died by suicide. For example, 24.9% (23.5%-26.4%) of nurse suicides involved poisoning, compared to 16.8% (16.6%-17.0%) of suicides in the general population.

Toxicology reports showed that the presence of antidepressants, benzodiazepines, barbiturates, and opiates was more common in clinician suicides than suicides in the general population.

Dr. Davis suggested the higher risk for suicide among nurses, compared with physicians, might be attributed to “high job demands – for example, nurses provide the majority of bedside care, work long shifts in stressful environments, and have less autonomy.

“Health care workers and friends and family of health care workers need to be aware of mental health issues and suicide risk that can be associated with the job and, most importantly, recognize those who may be struggling and encourage them to get help by calling the National Suicide Prevention Lifeline,” he said.

Other potential contributors include “avoidance of mental health services due to stigma and greater access to the means to commit suicide via medication,” Dr. Davis noted.
 

 

 

Benchmark research

Commenting on the study, Constance Guille, MD, MSCR, professor in the department of psychiatry and behavioral science, Medical University of South Carolina, Charleston, noted that nurses are “predominantly female” and that women tend to be twice as likely as men to experience depression, which is a major risk factor for suicide. Thus, this population is particularly vulnerable.

One reason the investigators did not find that suicide rates were higher among physicians is that the health care professionals whom the researchers studied were older than 30 years. Thus, the study “excludes younger physicians in early practice or training, who likely do have higher suicide rates than the general population,” she suggested.

Dr. Guille, who is the author of an accompanying editorial and was not involved with the study, recommended “taking a public health approach, implementing preventative interventions, identifying people at high risk, providing treatment for health care professionals struggling with mental health problems, and destigmatizing help seeking.”

She encouraged clinicians to “reach out to colleagues who are struggling in a way to help them seek services and check in with them because it’s helpful when peers reach out.”

Dr. Davis noted that these disturbing trends will likely increase in the aftermath of the COVID-19 pandemic. “The pandemic has placed enormous strain on the health care workforce, and we fear this may have made the situation even worse.”

The current findings “will serve as a benchmark for future comparisons,” he said.

No source of funding for the study was reported. Dr. Davis has received consulting fees as a statistical reviewer for the journal Regional Anesthesia and Pain Medicine. His coauthors disclosed no relevant financial relationships. Dr. Guille has received grants from the National Institute on Drug Abuse, the American Foundation on Suicide Prevention, and the Duke Endowment and serves on the advisory board and speakers bureau of Sage Therapeutics.

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

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Study: COVID-19 can kill months after infection

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Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.

Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.

Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.

“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.

Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.

Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.

The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.

Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.

Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.

Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”

“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”

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

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Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.

Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.

Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.

“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.

Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.

Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.

The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.

Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.

Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.

Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”

“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”

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

Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.

Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.

Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.

“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.

Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.

Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.

The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.

Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.

Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.

Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”

“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”

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

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Post–COVID-19 cardiac involvement in college athletes much rarer than thought

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Young athletes are unlikely to experience ongoing heart problems post–COVID-19 infection.

In a multicenter study conducted during September-December 2020, only 0.7% of 3,018 collegiate athletes who tested positive for SARS-CoV-2 infection were found to have definite, probable, or possible infection-related cardiac involvement.

None experienced an adverse cardiac event and only five (0.2%) required hospitalization for noncardiac complications of COVID-19.

“The take-home message is that cardiac involvement does not happen as much as we had initially feared. It’s in the range of 0.5% to 3%, depending on how you define cardiac involvement, which is not nothing, but it’s not the 30% or 50% that some early studies hinted at,” said Kimberly G. Harmon, MD, of the University of Washington, Seattle.

Dr. Kimberly G. Harmon


Dr. Harmon, along with Jeffrey A. Drezner, MD, also from UW, and Aaron L. Baggish, MD, of Massachusetts General Hospital, Boston, were co–primary investigators of the Outcomes Registry for Cardiac Conditions in Athletes (ORCCA) study. The group’s findings were published April 17 in Circulation.
 

Nearly 20,000 athletes tested

The researchers prospectively tested 19,378 athletes for SARS-CoV-2 infection from 42 U.S. colleges and universities during the study period. A total of 3,018 (16%; mean age, 20 years; 32% female) tested positive and underwent cardiac evaluation.

“We didn’t prescribe what the schools had to do in terms of cardiac evaluation, but most of these colleges are well resourced, and about 74% of athletes were evaluated using the triad testing strategy of 12-lead electrocardiography, cardiac troponin, and transthoracic echocardiography [TEE], with cardiac magnetic resonance [CMR ]when indicated,” explained Dr. Harmon. Only 198 athletes underwent primary screening with CMR.

Athletes were often tested multiple times for SARS-CoV-2 infection by participating institutions and were included in this study if they had any positive test and underwent postinfection cardiac screening.

The cohort includes athletes representing 26 distinct sporting disciplines, including American-style football (36%), basketball (9%), and cross country/track and field (8%). Most were asymptomatic or had only mild COVID-19 symptoms (33% and 29%, respectively).
 

‘Exercise appears to be protective’

Abnormal findings suggestive of SARS-CoV-2 cardiac involvement were detected by ECG in 0.7% of athletes (21 of 2,999), cardiac troponin elevation in 0.9% (24/2,719), and abnormal TTE findings in 0.9% (24/2,556).

The odds of having cardiac involvement was 3.1 times higher in athletes with cardiopulmonary symptoms.

“One thing we’ve seen in the literature and in this cohort, is that exercise appears to be protective to some extent from COVID-19. We had a lot of cases, but in the whole cohort, only five athletes were hospitalized with COVID and those were for noncardiac reasons,” said Dr. Harmon.

During a median clinical surveillance of 113 days, there was one (0.03%) adverse cardiac event likely unrelated to SARS-CoV-2 infection.

The diagnostic yield for probable or definite cardiac involvement was 6.7 times higher for a CMR obtained for clinical reasons (10.1%) versus a primary screening CMR (1.5%).

“This is data we desperately needed. Small, single-center studies early in the pandemic had indicated a higher prevalence of cardiac involvement, which led us to be very conservative about return-to-play in the early days,” said Jeffrey Lander, MD, who was not involved in the study.

Dr. Jeffrey Lander


The study is complementary, he noted, to one published in March that looked at professional athletes post–COVID-19 and also found cardiac pathology in fewer than 1%. The mean age in that study was 25 years.

“They saw a similarly low rate of cardiac involvement in professional athletes, and together with this study, it gives us new information that is also reassuring,” added Dr. Lander, codirector of sports cardiology at Saint Barnabas Medical Center in Livingston, N.J., an RWJBarnabas Health facility, and team cardiologist for Seton Hall University in South Orange, N.J.
 
 

 

Limit CMR to symptomatic athletes

“I think this data can be extended beyond the college athlete. And it’s fair to say to high school athletes and young recreational athletes who have had asymptomatic or mild infection, you probably don’t need further workup if you’re feeling fine,” suggested Dr. Harmon.

“For those with moderate or severe illness, then the triple screen protocol is a good idea, particularly if they are having any symptoms,” she added.

Dr. Lander agrees that athletes should be screened by appropriate providers before returning to sports, but that CMR should not be used routinely for return-to-play screening.

“We’ve never taken a group of, say, 1,000 college athletes who just recovered from the flu and done cardiac MRIs on them, so it’s a bit like opening Pandora’s box when it’s used too liberally. It’s difficult to assess if the findings are secondary to COVID infection or from something entirely unrelated,” he noted.

ORCCA is a collaboration of the American Heart Association and the American Medical Society for Sports Medicine to track COVID-19 cases among National Collegiate Athletic Association (NCAA) athletes. The current study was supported by a grant from the American Medical Society for Sports Medicine.

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Young athletes are unlikely to experience ongoing heart problems post–COVID-19 infection.

In a multicenter study conducted during September-December 2020, only 0.7% of 3,018 collegiate athletes who tested positive for SARS-CoV-2 infection were found to have definite, probable, or possible infection-related cardiac involvement.

None experienced an adverse cardiac event and only five (0.2%) required hospitalization for noncardiac complications of COVID-19.

“The take-home message is that cardiac involvement does not happen as much as we had initially feared. It’s in the range of 0.5% to 3%, depending on how you define cardiac involvement, which is not nothing, but it’s not the 30% or 50% that some early studies hinted at,” said Kimberly G. Harmon, MD, of the University of Washington, Seattle.

Dr. Kimberly G. Harmon


Dr. Harmon, along with Jeffrey A. Drezner, MD, also from UW, and Aaron L. Baggish, MD, of Massachusetts General Hospital, Boston, were co–primary investigators of the Outcomes Registry for Cardiac Conditions in Athletes (ORCCA) study. The group’s findings were published April 17 in Circulation.
 

Nearly 20,000 athletes tested

The researchers prospectively tested 19,378 athletes for SARS-CoV-2 infection from 42 U.S. colleges and universities during the study period. A total of 3,018 (16%; mean age, 20 years; 32% female) tested positive and underwent cardiac evaluation.

“We didn’t prescribe what the schools had to do in terms of cardiac evaluation, but most of these colleges are well resourced, and about 74% of athletes were evaluated using the triad testing strategy of 12-lead electrocardiography, cardiac troponin, and transthoracic echocardiography [TEE], with cardiac magnetic resonance [CMR ]when indicated,” explained Dr. Harmon. Only 198 athletes underwent primary screening with CMR.

Athletes were often tested multiple times for SARS-CoV-2 infection by participating institutions and were included in this study if they had any positive test and underwent postinfection cardiac screening.

The cohort includes athletes representing 26 distinct sporting disciplines, including American-style football (36%), basketball (9%), and cross country/track and field (8%). Most were asymptomatic or had only mild COVID-19 symptoms (33% and 29%, respectively).
 

‘Exercise appears to be protective’

Abnormal findings suggestive of SARS-CoV-2 cardiac involvement were detected by ECG in 0.7% of athletes (21 of 2,999), cardiac troponin elevation in 0.9% (24/2,719), and abnormal TTE findings in 0.9% (24/2,556).

The odds of having cardiac involvement was 3.1 times higher in athletes with cardiopulmonary symptoms.

“One thing we’ve seen in the literature and in this cohort, is that exercise appears to be protective to some extent from COVID-19. We had a lot of cases, but in the whole cohort, only five athletes were hospitalized with COVID and those were for noncardiac reasons,” said Dr. Harmon.

During a median clinical surveillance of 113 days, there was one (0.03%) adverse cardiac event likely unrelated to SARS-CoV-2 infection.

The diagnostic yield for probable or definite cardiac involvement was 6.7 times higher for a CMR obtained for clinical reasons (10.1%) versus a primary screening CMR (1.5%).

“This is data we desperately needed. Small, single-center studies early in the pandemic had indicated a higher prevalence of cardiac involvement, which led us to be very conservative about return-to-play in the early days,” said Jeffrey Lander, MD, who was not involved in the study.

Dr. Jeffrey Lander


The study is complementary, he noted, to one published in March that looked at professional athletes post–COVID-19 and also found cardiac pathology in fewer than 1%. The mean age in that study was 25 years.

“They saw a similarly low rate of cardiac involvement in professional athletes, and together with this study, it gives us new information that is also reassuring,” added Dr. Lander, codirector of sports cardiology at Saint Barnabas Medical Center in Livingston, N.J., an RWJBarnabas Health facility, and team cardiologist for Seton Hall University in South Orange, N.J.
 
 

 

Limit CMR to symptomatic athletes

“I think this data can be extended beyond the college athlete. And it’s fair to say to high school athletes and young recreational athletes who have had asymptomatic or mild infection, you probably don’t need further workup if you’re feeling fine,” suggested Dr. Harmon.

“For those with moderate or severe illness, then the triple screen protocol is a good idea, particularly if they are having any symptoms,” she added.

Dr. Lander agrees that athletes should be screened by appropriate providers before returning to sports, but that CMR should not be used routinely for return-to-play screening.

“We’ve never taken a group of, say, 1,000 college athletes who just recovered from the flu and done cardiac MRIs on them, so it’s a bit like opening Pandora’s box when it’s used too liberally. It’s difficult to assess if the findings are secondary to COVID infection or from something entirely unrelated,” he noted.

ORCCA is a collaboration of the American Heart Association and the American Medical Society for Sports Medicine to track COVID-19 cases among National Collegiate Athletic Association (NCAA) athletes. The current study was supported by a grant from the American Medical Society for Sports Medicine.

Young athletes are unlikely to experience ongoing heart problems post–COVID-19 infection.

In a multicenter study conducted during September-December 2020, only 0.7% of 3,018 collegiate athletes who tested positive for SARS-CoV-2 infection were found to have definite, probable, or possible infection-related cardiac involvement.

None experienced an adverse cardiac event and only five (0.2%) required hospitalization for noncardiac complications of COVID-19.

“The take-home message is that cardiac involvement does not happen as much as we had initially feared. It’s in the range of 0.5% to 3%, depending on how you define cardiac involvement, which is not nothing, but it’s not the 30% or 50% that some early studies hinted at,” said Kimberly G. Harmon, MD, of the University of Washington, Seattle.

Dr. Kimberly G. Harmon


Dr. Harmon, along with Jeffrey A. Drezner, MD, also from UW, and Aaron L. Baggish, MD, of Massachusetts General Hospital, Boston, were co–primary investigators of the Outcomes Registry for Cardiac Conditions in Athletes (ORCCA) study. The group’s findings were published April 17 in Circulation.
 

Nearly 20,000 athletes tested

The researchers prospectively tested 19,378 athletes for SARS-CoV-2 infection from 42 U.S. colleges and universities during the study period. A total of 3,018 (16%; mean age, 20 years; 32% female) tested positive and underwent cardiac evaluation.

“We didn’t prescribe what the schools had to do in terms of cardiac evaluation, but most of these colleges are well resourced, and about 74% of athletes were evaluated using the triad testing strategy of 12-lead electrocardiography, cardiac troponin, and transthoracic echocardiography [TEE], with cardiac magnetic resonance [CMR ]when indicated,” explained Dr. Harmon. Only 198 athletes underwent primary screening with CMR.

Athletes were often tested multiple times for SARS-CoV-2 infection by participating institutions and were included in this study if they had any positive test and underwent postinfection cardiac screening.

The cohort includes athletes representing 26 distinct sporting disciplines, including American-style football (36%), basketball (9%), and cross country/track and field (8%). Most were asymptomatic or had only mild COVID-19 symptoms (33% and 29%, respectively).
 

‘Exercise appears to be protective’

Abnormal findings suggestive of SARS-CoV-2 cardiac involvement were detected by ECG in 0.7% of athletes (21 of 2,999), cardiac troponin elevation in 0.9% (24/2,719), and abnormal TTE findings in 0.9% (24/2,556).

The odds of having cardiac involvement was 3.1 times higher in athletes with cardiopulmonary symptoms.

“One thing we’ve seen in the literature and in this cohort, is that exercise appears to be protective to some extent from COVID-19. We had a lot of cases, but in the whole cohort, only five athletes were hospitalized with COVID and those were for noncardiac reasons,” said Dr. Harmon.

During a median clinical surveillance of 113 days, there was one (0.03%) adverse cardiac event likely unrelated to SARS-CoV-2 infection.

The diagnostic yield for probable or definite cardiac involvement was 6.7 times higher for a CMR obtained for clinical reasons (10.1%) versus a primary screening CMR (1.5%).

“This is data we desperately needed. Small, single-center studies early in the pandemic had indicated a higher prevalence of cardiac involvement, which led us to be very conservative about return-to-play in the early days,” said Jeffrey Lander, MD, who was not involved in the study.

Dr. Jeffrey Lander


The study is complementary, he noted, to one published in March that looked at professional athletes post–COVID-19 and also found cardiac pathology in fewer than 1%. The mean age in that study was 25 years.

“They saw a similarly low rate of cardiac involvement in professional athletes, and together with this study, it gives us new information that is also reassuring,” added Dr. Lander, codirector of sports cardiology at Saint Barnabas Medical Center in Livingston, N.J., an RWJBarnabas Health facility, and team cardiologist for Seton Hall University in South Orange, N.J.
 
 

 

Limit CMR to symptomatic athletes

“I think this data can be extended beyond the college athlete. And it’s fair to say to high school athletes and young recreational athletes who have had asymptomatic or mild infection, you probably don’t need further workup if you’re feeling fine,” suggested Dr. Harmon.

“For those with moderate or severe illness, then the triple screen protocol is a good idea, particularly if they are having any symptoms,” she added.

Dr. Lander agrees that athletes should be screened by appropriate providers before returning to sports, but that CMR should not be used routinely for return-to-play screening.

“We’ve never taken a group of, say, 1,000 college athletes who just recovered from the flu and done cardiac MRIs on them, so it’s a bit like opening Pandora’s box when it’s used too liberally. It’s difficult to assess if the findings are secondary to COVID infection or from something entirely unrelated,” he noted.

ORCCA is a collaboration of the American Heart Association and the American Medical Society for Sports Medicine to track COVID-19 cases among National Collegiate Athletic Association (NCAA) athletes. The current study was supported by a grant from the American Medical Society for Sports Medicine.

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