Clinical

Background: Although multiple randomized, controlled trials have shown that routine preoperative testing prior to cataract surgery has low yield, most Medicare beneficiaries continue to undergo this testing. The American Board of Internal Medicine started the Choosing Wisely campaign to help educate patients and providers about a crisis of unnecessary testing and procedures. This prompted multiple centers to create quality improvement (QI) projects to decrease low-value care.

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Preoperative visits decreased from 93% to 24% in the intervention group and increased from 89% to 91% in the control group (between-group difference, −71%; 95% confidence interval, –80% to –62%). Chest x-rays, laboratory tests, and electrocardiograms also had a similar decrease in the intervention group.

The intervention hospital lost $42,241 the first year because of training costs but 3-year projections estimated $67,241 in savings. The authors estimated $217,322 savings in 3 years from a societal perspective. Interestingly, the decrease in utilization would lead to financial loss in fee-for-service payment ($88,151 loss in 3 years).

No causal relationship can be established since this was an observational study. Several assumptions were made for the cost analysis. Results are less generalizable since the study was at hospitals in a single city and health system. It is unclear which component of the QI initiative was most effective.

Bottom line: A multidisciplinary, multicomponent initiative can be successful in decreasing low-value preoperative testing of patients undergoing cataract surgery. Although this results in cost savings overall and for capitated payment systems, it would actually cause revenue loss in fee-for-service systems. This emphasizes a potential barrier to eradicate low-value care.

Citation: Mafi JN et al. Evaluation of an intervention to reduce low-value preoperative care for patients undergoing cataract surgery at a safety-net health system. JAMA Intern Med. Published online 2019 Mar 25. doi: 10.1001/jamainternmed.2018.8358.

Dr. Menon is a hospitalist at Duke University Health System.

Background: Although multiple randomized, controlled trials have shown that routine preoperative testing prior to cataract surgery has low yield, most Medicare beneficiaries continue to undergo this testing. The American Board of Internal Medicine started the Choosing Wisely campaign to help educate patients and providers about a crisis of unnecessary testing and procedures. This prompted multiple centers to create quality improvement (QI) projects to decrease low-value care.

_

Preoperative visits decreased from 93% to 24% in the intervention group and increased from 89% to 91% in the control group (between-group difference, −71%; 95% confidence interval, –80% to –62%). Chest x-rays, laboratory tests, and electrocardiograms also had a similar decrease in the intervention group.

The intervention hospital lost $42,241 the first year because of training costs but 3-year projections estimated $67,241 in savings. The authors estimated $217,322 savings in 3 years from a societal perspective. Interestingly, the decrease in utilization would lead to financial loss in fee-for-service payment ($88,151 loss in 3 years).

No causal relationship can be established since this was an observational study. Several assumptions were made for the cost analysis. Results are less generalizable since the study was at hospitals in a single city and health system. It is unclear which component of the QI initiative was most effective.

Bottom line: A multidisciplinary, multicomponent initiative can be successful in decreasing low-value preoperative testing of patients undergoing cataract surgery. Although this results in cost savings overall and for capitated payment systems, it would actually cause revenue loss in fee-for-service systems. This emphasizes a potential barrier to eradicate low-value care.

Citation: Mafi JN et al. Evaluation of an intervention to reduce low-value preoperative care for patients undergoing cataract surgery at a safety-net health system. JAMA Intern Med. Published online 2019 Mar 25. doi: 10.1001/jamainternmed.2018.8358.

Dr. Menon is a hospitalist at Duke University Health System.

Background: Although multiple randomized, controlled trials have shown that routine preoperative testing prior to cataract surgery has low yield, most Medicare beneficiaries continue to undergo this testing. The American Board of Internal Medicine started the Choosing Wisely campaign to help educate patients and providers about a crisis of unnecessary testing and procedures. This prompted multiple centers to create quality improvement (QI) projects to decrease low-value care.

_

Preoperative visits decreased from 93% to 24% in the intervention group and increased from 89% to 91% in the control group (between-group difference, −71%; 95% confidence interval, –80% to –62%). Chest x-rays, laboratory tests, and electrocardiograms also had a similar decrease in the intervention group.

The intervention hospital lost $42,241 the first year because of training costs but 3-year projections estimated $67,241 in savings. The authors estimated $217,322 savings in 3 years from a societal perspective. Interestingly, the decrease in utilization would lead to financial loss in fee-for-service payment ($88,151 loss in 3 years).

No causal relationship can be established since this was an observational study. Several assumptions were made for the cost analysis. Results are less generalizable since the study was at hospitals in a single city and health system. It is unclear which component of the QI initiative was most effective.

Bottom line: A multidisciplinary, multicomponent initiative can be successful in decreasing low-value preoperative testing of patients undergoing cataract surgery. Although this results in cost savings overall and for capitated payment systems, it would actually cause revenue loss in fee-for-service systems. This emphasizes a potential barrier to eradicate low-value care.

Citation: Mafi JN et al. Evaluation of an intervention to reduce low-value preoperative care for patients undergoing cataract surgery at a safety-net health system. JAMA Intern Med. Published online 2019 Mar 25. doi: 10.1001/jamainternmed.2018.8358.

Dr. Menon is a hospitalist at Duke University Health System.

Background: Midline catheters have gained popularity in inpatient medical settings as a convenient alternative to PICC lines. This is primarily because of the ability to avoid central line–associated bloodstream infections (CLABSI) since these catheters terminate in the peripheral veins and cannot be reported as such. Additionally, they are potentially able to dwell longer than are traditional peripheral intravenous catheters. However, insufficient data exist to accurately describe the rate of complications in these catheters, as prior studies are based on single-center experiences.

The article does not provide guidance on when and how midline catheters should be used in order to minimize risk; nor does it include a comparison with traditional peripheral intravenous catheters or with PICC lines. Further studies are needed to guide indications and practices for catheter placement in order to minimize risk. Providers should continue to carefully consider the risks and benefits of midline catheter placement in individual cases.

Bottom line: Midline catheter placement more commonly leads to minor rather than major complications, though patterns of use and outcomes vary substantially across sites.

Citation: Chopra V et al. Variation in use and outcomes related to midline catheters: results from a multicentre pilot study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2018-008554.

Dr. Marcantonio is a Med-Peds hospitalist at Duke University Health System.

Background: Midline catheters have gained popularity in inpatient medical settings as a convenient alternative to PICC lines. This is primarily because of the ability to avoid central line–associated bloodstream infections (CLABSI) since these catheters terminate in the peripheral veins and cannot be reported as such. Additionally, they are potentially able to dwell longer than are traditional peripheral intravenous catheters. However, insufficient data exist to accurately describe the rate of complications in these catheters, as prior studies are based on single-center experiences.

The article does not provide guidance on when and how midline catheters should be used in order to minimize risk; nor does it include a comparison with traditional peripheral intravenous catheters or with PICC lines. Further studies are needed to guide indications and practices for catheter placement in order to minimize risk. Providers should continue to carefully consider the risks and benefits of midline catheter placement in individual cases.

Bottom line: Midline catheter placement more commonly leads to minor rather than major complications, though patterns of use and outcomes vary substantially across sites.

Citation: Chopra V et al. Variation in use and outcomes related to midline catheters: results from a multicentre pilot study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2018-008554.

Dr. Marcantonio is a Med-Peds hospitalist at Duke University Health System.

Background: Midline catheters have gained popularity in inpatient medical settings as a convenient alternative to PICC lines. This is primarily because of the ability to avoid central line–associated bloodstream infections (CLABSI) since these catheters terminate in the peripheral veins and cannot be reported as such. Additionally, they are potentially able to dwell longer than are traditional peripheral intravenous catheters. However, insufficient data exist to accurately describe the rate of complications in these catheters, as prior studies are based on single-center experiences.

The article does not provide guidance on when and how midline catheters should be used in order to minimize risk; nor does it include a comparison with traditional peripheral intravenous catheters or with PICC lines. Further studies are needed to guide indications and practices for catheter placement in order to minimize risk. Providers should continue to carefully consider the risks and benefits of midline catheter placement in individual cases.

Bottom line: Midline catheter placement more commonly leads to minor rather than major complications, though patterns of use and outcomes vary substantially across sites.

Citation: Chopra V et al. Variation in use and outcomes related to midline catheters: results from a multicentre pilot study. BMJ Qual Saf. 2019 Mar 18. doi: 10.1136/bmjqs-2018-008554.

Dr. Marcantonio is a Med-Peds hospitalist at Duke University Health System.

The confluence of isolation, excess available time, and anxiety about illness or finances as a result of the COVID-19 pandemic have the potential to increase problem gambling behaviors during this public health emergency, so it’s essential to gather data and supply guidance on this issue, according to a call to action published May 18 in the Journal of Addiction Medicine.

humonia/iStock/Getty Images Plus

“When facing an unforeseen situation with confinement, fear of disease, and financial uncertainty for the future, problem gambling may be an important health hazard to monitor and prevent during and following the COVID-19 crisis, especially given current online gambling availability,” wrote Anders Håkansson, PhD, of Lund University in Sweden and coauthors.

Both stress and trauma have been linked to gambling problems, and both are occurring during the pandemic, said coauthor Marc N. Potenza, MD, PhD, of Yale University, New Haven, Conn., in an interview.

“People are likely to be experiencing stress at levels they haven’t experienced previously,” Dr. Potenza said. While multiple factors can contribute to addictive behaviors, “with respect to the pandemic, one concern is that so-called negative reinforcement motivations – engaging in an addictive behavior to escape from depressed or negative mood states – may be a driving motivation for a significant number of people during this time,” he said.

David Hodgins, PhD, CPsych, a professor of psychology at the University of Calgary in Alberta, who was not involved with the commentary, noted that gambling relapse is triggered by “negative emotional states, interpersonal stress, and financial stress” – all three of which the pandemic contributes to.

Financial stress can especially “inflame erroneous gambling-related cognitions,” he said in an interview, including “beliefs such as the idea that gambling can solve financial problems, even when this is statistically almost impossible as debt increases, and that debt has been caused by gambling.”

Increased social isolation also is particularly problematic, pointed out Shane W. Kraus, PhD, from the University of Nevada, Las Vegas. Dr. Kraus also was not involved with the paper.

“If someone is already struggling with already negative emotions, negative feelings, thoughts, and depression, and you’re now isolating them quite a bit, that’s not going to be a recipe for success,” Dr. Kraus said in an interview.

The mental health effects of the pandemic could be extensive and long-lasting, and such effects often co-occur with addictive behaviors, Dr. Potenza said.

“We should be mindful of ways in which people develop addictions in these settings,” he said. “One of the aspects of the pandemic is that many people are at home for longer periods of time, and they use digital technologies more frequently.”

The use of digital technologies can include interaction on social media platforms and on meeting applications such as Zoom, but such use also offers opportunities for problematic gambling, gaming, and pornography use. The World Health Organization recognizes addiction disorders for gambling and for gaming, and online gaming platforms and pornography sites have reported substantial increases in their traffic during the pandemic, Dr. Potenza said.

The increase in frequency is unsurprising and not necessarily a concern by itself, Dr. Kraus said.

“It’s all about loss of control or difficulty engaging or disengaging,” Dr. Kraus said. “When you can’t stop doing something even if you like it or love it, when it interferes with your day-to-day activities and relationships, that’s when it’s a problem.”
 

Gambling online: Easy, available

The authors note that past research has identified increased gambling problems during economic crises in other countries.

“While currently speculative, financial hardships may promote gambling as individuals may be motivated to gamble to try to win money,” the authors suggested. “Although presently limited, existing data suggest that COVID-19–related financial concerns may increase gambling-related harms, and this possibility merits systematic research.”

But trends and characteristics of the gambling market, including direct effects from the pandemic, can potentially influence behaviors, too. Most casinos have closed during the pandemic, and most of the sports that people bet on have been canceled or postponed.

“Fewer people are gambling on sports, but they turn then to other areas,” Dr. Potenza said. “If they can’t bet on major league type sports, they might gamble on more local sporting events, or they may bet on other activities going on in society during the pandemic.”

But online gambling poses greater risk.

“Properties of online gambling may constitute a particular health hazard when many people are confined to their homes and have had rapid changes in working conditions, psychosocial stress, anxiety, and depression, as has been described in China,” the paper’s authors wrote. “Online gambling may be particularly concerning due to its availability and velocity” and association with higher debt levels.

In addition to online gaming’s ease and availability, past research has found patients report boredom and escapism as reasons they turned to it.

Again, boredom on its own is not necessarily a problem, but for those who already struggle with addictive behaviors, it can be a trigger, Dr. Kraus said.

“Boredom is very tough for them because it’s often associated with negative emotions,” such as dwelling on things not going well in their lives, he said. “In a pandemic, people are by themselves quite a bit, socially isolated, so for those who are struggling already with some depression or anxiety, it’s only going to be increased.”

Online gaming trends may vary with demographics, however. Dr. Kraus noted that his former clinic at the Veterans Administration has been seeing lower gambling in patients with addictive disorders, but those patients are also older and primarily frequented casinos.

“It’s going to depend on age and familiarity with technology,” he said, but even if older problem gamblers are not going to the Internet now, “let’s wait and see what happens in the next 2 or 3 months.”

The authors noted results from a small survey of patients in treatment for gambling addiction at the Bellvitge University Hospital in Barcelona, Spain, where two of the coauthors work. They conducted telephone surveys with 26 patients about the first 4 weeks of sheltering in place because of the coronavirus. All but four of the patients were male, and their average age was 45 years.

“Most presented worries about increased uncertainties, such as the negative impact on their work, risk of COVID-19 infection of themselves or their loved ones and their treatment,” the authors reported.

Although 19% were completely abstinent, an additional 12% (n = 3) reported worsened gambling. In addition, almost half (46%) reported anxiety symptoms and more than a quarter (27%) had depressive symptoms.
 

Appropriate care

A particularly complicating factor of the pandemic is how it has disrupted traditional ways of seeking health care, particularly with how much mental health and other medical care has shifted to telehealth and online delivery, Dr. Potenza pointed out.

“This is a change for many people, and it’s important for both caretakers and people in treatment to be mindful of this and to try to ensure that appropriate services are maintained for people during this time,” he said.

For example, 12-step programs traditionally meet in person, which is largely impossible during the pandemic. Some have moved meetings online, and other programs have turned to apps, such as the Addiction Policy Forum’s app Connections, an empirically validated digital therapy platform that lets patients and clinicians remain connected with remote check-ins.

The move to more telehealth may actually increase access, suggested Dr. Hodgins.

“There is no evidence that this is less effective, and in fact, its convenience might be an advantage in reaching more people,” he said. “More challenging is offering group therapies remotely, but this is also feasible.”

The treatment with the strongest evidence remains cognitive-behavioral therapy (CBT), Dr. Hodgins said.

“This therapy, in part, helps people become aware of their erroneous cognitions and to challenge them, but also helps people restructure their activities to change their habits,” he said. He also noted the rise of online therapy, whether supported by a therapist or entirely self-directed, such as Gambling Self-help.

“These programs typically provide cognitive behavior content but also content that comes from studying how people recover from gambling problems,” he said. “The challenge of completely self-directed approaches is follow-through. Like most online content, people tend to flit around more than they might in therapy.” Still, he added, research has shown good outcomes from these programs.

Dr. Potenza also noted that several organizations, including the International Society of Addiction Medicine and Children and Screens, have been hosting webinars related to COVID-19 coping and/or addiction that clinicians and patients might find helpful.
 

Identification of problematic behaviors

One challenge in watching for problematic gambling behaviors during the pandemic is the set of unusual living circumstances for most people right now. At almost no other time in history have people been primarily confined to their homes, many unable to go to work or working from home, with extra leisure time and nowhere to go.

“With the COVID-19 pandemic, a lot of daily life has changed,” Dr. Potenza said. “It’s unclear whether certain behaviors that have become habitual during the pandemic, such as gaming or online gambling, will then interfere with daily life when the pandemic subsides.”

“The problem is, a small proportion of people who are very vulnerable will develop a disorder and might maintain it,” Dr. Kraus said. Those who already struggle with mental health and may be out of work have greater potential for problematic behaviors.

Dr. Potenza collaborated with other psychiatrists in drafting consensus guidelines on maintaining healthy use of the Internet specifically during the pandemic (Compr Psychiatry. 2020 Jul. doi: 10.10161/comppsych.2020.152180).

“It’s important to think about where one draws the line between normative everyday behaviors – behaviors that are not interfering with life functioning – and those that do interfere with life functioning,” Dr. Potenza said. “If someone is having difficulty making work or family or school obligations, these are important signs that the behavior may be problematic.”

He offered suggestions for things people can do to promote their health during the pandemic, such as having regular routines that include getting physical exercise and social interaction, dining with family if isolating together, and making time for self-care. He also recommended setting limits on the use of digital devices and aiming for a healthy balance in keeping up with the news. The idea is to stay aware of what’s happening without getting burned out or traumatized by news coverage.

Guidance for clinicians

An urgent need for research and guidelines related to gambling and the pandemic exists, the authors argued.

In the meantime, aside from various validated screeners available, Dr. Kraus offered some practical advice for clinicians checking in with their patients: “Ask your patients what they have been doing to cope with this difficult time.”

Some might mention their faith, family, or friends, and others might not have an answer or mention drinking, gaming, or engaging in other activities. “We all do things to cope. Sometimes you use healthy coping and sometimes you use unhealthy coping,” Dr. Kraus said. “I would have a dialogue with my patients around, ‘How are you getting through? What’s helping you? What are some things you’ve tried that are tripping you up?’ ”

If gambling in particular is a possible concern, he encouraged clinicians to ask their patients whether they have tried to quit or what would happen if they stopped gambling.

“What we’d expect is the problem gamblers will have more irritability, crankiness, difficulty with quitting,” he said.

Dr. Hodgins agreed that checking in on how patients’ lives and activities have changed, and their emotion reactions to those changes, is prudent.

“The change in activities might be healthy or might include increased addictive behaviors, including increased use of substances, gaming, pornography, food, and gambling,” he said.

In addition, the paper authors list several examples of guidelines that might be considered in drafting guidance for clinicians, including the following:

• Limiting the extent of gambling
• Not gambling to regulate negative emotions
• Not gambling in order to try to solve financial problems or financial concerns
• Not gambling under the influence of alcohol or drugs
• Carefully monitoring gambling-related time and financial expenditures
• Maintaining and establishing daily routines involving activities other than gambling
• Minding gambling-related attitudes and behaviors in the presence of minors
• Not starting to gamble because of stressors

The research did not receive external funding. Dr. Håkansson has received research funding from the Swedish Sport Foundation, the Swedish alcohol monopoly Systembolaget, and the Swedish state-owned gambling operator AB Svenska Spel. He is working with the company Kontigo Care on devices for gambling addiction follow-up care. Dr. Potenza has received consulting or advisory compensation from several entities, including the Addiction Policy Forum, AXA Gaming, Idorsia, Opiant, and RiverMend Health. Dr. Potenza has received research funding from Mohegan Sun casino and the National Center for Responsible Gaming. No other authors or outside sources had industry-related disclosures.

SOURCE: Håkansson A et al. J Addict Med. 2020 May 18. doi: 10.1097/ADM.0000000000000690.

The confluence of isolation, excess available time, and anxiety about illness or finances as a result of the COVID-19 pandemic have the potential to increase problem gambling behaviors during this public health emergency, so it’s essential to gather data and supply guidance on this issue, according to a call to action published May 18 in the Journal of Addiction Medicine.

humonia/iStock/Getty Images Plus

“When facing an unforeseen situation with confinement, fear of disease, and financial uncertainty for the future, problem gambling may be an important health hazard to monitor and prevent during and following the COVID-19 crisis, especially given current online gambling availability,” wrote Anders Håkansson, PhD, of Lund University in Sweden and coauthors.

Both stress and trauma have been linked to gambling problems, and both are occurring during the pandemic, said coauthor Marc N. Potenza, MD, PhD, of Yale University, New Haven, Conn., in an interview.

“People are likely to be experiencing stress at levels they haven’t experienced previously,” Dr. Potenza said. While multiple factors can contribute to addictive behaviors, “with respect to the pandemic, one concern is that so-called negative reinforcement motivations – engaging in an addictive behavior to escape from depressed or negative mood states – may be a driving motivation for a significant number of people during this time,” he said.

David Hodgins, PhD, CPsych, a professor of psychology at the University of Calgary in Alberta, who was not involved with the commentary, noted that gambling relapse is triggered by “negative emotional states, interpersonal stress, and financial stress” – all three of which the pandemic contributes to.

Financial stress can especially “inflame erroneous gambling-related cognitions,” he said in an interview, including “beliefs such as the idea that gambling can solve financial problems, even when this is statistically almost impossible as debt increases, and that debt has been caused by gambling.”

Increased social isolation also is particularly problematic, pointed out Shane W. Kraus, PhD, from the University of Nevada, Las Vegas. Dr. Kraus also was not involved with the paper.

“If someone is already struggling with already negative emotions, negative feelings, thoughts, and depression, and you’re now isolating them quite a bit, that’s not going to be a recipe for success,” Dr. Kraus said in an interview.

The mental health effects of the pandemic could be extensive and long-lasting, and such effects often co-occur with addictive behaviors, Dr. Potenza said.

“We should be mindful of ways in which people develop addictions in these settings,” he said. “One of the aspects of the pandemic is that many people are at home for longer periods of time, and they use digital technologies more frequently.”

The use of digital technologies can include interaction on social media platforms and on meeting applications such as Zoom, but such use also offers opportunities for problematic gambling, gaming, and pornography use. The World Health Organization recognizes addiction disorders for gambling and for gaming, and online gaming platforms and pornography sites have reported substantial increases in their traffic during the pandemic, Dr. Potenza said.

The increase in frequency is unsurprising and not necessarily a concern by itself, Dr. Kraus said.

“It’s all about loss of control or difficulty engaging or disengaging,” Dr. Kraus said. “When you can’t stop doing something even if you like it or love it, when it interferes with your day-to-day activities and relationships, that’s when it’s a problem.”
 

Gambling online: Easy, available

The authors note that past research has identified increased gambling problems during economic crises in other countries.

“While currently speculative, financial hardships may promote gambling as individuals may be motivated to gamble to try to win money,” the authors suggested. “Although presently limited, existing data suggest that COVID-19–related financial concerns may increase gambling-related harms, and this possibility merits systematic research.”

But trends and characteristics of the gambling market, including direct effects from the pandemic, can potentially influence behaviors, too. Most casinos have closed during the pandemic, and most of the sports that people bet on have been canceled or postponed.

“Fewer people are gambling on sports, but they turn then to other areas,” Dr. Potenza said. “If they can’t bet on major league type sports, they might gamble on more local sporting events, or they may bet on other activities going on in society during the pandemic.”

But online gambling poses greater risk.

“Properties of online gambling may constitute a particular health hazard when many people are confined to their homes and have had rapid changes in working conditions, psychosocial stress, anxiety, and depression, as has been described in China,” the paper’s authors wrote. “Online gambling may be particularly concerning due to its availability and velocity” and association with higher debt levels.

In addition to online gaming’s ease and availability, past research has found patients report boredom and escapism as reasons they turned to it.

Again, boredom on its own is not necessarily a problem, but for those who already struggle with addictive behaviors, it can be a trigger, Dr. Kraus said.

“Boredom is very tough for them because it’s often associated with negative emotions,” such as dwelling on things not going well in their lives, he said. “In a pandemic, people are by themselves quite a bit, socially isolated, so for those who are struggling already with some depression or anxiety, it’s only going to be increased.”

Online gaming trends may vary with demographics, however. Dr. Kraus noted that his former clinic at the Veterans Administration has been seeing lower gambling in patients with addictive disorders, but those patients are also older and primarily frequented casinos.

“It’s going to depend on age and familiarity with technology,” he said, but even if older problem gamblers are not going to the Internet now, “let’s wait and see what happens in the next 2 or 3 months.”

The authors noted results from a small survey of patients in treatment for gambling addiction at the Bellvitge University Hospital in Barcelona, Spain, where two of the coauthors work. They conducted telephone surveys with 26 patients about the first 4 weeks of sheltering in place because of the coronavirus. All but four of the patients were male, and their average age was 45 years.

“Most presented worries about increased uncertainties, such as the negative impact on their work, risk of COVID-19 infection of themselves or their loved ones and their treatment,” the authors reported.

Although 19% were completely abstinent, an additional 12% (n = 3) reported worsened gambling. In addition, almost half (46%) reported anxiety symptoms and more than a quarter (27%) had depressive symptoms.
 

Appropriate care

A particularly complicating factor of the pandemic is how it has disrupted traditional ways of seeking health care, particularly with how much mental health and other medical care has shifted to telehealth and online delivery, Dr. Potenza pointed out.

“This is a change for many people, and it’s important for both caretakers and people in treatment to be mindful of this and to try to ensure that appropriate services are maintained for people during this time,” he said.

For example, 12-step programs traditionally meet in person, which is largely impossible during the pandemic. Some have moved meetings online, and other programs have turned to apps, such as the Addiction Policy Forum’s app Connections, an empirically validated digital therapy platform that lets patients and clinicians remain connected with remote check-ins.

The move to more telehealth may actually increase access, suggested Dr. Hodgins.

“There is no evidence that this is less effective, and in fact, its convenience might be an advantage in reaching more people,” he said. “More challenging is offering group therapies remotely, but this is also feasible.”

The treatment with the strongest evidence remains cognitive-behavioral therapy (CBT), Dr. Hodgins said.

“This therapy, in part, helps people become aware of their erroneous cognitions and to challenge them, but also helps people restructure their activities to change their habits,” he said. He also noted the rise of online therapy, whether supported by a therapist or entirely self-directed, such as Gambling Self-help.

“These programs typically provide cognitive behavior content but also content that comes from studying how people recover from gambling problems,” he said. “The challenge of completely self-directed approaches is follow-through. Like most online content, people tend to flit around more than they might in therapy.” Still, he added, research has shown good outcomes from these programs.

Dr. Potenza also noted that several organizations, including the International Society of Addiction Medicine and Children and Screens, have been hosting webinars related to COVID-19 coping and/or addiction that clinicians and patients might find helpful.
 

Identification of problematic behaviors

One challenge in watching for problematic gambling behaviors during the pandemic is the set of unusual living circumstances for most people right now. At almost no other time in history have people been primarily confined to their homes, many unable to go to work or working from home, with extra leisure time and nowhere to go.

“With the COVID-19 pandemic, a lot of daily life has changed,” Dr. Potenza said. “It’s unclear whether certain behaviors that have become habitual during the pandemic, such as gaming or online gambling, will then interfere with daily life when the pandemic subsides.”

“The problem is, a small proportion of people who are very vulnerable will develop a disorder and might maintain it,” Dr. Kraus said. Those who already struggle with mental health and may be out of work have greater potential for problematic behaviors.

Dr. Potenza collaborated with other psychiatrists in drafting consensus guidelines on maintaining healthy use of the Internet specifically during the pandemic (Compr Psychiatry. 2020 Jul. doi: 10.10161/comppsych.2020.152180).

“It’s important to think about where one draws the line between normative everyday behaviors – behaviors that are not interfering with life functioning – and those that do interfere with life functioning,” Dr. Potenza said. “If someone is having difficulty making work or family or school obligations, these are important signs that the behavior may be problematic.”

He offered suggestions for things people can do to promote their health during the pandemic, such as having regular routines that include getting physical exercise and social interaction, dining with family if isolating together, and making time for self-care. He also recommended setting limits on the use of digital devices and aiming for a healthy balance in keeping up with the news. The idea is to stay aware of what’s happening without getting burned out or traumatized by news coverage.

Guidance for clinicians

An urgent need for research and guidelines related to gambling and the pandemic exists, the authors argued.

In the meantime, aside from various validated screeners available, Dr. Kraus offered some practical advice for clinicians checking in with their patients: “Ask your patients what they have been doing to cope with this difficult time.”

Some might mention their faith, family, or friends, and others might not have an answer or mention drinking, gaming, or engaging in other activities. “We all do things to cope. Sometimes you use healthy coping and sometimes you use unhealthy coping,” Dr. Kraus said. “I would have a dialogue with my patients around, ‘How are you getting through? What’s helping you? What are some things you’ve tried that are tripping you up?’ ”

If gambling in particular is a possible concern, he encouraged clinicians to ask their patients whether they have tried to quit or what would happen if they stopped gambling.

“What we’d expect is the problem gamblers will have more irritability, crankiness, difficulty with quitting,” he said.

Dr. Hodgins agreed that checking in on how patients’ lives and activities have changed, and their emotion reactions to those changes, is prudent.

“The change in activities might be healthy or might include increased addictive behaviors, including increased use of substances, gaming, pornography, food, and gambling,” he said.

In addition, the paper authors list several examples of guidelines that might be considered in drafting guidance for clinicians, including the following:

• Limiting the extent of gambling
• Not gambling to regulate negative emotions
• Not gambling in order to try to solve financial problems or financial concerns
• Not gambling under the influence of alcohol or drugs
• Carefully monitoring gambling-related time and financial expenditures
• Maintaining and establishing daily routines involving activities other than gambling
• Minding gambling-related attitudes and behaviors in the presence of minors
• Not starting to gamble because of stressors

The research did not receive external funding. Dr. Håkansson has received research funding from the Swedish Sport Foundation, the Swedish alcohol monopoly Systembolaget, and the Swedish state-owned gambling operator AB Svenska Spel. He is working with the company Kontigo Care on devices for gambling addiction follow-up care. Dr. Potenza has received consulting or advisory compensation from several entities, including the Addiction Policy Forum, AXA Gaming, Idorsia, Opiant, and RiverMend Health. Dr. Potenza has received research funding from Mohegan Sun casino and the National Center for Responsible Gaming. No other authors or outside sources had industry-related disclosures.

SOURCE: Håkansson A et al. J Addict Med. 2020 May 18. doi: 10.1097/ADM.0000000000000690.

The confluence of isolation, excess available time, and anxiety about illness or finances as a result of the COVID-19 pandemic have the potential to increase problem gambling behaviors during this public health emergency, so it’s essential to gather data and supply guidance on this issue, according to a call to action published May 18 in the Journal of Addiction Medicine.

humonia/iStock/Getty Images Plus

“When facing an unforeseen situation with confinement, fear of disease, and financial uncertainty for the future, problem gambling may be an important health hazard to monitor and prevent during and following the COVID-19 crisis, especially given current online gambling availability,” wrote Anders Håkansson, PhD, of Lund University in Sweden and coauthors.

Both stress and trauma have been linked to gambling problems, and both are occurring during the pandemic, said coauthor Marc N. Potenza, MD, PhD, of Yale University, New Haven, Conn., in an interview.

“People are likely to be experiencing stress at levels they haven’t experienced previously,” Dr. Potenza said. While multiple factors can contribute to addictive behaviors, “with respect to the pandemic, one concern is that so-called negative reinforcement motivations – engaging in an addictive behavior to escape from depressed or negative mood states – may be a driving motivation for a significant number of people during this time,” he said.

David Hodgins, PhD, CPsych, a professor of psychology at the University of Calgary in Alberta, who was not involved with the commentary, noted that gambling relapse is triggered by “negative emotional states, interpersonal stress, and financial stress” – all three of which the pandemic contributes to.

Financial stress can especially “inflame erroneous gambling-related cognitions,” he said in an interview, including “beliefs such as the idea that gambling can solve financial problems, even when this is statistically almost impossible as debt increases, and that debt has been caused by gambling.”

Increased social isolation also is particularly problematic, pointed out Shane W. Kraus, PhD, from the University of Nevada, Las Vegas. Dr. Kraus also was not involved with the paper.

“If someone is already struggling with already negative emotions, negative feelings, thoughts, and depression, and you’re now isolating them quite a bit, that’s not going to be a recipe for success,” Dr. Kraus said in an interview.

The mental health effects of the pandemic could be extensive and long-lasting, and such effects often co-occur with addictive behaviors, Dr. Potenza said.

“We should be mindful of ways in which people develop addictions in these settings,” he said. “One of the aspects of the pandemic is that many people are at home for longer periods of time, and they use digital technologies more frequently.”

The use of digital technologies can include interaction on social media platforms and on meeting applications such as Zoom, but such use also offers opportunities for problematic gambling, gaming, and pornography use. The World Health Organization recognizes addiction disorders for gambling and for gaming, and online gaming platforms and pornography sites have reported substantial increases in their traffic during the pandemic, Dr. Potenza said.

The increase in frequency is unsurprising and not necessarily a concern by itself, Dr. Kraus said.

“It’s all about loss of control or difficulty engaging or disengaging,” Dr. Kraus said. “When you can’t stop doing something even if you like it or love it, when it interferes with your day-to-day activities and relationships, that’s when it’s a problem.”
 

Gambling online: Easy, available

The authors note that past research has identified increased gambling problems during economic crises in other countries.

“While currently speculative, financial hardships may promote gambling as individuals may be motivated to gamble to try to win money,” the authors suggested. “Although presently limited, existing data suggest that COVID-19–related financial concerns may increase gambling-related harms, and this possibility merits systematic research.”

But trends and characteristics of the gambling market, including direct effects from the pandemic, can potentially influence behaviors, too. Most casinos have closed during the pandemic, and most of the sports that people bet on have been canceled or postponed.

“Fewer people are gambling on sports, but they turn then to other areas,” Dr. Potenza said. “If they can’t bet on major league type sports, they might gamble on more local sporting events, or they may bet on other activities going on in society during the pandemic.”

But online gambling poses greater risk.

“Properties of online gambling may constitute a particular health hazard when many people are confined to their homes and have had rapid changes in working conditions, psychosocial stress, anxiety, and depression, as has been described in China,” the paper’s authors wrote. “Online gambling may be particularly concerning due to its availability and velocity” and association with higher debt levels.

In addition to online gaming’s ease and availability, past research has found patients report boredom and escapism as reasons they turned to it.

Again, boredom on its own is not necessarily a problem, but for those who already struggle with addictive behaviors, it can be a trigger, Dr. Kraus said.

“Boredom is very tough for them because it’s often associated with negative emotions,” such as dwelling on things not going well in their lives, he said. “In a pandemic, people are by themselves quite a bit, socially isolated, so for those who are struggling already with some depression or anxiety, it’s only going to be increased.”

Online gaming trends may vary with demographics, however. Dr. Kraus noted that his former clinic at the Veterans Administration has been seeing lower gambling in patients with addictive disorders, but those patients are also older and primarily frequented casinos.

“It’s going to depend on age and familiarity with technology,” he said, but even if older problem gamblers are not going to the Internet now, “let’s wait and see what happens in the next 2 or 3 months.”

The authors noted results from a small survey of patients in treatment for gambling addiction at the Bellvitge University Hospital in Barcelona, Spain, where two of the coauthors work. They conducted telephone surveys with 26 patients about the first 4 weeks of sheltering in place because of the coronavirus. All but four of the patients were male, and their average age was 45 years.

“Most presented worries about increased uncertainties, such as the negative impact on their work, risk of COVID-19 infection of themselves or their loved ones and their treatment,” the authors reported.

Although 19% were completely abstinent, an additional 12% (n = 3) reported worsened gambling. In addition, almost half (46%) reported anxiety symptoms and more than a quarter (27%) had depressive symptoms.
 

Appropriate care

A particularly complicating factor of the pandemic is how it has disrupted traditional ways of seeking health care, particularly with how much mental health and other medical care has shifted to telehealth and online delivery, Dr. Potenza pointed out.

“This is a change for many people, and it’s important for both caretakers and people in treatment to be mindful of this and to try to ensure that appropriate services are maintained for people during this time,” he said.

For example, 12-step programs traditionally meet in person, which is largely impossible during the pandemic. Some have moved meetings online, and other programs have turned to apps, such as the Addiction Policy Forum’s app Connections, an empirically validated digital therapy platform that lets patients and clinicians remain connected with remote check-ins.

The move to more telehealth may actually increase access, suggested Dr. Hodgins.

“There is no evidence that this is less effective, and in fact, its convenience might be an advantage in reaching more people,” he said. “More challenging is offering group therapies remotely, but this is also feasible.”

The treatment with the strongest evidence remains cognitive-behavioral therapy (CBT), Dr. Hodgins said.

“This therapy, in part, helps people become aware of their erroneous cognitions and to challenge them, but also helps people restructure their activities to change their habits,” he said. He also noted the rise of online therapy, whether supported by a therapist or entirely self-directed, such as Gambling Self-help.

“These programs typically provide cognitive behavior content but also content that comes from studying how people recover from gambling problems,” he said. “The challenge of completely self-directed approaches is follow-through. Like most online content, people tend to flit around more than they might in therapy.” Still, he added, research has shown good outcomes from these programs.

Dr. Potenza also noted that several organizations, including the International Society of Addiction Medicine and Children and Screens, have been hosting webinars related to COVID-19 coping and/or addiction that clinicians and patients might find helpful.
 

Identification of problematic behaviors

One challenge in watching for problematic gambling behaviors during the pandemic is the set of unusual living circumstances for most people right now. At almost no other time in history have people been primarily confined to their homes, many unable to go to work or working from home, with extra leisure time and nowhere to go.

“With the COVID-19 pandemic, a lot of daily life has changed,” Dr. Potenza said. “It’s unclear whether certain behaviors that have become habitual during the pandemic, such as gaming or online gambling, will then interfere with daily life when the pandemic subsides.”

“The problem is, a small proportion of people who are very vulnerable will develop a disorder and might maintain it,” Dr. Kraus said. Those who already struggle with mental health and may be out of work have greater potential for problematic behaviors.

Dr. Potenza collaborated with other psychiatrists in drafting consensus guidelines on maintaining healthy use of the Internet specifically during the pandemic (Compr Psychiatry. 2020 Jul. doi: 10.10161/comppsych.2020.152180).

“It’s important to think about where one draws the line between normative everyday behaviors – behaviors that are not interfering with life functioning – and those that do interfere with life functioning,” Dr. Potenza said. “If someone is having difficulty making work or family or school obligations, these are important signs that the behavior may be problematic.”

He offered suggestions for things people can do to promote their health during the pandemic, such as having regular routines that include getting physical exercise and social interaction, dining with family if isolating together, and making time for self-care. He also recommended setting limits on the use of digital devices and aiming for a healthy balance in keeping up with the news. The idea is to stay aware of what’s happening without getting burned out or traumatized by news coverage.

Guidance for clinicians

An urgent need for research and guidelines related to gambling and the pandemic exists, the authors argued.

In the meantime, aside from various validated screeners available, Dr. Kraus offered some practical advice for clinicians checking in with their patients: “Ask your patients what they have been doing to cope with this difficult time.”

Some might mention their faith, family, or friends, and others might not have an answer or mention drinking, gaming, or engaging in other activities. “We all do things to cope. Sometimes you use healthy coping and sometimes you use unhealthy coping,” Dr. Kraus said. “I would have a dialogue with my patients around, ‘How are you getting through? What’s helping you? What are some things you’ve tried that are tripping you up?’ ”

If gambling in particular is a possible concern, he encouraged clinicians to ask their patients whether they have tried to quit or what would happen if they stopped gambling.

“What we’d expect is the problem gamblers will have more irritability, crankiness, difficulty with quitting,” he said.

Dr. Hodgins agreed that checking in on how patients’ lives and activities have changed, and their emotion reactions to those changes, is prudent.

“The change in activities might be healthy or might include increased addictive behaviors, including increased use of substances, gaming, pornography, food, and gambling,” he said.

In addition, the paper authors list several examples of guidelines that might be considered in drafting guidance for clinicians, including the following:

• Limiting the extent of gambling
• Not gambling to regulate negative emotions
• Not gambling in order to try to solve financial problems or financial concerns
• Not gambling under the influence of alcohol or drugs
• Carefully monitoring gambling-related time and financial expenditures
• Maintaining and establishing daily routines involving activities other than gambling
• Minding gambling-related attitudes and behaviors in the presence of minors
• Not starting to gamble because of stressors

The research did not receive external funding. Dr. Håkansson has received research funding from the Swedish Sport Foundation, the Swedish alcohol monopoly Systembolaget, and the Swedish state-owned gambling operator AB Svenska Spel. He is working with the company Kontigo Care on devices for gambling addiction follow-up care. Dr. Potenza has received consulting or advisory compensation from several entities, including the Addiction Policy Forum, AXA Gaming, Idorsia, Opiant, and RiverMend Health. Dr. Potenza has received research funding from Mohegan Sun casino and the National Center for Responsible Gaming. No other authors or outside sources had industry-related disclosures.

SOURCE: Håkansson A et al. J Addict Med. 2020 May 18. doi: 10.1097/ADM.0000000000000690.

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

Among patients with COPD, the presence of hypogammaglobulinemia confers a nearly 30% increased risk of hospitalization, results from a pooled analysis of four studies showed.

“Mechanistic studies are still warranted to better elucidate how IgG and other immunoglobulins, in particular IgA, may contribute to the local airway host defense,” researchers led by Fernando Sergio Leitao Filho, MD, PhD, wrote in a study published in Chest (2020 May 18. doi: 10.1016/j.chest.2020.04.058). “Nevertheless, our results raise the possibility that, in select COPD patients, IgG replacement therapy may be effective in reducing the risk of COPD hospitalizations. Given the growing rate of COPD hospitalization in the U.S. and elsewhere, there is a pressing need for a large well-designed trial to test this hypothesis.”

In an effort to evaluate the effect of IgG levels on the cumulative incidence of COPD hospitalizations, Dr. Leitao Filho, of the University of British Columbia, Vancouver, and colleagues drew from 2,259 patients who participated in four different trials: Azithromycin for Prevention of Exacerbations of COPD (MACRO), Simvastatin for the Prevention of Exacerbations in Moderate and Severe COPD (STATCOPE), the Long-Term Oxygen Treatment Trial (LOTT), and COPD Activity: Serotonin Transporter, Cytokines and Depression (CASCADE). The mean baseline age of study participants was 66 years, and 641 (28.4%) had hypogammaglobulinemia, which was defined as having a serum IgG levels of less than 7.0 g/L, while the remainder had normal IgG levels.

The pooled meta-analysis, which is believed to be the largest of its kind, revealed that the presence of hypogammaglobulinemia was associated with an incidence of COPD hospitalizations that was 1.29-fold higher than that observed among participants who had normal IgG levels (P = .01). The incidence was even higher among patients with prior COPD admissions (pooled subdistribution hazard ratio, 1.58; P < .01), yet the risk of COPD admissions was similar between IgG groups in patients with no prior hospitalizations (pooled SHR, 1.15; P = .34). Patients with hypogammaglobulinemia also showed significantly higher rates of COPD hospitalizations per person-year, compared with their counterparts who had normal IgG levels (0.48 vs. 0.29, respectively; P < .001.)

The authors acknowledged certain limitations of the study, including the fact that they measured serum IgG levels only at baseline “when participants were clinically stable; thus, the variability of IgG levels in a given individual over time and during the course of an AECOPD [severe acute exacerbation of COPD] is uncertain. Secondly, clinical data on corticosteroid use (formulations, dose, and length of use) were not readily available. However, systemic steroid use (one or more courses due to AECOPD prior to study entry) was accounted for in our analyses.”

The MACRO, STATCOPE, LOTT trials, and the CASCADE cohort were supported by the National Heart, Lung, and Blood Institute; National Institutes of Health; and Department of Health & Human Services. The current study was funded by the Canadian Institutes of Health Research and BC Lung Association. The authors reported having no relevant disclosures.

SOURCE: Leitao Filho SF et al. Chest. 2020 May 18. doi: 10.1016/j.chest.2020.04.058.

The Food and Drug Administration has approved ticagrelor (Brilinta/Brilique, AstraZeneca) for use with aspirin to cut the risk for a first myocardial infarction or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke, AstraZeneca announced today. 

Patients falling under the new indication do not need to have diabetes, although THEMIS had entered patients with diabetes and CAD, the latter defined as a 50% or greater narrowing of a coronary artery or a history of coronary revascularization but without a history of MI or stroke. 

The trial showed a significant reduction in the rate of the primary efficacy end point (P = .04), a composite of cardiovascular death, MI, and stroke. But the risk of TIMI (Thrombolysis in Myocardial Infarction) bleeding classification major bleeding was more than doubled in the ticagrelor group (P < .001) and the risk for intracranial hemorrhage went up 71% (P = .005). Net clinical benefit didn't differ significantly between the groups in an exploratory analysis. 

The benefit of dual-antiplatelet therapy with ticagrelor for the primary efficacy end point was even more pronounced in a prespecified THEMIS subanalysis of more than 11,000 patients with a history of percutaneous coronary intervention. In this group, the risk for  intracerebral hemorrhage didn't differ significantly between the groups, and the net clinical benefit favored ticagrelor by a significant 15%. 

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

The Food and Drug Administration has approved ticagrelor (Brilinta/Brilique, AstraZeneca) for use with aspirin to cut the risk for a first myocardial infarction or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke, AstraZeneca announced today. 

Patients falling under the new indication do not need to have diabetes, although THEMIS had entered patients with diabetes and CAD, the latter defined as a 50% or greater narrowing of a coronary artery or a history of coronary revascularization but without a history of MI or stroke. 

The trial showed a significant reduction in the rate of the primary efficacy end point (P = .04), a composite of cardiovascular death, MI, and stroke. But the risk of TIMI (Thrombolysis in Myocardial Infarction) bleeding classification major bleeding was more than doubled in the ticagrelor group (P < .001) and the risk for intracranial hemorrhage went up 71% (P = .005). Net clinical benefit didn't differ significantly between the groups in an exploratory analysis. 

The benefit of dual-antiplatelet therapy with ticagrelor for the primary efficacy end point was even more pronounced in a prespecified THEMIS subanalysis of more than 11,000 patients with a history of percutaneous coronary intervention. In this group, the risk for  intracerebral hemorrhage didn't differ significantly between the groups, and the net clinical benefit favored ticagrelor by a significant 15%. 

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

The Food and Drug Administration has approved ticagrelor (Brilinta/Brilique, AstraZeneca) for use with aspirin to cut the risk for a first myocardial infarction or stroke in high-risk patients with coronary artery disease (CAD) but no history of MI or stroke, AstraZeneca announced today. 

Patients falling under the new indication do not need to have diabetes, although THEMIS had entered patients with diabetes and CAD, the latter defined as a 50% or greater narrowing of a coronary artery or a history of coronary revascularization but without a history of MI or stroke. 

The trial showed a significant reduction in the rate of the primary efficacy end point (P = .04), a composite of cardiovascular death, MI, and stroke. But the risk of TIMI (Thrombolysis in Myocardial Infarction) bleeding classification major bleeding was more than doubled in the ticagrelor group (P < .001) and the risk for intracranial hemorrhage went up 71% (P = .005). Net clinical benefit didn't differ significantly between the groups in an exploratory analysis. 

The benefit of dual-antiplatelet therapy with ticagrelor for the primary efficacy end point was even more pronounced in a prespecified THEMIS subanalysis of more than 11,000 patients with a history of percutaneous coronary intervention. In this group, the risk for  intracerebral hemorrhage didn't differ significantly between the groups, and the net clinical benefit favored ticagrelor by a significant 15%. 

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.

The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.

“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.

The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.

The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.

A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).

The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).

Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.

The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.

Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”

The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.

Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.

“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”

Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”

While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”

Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.

SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .

A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.

The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.

“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.

The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.

The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.

A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).

The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).

Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.

The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.

Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”

The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.

Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.

“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”

Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”

While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”

Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.

SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .

A study that claims to be the first review of all the available evidence of the effectiveness of physical distancing, face masks, and eye protection to prevent spread of COVID-19 and other respiratory diseases has quantified the effectiveness of these protective measures. The study found that greater physical distancing from an exposed person significantly reduces risk of transmission and that N95 masks, particularly for health care workers, are more effective than other face coverings.

The meta-analysis, published online in The Lancet (2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9) also marks the first evaluation of these protective measures in both community and health care settings for COVID-19, the study authors stated.

“The risk for infection is highly dependent on distance to the individual infected and the type of face mask and eye protection worn,” wrote Derek K. Chu, MD, PhD, of McMaster University in Hamilton, Ont., and colleagues, reporting on behalf of the COVID-19 Systematic Urgent Review Group Effort, or SURGE.

The study reported that physical distancing of at least 1 meter, or about a yard, “seems to be strongly associated with a large protective effect,” but that distancing of 2 meters or about 6 feet could be more effective.

The study involved a systematic review of 172 observational studies across six continents that evaluated distance measures, face masks, and eye protection to prevent transmission between patients with confirmed or probable COVID-19, other severe acute respiratory syndrome (SARS) disease, and Middle East respiratory syndrome (MERS), and their family members, caregivers and health care workers up to May 3, 2020. The meta-analysis involved pooled estimates from 44 comparative studies with 25,697 participants, including seven studies of COVID-19 with 6,674 participants. None of the studies included in the meta-analysis were randomized clinical trials.

A subanalysis of 29 unadjusted and 9 adjusted studies found that the absolute risk of infection in proximity to an exposed individual was 12.8% at 1 m and 2.6% at 2 m. The risk remained constant even when the six COVID-19 studies in this subanalysis were isolated and regardless of being in a health care or non–health-care setting. Each meter of increased distance resulted in a doubling in the change in relative risk (P = .041).

The study also identified what Dr. Chu and colleagues characterized as a “large reduction” in infection risk with the use of both N95 or similar respirators or face masks, with an adjusted risk of infection of 3.1% with a face covering vs. a 17.4% without. The researchers also found a stronger association in health care settings vs. non–health care settings, with a relative risk of 0.3 vs. 0.56, respectively (P = .049). The protective effect of N95 or similar respirators was greater than other masks, with adjusted odds ratios of 0.04 vs. 0.33 (P = .09).

Eye protection was found to reduce the risk of infection to 5.5% vs. 16% without eye protection.

The study also identified potential barriers to social distancing and use of masks and eye protection: discomfort, resource use “linked with potentially decreased equity,” less clear communication, and a perceived lack of empathy on the part of providers toward patients.

Dr. Chu and colleagues wrote that more “high-quality” research, including randomized trials of the optimal physical distance and evaluation of different mask types in non–health care settings “is urgently needed.” They added, “Policymakers at all levels should, therefore, strive to address equity implications for groups with currently limited access to face masks and eye protection.”

The goal of this study was to “inform WHO guidance documents,” the study noted. “Governments and the public health community can use our results to give clear advice for community settings and healthcare workers on these protective measures to reduce infection risk,” said study co-leader Holger Schünemann, MD, MSc, PhD, of McMaster University.

Prof. Raina MacIntyre, MBBS, PhD, head of the biosecurity research program at the Kirby Institute at the University of New South Wales in Sydney, who authored the comment that accompanied the article, said that this study provides evidence for stronger PPE guidelines.

“The Centers for Disease Control and Prevention initially recommended N95s for health workers treating COVID-19 patients, but later downgraded this to surgical masks and even cloth masks and bandannas when there was a supply shortage,” she said. “This study shows that N95s are superior masks and should prompt a review of guidelines that recommend anything less for health workers.”

Recommending anything less than N95 masks for health workers is like sending troops into battle “unarmed or with bows and arrows against a fully armed enemy,” she said. “We are not talking about a device that costs hundreds or thousands of dollars; a N95 costs less than a dollar to produce. All that is needed to address the supply shortage is political will.”

While the study has some shortcomings – namely that it didn’t provide a breakdown of positive tests among COVID-19 participants – it does provide important insight for physicians, Sachin Gupta, MD, a pulmonary and critical care specialist in San Francisco, said in an interview. “The strength of a meta-analysis is that you’re able to get a composite idea; that’s one up side to this,” he said. “They’re confirming what we knew: that distance matters; that more protective masks reduce risk of infection; and that eye protection has an important role.”

Dr. Chu and colleagues have no relevant financial relationships to disclose. One member of SURGE is participating in a clinical trial comparing medical masks and N95 respirators. The World Health Organization provided partial funding for the study.

SOURCE: Chu DK et al. Lancet. 2020 Jun 2; doi.org/10.1016/ S0140-6736(20)31142-9 .

More than 1 in 10 people with diabetes hospitalized with COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
 

First study to examine specific characteristics at time of admission

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.

“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.

Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”

But he urged caution regarding the A_1c finding. “A_1c might be associated with admission to hospital but other factors far beyond A_1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”

And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.

“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
 

_{Yet again, high BMI emerges as a major risk factor}

The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.

Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.

The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).

Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.

On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.

In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m²; P = .0009),

Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.

Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.

Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.

Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.

When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
 

Analysis ongoing, ‘some new messages might pop up’

After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A_1c wasn’t associated with either outcome.

In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.

And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).

In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.

Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”

“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.

But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.

The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.

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

More than 1 in 10 people with diabetes hospitalized with COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
 

First study to examine specific characteristics at time of admission

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.

“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.

Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”

But he urged caution regarding the A_1c finding. “A_1c might be associated with admission to hospital but other factors far beyond A_1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”

And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.

“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
 

_{Yet again, high BMI emerges as a major risk factor}

The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.

Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.

The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).

Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.

On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.

In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m²; P = .0009),

Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.

Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.

Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.

Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.

When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
 

Analysis ongoing, ‘some new messages might pop up’

After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A_1c wasn’t associated with either outcome.

In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.

And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).

In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.

Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”

“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.

But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.

The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.

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

More than 1 in 10 people with diabetes hospitalized with COVID-19 die within a week, while nearly a third require mechanical ventilation, new research shows.

Data from the CORONADO (French Coronavirus SARS-CoV-2 and Diabetes Outcomes) study also revealed that body mass index (BMI) was independently associated with death or intubation at 7 days, while A_1c and use of renin-angiotensin-aldosterone system (RAAS) blockers and dipeptidyl peptidase–4 inhibitors were not.

The presence of diabetes-related complications and older age also increased the risk of death.

The findings were published online Diabetologia by Bertrand Cariou, MD, PhD, of the department of endocrinology at the Hôpital Guillaume et René Laennec in Nantes, France, and colleagues.
 

First study to examine specific characteristics at time of admission

Previous studies have linked diabetes to worse outcomes in COVID-19, but this is the first to examine specific characteristics before and at the time of hospital admission that predict worse outcomes among people with diabetes, study coauthor Samy Hadjadj, MD, PhD, said in an interview.

“Before the CORONADO study it was ‘all diabetes [patients] are the same.’ Now we can surely consider more precisely the risk, taking age, sex, BMI, complications, and [obstructive sleep apnea] as clear ‘very high-risk situations,’” said Dr. Hadjadj, of the same institution as Dr. Cariou.

Another clinical message, Dr. Hadjadj said, is that, “even in diabetes, each increase in BMI is associated with an increase in the risk of intubation and/or death in the 7 days following admission for COVID-19. So let’s target this population as a really important population to keep social distancing and stay alert on avoiding the virus.”

But he urged caution regarding the A_1c finding. “A_1c might be associated with admission to hospital but other factors far beyond A_1c drive the prognosis as soon as a patient is admitted. It’s surprising but reasonable speculation can explain this.”

And Dr. Hadjadj said that no obvious signals were identified with regard to medication use.

“Insulin is not suspected of having adverse effects closely related to COVID-19. RAAS blockers are not deleterious but indicative of hypertension, which is a comorbidity even in diabetes patients,” he said. (None of the patients studied were taking sodium-glucose cotransporter 2 inhibitors or glucagonlike peptide receptor agonists.)
 

_{Yet again, high BMI emerges as a major risk factor}

The study included 1,317 patients with diabetes and confirmed COVID-19 admitted to 53 French hospitals during March 10-31, 2020. Participants included 88.5% with type 2 diabetes, 3% with type 1 diabetes, and 3.1% newly diagnosed on admission. Mean age was 69.8 years.

Diabetes-related disorders on admission were reported in 11.1% of participants overall. These included 132 episodes of severe hyperglycemia, including 40 of ketosis, of which 19 were ketoacidosis, and 14 hypoglycemic events. Severe anorexia was reported in 6.3%.

The composite primary endpoint, tracheal intubation for mechanical ventilation and/or death within 7 days of admission, occurred in 29% of patients (n = 382).

Of the secondary outcomes, 31.1% (n = 410) were admitted to ICUs within 7 days of hospital admission, including 20.3% (n = 267) who required tracheal intubation for mechanical ventilation.

On day 7, 10.6% (n = 140) had died and 18.0% (n = 237) were discharged.

In the univariate analysis, the primary outcome was more frequent in men (69.1% vs. 63.2%; P = .0420) and those taking RAAS blockers (61.5% vs. 55.3%; P = .0386). Median BMI was significantly higher in those in whom the primary outcome occurred (29.1 vs 28.1 kg/m²; P = .0009),

Other characteristics prior to admission associated with risk of death on day 7 included age, hypertension, micro- and macrovascular diabetes-related complications, and comorbidities such as heart failure and treated obstructive sleep apnea.

Over 40% of those admitted had such complications. Of the patients analyzed, microvascular complications (eye, kidney, and neuropathy) were present in 47% and macrovascular complications (arteries of the heart, brain, and legs) were present in 41%.

Encouragingly, there were no deaths in patients aged under 65 years with type 1 diabetes, but only 39 participants had type 1 diabetes. Other work is ongoing to establish the effect of COVID-19 in this specific population, the researchers wrote.

Among prior medications, metformin use was lower in people who died, while insulin use, RAAS blockers, beta-blockers, loop diuretics, and mineralocorticoid-receptor antagonists were associated with death on day 7. The medication findings didn’t reach statistical significance, however.

When asked about the hint of a protective effect of metformin (odds ratio, 0.80; P = .4532), given that some experts have advised stopping it in the setting of COVID-19 because of the risk of lactic acidosis, Dr. Hadjadj said he wouldn’t necessarily stop it in all patients with COVID-19, but said, “let’s stop it in cases of severe condition.”
 

Analysis ongoing, ‘some new messages might pop up’

After adjustment for age and sex, BMI was significantly and positively associated with the primary outcome (P = .0001) but not with death on day 7 (P = .1488), and A_1c wasn’t associated with either outcome.

In a multivariable analysis that included characteristics prior to admission, BMI remained the only independent preadmission predictor associated with the primary outcome (adjusted odds ratio, 1.28), while factors independently associated with risk of death on day 7 included age, diabetes complication history, and treated obstructive sleep apnea.

And after adjustment for age and sex, admission plasma glucose level was significantly and positively associated with both the primary outcome (P = .0001) and death on day 7 (P = .0059).

In the multivariate analysis, admission characteristics that predicted the primary outcome were dyspnea, lymphopenia, increased AST, and increased C-reactive protein.

Dr. Hadjadj said his team is now “focusing on specific risk factors such as obesity, age, vascular complications, medications ... to perform some deeper analyses.”

“We look forward to analyzing the data on in-hospital stay up to day 28 after admission. Some new messages might well pop up,” he added.

But in the meantime, “Elderly populations with long-term diabetes with advanced diabetes-related complications and/or treated obstructive sleep apnea were particularly at risk of early death and might require specific management to avoid infection with the novel coronavirus,” the researchers stressed.

The study received funding from the Fondation Francophone de Recherche sur le Diabète and was supported by Novo Nordisk, MSD, Abbott, AstraZeneca, Lilly, and the Fédération Française des Diabétiques; Société Francophone du Diabète; and Air Liquide Healthcare International. Dr. Hadjadj reported receiving grants, personal fees, and/or nonfinancial support from AstraZeneca, Bayer, Boehringer Ingelheim, Dinno Santé, Eli Lilly, LVL, MSD, Novartis, Pierre Fabre Santé, Sanofi, Servier, and Valbiotis.

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

As mass protests continued in large and small cities across the country, officials expressed concerns on Sunday news shows about a potential spike in coronavirus cases in coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” said Scott Gottlieb, former FDA commissioner, on the CBS News show “Face the Nation.”

In Minnesota, he noted, COVID-19 cases and hospitalizations increased in recent days – even before the protests started.

“We still have pockets of spread in communities that aren’t under good control,” he said.

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing 6 feet apart is impossible.

Chanting, singing, and shouting may spread the virus through respiratory droplets. In addition, people who have the virus but don’t show symptoms may infect others without knowing it.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to the Associated Press.

Gottlieb and Bottoms also spoke Sunday about the disproportionate effect of the coronavirus on black and Hispanic people, who are contracting and dying from the virus at higher rates. Socioeconomic factors such as low incomes, limited health care access, underlying conditions and overcrowded housing play a role in the greater risk, Gottlieb said.

“It’s a symptom of broader racial inequities in our country that we need to work to resolve,” he said.

Protests against racial injustice, sparked by the death of George Floyd in Minneapolis last week, could harm those communities experiencing the most severe outcomes of the coronavirus, Bottoms added.

“We know what’s already happening in our community with this virus. We’re going to see the other side of this in a couple of weeks,” Bottoms said on CNN’s “State of the Union.”

The protests may affect the pandemic in other ways. Los Angeles Mayor Eric Garcetti said the city’s coronavirus testing centers were closed on Saturday because of “safety worries across the city,” according to KTLA.

“We need to make sure, especially in communities that have less power, that we are able to make sure people don’t disproportionately die because of the color of their skin,” he said. “We can’t do that when the city breaks down.”

This article first appeared on WebMD.com.

As mass protests continued in large and small cities across the country, officials expressed concerns on Sunday news shows about a potential spike in coronavirus cases in coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” said Scott Gottlieb, former FDA commissioner, on the CBS News show “Face the Nation.”

In Minnesota, he noted, COVID-19 cases and hospitalizations increased in recent days – even before the protests started.

“We still have pockets of spread in communities that aren’t under good control,” he said.

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing 6 feet apart is impossible.

Chanting, singing, and shouting may spread the virus through respiratory droplets. In addition, people who have the virus but don’t show symptoms may infect others without knowing it.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to the Associated Press.

Gottlieb and Bottoms also spoke Sunday about the disproportionate effect of the coronavirus on black and Hispanic people, who are contracting and dying from the virus at higher rates. Socioeconomic factors such as low incomes, limited health care access, underlying conditions and overcrowded housing play a role in the greater risk, Gottlieb said.

“It’s a symptom of broader racial inequities in our country that we need to work to resolve,” he said.

Protests against racial injustice, sparked by the death of George Floyd in Minneapolis last week, could harm those communities experiencing the most severe outcomes of the coronavirus, Bottoms added.

“We know what’s already happening in our community with this virus. We’re going to see the other side of this in a couple of weeks,” Bottoms said on CNN’s “State of the Union.”

The protests may affect the pandemic in other ways. Los Angeles Mayor Eric Garcetti said the city’s coronavirus testing centers were closed on Saturday because of “safety worries across the city,” according to KTLA.

“We need to make sure, especially in communities that have less power, that we are able to make sure people don’t disproportionately die because of the color of their skin,” he said. “We can’t do that when the city breaks down.”

This article first appeared on WebMD.com.

As mass protests continued in large and small cities across the country, officials expressed concerns on Sunday news shows about a potential spike in coronavirus cases in coming days.

“There’s going to be a lot of issues coming out of what’s happened in the last week, but one of them is going to be that chains of transmission will have become lit from these gatherings,” said Scott Gottlieb, former FDA commissioner, on the CBS News show “Face the Nation.”

In Minnesota, he noted, COVID-19 cases and hospitalizations increased in recent days – even before the protests started.

“We still have pockets of spread in communities that aren’t under good control,” he said.

The protests generally have started peacefully with some demonstrators following physical distancing rules. But they have evolved into sometimes violent gatherings of hundreds or thousands of people where standing 6 feet apart is impossible.

Chanting, singing, and shouting may spread the virus through respiratory droplets. In addition, people who have the virus but don’t show symptoms may infect others without knowing it.

“If you were out protesting last night, you probably need to go get a COVID test this week,” Atlanta Mayor Keisha Lance Bottoms said Saturday, according to the Associated Press.

Gottlieb and Bottoms also spoke Sunday about the disproportionate effect of the coronavirus on black and Hispanic people, who are contracting and dying from the virus at higher rates. Socioeconomic factors such as low incomes, limited health care access, underlying conditions and overcrowded housing play a role in the greater risk, Gottlieb said.

“It’s a symptom of broader racial inequities in our country that we need to work to resolve,” he said.

Protests against racial injustice, sparked by the death of George Floyd in Minneapolis last week, could harm those communities experiencing the most severe outcomes of the coronavirus, Bottoms added.

“We know what’s already happening in our community with this virus. We’re going to see the other side of this in a couple of weeks,” Bottoms said on CNN’s “State of the Union.”

The protests may affect the pandemic in other ways. Los Angeles Mayor Eric Garcetti said the city’s coronavirus testing centers were closed on Saturday because of “safety worries across the city,” according to KTLA.

“We need to make sure, especially in communities that have less power, that we are able to make sure people don’t disproportionately die because of the color of their skin,” he said. “We can’t do that when the city breaks down.”

This article first appeared on WebMD.com.

Background: Multidrug-resistant TB is more difficult to treat than is drug-susceptible TB. The 2011 World Health Organization (WHO) recommendations for the treatment of multidrug-resistant TB, based on very-low-quality and conditional evidence, consists of an intensive treatment phase of 8 months and total treatment duration of 20 months. Although cohort studies have shown promising cure rates among patients with multidrug-resistant TB who received existing drugs in regimens shorter than that recommended by the WHO, data from phase 3 randomized trials were lacking.

Bottom line: Short medication regimen (9-11 months) is noninferior to the traditional WHO-­recommended long regimen (20 months) for treating rifampin-resistant tuberculosis.

Citation: Nunn AJ et al. A trial of a shorter regimen for rifampin-resistant tuberculosis. N Engl J Med. 2019 Mar 28; 380:1201-13.

Dr. Kamath is an assistant professor of medicine at Duke University.

Background: Multidrug-resistant TB is more difficult to treat than is drug-susceptible TB. The 2011 World Health Organization (WHO) recommendations for the treatment of multidrug-resistant TB, based on very-low-quality and conditional evidence, consists of an intensive treatment phase of 8 months and total treatment duration of 20 months. Although cohort studies have shown promising cure rates among patients with multidrug-resistant TB who received existing drugs in regimens shorter than that recommended by the WHO, data from phase 3 randomized trials were lacking.

Bottom line: Short medication regimen (9-11 months) is noninferior to the traditional WHO-­recommended long regimen (20 months) for treating rifampin-resistant tuberculosis.

Citation: Nunn AJ et al. A trial of a shorter regimen for rifampin-resistant tuberculosis. N Engl J Med. 2019 Mar 28; 380:1201-13.

Dr. Kamath is an assistant professor of medicine at Duke University.

Background: Multidrug-resistant TB is more difficult to treat than is drug-susceptible TB. The 2011 World Health Organization (WHO) recommendations for the treatment of multidrug-resistant TB, based on very-low-quality and conditional evidence, consists of an intensive treatment phase of 8 months and total treatment duration of 20 months. Although cohort studies have shown promising cure rates among patients with multidrug-resistant TB who received existing drugs in regimens shorter than that recommended by the WHO, data from phase 3 randomized trials were lacking.

Bottom line: Short medication regimen (9-11 months) is noninferior to the traditional WHO-­recommended long regimen (20 months) for treating rifampin-resistant tuberculosis.

Citation: Nunn AJ et al. A trial of a shorter regimen for rifampin-resistant tuberculosis. N Engl J Med. 2019 Mar 28; 380:1201-13.

Dr. Kamath is an assistant professor of medicine at Duke University.