Clinical Endocrinology News

In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.

So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.

In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.

APS Physics Meetings

@APSMeetings

Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch

734 9:59 PM - Feb 29, 2020

Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.

Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.

All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.

Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:

• Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
• American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
• American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
• American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
• American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
• Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
• American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
• American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
• American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.

This article originally appeared on Medscape.com.

In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.

So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.

In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.

APS Physics Meetings

@APSMeetings

Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch

734 9:59 PM - Feb 29, 2020

Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.

Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.

All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.

Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:

• Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
• American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
• American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
• American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
• American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
• Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
• American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
• American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
• American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.

This article originally appeared on Medscape.com.

In a typical year, March marks the start of conference season, made all the more attractive by collegial gatherings and travel to warmer climes. But 2020 has already proven anything but typical as the number of novel coronavirus cases continues to increase around the globe. As a potential pandemic looms, these meetings – full of handshakes and crowded lecture halls – are also nirvana for opportunistic viruses. As are the airports, airplanes, and cabs required to get there.

So, as COVID-19 continues to spread, medical and scientific societies must make some difficult decisions. In Europe, at least a few societies have already suspended their upcoming meetings, while France has temporarily banned all gatherings over 5000 people.

In the United States, however, most medical conferences are moving forward as planned – at least for now. But one conference of 10,000 attendees, the American Physical Society annual meeting, which was scheduled for March 2-6 in Denver, was canceled the day before the meeting started. Although it’s not a medical conference, it speaks to the “rapidly escalating health concerns” that all conference organizers must grapple with.

APS Physics Meetings

@APSMeetings

Due to rapidly escalating health concerns relating to the spread of the coronavirus disease (COVID-19), the 2020 APS March Meeting in Denver, CO, has been canceled. Please do not travel to Denver to attend the March Meeting. More information will follow shortly. #apsmarch

734 9:59 PM - Feb 29, 2020

Just one smaller medical meeting, the Ataxia Conference, which was scheduled for March 6-7 in Denver, has been canceled.

Most societies hosting these meetings have put out statements to their attendees saying that they’re monitoring the situation and will adapt as necessary. The United States and Canadian Academy of Pathology, which is holding its annual meeting in Los Angeles this week, sent out an email beforehand asking international travelers to consider staying home. The Healthcare Information and Management Systems Society (HIMSS) Global Health Conference, which is slated to have about 50,000 attendees from around the world, has declared itself a “handshake-free” conference but otherwise intends to move ahead as planned.

All of these conferences will be pushing forward without at least one prominent group of attendees. New York University’s Langone Health has removed its employees from the decision-making process and instead is taking a proactive stance: The health system just declared a 60-day (minimum) ban preventing employees from attending any meetings or conferences and from all domestic and international work-related travel.

Here’s what some of the societies have said to attendees about their intent to proceed or modify their plans:

• Conference on Retroviruses and Opportunistic Infections (CROI), Boston, 3/8/20 - 3/11/20: Monitoring the situation and seeking input from local, state, and federal infectious-disease and public-health experts. Final decision expected by the evening of March 3.
• American Academy of Allergy, Asthma & Immunology (AAAAI), Philadelphia, 3/13/20 - 3/16/20: Monitoring developments but no plans to cancel or postpone at this time.
• American Academy of Orthopedic Surgeons (AAOS), Orlando, 3/24/20 - 3/28/20: Proceeding as planned.
• American Academy of Dermatology (AAD), Denver, 3/20/20 - 3/24/20: The AAD’s 2020 Annual Meeting is scheduled to take place as planned. The organization will increase the number of hand-sanitizing stations throughout the convention center, and it is adding a nursing station specifically designated for anyone with flu-like symptoms.
• American College of Cardiology (ACC), Chicago, 3/28/20 - 3/30/20: The organization is working with attendees, faculty, exhibitors, and other stakeholders in affected countries to ensure access to research and education from the meeting, but is otherwise proceeding as planned.
• Endocrine Society (ENDO), San Francisco, 3/28/20 - 3/31/20: ENDO 2020 will take place as scheduled, but this is an evolving situation worldwide. The society will continue to monitor and provide updates on its FAQ page.
• American College of Physicians Internal Medicine (ACP IM), Los Angeles, 4/23/20 - 4/25/20: ACP leadership is closely monitoring the COVID-19 situation and is actively working with the Centers for Disease Control and Prevention (CDC) to ensure authoritative communication of safety updates and recommendations as the situation evolves.
• American Association for Cancer Research (AACR), San Diego, 4/24/20 - 4/29/20: At this time, there is no plan to cancel or postpone any scheduled AACR meetings. The organization is tracking all travel restrictions as well as information and guidance from the CDC and World Health Organization.
• American Academy of Neurology (AAN), Toronto, 4/25/20 - 5/1/20: The group is continuing to closely monitor the situation in Toronto and will provide updates as the situation warrants.

This article originally appeared on Medscape.com.

Some instances of unprofessional behavior by medical trainees are universally deemed egregious and worthy of discipline — for example, looking up a friend’s medical data after HIPAA training.

Conversely, some professionalism lapses may be widely thought of as a teaching and consoling moment, such as the human error involved in forgetting a scheduled repositioning of a patient.

But between the extremes is a vast gray area. To deal with those cases appropriately, Jason Wasserman, PhD, and colleagues propose a new framework by which to judge each infraction.

The framework draws from “just culture” concepts used to evaluate medical errors, Wasserman, associate professor of biomedical science at Oakland University William Beaumont School of Medicine in Rochester, Michigan, told Medscape Medical News. Such an approach takes into account the environment in which the error was made, the knowledge and intent of the person making the error, and the severity and consequences of the infraction so that trainees and institutions can learn from mistakes.

“Trainees by definition are not going to fully get it,” he explained. “By definition they’re not going to fully achieve professional expectations. So how can we respond to the things we need to respond to, but do it in a way that’s educational?”

Wasserman and coauthors’ framework for remediation, which they published February 20 in The New England Journal of Medicine, takes into account several questions: Was the expectation clear? Were there factors beyond the trainees› control? What were the trainees› intentions and did they understand the consequences? Did the person genuinely believe the action was inconsequential?

An example requiring discipline, the authors say, would be using a crib sheet during an exam. In that case the intent is clear, there is no defensible belief that the action is inconsequential, and there is a clear understanding the action is wrong.

But a response of “affirm, support, and advise” is more appropriate, for example, when a student’s alarm doesn’t go off after a power outage and they miss a mandatory meeting.

Wasserman points out that this framework won’t cover all situations.

“This is not an algorithm for answering your questions about what to do,” he said. “It’s an architecture for clarifying the discussion about that. It can really tease out all the threads that need to be considered to best respond to and correct the professionalism lapse, but do it in a way that is developmentally appropriate.”
 

A Core Competency

For two decades, professionalism has been considered a core competency of medical education. In 1999, the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties formalized it as such. In 2013, the Association of American Medical Colleges formally required related professionalism competencies.

However, identifying lapses has operated largely on an “I-know-it-when-I-see-it” basis, leading to widely varying remediation practices judged by a small number of faculty members or administrators.

The ideas outlined by Wasserman and colleagues are “a terrific application of the ‘just-culture’ framework,” according to Nicole Treadway, MD, a first-year primary care resident at Emory School of Medicine in Atlanta, Georgia.

At Emory, discussions of professionalism start from day 1 of medical school and the subject is revisited throughout training in small groups, Treadway told Medscape Medical News.

But, she said, as the authors point out, definitions of unprofessionalism are not always clear and the examples the authors put forward help put lapses in context.

The framework also allows for looking at mistakes in light of the stress trainees encounter and the greater chance of making a professionalism error in those situations, she noted.

In her own work, she says, because she is juggling both inpatient and outpatient care, she is finding it is easy to get behind on correspondence or communicating lab results or having follow-up conversations.

Those delays could be seen as lapses in professionalism, but under this framework, there may be system solutions or training opportunities to consider.

“We do need this organizational architecture, and I think it could serve us well in really helping us identify and appropriately respond to what we see regarding professionalism,” she said.

Framework Helps Standardize Thinking

She said having a universal framework also helps because while standards of professionalism are easier to monitor in a single medical school, when students scatter to other hospitals for clinical training, those hospitals may have different professionalism standards.

Wasserman agrees, saying, “This could be easily adopted in any environment where people deal with professionalism lapses. I don’t even think it’s necessarily relegated to trainees. It’s a great way to think about any kind of lapses, just as hospitals think about medical errors.”

He said the next step is presenting the framework at various medical schools for feedback and research to see whether the framework improves processes.

Potential criticism, he said, might come from those who say such a construct avoids punishing students who make errors.

“There will always be people who say we’re pandering to medical students whenever we worry about the learning environment,” he said. “There are old-school purists who say when people screw up you should punish them.”

But he adds healthcare broadly has moved past that thinking.

“People recognized 20 years ago or more from the standpoint of improving healthcare systems and safety that is a bad strategy. You’ll never get error-free humans working in your system, and what you have to do is consider how the system is functioning and think about ways to optimize the system so people can be their best within it.”

Wasserman and Treadway have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Some instances of unprofessional behavior by medical trainees are universally deemed egregious and worthy of discipline — for example, looking up a friend’s medical data after HIPAA training.

Conversely, some professionalism lapses may be widely thought of as a teaching and consoling moment, such as the human error involved in forgetting a scheduled repositioning of a patient.

But between the extremes is a vast gray area. To deal with those cases appropriately, Jason Wasserman, PhD, and colleagues propose a new framework by which to judge each infraction.

The framework draws from “just culture” concepts used to evaluate medical errors, Wasserman, associate professor of biomedical science at Oakland University William Beaumont School of Medicine in Rochester, Michigan, told Medscape Medical News. Such an approach takes into account the environment in which the error was made, the knowledge and intent of the person making the error, and the severity and consequences of the infraction so that trainees and institutions can learn from mistakes.

“Trainees by definition are not going to fully get it,” he explained. “By definition they’re not going to fully achieve professional expectations. So how can we respond to the things we need to respond to, but do it in a way that’s educational?”

Wasserman and coauthors’ framework for remediation, which they published February 20 in The New England Journal of Medicine, takes into account several questions: Was the expectation clear? Were there factors beyond the trainees› control? What were the trainees› intentions and did they understand the consequences? Did the person genuinely believe the action was inconsequential?

An example requiring discipline, the authors say, would be using a crib sheet during an exam. In that case the intent is clear, there is no defensible belief that the action is inconsequential, and there is a clear understanding the action is wrong.

But a response of “affirm, support, and advise” is more appropriate, for example, when a student’s alarm doesn’t go off after a power outage and they miss a mandatory meeting.

Wasserman points out that this framework won’t cover all situations.

“This is not an algorithm for answering your questions about what to do,” he said. “It’s an architecture for clarifying the discussion about that. It can really tease out all the threads that need to be considered to best respond to and correct the professionalism lapse, but do it in a way that is developmentally appropriate.”
 

A Core Competency

For two decades, professionalism has been considered a core competency of medical education. In 1999, the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties formalized it as such. In 2013, the Association of American Medical Colleges formally required related professionalism competencies.

However, identifying lapses has operated largely on an “I-know-it-when-I-see-it” basis, leading to widely varying remediation practices judged by a small number of faculty members or administrators.

The ideas outlined by Wasserman and colleagues are “a terrific application of the ‘just-culture’ framework,” according to Nicole Treadway, MD, a first-year primary care resident at Emory School of Medicine in Atlanta, Georgia.

At Emory, discussions of professionalism start from day 1 of medical school and the subject is revisited throughout training in small groups, Treadway told Medscape Medical News.

But, she said, as the authors point out, definitions of unprofessionalism are not always clear and the examples the authors put forward help put lapses in context.

The framework also allows for looking at mistakes in light of the stress trainees encounter and the greater chance of making a professionalism error in those situations, she noted.

In her own work, she says, because she is juggling both inpatient and outpatient care, she is finding it is easy to get behind on correspondence or communicating lab results or having follow-up conversations.

Those delays could be seen as lapses in professionalism, but under this framework, there may be system solutions or training opportunities to consider.

“We do need this organizational architecture, and I think it could serve us well in really helping us identify and appropriately respond to what we see regarding professionalism,” she said.

Framework Helps Standardize Thinking

She said having a universal framework also helps because while standards of professionalism are easier to monitor in a single medical school, when students scatter to other hospitals for clinical training, those hospitals may have different professionalism standards.

Wasserman agrees, saying, “This could be easily adopted in any environment where people deal with professionalism lapses. I don’t even think it’s necessarily relegated to trainees. It’s a great way to think about any kind of lapses, just as hospitals think about medical errors.”

He said the next step is presenting the framework at various medical schools for feedback and research to see whether the framework improves processes.

Potential criticism, he said, might come from those who say such a construct avoids punishing students who make errors.

“There will always be people who say we’re pandering to medical students whenever we worry about the learning environment,” he said. “There are old-school purists who say when people screw up you should punish them.”

But he adds healthcare broadly has moved past that thinking.

“People recognized 20 years ago or more from the standpoint of improving healthcare systems and safety that is a bad strategy. You’ll never get error-free humans working in your system, and what you have to do is consider how the system is functioning and think about ways to optimize the system so people can be their best within it.”

Wasserman and Treadway have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Some instances of unprofessional behavior by medical trainees are universally deemed egregious and worthy of discipline — for example, looking up a friend’s medical data after HIPAA training.

Conversely, some professionalism lapses may be widely thought of as a teaching and consoling moment, such as the human error involved in forgetting a scheduled repositioning of a patient.

But between the extremes is a vast gray area. To deal with those cases appropriately, Jason Wasserman, PhD, and colleagues propose a new framework by which to judge each infraction.

The framework draws from “just culture” concepts used to evaluate medical errors, Wasserman, associate professor of biomedical science at Oakland University William Beaumont School of Medicine in Rochester, Michigan, told Medscape Medical News. Such an approach takes into account the environment in which the error was made, the knowledge and intent of the person making the error, and the severity and consequences of the infraction so that trainees and institutions can learn from mistakes.

“Trainees by definition are not going to fully get it,” he explained. “By definition they’re not going to fully achieve professional expectations. So how can we respond to the things we need to respond to, but do it in a way that’s educational?”

Wasserman and coauthors’ framework for remediation, which they published February 20 in The New England Journal of Medicine, takes into account several questions: Was the expectation clear? Were there factors beyond the trainees› control? What were the trainees› intentions and did they understand the consequences? Did the person genuinely believe the action was inconsequential?

An example requiring discipline, the authors say, would be using a crib sheet during an exam. In that case the intent is clear, there is no defensible belief that the action is inconsequential, and there is a clear understanding the action is wrong.

But a response of “affirm, support, and advise” is more appropriate, for example, when a student’s alarm doesn’t go off after a power outage and they miss a mandatory meeting.

Wasserman points out that this framework won’t cover all situations.

“This is not an algorithm for answering your questions about what to do,” he said. “It’s an architecture for clarifying the discussion about that. It can really tease out all the threads that need to be considered to best respond to and correct the professionalism lapse, but do it in a way that is developmentally appropriate.”
 

A Core Competency

For two decades, professionalism has been considered a core competency of medical education. In 1999, the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties formalized it as such. In 2013, the Association of American Medical Colleges formally required related professionalism competencies.

However, identifying lapses has operated largely on an “I-know-it-when-I-see-it” basis, leading to widely varying remediation practices judged by a small number of faculty members or administrators.

The ideas outlined by Wasserman and colleagues are “a terrific application of the ‘just-culture’ framework,” according to Nicole Treadway, MD, a first-year primary care resident at Emory School of Medicine in Atlanta, Georgia.

At Emory, discussions of professionalism start from day 1 of medical school and the subject is revisited throughout training in small groups, Treadway told Medscape Medical News.

But, she said, as the authors point out, definitions of unprofessionalism are not always clear and the examples the authors put forward help put lapses in context.

The framework also allows for looking at mistakes in light of the stress trainees encounter and the greater chance of making a professionalism error in those situations, she noted.

In her own work, she says, because she is juggling both inpatient and outpatient care, she is finding it is easy to get behind on correspondence or communicating lab results or having follow-up conversations.

Those delays could be seen as lapses in professionalism, but under this framework, there may be system solutions or training opportunities to consider.

“We do need this organizational architecture, and I think it could serve us well in really helping us identify and appropriately respond to what we see regarding professionalism,” she said.

Framework Helps Standardize Thinking

She said having a universal framework also helps because while standards of professionalism are easier to monitor in a single medical school, when students scatter to other hospitals for clinical training, those hospitals may have different professionalism standards.

Wasserman agrees, saying, “This could be easily adopted in any environment where people deal with professionalism lapses. I don’t even think it’s necessarily relegated to trainees. It’s a great way to think about any kind of lapses, just as hospitals think about medical errors.”

He said the next step is presenting the framework at various medical schools for feedback and research to see whether the framework improves processes.

Potential criticism, he said, might come from those who say such a construct avoids punishing students who make errors.

“There will always be people who say we’re pandering to medical students whenever we worry about the learning environment,” he said. “There are old-school purists who say when people screw up you should punish them.”

But he adds healthcare broadly has moved past that thinking.

“People recognized 20 years ago or more from the standpoint of improving healthcare systems and safety that is a bad strategy. You’ll never get error-free humans working in your system, and what you have to do is consider how the system is functioning and think about ways to optimize the system so people can be their best within it.”

Wasserman and Treadway have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

The U.S. Supreme Court has agreed to hear Texas v. California, a closely watched case that could upend the Affordable Care Act.

ETIENJones/thinkstockphotos

The justices will hear oral arguments in the case in fall 2020, with a ruling likely in 2021.

The Texas case, consolidated with a similar challenge, stems from a lawsuit by 20 Republican state attorneys general and governors that was filed after Congress zeroed out the ACA’s individual mandate penalty in 2017. The plaintiffs contend the now-valueless mandate is no longer constitutional and thus, the entire ACA should be struck down. Since the Trump administration declined to defend the ACA, a coalition of Democratic attorneys general and governors intervened in the case as defendants.

In 2018, a Texas district court ruled in favor of the plaintiffs and declared the entire health care law invalid. The 5th U.S. Circuit Court of Appeals partially affirmed the district court’s decision, ruling that the mandate was unconstitutional, but sending the case back to the lower court for more analysis on severability. On March 2, the U.S. Supreme Court granted two petitions by the defendants requesting that the high court review the appeals court decision.

The review follows a previous look at the ACA’s mandate by the Supreme Court in 2012. In National Federation of Independent Business v. Sebelius, justices upheld the ACA’s insurance mandate as constitutional, ruling the requirement was authorized by Congress’ power to levy taxes. The vote was 5-4, with Chief Justice John G. Roberts Jr. in agreement with the court’s four more liberal members.

agallegos@mdedge.com

A 59-year-old man is admitted with abdominal pain. He has a history of pancreatitis. A contrast CT scan is ordered. He reports a history of severe shellfish allergy when the radiology tech checks him in for the procedure. You are paged regarding what to do:

A) Continue with scan as ordered.

B) Switch to MRI scan.

C) Switch to MRI scan with gadolinium.

D) Continue with CT with contrast, give dose of Solu-Medrol.

E) Continue with CT with contrast give IV diphenhydramine.
 

The correct answer here is A, This patient can receive his scan and receive contrast as ordered.

For many years, patients have been asked about shellfish allergy as a proxy for having increased risk when receiving iodine containing contrast. The mistaken thought was that shellfish contains iodine, so allergy to shellfish was likely to portend allergy to iodine.

Allergy to shellfish is caused by individual proteins that are definitely not in iodine-containing contrast.¹ Beaty et al. studied the prevalence of the belief that allergy to shellfish is tied to iodine allergy in a survey given to 231 faculty radiologists and interventional cardiologists.² Almost 70% responded that they inquire about seafood allergy before procedures that require iodine contrast, and 37% reported they would withhold the contrast or premedicate patients if they had a seafood allergy.

In a more recent study, Westermann-Clark and colleagues surveyed 252 health professionals before and after an educational intervention to dispel the myth of shellfish allergy and iodinated contrast reactions.³ Before the intervention, 66% of participants felt it was important to ask about shellfish allergies and 93% felt it was important to ask about iodine allergies; 26% responded that they would withhold iodinated contrast material in patients with a shellfish allergy, and 56% would withhold in patients with an iodine allergy. A total of 62% reported they would premedicate patients with a shellfish allergy and 75% would premedicate patients with an iodine allergy. The numbers declined dramatically after the educational intervention.

Patients who have seafood allergy have a higher rate of reactions to iodinated contrast, but not at a higher rate than do patients with other food allergies or asthma.⁴ Most radiology departments do not screen for other food allergies despite the fact these allergies have the same increased risk as for patients with a seafood/shellfish allergy. These patients are more allergic, and in general, are more likely to have reactions. The American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering low- or iso-osmolar radiocontrast media or pretreating with either antihistamines or steroids in patients with a history of seafood allergy.⁵

• It is unnecessary and unhelpful to ask patients about seafood allergies before ordering radiologic studies involving contrast.
• Iodine allergy does not exist.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Narayan AK et al. Avoiding contrast-enhanced computed tomography scans in patients with shellfish allergies. J Hosp Med. 2016 Jun;11(6):435-7.

2. Beaty AD et al. Seafood allergy and radiocontrast media: Are physicians propagating a myth? Am J Med. 2008 Feb;121(2):158.e1-4.

3. Westermann-Clark E et al. Debunking myths about “allergy” to radiocontrast media in an academic institution. Postgrad Med. 2015 Apr;127(3):295-300.

4. Coakley FV and DM Panicek. Iodine allergy: An oyster without a pearl? AJR Am J Roentgenol. 1997 Oct;169(4):951-2.

5. American Academy of Allergy, Asthma & Immunology recommendations on low- or iso-osmolar radiocontrast media.

6. Schabelman E and M Witting. The relationship of radiocontrast, iodine, and seafood allergies: A medical myth exposed. J Emerg Med. 2010 Nov;39(5):701-7.

7. van Ketel WG and WH van den Berg. Sensitization to povidone-iodine. Dermatol Clin. 1990 Jan;8(1):107-9.

A 59-year-old man is admitted with abdominal pain. He has a history of pancreatitis. A contrast CT scan is ordered. He reports a history of severe shellfish allergy when the radiology tech checks him in for the procedure. You are paged regarding what to do:

A) Continue with scan as ordered.

B) Switch to MRI scan.

C) Switch to MRI scan with gadolinium.

D) Continue with CT with contrast, give dose of Solu-Medrol.

E) Continue with CT with contrast give IV diphenhydramine.
 

The correct answer here is A, This patient can receive his scan and receive contrast as ordered.

For many years, patients have been asked about shellfish allergy as a proxy for having increased risk when receiving iodine containing contrast. The mistaken thought was that shellfish contains iodine, so allergy to shellfish was likely to portend allergy to iodine.

Allergy to shellfish is caused by individual proteins that are definitely not in iodine-containing contrast.¹ Beaty et al. studied the prevalence of the belief that allergy to shellfish is tied to iodine allergy in a survey given to 231 faculty radiologists and interventional cardiologists.² Almost 70% responded that they inquire about seafood allergy before procedures that require iodine contrast, and 37% reported they would withhold the contrast or premedicate patients if they had a seafood allergy.

In a more recent study, Westermann-Clark and colleagues surveyed 252 health professionals before and after an educational intervention to dispel the myth of shellfish allergy and iodinated contrast reactions.³ Before the intervention, 66% of participants felt it was important to ask about shellfish allergies and 93% felt it was important to ask about iodine allergies; 26% responded that they would withhold iodinated contrast material in patients with a shellfish allergy, and 56% would withhold in patients with an iodine allergy. A total of 62% reported they would premedicate patients with a shellfish allergy and 75% would premedicate patients with an iodine allergy. The numbers declined dramatically after the educational intervention.

Patients who have seafood allergy have a higher rate of reactions to iodinated contrast, but not at a higher rate than do patients with other food allergies or asthma.⁴ Most radiology departments do not screen for other food allergies despite the fact these allergies have the same increased risk as for patients with a seafood/shellfish allergy. These patients are more allergic, and in general, are more likely to have reactions. The American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering low- or iso-osmolar radiocontrast media or pretreating with either antihistamines or steroids in patients with a history of seafood allergy.⁵

• It is unnecessary and unhelpful to ask patients about seafood allergies before ordering radiologic studies involving contrast.
• Iodine allergy does not exist.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Narayan AK et al. Avoiding contrast-enhanced computed tomography scans in patients with shellfish allergies. J Hosp Med. 2016 Jun;11(6):435-7.

2. Beaty AD et al. Seafood allergy and radiocontrast media: Are physicians propagating a myth? Am J Med. 2008 Feb;121(2):158.e1-4.

3. Westermann-Clark E et al. Debunking myths about “allergy” to radiocontrast media in an academic institution. Postgrad Med. 2015 Apr;127(3):295-300.

4. Coakley FV and DM Panicek. Iodine allergy: An oyster without a pearl? AJR Am J Roentgenol. 1997 Oct;169(4):951-2.

5. American Academy of Allergy, Asthma & Immunology recommendations on low- or iso-osmolar radiocontrast media.

6. Schabelman E and M Witting. The relationship of radiocontrast, iodine, and seafood allergies: A medical myth exposed. J Emerg Med. 2010 Nov;39(5):701-7.

7. van Ketel WG and WH van den Berg. Sensitization to povidone-iodine. Dermatol Clin. 1990 Jan;8(1):107-9.

A 59-year-old man is admitted with abdominal pain. He has a history of pancreatitis. A contrast CT scan is ordered. He reports a history of severe shellfish allergy when the radiology tech checks him in for the procedure. You are paged regarding what to do:

A) Continue with scan as ordered.

B) Switch to MRI scan.

C) Switch to MRI scan with gadolinium.

D) Continue with CT with contrast, give dose of Solu-Medrol.

E) Continue with CT with contrast give IV diphenhydramine.
 

The correct answer here is A, This patient can receive his scan and receive contrast as ordered.

For many years, patients have been asked about shellfish allergy as a proxy for having increased risk when receiving iodine containing contrast. The mistaken thought was that shellfish contains iodine, so allergy to shellfish was likely to portend allergy to iodine.

Allergy to shellfish is caused by individual proteins that are definitely not in iodine-containing contrast.¹ Beaty et al. studied the prevalence of the belief that allergy to shellfish is tied to iodine allergy in a survey given to 231 faculty radiologists and interventional cardiologists.² Almost 70% responded that they inquire about seafood allergy before procedures that require iodine contrast, and 37% reported they would withhold the contrast or premedicate patients if they had a seafood allergy.

In a more recent study, Westermann-Clark and colleagues surveyed 252 health professionals before and after an educational intervention to dispel the myth of shellfish allergy and iodinated contrast reactions.³ Before the intervention, 66% of participants felt it was important to ask about shellfish allergies and 93% felt it was important to ask about iodine allergies; 26% responded that they would withhold iodinated contrast material in patients with a shellfish allergy, and 56% would withhold in patients with an iodine allergy. A total of 62% reported they would premedicate patients with a shellfish allergy and 75% would premedicate patients with an iodine allergy. The numbers declined dramatically after the educational intervention.

Patients who have seafood allergy have a higher rate of reactions to iodinated contrast, but not at a higher rate than do patients with other food allergies or asthma.⁴ Most radiology departments do not screen for other food allergies despite the fact these allergies have the same increased risk as for patients with a seafood/shellfish allergy. These patients are more allergic, and in general, are more likely to have reactions. The American Academy of Allergy, Asthma, and Immunology recommends not routinely ordering low- or iso-osmolar radiocontrast media or pretreating with either antihistamines or steroids in patients with a history of seafood allergy.⁵

• It is unnecessary and unhelpful to ask patients about seafood allergies before ordering radiologic studies involving contrast.
• Iodine allergy does not exist.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Narayan AK et al. Avoiding contrast-enhanced computed tomography scans in patients with shellfish allergies. J Hosp Med. 2016 Jun;11(6):435-7.

2. Beaty AD et al. Seafood allergy and radiocontrast media: Are physicians propagating a myth? Am J Med. 2008 Feb;121(2):158.e1-4.

3. Westermann-Clark E et al. Debunking myths about “allergy” to radiocontrast media in an academic institution. Postgrad Med. 2015 Apr;127(3):295-300.

4. Coakley FV and DM Panicek. Iodine allergy: An oyster without a pearl? AJR Am J Roentgenol. 1997 Oct;169(4):951-2.

5. American Academy of Allergy, Asthma & Immunology recommendations on low- or iso-osmolar radiocontrast media.

6. Schabelman E and M Witting. The relationship of radiocontrast, iodine, and seafood allergies: A medical myth exposed. J Emerg Med. 2010 Nov;39(5):701-7.

7. van Ketel WG and WH van den Berg. Sensitization to povidone-iodine. Dermatol Clin. 1990 Jan;8(1):107-9.

Glucocorticoid use is associated with greater mortality and cardiovascular risk in RA patients, and the associated risk is greater still in patients with RA and comorbid diabetes. The findings come from a new retrospective analysis derived from U.K. primary care records.

Although patients with diabetes actually had a lower relative risk for mortality than the nondiabetes cohort, they had a greater mortality difference because of a greater baseline risk. Ultimately, glucocorticoid (GC) use was associated with an additional 44.9 deaths per 1,000 person-years in the diabetes group, compared with 34.4 per 1,000 person-years in the RA-only group.

The study, led by Ruth Costello and William Dixon, MBBS, PhD of the University of Manchester (England), was published in BMC Rheumatology.

The findings aren’t particularly surprising, given that steroid use and diabetes have associated cardiovascular risks, and physicians generally try to reduce or eliminate their use. “There’s a group [of physicians] saying that we don’t need to use steroids at all in rheumatoid arthritis, except maybe for [a] short time at diagnosis to bridge to other therapies, or during flares,” Gordon Starkebaum, MD, professor emeritus of rheumatology at the University of Washington, Seattle, said in an interview. He recounted a session at last year’s annual meeting of the American College of Rheumatology that advocated for only injectable steroid use during flare-ups. “That was provocative,” Dr. Starkebaum said.

“It’s a retrospective study, so it has some limitations, but it provides good insight, and some substantiation to what we already think,” added Brett Smith, DO, a rheumatologist practicing in Knoxville, Tenn.

Dr. Smith suggested that the study further underscores the need to follow treat-to-target protocols in RA. He emphasized that lifetime exposure to steroids is likely the greatest concern, and that steady accumulating doses are a sign of trouble. “If you need that much steroids, you need to go up on your medication – your methotrexate, or sulfasalazine, or your biologic,” said Dr. Smith. “At least 50% of people will need a biologic to [achieve] disease control, and if you get them on it, they’re going to have better disease control, compliance is typically better, and they’re going to have less steroid exposure.”

Dr. Smith also noted that comorbid diabetes shouldn’t affect treat-to-target strategies. In fact, in such patients “you should probably be following it more tightly to reduce the cardiovascular outcomes,” he said.

The retrospective analysis included 9,085 patients with RA and with or without type 2 diabetes, with a mean follow-up of 5.2 years. They were recruited to the study between 1998 and 2011. Among patients with comorbid diabetes, those exposed to GC had a mortality of 67.4 per 1,000 person-years, compared with 22.5 among those not exposed to GC. Among those with RA alone, mortality was 44.6 versus 10.2 with and without GC exposure, respectively. Those with diabetes had a lower risk ratio for mortality (2.99 vs. 4.37), but a higher mortality difference (44.9 vs. 34.4 per 1,000 person-years).

“The increased absolute hazard for all-cause mortality indicates the greater public health impact of people with RA using GCs if they have [diabetes],” the researchers wrote. “Rheumatologists should consider [diabetes] status when prescribing GCs to patients with RA given this potential impact of GC therapy on glucose control and mortality.”

The study was limited by a lack of information on GC dose and cumulative exposure. Given its retrospective nature, the study could have been affected by confounding by indication, as well as unknown confounders.

The study was funded by the Centre for Epidemiology Versus Arthritis and the National Institute for Health Research Biomedical Research Centre. Dr. Starkebaum has no relevant financial disclosures. Dr. Smith is on the speaker’s bureau for AbbVie and serves on the company’s advisory board. He is also on the advisory boards of Regeneron and Sanofi Genzyme.

SOURCE: Costello R et al. BMC Rheumatol. 2020 Feb 19. doi: 10.1186/s41927-019-0105-4.

Glucocorticoid use is associated with greater mortality and cardiovascular risk in RA patients, and the associated risk is greater still in patients with RA and comorbid diabetes. The findings come from a new retrospective analysis derived from U.K. primary care records.

Although patients with diabetes actually had a lower relative risk for mortality than the nondiabetes cohort, they had a greater mortality difference because of a greater baseline risk. Ultimately, glucocorticoid (GC) use was associated with an additional 44.9 deaths per 1,000 person-years in the diabetes group, compared with 34.4 per 1,000 person-years in the RA-only group.

The study, led by Ruth Costello and William Dixon, MBBS, PhD of the University of Manchester (England), was published in BMC Rheumatology.

The findings aren’t particularly surprising, given that steroid use and diabetes have associated cardiovascular risks, and physicians generally try to reduce or eliminate their use. “There’s a group [of physicians] saying that we don’t need to use steroids at all in rheumatoid arthritis, except maybe for [a] short time at diagnosis to bridge to other therapies, or during flares,” Gordon Starkebaum, MD, professor emeritus of rheumatology at the University of Washington, Seattle, said in an interview. He recounted a session at last year’s annual meeting of the American College of Rheumatology that advocated for only injectable steroid use during flare-ups. “That was provocative,” Dr. Starkebaum said.

“It’s a retrospective study, so it has some limitations, but it provides good insight, and some substantiation to what we already think,” added Brett Smith, DO, a rheumatologist practicing in Knoxville, Tenn.

Dr. Smith suggested that the study further underscores the need to follow treat-to-target protocols in RA. He emphasized that lifetime exposure to steroids is likely the greatest concern, and that steady accumulating doses are a sign of trouble. “If you need that much steroids, you need to go up on your medication – your methotrexate, or sulfasalazine, or your biologic,” said Dr. Smith. “At least 50% of people will need a biologic to [achieve] disease control, and if you get them on it, they’re going to have better disease control, compliance is typically better, and they’re going to have less steroid exposure.”

Dr. Smith also noted that comorbid diabetes shouldn’t affect treat-to-target strategies. In fact, in such patients “you should probably be following it more tightly to reduce the cardiovascular outcomes,” he said.

The retrospective analysis included 9,085 patients with RA and with or without type 2 diabetes, with a mean follow-up of 5.2 years. They were recruited to the study between 1998 and 2011. Among patients with comorbid diabetes, those exposed to GC had a mortality of 67.4 per 1,000 person-years, compared with 22.5 among those not exposed to GC. Among those with RA alone, mortality was 44.6 versus 10.2 with and without GC exposure, respectively. Those with diabetes had a lower risk ratio for mortality (2.99 vs. 4.37), but a higher mortality difference (44.9 vs. 34.4 per 1,000 person-years).

“The increased absolute hazard for all-cause mortality indicates the greater public health impact of people with RA using GCs if they have [diabetes],” the researchers wrote. “Rheumatologists should consider [diabetes] status when prescribing GCs to patients with RA given this potential impact of GC therapy on glucose control and mortality.”

The study was limited by a lack of information on GC dose and cumulative exposure. Given its retrospective nature, the study could have been affected by confounding by indication, as well as unknown confounders.

The study was funded by the Centre for Epidemiology Versus Arthritis and the National Institute for Health Research Biomedical Research Centre. Dr. Starkebaum has no relevant financial disclosures. Dr. Smith is on the speaker’s bureau for AbbVie and serves on the company’s advisory board. He is also on the advisory boards of Regeneron and Sanofi Genzyme.

SOURCE: Costello R et al. BMC Rheumatol. 2020 Feb 19. doi: 10.1186/s41927-019-0105-4.

Glucocorticoid use is associated with greater mortality and cardiovascular risk in RA patients, and the associated risk is greater still in patients with RA and comorbid diabetes. The findings come from a new retrospective analysis derived from U.K. primary care records.

Although patients with diabetes actually had a lower relative risk for mortality than the nondiabetes cohort, they had a greater mortality difference because of a greater baseline risk. Ultimately, glucocorticoid (GC) use was associated with an additional 44.9 deaths per 1,000 person-years in the diabetes group, compared with 34.4 per 1,000 person-years in the RA-only group.

The study, led by Ruth Costello and William Dixon, MBBS, PhD of the University of Manchester (England), was published in BMC Rheumatology.

The findings aren’t particularly surprising, given that steroid use and diabetes have associated cardiovascular risks, and physicians generally try to reduce or eliminate their use. “There’s a group [of physicians] saying that we don’t need to use steroids at all in rheumatoid arthritis, except maybe for [a] short time at diagnosis to bridge to other therapies, or during flares,” Gordon Starkebaum, MD, professor emeritus of rheumatology at the University of Washington, Seattle, said in an interview. He recounted a session at last year’s annual meeting of the American College of Rheumatology that advocated for only injectable steroid use during flare-ups. “That was provocative,” Dr. Starkebaum said.

“It’s a retrospective study, so it has some limitations, but it provides good insight, and some substantiation to what we already think,” added Brett Smith, DO, a rheumatologist practicing in Knoxville, Tenn.

Dr. Smith suggested that the study further underscores the need to follow treat-to-target protocols in RA. He emphasized that lifetime exposure to steroids is likely the greatest concern, and that steady accumulating doses are a sign of trouble. “If you need that much steroids, you need to go up on your medication – your methotrexate, or sulfasalazine, or your biologic,” said Dr. Smith. “At least 50% of people will need a biologic to [achieve] disease control, and if you get them on it, they’re going to have better disease control, compliance is typically better, and they’re going to have less steroid exposure.”

Dr. Smith also noted that comorbid diabetes shouldn’t affect treat-to-target strategies. In fact, in such patients “you should probably be following it more tightly to reduce the cardiovascular outcomes,” he said.

The retrospective analysis included 9,085 patients with RA and with or without type 2 diabetes, with a mean follow-up of 5.2 years. They were recruited to the study between 1998 and 2011. Among patients with comorbid diabetes, those exposed to GC had a mortality of 67.4 per 1,000 person-years, compared with 22.5 among those not exposed to GC. Among those with RA alone, mortality was 44.6 versus 10.2 with and without GC exposure, respectively. Those with diabetes had a lower risk ratio for mortality (2.99 vs. 4.37), but a higher mortality difference (44.9 vs. 34.4 per 1,000 person-years).

“The increased absolute hazard for all-cause mortality indicates the greater public health impact of people with RA using GCs if they have [diabetes],” the researchers wrote. “Rheumatologists should consider [diabetes] status when prescribing GCs to patients with RA given this potential impact of GC therapy on glucose control and mortality.”

The study was limited by a lack of information on GC dose and cumulative exposure. Given its retrospective nature, the study could have been affected by confounding by indication, as well as unknown confounders.

The study was funded by the Centre for Epidemiology Versus Arthritis and the National Institute for Health Research Biomedical Research Centre. Dr. Starkebaum has no relevant financial disclosures. Dr. Smith is on the speaker’s bureau for AbbVie and serves on the company’s advisory board. He is also on the advisory boards of Regeneron and Sanofi Genzyme.

SOURCE: Costello R et al. BMC Rheumatol. 2020 Feb 19. doi: 10.1186/s41927-019-0105-4.

GRAPEVINE, TEX. – Early postpartum glucose tolerance testing for women with gestational diabetes resulted in a 99% adherence rate, with similar sensitivity and specificity as the currently recommended 4- to 12-week postpartum testing schedule.

“Two-day postpartum glucose tolerance testing has similar diagnostic utility as the 4- to 12-week postpartum glucose tolerance test to identify impaired glucose metabolism and diabetes at 1 year postpartum,” said Erika Werner, MD, speaking at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Overall, 29% of women studied had impaired glucose metabolism at 2 days postpartum, as did 25% in the 4- to 12-weeks postpartum window. At 1 year, that figure was 35%. The number of women meeting diagnostic criteria for diabetes held steady at 4% for all three time points.

The findings warrant “consideration for the 2-day postpartum glucose tolerance test (GTT) as the initial postpartum test for women who have gestational diabetes, with repeat testing at 1 year,” said Dr. Werner, a maternal-fetal medicine physician at Brown University, Providence, R.I.

Glucose testing for women with gestational diabetes mellitus (GDM) is recommended at 4-12 weeks postpartum by both the American Diabetes Association and the American College of Obstetricians and Gynecologists.

Testing can allow detection and treatment of impaired glucose metabolism, seen in 15%-40% of women with a history of GDM. Up to 1 in 20 women with GDM will receive a postpartum diagnosis of type 2 diabetes.

However, fewer than one in five women will actually have postpartum glucose testing, representing a large missed opportunity, said Dr. Werner.

Several factors likely contribute to those screening failures, she added. In addition to the potential for public insurance to lapse at 6 weeks postpartum, the logistical realities and time demands of parenting a newborn are themselves a significant barrier.

“What if we changed the timing?” and shifted glucose testing to the early postpartum days, before hospital discharge, asked Dr. Werner. Several pilot studies had already compared glucose screening in the first few days postpartum with the routine schedule, finding good correlation between the early and routine GTT schedule.

Importantly, the earlier studies achieved an adherence rate of more than 90% for early GTT. By contrast, fewer than half of the participants in the usual-care arms actually returned for postpartum GTT in the 4- to 12-week postpartum window, even under the optimized conditions associated with a medical study.

The single-center prospective cohort study conducted by Dr. Werner and collaborators enrolled 300 women with GDM. Women agreed to participate in glucose tolerance testing as inpatients, at 2 days postpartum, in addition to receiving a GTT between 4 and 12 weeks postpartum, and additional screening that included a glycosylated hemoglobin (HbA_1c) test at 1 year postpartum.

The investigators obtained postpartum day 2 GTTs for all but four of the patients. A total of 201 patients returned in the 4- to 12-week postpartum window, and 168 of those participants returned for HbA1c testing at 1 year. Of the 95 patients who didn’t come back for the 4- to 12-week test, 33 did return at 1 year for HbA_1c testing.

Dr. Werner and her coinvestigators included adult women who spoke either fluent Spanish or English and had GDM diagnosed by the Carpenter-Coustan criteria, or by having a blood glucose level of 200 mg/dL or more in a 1-hour glucose challenge test.

The early GTT results weren’t shared with patients or their health care providers. For outpatient visits, participants were offered financial incentives and received multiple reminder phone calls and the offer of free transportation.

For the purposes of the study, impaired glucose metabolism was defined as fasting blood glucose of 100 mg/dL or greater, a 2-hour GTT blood glucose level of 140 mg/dL or greater, or HbA_1c of 5.7% or greater.

Participants were diagnosed with diabetes if they had a fasting blood glucose of 126 mg/dL or greater, a 2-hour GTT blood glucose level of 200 mg/dL or greater, or HbA_1c of 6.5% or greater.

Dr. Werner and colleagues conducted two analyses of their results. In the first, they included only women in both arms who had complete data. In the second analysis, they looked at all women who had data for the 1-year postpartum mark, assuming that interval GTTs were negative for women who were missing these values.

The statistical analysis showed that, for women with complete data, both early and later postpartum GTTs were similar in predicting impaired glucose metabolism at 1 year postpartum (areas under the receiver operating curve [AUC], 0.63 and 0.60, respectively).

For identifying diabetes at 1 year, both early and late testing had high negative predictive value (98% and 99%, respectively), but the later testing strategy had higher sensitivity and specificity, yielding an AUC of 0.83, compared with 0.65 for early testing.

Turning to the second analysis that included all women who had 1-year postpartum HbA_1c values, negative predictive values for diabetes were similarly high (98%) for both the early and late testing strategies. For identifying impaired glucose metabolism at 1 year in this group, both the positive and negative predictive value of the early and late strategies were similar.

Patients were about 32 years old at baseline, with a mean body mass index of 31.7 kg/m². More than half of patients (52.3%) had private insurance, and 22% had GDM in a pregnancy prior to the index pregnancy. Black patients made up about 9% of the study population; 54% of participants were white, and 23% Hispanic. About one-third of patients were nulliparous, and two-thirds had education beyond high school.

During their pregnancies, about 44% of patients managed GDM by diet alone, 40% required insulin, with an additional 1% also requiring an oral agent. The remainder required oral agents alone. Patients delivered at a mean 38.3 weeks gestation, with about 40% receiving cesarean deliveries.

Some of the study’s strengths included its prospective nature, the diverse population recruited, and the fact that participants and providers were both blinded to the 2-day GTT results. Although more than half of participants completed the study – besting the previous pilots – 44% of patients still had incomplete data, noted Dr. Werner.

The American Diabetes Association sponsored the study. Dr. Werner reported no other conflicts of interest.

koakes@mdedge.com

SOURCE: Werner E et al. SMFM 2020. Abstract 72.

GRAPEVINE, TEX. – Early postpartum glucose tolerance testing for women with gestational diabetes resulted in a 99% adherence rate, with similar sensitivity and specificity as the currently recommended 4- to 12-week postpartum testing schedule.

“Two-day postpartum glucose tolerance testing has similar diagnostic utility as the 4- to 12-week postpartum glucose tolerance test to identify impaired glucose metabolism and diabetes at 1 year postpartum,” said Erika Werner, MD, speaking at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Overall, 29% of women studied had impaired glucose metabolism at 2 days postpartum, as did 25% in the 4- to 12-weeks postpartum window. At 1 year, that figure was 35%. The number of women meeting diagnostic criteria for diabetes held steady at 4% for all three time points.

The findings warrant “consideration for the 2-day postpartum glucose tolerance test (GTT) as the initial postpartum test for women who have gestational diabetes, with repeat testing at 1 year,” said Dr. Werner, a maternal-fetal medicine physician at Brown University, Providence, R.I.

Glucose testing for women with gestational diabetes mellitus (GDM) is recommended at 4-12 weeks postpartum by both the American Diabetes Association and the American College of Obstetricians and Gynecologists.

Testing can allow detection and treatment of impaired glucose metabolism, seen in 15%-40% of women with a history of GDM. Up to 1 in 20 women with GDM will receive a postpartum diagnosis of type 2 diabetes.

However, fewer than one in five women will actually have postpartum glucose testing, representing a large missed opportunity, said Dr. Werner.

Several factors likely contribute to those screening failures, she added. In addition to the potential for public insurance to lapse at 6 weeks postpartum, the logistical realities and time demands of parenting a newborn are themselves a significant barrier.

“What if we changed the timing?” and shifted glucose testing to the early postpartum days, before hospital discharge, asked Dr. Werner. Several pilot studies had already compared glucose screening in the first few days postpartum with the routine schedule, finding good correlation between the early and routine GTT schedule.

Importantly, the earlier studies achieved an adherence rate of more than 90% for early GTT. By contrast, fewer than half of the participants in the usual-care arms actually returned for postpartum GTT in the 4- to 12-week postpartum window, even under the optimized conditions associated with a medical study.

The single-center prospective cohort study conducted by Dr. Werner and collaborators enrolled 300 women with GDM. Women agreed to participate in glucose tolerance testing as inpatients, at 2 days postpartum, in addition to receiving a GTT between 4 and 12 weeks postpartum, and additional screening that included a glycosylated hemoglobin (HbA_1c) test at 1 year postpartum.

The investigators obtained postpartum day 2 GTTs for all but four of the patients. A total of 201 patients returned in the 4- to 12-week postpartum window, and 168 of those participants returned for HbA1c testing at 1 year. Of the 95 patients who didn’t come back for the 4- to 12-week test, 33 did return at 1 year for HbA_1c testing.

Dr. Werner and her coinvestigators included adult women who spoke either fluent Spanish or English and had GDM diagnosed by the Carpenter-Coustan criteria, or by having a blood glucose level of 200 mg/dL or more in a 1-hour glucose challenge test.

The early GTT results weren’t shared with patients or their health care providers. For outpatient visits, participants were offered financial incentives and received multiple reminder phone calls and the offer of free transportation.

For the purposes of the study, impaired glucose metabolism was defined as fasting blood glucose of 100 mg/dL or greater, a 2-hour GTT blood glucose level of 140 mg/dL or greater, or HbA_1c of 5.7% or greater.

Participants were diagnosed with diabetes if they had a fasting blood glucose of 126 mg/dL or greater, a 2-hour GTT blood glucose level of 200 mg/dL or greater, or HbA_1c of 6.5% or greater.

Dr. Werner and colleagues conducted two analyses of their results. In the first, they included only women in both arms who had complete data. In the second analysis, they looked at all women who had data for the 1-year postpartum mark, assuming that interval GTTs were negative for women who were missing these values.

The statistical analysis showed that, for women with complete data, both early and later postpartum GTTs were similar in predicting impaired glucose metabolism at 1 year postpartum (areas under the receiver operating curve [AUC], 0.63 and 0.60, respectively).

For identifying diabetes at 1 year, both early and late testing had high negative predictive value (98% and 99%, respectively), but the later testing strategy had higher sensitivity and specificity, yielding an AUC of 0.83, compared with 0.65 for early testing.

Turning to the second analysis that included all women who had 1-year postpartum HbA_1c values, negative predictive values for diabetes were similarly high (98%) for both the early and late testing strategies. For identifying impaired glucose metabolism at 1 year in this group, both the positive and negative predictive value of the early and late strategies were similar.

Patients were about 32 years old at baseline, with a mean body mass index of 31.7 kg/m². More than half of patients (52.3%) had private insurance, and 22% had GDM in a pregnancy prior to the index pregnancy. Black patients made up about 9% of the study population; 54% of participants were white, and 23% Hispanic. About one-third of patients were nulliparous, and two-thirds had education beyond high school.

During their pregnancies, about 44% of patients managed GDM by diet alone, 40% required insulin, with an additional 1% also requiring an oral agent. The remainder required oral agents alone. Patients delivered at a mean 38.3 weeks gestation, with about 40% receiving cesarean deliveries.

Some of the study’s strengths included its prospective nature, the diverse population recruited, and the fact that participants and providers were both blinded to the 2-day GTT results. Although more than half of participants completed the study – besting the previous pilots – 44% of patients still had incomplete data, noted Dr. Werner.

The American Diabetes Association sponsored the study. Dr. Werner reported no other conflicts of interest.

koakes@mdedge.com

SOURCE: Werner E et al. SMFM 2020. Abstract 72.

GRAPEVINE, TEX. – Early postpartum glucose tolerance testing for women with gestational diabetes resulted in a 99% adherence rate, with similar sensitivity and specificity as the currently recommended 4- to 12-week postpartum testing schedule.

“Two-day postpartum glucose tolerance testing has similar diagnostic utility as the 4- to 12-week postpartum glucose tolerance test to identify impaired glucose metabolism and diabetes at 1 year postpartum,” said Erika Werner, MD, speaking at the meeting sponsored by the Society for Maternal-Fetal Medicine.

Overall, 29% of women studied had impaired glucose metabolism at 2 days postpartum, as did 25% in the 4- to 12-weeks postpartum window. At 1 year, that figure was 35%. The number of women meeting diagnostic criteria for diabetes held steady at 4% for all three time points.

The findings warrant “consideration for the 2-day postpartum glucose tolerance test (GTT) as the initial postpartum test for women who have gestational diabetes, with repeat testing at 1 year,” said Dr. Werner, a maternal-fetal medicine physician at Brown University, Providence, R.I.

Glucose testing for women with gestational diabetes mellitus (GDM) is recommended at 4-12 weeks postpartum by both the American Diabetes Association and the American College of Obstetricians and Gynecologists.

Testing can allow detection and treatment of impaired glucose metabolism, seen in 15%-40% of women with a history of GDM. Up to 1 in 20 women with GDM will receive a postpartum diagnosis of type 2 diabetes.

However, fewer than one in five women will actually have postpartum glucose testing, representing a large missed opportunity, said Dr. Werner.

Several factors likely contribute to those screening failures, she added. In addition to the potential for public insurance to lapse at 6 weeks postpartum, the logistical realities and time demands of parenting a newborn are themselves a significant barrier.

“What if we changed the timing?” and shifted glucose testing to the early postpartum days, before hospital discharge, asked Dr. Werner. Several pilot studies had already compared glucose screening in the first few days postpartum with the routine schedule, finding good correlation between the early and routine GTT schedule.

Importantly, the earlier studies achieved an adherence rate of more than 90% for early GTT. By contrast, fewer than half of the participants in the usual-care arms actually returned for postpartum GTT in the 4- to 12-week postpartum window, even under the optimized conditions associated with a medical study.

The single-center prospective cohort study conducted by Dr. Werner and collaborators enrolled 300 women with GDM. Women agreed to participate in glucose tolerance testing as inpatients, at 2 days postpartum, in addition to receiving a GTT between 4 and 12 weeks postpartum, and additional screening that included a glycosylated hemoglobin (HbA_1c) test at 1 year postpartum.

The investigators obtained postpartum day 2 GTTs for all but four of the patients. A total of 201 patients returned in the 4- to 12-week postpartum window, and 168 of those participants returned for HbA1c testing at 1 year. Of the 95 patients who didn’t come back for the 4- to 12-week test, 33 did return at 1 year for HbA_1c testing.

Dr. Werner and her coinvestigators included adult women who spoke either fluent Spanish or English and had GDM diagnosed by the Carpenter-Coustan criteria, or by having a blood glucose level of 200 mg/dL or more in a 1-hour glucose challenge test.

The early GTT results weren’t shared with patients or their health care providers. For outpatient visits, participants were offered financial incentives and received multiple reminder phone calls and the offer of free transportation.

For the purposes of the study, impaired glucose metabolism was defined as fasting blood glucose of 100 mg/dL or greater, a 2-hour GTT blood glucose level of 140 mg/dL or greater, or HbA_1c of 5.7% or greater.

Participants were diagnosed with diabetes if they had a fasting blood glucose of 126 mg/dL or greater, a 2-hour GTT blood glucose level of 200 mg/dL or greater, or HbA_1c of 6.5% or greater.

Dr. Werner and colleagues conducted two analyses of their results. In the first, they included only women in both arms who had complete data. In the second analysis, they looked at all women who had data for the 1-year postpartum mark, assuming that interval GTTs were negative for women who were missing these values.

The statistical analysis showed that, for women with complete data, both early and later postpartum GTTs were similar in predicting impaired glucose metabolism at 1 year postpartum (areas under the receiver operating curve [AUC], 0.63 and 0.60, respectively).

For identifying diabetes at 1 year, both early and late testing had high negative predictive value (98% and 99%, respectively), but the later testing strategy had higher sensitivity and specificity, yielding an AUC of 0.83, compared with 0.65 for early testing.

Turning to the second analysis that included all women who had 1-year postpartum HbA_1c values, negative predictive values for diabetes were similarly high (98%) for both the early and late testing strategies. For identifying impaired glucose metabolism at 1 year in this group, both the positive and negative predictive value of the early and late strategies were similar.

Patients were about 32 years old at baseline, with a mean body mass index of 31.7 kg/m². More than half of patients (52.3%) had private insurance, and 22% had GDM in a pregnancy prior to the index pregnancy. Black patients made up about 9% of the study population; 54% of participants were white, and 23% Hispanic. About one-third of patients were nulliparous, and two-thirds had education beyond high school.

During their pregnancies, about 44% of patients managed GDM by diet alone, 40% required insulin, with an additional 1% also requiring an oral agent. The remainder required oral agents alone. Patients delivered at a mean 38.3 weeks gestation, with about 40% receiving cesarean deliveries.

Some of the study’s strengths included its prospective nature, the diverse population recruited, and the fact that participants and providers were both blinded to the 2-day GTT results. Although more than half of participants completed the study – besting the previous pilots – 44% of patients still had incomplete data, noted Dr. Werner.

The American Diabetes Association sponsored the study. Dr. Werner reported no other conflicts of interest.

koakes@mdedge.com

SOURCE: Werner E et al. SMFM 2020. Abstract 72.

Latest guidelines on the treatment of osteoporosis have been released that include new recommendations for the use of romosozumab (Evenity) in postmenopausal women with severe osteoporosis, but they contain caveats as to which women should – and should not – receive the drug.

The updated clinical practice guideline from the Endocrine Society is in response to the approval of romosozumab by the Food and Drug Administration (FDA) in April 2019, and more recently, by the European Medicines Agency.

It was published online February 18 in the Journal of Clinical Endocrinology & Metabolism.

In the new guidelines, committee members recommend the use of romosozumab for postmenopausal women with osteoporosis at very high risk of fracture. Candidates would include women with severe osteoporosis (T-score of less than –2.5 and a prior fracture) or women with a history of multiple vertebral fractures.

Women should be treated with romosozumab for up to 1 year, followed by an antiresorptive agent to maintain bone mineral density gains and further reduce fracture risk.

“The recommended dosage is 210 mg monthly by subcutaneous injection for 12 months,” the authors wrote.

However, and very importantly, romosozumab should not be considered for women at high risk of cardiovascular disease (CVD) or cerebrovascular disease. A high risk of CVD includes women who have had a previous myocardial infarction (MI) or stroke.

Experts questioned by Medscape Medical News stressed that romosozumab should not be a first-line, or even generally a second-line, option for osteoporosis, but it can be a considered for select patients with severe osteoporosis, taking into account CV risk.

Boxed warning

In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH), there were more major adverse cardiovascular events (MACE) in the first year of the trial with romosozumab, and patients had a 31% higher risk of MACE with romosozumab, compared with the bisphosphonate alendronate.

As a result, the drug was initially rejected by a number of regulatory agencies.

In the United States and Canada, it was eventually approved with a boxed warning, which cautions against the use of the drug in patients at risk for myocardial infarction, stroke, and CVD-related death.

“Romosozumab offers promising results for postmenopausal women with severe osteoporosis or who have a history of fractures,” Clifford Rosen, MD, Maine Medical Center Research Institute in Scarborough and chair of the writing committee, said in an Endocrine Society statement. “It does, however, come with a risk of heart disease, so clinicians need to be careful when selecting patients for this therapy.”

Exact risk unknown

Asked by Medscape Medical News to comment, Kenneth Saag, MD, professor of medicine, University of Alabama at Birmingham and principle investigator of the ARCH study, said that physicians needed more data from real-world studies to resolve the issue around whether romosozumab heightens the risk of CV events in women with osteoporosis or whether that particular finding from ARCH was an artifact.

“Women who have had a recent cardiovascular event should not receive the drug,” he said, agreeing with the new guidelines.

But it remains unclear, for example, whether women who are at slightly higher risk of having a CV event by virtue of their age alone, are also at risk, he noted.

In the meantime, results from the ARCH study clearly showed that not only was romosozumab more effective than alendronate, “but it is more effective than other bone-building drugs as well,” Dr. Saag observed, and it leads to a significantly greater reduction in vertebral, nonvertebral, and hip fractures, compared with the alendronate, the current standard of care in osteoporosis.

“In patients who have very severe osteoporosis and who have had a recent fracture or who are at risk for imminent future fracture, physicians need to balance the benefit versus the risk in favor of using romosozumab,” Dr. Saag suggested.

“And while I would say most women prefer not to inject themselves, the women I have put on this medicine have all had recent fractures and they are very aware of the pain and the disability of having a broken bone, so it is something they are willing to do,” he added.
 

Not for all women

Giving his opinion, Bart Clarke, MD, of the Mayo Clinic in Rochester, Minnesota, underscored the fact that the Fracture Study in Postmenopausal Women With Osteoporosis (FRAME), again conducted in postmenopausal women, showed no increase in CV events in patients treated with romosozumab compared with placebo.

“So there are questions about what this means, because if these events really were a drug effect, then that effect would be even more evident compared with placebo and they did not see any signal of CV events [in FRAME],” said Dr. Clarke, past president of the American Society of Bone and Mineral Research.

Like everything else in medicine, “there is always some risk,” Dr. Clarke observed.

However, what physicians should do is talk to women, ensure they have not had either an MI or stroke in the last year, and if patients have severe osteoporosis and a high risk of fracture, “then we can say, here’s another option,” he suggested.

“Then, if a woman develops chest pain or shortness of breath while on the drug, [she needs] to let us know ,and then we’ll stop the drug and reassess the situation,” he added.

Dr. Clarke also pointed out that if the FDA had received further reports of CV events linked to romosozumab, physicians would know about it by now, but to his knowledge, there has been no change to the drug’s current warning label.

Furthermore, neither he nor any of his colleagues who treat metabolic bone disease at the Mayo Clinic has seen a single CV event in patients prescribed the agent.

“This is not a drug we would use as first-line for most patients, and we don’t even use it as second-line for most patients, but in people who have not responded to other drugs or who have had terrible things happen to them already, hip fracture especially, then we are saying, you can consider this, he concluded.

The guidelines were supported by the Endocrine Society. Dr. Rosen and Dr. Clarke reported no relevant financial relationships. Dr. Saag reported receiving grants and personal fees from Amgen, personal fees from Radius, and is a consultant for Amgen, Radius, Roche, and Daiichi Sankyo.

This article first appeared on Medscape.com.

Latest guidelines on the treatment of osteoporosis have been released that include new recommendations for the use of romosozumab (Evenity) in postmenopausal women with severe osteoporosis, but they contain caveats as to which women should – and should not – receive the drug.

The updated clinical practice guideline from the Endocrine Society is in response to the approval of romosozumab by the Food and Drug Administration (FDA) in April 2019, and more recently, by the European Medicines Agency.

It was published online February 18 in the Journal of Clinical Endocrinology & Metabolism.

In the new guidelines, committee members recommend the use of romosozumab for postmenopausal women with osteoporosis at very high risk of fracture. Candidates would include women with severe osteoporosis (T-score of less than –2.5 and a prior fracture) or women with a history of multiple vertebral fractures.

Women should be treated with romosozumab for up to 1 year, followed by an antiresorptive agent to maintain bone mineral density gains and further reduce fracture risk.

“The recommended dosage is 210 mg monthly by subcutaneous injection for 12 months,” the authors wrote.

However, and very importantly, romosozumab should not be considered for women at high risk of cardiovascular disease (CVD) or cerebrovascular disease. A high risk of CVD includes women who have had a previous myocardial infarction (MI) or stroke.

Experts questioned by Medscape Medical News stressed that romosozumab should not be a first-line, or even generally a second-line, option for osteoporosis, but it can be a considered for select patients with severe osteoporosis, taking into account CV risk.

Boxed warning

In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH), there were more major adverse cardiovascular events (MACE) in the first year of the trial with romosozumab, and patients had a 31% higher risk of MACE with romosozumab, compared with the bisphosphonate alendronate.

As a result, the drug was initially rejected by a number of regulatory agencies.

In the United States and Canada, it was eventually approved with a boxed warning, which cautions against the use of the drug in patients at risk for myocardial infarction, stroke, and CVD-related death.

“Romosozumab offers promising results for postmenopausal women with severe osteoporosis or who have a history of fractures,” Clifford Rosen, MD, Maine Medical Center Research Institute in Scarborough and chair of the writing committee, said in an Endocrine Society statement. “It does, however, come with a risk of heart disease, so clinicians need to be careful when selecting patients for this therapy.”

Exact risk unknown

Asked by Medscape Medical News to comment, Kenneth Saag, MD, professor of medicine, University of Alabama at Birmingham and principle investigator of the ARCH study, said that physicians needed more data from real-world studies to resolve the issue around whether romosozumab heightens the risk of CV events in women with osteoporosis or whether that particular finding from ARCH was an artifact.

“Women who have had a recent cardiovascular event should not receive the drug,” he said, agreeing with the new guidelines.

But it remains unclear, for example, whether women who are at slightly higher risk of having a CV event by virtue of their age alone, are also at risk, he noted.

In the meantime, results from the ARCH study clearly showed that not only was romosozumab more effective than alendronate, “but it is more effective than other bone-building drugs as well,” Dr. Saag observed, and it leads to a significantly greater reduction in vertebral, nonvertebral, and hip fractures, compared with the alendronate, the current standard of care in osteoporosis.

“In patients who have very severe osteoporosis and who have had a recent fracture or who are at risk for imminent future fracture, physicians need to balance the benefit versus the risk in favor of using romosozumab,” Dr. Saag suggested.

“And while I would say most women prefer not to inject themselves, the women I have put on this medicine have all had recent fractures and they are very aware of the pain and the disability of having a broken bone, so it is something they are willing to do,” he added.
 

Not for all women

Giving his opinion, Bart Clarke, MD, of the Mayo Clinic in Rochester, Minnesota, underscored the fact that the Fracture Study in Postmenopausal Women With Osteoporosis (FRAME), again conducted in postmenopausal women, showed no increase in CV events in patients treated with romosozumab compared with placebo.

“So there are questions about what this means, because if these events really were a drug effect, then that effect would be even more evident compared with placebo and they did not see any signal of CV events [in FRAME],” said Dr. Clarke, past president of the American Society of Bone and Mineral Research.

Like everything else in medicine, “there is always some risk,” Dr. Clarke observed.

However, what physicians should do is talk to women, ensure they have not had either an MI or stroke in the last year, and if patients have severe osteoporosis and a high risk of fracture, “then we can say, here’s another option,” he suggested.

“Then, if a woman develops chest pain or shortness of breath while on the drug, [she needs] to let us know ,and then we’ll stop the drug and reassess the situation,” he added.

Dr. Clarke also pointed out that if the FDA had received further reports of CV events linked to romosozumab, physicians would know about it by now, but to his knowledge, there has been no change to the drug’s current warning label.

Furthermore, neither he nor any of his colleagues who treat metabolic bone disease at the Mayo Clinic has seen a single CV event in patients prescribed the agent.

“This is not a drug we would use as first-line for most patients, and we don’t even use it as second-line for most patients, but in people who have not responded to other drugs or who have had terrible things happen to them already, hip fracture especially, then we are saying, you can consider this, he concluded.

The guidelines were supported by the Endocrine Society. Dr. Rosen and Dr. Clarke reported no relevant financial relationships. Dr. Saag reported receiving grants and personal fees from Amgen, personal fees from Radius, and is a consultant for Amgen, Radius, Roche, and Daiichi Sankyo.

This article first appeared on Medscape.com.

Latest guidelines on the treatment of osteoporosis have been released that include new recommendations for the use of romosozumab (Evenity) in postmenopausal women with severe osteoporosis, but they contain caveats as to which women should – and should not – receive the drug.

The updated clinical practice guideline from the Endocrine Society is in response to the approval of romosozumab by the Food and Drug Administration (FDA) in April 2019, and more recently, by the European Medicines Agency.

It was published online February 18 in the Journal of Clinical Endocrinology & Metabolism.

In the new guidelines, committee members recommend the use of romosozumab for postmenopausal women with osteoporosis at very high risk of fracture. Candidates would include women with severe osteoporosis (T-score of less than –2.5 and a prior fracture) or women with a history of multiple vertebral fractures.

Women should be treated with romosozumab for up to 1 year, followed by an antiresorptive agent to maintain bone mineral density gains and further reduce fracture risk.

“The recommended dosage is 210 mg monthly by subcutaneous injection for 12 months,” the authors wrote.

However, and very importantly, romosozumab should not be considered for women at high risk of cardiovascular disease (CVD) or cerebrovascular disease. A high risk of CVD includes women who have had a previous myocardial infarction (MI) or stroke.

Experts questioned by Medscape Medical News stressed that romosozumab should not be a first-line, or even generally a second-line, option for osteoporosis, but it can be a considered for select patients with severe osteoporosis, taking into account CV risk.

Boxed warning

In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH), there were more major adverse cardiovascular events (MACE) in the first year of the trial with romosozumab, and patients had a 31% higher risk of MACE with romosozumab, compared with the bisphosphonate alendronate.

As a result, the drug was initially rejected by a number of regulatory agencies.

In the United States and Canada, it was eventually approved with a boxed warning, which cautions against the use of the drug in patients at risk for myocardial infarction, stroke, and CVD-related death.

“Romosozumab offers promising results for postmenopausal women with severe osteoporosis or who have a history of fractures,” Clifford Rosen, MD, Maine Medical Center Research Institute in Scarborough and chair of the writing committee, said in an Endocrine Society statement. “It does, however, come with a risk of heart disease, so clinicians need to be careful when selecting patients for this therapy.”

Exact risk unknown

Asked by Medscape Medical News to comment, Kenneth Saag, MD, professor of medicine, University of Alabama at Birmingham and principle investigator of the ARCH study, said that physicians needed more data from real-world studies to resolve the issue around whether romosozumab heightens the risk of CV events in women with osteoporosis or whether that particular finding from ARCH was an artifact.

“Women who have had a recent cardiovascular event should not receive the drug,” he said, agreeing with the new guidelines.

But it remains unclear, for example, whether women who are at slightly higher risk of having a CV event by virtue of their age alone, are also at risk, he noted.

In the meantime, results from the ARCH study clearly showed that not only was romosozumab more effective than alendronate, “but it is more effective than other bone-building drugs as well,” Dr. Saag observed, and it leads to a significantly greater reduction in vertebral, nonvertebral, and hip fractures, compared with the alendronate, the current standard of care in osteoporosis.

“In patients who have very severe osteoporosis and who have had a recent fracture or who are at risk for imminent future fracture, physicians need to balance the benefit versus the risk in favor of using romosozumab,” Dr. Saag suggested.

“And while I would say most women prefer not to inject themselves, the women I have put on this medicine have all had recent fractures and they are very aware of the pain and the disability of having a broken bone, so it is something they are willing to do,” he added.
 

Not for all women

Giving his opinion, Bart Clarke, MD, of the Mayo Clinic in Rochester, Minnesota, underscored the fact that the Fracture Study in Postmenopausal Women With Osteoporosis (FRAME), again conducted in postmenopausal women, showed no increase in CV events in patients treated with romosozumab compared with placebo.

“So there are questions about what this means, because if these events really were a drug effect, then that effect would be even more evident compared with placebo and they did not see any signal of CV events [in FRAME],” said Dr. Clarke, past president of the American Society of Bone and Mineral Research.

Like everything else in medicine, “there is always some risk,” Dr. Clarke observed.

However, what physicians should do is talk to women, ensure they have not had either an MI or stroke in the last year, and if patients have severe osteoporosis and a high risk of fracture, “then we can say, here’s another option,” he suggested.

“Then, if a woman develops chest pain or shortness of breath while on the drug, [she needs] to let us know ,and then we’ll stop the drug and reassess the situation,” he added.

Dr. Clarke also pointed out that if the FDA had received further reports of CV events linked to romosozumab, physicians would know about it by now, but to his knowledge, there has been no change to the drug’s current warning label.

Furthermore, neither he nor any of his colleagues who treat metabolic bone disease at the Mayo Clinic has seen a single CV event in patients prescribed the agent.

“This is not a drug we would use as first-line for most patients, and we don’t even use it as second-line for most patients, but in people who have not responded to other drugs or who have had terrible things happen to them already, hip fracture especially, then we are saying, you can consider this, he concluded.

The guidelines were supported by the Endocrine Society. Dr. Rosen and Dr. Clarke reported no relevant financial relationships. Dr. Saag reported receiving grants and personal fees from Amgen, personal fees from Radius, and is a consultant for Amgen, Radius, Roche, and Daiichi Sankyo.

This article first appeared on Medscape.com.

MAUI, HAWAII – Specialists who study obesity and embrace the increasing number of treatment options are poised to lead the way in stemming the disease, which Andres Acosta, MD, PhD, calls the “epidemic of the century.”

“Gastroenterologists are in the first line of treatment for obesity management,” said Acosta, who runs the precision medicine for obesity lab at the Mayo Clinic in Rochester, Minn.

“Patients with obesity are already in our clinics,” he said in an interview. And too many physicians “are ignoring the problem.”

The vast majority of people with acid reflux have obesity, as do those with nonalcoholic fatty liver disease, he explained. “By targeting those two areas, we’ll be targeting more than 50% of our patients.” Recurring polyps and colon cancer are also often associated with obesity, he said.

Because of their skill as endoscopists, internists, and nutrition experts, gastroenterologists are uniquely positioned to care for obesity, said Acosta, who is first author of a white paper – Practice Guide on Obesity and Weight Management, Education and Resources – developed by the American Gastroenterological Association with input from nine medical societies.
 

More treatment choices

Physicians heard an update on options available in the continuum of obesity care from Christopher Thompson, MD, director of endoscopy at Brigham and Women’s Hospital in Boston, at the Gastroenterology Updates IBD Liver Disease Conference 2020. He discussed the potential weight-loss range and safety profile of each.

Some medications result in a body-weight loss of 5%, whereas gastric bypass surgeries can result in a loss of up to 40%, he said in an interview. And weight loss is typically 10% with intragastric balloon, 15%-20% with aspiration therapies and with endoscopic suturing techniques, and 25%-30% with sleeve gastrectomy.

“It’s nice to be able to offer all of those to patients,” he said, adding that he wants to get the message across to hesitant physicians that obesity management “is not as difficult as they think.”

Physicians can be reluctant to address obesity because of the social stigma associated with excess weight and a discomfort in talking about it.

But “there are ways to open that conversation, and it needs to start happening more,” said Thompson, who pointed out that obesity is the underlying cause of many other illnesses, including diabetes and heart diseases.

And new strategies are in the offing, he explained. His team at Brigham is currently involved in clinical trials to test whether the diversion of food and bile to the lower part of the bowel will generate a metabolic signal that affects insulin resistance and weight, he reported.

They are also testing whether gastric procedures can be combined with small bowel procedures to achieve the weight loss seen with bariatric surgery.

As treatment options for obesity increase, precision medicine will help maximize their potential, said Acosta.
 

Precision medicine will amp up treatments

Acosta outlined the four categories that patients who are obese generally fall into: those with a “hungry brain,” who think they need to eat more than they do; those with a “hungry gut,” whose gut is not sending the proper signal to the brain that it is full; those with “emotional hunger”; and those with abnormal metabolism.

“For each of those, there are genetic circumstances, metabolism, a hormonal profile, as well as pathophysiologic aspects of obesity, that make these groups unique,” he said.

Deciding which patients should get which treatment is the next frontier, he explained. “For example, if you give an intragastric balloon to all comers, patients will lose about 12% of their body weight. But if you separate responders from nonresponders and you select the right intervention, you can achieve an 18% loss of body weight in the right responders.”

At Mayo, they are working on a blood test to break down phenotypes and identify who will respond best to which treatment, he reported. That could lead to a much more efficient use of scarce resources.

“At the same time, I hope that more insurance companies will cover more obesity treatments,” said Acosta.
 

This article first appeared on Medscape.com.

MAUI, HAWAII – Specialists who study obesity and embrace the increasing number of treatment options are poised to lead the way in stemming the disease, which Andres Acosta, MD, PhD, calls the “epidemic of the century.”

“Gastroenterologists are in the first line of treatment for obesity management,” said Acosta, who runs the precision medicine for obesity lab at the Mayo Clinic in Rochester, Minn.

“Patients with obesity are already in our clinics,” he said in an interview. And too many physicians “are ignoring the problem.”

The vast majority of people with acid reflux have obesity, as do those with nonalcoholic fatty liver disease, he explained. “By targeting those two areas, we’ll be targeting more than 50% of our patients.” Recurring polyps and colon cancer are also often associated with obesity, he said.

Because of their skill as endoscopists, internists, and nutrition experts, gastroenterologists are uniquely positioned to care for obesity, said Acosta, who is first author of a white paper – Practice Guide on Obesity and Weight Management, Education and Resources – developed by the American Gastroenterological Association with input from nine medical societies.
 

More treatment choices

Physicians heard an update on options available in the continuum of obesity care from Christopher Thompson, MD, director of endoscopy at Brigham and Women’s Hospital in Boston, at the Gastroenterology Updates IBD Liver Disease Conference 2020. He discussed the potential weight-loss range and safety profile of each.

Some medications result in a body-weight loss of 5%, whereas gastric bypass surgeries can result in a loss of up to 40%, he said in an interview. And weight loss is typically 10% with intragastric balloon, 15%-20% with aspiration therapies and with endoscopic suturing techniques, and 25%-30% with sleeve gastrectomy.

“It’s nice to be able to offer all of those to patients,” he said, adding that he wants to get the message across to hesitant physicians that obesity management “is not as difficult as they think.”

Physicians can be reluctant to address obesity because of the social stigma associated with excess weight and a discomfort in talking about it.

But “there are ways to open that conversation, and it needs to start happening more,” said Thompson, who pointed out that obesity is the underlying cause of many other illnesses, including diabetes and heart diseases.

And new strategies are in the offing, he explained. His team at Brigham is currently involved in clinical trials to test whether the diversion of food and bile to the lower part of the bowel will generate a metabolic signal that affects insulin resistance and weight, he reported.

They are also testing whether gastric procedures can be combined with small bowel procedures to achieve the weight loss seen with bariatric surgery.

As treatment options for obesity increase, precision medicine will help maximize their potential, said Acosta.
 

Precision medicine will amp up treatments

Acosta outlined the four categories that patients who are obese generally fall into: those with a “hungry brain,” who think they need to eat more than they do; those with a “hungry gut,” whose gut is not sending the proper signal to the brain that it is full; those with “emotional hunger”; and those with abnormal metabolism.

“For each of those, there are genetic circumstances, metabolism, a hormonal profile, as well as pathophysiologic aspects of obesity, that make these groups unique,” he said.

Deciding which patients should get which treatment is the next frontier, he explained. “For example, if you give an intragastric balloon to all comers, patients will lose about 12% of their body weight. But if you separate responders from nonresponders and you select the right intervention, you can achieve an 18% loss of body weight in the right responders.”

At Mayo, they are working on a blood test to break down phenotypes and identify who will respond best to which treatment, he reported. That could lead to a much more efficient use of scarce resources.

“At the same time, I hope that more insurance companies will cover more obesity treatments,” said Acosta.
 

This article first appeared on Medscape.com.

MAUI, HAWAII – Specialists who study obesity and embrace the increasing number of treatment options are poised to lead the way in stemming the disease, which Andres Acosta, MD, PhD, calls the “epidemic of the century.”

“Gastroenterologists are in the first line of treatment for obesity management,” said Acosta, who runs the precision medicine for obesity lab at the Mayo Clinic in Rochester, Minn.

“Patients with obesity are already in our clinics,” he said in an interview. And too many physicians “are ignoring the problem.”

The vast majority of people with acid reflux have obesity, as do those with nonalcoholic fatty liver disease, he explained. “By targeting those two areas, we’ll be targeting more than 50% of our patients.” Recurring polyps and colon cancer are also often associated with obesity, he said.

Because of their skill as endoscopists, internists, and nutrition experts, gastroenterologists are uniquely positioned to care for obesity, said Acosta, who is first author of a white paper – Practice Guide on Obesity and Weight Management, Education and Resources – developed by the American Gastroenterological Association with input from nine medical societies.
 

More treatment choices

Physicians heard an update on options available in the continuum of obesity care from Christopher Thompson, MD, director of endoscopy at Brigham and Women’s Hospital in Boston, at the Gastroenterology Updates IBD Liver Disease Conference 2020. He discussed the potential weight-loss range and safety profile of each.

Some medications result in a body-weight loss of 5%, whereas gastric bypass surgeries can result in a loss of up to 40%, he said in an interview. And weight loss is typically 10% with intragastric balloon, 15%-20% with aspiration therapies and with endoscopic suturing techniques, and 25%-30% with sleeve gastrectomy.

“It’s nice to be able to offer all of those to patients,” he said, adding that he wants to get the message across to hesitant physicians that obesity management “is not as difficult as they think.”

Physicians can be reluctant to address obesity because of the social stigma associated with excess weight and a discomfort in talking about it.

But “there are ways to open that conversation, and it needs to start happening more,” said Thompson, who pointed out that obesity is the underlying cause of many other illnesses, including diabetes and heart diseases.

And new strategies are in the offing, he explained. His team at Brigham is currently involved in clinical trials to test whether the diversion of food and bile to the lower part of the bowel will generate a metabolic signal that affects insulin resistance and weight, he reported.

They are also testing whether gastric procedures can be combined with small bowel procedures to achieve the weight loss seen with bariatric surgery.

As treatment options for obesity increase, precision medicine will help maximize their potential, said Acosta.
 

Precision medicine will amp up treatments

Acosta outlined the four categories that patients who are obese generally fall into: those with a “hungry brain,” who think they need to eat more than they do; those with a “hungry gut,” whose gut is not sending the proper signal to the brain that it is full; those with “emotional hunger”; and those with abnormal metabolism.

“For each of those, there are genetic circumstances, metabolism, a hormonal profile, as well as pathophysiologic aspects of obesity, that make these groups unique,” he said.

Deciding which patients should get which treatment is the next frontier, he explained. “For example, if you give an intragastric balloon to all comers, patients will lose about 12% of their body weight. But if you separate responders from nonresponders and you select the right intervention, you can achieve an 18% loss of body weight in the right responders.”

At Mayo, they are working on a blood test to break down phenotypes and identify who will respond best to which treatment, he reported. That could lead to a much more efficient use of scarce resources.

“At the same time, I hope that more insurance companies will cover more obesity treatments,” said Acosta.
 

This article first appeared on Medscape.com.

Thyroid dysfunction is common in patients with diabetes, with a prevalence of around 17%, according to a new analysis of an Australian population.

The results add to the debate over whether patients with diabetes should undergo clinical or biochemical screening for thyroid dysfunction. The American Diabetes Association and U.K. National Institute for Health and Care Excellence guidelines do not recommend general thyroid function monitoring in type 2 diabetes, but the authors of the new study noted concerns that thyroid dysfunction could have metabolic consequences in type 2 disease.

Although the prevalence of undiagnosed thyroid disease in participants with type 2 diabetes was similar to that found in the general Australian population, the researchers, led by Kristen E. Peters, PhD, MedSc, and Timothy M.E. Davis, BMedSc MB, DPhil, of the University of Western Australia, Perth, noted in an article in Clinical Endocrinology that thyroid disease may worsen cardiometabolic risk factors, potentially giving it more significance in this population.

For their study, the researchers analyzed longitudinal data from 1,617 participants in the Fremantle Diabetes Study Phase II, of whom 8.0% had type 1 diabetes, 87.1% had type 2 diabetes, and 4.9% had latent autoimmune diabetes of adults (LADA).

All of the participants filled out questionnaires and underwent baseline fasting biochemical tests and were invited to return for biennial clinical and biochemical measures and to complete biennial questionnaires that were mailed to them. The participants were followed from 2008-2011 (baseline/recruitment period) to 2016. At baseline, 11.7% of the sample (189 of 1,617) had known thyroid disease, based on previous hospitalization of self-reported thyroid medication. Thyroid disease was more prevalent in women than in men (20.4% vs. 3.8%; P less than .001), and there was a nonsignificant trend for a higher prevalence of thyroid disease in participants with type 1 disease, compared with LADA and type 2 (16.9%, 11.4%, and 11.2%, respectively).

Among the 1,428 participants with no documented thyroid disease, 93 (6.5%) were found to have an abnormal thyroid-stimulating hormone (TSH) at baseline testing. Of those 93 participants, 79 had type 2 diabetes, 9 had type 1, and 5 had LADA; across all diabetes types, 5.1% of the participants had subclinical hypothyroidism, 1.1% had overt hypothyroidism, 0.1% had subclinical hyperthyroidism, and 0.2% had overt hyperthyroidism.

Overall, the baseline prevalence of any thyroid disease, known or previously undiagnosed, was 17.4% – 282 of 1,617 participants, of whom 23.8% had type 1 diabetes, 17.7% had LADA, and 16.8% had type 2.

At the end of year 4, serum concentrations were available for 844 participants who had no history of thyroid disease and normal baseline TSH. Over the course of the follow-up period (5,694 patient-years), 25 participants (3%) with normal baseline TSH levels had a first hospitalization for thyroid disease or started thyroid medication, including 2.8% of those with type 1 diabetes and 3.1% of those with type 2. Of the remaining 819 participants who did not have baseline thyroid disease, 3.4% developed subclinical hypothyroidism, 0.2% developed overt hypothyroidism, and 0.5% developed subclinical hyperthyroidism. In each case, there was no statistically significant difference in risk of developing thyroid dysfunction by diabetes type.

“The incidence of any new thyroid disease, including those [participants] with an abnormal follow-up TSH and those with known incident thyroid disease, was 59/844 (7.0%) during [4 years] of follow-up,” the authors noted. “The total incidence of new overt disease was 3.2% (27/844), with 7.4% (2/27) of these patients unaware of the condition. All of the patients with LADA remained euthyroid during follow-up.”

Among the limitations of the study, the authors noted, were that the identification of participants with thyroid disease depended on the available documentation in the databases the researchers used, they were not able to establish pretreatment of thyroid function in most participants with incident thyroid dysfunction, and they did not record free T3.

“Thyroid dysfunction, whether diagnosed or detected on biochemical screening, is common in diabetes regardless of type,” the authors wrote. “Subclinical hypothyroidism is the commonest form [of thyroid dysfunction], and it has a variable course. This latter observation alone makes an argument for periodic biochemical screening in all people with diabetes (not just type 1) as part of routine management.”

However, in an interview, Robert Eckel, MD, professor of medicine at University of Colorado at Denver, Aurora, said that the authors’ suggestion for routine thyroid function testing of patients with any type of diabetes may be premature. He noted that the study lacked a control group, making it difficult to justify a change in practice.

“My take-home message is that the current guidelines are probably not modified by [these findings], but the idea that 17% [of individuals with diabetes] have thyroid disease is worth noting. However, the absence of a control group limits changing recommendations based on this particular study,” said Dr. Eckel, who is also current president, medicine and science, of the ADA.

The study was supported by the National Health and Medical Research Council of Australia and the Spinnaker Health Research Foundation. The study authors did not disclose an financial conflicts.

SOURCE: Peters KE et al. Clin Endocrinol. 2020 Jan 27. doi: 10.1111/cen.14164.

Thyroid dysfunction is common in patients with diabetes, with a prevalence of around 17%, according to a new analysis of an Australian population.

The results add to the debate over whether patients with diabetes should undergo clinical or biochemical screening for thyroid dysfunction. The American Diabetes Association and U.K. National Institute for Health and Care Excellence guidelines do not recommend general thyroid function monitoring in type 2 diabetes, but the authors of the new study noted concerns that thyroid dysfunction could have metabolic consequences in type 2 disease.

Although the prevalence of undiagnosed thyroid disease in participants with type 2 diabetes was similar to that found in the general Australian population, the researchers, led by Kristen E. Peters, PhD, MedSc, and Timothy M.E. Davis, BMedSc MB, DPhil, of the University of Western Australia, Perth, noted in an article in Clinical Endocrinology that thyroid disease may worsen cardiometabolic risk factors, potentially giving it more significance in this population.

For their study, the researchers analyzed longitudinal data from 1,617 participants in the Fremantle Diabetes Study Phase II, of whom 8.0% had type 1 diabetes, 87.1% had type 2 diabetes, and 4.9% had latent autoimmune diabetes of adults (LADA).

All of the participants filled out questionnaires and underwent baseline fasting biochemical tests and were invited to return for biennial clinical and biochemical measures and to complete biennial questionnaires that were mailed to them. The participants were followed from 2008-2011 (baseline/recruitment period) to 2016. At baseline, 11.7% of the sample (189 of 1,617) had known thyroid disease, based on previous hospitalization of self-reported thyroid medication. Thyroid disease was more prevalent in women than in men (20.4% vs. 3.8%; P less than .001), and there was a nonsignificant trend for a higher prevalence of thyroid disease in participants with type 1 disease, compared with LADA and type 2 (16.9%, 11.4%, and 11.2%, respectively).

Among the 1,428 participants with no documented thyroid disease, 93 (6.5%) were found to have an abnormal thyroid-stimulating hormone (TSH) at baseline testing. Of those 93 participants, 79 had type 2 diabetes, 9 had type 1, and 5 had LADA; across all diabetes types, 5.1% of the participants had subclinical hypothyroidism, 1.1% had overt hypothyroidism, 0.1% had subclinical hyperthyroidism, and 0.2% had overt hyperthyroidism.

Overall, the baseline prevalence of any thyroid disease, known or previously undiagnosed, was 17.4% – 282 of 1,617 participants, of whom 23.8% had type 1 diabetes, 17.7% had LADA, and 16.8% had type 2.

At the end of year 4, serum concentrations were available for 844 participants who had no history of thyroid disease and normal baseline TSH. Over the course of the follow-up period (5,694 patient-years), 25 participants (3%) with normal baseline TSH levels had a first hospitalization for thyroid disease or started thyroid medication, including 2.8% of those with type 1 diabetes and 3.1% of those with type 2. Of the remaining 819 participants who did not have baseline thyroid disease, 3.4% developed subclinical hypothyroidism, 0.2% developed overt hypothyroidism, and 0.5% developed subclinical hyperthyroidism. In each case, there was no statistically significant difference in risk of developing thyroid dysfunction by diabetes type.

“The incidence of any new thyroid disease, including those [participants] with an abnormal follow-up TSH and those with known incident thyroid disease, was 59/844 (7.0%) during [4 years] of follow-up,” the authors noted. “The total incidence of new overt disease was 3.2% (27/844), with 7.4% (2/27) of these patients unaware of the condition. All of the patients with LADA remained euthyroid during follow-up.”

Among the limitations of the study, the authors noted, were that the identification of participants with thyroid disease depended on the available documentation in the databases the researchers used, they were not able to establish pretreatment of thyroid function in most participants with incident thyroid dysfunction, and they did not record free T3.

“Thyroid dysfunction, whether diagnosed or detected on biochemical screening, is common in diabetes regardless of type,” the authors wrote. “Subclinical hypothyroidism is the commonest form [of thyroid dysfunction], and it has a variable course. This latter observation alone makes an argument for periodic biochemical screening in all people with diabetes (not just type 1) as part of routine management.”

However, in an interview, Robert Eckel, MD, professor of medicine at University of Colorado at Denver, Aurora, said that the authors’ suggestion for routine thyroid function testing of patients with any type of diabetes may be premature. He noted that the study lacked a control group, making it difficult to justify a change in practice.

“My take-home message is that the current guidelines are probably not modified by [these findings], but the idea that 17% [of individuals with diabetes] have thyroid disease is worth noting. However, the absence of a control group limits changing recommendations based on this particular study,” said Dr. Eckel, who is also current president, medicine and science, of the ADA.

The study was supported by the National Health and Medical Research Council of Australia and the Spinnaker Health Research Foundation. The study authors did not disclose an financial conflicts.

SOURCE: Peters KE et al. Clin Endocrinol. 2020 Jan 27. doi: 10.1111/cen.14164.

Thyroid dysfunction is common in patients with diabetes, with a prevalence of around 17%, according to a new analysis of an Australian population.

The results add to the debate over whether patients with diabetes should undergo clinical or biochemical screening for thyroid dysfunction. The American Diabetes Association and U.K. National Institute for Health and Care Excellence guidelines do not recommend general thyroid function monitoring in type 2 diabetes, but the authors of the new study noted concerns that thyroid dysfunction could have metabolic consequences in type 2 disease.

Although the prevalence of undiagnosed thyroid disease in participants with type 2 diabetes was similar to that found in the general Australian population, the researchers, led by Kristen E. Peters, PhD, MedSc, and Timothy M.E. Davis, BMedSc MB, DPhil, of the University of Western Australia, Perth, noted in an article in Clinical Endocrinology that thyroid disease may worsen cardiometabolic risk factors, potentially giving it more significance in this population.

For their study, the researchers analyzed longitudinal data from 1,617 participants in the Fremantle Diabetes Study Phase II, of whom 8.0% had type 1 diabetes, 87.1% had type 2 diabetes, and 4.9% had latent autoimmune diabetes of adults (LADA).

All of the participants filled out questionnaires and underwent baseline fasting biochemical tests and were invited to return for biennial clinical and biochemical measures and to complete biennial questionnaires that were mailed to them. The participants were followed from 2008-2011 (baseline/recruitment period) to 2016. At baseline, 11.7% of the sample (189 of 1,617) had known thyroid disease, based on previous hospitalization of self-reported thyroid medication. Thyroid disease was more prevalent in women than in men (20.4% vs. 3.8%; P less than .001), and there was a nonsignificant trend for a higher prevalence of thyroid disease in participants with type 1 disease, compared with LADA and type 2 (16.9%, 11.4%, and 11.2%, respectively).

Among the 1,428 participants with no documented thyroid disease, 93 (6.5%) were found to have an abnormal thyroid-stimulating hormone (TSH) at baseline testing. Of those 93 participants, 79 had type 2 diabetes, 9 had type 1, and 5 had LADA; across all diabetes types, 5.1% of the participants had subclinical hypothyroidism, 1.1% had overt hypothyroidism, 0.1% had subclinical hyperthyroidism, and 0.2% had overt hyperthyroidism.

Overall, the baseline prevalence of any thyroid disease, known or previously undiagnosed, was 17.4% – 282 of 1,617 participants, of whom 23.8% had type 1 diabetes, 17.7% had LADA, and 16.8% had type 2.

At the end of year 4, serum concentrations were available for 844 participants who had no history of thyroid disease and normal baseline TSH. Over the course of the follow-up period (5,694 patient-years), 25 participants (3%) with normal baseline TSH levels had a first hospitalization for thyroid disease or started thyroid medication, including 2.8% of those with type 1 diabetes and 3.1% of those with type 2. Of the remaining 819 participants who did not have baseline thyroid disease, 3.4% developed subclinical hypothyroidism, 0.2% developed overt hypothyroidism, and 0.5% developed subclinical hyperthyroidism. In each case, there was no statistically significant difference in risk of developing thyroid dysfunction by diabetes type.

“The incidence of any new thyroid disease, including those [participants] with an abnormal follow-up TSH and those with known incident thyroid disease, was 59/844 (7.0%) during [4 years] of follow-up,” the authors noted. “The total incidence of new overt disease was 3.2% (27/844), with 7.4% (2/27) of these patients unaware of the condition. All of the patients with LADA remained euthyroid during follow-up.”

Among the limitations of the study, the authors noted, were that the identification of participants with thyroid disease depended on the available documentation in the databases the researchers used, they were not able to establish pretreatment of thyroid function in most participants with incident thyroid dysfunction, and they did not record free T3.

“Thyroid dysfunction, whether diagnosed or detected on biochemical screening, is common in diabetes regardless of type,” the authors wrote. “Subclinical hypothyroidism is the commonest form [of thyroid dysfunction], and it has a variable course. This latter observation alone makes an argument for periodic biochemical screening in all people with diabetes (not just type 1) as part of routine management.”

However, in an interview, Robert Eckel, MD, professor of medicine at University of Colorado at Denver, Aurora, said that the authors’ suggestion for routine thyroid function testing of patients with any type of diabetes may be premature. He noted that the study lacked a control group, making it difficult to justify a change in practice.

“My take-home message is that the current guidelines are probably not modified by [these findings], but the idea that 17% [of individuals with diabetes] have thyroid disease is worth noting. However, the absence of a control group limits changing recommendations based on this particular study,” said Dr. Eckel, who is also current president, medicine and science, of the ADA.

The study was supported by the National Health and Medical Research Council of Australia and the Spinnaker Health Research Foundation. The study authors did not disclose an financial conflicts.

SOURCE: Peters KE et al. Clin Endocrinol. 2020 Jan 27. doi: 10.1111/cen.14164.

NATIONAL HARBOR, MD. – If positive, a major ongoing phase 3 trial of CSL112, an agent designed to promote efflux of cholesterol from macrophages, is positioned to prove the HDL hypothesis, according to an outline of the rationale of the trial at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

“Twenty papers now show better efflux means better outcomes independent of standard risk factors” and “we know this drug improves efflux,” explained C. Michael Gibson, MD, an interventional cardiologist at Beth Israel Deaconess Hospital, Boston.

The HDL hypothesis was derived from the Framingham Heart Study, which correlated high levels of HDL cholesterol with a reduced risk of adverse cardiovascular (CV) outcomes, according to Dr. Gibson. Just as elevated LDL proved to be a treatable risk factor for CV events, reduced HDL was the target of numerous trials to achieve the same types of benefits.

All have failed.

The problem has been in seeing HDL as a number without addressing its function, Dr. Gibson said. In essence, he believes “the HDL hypothesis not been really tested to date.”

CSL112 is a novel formulation of apolipoprotein A-1 (apoA-1) that has been purified from human plasma and reconstituted to form HDL. In the experimental and clinical setting, including the AEGIS I pilot study, weekly infusions of CSL112 have been associated with a degree of cholesterol efflux that predicts major CV risk reductions.

At the same time that the multinational event-driven AEGIS II trial will determine whether cholesterol efflux with CSL112 does translate into protection from CV events, it will also examine the HDL side of the lipid equation. Dr. Gibson said that it is specifically designed to circumvent the weaknesses of previous efforts to target HDL for reducing CV risk.

“The previous studies were conducted in the wrong patients with the wrong drugs given in the wrong doses at the wrong times,” said Dr. Gibson, who is also professor of medicine at Harvard Medical School, Boston.

One major difference from previous trials is that AEGIS II is enrolling patients with an acute coronary syndrome rather than stable atherosclerosis. Many of those being enrolled have had a recent event. Also, rather than raising HDL, the goal of CSL112 is to increase cholesterol efflux, which is now considered to be the key function of HDL. Furthermore, the time frame for the primary outcome, which is a composite of major adverse cardiac outcomes (MACE), is 90 days rather than several years.

In patients with ACS, “it is the early period of vulnerability where efflux of cholesterol really appears to have the greatest influence on outcomes,” Dr. Gibson explained.

The failure of previous efforts to treat HDL now appears to be based on an incomplete understanding of the goals, according to Dr. Gibson. The doomed cholesteryl ester transfer protein (CETP) drugs, for example, effectively increased HDL levels, but generated a form of HDL that “was not all that functional.”

He noted that niacin raises HDL but has off-target effects. Apo-A1 Milano, a mutant variation of apo-A1, is now understood to reduce the endogenous form, which Dr. Gibson said might explain its counterproductive effect on CV protection.

Using a garbage truck analogy to explain the growing appreciation of factors involved in cholesterol accumulation in the macrophage, Dr. Gibson characterized ABCA1, a transporter protein sitting on the surface of the macrophage, as the loader. He described LCAT (lecithin-cholesterol acyltransferase), an enzyme that converts cholesterol into cholesteryl ester, as the compactor. He sees CRL112 as an empty garbage truck sent into the macrophage to reverse the process.

“We are moving beyond thinking of HDL as a number to try to better appreciate its function,” Dr. Gibson said.

The AEGIS II trial was opened in March of 2018. It has a planned enrollment of 17,400 patients, with an estimated completion date of October 2021.

Dr. Gibson reports financial relationships with Bayer, Janssen, Johnson & Johnson, and CSL Behring, the sponsor of the AEGIS II trial.

NATIONAL HARBOR, MD. – If positive, a major ongoing phase 3 trial of CSL112, an agent designed to promote efflux of cholesterol from macrophages, is positioned to prove the HDL hypothesis, according to an outline of the rationale of the trial at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

“Twenty papers now show better efflux means better outcomes independent of standard risk factors” and “we know this drug improves efflux,” explained C. Michael Gibson, MD, an interventional cardiologist at Beth Israel Deaconess Hospital, Boston.

The HDL hypothesis was derived from the Framingham Heart Study, which correlated high levels of HDL cholesterol with a reduced risk of adverse cardiovascular (CV) outcomes, according to Dr. Gibson. Just as elevated LDL proved to be a treatable risk factor for CV events, reduced HDL was the target of numerous trials to achieve the same types of benefits.

All have failed.

The problem has been in seeing HDL as a number without addressing its function, Dr. Gibson said. In essence, he believes “the HDL hypothesis not been really tested to date.”

CSL112 is a novel formulation of apolipoprotein A-1 (apoA-1) that has been purified from human plasma and reconstituted to form HDL. In the experimental and clinical setting, including the AEGIS I pilot study, weekly infusions of CSL112 have been associated with a degree of cholesterol efflux that predicts major CV risk reductions.

At the same time that the multinational event-driven AEGIS II trial will determine whether cholesterol efflux with CSL112 does translate into protection from CV events, it will also examine the HDL side of the lipid equation. Dr. Gibson said that it is specifically designed to circumvent the weaknesses of previous efforts to target HDL for reducing CV risk.

“The previous studies were conducted in the wrong patients with the wrong drugs given in the wrong doses at the wrong times,” said Dr. Gibson, who is also professor of medicine at Harvard Medical School, Boston.

One major difference from previous trials is that AEGIS II is enrolling patients with an acute coronary syndrome rather than stable atherosclerosis. Many of those being enrolled have had a recent event. Also, rather than raising HDL, the goal of CSL112 is to increase cholesterol efflux, which is now considered to be the key function of HDL. Furthermore, the time frame for the primary outcome, which is a composite of major adverse cardiac outcomes (MACE), is 90 days rather than several years.

In patients with ACS, “it is the early period of vulnerability where efflux of cholesterol really appears to have the greatest influence on outcomes,” Dr. Gibson explained.

The failure of previous efforts to treat HDL now appears to be based on an incomplete understanding of the goals, according to Dr. Gibson. The doomed cholesteryl ester transfer protein (CETP) drugs, for example, effectively increased HDL levels, but generated a form of HDL that “was not all that functional.”

He noted that niacin raises HDL but has off-target effects. Apo-A1 Milano, a mutant variation of apo-A1, is now understood to reduce the endogenous form, which Dr. Gibson said might explain its counterproductive effect on CV protection.

Using a garbage truck analogy to explain the growing appreciation of factors involved in cholesterol accumulation in the macrophage, Dr. Gibson characterized ABCA1, a transporter protein sitting on the surface of the macrophage, as the loader. He described LCAT (lecithin-cholesterol acyltransferase), an enzyme that converts cholesterol into cholesteryl ester, as the compactor. He sees CRL112 as an empty garbage truck sent into the macrophage to reverse the process.

“We are moving beyond thinking of HDL as a number to try to better appreciate its function,” Dr. Gibson said.

The AEGIS II trial was opened in March of 2018. It has a planned enrollment of 17,400 patients, with an estimated completion date of October 2021.

Dr. Gibson reports financial relationships with Bayer, Janssen, Johnson & Johnson, and CSL Behring, the sponsor of the AEGIS II trial.

NATIONAL HARBOR, MD. – If positive, a major ongoing phase 3 trial of CSL112, an agent designed to promote efflux of cholesterol from macrophages, is positioned to prove the HDL hypothesis, according to an outline of the rationale of the trial at CRT 2020 sponsored by MedStar Heart & Vascular Institute.

“Twenty papers now show better efflux means better outcomes independent of standard risk factors” and “we know this drug improves efflux,” explained C. Michael Gibson, MD, an interventional cardiologist at Beth Israel Deaconess Hospital, Boston.

The HDL hypothesis was derived from the Framingham Heart Study, which correlated high levels of HDL cholesterol with a reduced risk of adverse cardiovascular (CV) outcomes, according to Dr. Gibson. Just as elevated LDL proved to be a treatable risk factor for CV events, reduced HDL was the target of numerous trials to achieve the same types of benefits.

All have failed.

The problem has been in seeing HDL as a number without addressing its function, Dr. Gibson said. In essence, he believes “the HDL hypothesis not been really tested to date.”

CSL112 is a novel formulation of apolipoprotein A-1 (apoA-1) that has been purified from human plasma and reconstituted to form HDL. In the experimental and clinical setting, including the AEGIS I pilot study, weekly infusions of CSL112 have been associated with a degree of cholesterol efflux that predicts major CV risk reductions.

At the same time that the multinational event-driven AEGIS II trial will determine whether cholesterol efflux with CSL112 does translate into protection from CV events, it will also examine the HDL side of the lipid equation. Dr. Gibson said that it is specifically designed to circumvent the weaknesses of previous efforts to target HDL for reducing CV risk.

“The previous studies were conducted in the wrong patients with the wrong drugs given in the wrong doses at the wrong times,” said Dr. Gibson, who is also professor of medicine at Harvard Medical School, Boston.

One major difference from previous trials is that AEGIS II is enrolling patients with an acute coronary syndrome rather than stable atherosclerosis. Many of those being enrolled have had a recent event. Also, rather than raising HDL, the goal of CSL112 is to increase cholesterol efflux, which is now considered to be the key function of HDL. Furthermore, the time frame for the primary outcome, which is a composite of major adverse cardiac outcomes (MACE), is 90 days rather than several years.

In patients with ACS, “it is the early period of vulnerability where efflux of cholesterol really appears to have the greatest influence on outcomes,” Dr. Gibson explained.

The failure of previous efforts to treat HDL now appears to be based on an incomplete understanding of the goals, according to Dr. Gibson. The doomed cholesteryl ester transfer protein (CETP) drugs, for example, effectively increased HDL levels, but generated a form of HDL that “was not all that functional.”

He noted that niacin raises HDL but has off-target effects. Apo-A1 Milano, a mutant variation of apo-A1, is now understood to reduce the endogenous form, which Dr. Gibson said might explain its counterproductive effect on CV protection.

Using a garbage truck analogy to explain the growing appreciation of factors involved in cholesterol accumulation in the macrophage, Dr. Gibson characterized ABCA1, a transporter protein sitting on the surface of the macrophage, as the loader. He described LCAT (lecithin-cholesterol acyltransferase), an enzyme that converts cholesterol into cholesteryl ester, as the compactor. He sees CRL112 as an empty garbage truck sent into the macrophage to reverse the process.

“We are moving beyond thinking of HDL as a number to try to better appreciate its function,” Dr. Gibson said.

The AEGIS II trial was opened in March of 2018. It has a planned enrollment of 17,400 patients, with an estimated completion date of October 2021.

Dr. Gibson reports financial relationships with Bayer, Janssen, Johnson & Johnson, and CSL Behring, the sponsor of the AEGIS II trial.