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TAVI turmoil: Did an ANP perform transcatheter aortic valve replacement in the U.K.?

Article Type
Changed
Mon, 07/03/2023 - 08:40

Transcatheter aortic valve implantation/replacement (TAVI/TAVR) is typically the domain of cardiac surgeons and interventional cardiologists.

In the United Kingdom, John Steele, an advanced nurse practitioner (ANP) at Glenfield Hospital, part of the University Hospitals of Leicester NHS Trust (UHL), was congratulated on Twitter as “the first nurse-ANP who has performed the whole TAVI procedure as the first operator – true transformation addressing NHS needs.”



The now-deleted tweet from @GHCardiology is still visible in the Twitter thread of Mamas A. Mamas, a professor of interventional cardiology at Keele University, England. “This is so inappropriate on so many levels,” Dr. Mamas tweeted. “This is not safe for patients particularly given that there are numerous TAVI trained medically qualified operators in UK. You have also taken away training opportunities for medical / surgical trainees.”

Other followers also responded, largely negatively.

“This is crazy. Is this @TheOnion???” tweeted Martha Gulati, MD, director of preventive cardiology in the Smidt Heart Institute at Cedars-Sinai, Los Angeles, Calif., in response to Dr. Mamas, referring to the popular satirical news outlet. “Seriously I can’t see this as an actuality given the potential for so many other issues they wouldn’t know how to deal with.”
 

Could it happen in the U.S.?

Could a U.S.-based nurse practitioner perform TAVR? Possibly. Should they? No, says Andrew M. Goldsweig, MD, chair of the U.S. Society for Cardiovascular Angiography and Interventions Structural Heart Council. “Experienced nurse practitioners who have participated as secondary operators in many TAVR procedures and have observed the primary physician operators likely know the technical steps involved in an uncomplicated transfemoral TAVR procedure,” he told this news organization.

“However, a physician’s depth and breadth of training are absolutely required both to recognize and to address any periprocedural issues,” said Dr. Goldsweig, who is also director of the cardiac catheterization laboratory and director of cardiovascular clinical research at Baystate Medical Center in Springfield, Mass.
 

What it takes to do TAVR

Transcatheter aortic valves were first approved by the FDA in 2011 for use in patients with severe, inoperable, aortic stenosis. The procedure is now increasingly used as an alternative to surgical AVR in intermediate- and low-risk patients and has a longer history in Europe.

Dr. Goldsweig notes that “TAVR is a complex procedure with many potential challenges. Physicians are trained to diagnose and manage vascular access complications, heart failure and respiratory complications, rhythm disturbances, stroke, paravalvular leak, valve malpositioning/embolization, cardiogenic shock, and any other issues that may arise in the peri-TAVR period.

“Physicians can perform vascular imaging and interventions, transition to alternative access, manage intubation and ventilation, facilitate embolectomy, place a pacemaker, close a paravalvular leak, capture a misplaced valve, deploy mechanical circulatory support, and perform other diagnostic and interventional procedures as necessary that are required for TAVR operators and vastly exceed the training and scope of a nurse practitioner.”

The 2023 ACC/AHA/SCAI advanced training statement on interventional cardiology defines select competencies for interventional cardiologists who choose to focus their career on peripheral, vascular, or structural heart interventions.

In a recent article in Structural Heart, Dr. Goldsweig and colleagues write, “Training in SHD [structural heart disease] has historically been fragmented and informal. Current modes of SHD training include unaccredited fellowship training, industry-sponsored forums and device-specific training, and training through on-site proctorship.”

Such programs have grown “exponentially,” they write, “despite the conspicuous absence of formalized training requirements.”

In response to the John Steele uproar, the British Cardiovascular Intervention Society posted a statement on its website, noting, “As medicine has changed so there has increasingly been a role for allied health practitioners with advanced skills to take on responsibilities that were previously considered to be the domain of doctors ...

“TAVI procedures however carry a mortality risk, and the responsibility for undertaking a successful TAVI procedure will always lie with a Cardiologist who has had the breadth of training to manage the various complications that may occur during or after a procedure. This requires years of training, and there is no short-cut, or substitute.”

The BCIS promises a statement “later in the year [on] the expected training route for undertaking TAVI and other structural heart procedures.”
 

 

 

Why it matters: Scope creep

Despite the current upheaval, it’s not the first time that a nurse in the United Kingdom has performed a procedure normally performed by a medical doctor. A 3-year-old Reddit post on r/JuniorDoctorsUK points to a 2017 Guardian article titled, “Meet the nurse who will soon perform surgery on patients alone.” Although the “surgical care practitioner” seems to be performing within the scope of her practice, people responding to the post say it’s an example of “mid-level [scope] creep.”

More recently, a Reddit post in the same group points to a congratulatory post for a “nurse-led radial access.” One person commented, “Today they do the access. Tomorrow they do the full diagnostic. Day after they do the pressure wire. Next week they do the PCI [percutaneous coronary intervention].”

Broadly, “scope creep” refers to scope-of-practice expansions, but not turf wars, according to Rebekah Bernard, MD, a family physician in Fort Myers, Fla., who cowrote, “Patients at Risk: The Rise of the Nurse Practitioner and Physician Assistant in Healthcare,” with Niran Al-Agba, MD, a pediatrician in Silverdale, Wash.

The reasons behind U.K. scope creep aren’t clear. Some believe it’s money. Some say the system is broken and that doctors are being exploited.

In relation to the NP-TAVI case, the British Junior Cardiologist Association commented that it reflects a lack of support and advocacy for medical/surgical trainees who need the training opportunities that are going instead to allied health professionals.

In the United States, scope creep is being taken seriously (some may say too seriously) by the American Medical Association. The AMA is lobbying to stop “inappropriate scope expansions,” bolstered by its AMA Scope of Practice Partnership.

Pointing to a scope creep video produced by the AMA, one JuniorDoctorsUK Reddit post asks, “why isn’t the BMA doing anything similar?”
 

Time for a rethink?

Back to Glenfield Hospital. Not only has Cardiology Glenfield deleted the controversial tweet; it is now is backtracking on its congratulations to ANP Steele, tweeting, “We want to make clear that the lead operator for the procedure was a consultant structural interventionist. However, we are looking into the circumstances, including a review of clinical governance.” From the responses, few clinicians are buying that explanation.

In response to a request for a comment from Glenfield, Andrew Furlong, UHL medical director, reiterated to this news organization through communications manager Gareth Duggan, “We are investigating the circumstances of the procedure with our cardiology team and reviewing our governance processes.”

Dr. Goldsweig participated in a past speaking engagement for Edwards Lifesciences.

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

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Topics
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Transcatheter aortic valve implantation/replacement (TAVI/TAVR) is typically the domain of cardiac surgeons and interventional cardiologists.

In the United Kingdom, John Steele, an advanced nurse practitioner (ANP) at Glenfield Hospital, part of the University Hospitals of Leicester NHS Trust (UHL), was congratulated on Twitter as “the first nurse-ANP who has performed the whole TAVI procedure as the first operator – true transformation addressing NHS needs.”



The now-deleted tweet from @GHCardiology is still visible in the Twitter thread of Mamas A. Mamas, a professor of interventional cardiology at Keele University, England. “This is so inappropriate on so many levels,” Dr. Mamas tweeted. “This is not safe for patients particularly given that there are numerous TAVI trained medically qualified operators in UK. You have also taken away training opportunities for medical / surgical trainees.”

Other followers also responded, largely negatively.

“This is crazy. Is this @TheOnion???” tweeted Martha Gulati, MD, director of preventive cardiology in the Smidt Heart Institute at Cedars-Sinai, Los Angeles, Calif., in response to Dr. Mamas, referring to the popular satirical news outlet. “Seriously I can’t see this as an actuality given the potential for so many other issues they wouldn’t know how to deal with.”
 

Could it happen in the U.S.?

Could a U.S.-based nurse practitioner perform TAVR? Possibly. Should they? No, says Andrew M. Goldsweig, MD, chair of the U.S. Society for Cardiovascular Angiography and Interventions Structural Heart Council. “Experienced nurse practitioners who have participated as secondary operators in many TAVR procedures and have observed the primary physician operators likely know the technical steps involved in an uncomplicated transfemoral TAVR procedure,” he told this news organization.

“However, a physician’s depth and breadth of training are absolutely required both to recognize and to address any periprocedural issues,” said Dr. Goldsweig, who is also director of the cardiac catheterization laboratory and director of cardiovascular clinical research at Baystate Medical Center in Springfield, Mass.
 

What it takes to do TAVR

Transcatheter aortic valves were first approved by the FDA in 2011 for use in patients with severe, inoperable, aortic stenosis. The procedure is now increasingly used as an alternative to surgical AVR in intermediate- and low-risk patients and has a longer history in Europe.

Dr. Goldsweig notes that “TAVR is a complex procedure with many potential challenges. Physicians are trained to diagnose and manage vascular access complications, heart failure and respiratory complications, rhythm disturbances, stroke, paravalvular leak, valve malpositioning/embolization, cardiogenic shock, and any other issues that may arise in the peri-TAVR period.

“Physicians can perform vascular imaging and interventions, transition to alternative access, manage intubation and ventilation, facilitate embolectomy, place a pacemaker, close a paravalvular leak, capture a misplaced valve, deploy mechanical circulatory support, and perform other diagnostic and interventional procedures as necessary that are required for TAVR operators and vastly exceed the training and scope of a nurse practitioner.”

The 2023 ACC/AHA/SCAI advanced training statement on interventional cardiology defines select competencies for interventional cardiologists who choose to focus their career on peripheral, vascular, or structural heart interventions.

In a recent article in Structural Heart, Dr. Goldsweig and colleagues write, “Training in SHD [structural heart disease] has historically been fragmented and informal. Current modes of SHD training include unaccredited fellowship training, industry-sponsored forums and device-specific training, and training through on-site proctorship.”

Such programs have grown “exponentially,” they write, “despite the conspicuous absence of formalized training requirements.”

In response to the John Steele uproar, the British Cardiovascular Intervention Society posted a statement on its website, noting, “As medicine has changed so there has increasingly been a role for allied health practitioners with advanced skills to take on responsibilities that were previously considered to be the domain of doctors ...

“TAVI procedures however carry a mortality risk, and the responsibility for undertaking a successful TAVI procedure will always lie with a Cardiologist who has had the breadth of training to manage the various complications that may occur during or after a procedure. This requires years of training, and there is no short-cut, or substitute.”

The BCIS promises a statement “later in the year [on] the expected training route for undertaking TAVI and other structural heart procedures.”
 

 

 

Why it matters: Scope creep

Despite the current upheaval, it’s not the first time that a nurse in the United Kingdom has performed a procedure normally performed by a medical doctor. A 3-year-old Reddit post on r/JuniorDoctorsUK points to a 2017 Guardian article titled, “Meet the nurse who will soon perform surgery on patients alone.” Although the “surgical care practitioner” seems to be performing within the scope of her practice, people responding to the post say it’s an example of “mid-level [scope] creep.”

More recently, a Reddit post in the same group points to a congratulatory post for a “nurse-led radial access.” One person commented, “Today they do the access. Tomorrow they do the full diagnostic. Day after they do the pressure wire. Next week they do the PCI [percutaneous coronary intervention].”

Broadly, “scope creep” refers to scope-of-practice expansions, but not turf wars, according to Rebekah Bernard, MD, a family physician in Fort Myers, Fla., who cowrote, “Patients at Risk: The Rise of the Nurse Practitioner and Physician Assistant in Healthcare,” with Niran Al-Agba, MD, a pediatrician in Silverdale, Wash.

The reasons behind U.K. scope creep aren’t clear. Some believe it’s money. Some say the system is broken and that doctors are being exploited.

In relation to the NP-TAVI case, the British Junior Cardiologist Association commented that it reflects a lack of support and advocacy for medical/surgical trainees who need the training opportunities that are going instead to allied health professionals.

In the United States, scope creep is being taken seriously (some may say too seriously) by the American Medical Association. The AMA is lobbying to stop “inappropriate scope expansions,” bolstered by its AMA Scope of Practice Partnership.

Pointing to a scope creep video produced by the AMA, one JuniorDoctorsUK Reddit post asks, “why isn’t the BMA doing anything similar?”
 

Time for a rethink?

Back to Glenfield Hospital. Not only has Cardiology Glenfield deleted the controversial tweet; it is now is backtracking on its congratulations to ANP Steele, tweeting, “We want to make clear that the lead operator for the procedure was a consultant structural interventionist. However, we are looking into the circumstances, including a review of clinical governance.” From the responses, few clinicians are buying that explanation.

In response to a request for a comment from Glenfield, Andrew Furlong, UHL medical director, reiterated to this news organization through communications manager Gareth Duggan, “We are investigating the circumstances of the procedure with our cardiology team and reviewing our governance processes.”

Dr. Goldsweig participated in a past speaking engagement for Edwards Lifesciences.

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

Transcatheter aortic valve implantation/replacement (TAVI/TAVR) is typically the domain of cardiac surgeons and interventional cardiologists.

In the United Kingdom, John Steele, an advanced nurse practitioner (ANP) at Glenfield Hospital, part of the University Hospitals of Leicester NHS Trust (UHL), was congratulated on Twitter as “the first nurse-ANP who has performed the whole TAVI procedure as the first operator – true transformation addressing NHS needs.”



The now-deleted tweet from @GHCardiology is still visible in the Twitter thread of Mamas A. Mamas, a professor of interventional cardiology at Keele University, England. “This is so inappropriate on so many levels,” Dr. Mamas tweeted. “This is not safe for patients particularly given that there are numerous TAVI trained medically qualified operators in UK. You have also taken away training opportunities for medical / surgical trainees.”

Other followers also responded, largely negatively.

“This is crazy. Is this @TheOnion???” tweeted Martha Gulati, MD, director of preventive cardiology in the Smidt Heart Institute at Cedars-Sinai, Los Angeles, Calif., in response to Dr. Mamas, referring to the popular satirical news outlet. “Seriously I can’t see this as an actuality given the potential for so many other issues they wouldn’t know how to deal with.”
 

Could it happen in the U.S.?

Could a U.S.-based nurse practitioner perform TAVR? Possibly. Should they? No, says Andrew M. Goldsweig, MD, chair of the U.S. Society for Cardiovascular Angiography and Interventions Structural Heart Council. “Experienced nurse practitioners who have participated as secondary operators in many TAVR procedures and have observed the primary physician operators likely know the technical steps involved in an uncomplicated transfemoral TAVR procedure,” he told this news organization.

“However, a physician’s depth and breadth of training are absolutely required both to recognize and to address any periprocedural issues,” said Dr. Goldsweig, who is also director of the cardiac catheterization laboratory and director of cardiovascular clinical research at Baystate Medical Center in Springfield, Mass.
 

What it takes to do TAVR

Transcatheter aortic valves were first approved by the FDA in 2011 for use in patients with severe, inoperable, aortic stenosis. The procedure is now increasingly used as an alternative to surgical AVR in intermediate- and low-risk patients and has a longer history in Europe.

Dr. Goldsweig notes that “TAVR is a complex procedure with many potential challenges. Physicians are trained to diagnose and manage vascular access complications, heart failure and respiratory complications, rhythm disturbances, stroke, paravalvular leak, valve malpositioning/embolization, cardiogenic shock, and any other issues that may arise in the peri-TAVR period.

“Physicians can perform vascular imaging and interventions, transition to alternative access, manage intubation and ventilation, facilitate embolectomy, place a pacemaker, close a paravalvular leak, capture a misplaced valve, deploy mechanical circulatory support, and perform other diagnostic and interventional procedures as necessary that are required for TAVR operators and vastly exceed the training and scope of a nurse practitioner.”

The 2023 ACC/AHA/SCAI advanced training statement on interventional cardiology defines select competencies for interventional cardiologists who choose to focus their career on peripheral, vascular, or structural heart interventions.

In a recent article in Structural Heart, Dr. Goldsweig and colleagues write, “Training in SHD [structural heart disease] has historically been fragmented and informal. Current modes of SHD training include unaccredited fellowship training, industry-sponsored forums and device-specific training, and training through on-site proctorship.”

Such programs have grown “exponentially,” they write, “despite the conspicuous absence of formalized training requirements.”

In response to the John Steele uproar, the British Cardiovascular Intervention Society posted a statement on its website, noting, “As medicine has changed so there has increasingly been a role for allied health practitioners with advanced skills to take on responsibilities that were previously considered to be the domain of doctors ...

“TAVI procedures however carry a mortality risk, and the responsibility for undertaking a successful TAVI procedure will always lie with a Cardiologist who has had the breadth of training to manage the various complications that may occur during or after a procedure. This requires years of training, and there is no short-cut, or substitute.”

The BCIS promises a statement “later in the year [on] the expected training route for undertaking TAVI and other structural heart procedures.”
 

 

 

Why it matters: Scope creep

Despite the current upheaval, it’s not the first time that a nurse in the United Kingdom has performed a procedure normally performed by a medical doctor. A 3-year-old Reddit post on r/JuniorDoctorsUK points to a 2017 Guardian article titled, “Meet the nurse who will soon perform surgery on patients alone.” Although the “surgical care practitioner” seems to be performing within the scope of her practice, people responding to the post say it’s an example of “mid-level [scope] creep.”

More recently, a Reddit post in the same group points to a congratulatory post for a “nurse-led radial access.” One person commented, “Today they do the access. Tomorrow they do the full diagnostic. Day after they do the pressure wire. Next week they do the PCI [percutaneous coronary intervention].”

Broadly, “scope creep” refers to scope-of-practice expansions, but not turf wars, according to Rebekah Bernard, MD, a family physician in Fort Myers, Fla., who cowrote, “Patients at Risk: The Rise of the Nurse Practitioner and Physician Assistant in Healthcare,” with Niran Al-Agba, MD, a pediatrician in Silverdale, Wash.

The reasons behind U.K. scope creep aren’t clear. Some believe it’s money. Some say the system is broken and that doctors are being exploited.

In relation to the NP-TAVI case, the British Junior Cardiologist Association commented that it reflects a lack of support and advocacy for medical/surgical trainees who need the training opportunities that are going instead to allied health professionals.

In the United States, scope creep is being taken seriously (some may say too seriously) by the American Medical Association. The AMA is lobbying to stop “inappropriate scope expansions,” bolstered by its AMA Scope of Practice Partnership.

Pointing to a scope creep video produced by the AMA, one JuniorDoctorsUK Reddit post asks, “why isn’t the BMA doing anything similar?”
 

Time for a rethink?

Back to Glenfield Hospital. Not only has Cardiology Glenfield deleted the controversial tweet; it is now is backtracking on its congratulations to ANP Steele, tweeting, “We want to make clear that the lead operator for the procedure was a consultant structural interventionist. However, we are looking into the circumstances, including a review of clinical governance.” From the responses, few clinicians are buying that explanation.

In response to a request for a comment from Glenfield, Andrew Furlong, UHL medical director, reiterated to this news organization through communications manager Gareth Duggan, “We are investigating the circumstances of the procedure with our cardiology team and reviewing our governance processes.”

Dr. Goldsweig participated in a past speaking engagement for Edwards Lifesciences.

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

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Residency match process under scrutiny again, this time by AMA

Article Type
Changed
Fri, 06/30/2023 - 13:15

The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

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The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

The American Medical Association is considering whether to study alternatives to the current residency matching program in an effort to improve residents’ compensation and other job-related issues. A recent call-to-action resolution by the AMA’s House of Delegates is the latest in a long string of debates about whether to change the annual process that matches future doctors with compatible residency programs.

AMA’s Resident and Fellow Section introduced the resolution in March, and the delegates approved it earlier in June at AMA’s annual meeting. The resolution states that the match process of the National Resident Matching Program (NRMP) “poses significant anticompetition concerns.” Those include preventing residents from negotiating for higher wages, better benefits, and improved working conditions, according to the approved resolution.

The full AMA board still has to consider the resolution and hasn’t set a date for that review, though it’s expected to be in the next few months, according to Jennifer Sellers, AMA’s public information officer. She said in an interview that the organization declined to comment, wanting to hold off until the board decides how to proceed.

The NRMP, which oversees the matching process, told this news organization that the AMA doesn’t play a role in the Match.

The organization doesn’t believe studying alternative placement methods benefits applicants and residents, and returning to a pre-Match environment, would harm applicants and programs, according to Donna Lamb, DHSc, MBA, BSN, president and CEO.

“The NRMP has no role in determining, publishing, or setting resident salaries nor does the NRMP have a role in the contracting or employment of residents, and it never has.”

Dr. Lamb said changing the Match would “subject applicants to undue pressure and coercion to accept an offer of training. This will exacerbate disparities in candidate selection already evident in medical education and potentially result in salary reductions in more competitive specialties and in more desirable geographic locations.”

The latest push to reform the match process dates back two decades to a 2002 class action antitrust lawsuit by residents and doctors against the NRMP and other organizations involved in the Match.

The residents argued at that time that by restraining competition among teaching hospitals, the matching system allowed hospitals to keep residents’ wages artificially low. The defendants, which included large teaching hospitals, successfully lobbied Congress for an exemption to the antitrust laws, and the case was subsequently dismissed.

The AMA was one of the defendants, so if it moves forward to review the match process, it likely would pit the organization against the NRMP.

Sherman Marek, the attorney who represented the residents, said in an interview that he was not surprised by the latest AMA resolution. “Maybe the AMA leadership has come around to the idea that it’s better for young physicians to not have the match in place,” he says. “I would applaud that sort of evolution.”

Tyler Ramsey, DO, an internal medicine resident and AMA member, said he believes the group’s current president, Jesse Ehrenfeld, MD, MPH, empathizes with doctors in training. “I think he understands [our] views and is more progressive.”

The NRMP also has considered ways to improve the match process to make it easier and more equitable for applicants. In its latest effort, the organization is studying whether programs should certify their rank order list in advance of applicants. This change would give applicants more flexibility to visit residency locations before the programs consider changing their rankings, Dr. Lamb explained. The NRMP also is mulling the possibilities of a two-phase match after deciding in 2022 not to move forward with a previous version of the proposal.

The recent House of Delegates resolution states that “residents are using other means to obtain fair wages, safe working conditions, and other benefits that are unable to be negotiated within the current system.”

Dr. Ramsey, who trains in North Carolina, said the “other means” may include negotiating through a union. “The AMA realizes that there is a problem and that people are unionizing,” he said. “Obviously, as an organization, we’re not doing something correctly, to the point where people are feeling the need to get their rights a different way.”

The Committee of Interns and Residents, which represents 30,000 members, reported a rise in medical trainee unions across the country in 2022.

Not everyone believes that ditching the Match would benefit applicants and residents. Sam Payabvash, MD, assistant professor of radiology at Yale, New Haven, Conn., School of Medicine, tweeted about the resolution as part of a larger Twitter discussion that alternatives are likely to be “more onerous and expensive for applicants.”

An advantage of the match program, Dr. Lamb argued, is that it “improves the reach of applicants into medically underserved communities through widespread program participation.”

Dr. Ramsey agreed that the match program has benefits and drawbacks, but he believes it favors programs over residents. “It comes as no surprise that numerous residents suffer from depression and our suicide rates are the highest amongst all professions due to the lack of control or negotiation of fair salary and working conditions. Overall, the way things are now, residents just do not have a lot of rights.”

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

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Does colchicine have a role in treating excess ASCVD risk in patients with chronic inflammatory conditions?

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Thu, 08/10/2023 - 12:41

The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.

Potential in rheumatology

The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.

University of Wisconsin
Dr. Christie Bartels

The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.

She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.

However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.



“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”

However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.

Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.

 

 

Possibilities in dermatology

The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.

University of Pennsylvania
Dr. Joel Gelfand

Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.

“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”

Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.

The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.

Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
 

Would side effects bar use in gastroenterology?

Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.

Mayo Clinic
Dr. Edward Loftus Jr.

“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.

Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
 

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The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.

Potential in rheumatology

The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.

University of Wisconsin
Dr. Christie Bartels

The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.

She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.

However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.



“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”

However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.

Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.

 

 

Possibilities in dermatology

The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.

University of Pennsylvania
Dr. Joel Gelfand

Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.

“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”

Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.

The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.

Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
 

Would side effects bar use in gastroenterology?

Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.

Mayo Clinic
Dr. Edward Loftus Jr.

“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.

Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
 

The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.

Potential in rheumatology

The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.

University of Wisconsin
Dr. Christie Bartels

The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.

She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.

However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.



“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”

However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.

Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.

 

 

Possibilities in dermatology

The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.

University of Pennsylvania
Dr. Joel Gelfand

Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.

“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”

Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.

The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.

Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
 

Would side effects bar use in gastroenterology?

Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.

Mayo Clinic
Dr. Edward Loftus Jr.

“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.

Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
 

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MD rushes in after lightning strikes four people at White House

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Fri, 06/30/2023 - 12:05

It was one of those dog days of August where the humidity is palpable and the pressure is so hot and thick you can almost feel the ions in the air. At the time (2022), I was a White House fellow and senior adviser in the West Wing Office of Public Engagement and in the Office of the Vice President.

I was leaving the White House around 7:00 p.m. through the front gate on Lafayette Square. I had a dinner reservation with a friend, so I was in a rush. It was super overcast. Lo and behold, three steps after I closed the gate behind me, it started pouring. Rain came down so hard I had to take shelter.

There’s a stone building in front of the White House with archways, so I took cover underneath one of them, hoping that in a couple of minutes the rain would pass. Behind the archways are these thick, black, iron gates.

Just as I was about to make a run for it, I heard: BOOM!

It was like a bomb had gone off. In one moment, I saw the lightning bolt, heard the thunder, and felt the heat. It was all one rush of sensation. I couldn’t remember having been that scared in a long time.

I thought, “I definitely have to get out of here. In a couple of minutes there might be another strike, and I’m sitting next to iron gates!” I saw a little bit of a window in the downpour, so I started booking it. I knew there was a sheltered Secret Service area around the corner where they park their cars. A much safer place to be.

I was sprinting on the sidewalk and spotted a bunch of Secret Service agents on their bikes riding in the opposite direction, back toward the park. I knew they wouldn’t be out on bikes in this mess without a reason. As they reached me, one agent said, “Clear the sidewalk! We’re coming through with a bunch of equipment.”

I yelled, “What’s going on?”

“Four people were just struck by lightning,” he said as he zoomed past.

I thought: “Sh*t. I have to go back.”

It was like two different parts of my brain were active at the exact same time. My subcortical brain at the level of the amygdala was like: “You just ran from there, idiot. Why are you running back?” And another part of my brain was like: “This is who you are.”

The lightning had struck one of the largest trees in the park. Four bodies splayed out in one direction from the tree. They’d been taking shelter underneath it when they were hit and were blown off to one side. By the time I got there, two Secret Service agents were on the scene doing CPR. Some bystanders had started to run over.

I did a quick round of pulse checks to see everyone’s status, and all four were apneic and pulseless. I told the two Secret Service agents to keep doing compressions on the first person. Two bystanders also began compressions on another person, an older man.

More Secret Service agents arrived, and I said, “We need to do compressions on this other person right now.” One of the agents took a moment to question who I could be and why I was there. I said, “I’m a doctor. I know I’m not dressed like one, but I’m a physician.”

I told some agents to go find an AED, because these people needed to be shocked.

After they left, I was effectively trying to triage which of these four people would get the AED first. Initially, I spent more of my time on the young man, and we began to get some response from him. I then spent some time with the young woman.

It turned out there were AEDs in the pouches on the Secret Service bikes, but they were very small, dinky AEDs. We tried to apply the pads, but it was downpouring so much that the adhesive wouldn’t stick. I told one of the agents we needed a towel.

Through all this I was concerned we were going to be struck again. I mean, the metal statue of Lafayette was right there! They say lighting doesn’t strike in the same place twice, but who knows if that’s really true?

The towel arrived, and we were able to get the chests of the younger people dry enough for the AED pads. We applied two shocks first to the woman, then the young man. We got his pulse back quickly. The woman’s came back as well, but it felt much weaker.

EMS arrived shortly thereafter. We got all four patients on the transport, and they were transferred to the hospital.

The whole experience had taken 14 minutes.

At the time, I felt confident that the young man was going to survive. We’re taught that lightning bolt strikes are survivable if you can shock someone quickly. He also got pretty good CPR. But the next day I was watching the news and learned that he had passed away. So, of course I was thinking the worst about the others as well.

But a week and a half later, I learned that the young woman had been discharged from the ICU. She was the only one who made it. Her name is Amber, and we got connected through a reporter. About 2 weeks later, I invited her to the White House. I took her to the Oval Office. I met her mom and dad and husband, and we had dinner. We’ve been in touch ever since.

I remember the first time we talked on the phone, Amber said something along the lines of, “This sucks. Obviously, I was not planning for any of this to happen. But I also think there’s something good that could come from this.”

I was so surprised and happy to hear her say that. I had something similar happen to me when I was a teenager – caught in the wrong place at the wrong time. I tried to intervene in a gang fight in my neighborhood. I thought a kid was going to get killed, so I jumped in, imagining I could save the day. I didn’t. They broke a bunch of my bones and I was in the hospital for a bit.

I remember thinking then that my life was over. But after some time, I found a new perspective, which was: Maybe that life is over. But maybe this could be the beginning of a new one. And maybe those things that I’ve been afraid of doing, the dreams that I have, maybe now I’m actually free to go after them.

I told Amber, if there are things that you have been waiting to do, this could be the time. She wants to be an international human rights activist, and she is kicking butt in a graduate school program to begin on that pathway. It’s been really cool to watch her chase this dream with way more vigor than she had before.

I think we bonded because we’ve gone through – obviously not the same thing, but a similar moment of being confronted with your own mortality. Realizing that life can just shatter. And so, while we’re here, we might as well go for it with all the force of a person who knows this could all disappear in an instant.

It was an extremely humbling moment. It reaffirmed that my life is not about me. I have to use the time that I’ve got on behalf of other people as much as I can. What is my life about if not being useful?

Dr. Martin is an emergency medicine physician and faculty member at the MGH Center for Social Justice and Health Equity at Harvard Medical School, Boston.

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

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It was one of those dog days of August where the humidity is palpable and the pressure is so hot and thick you can almost feel the ions in the air. At the time (2022), I was a White House fellow and senior adviser in the West Wing Office of Public Engagement and in the Office of the Vice President.

I was leaving the White House around 7:00 p.m. through the front gate on Lafayette Square. I had a dinner reservation with a friend, so I was in a rush. It was super overcast. Lo and behold, three steps after I closed the gate behind me, it started pouring. Rain came down so hard I had to take shelter.

There’s a stone building in front of the White House with archways, so I took cover underneath one of them, hoping that in a couple of minutes the rain would pass. Behind the archways are these thick, black, iron gates.

Just as I was about to make a run for it, I heard: BOOM!

It was like a bomb had gone off. In one moment, I saw the lightning bolt, heard the thunder, and felt the heat. It was all one rush of sensation. I couldn’t remember having been that scared in a long time.

I thought, “I definitely have to get out of here. In a couple of minutes there might be another strike, and I’m sitting next to iron gates!” I saw a little bit of a window in the downpour, so I started booking it. I knew there was a sheltered Secret Service area around the corner where they park their cars. A much safer place to be.

I was sprinting on the sidewalk and spotted a bunch of Secret Service agents on their bikes riding in the opposite direction, back toward the park. I knew they wouldn’t be out on bikes in this mess without a reason. As they reached me, one agent said, “Clear the sidewalk! We’re coming through with a bunch of equipment.”

I yelled, “What’s going on?”

“Four people were just struck by lightning,” he said as he zoomed past.

I thought: “Sh*t. I have to go back.”

It was like two different parts of my brain were active at the exact same time. My subcortical brain at the level of the amygdala was like: “You just ran from there, idiot. Why are you running back?” And another part of my brain was like: “This is who you are.”

The lightning had struck one of the largest trees in the park. Four bodies splayed out in one direction from the tree. They’d been taking shelter underneath it when they were hit and were blown off to one side. By the time I got there, two Secret Service agents were on the scene doing CPR. Some bystanders had started to run over.

I did a quick round of pulse checks to see everyone’s status, and all four were apneic and pulseless. I told the two Secret Service agents to keep doing compressions on the first person. Two bystanders also began compressions on another person, an older man.

More Secret Service agents arrived, and I said, “We need to do compressions on this other person right now.” One of the agents took a moment to question who I could be and why I was there. I said, “I’m a doctor. I know I’m not dressed like one, but I’m a physician.”

I told some agents to go find an AED, because these people needed to be shocked.

After they left, I was effectively trying to triage which of these four people would get the AED first. Initially, I spent more of my time on the young man, and we began to get some response from him. I then spent some time with the young woman.

It turned out there were AEDs in the pouches on the Secret Service bikes, but they were very small, dinky AEDs. We tried to apply the pads, but it was downpouring so much that the adhesive wouldn’t stick. I told one of the agents we needed a towel.

Through all this I was concerned we were going to be struck again. I mean, the metal statue of Lafayette was right there! They say lighting doesn’t strike in the same place twice, but who knows if that’s really true?

The towel arrived, and we were able to get the chests of the younger people dry enough for the AED pads. We applied two shocks first to the woman, then the young man. We got his pulse back quickly. The woman’s came back as well, but it felt much weaker.

EMS arrived shortly thereafter. We got all four patients on the transport, and they were transferred to the hospital.

The whole experience had taken 14 minutes.

At the time, I felt confident that the young man was going to survive. We’re taught that lightning bolt strikes are survivable if you can shock someone quickly. He also got pretty good CPR. But the next day I was watching the news and learned that he had passed away. So, of course I was thinking the worst about the others as well.

But a week and a half later, I learned that the young woman had been discharged from the ICU. She was the only one who made it. Her name is Amber, and we got connected through a reporter. About 2 weeks later, I invited her to the White House. I took her to the Oval Office. I met her mom and dad and husband, and we had dinner. We’ve been in touch ever since.

I remember the first time we talked on the phone, Amber said something along the lines of, “This sucks. Obviously, I was not planning for any of this to happen. But I also think there’s something good that could come from this.”

I was so surprised and happy to hear her say that. I had something similar happen to me when I was a teenager – caught in the wrong place at the wrong time. I tried to intervene in a gang fight in my neighborhood. I thought a kid was going to get killed, so I jumped in, imagining I could save the day. I didn’t. They broke a bunch of my bones and I was in the hospital for a bit.

I remember thinking then that my life was over. But after some time, I found a new perspective, which was: Maybe that life is over. But maybe this could be the beginning of a new one. And maybe those things that I’ve been afraid of doing, the dreams that I have, maybe now I’m actually free to go after them.

I told Amber, if there are things that you have been waiting to do, this could be the time. She wants to be an international human rights activist, and she is kicking butt in a graduate school program to begin on that pathway. It’s been really cool to watch her chase this dream with way more vigor than she had before.

I think we bonded because we’ve gone through – obviously not the same thing, but a similar moment of being confronted with your own mortality. Realizing that life can just shatter. And so, while we’re here, we might as well go for it with all the force of a person who knows this could all disappear in an instant.

It was an extremely humbling moment. It reaffirmed that my life is not about me. I have to use the time that I’ve got on behalf of other people as much as I can. What is my life about if not being useful?

Dr. Martin is an emergency medicine physician and faculty member at the MGH Center for Social Justice and Health Equity at Harvard Medical School, Boston.

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

It was one of those dog days of August where the humidity is palpable and the pressure is so hot and thick you can almost feel the ions in the air. At the time (2022), I was a White House fellow and senior adviser in the West Wing Office of Public Engagement and in the Office of the Vice President.

I was leaving the White House around 7:00 p.m. through the front gate on Lafayette Square. I had a dinner reservation with a friend, so I was in a rush. It was super overcast. Lo and behold, three steps after I closed the gate behind me, it started pouring. Rain came down so hard I had to take shelter.

There’s a stone building in front of the White House with archways, so I took cover underneath one of them, hoping that in a couple of minutes the rain would pass. Behind the archways are these thick, black, iron gates.

Just as I was about to make a run for it, I heard: BOOM!

It was like a bomb had gone off. In one moment, I saw the lightning bolt, heard the thunder, and felt the heat. It was all one rush of sensation. I couldn’t remember having been that scared in a long time.

I thought, “I definitely have to get out of here. In a couple of minutes there might be another strike, and I’m sitting next to iron gates!” I saw a little bit of a window in the downpour, so I started booking it. I knew there was a sheltered Secret Service area around the corner where they park their cars. A much safer place to be.

I was sprinting on the sidewalk and spotted a bunch of Secret Service agents on their bikes riding in the opposite direction, back toward the park. I knew they wouldn’t be out on bikes in this mess without a reason. As they reached me, one agent said, “Clear the sidewalk! We’re coming through with a bunch of equipment.”

I yelled, “What’s going on?”

“Four people were just struck by lightning,” he said as he zoomed past.

I thought: “Sh*t. I have to go back.”

It was like two different parts of my brain were active at the exact same time. My subcortical brain at the level of the amygdala was like: “You just ran from there, idiot. Why are you running back?” And another part of my brain was like: “This is who you are.”

The lightning had struck one of the largest trees in the park. Four bodies splayed out in one direction from the tree. They’d been taking shelter underneath it when they were hit and were blown off to one side. By the time I got there, two Secret Service agents were on the scene doing CPR. Some bystanders had started to run over.

I did a quick round of pulse checks to see everyone’s status, and all four were apneic and pulseless. I told the two Secret Service agents to keep doing compressions on the first person. Two bystanders also began compressions on another person, an older man.

More Secret Service agents arrived, and I said, “We need to do compressions on this other person right now.” One of the agents took a moment to question who I could be and why I was there. I said, “I’m a doctor. I know I’m not dressed like one, but I’m a physician.”

I told some agents to go find an AED, because these people needed to be shocked.

After they left, I was effectively trying to triage which of these four people would get the AED first. Initially, I spent more of my time on the young man, and we began to get some response from him. I then spent some time with the young woman.

It turned out there were AEDs in the pouches on the Secret Service bikes, but they were very small, dinky AEDs. We tried to apply the pads, but it was downpouring so much that the adhesive wouldn’t stick. I told one of the agents we needed a towel.

Through all this I was concerned we were going to be struck again. I mean, the metal statue of Lafayette was right there! They say lighting doesn’t strike in the same place twice, but who knows if that’s really true?

The towel arrived, and we were able to get the chests of the younger people dry enough for the AED pads. We applied two shocks first to the woman, then the young man. We got his pulse back quickly. The woman’s came back as well, but it felt much weaker.

EMS arrived shortly thereafter. We got all four patients on the transport, and they were transferred to the hospital.

The whole experience had taken 14 minutes.

At the time, I felt confident that the young man was going to survive. We’re taught that lightning bolt strikes are survivable if you can shock someone quickly. He also got pretty good CPR. But the next day I was watching the news and learned that he had passed away. So, of course I was thinking the worst about the others as well.

But a week and a half later, I learned that the young woman had been discharged from the ICU. She was the only one who made it. Her name is Amber, and we got connected through a reporter. About 2 weeks later, I invited her to the White House. I took her to the Oval Office. I met her mom and dad and husband, and we had dinner. We’ve been in touch ever since.

I remember the first time we talked on the phone, Amber said something along the lines of, “This sucks. Obviously, I was not planning for any of this to happen. But I also think there’s something good that could come from this.”

I was so surprised and happy to hear her say that. I had something similar happen to me when I was a teenager – caught in the wrong place at the wrong time. I tried to intervene in a gang fight in my neighborhood. I thought a kid was going to get killed, so I jumped in, imagining I could save the day. I didn’t. They broke a bunch of my bones and I was in the hospital for a bit.

I remember thinking then that my life was over. But after some time, I found a new perspective, which was: Maybe that life is over. But maybe this could be the beginning of a new one. And maybe those things that I’ve been afraid of doing, the dreams that I have, maybe now I’m actually free to go after them.

I told Amber, if there are things that you have been waiting to do, this could be the time. She wants to be an international human rights activist, and she is kicking butt in a graduate school program to begin on that pathway. It’s been really cool to watch her chase this dream with way more vigor than she had before.

I think we bonded because we’ve gone through – obviously not the same thing, but a similar moment of being confronted with your own mortality. Realizing that life can just shatter. And so, while we’re here, we might as well go for it with all the force of a person who knows this could all disappear in an instant.

It was an extremely humbling moment. It reaffirmed that my life is not about me. I have to use the time that I’ve got on behalf of other people as much as I can. What is my life about if not being useful?

Dr. Martin is an emergency medicine physician and faculty member at the MGH Center for Social Justice and Health Equity at Harvard Medical School, Boston.

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

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AHA statement addresses equity in cardio-oncology care

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Mon, 07/03/2023 - 10:05

A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.

A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.

For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.

With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.

Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.

These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.

The scientific statement was published online in Circulation.
 

Evidence gaps and the path forward

“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.

Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.

They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.

The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.

These include the following:

  • Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
  • Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
  • Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
  • Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
  • Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.

“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.

The research had no commercial funding. No conflicts of interest were reported.

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

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A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.

A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.

For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.

With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.

Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.

These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.

The scientific statement was published online in Circulation.
 

Evidence gaps and the path forward

“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.

Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.

They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.

The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.

These include the following:

  • Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
  • Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
  • Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
  • Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
  • Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.

“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.

The research had no commercial funding. No conflicts of interest were reported.

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

A new scientific statement from the American Heart Association focuses on equity in cardio-oncology care and research.

A “growing body of evidence” suggests that women and people from underrepresented patient groups experience disproportionately higher cardiovascular effects from new and emerging anticancer therapies, the writing group, led by Daniel Addison, MD, with the Ohio State University, Columbus, pointed out.

For example, women appear to be at higher risk of immune checkpoint inhibitor–related toxicities, whereas Black patients with cancer face up to a threefold higher risk of cardiotoxicity with anticancer therapies.

With reduced screening and delayed preventive measures, Hispanic patients have more complex heart disease, cancer is diagnosed at later stages, and they receive more cardiotoxic regimens because of a lack of eligibility for novel treatments. Ultimately, this contributes to a higher incidence of treatment complications, cardiac dysfunction, and adverse patient outcomes for this patient group, they write.

Although no studies have specifically addressed cardio-oncology disparities in the LGBTQIA+ population, such disparities can be inferred from known cardiovascular disease and oncology disparities, the writing group noted.

These disparities are supported by “disparately high” risk of death after a cancer diagnosis among women and individuals from underrepresented groups, even after accounting for socioeconomic and behavioral patterns, they pointed out.

The scientific statement was published online in Circulation.
 

Evidence gaps and the path forward

“Despite advances in strategies to limit the risks of cardiovascular events among cancer survivors, relatively limited guidance is available to address the rapidly growing problem of disparate cardiotoxic risks among women and underrepresented patient populations,” the writing group said.

Decentralized and sporadic evaluations have led to a lack of consensus on the definitions, investigations, and potential optimal strategies to address disparate cardiotoxicity with contemporary cancer immunotherapy, as well as biologic and cytotoxic therapies, they noted.

They said caution is needed when interpreting clinical trial data about cardiotoxicity and in generalizing the results because people from diverse racial and ethnic groups have not been well represented in many trials.

The writing group outlined key evidence gaps and future research directions for addressing cardio-oncology disparities, as well as strategies to improve equity in cardio-oncology care and research.

These include the following:

  • Identifying specific predictive factors of long-term cardiotoxic risk with targeted and immune-based cancer therapies in women and underrepresented populations.
  • Investigating biological mechanisms that may underlie differences in cardiotoxicities between different patient groups.
  • Developing personalized cardioprotection strategies that integrate biological, genetic, and social determinant markers.
  • Intentionally diversifying clinical trials and identifying optimal strategies to improve representation in cancer clinical trials.
  • Determining the role of technology, such as artificial intelligence, in improving cardiotoxicity disparities.

“Conscientiously leveraging technology and designing trials with outcomes related to these issues in practice (considering feasibility and cost) will critically accelerate the field of cardio-oncology in the 21st century. With tangible goals, we can improve health inequities in cardio-oncology,” the writing group said.

The research had no commercial funding. No conflicts of interest were reported.

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

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Indefinite anticoagulation likely not cost effective after unprovoked VTE

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Changed
Thu, 06/29/2023 - 16:41

Continuing anticoagulation indefinitely in patients with a first unprovoked venous thromboembolism (VTE) may have benefits for certain patients but is unlikely to be cost effective, say authors of a new study.

Continued anticoagulation for such patients “has little chance of improving life expectancy but might provide a mortality benefit in certain subgroups including patients with an initial PE (pulmonary embolism) or those at a very low risk for major bleeding,” wrote the authors, led by Faizan Khan, PhD, with the O’Brien Institute for Public Health, University of Calgary (Alta.).

Therefore, shared decision-making between patients with unprovoked VTE and physicians that includes discussion of preferences and values and use of validated prediction tools is important.

The authors noted that some patients might value avoiding morbidities of recurrent VTE the most and want to have lifelong anticoagulation. Some might be more fearful of major bleeding than VTE repercussions or don’t want the inconveniences of taking anticoagulants for a lifetime.

The findings were published in Annals of Internal Medicine.
 

Current guidelines recommend indefinite anticoagulation

Clinical practice guidelines now recommend indefinite anticoagulation for a first unprovoked VTE.

The authors did a modeling study in a hypothetical cohort of 1,000 patients aged 55 years with a first unprovoked VTE who had completed 3-6 months of initial anticoagulation. The study found indefinite anticoagulation, compared with discontinuing anticoagulation, on average, resulted in 368 fewer recurrent VTE events and 14 fewer fatal PE events.

At the same time, indefinite coagulation in the hypothetical group induced an additional 114 major bleeding events, 30 intracerebral hemorrhages, and 11 fatal bleeding events over 40 years.

As for cost effectiveness, from the perspective of Canada’s health care system, continuing anticoagulation indefinitely, on average, increased costs by $16,014 Canadian dollars per person ($12,140 USD) without improving quality-adjusted life-years (incremental difference, 0.075 per person; 95% uncertainty interval, –0.192 to 0.017).

The authors noted that cost is a prime consideration as the estimated annual health care costs of VTE and its complications is $600 Canadian dollars ($7 billion–$10 billion USD).
 

High probability of small benefit

The authors spelled out the small benefit in patients with an initial PE.

According to the study, indefinite anticoagulation would result in an 80% probability of a marginal added clinical benefit (average increase of 57 days of perfect health over a lifetime) in patients with an initial PE (but with only a 24% chance of being cost effective).

“This high probability of an additional clinical benefit is plausible due to the higher proportion of recurrent VTE events presenting as PE (approximately 70% of episodes) in patients initially presenting with PE, in turn, resulting in a two- to threefold higher case-fatality rate of recurrent VTE in this patient subgroup.”
 

Tools to estimate bleeding risk imprecise

Scott Woller, MD, an internal medicine specialist and chair of medicine at Intermountain Medical Center, Murray, Utah, said in an interview that these results should help physicians’ discuss with their patients about duration of anticoagulation after the treatment phase.

He noted that the authors suggest that a low estimated annual risk for major bleeding should be assumed (< 0.67%) to make the choice for indefinite anticoagulation.

“This is a sticky wicket,” he said, “as tools to estimate bleeding risk among VTE patients are presently imprecise. For these reasons PCPs should take into account patient risk estimates – and the limitations that exist surrounding how we calculate these estimates – in addition to their values and preferences. This is really key in electing duration of anticoagulation.” 

A limitation of the study is that the model assumed that risks for recurrent VTE and major bleeding in clinical trials at 1 year remained constant during extended anticoagulation.

Dr. Woller said about that limitation: “One might argue that this is unlikely; age is a risk factor for major bleeding and therefore risks may be underestimated. However, in the ‘real world’ those that are perceived at lowest risk and demonstrate good tolerance to anticoagulation might likely preferentially continue anticoagulants and therefore risks may be overestimated.”

One coauthor reported being a clinical investigator for trials sponsored by Pfizer and Bristol-Myers Squibb and receiving honoraria from Pfizer, Sanofi and Aspen Pharma. The other authors disclosed no other relevant financial relationships. Dr. Woller is cochair of the CHEST guidelines on the treatment of venous thromboembolic disease.

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Continuing anticoagulation indefinitely in patients with a first unprovoked venous thromboembolism (VTE) may have benefits for certain patients but is unlikely to be cost effective, say authors of a new study.

Continued anticoagulation for such patients “has little chance of improving life expectancy but might provide a mortality benefit in certain subgroups including patients with an initial PE (pulmonary embolism) or those at a very low risk for major bleeding,” wrote the authors, led by Faizan Khan, PhD, with the O’Brien Institute for Public Health, University of Calgary (Alta.).

Therefore, shared decision-making between patients with unprovoked VTE and physicians that includes discussion of preferences and values and use of validated prediction tools is important.

The authors noted that some patients might value avoiding morbidities of recurrent VTE the most and want to have lifelong anticoagulation. Some might be more fearful of major bleeding than VTE repercussions or don’t want the inconveniences of taking anticoagulants for a lifetime.

The findings were published in Annals of Internal Medicine.
 

Current guidelines recommend indefinite anticoagulation

Clinical practice guidelines now recommend indefinite anticoagulation for a first unprovoked VTE.

The authors did a modeling study in a hypothetical cohort of 1,000 patients aged 55 years with a first unprovoked VTE who had completed 3-6 months of initial anticoagulation. The study found indefinite anticoagulation, compared with discontinuing anticoagulation, on average, resulted in 368 fewer recurrent VTE events and 14 fewer fatal PE events.

At the same time, indefinite coagulation in the hypothetical group induced an additional 114 major bleeding events, 30 intracerebral hemorrhages, and 11 fatal bleeding events over 40 years.

As for cost effectiveness, from the perspective of Canada’s health care system, continuing anticoagulation indefinitely, on average, increased costs by $16,014 Canadian dollars per person ($12,140 USD) without improving quality-adjusted life-years (incremental difference, 0.075 per person; 95% uncertainty interval, –0.192 to 0.017).

The authors noted that cost is a prime consideration as the estimated annual health care costs of VTE and its complications is $600 Canadian dollars ($7 billion–$10 billion USD).
 

High probability of small benefit

The authors spelled out the small benefit in patients with an initial PE.

According to the study, indefinite anticoagulation would result in an 80% probability of a marginal added clinical benefit (average increase of 57 days of perfect health over a lifetime) in patients with an initial PE (but with only a 24% chance of being cost effective).

“This high probability of an additional clinical benefit is plausible due to the higher proportion of recurrent VTE events presenting as PE (approximately 70% of episodes) in patients initially presenting with PE, in turn, resulting in a two- to threefold higher case-fatality rate of recurrent VTE in this patient subgroup.”
 

Tools to estimate bleeding risk imprecise

Scott Woller, MD, an internal medicine specialist and chair of medicine at Intermountain Medical Center, Murray, Utah, said in an interview that these results should help physicians’ discuss with their patients about duration of anticoagulation after the treatment phase.

He noted that the authors suggest that a low estimated annual risk for major bleeding should be assumed (< 0.67%) to make the choice for indefinite anticoagulation.

“This is a sticky wicket,” he said, “as tools to estimate bleeding risk among VTE patients are presently imprecise. For these reasons PCPs should take into account patient risk estimates – and the limitations that exist surrounding how we calculate these estimates – in addition to their values and preferences. This is really key in electing duration of anticoagulation.” 

A limitation of the study is that the model assumed that risks for recurrent VTE and major bleeding in clinical trials at 1 year remained constant during extended anticoagulation.

Dr. Woller said about that limitation: “One might argue that this is unlikely; age is a risk factor for major bleeding and therefore risks may be underestimated. However, in the ‘real world’ those that are perceived at lowest risk and demonstrate good tolerance to anticoagulation might likely preferentially continue anticoagulants and therefore risks may be overestimated.”

One coauthor reported being a clinical investigator for trials sponsored by Pfizer and Bristol-Myers Squibb and receiving honoraria from Pfizer, Sanofi and Aspen Pharma. The other authors disclosed no other relevant financial relationships. Dr. Woller is cochair of the CHEST guidelines on the treatment of venous thromboembolic disease.

Continuing anticoagulation indefinitely in patients with a first unprovoked venous thromboembolism (VTE) may have benefits for certain patients but is unlikely to be cost effective, say authors of a new study.

Continued anticoagulation for such patients “has little chance of improving life expectancy but might provide a mortality benefit in certain subgroups including patients with an initial PE (pulmonary embolism) or those at a very low risk for major bleeding,” wrote the authors, led by Faizan Khan, PhD, with the O’Brien Institute for Public Health, University of Calgary (Alta.).

Therefore, shared decision-making between patients with unprovoked VTE and physicians that includes discussion of preferences and values and use of validated prediction tools is important.

The authors noted that some patients might value avoiding morbidities of recurrent VTE the most and want to have lifelong anticoagulation. Some might be more fearful of major bleeding than VTE repercussions or don’t want the inconveniences of taking anticoagulants for a lifetime.

The findings were published in Annals of Internal Medicine.
 

Current guidelines recommend indefinite anticoagulation

Clinical practice guidelines now recommend indefinite anticoagulation for a first unprovoked VTE.

The authors did a modeling study in a hypothetical cohort of 1,000 patients aged 55 years with a first unprovoked VTE who had completed 3-6 months of initial anticoagulation. The study found indefinite anticoagulation, compared with discontinuing anticoagulation, on average, resulted in 368 fewer recurrent VTE events and 14 fewer fatal PE events.

At the same time, indefinite coagulation in the hypothetical group induced an additional 114 major bleeding events, 30 intracerebral hemorrhages, and 11 fatal bleeding events over 40 years.

As for cost effectiveness, from the perspective of Canada’s health care system, continuing anticoagulation indefinitely, on average, increased costs by $16,014 Canadian dollars per person ($12,140 USD) without improving quality-adjusted life-years (incremental difference, 0.075 per person; 95% uncertainty interval, –0.192 to 0.017).

The authors noted that cost is a prime consideration as the estimated annual health care costs of VTE and its complications is $600 Canadian dollars ($7 billion–$10 billion USD).
 

High probability of small benefit

The authors spelled out the small benefit in patients with an initial PE.

According to the study, indefinite anticoagulation would result in an 80% probability of a marginal added clinical benefit (average increase of 57 days of perfect health over a lifetime) in patients with an initial PE (but with only a 24% chance of being cost effective).

“This high probability of an additional clinical benefit is plausible due to the higher proportion of recurrent VTE events presenting as PE (approximately 70% of episodes) in patients initially presenting with PE, in turn, resulting in a two- to threefold higher case-fatality rate of recurrent VTE in this patient subgroup.”
 

Tools to estimate bleeding risk imprecise

Scott Woller, MD, an internal medicine specialist and chair of medicine at Intermountain Medical Center, Murray, Utah, said in an interview that these results should help physicians’ discuss with their patients about duration of anticoagulation after the treatment phase.

He noted that the authors suggest that a low estimated annual risk for major bleeding should be assumed (< 0.67%) to make the choice for indefinite anticoagulation.

“This is a sticky wicket,” he said, “as tools to estimate bleeding risk among VTE patients are presently imprecise. For these reasons PCPs should take into account patient risk estimates – and the limitations that exist surrounding how we calculate these estimates – in addition to their values and preferences. This is really key in electing duration of anticoagulation.” 

A limitation of the study is that the model assumed that risks for recurrent VTE and major bleeding in clinical trials at 1 year remained constant during extended anticoagulation.

Dr. Woller said about that limitation: “One might argue that this is unlikely; age is a risk factor for major bleeding and therefore risks may be underestimated. However, in the ‘real world’ those that are perceived at lowest risk and demonstrate good tolerance to anticoagulation might likely preferentially continue anticoagulants and therefore risks may be overestimated.”

One coauthor reported being a clinical investigator for trials sponsored by Pfizer and Bristol-Myers Squibb and receiving honoraria from Pfizer, Sanofi and Aspen Pharma. The other authors disclosed no other relevant financial relationships. Dr. Woller is cochair of the CHEST guidelines on the treatment of venous thromboembolic disease.

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Placebo effect can be found in a cup of coffee

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Changed
Thu, 06/29/2023 - 09:15

 

The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

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The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

 

The best part of waking up is placebo in your cup

Coffee makes the world go round. It’s impossible to picture any workplace without a cast of forlorn characters huddled around the office coffee maker on a Monday morning, imbibing their beverage du jour until they’ve been lifted out of their semi-zombified stupor.

PxHere

Millions upon millions of people swear by their morning coffee. And if they don’t get that sweet, sweet caffeine boost, they’ll make Garfield and the Boomtown Rats’ opinions of Mondays look tame. And it only makes sense that they’d believe that. After all, caffeine is a stimulant. It helps your brain focus and kicks it into overdrive. Of course drinking a beverage full of caffeine wakes you up. Right?

Not so fast, a group of Portuguese researchers say. That morning cup of coffee? It may actually be a placebo. Cue the dramatic sound effect.

Here’s the scoop: After recruiting a group of coffee drinkers (at least one cup a day), the researchers kept their test subjects off of coffee for at least 3 hours, then performed a brief functional MRI scan on all test subjects. Half an hour later, study participants received either a standard cup of coffee or pure caffeine. Half an hour after consuming their respective study product, the subjects underwent a second MRI.

As expected, both people who consumed coffee and those who consumed pure caffeine showed decreased connectivity in the default mode network after consumption, indicating preparation in the brain to move from resting to working on tasks. However, those who had pure caffeine did not show increased connectivity in the visual and executive control networks, while those who had coffee did. Simply put, caffeine may wake you up, but it doesn’t make you any sharper. Only coffee gets you in shape for that oh-so-important Monday meeting.

This doesn’t make a lot of sense. How can the drug part of coffee not be responsible for every effect the drink gives you? That’s where the placebo comes in, according to the scientists. It’s possible the effect they saw was caused by withdrawal – after just 3 hours? Yikes, hope not – but it’s more likely it comes down to psychology. We expect coffee to wake us up and make us ready for the day, so that’s exactly what it does. Hey, if that’s all it takes, time to convince ourselves that eating an entire pizza is actually an incredibly effective weight loss tool. Don’t let us down now, placebo effect.
 

Bread, milk, toilet paper, AFib diagnosis

Now consider the shopping cart. It does its job of carrying stuff around the store well enough, but can it lift you out of a semi-zombified stupor in the morning? No. Can it identify undiagnosed atrial fibrillation? Again, no.

Gustavo Fring

Not so fast, say the investigators conducting the SHOPS-AF (Supermarket/Hypermarket Opportunistic Screening for Atrial Fibrillation) study. They built a better shopping cart. Except they call it a trolley, not a cart, since the study was conducted in England, where they sometimes have funny names for things.

Their improved shopping trolley – we’re just going to call it a cart from here on – has an electrocardiogram sensor embedded into the handlebar, so it can effectively detect AFib in shoppers who held it for at least 60 seconds. The sensor lights up red if it detects an irregular heartbeat and green if it does not. Let’s see a cup of coffee do that.

They put 10 of these modified carts in four supermarkets in Liverpool to see what would happen. Would shoppers be able to tell that we secretly replaced the fine coffee they usually serve with Folger’s crystals? Oops. Sorry about that. Coffee on the brain, apparently. Back to the carts.

A total of 2,155 adult shoppers used one of the carts over 2 months, and electrocardiogram data were available for 220 participants who either had a red light on the sensor and/or an irregular pulse that suggested atrial fibrillation. After further review by the SHOPS-AF cardiologist, AFib was diagnosed in 59 shoppers, of whom 39 were previously undiagnosed.

They’re already working to cut the scan time to 30 seconds for SHOPS-AF II, but we’re wondering about a possible flaw in the whole health-care-delivery-through-shopping-cart scenario. When we go to the local super/hyper/megamart, it seems like half of the people trundling up and down the aisles are store employees filling orders for customers who won’t even set foot inside. Is the shopping cart on its way out? Maybe. Who wants to tell the SHOPS-AF II team? Not us.
 

 

 

Put pneumonia where your mouth is

Getting dentures does not mean the end of dental care. If anything, new research reveals a huge reason for staying on top of one’s denture care: pneumonia.

Pxfuel

It all started with swabs. Scientists in the United Kingdom took mouth, tongue, and denture specimens from frail elderly hospital patients who had pneumonia and wore dentures and from similar patients in care homes who wore dentures and did not have pneumonia. When they compared the microbial populations of the two groups, the investigators found about 20 times the number of respiratory pathogens on the dentures of those with pneumonia.

The research team suggested that dentures may play a role in causing pneumonia, but lead author Josh Twigg, BDS, PhD, also noted that “you certainly couldn’t say that people got pneumonia because they were wearing dentures. It’s just showing that there is an association there.” Improper cleaning, though, could lead to microbial colonization of the dentures, and patients could be inhaling those microbes into their lungs, thereby turning a dental issue into a respiratory issue.

More research needs to be done on the association between dentures and pneumonia, but Dr. Twigg hoped that the results of this study could be presented to the public. The message? “It is important to clean dentures thoroughly” and visit the dentist regularly, he said, but the best way to prevent denture-related infections is to avoid needing to wear dentures entirely.

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Physician suicide roundtable: 8 important initiatives that can help 

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Changed
Mon, 07/03/2023 - 12:48

Physician suicide continues to be a challenging problem in the United States. Each year, 1 in 10 doctors think about or attempt suicide, and 400 die by suicide each year. More than half of the doctors reading this know a colleague who has attempted or died by suicide.

This news organization recently sat down with three psychiatric experts to talk about the newest risk-reduction initiatives. These are part of a public health suicide prevention strategy, the preferred method for prevention, in hospitals and institutions around the country. A public health model for preventing suicide is a multifaceted approach that includes universal education, health promotion, selective and targeted prevention, and treatment and recovery. 

These physicians hope to continue creating and implementing these and other risk-reduction measures across all health care organizations.
 

Our physician experts for this discussion

Mary Moffit, PhD, is an associate professor in the department of psychiatry at Oregon Health & Science University, Portland. She directs the resident and faculty wellness program and is director of the OHSU peer support program. She helped design and developed a comprehensive wellness program that is now a national model for academic medical centers.

Christine Yu Moutier, MD, is the chief medical officer of the American Foundation for Suicide Prevention. She is the author of “Suicide Prevention,” a Cambridge University Press clinical handbook. She has been a practicing psychiatrist, professor of psychiatry, dean in the medical school at the University of California, San Diego, and medical director of the inpatient psychiatric unit at the VA Medical Center in La Jolla, Calif.

Michael F. Myers, MD, is a professor of clinical psychiatry in the department of psychiatry & behavioral sciences at the State University of New York, Brooklyn. He is recent past vice-chair of education and director of training in the department of psychiatry & behavioral sciences at the university. He is the author of several books, including “Why Physicians Die By Suicide,” “The Physician as Patient,” and “Touched by Suicide.”

The participants discussed these risk-reduction initiatives as having much potential for helping physicians at risk for suicide and suicidal ideations.
 

The importance of peer support programs

Peer support program models may differ across institutions but typically describe colleagues providing some degree of emotional first aid to peers who may be at risk.

Dr. Moffit: The Pew support program that we have in place at OHSU, similar to what’s available in many hospitals and systems nationwide, trains individual physicians across multiple specialties in a peer support model. It’s not specifically emotional first aid, although that’s integral to it. It’s also for adverse events: Having a tragic patient death, having learned that you will be named in a lawsuit, and exposure to trauma in the medical role.

Peer to peer is not where we anticipate physicians seeking someone to talk to about their marital relationship not going well. However, the peer supporter will know about resources throughout the university and the community for what is needed. We’ve got 20-30 peer supporters. We try to match them – for example, a surgeon with a surgeon, a primary care doc with a primary care doc. Physicians who use peer support aren’t tracked, and no notes are taken or documented. It takes place informally but has changed the culture and lowered a barrier. We have a waiting list of people who want to be peer supporters. 

Dr. Moutier: Peer-to-peer support is usually part of a multi-pronged program and is usually not the only effort going on. Depending on how they’re set up, the goals may be slightly different for each program. Peer-to-peer can be one of the most powerful ways to augment awareness raising and education, which is almost always a basic first step.

Dr. Myers: It doesn’t feel as threatening when people start in a peer-to-peer support group. Users may have been afraid of getting a mental health diagnosis, but with peers, many of whom are often not psychiatrists, that eases distress. Peer support can break down that sense of isolation and loneliness so that someone can take the next step.

Dr. Moutier: To be connected to family, to any community resource, frankly, is a protective factor that mitigates suicide risk. So that’s the logic model from a suicide prevention standpoint. It may be the only opportunity for someone to start disclosing what they’re experiencing, receive validation and support, and not a judgmental response. It can open up the avenue toward help-seeking.

Opt-in/opt-out support for medical residents

This initiative matches residents with a counselor as part of their orientation.

Dr. Moffit: Each resident has a meet and greet with a counselor when they arrive or in their first 6 months at their university. The resident can opt out and cancel the meeting, but they’re scheduled for it as part of their “curriculum.” Institutions like Michigan, Columbia, Montefiore, Mount Sinai, and the University of California, San Diego, have this in place. It starts something like: ‘Hello. Good afternoon. How’s it going? I’m Dr. Moffitt, and here are the services available in this program.’

Dr. Myers: It’s another excellent example of normalizing the stress in the rigors of training and making it part of the wellness initiative.

Dr. Moutier:  It’s just a normal part of orientation. Again, as a universal strategy, one thing that I was doing at UCSD with a particular group of medical students, who were at higher risk, was a postbaccalaureate program that found students from underrepresented, under-resourced backgrounds and brought them into this post-bacc year. I was directing it and mentoring these students.

So, I could afford a lot more intensive time and attention to them because it was a small group, but every one of them had regular meetings with me every 2 weeks. My approach was to help them uncover their unique strengths and vulnerabilities as they started this program. They all made it into med school.

It was a very intensive and more concierge-personalized approach. It’s like personalized medicine. What specific self-care, mentoring, and mental health care plan would each student codesign with me to stay on track?

And it would involve very holistic things, like if part of their vulnerability was that leaving their Chicano family was creating stress because their father had said: ‘You’re leaving our culture and our family by going into the profession of medicine,’ then we had specific plans around how to care for that aspect of their struggle. It was a much more informed, customized mentoring approach called the UCSD CAP (Conditional Acceptance Post-Baccalaureate Program). It could be a feature in a more specialized opt-in/opt-out program.
 

 

 

One-question survey: How full is your gas tank?

This initiative is a one-question survey emailed/texted to residents to check in on their wellness. We ask, how full is your gas tank? Select 1 to 5 (Empty to Full). If they flag low, they receive a follow-up.

Dr. Moffit: It’s certainly a metaphor that we use. It’s the idea of being depleted in combination with being extremely sleep deprived and the inability to access the usual sources of support or outlets, and how that can create a perfect storm of a level of distress that can put physicians at risk.

Dr. Moutier: It is a way to help people realize that there are things they can do proactively to keep that tank at least somewhat full enough.

Dr. Myers: Using colloquial or figurative language can get better buy-in than “Here’s a PHQ-9.” It also has a caring or intimate tone to it. Somebody could feel they’re a 1 in this rotation but a 4-5 the next. We know from a lot of the literature that when residents get a good, welcoming orientation, their satisfaction with that rotation is uniformly better than if they’re thrown to the wolves. And we know trial by fire can put trainees at risk.

A buddy to check in with

This initiative is when you’re assigned a buddy in or out of residency that you regularly check in with about how you’re doing.

Dr. Myers: Not to be cynical, but there has been some mentor/mentee research that if you’re assigned a mentor, the results are not nearly as good. And if it’s left to the individual to find a mentor, results could be marginal as well. You need a guide to say, ‘Here are some potential mentors for you, but you decide.’ We do a lot of that at (SUNY) Downstate instead of assigning a person. So, it may require some oversight. Picking a check-in buddy from a list provided rather than having one assigned may be more beneficial.

A lot of what we’re talking about are universal strategies that allow for increased interpersonal connection, which is a protective factor that normalizes help-seeking.
 

A platform or social media forum to share experiences

An online forum or platform where medical students, residents, and physicians can discuss mental health and suicide prevention. Physicians with personal experience could provide testimonials.

Dr. Myers: I’ve recently signed a book contract, and the working title is “Physicians With Lived Experience: How Their Stories Give Clinical Guidance.” When I talk with doctors who have published their personal stories in the New England Journal of Medicine, JAMA, or sometimes The Washington Post or The New York Times, many of them have said they had no idea at the beginning of their journey that they would do something like this: be transparent about their story. It’s a measure of their health, growth, and grace.

Dr. Moutier: The current president of the Academic Association of Surgeons, Carrie Cunningham, MD, MPH, used her platform at the annual AAS conference in 2022 to focus on suicide prevention. She told her own recent story of having gotten into recovery after having been near suicide and struggling with addiction. It was a groundbreaking moment for the field of surgery and produced a ripple effect. She risked everything to tell her story, which was highly emotional since it was still raw. It got everyone engaged, a real turning point for that field. Storytelling and a place for trainees to discuss suicide prevention, and physicians to recall their lived experiences can be highly beneficial.

 

 

Interactive Screening Program

The Interactive Screening Program (ISP) is used in higher education to allow physicians to take a safe, confidential screening test and receive a personalized response that can connect them to mental health services before a crisis emerges.

Dr. Moutier: ISP is a tool within a public health model that can afford anonymity to the user so they can safely have their needs addressed. It’s a way for high-risk individuals to sync up with treatment and support. It’s sometimes used in the universal approach because it can be offered to everyone within the health system community of physicians and staff.

It can produce a ripple effect of normalizing that we all have mental health to take care of. Its intended value is in identifying those with a higher risk for suicide, but it doesn’t stop at identifying those at risk. It helps physicians move past a stage of suffering in silence.

Our data show that 86% of a very high-risk group (currently having suicidal ideation, a recent attempt, or other high-risk factors for suicide) aren’t in any form of treatment and have not disclosed their situation to anyone. A fairly high percentage of those going through ISP request a referral to treatment. It’s a unique, very niche tool, and because users remain anonymous, that affords safety around confidentiality.

It’s usually part of a multipronged approach with education, stigma reduction, storytelling, peer support, and other modalities. In my experience with the UCSD HEAR (Healer Assessment Education and Recovery) program, which is still going strong in about its 15th year, the program went from seeing 13 physicians die by suicide in the years leading up to its launch and in the 15 years since it’s been going, one suicide. We all believe that the ISP is the heart of prevention.

Even though all of the universal strategies are important, they probably wouldn’t be sufficient by themselves because the risk [for suicide] is dynamic, and you have to catch people when they are suffering and ready to seek treatment. Suicide prevention is challenging and must be strategic, multifaceted, and sustained over time.
 

The importance of confidentiality for physicians

In the past, physicians may have been hesitant to seek treatment when struggling with mental health, substance use disorder and suicidal ideations because they heard stories from doctors who said they had to disclose mental health treatment to medical and state licensing boards.

Dr. Myers: There is so much dated stuff out there, and it gets propagated by people who have had a bad experience. I’m not challenging the authenticity of that, but I feel like those are in the minority. The vast majority of people are seeking help. The Federation of State Physician Health Programs is working with state boards to update and get rid of antiquated questions, and they’re working with credentialing groups.

When I was in practice and my patient was petrified of having to come into the hospital [because of confidentiality] I would just be their physician and say: “Look, I know that this is a worry for you [licensing and credentialing issues] but trust me, I’m going to help you get well; that’s my job. And I’m going to help you sort all that out afterward.” It was part of my work as their physician that if they were going to have to jump through hurdles to get their license reinstated, etc., I could help. 

The Dr. Lorna Breen Heroes’ Foundation is also doing so much good work in this area, especially with their toolkits to audit, change, remove, and communicate the changes about intrusive language in licensing applications and credentialing. (Dr. Breen was a New York City ED physician who died by suicide in April 2020 during the early days and height of the COVID-19 pandemic. Her father was quoted as saying: “She was in the trenches. She was a hero.”)

Dr. Moutier: We’re seeing hundreds of physicians get therapy and psychiatric treatment annually. And the advocacy effort is incredibly important, and I think we are witnessing a swifter pace to eliminate those inappropriate and illegal questions about mental health and mental health treatment for physicians and nurses.

Dr. Moffit: We have lowered barriers, not only in individual institutions but also with programming. We have also worked with the Federation of State Medical Boards and The Lorna Breen Foundation to change the legislation. The Foundation has audited and changed 20 state medical boards to remove intrusive language from licensing applications.

Support for colleagues working to help each other

Dr. Myers: One final note for those physicians who need to take time out for medical leave: In my clinical experience, I find that they felt lonely as they were getting well. I can’t tell you how much it made a difference for those who received a phone call, a card, or an email from their colleagues at work. It doesn’t take long for a vibrant, active physician to feel out of the loop when ill.

We know from suicide literature that when somebody’s discharged from the hospital or the emergency department, caring communications, brief expressions of care and concern by email, letter, card, text message, etc., can make all the difference to their recovery. Reaching out to those struggling and those in recovery can help your fellow physician.

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

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Physician suicide continues to be a challenging problem in the United States. Each year, 1 in 10 doctors think about or attempt suicide, and 400 die by suicide each year. More than half of the doctors reading this know a colleague who has attempted or died by suicide.

This news organization recently sat down with three psychiatric experts to talk about the newest risk-reduction initiatives. These are part of a public health suicide prevention strategy, the preferred method for prevention, in hospitals and institutions around the country. A public health model for preventing suicide is a multifaceted approach that includes universal education, health promotion, selective and targeted prevention, and treatment and recovery. 

These physicians hope to continue creating and implementing these and other risk-reduction measures across all health care organizations.
 

Our physician experts for this discussion

Mary Moffit, PhD, is an associate professor in the department of psychiatry at Oregon Health & Science University, Portland. She directs the resident and faculty wellness program and is director of the OHSU peer support program. She helped design and developed a comprehensive wellness program that is now a national model for academic medical centers.

Christine Yu Moutier, MD, is the chief medical officer of the American Foundation for Suicide Prevention. She is the author of “Suicide Prevention,” a Cambridge University Press clinical handbook. She has been a practicing psychiatrist, professor of psychiatry, dean in the medical school at the University of California, San Diego, and medical director of the inpatient psychiatric unit at the VA Medical Center in La Jolla, Calif.

Michael F. Myers, MD, is a professor of clinical psychiatry in the department of psychiatry & behavioral sciences at the State University of New York, Brooklyn. He is recent past vice-chair of education and director of training in the department of psychiatry & behavioral sciences at the university. He is the author of several books, including “Why Physicians Die By Suicide,” “The Physician as Patient,” and “Touched by Suicide.”

The participants discussed these risk-reduction initiatives as having much potential for helping physicians at risk for suicide and suicidal ideations.
 

The importance of peer support programs

Peer support program models may differ across institutions but typically describe colleagues providing some degree of emotional first aid to peers who may be at risk.

Dr. Moffit: The Pew support program that we have in place at OHSU, similar to what’s available in many hospitals and systems nationwide, trains individual physicians across multiple specialties in a peer support model. It’s not specifically emotional first aid, although that’s integral to it. It’s also for adverse events: Having a tragic patient death, having learned that you will be named in a lawsuit, and exposure to trauma in the medical role.

Peer to peer is not where we anticipate physicians seeking someone to talk to about their marital relationship not going well. However, the peer supporter will know about resources throughout the university and the community for what is needed. We’ve got 20-30 peer supporters. We try to match them – for example, a surgeon with a surgeon, a primary care doc with a primary care doc. Physicians who use peer support aren’t tracked, and no notes are taken or documented. It takes place informally but has changed the culture and lowered a barrier. We have a waiting list of people who want to be peer supporters. 

Dr. Moutier: Peer-to-peer support is usually part of a multi-pronged program and is usually not the only effort going on. Depending on how they’re set up, the goals may be slightly different for each program. Peer-to-peer can be one of the most powerful ways to augment awareness raising and education, which is almost always a basic first step.

Dr. Myers: It doesn’t feel as threatening when people start in a peer-to-peer support group. Users may have been afraid of getting a mental health diagnosis, but with peers, many of whom are often not psychiatrists, that eases distress. Peer support can break down that sense of isolation and loneliness so that someone can take the next step.

Dr. Moutier: To be connected to family, to any community resource, frankly, is a protective factor that mitigates suicide risk. So that’s the logic model from a suicide prevention standpoint. It may be the only opportunity for someone to start disclosing what they’re experiencing, receive validation and support, and not a judgmental response. It can open up the avenue toward help-seeking.

Opt-in/opt-out support for medical residents

This initiative matches residents with a counselor as part of their orientation.

Dr. Moffit: Each resident has a meet and greet with a counselor when they arrive or in their first 6 months at their university. The resident can opt out and cancel the meeting, but they’re scheduled for it as part of their “curriculum.” Institutions like Michigan, Columbia, Montefiore, Mount Sinai, and the University of California, San Diego, have this in place. It starts something like: ‘Hello. Good afternoon. How’s it going? I’m Dr. Moffitt, and here are the services available in this program.’

Dr. Myers: It’s another excellent example of normalizing the stress in the rigors of training and making it part of the wellness initiative.

Dr. Moutier:  It’s just a normal part of orientation. Again, as a universal strategy, one thing that I was doing at UCSD with a particular group of medical students, who were at higher risk, was a postbaccalaureate program that found students from underrepresented, under-resourced backgrounds and brought them into this post-bacc year. I was directing it and mentoring these students.

So, I could afford a lot more intensive time and attention to them because it was a small group, but every one of them had regular meetings with me every 2 weeks. My approach was to help them uncover their unique strengths and vulnerabilities as they started this program. They all made it into med school.

It was a very intensive and more concierge-personalized approach. It’s like personalized medicine. What specific self-care, mentoring, and mental health care plan would each student codesign with me to stay on track?

And it would involve very holistic things, like if part of their vulnerability was that leaving their Chicano family was creating stress because their father had said: ‘You’re leaving our culture and our family by going into the profession of medicine,’ then we had specific plans around how to care for that aspect of their struggle. It was a much more informed, customized mentoring approach called the UCSD CAP (Conditional Acceptance Post-Baccalaureate Program). It could be a feature in a more specialized opt-in/opt-out program.
 

 

 

One-question survey: How full is your gas tank?

This initiative is a one-question survey emailed/texted to residents to check in on their wellness. We ask, how full is your gas tank? Select 1 to 5 (Empty to Full). If they flag low, they receive a follow-up.

Dr. Moffit: It’s certainly a metaphor that we use. It’s the idea of being depleted in combination with being extremely sleep deprived and the inability to access the usual sources of support or outlets, and how that can create a perfect storm of a level of distress that can put physicians at risk.

Dr. Moutier: It is a way to help people realize that there are things they can do proactively to keep that tank at least somewhat full enough.

Dr. Myers: Using colloquial or figurative language can get better buy-in than “Here’s a PHQ-9.” It also has a caring or intimate tone to it. Somebody could feel they’re a 1 in this rotation but a 4-5 the next. We know from a lot of the literature that when residents get a good, welcoming orientation, their satisfaction with that rotation is uniformly better than if they’re thrown to the wolves. And we know trial by fire can put trainees at risk.

A buddy to check in with

This initiative is when you’re assigned a buddy in or out of residency that you regularly check in with about how you’re doing.

Dr. Myers: Not to be cynical, but there has been some mentor/mentee research that if you’re assigned a mentor, the results are not nearly as good. And if it’s left to the individual to find a mentor, results could be marginal as well. You need a guide to say, ‘Here are some potential mentors for you, but you decide.’ We do a lot of that at (SUNY) Downstate instead of assigning a person. So, it may require some oversight. Picking a check-in buddy from a list provided rather than having one assigned may be more beneficial.

A lot of what we’re talking about are universal strategies that allow for increased interpersonal connection, which is a protective factor that normalizes help-seeking.
 

A platform or social media forum to share experiences

An online forum or platform where medical students, residents, and physicians can discuss mental health and suicide prevention. Physicians with personal experience could provide testimonials.

Dr. Myers: I’ve recently signed a book contract, and the working title is “Physicians With Lived Experience: How Their Stories Give Clinical Guidance.” When I talk with doctors who have published their personal stories in the New England Journal of Medicine, JAMA, or sometimes The Washington Post or The New York Times, many of them have said they had no idea at the beginning of their journey that they would do something like this: be transparent about their story. It’s a measure of their health, growth, and grace.

Dr. Moutier: The current president of the Academic Association of Surgeons, Carrie Cunningham, MD, MPH, used her platform at the annual AAS conference in 2022 to focus on suicide prevention. She told her own recent story of having gotten into recovery after having been near suicide and struggling with addiction. It was a groundbreaking moment for the field of surgery and produced a ripple effect. She risked everything to tell her story, which was highly emotional since it was still raw. It got everyone engaged, a real turning point for that field. Storytelling and a place for trainees to discuss suicide prevention, and physicians to recall their lived experiences can be highly beneficial.

 

 

Interactive Screening Program

The Interactive Screening Program (ISP) is used in higher education to allow physicians to take a safe, confidential screening test and receive a personalized response that can connect them to mental health services before a crisis emerges.

Dr. Moutier: ISP is a tool within a public health model that can afford anonymity to the user so they can safely have their needs addressed. It’s a way for high-risk individuals to sync up with treatment and support. It’s sometimes used in the universal approach because it can be offered to everyone within the health system community of physicians and staff.

It can produce a ripple effect of normalizing that we all have mental health to take care of. Its intended value is in identifying those with a higher risk for suicide, but it doesn’t stop at identifying those at risk. It helps physicians move past a stage of suffering in silence.

Our data show that 86% of a very high-risk group (currently having suicidal ideation, a recent attempt, or other high-risk factors for suicide) aren’t in any form of treatment and have not disclosed their situation to anyone. A fairly high percentage of those going through ISP request a referral to treatment. It’s a unique, very niche tool, and because users remain anonymous, that affords safety around confidentiality.

It’s usually part of a multipronged approach with education, stigma reduction, storytelling, peer support, and other modalities. In my experience with the UCSD HEAR (Healer Assessment Education and Recovery) program, which is still going strong in about its 15th year, the program went from seeing 13 physicians die by suicide in the years leading up to its launch and in the 15 years since it’s been going, one suicide. We all believe that the ISP is the heart of prevention.

Even though all of the universal strategies are important, they probably wouldn’t be sufficient by themselves because the risk [for suicide] is dynamic, and you have to catch people when they are suffering and ready to seek treatment. Suicide prevention is challenging and must be strategic, multifaceted, and sustained over time.
 

The importance of confidentiality for physicians

In the past, physicians may have been hesitant to seek treatment when struggling with mental health, substance use disorder and suicidal ideations because they heard stories from doctors who said they had to disclose mental health treatment to medical and state licensing boards.

Dr. Myers: There is so much dated stuff out there, and it gets propagated by people who have had a bad experience. I’m not challenging the authenticity of that, but I feel like those are in the minority. The vast majority of people are seeking help. The Federation of State Physician Health Programs is working with state boards to update and get rid of antiquated questions, and they’re working with credentialing groups.

When I was in practice and my patient was petrified of having to come into the hospital [because of confidentiality] I would just be their physician and say: “Look, I know that this is a worry for you [licensing and credentialing issues] but trust me, I’m going to help you get well; that’s my job. And I’m going to help you sort all that out afterward.” It was part of my work as their physician that if they were going to have to jump through hurdles to get their license reinstated, etc., I could help. 

The Dr. Lorna Breen Heroes’ Foundation is also doing so much good work in this area, especially with their toolkits to audit, change, remove, and communicate the changes about intrusive language in licensing applications and credentialing. (Dr. Breen was a New York City ED physician who died by suicide in April 2020 during the early days and height of the COVID-19 pandemic. Her father was quoted as saying: “She was in the trenches. She was a hero.”)

Dr. Moutier: We’re seeing hundreds of physicians get therapy and psychiatric treatment annually. And the advocacy effort is incredibly important, and I think we are witnessing a swifter pace to eliminate those inappropriate and illegal questions about mental health and mental health treatment for physicians and nurses.

Dr. Moffit: We have lowered barriers, not only in individual institutions but also with programming. We have also worked with the Federation of State Medical Boards and The Lorna Breen Foundation to change the legislation. The Foundation has audited and changed 20 state medical boards to remove intrusive language from licensing applications.

Support for colleagues working to help each other

Dr. Myers: One final note for those physicians who need to take time out for medical leave: In my clinical experience, I find that they felt lonely as they were getting well. I can’t tell you how much it made a difference for those who received a phone call, a card, or an email from their colleagues at work. It doesn’t take long for a vibrant, active physician to feel out of the loop when ill.

We know from suicide literature that when somebody’s discharged from the hospital or the emergency department, caring communications, brief expressions of care and concern by email, letter, card, text message, etc., can make all the difference to their recovery. Reaching out to those struggling and those in recovery can help your fellow physician.

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

Physician suicide continues to be a challenging problem in the United States. Each year, 1 in 10 doctors think about or attempt suicide, and 400 die by suicide each year. More than half of the doctors reading this know a colleague who has attempted or died by suicide.

This news organization recently sat down with three psychiatric experts to talk about the newest risk-reduction initiatives. These are part of a public health suicide prevention strategy, the preferred method for prevention, in hospitals and institutions around the country. A public health model for preventing suicide is a multifaceted approach that includes universal education, health promotion, selective and targeted prevention, and treatment and recovery. 

These physicians hope to continue creating and implementing these and other risk-reduction measures across all health care organizations.
 

Our physician experts for this discussion

Mary Moffit, PhD, is an associate professor in the department of psychiatry at Oregon Health & Science University, Portland. She directs the resident and faculty wellness program and is director of the OHSU peer support program. She helped design and developed a comprehensive wellness program that is now a national model for academic medical centers.

Christine Yu Moutier, MD, is the chief medical officer of the American Foundation for Suicide Prevention. She is the author of “Suicide Prevention,” a Cambridge University Press clinical handbook. She has been a practicing psychiatrist, professor of psychiatry, dean in the medical school at the University of California, San Diego, and medical director of the inpatient psychiatric unit at the VA Medical Center in La Jolla, Calif.

Michael F. Myers, MD, is a professor of clinical psychiatry in the department of psychiatry & behavioral sciences at the State University of New York, Brooklyn. He is recent past vice-chair of education and director of training in the department of psychiatry & behavioral sciences at the university. He is the author of several books, including “Why Physicians Die By Suicide,” “The Physician as Patient,” and “Touched by Suicide.”

The participants discussed these risk-reduction initiatives as having much potential for helping physicians at risk for suicide and suicidal ideations.
 

The importance of peer support programs

Peer support program models may differ across institutions but typically describe colleagues providing some degree of emotional first aid to peers who may be at risk.

Dr. Moffit: The Pew support program that we have in place at OHSU, similar to what’s available in many hospitals and systems nationwide, trains individual physicians across multiple specialties in a peer support model. It’s not specifically emotional first aid, although that’s integral to it. It’s also for adverse events: Having a tragic patient death, having learned that you will be named in a lawsuit, and exposure to trauma in the medical role.

Peer to peer is not where we anticipate physicians seeking someone to talk to about their marital relationship not going well. However, the peer supporter will know about resources throughout the university and the community for what is needed. We’ve got 20-30 peer supporters. We try to match them – for example, a surgeon with a surgeon, a primary care doc with a primary care doc. Physicians who use peer support aren’t tracked, and no notes are taken or documented. It takes place informally but has changed the culture and lowered a barrier. We have a waiting list of people who want to be peer supporters. 

Dr. Moutier: Peer-to-peer support is usually part of a multi-pronged program and is usually not the only effort going on. Depending on how they’re set up, the goals may be slightly different for each program. Peer-to-peer can be one of the most powerful ways to augment awareness raising and education, which is almost always a basic first step.

Dr. Myers: It doesn’t feel as threatening when people start in a peer-to-peer support group. Users may have been afraid of getting a mental health diagnosis, but with peers, many of whom are often not psychiatrists, that eases distress. Peer support can break down that sense of isolation and loneliness so that someone can take the next step.

Dr. Moutier: To be connected to family, to any community resource, frankly, is a protective factor that mitigates suicide risk. So that’s the logic model from a suicide prevention standpoint. It may be the only opportunity for someone to start disclosing what they’re experiencing, receive validation and support, and not a judgmental response. It can open up the avenue toward help-seeking.

Opt-in/opt-out support for medical residents

This initiative matches residents with a counselor as part of their orientation.

Dr. Moffit: Each resident has a meet and greet with a counselor when they arrive or in their first 6 months at their university. The resident can opt out and cancel the meeting, but they’re scheduled for it as part of their “curriculum.” Institutions like Michigan, Columbia, Montefiore, Mount Sinai, and the University of California, San Diego, have this in place. It starts something like: ‘Hello. Good afternoon. How’s it going? I’m Dr. Moffitt, and here are the services available in this program.’

Dr. Myers: It’s another excellent example of normalizing the stress in the rigors of training and making it part of the wellness initiative.

Dr. Moutier:  It’s just a normal part of orientation. Again, as a universal strategy, one thing that I was doing at UCSD with a particular group of medical students, who were at higher risk, was a postbaccalaureate program that found students from underrepresented, under-resourced backgrounds and brought them into this post-bacc year. I was directing it and mentoring these students.

So, I could afford a lot more intensive time and attention to them because it was a small group, but every one of them had regular meetings with me every 2 weeks. My approach was to help them uncover their unique strengths and vulnerabilities as they started this program. They all made it into med school.

It was a very intensive and more concierge-personalized approach. It’s like personalized medicine. What specific self-care, mentoring, and mental health care plan would each student codesign with me to stay on track?

And it would involve very holistic things, like if part of their vulnerability was that leaving their Chicano family was creating stress because their father had said: ‘You’re leaving our culture and our family by going into the profession of medicine,’ then we had specific plans around how to care for that aspect of their struggle. It was a much more informed, customized mentoring approach called the UCSD CAP (Conditional Acceptance Post-Baccalaureate Program). It could be a feature in a more specialized opt-in/opt-out program.
 

 

 

One-question survey: How full is your gas tank?

This initiative is a one-question survey emailed/texted to residents to check in on their wellness. We ask, how full is your gas tank? Select 1 to 5 (Empty to Full). If they flag low, they receive a follow-up.

Dr. Moffit: It’s certainly a metaphor that we use. It’s the idea of being depleted in combination with being extremely sleep deprived and the inability to access the usual sources of support or outlets, and how that can create a perfect storm of a level of distress that can put physicians at risk.

Dr. Moutier: It is a way to help people realize that there are things they can do proactively to keep that tank at least somewhat full enough.

Dr. Myers: Using colloquial or figurative language can get better buy-in than “Here’s a PHQ-9.” It also has a caring or intimate tone to it. Somebody could feel they’re a 1 in this rotation but a 4-5 the next. We know from a lot of the literature that when residents get a good, welcoming orientation, their satisfaction with that rotation is uniformly better than if they’re thrown to the wolves. And we know trial by fire can put trainees at risk.

A buddy to check in with

This initiative is when you’re assigned a buddy in or out of residency that you regularly check in with about how you’re doing.

Dr. Myers: Not to be cynical, but there has been some mentor/mentee research that if you’re assigned a mentor, the results are not nearly as good. And if it’s left to the individual to find a mentor, results could be marginal as well. You need a guide to say, ‘Here are some potential mentors for you, but you decide.’ We do a lot of that at (SUNY) Downstate instead of assigning a person. So, it may require some oversight. Picking a check-in buddy from a list provided rather than having one assigned may be more beneficial.

A lot of what we’re talking about are universal strategies that allow for increased interpersonal connection, which is a protective factor that normalizes help-seeking.
 

A platform or social media forum to share experiences

An online forum or platform where medical students, residents, and physicians can discuss mental health and suicide prevention. Physicians with personal experience could provide testimonials.

Dr. Myers: I’ve recently signed a book contract, and the working title is “Physicians With Lived Experience: How Their Stories Give Clinical Guidance.” When I talk with doctors who have published their personal stories in the New England Journal of Medicine, JAMA, or sometimes The Washington Post or The New York Times, many of them have said they had no idea at the beginning of their journey that they would do something like this: be transparent about their story. It’s a measure of their health, growth, and grace.

Dr. Moutier: The current president of the Academic Association of Surgeons, Carrie Cunningham, MD, MPH, used her platform at the annual AAS conference in 2022 to focus on suicide prevention. She told her own recent story of having gotten into recovery after having been near suicide and struggling with addiction. It was a groundbreaking moment for the field of surgery and produced a ripple effect. She risked everything to tell her story, which was highly emotional since it was still raw. It got everyone engaged, a real turning point for that field. Storytelling and a place for trainees to discuss suicide prevention, and physicians to recall their lived experiences can be highly beneficial.

 

 

Interactive Screening Program

The Interactive Screening Program (ISP) is used in higher education to allow physicians to take a safe, confidential screening test and receive a personalized response that can connect them to mental health services before a crisis emerges.

Dr. Moutier: ISP is a tool within a public health model that can afford anonymity to the user so they can safely have their needs addressed. It’s a way for high-risk individuals to sync up with treatment and support. It’s sometimes used in the universal approach because it can be offered to everyone within the health system community of physicians and staff.

It can produce a ripple effect of normalizing that we all have mental health to take care of. Its intended value is in identifying those with a higher risk for suicide, but it doesn’t stop at identifying those at risk. It helps physicians move past a stage of suffering in silence.

Our data show that 86% of a very high-risk group (currently having suicidal ideation, a recent attempt, or other high-risk factors for suicide) aren’t in any form of treatment and have not disclosed their situation to anyone. A fairly high percentage of those going through ISP request a referral to treatment. It’s a unique, very niche tool, and because users remain anonymous, that affords safety around confidentiality.

It’s usually part of a multipronged approach with education, stigma reduction, storytelling, peer support, and other modalities. In my experience with the UCSD HEAR (Healer Assessment Education and Recovery) program, which is still going strong in about its 15th year, the program went from seeing 13 physicians die by suicide in the years leading up to its launch and in the 15 years since it’s been going, one suicide. We all believe that the ISP is the heart of prevention.

Even though all of the universal strategies are important, they probably wouldn’t be sufficient by themselves because the risk [for suicide] is dynamic, and you have to catch people when they are suffering and ready to seek treatment. Suicide prevention is challenging and must be strategic, multifaceted, and sustained over time.
 

The importance of confidentiality for physicians

In the past, physicians may have been hesitant to seek treatment when struggling with mental health, substance use disorder and suicidal ideations because they heard stories from doctors who said they had to disclose mental health treatment to medical and state licensing boards.

Dr. Myers: There is so much dated stuff out there, and it gets propagated by people who have had a bad experience. I’m not challenging the authenticity of that, but I feel like those are in the minority. The vast majority of people are seeking help. The Federation of State Physician Health Programs is working with state boards to update and get rid of antiquated questions, and they’re working with credentialing groups.

When I was in practice and my patient was petrified of having to come into the hospital [because of confidentiality] I would just be their physician and say: “Look, I know that this is a worry for you [licensing and credentialing issues] but trust me, I’m going to help you get well; that’s my job. And I’m going to help you sort all that out afterward.” It was part of my work as their physician that if they were going to have to jump through hurdles to get their license reinstated, etc., I could help. 

The Dr. Lorna Breen Heroes’ Foundation is also doing so much good work in this area, especially with their toolkits to audit, change, remove, and communicate the changes about intrusive language in licensing applications and credentialing. (Dr. Breen was a New York City ED physician who died by suicide in April 2020 during the early days and height of the COVID-19 pandemic. Her father was quoted as saying: “She was in the trenches. She was a hero.”)

Dr. Moutier: We’re seeing hundreds of physicians get therapy and psychiatric treatment annually. And the advocacy effort is incredibly important, and I think we are witnessing a swifter pace to eliminate those inappropriate and illegal questions about mental health and mental health treatment for physicians and nurses.

Dr. Moffit: We have lowered barriers, not only in individual institutions but also with programming. We have also worked with the Federation of State Medical Boards and The Lorna Breen Foundation to change the legislation. The Foundation has audited and changed 20 state medical boards to remove intrusive language from licensing applications.

Support for colleagues working to help each other

Dr. Myers: One final note for those physicians who need to take time out for medical leave: In my clinical experience, I find that they felt lonely as they were getting well. I can’t tell you how much it made a difference for those who received a phone call, a card, or an email from their colleagues at work. It doesn’t take long for a vibrant, active physician to feel out of the loop when ill.

We know from suicide literature that when somebody’s discharged from the hospital or the emergency department, caring communications, brief expressions of care and concern by email, letter, card, text message, etc., can make all the difference to their recovery. Reaching out to those struggling and those in recovery can help your fellow physician.

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

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Time for mental stress testing in ANOCA?

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Tue, 06/27/2023 - 12:04

Among women with angina without obstructive coronary artery disease (ANOCA), mental stress induced a greater degree of myocardial ischemia than among those without ANOCA, new results show.

Further analysis in the small study suggested that mental stress–induced myocardial ischemia (MSIMI) was not statistically related to coronary microvascular dysfunction (CMD).

“Since the findings do not support a correlation between MSIMI and CMD, which has been a widely accepted mechanistic explanation of ANOCA, routine mental stress testing in patients with ANOCA seems necessary,” researchers led by Qingshan Geng, MD, PhD, of Shenzhen People’s Hospital, Guangdong, China, conclude in a report published online in the Journal of the American College of Cardiology.

Dr. Geng said in an interview that the use of virtual reality devices to administer mental stress tests “ensures standardized experimental procedures, with each participant receiving an objectively equivalent level of stress load.

“The immersive experience provided by VR lowers the environmental requirements for the test,” he noted. “Furthermore, the application of VR reduces the workload of personnel responsible for inducing mental stress, simplifying the experimental process.”

The team also developed a mobile app that enables remote monitoring of participants’ visual experiences during PET/CT scans and facilitates communication, he added.
 

Mental stress testing and meds?

Both ANOCA and MSIMI in patients with coronary artery disease disproportionately affect women and are associated with poor cardiovascular prognosis, the researchers write.

“However, the role of MSIMI and the exact influence of mental stress in ANOCA have not previously been studied,” they point out.

For this investigation, 84 women with ANOCA and 42 age-matched controls underwent three mental stress challenges delivered via VR.

Tests included mental arithmetic, making a public speech describing a recent emotionally upsetting event, and a task-modified Stroop test, in which participants were asked to say the color in which the word appears, not the color that the word names. For example, if the word “yellow” appears in blue type, blue would be the correct answer.

An adenosine stress test was given 5-8 minutes after the mental stress challenges started, and cardiac PET/CT was used to examine myocardial blood flow and perfusion.

The investigators report that women with ANOCA had a much higher rate of MSIMI (42.9%), compared with control participants (one patient; 2.4%). They also had a higher proportion of coronary microvascular dysfunction (CMD; 24.6% vs. 8.6%), but the occurrence of MSIMI and CMD was not related, the authors note.

Consistent with previous studies, “we observed that CMD is more prevalent in ANOCA women than the age-matched healthy individuals. MSIMI rate, however, was notably higher than the rate of CMD in our female ANOCA population,” they write. “The lack of a significant association between MSIMI and CMD indicates the mechanisms of MSIMI cannot be well explained by the adenosine-induced CMD.”

Dr. Geng suggested that ANOCA patients may benefit from treatment with escitalopram.

“Compelling evidence” from the REMIT randomized, placebo-controlled trial validates the efficacy of the drug as an MSIMI treatment, he said.
 

Sample size too small?

Asked for comment on the findings, Viola Vaccarino, MD, PhD, Wilton Looney Distinguished Professor of Cardiovascular Research at Emory University’s Rollins School of Public Health and a professor in the university’s School of Medicine, Atlanta, said she disagreed with several aspects of this study and the investigators’ conclusions.

Although the study suggests that MSIMI is prevalent among women with ANOCA, “the sample size was too small to make any definite conclusions,” she said in an interview.

“In fact,” she said, “I do not agree with the authors’ conclusions that MSIMI and CMD were not related, based on the data presented, even though the P value was not significant.”

In addition, more research is needed before screening can be recommended, she said. “The effectiveness of this testing modality in this population should be demonstrated first.”

Furthermore, she added, “an established treatment for MSIMI has yet to be tested in large, controlled trials, which limits the potential clinical benefit that may result from this [screening] test.”

For now, to ameliorate potential MSIMI in women with ANOCA, Dr. Vaccarino recommends behavioral modalities or stress-reduction management techniques, including biofeedback, meditation, breathing exercises, and “just plain regular physical activity,” rather than the use of psychotropic medications.

Dr. Vaccarino’s team has a study underway that builds on earlier work involving more than 900 participants, which showed that MSIMI was significantly associated with an increased risk of cardiovascular death or nonfatal myocardial infarction (hazard ratio, 2.5).

The ongoing study, which investigates the link between emotional stress and heart disease in men and women, should be completed in about 3 years, she said.
 

Microvascular disease or spasm?

Leslie Cho, MD, chair of the American College of Cardiology’s Cardiovascular Disease in Women Committee, director of the Cleveland Clinic’s Women’s Cardiovascular Center, and professor of medicine at Cleveland Clinic Lerner School of Medicine and Case Western Reserve Medical School, commented on the mental stress–heart connection and mental stress testing for this article.

A “very big flaw” of the JACC study, she said, is that although PET testing can detect microvascular disease, it cannot detect microvascular spasm.

PET can show the coronary flow reserve, “which is a nice way to assess microvascular dysfunction,” she acknowledged, “but it really can’t tell microvascular spasm, because adenosine works in a different pathway than acetylcholine – and I think it’s important for people to have the right diagnosis.

“We do physiologic testing to distinguish the two conditions,” she noted. “We do the gold standard, which is the cath lab.”

“The problem with women with chest pain for years is that they get a stress test, they get a cath, and everything’s normal. Then they get blown off as anxious or whatever.”

Clinicians should conduct the gold standard workup – provocative physiologic testing – for these women who continue to have chest pain when results of other tests are negative, she said. “The test used to be very cumbersome, but today, we have systems that make it super easy to use and to distinguish microvascular disease and microvascular spasm.”

Importantly, she added, physiologic testing should be performed when women are off therapy – something that doesn’t always happen in the clinic.

Regarding treatment, she added, “if you’re having emotional stress, the answer is not another medicine. The answer is cognitive-behavioral therapy or another behavioral intervention to overcome anxiety.”
 

Tune in and advocate

What can clinicians do for women with ANOCA after testing reveals no significant coronary artery disease or microvascular spasms?

“Very often, it’s a matter of the doctor listening and responding to the patient,” Johanna Contreras, MD, a cardiologist at Mount Sinai Hospital, New York, said in an intereview.

In her practice, Dr. Contreras sees highly stressed women on a daily basis. Many of her patients are women from diverse racial/ethnic groups, often of lower socioeconomic status, who are heads of households, work more than one job, and experience other major stressors.

“My message to clinicians is: don’t give up on a woman just because you looked at the arteries and couldn’t find anything specific. If she keeps coming back with the same symptom, it’s important to address it,” she said. “Maybe it isn’t the symptom. Maybe she needs to talk about her situation, about the physiological and psychosocial factors contributing to the symptom that a test alone won’t reveal.”

Regarding cardiovascular spasms that are identified through physiologic testing, she said, “I don’t know that medications such as SSRIs [selective serotonin reuptake inhibitors] are going to change anything. But many things can be changed by listening or helping the patient to stop and think about her mental health.”

Following up with a referral to a therapist can help, she said; “Take away the mental health stigma by telling the patient that the referral is simply to help her cope.”

Dr. Contreras urges clinicians to be advocates for such patients. If an insurance company says it will cover only three therapy sessions, “tell them that three appointments are not enough” to address multiple issues.

“If we invest money in helping patients identify and cope with these issues, we are likely to get better long-term outcomes, rather than having that woman come into the emergency department with chest pain over and over and doing 20,000 tests that are going to show exactly the same thing,” Dr. Contreras concluded.

Dr. Geng’s study was supported by the High-Level Hospital Construction Project of Guangdong Provincial People’s Hospital, by a grant from Guangdong Provincial Bureau of Traditional Chinese Medicine, and by a grant from Guangdong Medical Science and Technology Research Foundation. The authors, Dr. Vaccarino, Dr. Contreras, and Dr. Cho report no relevant financial relationships.

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

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Among women with angina without obstructive coronary artery disease (ANOCA), mental stress induced a greater degree of myocardial ischemia than among those without ANOCA, new results show.

Further analysis in the small study suggested that mental stress–induced myocardial ischemia (MSIMI) was not statistically related to coronary microvascular dysfunction (CMD).

“Since the findings do not support a correlation between MSIMI and CMD, which has been a widely accepted mechanistic explanation of ANOCA, routine mental stress testing in patients with ANOCA seems necessary,” researchers led by Qingshan Geng, MD, PhD, of Shenzhen People’s Hospital, Guangdong, China, conclude in a report published online in the Journal of the American College of Cardiology.

Dr. Geng said in an interview that the use of virtual reality devices to administer mental stress tests “ensures standardized experimental procedures, with each participant receiving an objectively equivalent level of stress load.

“The immersive experience provided by VR lowers the environmental requirements for the test,” he noted. “Furthermore, the application of VR reduces the workload of personnel responsible for inducing mental stress, simplifying the experimental process.”

The team also developed a mobile app that enables remote monitoring of participants’ visual experiences during PET/CT scans and facilitates communication, he added.
 

Mental stress testing and meds?

Both ANOCA and MSIMI in patients with coronary artery disease disproportionately affect women and are associated with poor cardiovascular prognosis, the researchers write.

“However, the role of MSIMI and the exact influence of mental stress in ANOCA have not previously been studied,” they point out.

For this investigation, 84 women with ANOCA and 42 age-matched controls underwent three mental stress challenges delivered via VR.

Tests included mental arithmetic, making a public speech describing a recent emotionally upsetting event, and a task-modified Stroop test, in which participants were asked to say the color in which the word appears, not the color that the word names. For example, if the word “yellow” appears in blue type, blue would be the correct answer.

An adenosine stress test was given 5-8 minutes after the mental stress challenges started, and cardiac PET/CT was used to examine myocardial blood flow and perfusion.

The investigators report that women with ANOCA had a much higher rate of MSIMI (42.9%), compared with control participants (one patient; 2.4%). They also had a higher proportion of coronary microvascular dysfunction (CMD; 24.6% vs. 8.6%), but the occurrence of MSIMI and CMD was not related, the authors note.

Consistent with previous studies, “we observed that CMD is more prevalent in ANOCA women than the age-matched healthy individuals. MSIMI rate, however, was notably higher than the rate of CMD in our female ANOCA population,” they write. “The lack of a significant association between MSIMI and CMD indicates the mechanisms of MSIMI cannot be well explained by the adenosine-induced CMD.”

Dr. Geng suggested that ANOCA patients may benefit from treatment with escitalopram.

“Compelling evidence” from the REMIT randomized, placebo-controlled trial validates the efficacy of the drug as an MSIMI treatment, he said.
 

Sample size too small?

Asked for comment on the findings, Viola Vaccarino, MD, PhD, Wilton Looney Distinguished Professor of Cardiovascular Research at Emory University’s Rollins School of Public Health and a professor in the university’s School of Medicine, Atlanta, said she disagreed with several aspects of this study and the investigators’ conclusions.

Although the study suggests that MSIMI is prevalent among women with ANOCA, “the sample size was too small to make any definite conclusions,” she said in an interview.

“In fact,” she said, “I do not agree with the authors’ conclusions that MSIMI and CMD were not related, based on the data presented, even though the P value was not significant.”

In addition, more research is needed before screening can be recommended, she said. “The effectiveness of this testing modality in this population should be demonstrated first.”

Furthermore, she added, “an established treatment for MSIMI has yet to be tested in large, controlled trials, which limits the potential clinical benefit that may result from this [screening] test.”

For now, to ameliorate potential MSIMI in women with ANOCA, Dr. Vaccarino recommends behavioral modalities or stress-reduction management techniques, including biofeedback, meditation, breathing exercises, and “just plain regular physical activity,” rather than the use of psychotropic medications.

Dr. Vaccarino’s team has a study underway that builds on earlier work involving more than 900 participants, which showed that MSIMI was significantly associated with an increased risk of cardiovascular death or nonfatal myocardial infarction (hazard ratio, 2.5).

The ongoing study, which investigates the link between emotional stress and heart disease in men and women, should be completed in about 3 years, she said.
 

Microvascular disease or spasm?

Leslie Cho, MD, chair of the American College of Cardiology’s Cardiovascular Disease in Women Committee, director of the Cleveland Clinic’s Women’s Cardiovascular Center, and professor of medicine at Cleveland Clinic Lerner School of Medicine and Case Western Reserve Medical School, commented on the mental stress–heart connection and mental stress testing for this article.

A “very big flaw” of the JACC study, she said, is that although PET testing can detect microvascular disease, it cannot detect microvascular spasm.

PET can show the coronary flow reserve, “which is a nice way to assess microvascular dysfunction,” she acknowledged, “but it really can’t tell microvascular spasm, because adenosine works in a different pathway than acetylcholine – and I think it’s important for people to have the right diagnosis.

“We do physiologic testing to distinguish the two conditions,” she noted. “We do the gold standard, which is the cath lab.”

“The problem with women with chest pain for years is that they get a stress test, they get a cath, and everything’s normal. Then they get blown off as anxious or whatever.”

Clinicians should conduct the gold standard workup – provocative physiologic testing – for these women who continue to have chest pain when results of other tests are negative, she said. “The test used to be very cumbersome, but today, we have systems that make it super easy to use and to distinguish microvascular disease and microvascular spasm.”

Importantly, she added, physiologic testing should be performed when women are off therapy – something that doesn’t always happen in the clinic.

Regarding treatment, she added, “if you’re having emotional stress, the answer is not another medicine. The answer is cognitive-behavioral therapy or another behavioral intervention to overcome anxiety.”
 

Tune in and advocate

What can clinicians do for women with ANOCA after testing reveals no significant coronary artery disease or microvascular spasms?

“Very often, it’s a matter of the doctor listening and responding to the patient,” Johanna Contreras, MD, a cardiologist at Mount Sinai Hospital, New York, said in an intereview.

In her practice, Dr. Contreras sees highly stressed women on a daily basis. Many of her patients are women from diverse racial/ethnic groups, often of lower socioeconomic status, who are heads of households, work more than one job, and experience other major stressors.

“My message to clinicians is: don’t give up on a woman just because you looked at the arteries and couldn’t find anything specific. If she keeps coming back with the same symptom, it’s important to address it,” she said. “Maybe it isn’t the symptom. Maybe she needs to talk about her situation, about the physiological and psychosocial factors contributing to the symptom that a test alone won’t reveal.”

Regarding cardiovascular spasms that are identified through physiologic testing, she said, “I don’t know that medications such as SSRIs [selective serotonin reuptake inhibitors] are going to change anything. But many things can be changed by listening or helping the patient to stop and think about her mental health.”

Following up with a referral to a therapist can help, she said; “Take away the mental health stigma by telling the patient that the referral is simply to help her cope.”

Dr. Contreras urges clinicians to be advocates for such patients. If an insurance company says it will cover only three therapy sessions, “tell them that three appointments are not enough” to address multiple issues.

“If we invest money in helping patients identify and cope with these issues, we are likely to get better long-term outcomes, rather than having that woman come into the emergency department with chest pain over and over and doing 20,000 tests that are going to show exactly the same thing,” Dr. Contreras concluded.

Dr. Geng’s study was supported by the High-Level Hospital Construction Project of Guangdong Provincial People’s Hospital, by a grant from Guangdong Provincial Bureau of Traditional Chinese Medicine, and by a grant from Guangdong Medical Science and Technology Research Foundation. The authors, Dr. Vaccarino, Dr. Contreras, and Dr. Cho report no relevant financial relationships.

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

Among women with angina without obstructive coronary artery disease (ANOCA), mental stress induced a greater degree of myocardial ischemia than among those without ANOCA, new results show.

Further analysis in the small study suggested that mental stress–induced myocardial ischemia (MSIMI) was not statistically related to coronary microvascular dysfunction (CMD).

“Since the findings do not support a correlation between MSIMI and CMD, which has been a widely accepted mechanistic explanation of ANOCA, routine mental stress testing in patients with ANOCA seems necessary,” researchers led by Qingshan Geng, MD, PhD, of Shenzhen People’s Hospital, Guangdong, China, conclude in a report published online in the Journal of the American College of Cardiology.

Dr. Geng said in an interview that the use of virtual reality devices to administer mental stress tests “ensures standardized experimental procedures, with each participant receiving an objectively equivalent level of stress load.

“The immersive experience provided by VR lowers the environmental requirements for the test,” he noted. “Furthermore, the application of VR reduces the workload of personnel responsible for inducing mental stress, simplifying the experimental process.”

The team also developed a mobile app that enables remote monitoring of participants’ visual experiences during PET/CT scans and facilitates communication, he added.
 

Mental stress testing and meds?

Both ANOCA and MSIMI in patients with coronary artery disease disproportionately affect women and are associated with poor cardiovascular prognosis, the researchers write.

“However, the role of MSIMI and the exact influence of mental stress in ANOCA have not previously been studied,” they point out.

For this investigation, 84 women with ANOCA and 42 age-matched controls underwent three mental stress challenges delivered via VR.

Tests included mental arithmetic, making a public speech describing a recent emotionally upsetting event, and a task-modified Stroop test, in which participants were asked to say the color in which the word appears, not the color that the word names. For example, if the word “yellow” appears in blue type, blue would be the correct answer.

An adenosine stress test was given 5-8 minutes after the mental stress challenges started, and cardiac PET/CT was used to examine myocardial blood flow and perfusion.

The investigators report that women with ANOCA had a much higher rate of MSIMI (42.9%), compared with control participants (one patient; 2.4%). They also had a higher proportion of coronary microvascular dysfunction (CMD; 24.6% vs. 8.6%), but the occurrence of MSIMI and CMD was not related, the authors note.

Consistent with previous studies, “we observed that CMD is more prevalent in ANOCA women than the age-matched healthy individuals. MSIMI rate, however, was notably higher than the rate of CMD in our female ANOCA population,” they write. “The lack of a significant association between MSIMI and CMD indicates the mechanisms of MSIMI cannot be well explained by the adenosine-induced CMD.”

Dr. Geng suggested that ANOCA patients may benefit from treatment with escitalopram.

“Compelling evidence” from the REMIT randomized, placebo-controlled trial validates the efficacy of the drug as an MSIMI treatment, he said.
 

Sample size too small?

Asked for comment on the findings, Viola Vaccarino, MD, PhD, Wilton Looney Distinguished Professor of Cardiovascular Research at Emory University’s Rollins School of Public Health and a professor in the university’s School of Medicine, Atlanta, said she disagreed with several aspects of this study and the investigators’ conclusions.

Although the study suggests that MSIMI is prevalent among women with ANOCA, “the sample size was too small to make any definite conclusions,” she said in an interview.

“In fact,” she said, “I do not agree with the authors’ conclusions that MSIMI and CMD were not related, based on the data presented, even though the P value was not significant.”

In addition, more research is needed before screening can be recommended, she said. “The effectiveness of this testing modality in this population should be demonstrated first.”

Furthermore, she added, “an established treatment for MSIMI has yet to be tested in large, controlled trials, which limits the potential clinical benefit that may result from this [screening] test.”

For now, to ameliorate potential MSIMI in women with ANOCA, Dr. Vaccarino recommends behavioral modalities or stress-reduction management techniques, including biofeedback, meditation, breathing exercises, and “just plain regular physical activity,” rather than the use of psychotropic medications.

Dr. Vaccarino’s team has a study underway that builds on earlier work involving more than 900 participants, which showed that MSIMI was significantly associated with an increased risk of cardiovascular death or nonfatal myocardial infarction (hazard ratio, 2.5).

The ongoing study, which investigates the link between emotional stress and heart disease in men and women, should be completed in about 3 years, she said.
 

Microvascular disease or spasm?

Leslie Cho, MD, chair of the American College of Cardiology’s Cardiovascular Disease in Women Committee, director of the Cleveland Clinic’s Women’s Cardiovascular Center, and professor of medicine at Cleveland Clinic Lerner School of Medicine and Case Western Reserve Medical School, commented on the mental stress–heart connection and mental stress testing for this article.

A “very big flaw” of the JACC study, she said, is that although PET testing can detect microvascular disease, it cannot detect microvascular spasm.

PET can show the coronary flow reserve, “which is a nice way to assess microvascular dysfunction,” she acknowledged, “but it really can’t tell microvascular spasm, because adenosine works in a different pathway than acetylcholine – and I think it’s important for people to have the right diagnosis.

“We do physiologic testing to distinguish the two conditions,” she noted. “We do the gold standard, which is the cath lab.”

“The problem with women with chest pain for years is that they get a stress test, they get a cath, and everything’s normal. Then they get blown off as anxious or whatever.”

Clinicians should conduct the gold standard workup – provocative physiologic testing – for these women who continue to have chest pain when results of other tests are negative, she said. “The test used to be very cumbersome, but today, we have systems that make it super easy to use and to distinguish microvascular disease and microvascular spasm.”

Importantly, she added, physiologic testing should be performed when women are off therapy – something that doesn’t always happen in the clinic.

Regarding treatment, she added, “if you’re having emotional stress, the answer is not another medicine. The answer is cognitive-behavioral therapy or another behavioral intervention to overcome anxiety.”
 

Tune in and advocate

What can clinicians do for women with ANOCA after testing reveals no significant coronary artery disease or microvascular spasms?

“Very often, it’s a matter of the doctor listening and responding to the patient,” Johanna Contreras, MD, a cardiologist at Mount Sinai Hospital, New York, said in an intereview.

In her practice, Dr. Contreras sees highly stressed women on a daily basis. Many of her patients are women from diverse racial/ethnic groups, often of lower socioeconomic status, who are heads of households, work more than one job, and experience other major stressors.

“My message to clinicians is: don’t give up on a woman just because you looked at the arteries and couldn’t find anything specific. If she keeps coming back with the same symptom, it’s important to address it,” she said. “Maybe it isn’t the symptom. Maybe she needs to talk about her situation, about the physiological and psychosocial factors contributing to the symptom that a test alone won’t reveal.”

Regarding cardiovascular spasms that are identified through physiologic testing, she said, “I don’t know that medications such as SSRIs [selective serotonin reuptake inhibitors] are going to change anything. But many things can be changed by listening or helping the patient to stop and think about her mental health.”

Following up with a referral to a therapist can help, she said; “Take away the mental health stigma by telling the patient that the referral is simply to help her cope.”

Dr. Contreras urges clinicians to be advocates for such patients. If an insurance company says it will cover only three therapy sessions, “tell them that three appointments are not enough” to address multiple issues.

“If we invest money in helping patients identify and cope with these issues, we are likely to get better long-term outcomes, rather than having that woman come into the emergency department with chest pain over and over and doing 20,000 tests that are going to show exactly the same thing,” Dr. Contreras concluded.

Dr. Geng’s study was supported by the High-Level Hospital Construction Project of Guangdong Provincial People’s Hospital, by a grant from Guangdong Provincial Bureau of Traditional Chinese Medicine, and by a grant from Guangdong Medical Science and Technology Research Foundation. The authors, Dr. Vaccarino, Dr. Contreras, and Dr. Cho report no relevant financial relationships.

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

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OASIS and PIONEER PLUS support high-dose oral semaglutide

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Tue, 06/27/2023 - 08:33

Higher doses of oral semaglutide than the 14-mg/day dose that is currently approved for type 2 diabetes may be additional options for patients with prediabetes or diabetes and obesity, according to the results of two new phase 3 clinical trials.

The two trials, OASIS in patients with overweight or obesity without diabetes and PIONEER PLUS in patients with inadequately controlled type 2 diabetes, were presented at the annual scientific sessions of the American Diabetes Association and simultaneously published in The Lancet.

Dr. Vanita R. Aroda

Filip K. Knop, MD, PhD, University of Copenhagen, presented highlights of the OASIS-1 results, and Vanita R. Aroda, MD, Brigham and Women’s Hospital and Harvard University, Boston, presented key findings of PIONEER PLUS, during a press briefing prior to the ADA session.

OASIS-1 showed that “oral semaglutide 50 mg may represent an effective option for the treatment of obesity, particularly in patients who prefer oral administration,” Dr. Knop summarized.

And “the PIONEER PLUS trial showed superior glycemic control and body-weight loss and improvement in cardiometabolic risk factors, with higher doses of once-daily oral semaglutide (25 mg and 50 mg) compared with the currently [highest] approved 14-mg dose,” said Dr. Aroda.

Session chair Marion Pragnell, PhD, vice president of research & science at ADA, said in an interview there is a need for multiple treatment options, as different patients respond differently to individual drugs. The oral dose of semaglutide has to be higher than that approved for subcutaneous injection (as Ozempic or Wegovy) because of bioavailability, but small-molecule research is advancing such that in future lower doses of oral drugs may have the same effect as the current lower subcutaneous doses of the drug.

The oral version of semaglutide (Rybelsus) was approved in the United States for type 2 diabetes in doses of 7 mg or 14 mg per day in 2019; it has not been approved for use in obesity.

Dr. Knop remarked that, in his clinical practice, about 25% of patients with type 2 diabetes prefer daily oral semaglutide and the rest prefer weekly injected semaglutide.

“Having an oral formulation of semaglutide in addition to the subcutaneous, or injectable, formula available will allow people who struggle to lose weight with diet and physical activity alone to take this effective medication in a way that best suits them,” he added.

Participants in OASIS and PIONEER PLUS were instructed to take the once-daily study drug tablet in the morning, in the fasting state, with up to half a glass of water (120 mL) at least 30 minutes before intake of any other food, beverage, or oral medication.
 

OASIS: 50-mg daily pill in adults with overweight or obesity

OASIS is, to their knowledge, “the first trial to assess the bodyweight-lowering effect of an oral GLP-1 agonist (semaglutide 50 mg taken once per day) in adults with overweight or obesity, without type 2 diabetes,” Dr. Knop and colleagues wrote.

The 50-mg dose induced clinically meaningful reductions in bodyweight, with accompanying improvements in cardiometabolic risk factors, consistent with results reported for subcutaneous semaglutide 2.4 mg once weekly (Wegovy) in a similar population.

As an adjunct to diet and physical activity, oral semaglutide 50 mg led to a mean bodyweight reduction of 15.1%, compared with 2.4% in the placebo group, and greater percentages of participants reaching bodyweight reduction targets of at least 5%, 10%, 15%, and 20%.

Body-weight reductions were accompanied by significant improvements in cardiometabolic risk factors, compared with placebo.

“These results indicate that oral semaglutide 50 mg could provide an effective, future option for people with overweight or obesity who would benefit from a GLP-1 receptor agonist,” they concluded.
 

 

 

PIONEER PLUS: Inadequately controlled type 2 diabetes

Reporting the PIONEER PLUS data, Dr. Aroda and colleagues said: “For people with inadequately controlled type 2 diabetes on a stable dose of one to three oral glucose-lowering drugs, higher doses (25 mg and 50 mg) of once-daily oral semaglutide provided more effective glycemic control and greater bodyweight loss than 14 mg semaglutide, without additional safety concerns.”

PIONEER PLUS is the first study to indicate that these bigger doses of semaglutide might provide a highly effective oral option to improve both glycemic control and weight loss in type 2 diabetes.

“This trial provides compelling evidence that the availability of a wider range of doses of oral semaglutide will allow for individualized dosing to the desired effect, and the ability to intensify treatment as needed,” said Dr. Aroda. “We are hopeful that these results encourage earlier effective management of type 2 diabetes and allow for broader management in the primary care setting.”

In an accompanying editorial Christina H. Sherrill, PharmD, and Andrew Y. Hwang, PharmD, write: “This expansion in dosing titration might provide clinicians with more opportunities to obtain the maximum efficacy of this oral GLP-1 agonist.”

But additional investigations “to establish whether the superior glycemic reduction seen at these higher doses translates into cardiovascular risk reduction” are needed, said Dr. Sherrill, of High Point (N.C.) University, and Dr. Hwang, of Massachusetts College of Pharmacy and Health Sciences University, Boston.

Such investigations “would further elucidate the place in therapy of high-dose oral semaglutide,” they concluded.

Dr. Aroda and colleagues agreed: “Future real-world studies will be needed to investigate the clinical impact of the availability of higher doses of oral semaglutide.”

The trials were funded by Novo Nordisk.

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

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Higher doses of oral semaglutide than the 14-mg/day dose that is currently approved for type 2 diabetes may be additional options for patients with prediabetes or diabetes and obesity, according to the results of two new phase 3 clinical trials.

The two trials, OASIS in patients with overweight or obesity without diabetes and PIONEER PLUS in patients with inadequately controlled type 2 diabetes, were presented at the annual scientific sessions of the American Diabetes Association and simultaneously published in The Lancet.

Dr. Vanita R. Aroda

Filip K. Knop, MD, PhD, University of Copenhagen, presented highlights of the OASIS-1 results, and Vanita R. Aroda, MD, Brigham and Women’s Hospital and Harvard University, Boston, presented key findings of PIONEER PLUS, during a press briefing prior to the ADA session.

OASIS-1 showed that “oral semaglutide 50 mg may represent an effective option for the treatment of obesity, particularly in patients who prefer oral administration,” Dr. Knop summarized.

And “the PIONEER PLUS trial showed superior glycemic control and body-weight loss and improvement in cardiometabolic risk factors, with higher doses of once-daily oral semaglutide (25 mg and 50 mg) compared with the currently [highest] approved 14-mg dose,” said Dr. Aroda.

Session chair Marion Pragnell, PhD, vice president of research & science at ADA, said in an interview there is a need for multiple treatment options, as different patients respond differently to individual drugs. The oral dose of semaglutide has to be higher than that approved for subcutaneous injection (as Ozempic or Wegovy) because of bioavailability, but small-molecule research is advancing such that in future lower doses of oral drugs may have the same effect as the current lower subcutaneous doses of the drug.

The oral version of semaglutide (Rybelsus) was approved in the United States for type 2 diabetes in doses of 7 mg or 14 mg per day in 2019; it has not been approved for use in obesity.

Dr. Knop remarked that, in his clinical practice, about 25% of patients with type 2 diabetes prefer daily oral semaglutide and the rest prefer weekly injected semaglutide.

“Having an oral formulation of semaglutide in addition to the subcutaneous, or injectable, formula available will allow people who struggle to lose weight with diet and physical activity alone to take this effective medication in a way that best suits them,” he added.

Participants in OASIS and PIONEER PLUS were instructed to take the once-daily study drug tablet in the morning, in the fasting state, with up to half a glass of water (120 mL) at least 30 minutes before intake of any other food, beverage, or oral medication.
 

OASIS: 50-mg daily pill in adults with overweight or obesity

OASIS is, to their knowledge, “the first trial to assess the bodyweight-lowering effect of an oral GLP-1 agonist (semaglutide 50 mg taken once per day) in adults with overweight or obesity, without type 2 diabetes,” Dr. Knop and colleagues wrote.

The 50-mg dose induced clinically meaningful reductions in bodyweight, with accompanying improvements in cardiometabolic risk factors, consistent with results reported for subcutaneous semaglutide 2.4 mg once weekly (Wegovy) in a similar population.

As an adjunct to diet and physical activity, oral semaglutide 50 mg led to a mean bodyweight reduction of 15.1%, compared with 2.4% in the placebo group, and greater percentages of participants reaching bodyweight reduction targets of at least 5%, 10%, 15%, and 20%.

Body-weight reductions were accompanied by significant improvements in cardiometabolic risk factors, compared with placebo.

“These results indicate that oral semaglutide 50 mg could provide an effective, future option for people with overweight or obesity who would benefit from a GLP-1 receptor agonist,” they concluded.
 

 

 

PIONEER PLUS: Inadequately controlled type 2 diabetes

Reporting the PIONEER PLUS data, Dr. Aroda and colleagues said: “For people with inadequately controlled type 2 diabetes on a stable dose of one to three oral glucose-lowering drugs, higher doses (25 mg and 50 mg) of once-daily oral semaglutide provided more effective glycemic control and greater bodyweight loss than 14 mg semaglutide, without additional safety concerns.”

PIONEER PLUS is the first study to indicate that these bigger doses of semaglutide might provide a highly effective oral option to improve both glycemic control and weight loss in type 2 diabetes.

“This trial provides compelling evidence that the availability of a wider range of doses of oral semaglutide will allow for individualized dosing to the desired effect, and the ability to intensify treatment as needed,” said Dr. Aroda. “We are hopeful that these results encourage earlier effective management of type 2 diabetes and allow for broader management in the primary care setting.”

In an accompanying editorial Christina H. Sherrill, PharmD, and Andrew Y. Hwang, PharmD, write: “This expansion in dosing titration might provide clinicians with more opportunities to obtain the maximum efficacy of this oral GLP-1 agonist.”

But additional investigations “to establish whether the superior glycemic reduction seen at these higher doses translates into cardiovascular risk reduction” are needed, said Dr. Sherrill, of High Point (N.C.) University, and Dr. Hwang, of Massachusetts College of Pharmacy and Health Sciences University, Boston.

Such investigations “would further elucidate the place in therapy of high-dose oral semaglutide,” they concluded.

Dr. Aroda and colleagues agreed: “Future real-world studies will be needed to investigate the clinical impact of the availability of higher doses of oral semaglutide.”

The trials were funded by Novo Nordisk.

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

Higher doses of oral semaglutide than the 14-mg/day dose that is currently approved for type 2 diabetes may be additional options for patients with prediabetes or diabetes and obesity, according to the results of two new phase 3 clinical trials.

The two trials, OASIS in patients with overweight or obesity without diabetes and PIONEER PLUS in patients with inadequately controlled type 2 diabetes, were presented at the annual scientific sessions of the American Diabetes Association and simultaneously published in The Lancet.

Dr. Vanita R. Aroda

Filip K. Knop, MD, PhD, University of Copenhagen, presented highlights of the OASIS-1 results, and Vanita R. Aroda, MD, Brigham and Women’s Hospital and Harvard University, Boston, presented key findings of PIONEER PLUS, during a press briefing prior to the ADA session.

OASIS-1 showed that “oral semaglutide 50 mg may represent an effective option for the treatment of obesity, particularly in patients who prefer oral administration,” Dr. Knop summarized.

And “the PIONEER PLUS trial showed superior glycemic control and body-weight loss and improvement in cardiometabolic risk factors, with higher doses of once-daily oral semaglutide (25 mg and 50 mg) compared with the currently [highest] approved 14-mg dose,” said Dr. Aroda.

Session chair Marion Pragnell, PhD, vice president of research & science at ADA, said in an interview there is a need for multiple treatment options, as different patients respond differently to individual drugs. The oral dose of semaglutide has to be higher than that approved for subcutaneous injection (as Ozempic or Wegovy) because of bioavailability, but small-molecule research is advancing such that in future lower doses of oral drugs may have the same effect as the current lower subcutaneous doses of the drug.

The oral version of semaglutide (Rybelsus) was approved in the United States for type 2 diabetes in doses of 7 mg or 14 mg per day in 2019; it has not been approved for use in obesity.

Dr. Knop remarked that, in his clinical practice, about 25% of patients with type 2 diabetes prefer daily oral semaglutide and the rest prefer weekly injected semaglutide.

“Having an oral formulation of semaglutide in addition to the subcutaneous, or injectable, formula available will allow people who struggle to lose weight with diet and physical activity alone to take this effective medication in a way that best suits them,” he added.

Participants in OASIS and PIONEER PLUS were instructed to take the once-daily study drug tablet in the morning, in the fasting state, with up to half a glass of water (120 mL) at least 30 minutes before intake of any other food, beverage, or oral medication.
 

OASIS: 50-mg daily pill in adults with overweight or obesity

OASIS is, to their knowledge, “the first trial to assess the bodyweight-lowering effect of an oral GLP-1 agonist (semaglutide 50 mg taken once per day) in adults with overweight or obesity, without type 2 diabetes,” Dr. Knop and colleagues wrote.

The 50-mg dose induced clinically meaningful reductions in bodyweight, with accompanying improvements in cardiometabolic risk factors, consistent with results reported for subcutaneous semaglutide 2.4 mg once weekly (Wegovy) in a similar population.

As an adjunct to diet and physical activity, oral semaglutide 50 mg led to a mean bodyweight reduction of 15.1%, compared with 2.4% in the placebo group, and greater percentages of participants reaching bodyweight reduction targets of at least 5%, 10%, 15%, and 20%.

Body-weight reductions were accompanied by significant improvements in cardiometabolic risk factors, compared with placebo.

“These results indicate that oral semaglutide 50 mg could provide an effective, future option for people with overweight or obesity who would benefit from a GLP-1 receptor agonist,” they concluded.
 

 

 

PIONEER PLUS: Inadequately controlled type 2 diabetes

Reporting the PIONEER PLUS data, Dr. Aroda and colleagues said: “For people with inadequately controlled type 2 diabetes on a stable dose of one to three oral glucose-lowering drugs, higher doses (25 mg and 50 mg) of once-daily oral semaglutide provided more effective glycemic control and greater bodyweight loss than 14 mg semaglutide, without additional safety concerns.”

PIONEER PLUS is the first study to indicate that these bigger doses of semaglutide might provide a highly effective oral option to improve both glycemic control and weight loss in type 2 diabetes.

“This trial provides compelling evidence that the availability of a wider range of doses of oral semaglutide will allow for individualized dosing to the desired effect, and the ability to intensify treatment as needed,” said Dr. Aroda. “We are hopeful that these results encourage earlier effective management of type 2 diabetes and allow for broader management in the primary care setting.”

In an accompanying editorial Christina H. Sherrill, PharmD, and Andrew Y. Hwang, PharmD, write: “This expansion in dosing titration might provide clinicians with more opportunities to obtain the maximum efficacy of this oral GLP-1 agonist.”

But additional investigations “to establish whether the superior glycemic reduction seen at these higher doses translates into cardiovascular risk reduction” are needed, said Dr. Sherrill, of High Point (N.C.) University, and Dr. Hwang, of Massachusetts College of Pharmacy and Health Sciences University, Boston.

Such investigations “would further elucidate the place in therapy of high-dose oral semaglutide,” they concluded.

Dr. Aroda and colleagues agreed: “Future real-world studies will be needed to investigate the clinical impact of the availability of higher doses of oral semaglutide.”

The trials were funded by Novo Nordisk.

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

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