It was 2 p.m. on a sunny and humid day, 1 hour before my 8-hour shift was over in the emergency department at the community hospital that I was rotating through. It was part of my fourth-year emergency medicine (EM) clerkship. Not that I would have noticed the weather, save for the few seconds the sliding door to the ED would open periodically, as if on its own cadence, with the sounds of stomping boots and a rolling gurney making its way through.

We were busy. At this particular hospital, I was told, EM volume is already up 35% this year compared with the previous year, and bed holds had been hitting new highs each week.

One more hour until my shift is over and a poor soul will take over my computer, seat, and the chaos.

I took a glance at the electronic health record again, seeing whether there was anything I could do to discharge any of the patients to relieve some of the strain. Knee pain, toe pain, headache/migraine, shoulder pain, elevated blood pressure. Although it’s true that any of these listed complaints could have emergent etiologies, the truth was that all of these patients were here owing to exacerbations of chronic issues. And yet most, if not all, of these patients had been here for nearly 8 hours, some even longer, waiting for treatment and exacerbating an already busy ED.

“I don’t understand. Couldn’t these patients have sought care outpatient with their PCP [primary care physician]? It would have been a lot cheaper and faster.” I asked. A seasoned ED physician, bald, graying, and whom I had just met today and hadn’t spoken to much until this very moment, turned to me and said: “We have become the dumping ground for primary care complaints.”

‘Go to the ED’

“PCPs are already too busy,” the physician continued. “It’s just easier to say: ‘Go to the ED. They’ll take care of it.’ ”

He continued: “In my 30 years of practicing, emergency medicine has changed so much. When I first started in the 1980s, I was only seeing emergencies, and it was fun. Now, 80% of my patients are primary care complaints. These days, I am more of a primary care physician than an emergency physician.”

Hmmm, I thought. Was this physician burned out and jaded? Quite possibly. Was this change the physician experienced throughout his career more likely attributed to a capitalist-run, profit-driven health care system and its cohort of underinsured and noninsured citizens? Certainly. I’m only a fourth-year medical student, so my view of the situation is no doubt limited.

But something he said definitely rang my bell: I’m more of a primary care physician than an emergency physician. That is an argument I can consider. Whether it is caused by poorly designed reimbursement schedules or the state of America’s profit-driven health care system, there is no doubt that these days, emergency physicians are in fact seeing a lot of primary care complaints, which effectively makes these physicians double as PCPs on a daily basis.

I let this thought ruminate on my drive home, along with how there’s a such a huge demand for PCPs, resulting in it taking up to 3 months to get an appointment with one. That’s crazy, and I understand the need to come to the ED where you’ll (hopefully) be seen the same day.

I also ruminated on how emergency physicians have the highest rate of burnout among all the specialties, with no career recourse afterward. Either you’re part of the hospital machine complex, or you’re out. Practicing EM for nearly 30 years is apparently a rarity these days. Most emergency physicians last 5 years, 10 years tops, and then are so burned out that they retire to pursue a life outside of medicine (real estate seems to be popular). But this is a shame.

Emergency docs exiting medicine

Emergency physicians have seen a ton of wildly different pathologies and have treated a variety of different conditions, including conditions usually reserved for primary care. To let knowledgeable, experienced emergency physicians just exit medicine, with no recourse to further contribute to this country’s health system outside of the hospital machine, is a travesty in its own right.

I ruminated further on the 2021 American College of Emergency Physicians 2021 report on the EM physician workforce, which stated that there is projected to be an oversupply of emergency physicians by 2030, leaving thousands of them out of work. No doubt that report has left an impact on the volume of residency applications into EM in 2021. No one wants to go through residency and be unemployed at the end of it.

And finally, I ruminated on the sheer volume of patients visiting EDs across the country. Patient volumes are up, wait times in general are up, wait times in the ED are up, and bed holds to get admitted are hitting highs across the country each week. The deluge of patients visiting the ED is not getting better, and it’s only likely to get worse as the population ages.

It’s time to offer emergency physicians a path to outpatient primary care.

Now before I get hung for this suggestion (“I went into EM precisely not to do outpatient care!”), hear me out: Such a path should be offered via a 1-year accelerated fellowship and will allow emergency physicians to practice outpatient primary care medicine independently. And although working in urgent care centers is already an option, the opportunity to own and operate their own primary care practice should also exist.

In my humble opinion, by offering such a path, the following objectives could be accomplished:

Alleviate the pressure on primary care medicine in the United States. It’s no secret that the United States needs more primary care physicians. Allowing emergency physicians who got burnt out by hospital life an alternative way to serve their community and country via outpatient primary care would greatly alleviate the pressure on the need for PCPs today.

Provide an alternative career path for emergency physicians. We would be doing a disservice if we don’t offer emergency physicians a way to revive their burnout and utilize their skill set in a post-ED life. Outpatient primary care is the perfect way to do this, and it’s a win-win-win on several fronts: We need more outpatient physicians, they need an opportunity to flex their knowledge in an alternative setting.

Solve the “ACEP” problem. The ACEP report scared medical students away from applying to residency in EM. Who wants to go through 3 years of residency only to be unemployed at the end of it? By offering a path to outpatient primary care, we can offer an important and viable path for those emergency physicians who would be unemployed to continue to practice medicine and serve the community, thereby alleviating concern about an oversupply.

For better or for worse, because of the state of health care today, ED physicians have been exposed to a myriad of primary care concerns, all of which have prepared them for a career as an outpatient PCP. By offering such a path, we can provide more flexibility for an emergency physician’s career, help alleviate the primary care shortage affecting the United States, and serve our community and country in new and helpful ways.

Dr. Gogna is a fourth-year medical student at Philadelphia College of Osteopathic Medicine Georgia, Suwanee. He reported no relevant conflicts of interest.

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

It was 2 p.m. on a sunny and humid day, 1 hour before my 8-hour shift was over in the emergency department at the community hospital that I was rotating through. It was part of my fourth-year emergency medicine (EM) clerkship. Not that I would have noticed the weather, save for the few seconds the sliding door to the ED would open periodically, as if on its own cadence, with the sounds of stomping boots and a rolling gurney making its way through.

We were busy. At this particular hospital, I was told, EM volume is already up 35% this year compared with the previous year, and bed holds had been hitting new highs each week.

One more hour until my shift is over and a poor soul will take over my computer, seat, and the chaos.

I took a glance at the electronic health record again, seeing whether there was anything I could do to discharge any of the patients to relieve some of the strain. Knee pain, toe pain, headache/migraine, shoulder pain, elevated blood pressure. Although it’s true that any of these listed complaints could have emergent etiologies, the truth was that all of these patients were here owing to exacerbations of chronic issues. And yet most, if not all, of these patients had been here for nearly 8 hours, some even longer, waiting for treatment and exacerbating an already busy ED.

“I don’t understand. Couldn’t these patients have sought care outpatient with their PCP [primary care physician]? It would have been a lot cheaper and faster.” I asked. A seasoned ED physician, bald, graying, and whom I had just met today and hadn’t spoken to much until this very moment, turned to me and said: “We have become the dumping ground for primary care complaints.”

‘Go to the ED’

“PCPs are already too busy,” the physician continued. “It’s just easier to say: ‘Go to the ED. They’ll take care of it.’ ”

He continued: “In my 30 years of practicing, emergency medicine has changed so much. When I first started in the 1980s, I was only seeing emergencies, and it was fun. Now, 80% of my patients are primary care complaints. These days, I am more of a primary care physician than an emergency physician.”

Hmmm, I thought. Was this physician burned out and jaded? Quite possibly. Was this change the physician experienced throughout his career more likely attributed to a capitalist-run, profit-driven health care system and its cohort of underinsured and noninsured citizens? Certainly. I’m only a fourth-year medical student, so my view of the situation is no doubt limited.

But something he said definitely rang my bell: I’m more of a primary care physician than an emergency physician. That is an argument I can consider. Whether it is caused by poorly designed reimbursement schedules or the state of America’s profit-driven health care system, there is no doubt that these days, emergency physicians are in fact seeing a lot of primary care complaints, which effectively makes these physicians double as PCPs on a daily basis.

I let this thought ruminate on my drive home, along with how there’s a such a huge demand for PCPs, resulting in it taking up to 3 months to get an appointment with one. That’s crazy, and I understand the need to come to the ED where you’ll (hopefully) be seen the same day.

I also ruminated on how emergency physicians have the highest rate of burnout among all the specialties, with no career recourse afterward. Either you’re part of the hospital machine complex, or you’re out. Practicing EM for nearly 30 years is apparently a rarity these days. Most emergency physicians last 5 years, 10 years tops, and then are so burned out that they retire to pursue a life outside of medicine (real estate seems to be popular). But this is a shame.

Emergency docs exiting medicine

Emergency physicians have seen a ton of wildly different pathologies and have treated a variety of different conditions, including conditions usually reserved for primary care. To let knowledgeable, experienced emergency physicians just exit medicine, with no recourse to further contribute to this country’s health system outside of the hospital machine, is a travesty in its own right.

I ruminated further on the 2021 American College of Emergency Physicians 2021 report on the EM physician workforce, which stated that there is projected to be an oversupply of emergency physicians by 2030, leaving thousands of them out of work. No doubt that report has left an impact on the volume of residency applications into EM in 2021. No one wants to go through residency and be unemployed at the end of it.

And finally, I ruminated on the sheer volume of patients visiting EDs across the country. Patient volumes are up, wait times in general are up, wait times in the ED are up, and bed holds to get admitted are hitting highs across the country each week. The deluge of patients visiting the ED is not getting better, and it’s only likely to get worse as the population ages.

It’s time to offer emergency physicians a path to outpatient primary care.

Now before I get hung for this suggestion (“I went into EM precisely not to do outpatient care!”), hear me out: Such a path should be offered via a 1-year accelerated fellowship and will allow emergency physicians to practice outpatient primary care medicine independently. And although working in urgent care centers is already an option, the opportunity to own and operate their own primary care practice should also exist.

In my humble opinion, by offering such a path, the following objectives could be accomplished:

Alleviate the pressure on primary care medicine in the United States. It’s no secret that the United States needs more primary care physicians. Allowing emergency physicians who got burnt out by hospital life an alternative way to serve their community and country via outpatient primary care would greatly alleviate the pressure on the need for PCPs today.

Provide an alternative career path for emergency physicians. We would be doing a disservice if we don’t offer emergency physicians a way to revive their burnout and utilize their skill set in a post-ED life. Outpatient primary care is the perfect way to do this, and it’s a win-win-win on several fronts: We need more outpatient physicians, they need an opportunity to flex their knowledge in an alternative setting.

Solve the “ACEP” problem. The ACEP report scared medical students away from applying to residency in EM. Who wants to go through 3 years of residency only to be unemployed at the end of it? By offering a path to outpatient primary care, we can offer an important and viable path for those emergency physicians who would be unemployed to continue to practice medicine and serve the community, thereby alleviating concern about an oversupply.

For better or for worse, because of the state of health care today, ED physicians have been exposed to a myriad of primary care concerns, all of which have prepared them for a career as an outpatient PCP. By offering such a path, we can provide more flexibility for an emergency physician’s career, help alleviate the primary care shortage affecting the United States, and serve our community and country in new and helpful ways.

Dr. Gogna is a fourth-year medical student at Philadelphia College of Osteopathic Medicine Georgia, Suwanee. He reported no relevant conflicts of interest.

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

It was 2 p.m. on a sunny and humid day, 1 hour before my 8-hour shift was over in the emergency department at the community hospital that I was rotating through. It was part of my fourth-year emergency medicine (EM) clerkship. Not that I would have noticed the weather, save for the few seconds the sliding door to the ED would open periodically, as if on its own cadence, with the sounds of stomping boots and a rolling gurney making its way through.

We were busy. At this particular hospital, I was told, EM volume is already up 35% this year compared with the previous year, and bed holds had been hitting new highs each week.

One more hour until my shift is over and a poor soul will take over my computer, seat, and the chaos.

I took a glance at the electronic health record again, seeing whether there was anything I could do to discharge any of the patients to relieve some of the strain. Knee pain, toe pain, headache/migraine, shoulder pain, elevated blood pressure. Although it’s true that any of these listed complaints could have emergent etiologies, the truth was that all of these patients were here owing to exacerbations of chronic issues. And yet most, if not all, of these patients had been here for nearly 8 hours, some even longer, waiting for treatment and exacerbating an already busy ED.

“I don’t understand. Couldn’t these patients have sought care outpatient with their PCP [primary care physician]? It would have been a lot cheaper and faster.” I asked. A seasoned ED physician, bald, graying, and whom I had just met today and hadn’t spoken to much until this very moment, turned to me and said: “We have become the dumping ground for primary care complaints.”

‘Go to the ED’

“PCPs are already too busy,” the physician continued. “It’s just easier to say: ‘Go to the ED. They’ll take care of it.’ ”

He continued: “In my 30 years of practicing, emergency medicine has changed so much. When I first started in the 1980s, I was only seeing emergencies, and it was fun. Now, 80% of my patients are primary care complaints. These days, I am more of a primary care physician than an emergency physician.”

Hmmm, I thought. Was this physician burned out and jaded? Quite possibly. Was this change the physician experienced throughout his career more likely attributed to a capitalist-run, profit-driven health care system and its cohort of underinsured and noninsured citizens? Certainly. I’m only a fourth-year medical student, so my view of the situation is no doubt limited.

But something he said definitely rang my bell: I’m more of a primary care physician than an emergency physician. That is an argument I can consider. Whether it is caused by poorly designed reimbursement schedules or the state of America’s profit-driven health care system, there is no doubt that these days, emergency physicians are in fact seeing a lot of primary care complaints, which effectively makes these physicians double as PCPs on a daily basis.

I let this thought ruminate on my drive home, along with how there’s a such a huge demand for PCPs, resulting in it taking up to 3 months to get an appointment with one. That’s crazy, and I understand the need to come to the ED where you’ll (hopefully) be seen the same day.

I also ruminated on how emergency physicians have the highest rate of burnout among all the specialties, with no career recourse afterward. Either you’re part of the hospital machine complex, or you’re out. Practicing EM for nearly 30 years is apparently a rarity these days. Most emergency physicians last 5 years, 10 years tops, and then are so burned out that they retire to pursue a life outside of medicine (real estate seems to be popular). But this is a shame.

Emergency docs exiting medicine

Emergency physicians have seen a ton of wildly different pathologies and have treated a variety of different conditions, including conditions usually reserved for primary care. To let knowledgeable, experienced emergency physicians just exit medicine, with no recourse to further contribute to this country’s health system outside of the hospital machine, is a travesty in its own right.

I ruminated further on the 2021 American College of Emergency Physicians 2021 report on the EM physician workforce, which stated that there is projected to be an oversupply of emergency physicians by 2030, leaving thousands of them out of work. No doubt that report has left an impact on the volume of residency applications into EM in 2021. No one wants to go through residency and be unemployed at the end of it.

And finally, I ruminated on the sheer volume of patients visiting EDs across the country. Patient volumes are up, wait times in general are up, wait times in the ED are up, and bed holds to get admitted are hitting highs across the country each week. The deluge of patients visiting the ED is not getting better, and it’s only likely to get worse as the population ages.

It’s time to offer emergency physicians a path to outpatient primary care.

Now before I get hung for this suggestion (“I went into EM precisely not to do outpatient care!”), hear me out: Such a path should be offered via a 1-year accelerated fellowship and will allow emergency physicians to practice outpatient primary care medicine independently. And although working in urgent care centers is already an option, the opportunity to own and operate their own primary care practice should also exist.

In my humble opinion, by offering such a path, the following objectives could be accomplished:

Alleviate the pressure on primary care medicine in the United States. It’s no secret that the United States needs more primary care physicians. Allowing emergency physicians who got burnt out by hospital life an alternative way to serve their community and country via outpatient primary care would greatly alleviate the pressure on the need for PCPs today.

Provide an alternative career path for emergency physicians. We would be doing a disservice if we don’t offer emergency physicians a way to revive their burnout and utilize their skill set in a post-ED life. Outpatient primary care is the perfect way to do this, and it’s a win-win-win on several fronts: We need more outpatient physicians, they need an opportunity to flex their knowledge in an alternative setting.

Solve the “ACEP” problem. The ACEP report scared medical students away from applying to residency in EM. Who wants to go through 3 years of residency only to be unemployed at the end of it? By offering a path to outpatient primary care, we can offer an important and viable path for those emergency physicians who would be unemployed to continue to practice medicine and serve the community, thereby alleviating concern about an oversupply.

For better or for worse, because of the state of health care today, ED physicians have been exposed to a myriad of primary care concerns, all of which have prepared them for a career as an outpatient PCP. By offering such a path, we can provide more flexibility for an emergency physician’s career, help alleviate the primary care shortage affecting the United States, and serve our community and country in new and helpful ways.

Dr. Gogna is a fourth-year medical student at Philadelphia College of Osteopathic Medicine Georgia, Suwanee. He reported no relevant conflicts of interest.

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

Nursing oversight groups in the United States and Canada are holding the line on testing standards as more would-be nurses fail entry exams. As a result, pressure is growing to make tests easier to pass given widespread nursing shortages, and some critics wonder whether the exams accurately assess students’ true abilities.

When it comes to training more nurses to keep up with growing demand, the U.S. organization that oversees the main licensing exams for nurses decided earlier this month not to change the passing standards for entry-level tests. Meanwhile, nursing test examiners have seen a drop in passing rates for nurses taking the standard licensing exam since the pandemic began.

A similar scenario also is unfolding in Quebec, where the agency overseeing nurse licensing exams announced last month it is holding the line on its passing rates despite an outcry from nurses after more than half of those taking the exam in September failed. Quebec’s commissioner for professional admissions is investigating dozens of complaints from nurses about the failure rate. Nurses who failed the test can sign up to retake it in March.

Joseph Oujeil, DESS, DEF, has been teaching in Canada for 4 years, now at two Quebec nursing schools. “This is surprising and very shocking to our students as well as nurses from outside Quebec who were [completing] an integration program to adjust their practice to Quebec guidelines,” Mr. Oujeil told this news organization. Students from outside the province failed the licensing exam at a higher rate than their Quebec-native peers, he explained.

Quebec’s professional Order of Nurses of Quebec (OIIQ) responded to the nurses’ outcry in a press release last month, saying that the pandemic may be partly to blame for the lower passing rate because it made it more difficult to access internships, labs, and face-to-face teaching. Some students weren’t able to demonstrate their ability to practice during the exam as in previous years, OIIQ reported.

Mr. Oujeil agreed. “I’m sure the pandemic has an impact on the situation as well as some students did less training in hospitals” because of restrictions caused by the pandemic, he said. But students also told Mr. Oujeil some questions seemed ambiguous.

OIIQ stated in its release that it doesn’t want to lower the standard. The goal is to protect the public “by and with nurses,” to “ensure the competence and integrity of nurses in Quebec,” and “promote quality nursing practice,” the release noted.

Similarly in the United States, the National Council of State Boards of Nursing (NCSBN) announced Dec. 8 that it would uphold the current passing standards for its entry-level NCLEX tests for registered nurses and practical nurses. NCSBN analyzes the passing standard every 3 years “to keep the test plan and passing standard current,” a press release explains.

NCLEX pass rates have dropped from about 73% for all candidates and 88% for first-time U.S.-educated candidates to 69% and 82% respectively in 2021, the last full year for which results are available, NCSBN spokesperson Dawn Kappel told this news organization.

Over the past 3 years, including during the pandemic, the board decided “that the current passing standard is appropriate as a measure of safe and effective entry-level nurse practice,” after reviewing national nurse surveys and the findings of panels of nurses representing NCSBN’s geographic areas in the United States and Canada, board president Jay Douglas, MSM, RN, CSAC, said in a press release.

Still, NCSBN is not blind to the larger issues facing nursing, Ms. Kappel told this news organization. “There is a huge nursing shortage in the U.S. and Canada. We want as many nurses in the workforce as possible, but we want to ensure safe practice,” she said.

“Everyone has access to the same test, regardless of which state, province, or country they take it in,” she said. Some international students may not perform as well as U.S.-educated students because of their command of English and the nursing education standards in their home countries, Ms. Kappel added.

“Obviously COVID and the challenge of education in general” affected the results, she said.

Mr. Oujeil, the nursing school professor, said he is frustrated by the test results because the majority of students who failed maintained good grades and passed all of their trainings. Yet they scored just below the passing rate of 55%. He said students are proposing the passing rate be lowered to 50%. The current test doesn’t reflect what students are learning in the classroom or during clinical trainings, Mr. Oujeil added. “I don’t know of any students who scored more than 60%.”

He said he understands that the mission of the OIIQ is protecting the population, but he doesn’t believe lowering the passing rate to 50% will put the population at risk – and it will help offset the staffing shortage.

“I’m especially frustrated by those who were doing integration programs – mothers and fathers with children with family lives and financial responsibilities. Many of them are good, hard workers and were shocked they should have to pass the exam another time.”

Since 2018, the pass rate on the first attempt at the Quebec test has generally been between 71% and 96%, compared with 51.4% during the exam in September, according to the OIIQ press release. Meanwhile, graduates from 30 of the 55 schools and universities in Quebec teaching nurses performed above the average on the recent professional exam, OIIQ reported.

The professional licensing organization pointed out that nursing candidates have three attempts to pass their exam. “In order to better prepare for their next attempt, all those who failed received an individual response detailing the difficulties encountered. The OIIQ offers all the tools necessary to pass the exam; a detailed guide and preparatory workshops are available online.

“In the run up to the next exams, we will continue to support students by working with educational institutions to provide the optimal conditions for passing the exam. This exam is usually successful and we are convinced that the return to face-to-face teaching, as well as support for students, will be factors of success,” OIIQ President Luc Mathieu said in a press release.

Nursing candidates “who have not passed the exam will be put to work in the network, with the possibility of practicing under the supervision of a nurse. ... In addition, we will contact health establishments in order to support them in their supervision activities” of the candidates, he said.

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

Nursing oversight groups in the United States and Canada are holding the line on testing standards as more would-be nurses fail entry exams. As a result, pressure is growing to make tests easier to pass given widespread nursing shortages, and some critics wonder whether the exams accurately assess students’ true abilities.

When it comes to training more nurses to keep up with growing demand, the U.S. organization that oversees the main licensing exams for nurses decided earlier this month not to change the passing standards for entry-level tests. Meanwhile, nursing test examiners have seen a drop in passing rates for nurses taking the standard licensing exam since the pandemic began.

A similar scenario also is unfolding in Quebec, where the agency overseeing nurse licensing exams announced last month it is holding the line on its passing rates despite an outcry from nurses after more than half of those taking the exam in September failed. Quebec’s commissioner for professional admissions is investigating dozens of complaints from nurses about the failure rate. Nurses who failed the test can sign up to retake it in March.

Joseph Oujeil, DESS, DEF, has been teaching in Canada for 4 years, now at two Quebec nursing schools. “This is surprising and very shocking to our students as well as nurses from outside Quebec who were [completing] an integration program to adjust their practice to Quebec guidelines,” Mr. Oujeil told this news organization. Students from outside the province failed the licensing exam at a higher rate than their Quebec-native peers, he explained.

Quebec’s professional Order of Nurses of Quebec (OIIQ) responded to the nurses’ outcry in a press release last month, saying that the pandemic may be partly to blame for the lower passing rate because it made it more difficult to access internships, labs, and face-to-face teaching. Some students weren’t able to demonstrate their ability to practice during the exam as in previous years, OIIQ reported.

Mr. Oujeil agreed. “I’m sure the pandemic has an impact on the situation as well as some students did less training in hospitals” because of restrictions caused by the pandemic, he said. But students also told Mr. Oujeil some questions seemed ambiguous.

OIIQ stated in its release that it doesn’t want to lower the standard. The goal is to protect the public “by and with nurses,” to “ensure the competence and integrity of nurses in Quebec,” and “promote quality nursing practice,” the release noted.

Similarly in the United States, the National Council of State Boards of Nursing (NCSBN) announced Dec. 8 that it would uphold the current passing standards for its entry-level NCLEX tests for registered nurses and practical nurses. NCSBN analyzes the passing standard every 3 years “to keep the test plan and passing standard current,” a press release explains.

NCLEX pass rates have dropped from about 73% for all candidates and 88% for first-time U.S.-educated candidates to 69% and 82% respectively in 2021, the last full year for which results are available, NCSBN spokesperson Dawn Kappel told this news organization.

Over the past 3 years, including during the pandemic, the board decided “that the current passing standard is appropriate as a measure of safe and effective entry-level nurse practice,” after reviewing national nurse surveys and the findings of panels of nurses representing NCSBN’s geographic areas in the United States and Canada, board president Jay Douglas, MSM, RN, CSAC, said in a press release.

Still, NCSBN is not blind to the larger issues facing nursing, Ms. Kappel told this news organization. “There is a huge nursing shortage in the U.S. and Canada. We want as many nurses in the workforce as possible, but we want to ensure safe practice,” she said.

“Everyone has access to the same test, regardless of which state, province, or country they take it in,” she said. Some international students may not perform as well as U.S.-educated students because of their command of English and the nursing education standards in their home countries, Ms. Kappel added.

“Obviously COVID and the challenge of education in general” affected the results, she said.

Mr. Oujeil, the nursing school professor, said he is frustrated by the test results because the majority of students who failed maintained good grades and passed all of their trainings. Yet they scored just below the passing rate of 55%. He said students are proposing the passing rate be lowered to 50%. The current test doesn’t reflect what students are learning in the classroom or during clinical trainings, Mr. Oujeil added. “I don’t know of any students who scored more than 60%.”

He said he understands that the mission of the OIIQ is protecting the population, but he doesn’t believe lowering the passing rate to 50% will put the population at risk – and it will help offset the staffing shortage.

“I’m especially frustrated by those who were doing integration programs – mothers and fathers with children with family lives and financial responsibilities. Many of them are good, hard workers and were shocked they should have to pass the exam another time.”

Since 2018, the pass rate on the first attempt at the Quebec test has generally been between 71% and 96%, compared with 51.4% during the exam in September, according to the OIIQ press release. Meanwhile, graduates from 30 of the 55 schools and universities in Quebec teaching nurses performed above the average on the recent professional exam, OIIQ reported.

The professional licensing organization pointed out that nursing candidates have three attempts to pass their exam. “In order to better prepare for their next attempt, all those who failed received an individual response detailing the difficulties encountered. The OIIQ offers all the tools necessary to pass the exam; a detailed guide and preparatory workshops are available online.

“In the run up to the next exams, we will continue to support students by working with educational institutions to provide the optimal conditions for passing the exam. This exam is usually successful and we are convinced that the return to face-to-face teaching, as well as support for students, will be factors of success,” OIIQ President Luc Mathieu said in a press release.

Nursing candidates “who have not passed the exam will be put to work in the network, with the possibility of practicing under the supervision of a nurse. ... In addition, we will contact health establishments in order to support them in their supervision activities” of the candidates, he said.

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

Nursing oversight groups in the United States and Canada are holding the line on testing standards as more would-be nurses fail entry exams. As a result, pressure is growing to make tests easier to pass given widespread nursing shortages, and some critics wonder whether the exams accurately assess students’ true abilities.

When it comes to training more nurses to keep up with growing demand, the U.S. organization that oversees the main licensing exams for nurses decided earlier this month not to change the passing standards for entry-level tests. Meanwhile, nursing test examiners have seen a drop in passing rates for nurses taking the standard licensing exam since the pandemic began.

A similar scenario also is unfolding in Quebec, where the agency overseeing nurse licensing exams announced last month it is holding the line on its passing rates despite an outcry from nurses after more than half of those taking the exam in September failed. Quebec’s commissioner for professional admissions is investigating dozens of complaints from nurses about the failure rate. Nurses who failed the test can sign up to retake it in March.

Joseph Oujeil, DESS, DEF, has been teaching in Canada for 4 years, now at two Quebec nursing schools. “This is surprising and very shocking to our students as well as nurses from outside Quebec who were [completing] an integration program to adjust their practice to Quebec guidelines,” Mr. Oujeil told this news organization. Students from outside the province failed the licensing exam at a higher rate than their Quebec-native peers, he explained.

Quebec’s professional Order of Nurses of Quebec (OIIQ) responded to the nurses’ outcry in a press release last month, saying that the pandemic may be partly to blame for the lower passing rate because it made it more difficult to access internships, labs, and face-to-face teaching. Some students weren’t able to demonstrate their ability to practice during the exam as in previous years, OIIQ reported.

Mr. Oujeil agreed. “I’m sure the pandemic has an impact on the situation as well as some students did less training in hospitals” because of restrictions caused by the pandemic, he said. But students also told Mr. Oujeil some questions seemed ambiguous.

OIIQ stated in its release that it doesn’t want to lower the standard. The goal is to protect the public “by and with nurses,” to “ensure the competence and integrity of nurses in Quebec,” and “promote quality nursing practice,” the release noted.

Similarly in the United States, the National Council of State Boards of Nursing (NCSBN) announced Dec. 8 that it would uphold the current passing standards for its entry-level NCLEX tests for registered nurses and practical nurses. NCSBN analyzes the passing standard every 3 years “to keep the test plan and passing standard current,” a press release explains.

NCLEX pass rates have dropped from about 73% for all candidates and 88% for first-time U.S.-educated candidates to 69% and 82% respectively in 2021, the last full year for which results are available, NCSBN spokesperson Dawn Kappel told this news organization.

Over the past 3 years, including during the pandemic, the board decided “that the current passing standard is appropriate as a measure of safe and effective entry-level nurse practice,” after reviewing national nurse surveys and the findings of panels of nurses representing NCSBN’s geographic areas in the United States and Canada, board president Jay Douglas, MSM, RN, CSAC, said in a press release.

Still, NCSBN is not blind to the larger issues facing nursing, Ms. Kappel told this news organization. “There is a huge nursing shortage in the U.S. and Canada. We want as many nurses in the workforce as possible, but we want to ensure safe practice,” she said.

“Everyone has access to the same test, regardless of which state, province, or country they take it in,” she said. Some international students may not perform as well as U.S.-educated students because of their command of English and the nursing education standards in their home countries, Ms. Kappel added.

“Obviously COVID and the challenge of education in general” affected the results, she said.

Mr. Oujeil, the nursing school professor, said he is frustrated by the test results because the majority of students who failed maintained good grades and passed all of their trainings. Yet they scored just below the passing rate of 55%. He said students are proposing the passing rate be lowered to 50%. The current test doesn’t reflect what students are learning in the classroom or during clinical trainings, Mr. Oujeil added. “I don’t know of any students who scored more than 60%.”

He said he understands that the mission of the OIIQ is protecting the population, but he doesn’t believe lowering the passing rate to 50% will put the population at risk – and it will help offset the staffing shortage.

“I’m especially frustrated by those who were doing integration programs – mothers and fathers with children with family lives and financial responsibilities. Many of them are good, hard workers and were shocked they should have to pass the exam another time.”

Since 2018, the pass rate on the first attempt at the Quebec test has generally been between 71% and 96%, compared with 51.4% during the exam in September, according to the OIIQ press release. Meanwhile, graduates from 30 of the 55 schools and universities in Quebec teaching nurses performed above the average on the recent professional exam, OIIQ reported.

The professional licensing organization pointed out that nursing candidates have three attempts to pass their exam. “In order to better prepare for their next attempt, all those who failed received an individual response detailing the difficulties encountered. The OIIQ offers all the tools necessary to pass the exam; a detailed guide and preparatory workshops are available online.

“In the run up to the next exams, we will continue to support students by working with educational institutions to provide the optimal conditions for passing the exam. This exam is usually successful and we are convinced that the return to face-to-face teaching, as well as support for students, will be factors of success,” OIIQ President Luc Mathieu said in a press release.

Nursing candidates “who have not passed the exam will be put to work in the network, with the possibility of practicing under the supervision of a nurse. ... In addition, we will contact health establishments in order to support them in their supervision activities” of the candidates, he said.

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

A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

• Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
• Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
• Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
• Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
• Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
• Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
• Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
• Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
• Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

• Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
• Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
• Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
• Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
• Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
• Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
• Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
• Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
• Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

A new analysis finds that vonoprazan triple therapy (Voquezna) is the most cost-effective first-line regimen to eradicate Helicobacter pylori infection in the United States.

Rifabutin triple therapy (Talicia) is the second most cost-effective strategy for H. pylori eradication, followed in order of decreasing cost-effectiveness by vonoprazan dual therapy, bismuth quadruple therapy, and clarithromycin triple therapy.

The analysis is believed to be the first to report on the cost-effectiveness of vonoprazan- and rifabutin-based regimens as first-line treatments for H. pylori infection from the perspective of U.S. health care payers.

The findings “strongly” suggest that vonoprazan triple therapy would provide the greatest net health benefit and monetary benefit for U.S. payers, reported Ismaeel Yunusa, PharmD, PhD, of the University of South Carolina College of Pharmacy in Columbia, and colleagues.

The study was published online in the American Journal of Gastroenterology.

It’s estimated that more than 114 million people in the United States have H. pylori infection. Clinical practice guidelines recommend H. pylori eradication in all patients with a positive test of active infection.

Using a Markov model, Dr. Yunusa and colleagues estimated the cost-effectiveness of five prepackaged or co-formulated H. pylori eradication regimens: clarithromycin triple therapy, bismuth quadruple therapy, vonoprazan dual therapy, vonoprazan triple therapy, and rifabutin triple therapy.

The model estimated the expected costs in 2022 U.S. dollars, expected quality-adjusted life years (QALYs), incremental cost-effectiveness ratio (ICERs), and expected net monetary benefit over 20 years.

Among their key findings and conclusions:

• Bismuth quadruple therapy had the highest expected cost ($1,439) and rifabutin triple regimen had the lowest expected cost ($1,048).
• Because rifabutin triple therapy was predicted to cost less and was more effective than clarithromycin triple therapy, bismuth quadruple therapy, and vonoprazan dual therapy, it dominated all treatment strategies – except for vonoprazan triple therapy.
• Compared with rifabutin triple therapy, vonoprazan triple therapy had a higher expected cost ($1,172 vs. $1,048) and expected QALY (14.262 vs. 14.256), yielding an ICER of $22,573 per QALY. 
• Vonoprazan triple therapy had the highest expected net monetary benefit and was the most cost-effective at willingness to pay thresholds between $50,000 and $150,000 per QALY, followed by rifabutin triple therapy.
• Vonoprazan triple therapy would result on average in an incremental net benefit of $1,655 per patient than clarithromycin triple therapy.
• Because the rifabutin-based regimen was more cost-effective than all but vonoprazan triple therapy, it has a potential role as an alternative first-line treatment.
• Rifabutin triple therapy and vonoprazan dual therapy would need to be considerably discounted (by 15%-43% and by 44%-85%, respectively), to be cost-effective at commonly used cost-effectiveness thresholds.
• Vonoprazan dual therapy demonstrated limited value relative to other available options; thus, its widespread adoption as a first-line strategy seems unlikely.
• Based on the results, it would be hard to justify the use of bismuth quadruple therapy or clarithromycin triple therapy since they provide the lowest net monetary benefit and have lower eradication rates.

The investigators noted that their analysis considered only direct costs of therapy, not other costs such as appointments, travel, and time away from work.

They also assumed medical costs, including endoscopy and H. pylori testing, would not change regardless of treatment regimen. Therefore, total health care costs may be underestimated.

The study did not receive any funding. The authors have declared no relevant financial relationships.

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

A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD). 

Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.

“The implication is that muscular strength and mobility influence brain health and can potentially be modified to improve outcomes in persons with Alzheimer’s,” study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.

The study was published online in the Journal of Alzheimer’s Disease.
 

Brain-body connection

The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”

They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.

The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).

Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.

“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.

The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
 

‘Use it or lose it’

The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure. 

In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.

The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.

However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.

“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.

“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.

This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.

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

A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD). 

Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.

“The implication is that muscular strength and mobility influence brain health and can potentially be modified to improve outcomes in persons with Alzheimer’s,” study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.

The study was published online in the Journal of Alzheimer’s Disease.
 

Brain-body connection

The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”

They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.

The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).

Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.

“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.

The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
 

‘Use it or lose it’

The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure. 

In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.

The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.

However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.

“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.

“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.

This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.

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

A new study shows a strong correlation between muscle strength, mobility, and brain volume, including in the hippocampus that underlies memory function, in adults with Alzheimer’s disease (AD). 

Investigators found statistically significant relationships between better handgrip strength and mobility and hippocampal and lobar brain volumes in 38 cognitively impaired adults with biomarker evidence of AD.

“The implication is that muscular strength and mobility influence brain health and can potentially be modified to improve outcomes in persons with Alzheimer’s,” study investigator Cyrus Raji, MD, PhD, Mallinckrodt Institute of Radiology, Washington University, St. Louis, told this news organization.

The study was published online in the Journal of Alzheimer’s Disease.
 

Brain-body connection

The researchers measured handgrip strength in patients’ dominant and nondominant hands using a hand dynamometer and calculated handgrip asymmetry. Mobility was measured via the 2-minute walk test. Together, the test results were used to categorize patients as “frail” or “not frail.”

They measured regional brain volumes using Neuroreader (Brainreader), a U.S. Food and Drug Administration–approved software application that measures brain volumes on MRI scans.

The investigators found higher nondominant handgrip strength was significantly associated with larger volumes in the hippocampal volume (P = .02). In addition, higher dominant handgrip strength correlated with higher frontal lobe volume (P = .02).

Results also showed higher scores on the 2-minute walk test were associated with larger hippocampal (P = .04), frontal (P = .01), temporal (P = .03), parietal (P = .009), and occipital lobe (P = .005) volumes. Frailty was associated with reduced frontal, temporal, and parietal lobe volumes.

“In this study we combined objective evaluations of frailty with measurable determinants of brain structure on MRI to demonstrate a link between frailty and brain health in patients with both biomarker evidence of AD and cognitive impairment,” study investigator Somayeh Meysami, MD, with Pacific Brain Health Center, Pacific Neuroscience Institute Foundation (PNI), Santa Monica, Calif., told this news organization.

The researchers noted that it’s possible that interventions specifically focused on improving ambulatory mobility and handgrip strength could be beneficial in improving dementia trajectories.
 

‘Use it or lose it’

The chief limitation of the study is the cross-sectional design that precludes drawing firm conclusions about the causal relationships between handgrip strength and changes in brain structure. 

In addition, the study used a relatively small convenience sample of outpatients from a specialty memory clinic.

The researchers say future longitudinal analyses with a larger sample size will be important to better understand the possible directions of causality between handgrip strength and progression of atrophy in AD.

However, despite these limitations, the findings emphasize the importance of “body-brain connections,” added David A. Merrill, MD, PhD, director of the Pacific Brain Health Center at PNI.

“Training our muscles helps sustain our brains and vice versa. It’s ‘use it or lose it’ for both body and mind. Exercise remains among the best strategies for maintaining a healthy body and mind with aging,” Dr. Merrill said in an interview.

“While it’s long been appreciated that aerobic training helps the brain, these findings add to the importance of strength training in supporting successful aging,” he added.

This work was supported by Providence St. Joseph Health, Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute Foundation; and the National Institutes of Health. Dr. Raji is a consultant for Brainreader, Apollo Health, Pacific Neuroscience Foundation, and Neurevolution. Dr. Merrill and Dr. Meysami reported no relevant disclosures.

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

Q2. Correct answer: A. Enteric infection 

Rationale 

Despite the numerous side effects associated with long-term PPI use, the quality of evidence and risk of confounding from these studies limits the ability to ascribe sufficient cause and effect between PPI use and these outcomes. However, a recent large randomized controlled trial that evaluated the use of pantoprazole versus placebo demonstrated a statistically significant difference between the pantoprazole and placebo groups only in enteric infections (1.4% vs 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Despite a nearly double increased risk of Clostridioides difficile infection in the PPI group, compared with the placebo group, the number of events was low, and the difference did not reach statistical significance. In the context of these data, and more recent studies suggesting an increased risk of COVID-19 in patients who take PPIs, compared with those who do not, the risk of enteric infections is likely small but significantly increased among long-term PPI users. 

References 

• Freedberg DE et al. Gastroenterology. 2017;152(4):706-15. doi: 10.1053/j.gastro.2017.01.031. 
• Moayyedi P et al. Gastroenterology. 2019;157(3):682-91.e2. doi: 10.1053/j.gastro.2019.05.056.

Q2. Correct answer: A. Enteric infection 

Rationale 

Despite the numerous side effects associated with long-term PPI use, the quality of evidence and risk of confounding from these studies limits the ability to ascribe sufficient cause and effect between PPI use and these outcomes. However, a recent large randomized controlled trial that evaluated the use of pantoprazole versus placebo demonstrated a statistically significant difference between the pantoprazole and placebo groups only in enteric infections (1.4% vs 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Despite a nearly double increased risk of Clostridioides difficile infection in the PPI group, compared with the placebo group, the number of events was low, and the difference did not reach statistical significance. In the context of these data, and more recent studies suggesting an increased risk of COVID-19 in patients who take PPIs, compared with those who do not, the risk of enteric infections is likely small but significantly increased among long-term PPI users. 

References 

• Freedberg DE et al. Gastroenterology. 2017;152(4):706-15. doi: 10.1053/j.gastro.2017.01.031. 
• Moayyedi P et al. Gastroenterology. 2019;157(3):682-91.e2. doi: 10.1053/j.gastro.2019.05.056.

Q2. Correct answer: A. Enteric infection 

Rationale 

Despite the numerous side effects associated with long-term PPI use, the quality of evidence and risk of confounding from these studies limits the ability to ascribe sufficient cause and effect between PPI use and these outcomes. However, a recent large randomized controlled trial that evaluated the use of pantoprazole versus placebo demonstrated a statistically significant difference between the pantoprazole and placebo groups only in enteric infections (1.4% vs 1.0%; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). Despite a nearly double increased risk of Clostridioides difficile infection in the PPI group, compared with the placebo group, the number of events was low, and the difference did not reach statistical significance. In the context of these data, and more recent studies suggesting an increased risk of COVID-19 in patients who take PPIs, compared with those who do not, the risk of enteric infections is likely small but significantly increased among long-term PPI users. 

References 

• Freedberg DE et al. Gastroenterology. 2017;152(4):706-15. doi: 10.1053/j.gastro.2017.01.031. 
• Moayyedi P et al. Gastroenterology. 2019;157(3):682-91.e2. doi: 10.1053/j.gastro.2019.05.056.

Q1. Correct answer: D. Rabeprazole 

Rationale 

Within-class switching of proton pump inhibitors (PPIs) for patients with incomplete control of symptoms is frequently done in clinical practice. For the management of gastroesophageal reflux disease, this practice can be "considered" according to guidelines. More recent data suggest varying potencies of PPIs might be responsible for some patient's incomplete response. When measured as omeprazole equivalents, the relative potencies of standard-dose pantoprazole, lansoprazole, omeprazole, esomeprazole, and rabeprazole have been estimated at 0.23, 0.90, 1.00, 1.60, and 1.82 OEs, respectively. 

References 

• Graham DY and Tansel A. Clin Gastroenterol Hepatol. 2018;16(6):800-8.e7. doi: 10.1016/j.cgh.2017.09.033 
• Katz PO et al. Am J Gastroenterol. 2022;117(1):27-56. doi: 10.14309/ ajg.0000000000001538 
• Kirchheiner J et al. Eur J Clin Pharmacol. 2009;65(1):19-31. doi: 10.1007/s00228-008-0576-5

Q1. Correct answer: D. Rabeprazole 

Rationale 

Within-class switching of proton pump inhibitors (PPIs) for patients with incomplete control of symptoms is frequently done in clinical practice. For the management of gastroesophageal reflux disease, this practice can be "considered" according to guidelines. More recent data suggest varying potencies of PPIs might be responsible for some patient's incomplete response. When measured as omeprazole equivalents, the relative potencies of standard-dose pantoprazole, lansoprazole, omeprazole, esomeprazole, and rabeprazole have been estimated at 0.23, 0.90, 1.00, 1.60, and 1.82 OEs, respectively. 

References 

• Graham DY and Tansel A. Clin Gastroenterol Hepatol. 2018;16(6):800-8.e7. doi: 10.1016/j.cgh.2017.09.033 
• Katz PO et al. Am J Gastroenterol. 2022;117(1):27-56. doi: 10.14309/ ajg.0000000000001538 
• Kirchheiner J et al. Eur J Clin Pharmacol. 2009;65(1):19-31. doi: 10.1007/s00228-008-0576-5

Q1. Correct answer: D. Rabeprazole 

Rationale 

Within-class switching of proton pump inhibitors (PPIs) for patients with incomplete control of symptoms is frequently done in clinical practice. For the management of gastroesophageal reflux disease, this practice can be "considered" according to guidelines. More recent data suggest varying potencies of PPIs might be responsible for some patient's incomplete response. When measured as omeprazole equivalents, the relative potencies of standard-dose pantoprazole, lansoprazole, omeprazole, esomeprazole, and rabeprazole have been estimated at 0.23, 0.90, 1.00, 1.60, and 1.82 OEs, respectively. 

References 

• Graham DY and Tansel A. Clin Gastroenterol Hepatol. 2018;16(6):800-8.e7. doi: 10.1016/j.cgh.2017.09.033 
• Katz PO et al. Am J Gastroenterol. 2022;117(1):27-56. doi: 10.14309/ ajg.0000000000001538 
• Kirchheiner J et al. Eur J Clin Pharmacol. 2009;65(1):19-31. doi: 10.1007/s00228-008-0576-5

This patient's clinical presentation of weight gain and associated symptoms are most closely related to a diagnosis of obesity. In addition, her laboratory findings are consistent with common obesity complications, including prediabetes and dyslipidemia, and her blood pressure is borderline high. 

Obesity is a chronic, multifactorial disease with a complex pathogenesis comprising of genetic, biological, psychosocial, socioeconomic, and environmental factors. It is a heterogeneous disease characterized by a dysfunction of the normal pathways and mechanisms that are involved in body fat regulation (often referred to as weight regulation), which may lead to variable presentation and complications. According to the US Centers for Disease Control and Prevention, the highest age-adjusted prevalence of obesity is seen in non-Hispanic Black adults (49.9%), followed by Hispanic adults (45.6%), non-Hispanic White adults (41.4%), and non-Hispanic Asian adults (16.1%).

Epidemiologic studies have defined obesity as a BMI > 30, which is then subclassified into class 1 (BMI of 30-34.9), class 2 (BMI of 35-39.9), or class 3 (BMI ≥ 40) obesity. Though BMI is widely used to evaluate and classify obesity, it mainly represents general adiposity and can be confounded by excessive muscle mass or frailty. Guidelines from the American Diabetes Association state that in addition to weight and BMI, clinicians should consider weight distribution (including predisposition for central/visceral adipose deposition) and weight gain pattern and trajectory because these can help guide risk stratification and treatment options.

Increasingly, evidence supports visceral adiposity, or abdominal obesity, as a marker of cardiovascular risk. Abdominal obesity has been shown to be a strong independent predictor of mortality. On its own, BMI is an insufficient biomarker of abdominal obesity. Not all individuals with obesity have a central distribution of their weight; some individuals may have central obesity without meeting the criteria for the BMI definition of obesity. This can lead to misclassification and underdiagnosis of health risks in clinical practice. Consequently, numerous organizations and expert panels have recommended that waist circumference be measured along with BMI, specifically when the BMI < 35. Measurement of both BMI and waist circumference provides valuable opportunities to counsel patients regarding their risk for cardiovascular disease and other complications of obesity. Waist-to-hip ratio has also been shown to be a stronger predictor for mortality compared with BMI; however, it is rarely measured in clinical practice.

Although rarely performed outside of research settings, measurement of epicardial and pericardial fat via CT is also emerging as a potentially useful approach for informing predictive and precision medicine strategies. Recently, the Jackson Heart Study showed pericardial and visceral fat volumes were associated with incident heart failure, particularly heart failure with preserved ejection fraction, and all-cause mortality among Black participants even after adjusting for age, sex, education, and smoking status. Another recent study showed an increased risk of heart failure, particularly heart failure with preserved ejection fraction, among men and women with high pericardial fat volume. The Multi-Ethnic Study of Atherosclerosis showed that pericardial fat was associated with a higher risk of all-cause cardiovascular disease, hard atherosclerotic cardiovascular disease, and heart failure. Epicardial fat is directly correlated with BMI, visceral adiposity, and waist circumference.

Best practices for the management of obesity begin with recognizing and treating it as a complex chronic disease rather than the result of an individual's lifestyle choices. According to a 2020 joint international consensus statement for ending the stigma of obesity, the assumption that choosing to eat less and/or exercise more can entirely prevent or reverse obesity is contradicted by a definitive body of biological and clinical evidence that shows obesity results primarily from a complex combination of genetic, epigenetic, and environmental factors. When diagnosing patients with obesity, it may be helpful for clinicians to acknowledge that the term obesity is often perceived as an undesirable term because it has been associated with stigma but that it is in fact a clinical diagnosis, not a judgement. Many patients prefer the neutral term unhealthy weight over obesity.

As with other chronic diseases, individualized treatment and long-term support along with shared decision-making are essential for optimizing outcomes. Key components of obesity management include diet, exercise, and behavioral modification. In addition, an increasing array of pharmacologic therapies are also showing unprecedented efficacy for weight management, including several drugs that are also approved for the management of type 2 diabetes. In particular, the glucagonlike peptide 1 (GLP-1) agonists, semaglutide and liraglutide, and the novel glucose-dependent insulinotropic polypeptide (GIP)–GLP-1 receptor agonist, tirzepatide have been associated with significant weight loss. Semaglutide and liraglutide have been US Food and Drug Administration (FDA)–approved for chronic weight management and tirzepatide was granted fast track designation for the treatment of obesity by the FDA in October 2022. These drugs may also help to prevent the progression of prediabetes to diabetes. For individuals with severe obesity, metabolic and bariatric surgery is an effective treatment option that is associated with clinically significant and relatively sustained weight reduction in addition to significant amelioration of related complications.

W. Scott Butsch, MD, MSc, Director of Obesity Medicine, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio.

Dr. Butsch has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Novo Nordisk, Inc.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

This patient's clinical presentation of weight gain and associated symptoms are most closely related to a diagnosis of obesity. In addition, her laboratory findings are consistent with common obesity complications, including prediabetes and dyslipidemia, and her blood pressure is borderline high. 

Obesity is a chronic, multifactorial disease with a complex pathogenesis comprising of genetic, biological, psychosocial, socioeconomic, and environmental factors. It is a heterogeneous disease characterized by a dysfunction of the normal pathways and mechanisms that are involved in body fat regulation (often referred to as weight regulation), which may lead to variable presentation and complications. According to the US Centers for Disease Control and Prevention, the highest age-adjusted prevalence of obesity is seen in non-Hispanic Black adults (49.9%), followed by Hispanic adults (45.6%), non-Hispanic White adults (41.4%), and non-Hispanic Asian adults (16.1%).

Epidemiologic studies have defined obesity as a BMI > 30, which is then subclassified into class 1 (BMI of 30-34.9), class 2 (BMI of 35-39.9), or class 3 (BMI ≥ 40) obesity. Though BMI is widely used to evaluate and classify obesity, it mainly represents general adiposity and can be confounded by excessive muscle mass or frailty. Guidelines from the American Diabetes Association state that in addition to weight and BMI, clinicians should consider weight distribution (including predisposition for central/visceral adipose deposition) and weight gain pattern and trajectory because these can help guide risk stratification and treatment options.

Increasingly, evidence supports visceral adiposity, or abdominal obesity, as a marker of cardiovascular risk. Abdominal obesity has been shown to be a strong independent predictor of mortality. On its own, BMI is an insufficient biomarker of abdominal obesity. Not all individuals with obesity have a central distribution of their weight; some individuals may have central obesity without meeting the criteria for the BMI definition of obesity. This can lead to misclassification and underdiagnosis of health risks in clinical practice. Consequently, numerous organizations and expert panels have recommended that waist circumference be measured along with BMI, specifically when the BMI < 35. Measurement of both BMI and waist circumference provides valuable opportunities to counsel patients regarding their risk for cardiovascular disease and other complications of obesity. Waist-to-hip ratio has also been shown to be a stronger predictor for mortality compared with BMI; however, it is rarely measured in clinical practice.

Although rarely performed outside of research settings, measurement of epicardial and pericardial fat via CT is also emerging as a potentially useful approach for informing predictive and precision medicine strategies. Recently, the Jackson Heart Study showed pericardial and visceral fat volumes were associated with incident heart failure, particularly heart failure with preserved ejection fraction, and all-cause mortality among Black participants even after adjusting for age, sex, education, and smoking status. Another recent study showed an increased risk of heart failure, particularly heart failure with preserved ejection fraction, among men and women with high pericardial fat volume. The Multi-Ethnic Study of Atherosclerosis showed that pericardial fat was associated with a higher risk of all-cause cardiovascular disease, hard atherosclerotic cardiovascular disease, and heart failure. Epicardial fat is directly correlated with BMI, visceral adiposity, and waist circumference.

Best practices for the management of obesity begin with recognizing and treating it as a complex chronic disease rather than the result of an individual's lifestyle choices. According to a 2020 joint international consensus statement for ending the stigma of obesity, the assumption that choosing to eat less and/or exercise more can entirely prevent or reverse obesity is contradicted by a definitive body of biological and clinical evidence that shows obesity results primarily from a complex combination of genetic, epigenetic, and environmental factors. When diagnosing patients with obesity, it may be helpful for clinicians to acknowledge that the term obesity is often perceived as an undesirable term because it has been associated with stigma but that it is in fact a clinical diagnosis, not a judgement. Many patients prefer the neutral term unhealthy weight over obesity.

As with other chronic diseases, individualized treatment and long-term support along with shared decision-making are essential for optimizing outcomes. Key components of obesity management include diet, exercise, and behavioral modification. In addition, an increasing array of pharmacologic therapies are also showing unprecedented efficacy for weight management, including several drugs that are also approved for the management of type 2 diabetes. In particular, the glucagonlike peptide 1 (GLP-1) agonists, semaglutide and liraglutide, and the novel glucose-dependent insulinotropic polypeptide (GIP)–GLP-1 receptor agonist, tirzepatide have been associated with significant weight loss. Semaglutide and liraglutide have been US Food and Drug Administration (FDA)–approved for chronic weight management and tirzepatide was granted fast track designation for the treatment of obesity by the FDA in October 2022. These drugs may also help to prevent the progression of prediabetes to diabetes. For individuals with severe obesity, metabolic and bariatric surgery is an effective treatment option that is associated with clinically significant and relatively sustained weight reduction in addition to significant amelioration of related complications.

W. Scott Butsch, MD, MSc, Director of Obesity Medicine, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio.

Dr. Butsch has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Novo Nordisk, Inc.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

This patient's clinical presentation of weight gain and associated symptoms are most closely related to a diagnosis of obesity. In addition, her laboratory findings are consistent with common obesity complications, including prediabetes and dyslipidemia, and her blood pressure is borderline high. 

Obesity is a chronic, multifactorial disease with a complex pathogenesis comprising of genetic, biological, psychosocial, socioeconomic, and environmental factors. It is a heterogeneous disease characterized by a dysfunction of the normal pathways and mechanisms that are involved in body fat regulation (often referred to as weight regulation), which may lead to variable presentation and complications. According to the US Centers for Disease Control and Prevention, the highest age-adjusted prevalence of obesity is seen in non-Hispanic Black adults (49.9%), followed by Hispanic adults (45.6%), non-Hispanic White adults (41.4%), and non-Hispanic Asian adults (16.1%).

Epidemiologic studies have defined obesity as a BMI > 30, which is then subclassified into class 1 (BMI of 30-34.9), class 2 (BMI of 35-39.9), or class 3 (BMI ≥ 40) obesity. Though BMI is widely used to evaluate and classify obesity, it mainly represents general adiposity and can be confounded by excessive muscle mass or frailty. Guidelines from the American Diabetes Association state that in addition to weight and BMI, clinicians should consider weight distribution (including predisposition for central/visceral adipose deposition) and weight gain pattern and trajectory because these can help guide risk stratification and treatment options.

Increasingly, evidence supports visceral adiposity, or abdominal obesity, as a marker of cardiovascular risk. Abdominal obesity has been shown to be a strong independent predictor of mortality. On its own, BMI is an insufficient biomarker of abdominal obesity. Not all individuals with obesity have a central distribution of their weight; some individuals may have central obesity without meeting the criteria for the BMI definition of obesity. This can lead to misclassification and underdiagnosis of health risks in clinical practice. Consequently, numerous organizations and expert panels have recommended that waist circumference be measured along with BMI, specifically when the BMI < 35. Measurement of both BMI and waist circumference provides valuable opportunities to counsel patients regarding their risk for cardiovascular disease and other complications of obesity. Waist-to-hip ratio has also been shown to be a stronger predictor for mortality compared with BMI; however, it is rarely measured in clinical practice.

Although rarely performed outside of research settings, measurement of epicardial and pericardial fat via CT is also emerging as a potentially useful approach for informing predictive and precision medicine strategies. Recently, the Jackson Heart Study showed pericardial and visceral fat volumes were associated with incident heart failure, particularly heart failure with preserved ejection fraction, and all-cause mortality among Black participants even after adjusting for age, sex, education, and smoking status. Another recent study showed an increased risk of heart failure, particularly heart failure with preserved ejection fraction, among men and women with high pericardial fat volume. The Multi-Ethnic Study of Atherosclerosis showed that pericardial fat was associated with a higher risk of all-cause cardiovascular disease, hard atherosclerotic cardiovascular disease, and heart failure. Epicardial fat is directly correlated with BMI, visceral adiposity, and waist circumference.

Best practices for the management of obesity begin with recognizing and treating it as a complex chronic disease rather than the result of an individual's lifestyle choices. According to a 2020 joint international consensus statement for ending the stigma of obesity, the assumption that choosing to eat less and/or exercise more can entirely prevent or reverse obesity is contradicted by a definitive body of biological and clinical evidence that shows obesity results primarily from a complex combination of genetic, epigenetic, and environmental factors. When diagnosing patients with obesity, it may be helpful for clinicians to acknowledge that the term obesity is often perceived as an undesirable term because it has been associated with stigma but that it is in fact a clinical diagnosis, not a judgement. Many patients prefer the neutral term unhealthy weight over obesity.

As with other chronic diseases, individualized treatment and long-term support along with shared decision-making are essential for optimizing outcomes. Key components of obesity management include diet, exercise, and behavioral modification. In addition, an increasing array of pharmacologic therapies are also showing unprecedented efficacy for weight management, including several drugs that are also approved for the management of type 2 diabetes. In particular, the glucagonlike peptide 1 (GLP-1) agonists, semaglutide and liraglutide, and the novel glucose-dependent insulinotropic polypeptide (GIP)–GLP-1 receptor agonist, tirzepatide have been associated with significant weight loss. Semaglutide and liraglutide have been US Food and Drug Administration (FDA)–approved for chronic weight management and tirzepatide was granted fast track designation for the treatment of obesity by the FDA in October 2022. These drugs may also help to prevent the progression of prediabetes to diabetes. For individuals with severe obesity, metabolic and bariatric surgery is an effective treatment option that is associated with clinically significant and relatively sustained weight reduction in addition to significant amelioration of related complications.

W. Scott Butsch, MD, MSc, Director of Obesity Medicine, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio.

Dr. Butsch has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Novo Nordisk, Inc.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

LAS VEGAS – Vitiligo affects individuals of all ages, and “the social impact is huge,” David Rosmarin, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Vitiligo, an autoimmune condition that results in patches of skin depigmentation, occurs in 0.5% to 2% of the population. The average age of onset is 20 years, with 25% of cases occurring before age 10, and 70%-80% of cases by age 30 years, which means a long-term effect on quality of life, especially for younger patients, said Dr. Rosmarin, vice chair of education and research and director of the clinical trials unit at Tufts University, Boston.

SolStock/Moment/Getty Images

Studies have shown that 95% of 15- to 17-year-olds with vitiligo are bothered by it, as are approximately 50% of children aged 6-14 years, he said. Although patients with more extensive lesions on the face, arms, legs, and hands report worse quality of life, they report that uncontrolled progression of vitiligo is more concerning than the presence of lesions in exposed areas, he noted.

The current strategy for getting vitiligo under control is a two-step process, said Dr. Rosmarin. First, improve the skin environment by suppressing the overactive immune system, then encourage repigmentation and “nudge the melanocytes to return,” he said.

Topical ruxolitinib, a Janus kinase (JAK) inhibitor, is the latest tool for dermatologists to help give the melanocytes that nudge. In July 2022, the Food and Drug Administration approved ruxolitinib cream for treating nonsegmental vitiligo in patients 12 years of age and older – the first treatment approved to repigment patients with vitiligo.

Vitiligo is driven in part by interferon (IFN)-gamma signaling through JAK 1 and 2, and ruxolitinib acts as an inhibitor, Dr. Rosmarin said.

In the TRuE-V1 and TRuE-V2 studies presented at the 2022 European Academy of Dermatology and Venereology meeting in Milan, adolescents and adults with vitiligo who were randomized to 1.5% ruxolitinib cream twice daily showed significant improvement over those randomized to the vehicle by 24 weeks, at which time all patients could continue with ruxolitinib through 52 weeks, he said.

Dr. Rosmarin presented 52-week data from the TRuE-V1 and TRuE-V2 studies at the 2022 American Academy of Dermatology meeting in Boston. He was the lead author of the studies that were subsequently published in the New England Journal of Medicine.

In the two studies, 52.6% and 48% of the patients in the ruxolitinib groups achieved the primary outcome of at least 75% improvement on the Facial Vitiligo Area Scoring Index (F-VASI75) by 52 weeks, compared with 26.8% and 29.6% of patients on the vehicle, respectively.

In addition, at 52 weeks, 53.2% and 49.2% of patients treated with ruxolitinib in the two studies achieved 50% improvement on the Total Vitiligo Area Scoring Index (T-VASI50), a clinician assessment of affected body surface area and level of depigmentation, compared with 31.7% and 22.2% of those on vehicle, respectively.

Patient satisfaction was high with ruxolitinib, Dr. Rosmarin said. In the TRuE-V1 and TRuE-V2 studies, 39.9% and 32.8% of patients, respectively, achieved a successful treatment response based on the patient-reported Vitiligo Noticeability Scale (VNS) by week 52, versus 19.5% and 13.6% of those on vehicle.

Ruxolitinib cream was well tolerated, with “no clinically significant application site reactions or serious treatment-related adverse events,” he noted. The most common treatment-related adverse events across the TRuE-V1 and TRuE-V2 studies were acne at the application site (affecting about 6% of patients) and pruritus at the application site about (affecting 5%), said Dr. Rosmarin.

JAK inhibitors, including ruxolitinib, baricitinib, and tofacitinib, have shown effectiveness for vitiligo, which supports the potential role of the IFN-gamma-chemokine signaling axis in the pathogenesis of the disease, said Dr. Rosmarin. However, more studies are required to determine the ideal dosage of JAK inhibitors for the treatment of vitiligo, and to identify other inflammatory pathways that may be implicated in the pathogenesis of this condition.

Ruxolitinib’s success has been consistent across subgroups of age, gender, race, geographic region, and Fitzpatrick skin phototype. Notably, ruxolitinib was effective among the adolescent population, with approximately 60% achieving T-VASI50 and success based on VNS in TRuE-V1 and TRuE-V2.

An oral version of ruxolitinib is in clinical trials, which “makes a lot of sense,” Dr. Rosmarin said. “Patients don’t always have localized disease,” and such patients may benefit from an oral therapy. Topicals may have the advantage in terms of safety, but questions of maintenance remain, he said. Oral treatments may be useful for patients with large body surface areas affected, and those with unstable or progressive disease, he added.

Areas for additional research include combination therapy with ruxolitinib and phototherapy, and an anti-IL 15 therapy in the pipeline has the potential to drive vitiligo into remission, Dr. Rosmarin said. In a study known as REVEAL that is still recruiting patients, researchers will test the efficacy of an IL-15 inhibitor known as AMG 714 to induce facial repigmentation in adults with vitiligo.

Dr. Rosmarin disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb Company, Celgene, Concert Pharmaceuticals, CSL Behring, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Kyowa Kirin, Merck, Novartis, Pfizer, Regeneron, Revolo, Sanofi, Sun, UCB, and Viela Bio.

MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – Vitiligo affects individuals of all ages, and “the social impact is huge,” David Rosmarin, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Vitiligo, an autoimmune condition that results in patches of skin depigmentation, occurs in 0.5% to 2% of the population. The average age of onset is 20 years, with 25% of cases occurring before age 10, and 70%-80% of cases by age 30 years, which means a long-term effect on quality of life, especially for younger patients, said Dr. Rosmarin, vice chair of education and research and director of the clinical trials unit at Tufts University, Boston.

SolStock/Moment/Getty Images

Studies have shown that 95% of 15- to 17-year-olds with vitiligo are bothered by it, as are approximately 50% of children aged 6-14 years, he said. Although patients with more extensive lesions on the face, arms, legs, and hands report worse quality of life, they report that uncontrolled progression of vitiligo is more concerning than the presence of lesions in exposed areas, he noted.

The current strategy for getting vitiligo under control is a two-step process, said Dr. Rosmarin. First, improve the skin environment by suppressing the overactive immune system, then encourage repigmentation and “nudge the melanocytes to return,” he said.

Topical ruxolitinib, a Janus kinase (JAK) inhibitor, is the latest tool for dermatologists to help give the melanocytes that nudge. In July 2022, the Food and Drug Administration approved ruxolitinib cream for treating nonsegmental vitiligo in patients 12 years of age and older – the first treatment approved to repigment patients with vitiligo.

Vitiligo is driven in part by interferon (IFN)-gamma signaling through JAK 1 and 2, and ruxolitinib acts as an inhibitor, Dr. Rosmarin said.

In the TRuE-V1 and TRuE-V2 studies presented at the 2022 European Academy of Dermatology and Venereology meeting in Milan, adolescents and adults with vitiligo who were randomized to 1.5% ruxolitinib cream twice daily showed significant improvement over those randomized to the vehicle by 24 weeks, at which time all patients could continue with ruxolitinib through 52 weeks, he said.

Dr. Rosmarin presented 52-week data from the TRuE-V1 and TRuE-V2 studies at the 2022 American Academy of Dermatology meeting in Boston. He was the lead author of the studies that were subsequently published in the New England Journal of Medicine.

In the two studies, 52.6% and 48% of the patients in the ruxolitinib groups achieved the primary outcome of at least 75% improvement on the Facial Vitiligo Area Scoring Index (F-VASI75) by 52 weeks, compared with 26.8% and 29.6% of patients on the vehicle, respectively.

In addition, at 52 weeks, 53.2% and 49.2% of patients treated with ruxolitinib in the two studies achieved 50% improvement on the Total Vitiligo Area Scoring Index (T-VASI50), a clinician assessment of affected body surface area and level of depigmentation, compared with 31.7% and 22.2% of those on vehicle, respectively.

Patient satisfaction was high with ruxolitinib, Dr. Rosmarin said. In the TRuE-V1 and TRuE-V2 studies, 39.9% and 32.8% of patients, respectively, achieved a successful treatment response based on the patient-reported Vitiligo Noticeability Scale (VNS) by week 52, versus 19.5% and 13.6% of those on vehicle.

Ruxolitinib cream was well tolerated, with “no clinically significant application site reactions or serious treatment-related adverse events,” he noted. The most common treatment-related adverse events across the TRuE-V1 and TRuE-V2 studies were acne at the application site (affecting about 6% of patients) and pruritus at the application site about (affecting 5%), said Dr. Rosmarin.

JAK inhibitors, including ruxolitinib, baricitinib, and tofacitinib, have shown effectiveness for vitiligo, which supports the potential role of the IFN-gamma-chemokine signaling axis in the pathogenesis of the disease, said Dr. Rosmarin. However, more studies are required to determine the ideal dosage of JAK inhibitors for the treatment of vitiligo, and to identify other inflammatory pathways that may be implicated in the pathogenesis of this condition.

Ruxolitinib’s success has been consistent across subgroups of age, gender, race, geographic region, and Fitzpatrick skin phototype. Notably, ruxolitinib was effective among the adolescent population, with approximately 60% achieving T-VASI50 and success based on VNS in TRuE-V1 and TRuE-V2.

An oral version of ruxolitinib is in clinical trials, which “makes a lot of sense,” Dr. Rosmarin said. “Patients don’t always have localized disease,” and such patients may benefit from an oral therapy. Topicals may have the advantage in terms of safety, but questions of maintenance remain, he said. Oral treatments may be useful for patients with large body surface areas affected, and those with unstable or progressive disease, he added.

Areas for additional research include combination therapy with ruxolitinib and phototherapy, and an anti-IL 15 therapy in the pipeline has the potential to drive vitiligo into remission, Dr. Rosmarin said. In a study known as REVEAL that is still recruiting patients, researchers will test the efficacy of an IL-15 inhibitor known as AMG 714 to induce facial repigmentation in adults with vitiligo.

Dr. Rosmarin disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb Company, Celgene, Concert Pharmaceuticals, CSL Behring, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Kyowa Kirin, Merck, Novartis, Pfizer, Regeneron, Revolo, Sanofi, Sun, UCB, and Viela Bio.

MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – Vitiligo affects individuals of all ages, and “the social impact is huge,” David Rosmarin, MD, said in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.

Vitiligo, an autoimmune condition that results in patches of skin depigmentation, occurs in 0.5% to 2% of the population. The average age of onset is 20 years, with 25% of cases occurring before age 10, and 70%-80% of cases by age 30 years, which means a long-term effect on quality of life, especially for younger patients, said Dr. Rosmarin, vice chair of education and research and director of the clinical trials unit at Tufts University, Boston.

SolStock/Moment/Getty Images

Studies have shown that 95% of 15- to 17-year-olds with vitiligo are bothered by it, as are approximately 50% of children aged 6-14 years, he said. Although patients with more extensive lesions on the face, arms, legs, and hands report worse quality of life, they report that uncontrolled progression of vitiligo is more concerning than the presence of lesions in exposed areas, he noted.

The current strategy for getting vitiligo under control is a two-step process, said Dr. Rosmarin. First, improve the skin environment by suppressing the overactive immune system, then encourage repigmentation and “nudge the melanocytes to return,” he said.

Topical ruxolitinib, a Janus kinase (JAK) inhibitor, is the latest tool for dermatologists to help give the melanocytes that nudge. In July 2022, the Food and Drug Administration approved ruxolitinib cream for treating nonsegmental vitiligo in patients 12 years of age and older – the first treatment approved to repigment patients with vitiligo.

Vitiligo is driven in part by interferon (IFN)-gamma signaling through JAK 1 and 2, and ruxolitinib acts as an inhibitor, Dr. Rosmarin said.

In the TRuE-V1 and TRuE-V2 studies presented at the 2022 European Academy of Dermatology and Venereology meeting in Milan, adolescents and adults with vitiligo who were randomized to 1.5% ruxolitinib cream twice daily showed significant improvement over those randomized to the vehicle by 24 weeks, at which time all patients could continue with ruxolitinib through 52 weeks, he said.

Dr. Rosmarin presented 52-week data from the TRuE-V1 and TRuE-V2 studies at the 2022 American Academy of Dermatology meeting in Boston. He was the lead author of the studies that were subsequently published in the New England Journal of Medicine.

In the two studies, 52.6% and 48% of the patients in the ruxolitinib groups achieved the primary outcome of at least 75% improvement on the Facial Vitiligo Area Scoring Index (F-VASI75) by 52 weeks, compared with 26.8% and 29.6% of patients on the vehicle, respectively.

In addition, at 52 weeks, 53.2% and 49.2% of patients treated with ruxolitinib in the two studies achieved 50% improvement on the Total Vitiligo Area Scoring Index (T-VASI50), a clinician assessment of affected body surface area and level of depigmentation, compared with 31.7% and 22.2% of those on vehicle, respectively.

Patient satisfaction was high with ruxolitinib, Dr. Rosmarin said. In the TRuE-V1 and TRuE-V2 studies, 39.9% and 32.8% of patients, respectively, achieved a successful treatment response based on the patient-reported Vitiligo Noticeability Scale (VNS) by week 52, versus 19.5% and 13.6% of those on vehicle.

Ruxolitinib cream was well tolerated, with “no clinically significant application site reactions or serious treatment-related adverse events,” he noted. The most common treatment-related adverse events across the TRuE-V1 and TRuE-V2 studies were acne at the application site (affecting about 6% of patients) and pruritus at the application site about (affecting 5%), said Dr. Rosmarin.

JAK inhibitors, including ruxolitinib, baricitinib, and tofacitinib, have shown effectiveness for vitiligo, which supports the potential role of the IFN-gamma-chemokine signaling axis in the pathogenesis of the disease, said Dr. Rosmarin. However, more studies are required to determine the ideal dosage of JAK inhibitors for the treatment of vitiligo, and to identify other inflammatory pathways that may be implicated in the pathogenesis of this condition.

Ruxolitinib’s success has been consistent across subgroups of age, gender, race, geographic region, and Fitzpatrick skin phototype. Notably, ruxolitinib was effective among the adolescent population, with approximately 60% achieving T-VASI50 and success based on VNS in TRuE-V1 and TRuE-V2.

An oral version of ruxolitinib is in clinical trials, which “makes a lot of sense,” Dr. Rosmarin said. “Patients don’t always have localized disease,” and such patients may benefit from an oral therapy. Topicals may have the advantage in terms of safety, but questions of maintenance remain, he said. Oral treatments may be useful for patients with large body surface areas affected, and those with unstable or progressive disease, he added.

Areas for additional research include combination therapy with ruxolitinib and phototherapy, and an anti-IL 15 therapy in the pipeline has the potential to drive vitiligo into remission, Dr. Rosmarin said. In a study known as REVEAL that is still recruiting patients, researchers will test the efficacy of an IL-15 inhibitor known as AMG 714 to induce facial repigmentation in adults with vitiligo.

Dr. Rosmarin disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb Company, Celgene, Concert Pharmaceuticals, CSL Behring, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Kyowa Kirin, Merck, Novartis, Pfizer, Regeneron, Revolo, Sanofi, Sun, UCB, and Viela Bio.

MedscapeLive and this news organization are owned by the same parent company.

Topical minoxidil is widely used to treat hair loss, but new findings suggest that a combination of oral and topical minoxidil could be effective for women with breast cancer who have experienced alopecia from anticancer treatment.

In a retrospective cohort study of women with breast cancer and anticancer therapy–induced alopecia, researchers found that combining low-dose oral minoxidil (LDOM) and topical minoxidil achieved better results than topical minoxidil alone and that the treatment was well tolerated. A total of 5 of the 37 patients (13.5%) in the combination therapy group achieved a complete response, defined as an improvement of alopecia severity from grade 2 to grade 1, compared with none of the 19 patients in the topical therapy–only group.

In contrast, none of the patients in the combination group experienced worsening of alopecia, compared with two (10.5%) in the topical monotherapy group.

The study was published online in the Journal of the American Academy of Dermatology. Topical minoxidil is approved by the Food and Drug Administration to treat androgenetic alopecia. Oral minoxidil is not approved for treating hair loss but has been receiving increased attention as an adjunctive therapy for hair loss, particularly for women. Oral minoxidil is approved for treating hypertension but at much higher doses.

An increasing number of studies have been conducted on the use of oral minoxidil for the treatment of female pattern hair loss, dating back to a pilot study in 2017, with promising results. The findings suggest that LDOM might be more effective than topical therapy, well tolerated, and more convenient for individuals to take.

Hypothesis generating

In a comment, Kai Johnson, MD, a medical oncologist who specializes in treating patients with breast cancer at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, noted that the study, like most small-scale retrospective studies, is hypothesis generating. However, “I’d be hesitant to broadly recommend this practice of dual therapy – oral and topical minoxidil together – until we see a placebo-controlled prospective study performed demonstrating clinically meaningful benefits for patients.”

Another factor is the study endpoints. “While there was a statistically significant benefit documented with dual therapy in this study, it’s important to have study endpoints that are more patient oriented,” Dr. Johnson said. The most important endpoint for patients would be improvements “in the actual alopecia grade, which did occur in 5 of the 37 of dual-therapy patients, versus 0 topical minoxidil patients.”

George Cotsarelis, MD, chair of the department of dermatology and professor of dermatology at the University of Pennsylvania, Philadelphia, also weighed in. He questioned whether adding the topical therapy to oral minoxidil actually improved the results. “What was missing was a study arm that used the oral alone,” he said in an interview. “So we don’t know how effective the oral therapy would be by itself and if combining it with the topical is really adding anything.”

Oral minoxidil as a treatment for hair loss is gaining traction, and it’s clear that it is effective. However, the risk of side effects is higher, he said. “The risk isn’t that high with the low dose, but it can grow hair on places other than the scalp, and that can be disconcerting.” In this study, two women who took the oral drug reported edema, and one reported headache and dizziness. Hypertrichosis was reported by five patients who received the combination.
 

Study details

In the study, Jeewoo Kang, MD, and colleagues from the Seoul National University evaluated the efficacy of LDOM in 100 patients with breast cancer who had been diagnosed with persistent chemotherapy-induced alopecia (pCIA) and endocrine therapy–induced alopecia (EIA) at a dermatology clinic.

They conducted an analysis of medical records, standardized clinical photographs, and trichoscopic images to evaluate the alopecia pattern, severity, treatment response, and posttreatment changes in vertex hair density and thickness.

Compared with those with EIA alone, patients with pCIA were significantly more likely to have diffuse alopecia (P < .001), and they were more likely to have more severe alopecia, although this difference was not significant (P = .058). Outcomes were evaluated for 56 patients who were treated with minoxidil (19 with topical minoxidil alone and 37 with both LDOM and topical minoxidil) and for whom clinical and trichoscopic photos were available at baseline and at the last follow-up (all patients were scheduled for follow-up at 3-month intervals).

The results showed that those treated with 1.25-5.0 mg/d of oral minoxidil and 5% topical minoxidil solution once a day had better responses (P = .002) and a higher percentage increase in hair density from baseline (P = .003), compared with those who received topical minoxidil monotherapy.

However, changes in hair thickness after treatment were not significantly different between the two groups (P = .540).

In addition to the five (13.5%) cases of hypertrichosis, two cases of edema (5.4%), and one case of headache/dizziness (2.7%) among those who received the combination, there was also one report of palpitations (2.7%). Palpitations were reported in one patient (5%) who received topical monotherapy, the only adverse event reported in this group.

Dr. Johnson noted that, at his institution, a dermatologist is conducting a clinical trial with oncology patients post chemotherapy and endocrine therapy. “She is looking at a similar question, although she is comparing oral minoxidil to topical minoxidil directly rather than in combination.” There is also an active clinical trial at Northwestern University, Chicago, of LDOM alone for patients with chemotherapy-induced alopecia.

“So there is a lot of momentum surrounding this concept, and I feel we will continue to see it come up as a possible treatment option, but more data are needed at this time before it can become standard of care,” Dr. Johnson added.

No funding for the study was reported. The authors disclosed no relevant financial relationships.

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

Topical minoxidil is widely used to treat hair loss, but new findings suggest that a combination of oral and topical minoxidil could be effective for women with breast cancer who have experienced alopecia from anticancer treatment.

In a retrospective cohort study of women with breast cancer and anticancer therapy–induced alopecia, researchers found that combining low-dose oral minoxidil (LDOM) and topical minoxidil achieved better results than topical minoxidil alone and that the treatment was well tolerated. A total of 5 of the 37 patients (13.5%) in the combination therapy group achieved a complete response, defined as an improvement of alopecia severity from grade 2 to grade 1, compared with none of the 19 patients in the topical therapy–only group.

In contrast, none of the patients in the combination group experienced worsening of alopecia, compared with two (10.5%) in the topical monotherapy group.

The study was published online in the Journal of the American Academy of Dermatology. Topical minoxidil is approved by the Food and Drug Administration to treat androgenetic alopecia. Oral minoxidil is not approved for treating hair loss but has been receiving increased attention as an adjunctive therapy for hair loss, particularly for women. Oral minoxidil is approved for treating hypertension but at much higher doses.

An increasing number of studies have been conducted on the use of oral minoxidil for the treatment of female pattern hair loss, dating back to a pilot study in 2017, with promising results. The findings suggest that LDOM might be more effective than topical therapy, well tolerated, and more convenient for individuals to take.

Hypothesis generating

In a comment, Kai Johnson, MD, a medical oncologist who specializes in treating patients with breast cancer at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, noted that the study, like most small-scale retrospective studies, is hypothesis generating. However, “I’d be hesitant to broadly recommend this practice of dual therapy – oral and topical minoxidil together – until we see a placebo-controlled prospective study performed demonstrating clinically meaningful benefits for patients.”

Another factor is the study endpoints. “While there was a statistically significant benefit documented with dual therapy in this study, it’s important to have study endpoints that are more patient oriented,” Dr. Johnson said. The most important endpoint for patients would be improvements “in the actual alopecia grade, which did occur in 5 of the 37 of dual-therapy patients, versus 0 topical minoxidil patients.”

George Cotsarelis, MD, chair of the department of dermatology and professor of dermatology at the University of Pennsylvania, Philadelphia, also weighed in. He questioned whether adding the topical therapy to oral minoxidil actually improved the results. “What was missing was a study arm that used the oral alone,” he said in an interview. “So we don’t know how effective the oral therapy would be by itself and if combining it with the topical is really adding anything.”

Oral minoxidil as a treatment for hair loss is gaining traction, and it’s clear that it is effective. However, the risk of side effects is higher, he said. “The risk isn’t that high with the low dose, but it can grow hair on places other than the scalp, and that can be disconcerting.” In this study, two women who took the oral drug reported edema, and one reported headache and dizziness. Hypertrichosis was reported by five patients who received the combination.
 

Study details

In the study, Jeewoo Kang, MD, and colleagues from the Seoul National University evaluated the efficacy of LDOM in 100 patients with breast cancer who had been diagnosed with persistent chemotherapy-induced alopecia (pCIA) and endocrine therapy–induced alopecia (EIA) at a dermatology clinic.

They conducted an analysis of medical records, standardized clinical photographs, and trichoscopic images to evaluate the alopecia pattern, severity, treatment response, and posttreatment changes in vertex hair density and thickness.

Compared with those with EIA alone, patients with pCIA were significantly more likely to have diffuse alopecia (P < .001), and they were more likely to have more severe alopecia, although this difference was not significant (P = .058). Outcomes were evaluated for 56 patients who were treated with minoxidil (19 with topical minoxidil alone and 37 with both LDOM and topical minoxidil) and for whom clinical and trichoscopic photos were available at baseline and at the last follow-up (all patients were scheduled for follow-up at 3-month intervals).

The results showed that those treated with 1.25-5.0 mg/d of oral minoxidil and 5% topical minoxidil solution once a day had better responses (P = .002) and a higher percentage increase in hair density from baseline (P = .003), compared with those who received topical minoxidil monotherapy.

However, changes in hair thickness after treatment were not significantly different between the two groups (P = .540).

In addition to the five (13.5%) cases of hypertrichosis, two cases of edema (5.4%), and one case of headache/dizziness (2.7%) among those who received the combination, there was also one report of palpitations (2.7%). Palpitations were reported in one patient (5%) who received topical monotherapy, the only adverse event reported in this group.

Dr. Johnson noted that, at his institution, a dermatologist is conducting a clinical trial with oncology patients post chemotherapy and endocrine therapy. “She is looking at a similar question, although she is comparing oral minoxidil to topical minoxidil directly rather than in combination.” There is also an active clinical trial at Northwestern University, Chicago, of LDOM alone for patients with chemotherapy-induced alopecia.

“So there is a lot of momentum surrounding this concept, and I feel we will continue to see it come up as a possible treatment option, but more data are needed at this time before it can become standard of care,” Dr. Johnson added.

No funding for the study was reported. The authors disclosed no relevant financial relationships.

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

Topical minoxidil is widely used to treat hair loss, but new findings suggest that a combination of oral and topical minoxidil could be effective for women with breast cancer who have experienced alopecia from anticancer treatment.

In a retrospective cohort study of women with breast cancer and anticancer therapy–induced alopecia, researchers found that combining low-dose oral minoxidil (LDOM) and topical minoxidil achieved better results than topical minoxidil alone and that the treatment was well tolerated. A total of 5 of the 37 patients (13.5%) in the combination therapy group achieved a complete response, defined as an improvement of alopecia severity from grade 2 to grade 1, compared with none of the 19 patients in the topical therapy–only group.

In contrast, none of the patients in the combination group experienced worsening of alopecia, compared with two (10.5%) in the topical monotherapy group.

The study was published online in the Journal of the American Academy of Dermatology. Topical minoxidil is approved by the Food and Drug Administration to treat androgenetic alopecia. Oral minoxidil is not approved for treating hair loss but has been receiving increased attention as an adjunctive therapy for hair loss, particularly for women. Oral minoxidil is approved for treating hypertension but at much higher doses.

An increasing number of studies have been conducted on the use of oral minoxidil for the treatment of female pattern hair loss, dating back to a pilot study in 2017, with promising results. The findings suggest that LDOM might be more effective than topical therapy, well tolerated, and more convenient for individuals to take.

Hypothesis generating

In a comment, Kai Johnson, MD, a medical oncologist who specializes in treating patients with breast cancer at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, noted that the study, like most small-scale retrospective studies, is hypothesis generating. However, “I’d be hesitant to broadly recommend this practice of dual therapy – oral and topical minoxidil together – until we see a placebo-controlled prospective study performed demonstrating clinically meaningful benefits for patients.”

Another factor is the study endpoints. “While there was a statistically significant benefit documented with dual therapy in this study, it’s important to have study endpoints that are more patient oriented,” Dr. Johnson said. The most important endpoint for patients would be improvements “in the actual alopecia grade, which did occur in 5 of the 37 of dual-therapy patients, versus 0 topical minoxidil patients.”

George Cotsarelis, MD, chair of the department of dermatology and professor of dermatology at the University of Pennsylvania, Philadelphia, also weighed in. He questioned whether adding the topical therapy to oral minoxidil actually improved the results. “What was missing was a study arm that used the oral alone,” he said in an interview. “So we don’t know how effective the oral therapy would be by itself and if combining it with the topical is really adding anything.”

Oral minoxidil as a treatment for hair loss is gaining traction, and it’s clear that it is effective. However, the risk of side effects is higher, he said. “The risk isn’t that high with the low dose, but it can grow hair on places other than the scalp, and that can be disconcerting.” In this study, two women who took the oral drug reported edema, and one reported headache and dizziness. Hypertrichosis was reported by five patients who received the combination.
 

Study details

In the study, Jeewoo Kang, MD, and colleagues from the Seoul National University evaluated the efficacy of LDOM in 100 patients with breast cancer who had been diagnosed with persistent chemotherapy-induced alopecia (pCIA) and endocrine therapy–induced alopecia (EIA) at a dermatology clinic.

They conducted an analysis of medical records, standardized clinical photographs, and trichoscopic images to evaluate the alopecia pattern, severity, treatment response, and posttreatment changes in vertex hair density and thickness.

Compared with those with EIA alone, patients with pCIA were significantly more likely to have diffuse alopecia (P < .001), and they were more likely to have more severe alopecia, although this difference was not significant (P = .058). Outcomes were evaluated for 56 patients who were treated with minoxidil (19 with topical minoxidil alone and 37 with both LDOM and topical minoxidil) and for whom clinical and trichoscopic photos were available at baseline and at the last follow-up (all patients were scheduled for follow-up at 3-month intervals).

The results showed that those treated with 1.25-5.0 mg/d of oral minoxidil and 5% topical minoxidil solution once a day had better responses (P = .002) and a higher percentage increase in hair density from baseline (P = .003), compared with those who received topical minoxidil monotherapy.

However, changes in hair thickness after treatment were not significantly different between the two groups (P = .540).

In addition to the five (13.5%) cases of hypertrichosis, two cases of edema (5.4%), and one case of headache/dizziness (2.7%) among those who received the combination, there was also one report of palpitations (2.7%). Palpitations were reported in one patient (5%) who received topical monotherapy, the only adverse event reported in this group.

Dr. Johnson noted that, at his institution, a dermatologist is conducting a clinical trial with oncology patients post chemotherapy and endocrine therapy. “She is looking at a similar question, although she is comparing oral minoxidil to topical minoxidil directly rather than in combination.” There is also an active clinical trial at Northwestern University, Chicago, of LDOM alone for patients with chemotherapy-induced alopecia.

“So there is a lot of momentum surrounding this concept, and I feel we will continue to see it come up as a possible treatment option, but more data are needed at this time before it can become standard of care,” Dr. Johnson added.

No funding for the study was reported. The authors disclosed no relevant financial relationships.

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

Among patients with metastatic melanoma who undergo treatment with single or combination immune checkpoint inhibitors (ICIs) and who experience immune adverse events, overall survival is significantly longer, regardless of the need for hospitalization. Survival is further improved if the immunotherapy is continued after the adverse event develops, a new study confirms.

“In the largest clinical cohort to date, our data support a positive association with overall survival for patients who develop clinically significant immune-related adverse events while receiving combination immune checkpoint blockade, in keeping with other reported series,” the authors wrote.

The study was published online in JAMA Network Open.

Immune-related adverse events are common with these drugs. Severe events of grade 3 or higher occur in 59% of trial patients who receive combination ICI therapy.

The adverse events have increasingly been positively associated with survival. However, the effects for patients with metastatic melanoma, in particular, are less clear. There is little research on the effects in relation to combination therapy with ipilimumab and nivolumab, which is the standard of care for many patients with metastatic melanoma.

To investigate, Alexander S. Watson, MD, and colleagues evaluated data on 492 patients with metastatic melanoma who had been treated with one or more doses of an anti–programmed death 1 agent as single or combination immune checkpoint blockade in the multicenter Alberta Immunotherapy Database from August 2013 to May 2020.

Of these 492 patients, 198 patients (40%) developed immune-related adverse events. The mean age of the patients who developed adverse events was 61.8 years; of those who did not develop adverse events, the mean age was 65.5 years. Men made up 69.2% and 62.2%, respectively.

A total of 288 patients received pembrolizumab as their first ICI therapy, 80 received nivolumab, and 124 received combination blockade with ipilimumab-nivolumab.

Overall, with a median follow-up of 36.6 months, among patients who experienced clinically significant immune-related adverse events, defined as requiring systemic corticosteroids and/or a treatment delay, median overall survival was significantly improved, at 56.3 months, compared with 18.5 months among those who did not experience immune-related adverse events (P < .001).

In addition, among those who received combination ICI treatment, the median overall survival was 56.2 months for those who experienced adverse events versus 19.0 months for those who did not (P < .001).

There were no significant differences in overall survival between those who were and those who were not hospitalized for their immune-related adverse events (P = .53).

For patients who resumed their ICI therapy following the adverse events, overall survival was longer, compared with those who did not resume the therapy (median, 56.3 months vs. 31.5 months; P = .009).

The improvements in overall survival seen with immune-related adverse events remained consistent after adjustment in a multivariable analysis (hazard ratio for death, 0.382; P < .001).

There were no significant differences in the median number of cycles of ICIs between those with and those without the adverse events.

The risk of recurrence of immune-related adverse events following the reintroduction of therapy after initial events was a concern, so the improved overall survival among those patients is encouraging, although further investigation is needed, commented lead author Dr. Watson, from the department of oncology, University of Calgary (Alta.).

“It may be, for certain patients with immune-related adverse events, that continued immune-priming is safe and optimizes anticancer response,” he told this news organization. “However, in a retrospective analysis such as ours, selection bias can have an impact.”

“Confirming this finding and better identifying patients who may benefit from resumption will be an area for future investigation,” he said.  

Patients who developed immune-related adverse events were more likely to be younger than 50 years (21.8% vs. 13.9%), have normal albumin levels (86.4% vs. 74.8%), and have a more robust Eastern Cooperative Oncology Group status, which is consistent with other studies that have shown survival benefits among those who experience adverse events.

“We, and others, speculate this could be due to such groups having immune systems more ready to respond strongly to immunotherapy,” Dr. Watson explained.

After controlling for age and performance status in the multivariable analysis, however, “immune-related adverse events remained strongly associated with survival, potentially [indicating] that robust responses to immunotherapy lead to both cancer control and immune-related adverse events,” he said.

Overall, “we feel these findings will help clinicians in discussions with patients and in clinical decision-making after adverse events develop,” Dr. Watson said.

Dr. Watson has received personal fees from Apobiologix Canada.

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

Among patients with metastatic melanoma who undergo treatment with single or combination immune checkpoint inhibitors (ICIs) and who experience immune adverse events, overall survival is significantly longer, regardless of the need for hospitalization. Survival is further improved if the immunotherapy is continued after the adverse event develops, a new study confirms.

“In the largest clinical cohort to date, our data support a positive association with overall survival for patients who develop clinically significant immune-related adverse events while receiving combination immune checkpoint blockade, in keeping with other reported series,” the authors wrote.

The study was published online in JAMA Network Open.

Immune-related adverse events are common with these drugs. Severe events of grade 3 or higher occur in 59% of trial patients who receive combination ICI therapy.

The adverse events have increasingly been positively associated with survival. However, the effects for patients with metastatic melanoma, in particular, are less clear. There is little research on the effects in relation to combination therapy with ipilimumab and nivolumab, which is the standard of care for many patients with metastatic melanoma.

To investigate, Alexander S. Watson, MD, and colleagues evaluated data on 492 patients with metastatic melanoma who had been treated with one or more doses of an anti–programmed death 1 agent as single or combination immune checkpoint blockade in the multicenter Alberta Immunotherapy Database from August 2013 to May 2020.

Of these 492 patients, 198 patients (40%) developed immune-related adverse events. The mean age of the patients who developed adverse events was 61.8 years; of those who did not develop adverse events, the mean age was 65.5 years. Men made up 69.2% and 62.2%, respectively.

A total of 288 patients received pembrolizumab as their first ICI therapy, 80 received nivolumab, and 124 received combination blockade with ipilimumab-nivolumab.

Overall, with a median follow-up of 36.6 months, among patients who experienced clinically significant immune-related adverse events, defined as requiring systemic corticosteroids and/or a treatment delay, median overall survival was significantly improved, at 56.3 months, compared with 18.5 months among those who did not experience immune-related adverse events (P < .001).

In addition, among those who received combination ICI treatment, the median overall survival was 56.2 months for those who experienced adverse events versus 19.0 months for those who did not (P < .001).

There were no significant differences in overall survival between those who were and those who were not hospitalized for their immune-related adverse events (P = .53).

For patients who resumed their ICI therapy following the adverse events, overall survival was longer, compared with those who did not resume the therapy (median, 56.3 months vs. 31.5 months; P = .009).

The improvements in overall survival seen with immune-related adverse events remained consistent after adjustment in a multivariable analysis (hazard ratio for death, 0.382; P < .001).

There were no significant differences in the median number of cycles of ICIs between those with and those without the adverse events.

The risk of recurrence of immune-related adverse events following the reintroduction of therapy after initial events was a concern, so the improved overall survival among those patients is encouraging, although further investigation is needed, commented lead author Dr. Watson, from the department of oncology, University of Calgary (Alta.).

“It may be, for certain patients with immune-related adverse events, that continued immune-priming is safe and optimizes anticancer response,” he told this news organization. “However, in a retrospective analysis such as ours, selection bias can have an impact.”

“Confirming this finding and better identifying patients who may benefit from resumption will be an area for future investigation,” he said.  

Patients who developed immune-related adverse events were more likely to be younger than 50 years (21.8% vs. 13.9%), have normal albumin levels (86.4% vs. 74.8%), and have a more robust Eastern Cooperative Oncology Group status, which is consistent with other studies that have shown survival benefits among those who experience adverse events.

“We, and others, speculate this could be due to such groups having immune systems more ready to respond strongly to immunotherapy,” Dr. Watson explained.

After controlling for age and performance status in the multivariable analysis, however, “immune-related adverse events remained strongly associated with survival, potentially [indicating] that robust responses to immunotherapy lead to both cancer control and immune-related adverse events,” he said.

Overall, “we feel these findings will help clinicians in discussions with patients and in clinical decision-making after adverse events develop,” Dr. Watson said.

Dr. Watson has received personal fees from Apobiologix Canada.

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

Among patients with metastatic melanoma who undergo treatment with single or combination immune checkpoint inhibitors (ICIs) and who experience immune adverse events, overall survival is significantly longer, regardless of the need for hospitalization. Survival is further improved if the immunotherapy is continued after the adverse event develops, a new study confirms.

“In the largest clinical cohort to date, our data support a positive association with overall survival for patients who develop clinically significant immune-related adverse events while receiving combination immune checkpoint blockade, in keeping with other reported series,” the authors wrote.

The study was published online in JAMA Network Open.

Immune-related adverse events are common with these drugs. Severe events of grade 3 or higher occur in 59% of trial patients who receive combination ICI therapy.

The adverse events have increasingly been positively associated with survival. However, the effects for patients with metastatic melanoma, in particular, are less clear. There is little research on the effects in relation to combination therapy with ipilimumab and nivolumab, which is the standard of care for many patients with metastatic melanoma.

To investigate, Alexander S. Watson, MD, and colleagues evaluated data on 492 patients with metastatic melanoma who had been treated with one or more doses of an anti–programmed death 1 agent as single or combination immune checkpoint blockade in the multicenter Alberta Immunotherapy Database from August 2013 to May 2020.

Of these 492 patients, 198 patients (40%) developed immune-related adverse events. The mean age of the patients who developed adverse events was 61.8 years; of those who did not develop adverse events, the mean age was 65.5 years. Men made up 69.2% and 62.2%, respectively.

A total of 288 patients received pembrolizumab as their first ICI therapy, 80 received nivolumab, and 124 received combination blockade with ipilimumab-nivolumab.

Overall, with a median follow-up of 36.6 months, among patients who experienced clinically significant immune-related adverse events, defined as requiring systemic corticosteroids and/or a treatment delay, median overall survival was significantly improved, at 56.3 months, compared with 18.5 months among those who did not experience immune-related adverse events (P < .001).

In addition, among those who received combination ICI treatment, the median overall survival was 56.2 months for those who experienced adverse events versus 19.0 months for those who did not (P < .001).

There were no significant differences in overall survival between those who were and those who were not hospitalized for their immune-related adverse events (P = .53).

For patients who resumed their ICI therapy following the adverse events, overall survival was longer, compared with those who did not resume the therapy (median, 56.3 months vs. 31.5 months; P = .009).

The improvements in overall survival seen with immune-related adverse events remained consistent after adjustment in a multivariable analysis (hazard ratio for death, 0.382; P < .001).

There were no significant differences in the median number of cycles of ICIs between those with and those without the adverse events.

The risk of recurrence of immune-related adverse events following the reintroduction of therapy after initial events was a concern, so the improved overall survival among those patients is encouraging, although further investigation is needed, commented lead author Dr. Watson, from the department of oncology, University of Calgary (Alta.).

“It may be, for certain patients with immune-related adverse events, that continued immune-priming is safe and optimizes anticancer response,” he told this news organization. “However, in a retrospective analysis such as ours, selection bias can have an impact.”

“Confirming this finding and better identifying patients who may benefit from resumption will be an area for future investigation,” he said.  

Patients who developed immune-related adverse events were more likely to be younger than 50 years (21.8% vs. 13.9%), have normal albumin levels (86.4% vs. 74.8%), and have a more robust Eastern Cooperative Oncology Group status, which is consistent with other studies that have shown survival benefits among those who experience adverse events.

“We, and others, speculate this could be due to such groups having immune systems more ready to respond strongly to immunotherapy,” Dr. Watson explained.

After controlling for age and performance status in the multivariable analysis, however, “immune-related adverse events remained strongly associated with survival, potentially [indicating] that robust responses to immunotherapy lead to both cancer control and immune-related adverse events,” he said.

Overall, “we feel these findings will help clinicians in discussions with patients and in clinical decision-making after adverse events develop,” Dr. Watson said.

Dr. Watson has received personal fees from Apobiologix Canada.

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