Mixed Topics

Nathan Chomilo, MD, the Medicaid medical director for the state of Minnesota and assistant adjunct professor of pediatrics at the University of Minnesota, Minneapolis, was prepared to deliver a talk on structural racism in the U.S. health care system at Hospital Medicine 2020 meeting (HM20) in April 2020. But that changed in the COVID-19 era.

When the pandemic hit, the problems Dr. Chomilo was going to point out began to play out dramatically around the country: Black, Indigenous, and Latinx people – many of them under-insured; in high-exposure, frontline jobs; and already burdened with health comorbidities – are at a higher risk of contracting COVID-19 and dying from it.

He will now be giving his talk at HM20 Virtual in a session called “Structural Racism and Bias in Hospital Medicine During Two Pandemics,” with the powerful narrative of COVID-19 to get his message to sink in: For centuries, the medical field and the health care system more broadly have enabled racism to play out in a structural way, and this is leading to sickness and death.

“It’s something that’s been going on since the start of our country,” said Dr. Chomilo, who is also a founding member of Minnesota Doctors for Health Equity. Physicians, he said, participated in upholding the institution of slavery by trying to describe the physical discrepancies between White people and non-White people.

Now, the way health care is provided in the United States fundamentally favors Whites over Black, Indigenous, and Latinx patients.

“We have a health care system here in the United States that is based on employer-sponsored insurance,” he said. “And who has had access to those jobs over the course of our country’s history has been mostly White people.” That impacts who is more at risk of contracting the virus, who is able to shelter in place, and who has the financial reserves to withstand furloughs and unemployment.

In a recent blog post in Health Affairs, Dr. Chomilo and his coauthors discussed articles from the New England Journal of Medicine and the Journal of the American Medical Association that try to offer an ethical framework for allocating scarce medical resources – such as intensive-care beds and ventilators – during the pandemic.

“Unfortunately, neither article acknowledged the structural racial inequities that inherently bias its proposals, nor did either piece adequately acknowledge how its care rationing plan might worsen already racially disparate health outcomes,” Dr. Chomilo and his coauthors wrote. For instance, the life expectancy of a White female in the United States is 81 years, compared with 72 years for Black males, and any allocation plan that prioritizes preserving years of life would automatically be tilted against black patients.

In his talk, Dr. Chomilo will also discuss how physicians can make a difference by looking at their own perceptions and habits and then start helping others and the systems in which they work.

“The first thing is, we have to look at ourselves,” he said.

In the same session, Benji Mathews, MD, SFHM – chief of hospital medicine at Regions Hospital in St. Paul, Minn., which is part of HealthPartners; associate professor of medicine at the University of Minnesota, Minneapolis; and the Annual Conference’s course director – said he will be discussing the way social inequities are “patterned by place” and how resources for staying healthy vary neighborhood to neighborhood. He will point to dense housing and multigenerational households as a chief driver of COVID-19 infection risk. People of color are often “first fired, last hired, and in the front lines of fire,” he said, and they are experiencing a more severe impact from the pandemic.

And he will get deeper into the other disparities that track along racial lines, such as insurance disparities. For instance, the percentage of African Americans on Medicaid is three times as high as the percentage of White, non-Hispanic patients, he said.

Dr. Mathews will also discuss race’s role in the biases that everyone has and how health care professionals might, with deliberate reflection, be able to reshape or mitigate their own biases and deliver care more equitably.

“The associations we have, and our biases, are not necessarily declared beliefs or even reflect our stances that we explicitly endorse – sometimes it comes through in our default stance, and generally favor our in-group,” he said. “These implicit biases are malleable, so that allows us some hope. There are some ways they can be unlearned or progressively acted upon with some coaching – some active, intentional development.”
 

Structural Racism and Bias in Hospital Medicine During Two Pandemics

Nathan Chomilo, MD, the Medicaid medical director for the state of Minnesota and assistant adjunct professor of pediatrics at the University of Minnesota, Minneapolis, was prepared to deliver a talk on structural racism in the U.S. health care system at Hospital Medicine 2020 meeting (HM20) in April 2020. But that changed in the COVID-19 era.

When the pandemic hit, the problems Dr. Chomilo was going to point out began to play out dramatically around the country: Black, Indigenous, and Latinx people – many of them under-insured; in high-exposure, frontline jobs; and already burdened with health comorbidities – are at a higher risk of contracting COVID-19 and dying from it.

He will now be giving his talk at HM20 Virtual in a session called “Structural Racism and Bias in Hospital Medicine During Two Pandemics,” with the powerful narrative of COVID-19 to get his message to sink in: For centuries, the medical field and the health care system more broadly have enabled racism to play out in a structural way, and this is leading to sickness and death.

“It’s something that’s been going on since the start of our country,” said Dr. Chomilo, who is also a founding member of Minnesota Doctors for Health Equity. Physicians, he said, participated in upholding the institution of slavery by trying to describe the physical discrepancies between White people and non-White people.

Now, the way health care is provided in the United States fundamentally favors Whites over Black, Indigenous, and Latinx patients.

“We have a health care system here in the United States that is based on employer-sponsored insurance,” he said. “And who has had access to those jobs over the course of our country’s history has been mostly White people.” That impacts who is more at risk of contracting the virus, who is able to shelter in place, and who has the financial reserves to withstand furloughs and unemployment.

In a recent blog post in Health Affairs, Dr. Chomilo and his coauthors discussed articles from the New England Journal of Medicine and the Journal of the American Medical Association that try to offer an ethical framework for allocating scarce medical resources – such as intensive-care beds and ventilators – during the pandemic.

“Unfortunately, neither article acknowledged the structural racial inequities that inherently bias its proposals, nor did either piece adequately acknowledge how its care rationing plan might worsen already racially disparate health outcomes,” Dr. Chomilo and his coauthors wrote. For instance, the life expectancy of a White female in the United States is 81 years, compared with 72 years for Black males, and any allocation plan that prioritizes preserving years of life would automatically be tilted against black patients.

In his talk, Dr. Chomilo will also discuss how physicians can make a difference by looking at their own perceptions and habits and then start helping others and the systems in which they work.

“The first thing is, we have to look at ourselves,” he said.

In the same session, Benji Mathews, MD, SFHM – chief of hospital medicine at Regions Hospital in St. Paul, Minn., which is part of HealthPartners; associate professor of medicine at the University of Minnesota, Minneapolis; and the Annual Conference’s course director – said he will be discussing the way social inequities are “patterned by place” and how resources for staying healthy vary neighborhood to neighborhood. He will point to dense housing and multigenerational households as a chief driver of COVID-19 infection risk. People of color are often “first fired, last hired, and in the front lines of fire,” he said, and they are experiencing a more severe impact from the pandemic.

And he will get deeper into the other disparities that track along racial lines, such as insurance disparities. For instance, the percentage of African Americans on Medicaid is three times as high as the percentage of White, non-Hispanic patients, he said.

Dr. Mathews will also discuss race’s role in the biases that everyone has and how health care professionals might, with deliberate reflection, be able to reshape or mitigate their own biases and deliver care more equitably.

“The associations we have, and our biases, are not necessarily declared beliefs or even reflect our stances that we explicitly endorse – sometimes it comes through in our default stance, and generally favor our in-group,” he said. “These implicit biases are malleable, so that allows us some hope. There are some ways they can be unlearned or progressively acted upon with some coaching – some active, intentional development.”
 

Structural Racism and Bias in Hospital Medicine During Two Pandemics

Nathan Chomilo, MD, the Medicaid medical director for the state of Minnesota and assistant adjunct professor of pediatrics at the University of Minnesota, Minneapolis, was prepared to deliver a talk on structural racism in the U.S. health care system at Hospital Medicine 2020 meeting (HM20) in April 2020. But that changed in the COVID-19 era.

When the pandemic hit, the problems Dr. Chomilo was going to point out began to play out dramatically around the country: Black, Indigenous, and Latinx people – many of them under-insured; in high-exposure, frontline jobs; and already burdened with health comorbidities – are at a higher risk of contracting COVID-19 and dying from it.

He will now be giving his talk at HM20 Virtual in a session called “Structural Racism and Bias in Hospital Medicine During Two Pandemics,” with the powerful narrative of COVID-19 to get his message to sink in: For centuries, the medical field and the health care system more broadly have enabled racism to play out in a structural way, and this is leading to sickness and death.

“It’s something that’s been going on since the start of our country,” said Dr. Chomilo, who is also a founding member of Minnesota Doctors for Health Equity. Physicians, he said, participated in upholding the institution of slavery by trying to describe the physical discrepancies between White people and non-White people.

Now, the way health care is provided in the United States fundamentally favors Whites over Black, Indigenous, and Latinx patients.

“We have a health care system here in the United States that is based on employer-sponsored insurance,” he said. “And who has had access to those jobs over the course of our country’s history has been mostly White people.” That impacts who is more at risk of contracting the virus, who is able to shelter in place, and who has the financial reserves to withstand furloughs and unemployment.

In a recent blog post in Health Affairs, Dr. Chomilo and his coauthors discussed articles from the New England Journal of Medicine and the Journal of the American Medical Association that try to offer an ethical framework for allocating scarce medical resources – such as intensive-care beds and ventilators – during the pandemic.

“Unfortunately, neither article acknowledged the structural racial inequities that inherently bias its proposals, nor did either piece adequately acknowledge how its care rationing plan might worsen already racially disparate health outcomes,” Dr. Chomilo and his coauthors wrote. For instance, the life expectancy of a White female in the United States is 81 years, compared with 72 years for Black males, and any allocation plan that prioritizes preserving years of life would automatically be tilted against black patients.

In his talk, Dr. Chomilo will also discuss how physicians can make a difference by looking at their own perceptions and habits and then start helping others and the systems in which they work.

“The first thing is, we have to look at ourselves,” he said.

In the same session, Benji Mathews, MD, SFHM – chief of hospital medicine at Regions Hospital in St. Paul, Minn., which is part of HealthPartners; associate professor of medicine at the University of Minnesota, Minneapolis; and the Annual Conference’s course director – said he will be discussing the way social inequities are “patterned by place” and how resources for staying healthy vary neighborhood to neighborhood. He will point to dense housing and multigenerational households as a chief driver of COVID-19 infection risk. People of color are often “first fired, last hired, and in the front lines of fire,” he said, and they are experiencing a more severe impact from the pandemic.

And he will get deeper into the other disparities that track along racial lines, such as insurance disparities. For instance, the percentage of African Americans on Medicaid is three times as high as the percentage of White, non-Hispanic patients, he said.

Dr. Mathews will also discuss race’s role in the biases that everyone has and how health care professionals might, with deliberate reflection, be able to reshape or mitigate their own biases and deliver care more equitably.

“The associations we have, and our biases, are not necessarily declared beliefs or even reflect our stances that we explicitly endorse – sometimes it comes through in our default stance, and generally favor our in-group,” he said. “These implicit biases are malleable, so that allows us some hope. There are some ways they can be unlearned or progressively acted upon with some coaching – some active, intentional development.”
 

Structural Racism and Bias in Hospital Medicine During Two Pandemics

An atlas that displays the unique nuances between different skin types across the spectrum of dermatologic disease is scheduled for release this coming winter.

Available as an e-book or physical text, “Dermatology: A Diverse and Inclusive Color Atlas,” will display side-by-side images of the most common dermatology conditions in multiple skin types, with experts providing commentary on unique morphologies and features. Dermatologists need to know what skin diseases look like on all types of skin, said Adam Friedman, MD, who is developing this e-book with Misty Eleryan, MD, MS.

From the SARS-CoV-2 pandemic, multiple nonviral pandemics have rapidly emerged, “most notably the persistent and well-masked racism that maintains disparities in all facets of life, from economics to health care,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview.

In dermatology, “clear disparities in workforce representation and trainee/practitioner education have become more apparent than ever before,” he added.

The project is a collaboration of George Washington University and education publishers Sanova Works and Educational Testing & Assessment Systems.

As a person of color who recently completed her residency in dermatology at George Washington University, Dr. Eleryan had noticed a lack of diversity in photos of common dermatoses. This can contribute to misdiagnoses and delays in treatment in patients of color, Dr. Eleryan, who is now a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, said in an interview.

“We recognized the gap, which is the lack of diversity/variation of skin tones in our dermatology textbooks and atlases,” she added.

The project was several years in the making, Dr. Friedman said. To do this right, “you need resources, funding, and a collaborative and galvanized team of experts.” That involved coordinating with several medical publishers and amassing a team of medical photographers and an expert panel that will assist in evaluating and securing difficult-to-access clinical images.

The atlas is one of several initiatives in the dermatology field to address racial disparities in patient care.

Noticing similar information gaps about clinical presentations in darker skin, a medical student in the United Kingdom, Malone Mukwende, created “Mind the Gap,” a handbook that presents side-by-side images of diseases and illnesses in light and dark skin. This project “highlights how far behind we are, that a medical student with minimal dermatology exposure and experience not only recognized the need but was ready to do something about it,” Dr. Friedman noted.

Others in the field have spotlighted disparities in the medical literature. The SARS-CoV-2 pandemic has especially brought this out, Graeme M. Lipper, MD wrote in a recent editorial for this news organization.

He referred to a literature review of 46 articles describing COVID-19–associated skin manifestations, which included mostly (92%) images in patients with skin types I-III (92%) and none in patients with skin types V or VI.

“These investigators have identified a damning lack of images of COVID-19–associated skin manifestations in patients with darker skin,” added Dr. Lipper, an assistant clinical professor at the University of Vermont, Burlington, and a staff physician in the department of dermatology at Danbury (Conn.) Hospital.

For now, Dr. Friedman said that the atlas won’t contain a specific section on COVID-19 skin manifestations, although viral-associated skin reactions like morbilliform eruptions, urticaria, and retiform purpura will be displayed. Overall, the atlas will address 60-70 skin conditions.

Physicians who fail to educate themselves on the variations of skin conditions in all skin types may potentially harm patients of color, Dr. Eleryan said. As Dr. Lipper noted in his editorial, nearly half of all dermatologists feel they haven’t had adequate exposure to diseases in skin of color.

“Our atlas will fill that void and hopefully assist in closing the gap in health disparities among patients of color, who are often misdiagnosed or rendered diagnoses very late in the disease process,” Dr. Eleryan said.

An atlas that displays the unique nuances between different skin types across the spectrum of dermatologic disease is scheduled for release this coming winter.

Available as an e-book or physical text, “Dermatology: A Diverse and Inclusive Color Atlas,” will display side-by-side images of the most common dermatology conditions in multiple skin types, with experts providing commentary on unique morphologies and features. Dermatologists need to know what skin diseases look like on all types of skin, said Adam Friedman, MD, who is developing this e-book with Misty Eleryan, MD, MS.

From the SARS-CoV-2 pandemic, multiple nonviral pandemics have rapidly emerged, “most notably the persistent and well-masked racism that maintains disparities in all facets of life, from economics to health care,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview.

In dermatology, “clear disparities in workforce representation and trainee/practitioner education have become more apparent than ever before,” he added.

The project is a collaboration of George Washington University and education publishers Sanova Works and Educational Testing & Assessment Systems.

As a person of color who recently completed her residency in dermatology at George Washington University, Dr. Eleryan had noticed a lack of diversity in photos of common dermatoses. This can contribute to misdiagnoses and delays in treatment in patients of color, Dr. Eleryan, who is now a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, said in an interview.

“We recognized the gap, which is the lack of diversity/variation of skin tones in our dermatology textbooks and atlases,” she added.

The project was several years in the making, Dr. Friedman said. To do this right, “you need resources, funding, and a collaborative and galvanized team of experts.” That involved coordinating with several medical publishers and amassing a team of medical photographers and an expert panel that will assist in evaluating and securing difficult-to-access clinical images.

The atlas is one of several initiatives in the dermatology field to address racial disparities in patient care.

Noticing similar information gaps about clinical presentations in darker skin, a medical student in the United Kingdom, Malone Mukwende, created “Mind the Gap,” a handbook that presents side-by-side images of diseases and illnesses in light and dark skin. This project “highlights how far behind we are, that a medical student with minimal dermatology exposure and experience not only recognized the need but was ready to do something about it,” Dr. Friedman noted.

Others in the field have spotlighted disparities in the medical literature. The SARS-CoV-2 pandemic has especially brought this out, Graeme M. Lipper, MD wrote in a recent editorial for this news organization.

He referred to a literature review of 46 articles describing COVID-19–associated skin manifestations, which included mostly (92%) images in patients with skin types I-III (92%) and none in patients with skin types V or VI.

“These investigators have identified a damning lack of images of COVID-19–associated skin manifestations in patients with darker skin,” added Dr. Lipper, an assistant clinical professor at the University of Vermont, Burlington, and a staff physician in the department of dermatology at Danbury (Conn.) Hospital.

For now, Dr. Friedman said that the atlas won’t contain a specific section on COVID-19 skin manifestations, although viral-associated skin reactions like morbilliform eruptions, urticaria, and retiform purpura will be displayed. Overall, the atlas will address 60-70 skin conditions.

Physicians who fail to educate themselves on the variations of skin conditions in all skin types may potentially harm patients of color, Dr. Eleryan said. As Dr. Lipper noted in his editorial, nearly half of all dermatologists feel they haven’t had adequate exposure to diseases in skin of color.

“Our atlas will fill that void and hopefully assist in closing the gap in health disparities among patients of color, who are often misdiagnosed or rendered diagnoses very late in the disease process,” Dr. Eleryan said.

An atlas that displays the unique nuances between different skin types across the spectrum of dermatologic disease is scheduled for release this coming winter.

Available as an e-book or physical text, “Dermatology: A Diverse and Inclusive Color Atlas,” will display side-by-side images of the most common dermatology conditions in multiple skin types, with experts providing commentary on unique morphologies and features. Dermatologists need to know what skin diseases look like on all types of skin, said Adam Friedman, MD, who is developing this e-book with Misty Eleryan, MD, MS.

From the SARS-CoV-2 pandemic, multiple nonviral pandemics have rapidly emerged, “most notably the persistent and well-masked racism that maintains disparities in all facets of life, from economics to health care,” Dr. Friedman, professor and interim chair of dermatology at George Washington University, Washington, said in an interview.

In dermatology, “clear disparities in workforce representation and trainee/practitioner education have become more apparent than ever before,” he added.

The project is a collaboration of George Washington University and education publishers Sanova Works and Educational Testing & Assessment Systems.

As a person of color who recently completed her residency in dermatology at George Washington University, Dr. Eleryan had noticed a lack of diversity in photos of common dermatoses. This can contribute to misdiagnoses and delays in treatment in patients of color, Dr. Eleryan, who is now a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, said in an interview.

“We recognized the gap, which is the lack of diversity/variation of skin tones in our dermatology textbooks and atlases,” she added.

The project was several years in the making, Dr. Friedman said. To do this right, “you need resources, funding, and a collaborative and galvanized team of experts.” That involved coordinating with several medical publishers and amassing a team of medical photographers and an expert panel that will assist in evaluating and securing difficult-to-access clinical images.

The atlas is one of several initiatives in the dermatology field to address racial disparities in patient care.

Noticing similar information gaps about clinical presentations in darker skin, a medical student in the United Kingdom, Malone Mukwende, created “Mind the Gap,” a handbook that presents side-by-side images of diseases and illnesses in light and dark skin. This project “highlights how far behind we are, that a medical student with minimal dermatology exposure and experience not only recognized the need but was ready to do something about it,” Dr. Friedman noted.

Others in the field have spotlighted disparities in the medical literature. The SARS-CoV-2 pandemic has especially brought this out, Graeme M. Lipper, MD wrote in a recent editorial for this news organization.

He referred to a literature review of 46 articles describing COVID-19–associated skin manifestations, which included mostly (92%) images in patients with skin types I-III (92%) and none in patients with skin types V or VI.

“These investigators have identified a damning lack of images of COVID-19–associated skin manifestations in patients with darker skin,” added Dr. Lipper, an assistant clinical professor at the University of Vermont, Burlington, and a staff physician in the department of dermatology at Danbury (Conn.) Hospital.

For now, Dr. Friedman said that the atlas won’t contain a specific section on COVID-19 skin manifestations, although viral-associated skin reactions like morbilliform eruptions, urticaria, and retiform purpura will be displayed. Overall, the atlas will address 60-70 skin conditions.

Physicians who fail to educate themselves on the variations of skin conditions in all skin types may potentially harm patients of color, Dr. Eleryan said. As Dr. Lipper noted in his editorial, nearly half of all dermatologists feel they haven’t had adequate exposure to diseases in skin of color.

“Our atlas will fill that void and hopefully assist in closing the gap in health disparities among patients of color, who are often misdiagnosed or rendered diagnoses very late in the disease process,” Dr. Eleryan said.

Welcome to the HM20 virtual conference! We’re glad to have you join us to virtually experience sessions from our most popular SHM annual conference tracks including Rapid Fire, Clinical Updates, and High-Value Care! We also have added some new timely topics given our current times that you won’t want to miss. We encourage you to engage with the larger community via social media at #HM20Virtual.

HM20 in San Diego, scheduled originally for April 2020, was trending to be the highest in-person attended SHM annual conference with a fantastic line-up of offerings. Unfortunately, then came our pandemic, or pandemics. In mid-March, the Society of Hospital Medicine board of directors concluded that it was impossible for SHM to move forward with Hospital Medicine 2020 in San Diego because of the continued spread of COVID-19. Canceling the in-person conference during this unprecedented time was the right thing to do. I have valued the SHM leadership team and the larger SHM community for their support in being even more engaged on the front lines and with each other across our world during this time.

The COVID-19 pandemic has created a systemic challenge for health care systems across the nation. As hospitalists continue to be on the front lines of care and also innovations, organizations have leveraged telemedicine to support their patients, protect their clinicians, and conserve scarce resources. It is hospital medicine that has been on the front lines of change and adaptations and have led in this pandemic in many organizations across the nation and the world.

Unfortunately, known health disparities have also been amplified and there came an acute worsening of the chronic issues in this nation. On March 13, 2020, 26-year-old Breonna Taylor was shot after police forcibly entered her home. Armaud Arbery was shot and killed by armed neighbors while running through a neighborhood in Brunswick, Ga. Then on May 25, 5 miles from where I call home here in the Twin Cities in Minnesota, George Floyd, a 46-year-old father arrested for suspected use of a counterfeit $20 bill, died after police kneeled on his neck for over 8 minutes. This pandemic has also shaken up the status quo and laid bare a lot of our country’s long and deep-seated issues – from massive economic inequities to ongoing racial disparities to immigration concerns. It’s woken a lot of our valued hospitalists to the fact that the old ways of doing things just don’t work.

I’m grateful our society has taken steps to speak into these timely topics, and to share via publications, Twitter chats, advocacy items, and more! I want to encourage all of us to use the immense network of our hospitalist communities to comfort each other, learn, grow, and engage. We have not achieved big changes by ourselves. We’ve created valued offerings and innovative changes, and we’ve led on the front lines, in policies and procedures, by doing it together. Meaningful change requires allies in a common cause. We stand with our black and brown brothers and sisters who are particularly attuned to injustice, inequality, and struggle. We in hospital medicine stand up with many others who are struggling, our African American, Latin American, Native American, immigrant, LGBTQ+ communities. This intersection of the crisis of the COVID-19 pandemic and the racism pandemic have led us to a pivotal point in the arc of change and justice. I invite you to comfort each other, learn from each other, and act together in this community. To this end we have included timely resources in our HM20 virtual offering on these topics.

This year has been a big transition year. Not only did 2020 usher in a new decade, along with COVID-19 and our double pandemic, SHM has also had important transitions within its senior leadership. We say farewell to Larry Wellikson, MD, who has been at the helm of SHM since the beginning. On behalf of this annual conference, we want to celebrate and thank you, Larry, for your years of dedication and service to SHM. You have taken the specialty of hospital medicine and created a movement in SHM, where the entire hospital medicine team may gather under a bigger tent for education, community, and for the betterment of care for our patients.

We extend a welcome to Eric Howell, MD, who succeeds Dr. Wellikson as SHM’s CEO. We also welcome Danielle Scheurer, MD, as the new SHM president, succeeding the great leadership offered this past year by Christopher Frost, MD. In addition, Jerome C. Siy, MD, was voted president-elect, Dr. Rachel Thompson, MD, was elected treasurer, Kris Rehm, MD, was voted secretary, and Darlene Tad-y, MD, was elected to the board of directors. We welcome these new officers.

HM20 Virtual will consist of prerecorded on-demand sessions that can be viewed at your convenience as well as live Q&A and attendee networking that will take place during specific dates/times. A few of the top-rated sessions from our historically popular tracks include: Update in Clinical Practice Guidelines, Antibiotics Made Ridiculously Simple, Getting to Know Oncology Emergencies, Inpatient Pain Management in the Era of the Opioid Epidemic, Updates in Heart Failure, and Hyponatremia: Don’t Drink the Water. Additionally, we have some of our perennial favorites including the Update in Hospital Medicine and Top Pediatric Articles of 2019. There will be COVID-19 specific content from expertise throughout the nation focusing on care pathways, clinical updates, telemedicine, point-of-care ultrasound, and more! To view the HM20 Virtual Opening Session and discover what you can expect in this educational experience, click here.

The Journal of Hospital Medicine has had a large presence in our meetings for many years. We are grateful for Samir Shah, MD, and his leadership during this double pandemic, for identifying areas where we can advance the field responsibly in the face of relatively limited evidence, and rapidly evolving news. As part of his commitment, all JHM articles related to COVID-19 and published during the pandemic are open access. A pre-COVID goal that has been realized during the pandemic was to bring more of the journal into our annual conference and the conference contents into the journal. We are proud to say this has been a great collaboration, particularly during this pandemic, and much thanks to Dr. Shah’s leadership for highlighting timely pieces. Kimberly Manning, MD, had an especially powerful piece on the topic of racism and our double pandemic, and she is a featured speaker during our HM20 Virtual offering, under the same title as her article: “When Grief and Crises Intersect: Perspectives of a Black Physician in the Time of Two Pandemics.” Additionally, Manpreet Malik, MD, and I will be copresenting on a timely topic about the “Immigrant Hospitalist during COVID-19.”

Aside from these sessions for HM20 Virtual, the real can’t miss(es) for the conference are the Research, Innovations, and Clinical Vignette (RIV) posters sessions. I am grateful for the leadership of Stephanie Mueller, MD, who served as chair for this year’s RIV. This unique year has led to the hosting of a virtual poster competition with judging and the opening of a virtual gallery. We are so pleased to be able to share and highlight the work of many of learners and staff hospitalists! I love that a hospitalist on one side of the country can help provide pearls on a case, an innovation, or a research idea that can help improve diagnosis for a patient at the other side of the country. Keep an eye on SHM’s social media and the presentation by Dr. Mueller for announcements of the winners.

A favorite reason many of us attend the annual conference is for the people and community. We wanted to keep this value as we shifted to a virtual offering. Networking will occur through a variety of offerings including Simulive sessions and Special Interest Forums. Simulive sessions will run for 3 weeks from August 11 to August 27. For those of you new to the term, Simulive may sound like a made-up word, but it is an actual amalgamation of a prerecorded webinar and a live interaction (simulated + live = Simulive). Simulive allows the faculty to sit in on their prerecorded session and interact with the audience via the chat feature during the live scheduled recording and spend time afterwards for a live Q&A from the audience.

There will also be over 20 Special Interest Forums hosted in the evenings after these Simulive sessions have concluded to give you a chance to connect with individuals, share experiences, and have meaningful discussions that can directly impact your practice. Samples of the forums include: Diversity and Inclusion, Rural Hospital Medicine, Pediatrics, NP/PA, Perioperative and Comanagement, Health Information Technology, and Point of Care Ultrasound! Take a look at the HM20 registration page for further information. You will receive direct information on how to attend. We encourage you to join!

HM20 also features a virtual 5K! Whether you run on a treadmill or jog in your neighborhood or local park, you can participate in HM20’s Virtual Fun Run or Walk. To participate, simply run your 5K during the weeks of HM20 Virtual and when you’re done, fill out our form to log your time. We encourage you to post a picture on social media as well with #HM20Virtual. You’ll also receive a certificate of completion at the close of HM20 Virtual.

All HM20 Virtual sessions will be available as on-demand after August 31. HM20 virtual offers more than 60 CME hours and over 35 MOC hours that you can claim at your convenience! That’s the most amount of CME and MOC ever offered at SHM for an event! This conference would not be possible without the tireless and relentless effort of SHM staff and leadership, our terrific speakers and faculty, and all the volunteer committee members of SHM. A huge thanks to the Annual Conference Committee who had the charge to develop the content for the Annual Conference, including topics, speakers, and learning objectives. I am grateful to have had the opportunity to serve on this committee for the past 7 years and to lead HM20 this year. Thanks to Brittany Evans, Hayleigh Lawrence, and Michelle Kann for their valued support this past year from an SHM staff perspective; to my assistant course director, Dan Steinberg, MD; and to the immediate past course director, Dustin Smith, MD, for their support.

Once again, we are excited to have you join, and we hope this conference elevates your education in hospital medicine, advances your career, stimulates innovative thinking, and provides you with enduring networking opportunities. We sincerely thank you for attending HM20 Virtual. Welcome!

Dr. Mathews is chief of hospital medicine at Regions Hospital, HealthPartners in St. Paul, Minn., an associate professor at the University of Minnesota, Minneapolis, and course director of HM20.

Welcome to the HM20 virtual conference! We’re glad to have you join us to virtually experience sessions from our most popular SHM annual conference tracks including Rapid Fire, Clinical Updates, and High-Value Care! We also have added some new timely topics given our current times that you won’t want to miss. We encourage you to engage with the larger community via social media at #HM20Virtual.

HM20 in San Diego, scheduled originally for April 2020, was trending to be the highest in-person attended SHM annual conference with a fantastic line-up of offerings. Unfortunately, then came our pandemic, or pandemics. In mid-March, the Society of Hospital Medicine board of directors concluded that it was impossible for SHM to move forward with Hospital Medicine 2020 in San Diego because of the continued spread of COVID-19. Canceling the in-person conference during this unprecedented time was the right thing to do. I have valued the SHM leadership team and the larger SHM community for their support in being even more engaged on the front lines and with each other across our world during this time.

The COVID-19 pandemic has created a systemic challenge for health care systems across the nation. As hospitalists continue to be on the front lines of care and also innovations, organizations have leveraged telemedicine to support their patients, protect their clinicians, and conserve scarce resources. It is hospital medicine that has been on the front lines of change and adaptations and have led in this pandemic in many organizations across the nation and the world.

Unfortunately, known health disparities have also been amplified and there came an acute worsening of the chronic issues in this nation. On March 13, 2020, 26-year-old Breonna Taylor was shot after police forcibly entered her home. Armaud Arbery was shot and killed by armed neighbors while running through a neighborhood in Brunswick, Ga. Then on May 25, 5 miles from where I call home here in the Twin Cities in Minnesota, George Floyd, a 46-year-old father arrested for suspected use of a counterfeit $20 bill, died after police kneeled on his neck for over 8 minutes. This pandemic has also shaken up the status quo and laid bare a lot of our country’s long and deep-seated issues – from massive economic inequities to ongoing racial disparities to immigration concerns. It’s woken a lot of our valued hospitalists to the fact that the old ways of doing things just don’t work.

I’m grateful our society has taken steps to speak into these timely topics, and to share via publications, Twitter chats, advocacy items, and more! I want to encourage all of us to use the immense network of our hospitalist communities to comfort each other, learn, grow, and engage. We have not achieved big changes by ourselves. We’ve created valued offerings and innovative changes, and we’ve led on the front lines, in policies and procedures, by doing it together. Meaningful change requires allies in a common cause. We stand with our black and brown brothers and sisters who are particularly attuned to injustice, inequality, and struggle. We in hospital medicine stand up with many others who are struggling, our African American, Latin American, Native American, immigrant, LGBTQ+ communities. This intersection of the crisis of the COVID-19 pandemic and the racism pandemic have led us to a pivotal point in the arc of change and justice. I invite you to comfort each other, learn from each other, and act together in this community. To this end we have included timely resources in our HM20 virtual offering on these topics.

This year has been a big transition year. Not only did 2020 usher in a new decade, along with COVID-19 and our double pandemic, SHM has also had important transitions within its senior leadership. We say farewell to Larry Wellikson, MD, who has been at the helm of SHM since the beginning. On behalf of this annual conference, we want to celebrate and thank you, Larry, for your years of dedication and service to SHM. You have taken the specialty of hospital medicine and created a movement in SHM, where the entire hospital medicine team may gather under a bigger tent for education, community, and for the betterment of care for our patients.

We extend a welcome to Eric Howell, MD, who succeeds Dr. Wellikson as SHM’s CEO. We also welcome Danielle Scheurer, MD, as the new SHM president, succeeding the great leadership offered this past year by Christopher Frost, MD. In addition, Jerome C. Siy, MD, was voted president-elect, Dr. Rachel Thompson, MD, was elected treasurer, Kris Rehm, MD, was voted secretary, and Darlene Tad-y, MD, was elected to the board of directors. We welcome these new officers.

HM20 Virtual will consist of prerecorded on-demand sessions that can be viewed at your convenience as well as live Q&A and attendee networking that will take place during specific dates/times. A few of the top-rated sessions from our historically popular tracks include: Update in Clinical Practice Guidelines, Antibiotics Made Ridiculously Simple, Getting to Know Oncology Emergencies, Inpatient Pain Management in the Era of the Opioid Epidemic, Updates in Heart Failure, and Hyponatremia: Don’t Drink the Water. Additionally, we have some of our perennial favorites including the Update in Hospital Medicine and Top Pediatric Articles of 2019. There will be COVID-19 specific content from expertise throughout the nation focusing on care pathways, clinical updates, telemedicine, point-of-care ultrasound, and more! To view the HM20 Virtual Opening Session and discover what you can expect in this educational experience, click here.

The Journal of Hospital Medicine has had a large presence in our meetings for many years. We are grateful for Samir Shah, MD, and his leadership during this double pandemic, for identifying areas where we can advance the field responsibly in the face of relatively limited evidence, and rapidly evolving news. As part of his commitment, all JHM articles related to COVID-19 and published during the pandemic are open access. A pre-COVID goal that has been realized during the pandemic was to bring more of the journal into our annual conference and the conference contents into the journal. We are proud to say this has been a great collaboration, particularly during this pandemic, and much thanks to Dr. Shah’s leadership for highlighting timely pieces. Kimberly Manning, MD, had an especially powerful piece on the topic of racism and our double pandemic, and she is a featured speaker during our HM20 Virtual offering, under the same title as her article: “When Grief and Crises Intersect: Perspectives of a Black Physician in the Time of Two Pandemics.” Additionally, Manpreet Malik, MD, and I will be copresenting on a timely topic about the “Immigrant Hospitalist during COVID-19.”

Aside from these sessions for HM20 Virtual, the real can’t miss(es) for the conference are the Research, Innovations, and Clinical Vignette (RIV) posters sessions. I am grateful for the leadership of Stephanie Mueller, MD, who served as chair for this year’s RIV. This unique year has led to the hosting of a virtual poster competition with judging and the opening of a virtual gallery. We are so pleased to be able to share and highlight the work of many of learners and staff hospitalists! I love that a hospitalist on one side of the country can help provide pearls on a case, an innovation, or a research idea that can help improve diagnosis for a patient at the other side of the country. Keep an eye on SHM’s social media and the presentation by Dr. Mueller for announcements of the winners.

A favorite reason many of us attend the annual conference is for the people and community. We wanted to keep this value as we shifted to a virtual offering. Networking will occur through a variety of offerings including Simulive sessions and Special Interest Forums. Simulive sessions will run for 3 weeks from August 11 to August 27. For those of you new to the term, Simulive may sound like a made-up word, but it is an actual amalgamation of a prerecorded webinar and a live interaction (simulated + live = Simulive). Simulive allows the faculty to sit in on their prerecorded session and interact with the audience via the chat feature during the live scheduled recording and spend time afterwards for a live Q&A from the audience.

There will also be over 20 Special Interest Forums hosted in the evenings after these Simulive sessions have concluded to give you a chance to connect with individuals, share experiences, and have meaningful discussions that can directly impact your practice. Samples of the forums include: Diversity and Inclusion, Rural Hospital Medicine, Pediatrics, NP/PA, Perioperative and Comanagement, Health Information Technology, and Point of Care Ultrasound! Take a look at the HM20 registration page for further information. You will receive direct information on how to attend. We encourage you to join!

HM20 also features a virtual 5K! Whether you run on a treadmill or jog in your neighborhood or local park, you can participate in HM20’s Virtual Fun Run or Walk. To participate, simply run your 5K during the weeks of HM20 Virtual and when you’re done, fill out our form to log your time. We encourage you to post a picture on social media as well with #HM20Virtual. You’ll also receive a certificate of completion at the close of HM20 Virtual.

All HM20 Virtual sessions will be available as on-demand after August 31. HM20 virtual offers more than 60 CME hours and over 35 MOC hours that you can claim at your convenience! That’s the most amount of CME and MOC ever offered at SHM for an event! This conference would not be possible without the tireless and relentless effort of SHM staff and leadership, our terrific speakers and faculty, and all the volunteer committee members of SHM. A huge thanks to the Annual Conference Committee who had the charge to develop the content for the Annual Conference, including topics, speakers, and learning objectives. I am grateful to have had the opportunity to serve on this committee for the past 7 years and to lead HM20 this year. Thanks to Brittany Evans, Hayleigh Lawrence, and Michelle Kann for their valued support this past year from an SHM staff perspective; to my assistant course director, Dan Steinberg, MD; and to the immediate past course director, Dustin Smith, MD, for their support.

Once again, we are excited to have you join, and we hope this conference elevates your education in hospital medicine, advances your career, stimulates innovative thinking, and provides you with enduring networking opportunities. We sincerely thank you for attending HM20 Virtual. Welcome!

Dr. Mathews is chief of hospital medicine at Regions Hospital, HealthPartners in St. Paul, Minn., an associate professor at the University of Minnesota, Minneapolis, and course director of HM20.

Welcome to the HM20 virtual conference! We’re glad to have you join us to virtually experience sessions from our most popular SHM annual conference tracks including Rapid Fire, Clinical Updates, and High-Value Care! We also have added some new timely topics given our current times that you won’t want to miss. We encourage you to engage with the larger community via social media at #HM20Virtual.

HM20 in San Diego, scheduled originally for April 2020, was trending to be the highest in-person attended SHM annual conference with a fantastic line-up of offerings. Unfortunately, then came our pandemic, or pandemics. In mid-March, the Society of Hospital Medicine board of directors concluded that it was impossible for SHM to move forward with Hospital Medicine 2020 in San Diego because of the continued spread of COVID-19. Canceling the in-person conference during this unprecedented time was the right thing to do. I have valued the SHM leadership team and the larger SHM community for their support in being even more engaged on the front lines and with each other across our world during this time.

The COVID-19 pandemic has created a systemic challenge for health care systems across the nation. As hospitalists continue to be on the front lines of care and also innovations, organizations have leveraged telemedicine to support their patients, protect their clinicians, and conserve scarce resources. It is hospital medicine that has been on the front lines of change and adaptations and have led in this pandemic in many organizations across the nation and the world.

Unfortunately, known health disparities have also been amplified and there came an acute worsening of the chronic issues in this nation. On March 13, 2020, 26-year-old Breonna Taylor was shot after police forcibly entered her home. Armaud Arbery was shot and killed by armed neighbors while running through a neighborhood in Brunswick, Ga. Then on May 25, 5 miles from where I call home here in the Twin Cities in Minnesota, George Floyd, a 46-year-old father arrested for suspected use of a counterfeit $20 bill, died after police kneeled on his neck for over 8 minutes. This pandemic has also shaken up the status quo and laid bare a lot of our country’s long and deep-seated issues – from massive economic inequities to ongoing racial disparities to immigration concerns. It’s woken a lot of our valued hospitalists to the fact that the old ways of doing things just don’t work.

I’m grateful our society has taken steps to speak into these timely topics, and to share via publications, Twitter chats, advocacy items, and more! I want to encourage all of us to use the immense network of our hospitalist communities to comfort each other, learn, grow, and engage. We have not achieved big changes by ourselves. We’ve created valued offerings and innovative changes, and we’ve led on the front lines, in policies and procedures, by doing it together. Meaningful change requires allies in a common cause. We stand with our black and brown brothers and sisters who are particularly attuned to injustice, inequality, and struggle. We in hospital medicine stand up with many others who are struggling, our African American, Latin American, Native American, immigrant, LGBTQ+ communities. This intersection of the crisis of the COVID-19 pandemic and the racism pandemic have led us to a pivotal point in the arc of change and justice. I invite you to comfort each other, learn from each other, and act together in this community. To this end we have included timely resources in our HM20 virtual offering on these topics.

This year has been a big transition year. Not only did 2020 usher in a new decade, along with COVID-19 and our double pandemic, SHM has also had important transitions within its senior leadership. We say farewell to Larry Wellikson, MD, who has been at the helm of SHM since the beginning. On behalf of this annual conference, we want to celebrate and thank you, Larry, for your years of dedication and service to SHM. You have taken the specialty of hospital medicine and created a movement in SHM, where the entire hospital medicine team may gather under a bigger tent for education, community, and for the betterment of care for our patients.

We extend a welcome to Eric Howell, MD, who succeeds Dr. Wellikson as SHM’s CEO. We also welcome Danielle Scheurer, MD, as the new SHM president, succeeding the great leadership offered this past year by Christopher Frost, MD. In addition, Jerome C. Siy, MD, was voted president-elect, Dr. Rachel Thompson, MD, was elected treasurer, Kris Rehm, MD, was voted secretary, and Darlene Tad-y, MD, was elected to the board of directors. We welcome these new officers.

HM20 Virtual will consist of prerecorded on-demand sessions that can be viewed at your convenience as well as live Q&A and attendee networking that will take place during specific dates/times. A few of the top-rated sessions from our historically popular tracks include: Update in Clinical Practice Guidelines, Antibiotics Made Ridiculously Simple, Getting to Know Oncology Emergencies, Inpatient Pain Management in the Era of the Opioid Epidemic, Updates in Heart Failure, and Hyponatremia: Don’t Drink the Water. Additionally, we have some of our perennial favorites including the Update in Hospital Medicine and Top Pediatric Articles of 2019. There will be COVID-19 specific content from expertise throughout the nation focusing on care pathways, clinical updates, telemedicine, point-of-care ultrasound, and more! To view the HM20 Virtual Opening Session and discover what you can expect in this educational experience, click here.

The Journal of Hospital Medicine has had a large presence in our meetings for many years. We are grateful for Samir Shah, MD, and his leadership during this double pandemic, for identifying areas where we can advance the field responsibly in the face of relatively limited evidence, and rapidly evolving news. As part of his commitment, all JHM articles related to COVID-19 and published during the pandemic are open access. A pre-COVID goal that has been realized during the pandemic was to bring more of the journal into our annual conference and the conference contents into the journal. We are proud to say this has been a great collaboration, particularly during this pandemic, and much thanks to Dr. Shah’s leadership for highlighting timely pieces. Kimberly Manning, MD, had an especially powerful piece on the topic of racism and our double pandemic, and she is a featured speaker during our HM20 Virtual offering, under the same title as her article: “When Grief and Crises Intersect: Perspectives of a Black Physician in the Time of Two Pandemics.” Additionally, Manpreet Malik, MD, and I will be copresenting on a timely topic about the “Immigrant Hospitalist during COVID-19.”

Aside from these sessions for HM20 Virtual, the real can’t miss(es) for the conference are the Research, Innovations, and Clinical Vignette (RIV) posters sessions. I am grateful for the leadership of Stephanie Mueller, MD, who served as chair for this year’s RIV. This unique year has led to the hosting of a virtual poster competition with judging and the opening of a virtual gallery. We are so pleased to be able to share and highlight the work of many of learners and staff hospitalists! I love that a hospitalist on one side of the country can help provide pearls on a case, an innovation, or a research idea that can help improve diagnosis for a patient at the other side of the country. Keep an eye on SHM’s social media and the presentation by Dr. Mueller for announcements of the winners.

A favorite reason many of us attend the annual conference is for the people and community. We wanted to keep this value as we shifted to a virtual offering. Networking will occur through a variety of offerings including Simulive sessions and Special Interest Forums. Simulive sessions will run for 3 weeks from August 11 to August 27. For those of you new to the term, Simulive may sound like a made-up word, but it is an actual amalgamation of a prerecorded webinar and a live interaction (simulated + live = Simulive). Simulive allows the faculty to sit in on their prerecorded session and interact with the audience via the chat feature during the live scheduled recording and spend time afterwards for a live Q&A from the audience.

There will also be over 20 Special Interest Forums hosted in the evenings after these Simulive sessions have concluded to give you a chance to connect with individuals, share experiences, and have meaningful discussions that can directly impact your practice. Samples of the forums include: Diversity and Inclusion, Rural Hospital Medicine, Pediatrics, NP/PA, Perioperative and Comanagement, Health Information Technology, and Point of Care Ultrasound! Take a look at the HM20 registration page for further information. You will receive direct information on how to attend. We encourage you to join!

HM20 also features a virtual 5K! Whether you run on a treadmill or jog in your neighborhood or local park, you can participate in HM20’s Virtual Fun Run or Walk. To participate, simply run your 5K during the weeks of HM20 Virtual and when you’re done, fill out our form to log your time. We encourage you to post a picture on social media as well with #HM20Virtual. You’ll also receive a certificate of completion at the close of HM20 Virtual.

All HM20 Virtual sessions will be available as on-demand after August 31. HM20 virtual offers more than 60 CME hours and over 35 MOC hours that you can claim at your convenience! That’s the most amount of CME and MOC ever offered at SHM for an event! This conference would not be possible without the tireless and relentless effort of SHM staff and leadership, our terrific speakers and faculty, and all the volunteer committee members of SHM. A huge thanks to the Annual Conference Committee who had the charge to develop the content for the Annual Conference, including topics, speakers, and learning objectives. I am grateful to have had the opportunity to serve on this committee for the past 7 years and to lead HM20 this year. Thanks to Brittany Evans, Hayleigh Lawrence, and Michelle Kann for their valued support this past year from an SHM staff perspective; to my assistant course director, Dan Steinberg, MD; and to the immediate past course director, Dustin Smith, MD, for their support.

Once again, we are excited to have you join, and we hope this conference elevates your education in hospital medicine, advances your career, stimulates innovative thinking, and provides you with enduring networking opportunities. We sincerely thank you for attending HM20 Virtual. Welcome!

Dr. Mathews is chief of hospital medicine at Regions Hospital, HealthPartners in St. Paul, Minn., an associate professor at the University of Minnesota, Minneapolis, and course director of HM20.

Evidence for a link between cannabis use and cardiovascular health remains unsupported, and the potential risks outweigh any potential benefits, according to a scientific statement from the American Heart Association.

American Heart Association

The increased legalization of cannabis and cannabis products in the United States has driven medical professionals to evaluate the safety and efficacy of cannabis in relation to health conditions, wrote Robert L. Page II, PharmD, of the University of Colorado, Aurora, and colleagues.

In a statement published in Circulation, the researchers noted that although cannabis has been shown to relieve pain and other symptoms in certain conditions, clinicians in the United States have been limited from studying its health effects because of federal law restrictions. “Cannabis remains a schedule I controlled substance, deeming no accepted medical use, a high potential for abuse, and an unacceptable safety profile,” the researchers wrote.

The statement addresses issues with the use of cannabis by individuals with cardiovascular disease or those at increased risk. Observational studies have shown no cardiovascular benefits associated with cannabis, the writers noted. The most common chemicals in cannabis include THC (tetrahydrocannabinolic acid) and CBD (cannabidiol).

Some research has shown associations between CBD cardiovascular features including lower blood pressure and reduced inflammation, the writers noted. However, THC, the component of cannabis associated with a “high” or intoxication, has been associated with heart rhythm abnormalities. The writers cited data suggesting an increased risk of heart attacks, atrial fibrillation and heart failure, although more research is needed.

The statement outlines common cannabis formulations including plant-based, extracts, crystalline forms, edible products, and tinctures. In addition, the statement notes that synthetic cannabis products are marketed and used in the United States without subject to regulation.

“Over the past 5 years, we have seen a surge in cannabis use, particularly during the COVID-19 pandemic here in Colorado, especially among adolescents and young adults,” Dr. Page said in an interview. Because of the surge, health care practitioners need to familiarize themselves with not only the benefits, but risks associated with cannabis use regardless of the formulation,” he said. As heart disease remains a leading cause of death in the United States, understanding the cardiovascular risks associated with cannabis is crucial at this time.

Dr. Page noted that popular attitudes about cannabis could pose risks to users’ cardiovascular health. “One leading misconception about cannabis is because it is ‘natural’ it must be safe,” Dr. Page said. “As with all medications, cannabis has side effects, some of which can be cardiovascular in nature,” he said. “Significant drug-drug interactions can occur as CBD and THC, both found in cannabis, inhibit CYP3A4, which metabolizes a large number of medications used to treat many cardiovascular conditions,” he noted.

“Unfortunately, much of the published data is observational in nature due to the federal restrictions on cannabis as a schedule I drug,” said Dr. Page. “Nonetheless, safety signals have emerged regarding cannabis use and adverse cardiovascular outcomes, including myocardial infarction, heart failure, and atrial fibrillation. Carefully designed prospective short- and long-term studies regarding cannabis use and cardiovascular safety are needed,” he emphasized.

Areas in particular need of additional research include the cardiovascular effects of cannabis in several vulnerable populations such as adolescents, older adults, pregnant women, transplant recipients, and those with underlying cardiovascular disease, said Dr. Page.

“Nonetheless, based on the safety signals described within this Clinical Science Statement, an open discussion regarding the risks of using cannabis needs to occur between patient and health care providers,” he said. “Furthermore, patients must be transparent regarding their cannabis use with their cardiologist and primary care provider. The cannabis story will continue to evolve and is a rapidly moving/changing target,” he said.

“Whether cannabis use is a definitive risk factor for cardiovascular disease as with tobacco use is still unknown, and both acute and long-term studies are desperately needed to address this issue,” he said.

Dr. Page had no relevant financial conflicts to disclose.

SOURCE: Page et al. Circulation. 2020 Aug 5. doi: 10.1161/CIR.0000000000000883.

Evidence for a link between cannabis use and cardiovascular health remains unsupported, and the potential risks outweigh any potential benefits, according to a scientific statement from the American Heart Association.

American Heart Association

The increased legalization of cannabis and cannabis products in the United States has driven medical professionals to evaluate the safety and efficacy of cannabis in relation to health conditions, wrote Robert L. Page II, PharmD, of the University of Colorado, Aurora, and colleagues.

In a statement published in Circulation, the researchers noted that although cannabis has been shown to relieve pain and other symptoms in certain conditions, clinicians in the United States have been limited from studying its health effects because of federal law restrictions. “Cannabis remains a schedule I controlled substance, deeming no accepted medical use, a high potential for abuse, and an unacceptable safety profile,” the researchers wrote.

The statement addresses issues with the use of cannabis by individuals with cardiovascular disease or those at increased risk. Observational studies have shown no cardiovascular benefits associated with cannabis, the writers noted. The most common chemicals in cannabis include THC (tetrahydrocannabinolic acid) and CBD (cannabidiol).

Some research has shown associations between CBD cardiovascular features including lower blood pressure and reduced inflammation, the writers noted. However, THC, the component of cannabis associated with a “high” or intoxication, has been associated with heart rhythm abnormalities. The writers cited data suggesting an increased risk of heart attacks, atrial fibrillation and heart failure, although more research is needed.

The statement outlines common cannabis formulations including plant-based, extracts, crystalline forms, edible products, and tinctures. In addition, the statement notes that synthetic cannabis products are marketed and used in the United States without subject to regulation.

“Over the past 5 years, we have seen a surge in cannabis use, particularly during the COVID-19 pandemic here in Colorado, especially among adolescents and young adults,” Dr. Page said in an interview. Because of the surge, health care practitioners need to familiarize themselves with not only the benefits, but risks associated with cannabis use regardless of the formulation,” he said. As heart disease remains a leading cause of death in the United States, understanding the cardiovascular risks associated with cannabis is crucial at this time.

Dr. Page noted that popular attitudes about cannabis could pose risks to users’ cardiovascular health. “One leading misconception about cannabis is because it is ‘natural’ it must be safe,” Dr. Page said. “As with all medications, cannabis has side effects, some of which can be cardiovascular in nature,” he said. “Significant drug-drug interactions can occur as CBD and THC, both found in cannabis, inhibit CYP3A4, which metabolizes a large number of medications used to treat many cardiovascular conditions,” he noted.

“Unfortunately, much of the published data is observational in nature due to the federal restrictions on cannabis as a schedule I drug,” said Dr. Page. “Nonetheless, safety signals have emerged regarding cannabis use and adverse cardiovascular outcomes, including myocardial infarction, heart failure, and atrial fibrillation. Carefully designed prospective short- and long-term studies regarding cannabis use and cardiovascular safety are needed,” he emphasized.

Areas in particular need of additional research include the cardiovascular effects of cannabis in several vulnerable populations such as adolescents, older adults, pregnant women, transplant recipients, and those with underlying cardiovascular disease, said Dr. Page.

“Nonetheless, based on the safety signals described within this Clinical Science Statement, an open discussion regarding the risks of using cannabis needs to occur between patient and health care providers,” he said. “Furthermore, patients must be transparent regarding their cannabis use with their cardiologist and primary care provider. The cannabis story will continue to evolve and is a rapidly moving/changing target,” he said.

“Whether cannabis use is a definitive risk factor for cardiovascular disease as with tobacco use is still unknown, and both acute and long-term studies are desperately needed to address this issue,” he said.

Dr. Page had no relevant financial conflicts to disclose.

SOURCE: Page et al. Circulation. 2020 Aug 5. doi: 10.1161/CIR.0000000000000883.

Evidence for a link between cannabis use and cardiovascular health remains unsupported, and the potential risks outweigh any potential benefits, according to a scientific statement from the American Heart Association.

American Heart Association

The increased legalization of cannabis and cannabis products in the United States has driven medical professionals to evaluate the safety and efficacy of cannabis in relation to health conditions, wrote Robert L. Page II, PharmD, of the University of Colorado, Aurora, and colleagues.

In a statement published in Circulation, the researchers noted that although cannabis has been shown to relieve pain and other symptoms in certain conditions, clinicians in the United States have been limited from studying its health effects because of federal law restrictions. “Cannabis remains a schedule I controlled substance, deeming no accepted medical use, a high potential for abuse, and an unacceptable safety profile,” the researchers wrote.

The statement addresses issues with the use of cannabis by individuals with cardiovascular disease or those at increased risk. Observational studies have shown no cardiovascular benefits associated with cannabis, the writers noted. The most common chemicals in cannabis include THC (tetrahydrocannabinolic acid) and CBD (cannabidiol).

Some research has shown associations between CBD cardiovascular features including lower blood pressure and reduced inflammation, the writers noted. However, THC, the component of cannabis associated with a “high” or intoxication, has been associated with heart rhythm abnormalities. The writers cited data suggesting an increased risk of heart attacks, atrial fibrillation and heart failure, although more research is needed.

The statement outlines common cannabis formulations including plant-based, extracts, crystalline forms, edible products, and tinctures. In addition, the statement notes that synthetic cannabis products are marketed and used in the United States without subject to regulation.

“Over the past 5 years, we have seen a surge in cannabis use, particularly during the COVID-19 pandemic here in Colorado, especially among adolescents and young adults,” Dr. Page said in an interview. Because of the surge, health care practitioners need to familiarize themselves with not only the benefits, but risks associated with cannabis use regardless of the formulation,” he said. As heart disease remains a leading cause of death in the United States, understanding the cardiovascular risks associated with cannabis is crucial at this time.

Dr. Page noted that popular attitudes about cannabis could pose risks to users’ cardiovascular health. “One leading misconception about cannabis is because it is ‘natural’ it must be safe,” Dr. Page said. “As with all medications, cannabis has side effects, some of which can be cardiovascular in nature,” he said. “Significant drug-drug interactions can occur as CBD and THC, both found in cannabis, inhibit CYP3A4, which metabolizes a large number of medications used to treat many cardiovascular conditions,” he noted.

“Unfortunately, much of the published data is observational in nature due to the federal restrictions on cannabis as a schedule I drug,” said Dr. Page. “Nonetheless, safety signals have emerged regarding cannabis use and adverse cardiovascular outcomes, including myocardial infarction, heart failure, and atrial fibrillation. Carefully designed prospective short- and long-term studies regarding cannabis use and cardiovascular safety are needed,” he emphasized.

Areas in particular need of additional research include the cardiovascular effects of cannabis in several vulnerable populations such as adolescents, older adults, pregnant women, transplant recipients, and those with underlying cardiovascular disease, said Dr. Page.

“Nonetheless, based on the safety signals described within this Clinical Science Statement, an open discussion regarding the risks of using cannabis needs to occur between patient and health care providers,” he said. “Furthermore, patients must be transparent regarding their cannabis use with their cardiologist and primary care provider. The cannabis story will continue to evolve and is a rapidly moving/changing target,” he said.

“Whether cannabis use is a definitive risk factor for cardiovascular disease as with tobacco use is still unknown, and both acute and long-term studies are desperately needed to address this issue,” he said.

Dr. Page had no relevant financial conflicts to disclose.

SOURCE: Page et al. Circulation. 2020 Aug 5. doi: 10.1161/CIR.0000000000000883.

Background: An estimated 600,000 patients in U.S. hospitals had an order placed in their record that was meant for another patient in 2016. The Office of the National Coordinator for Health Information Technology and the Joint Commission recommend that EHRs limit the number of open records to one at a time based on expert opinion only. There is wide variation in the number of open records allowed among EHRs across the United States currently.

Despite the ability to have up to four open records at one time in the unrestricted group, 66% of the order sessions were completed with only one record open in that group. This limited the power of the study to detect a difference in risk of order errors between the restricted and unrestricted groups.

Bottom line: Limiting clinicians to only one open record did not reduce the proportion of wrong-patient orders, compared with allowing up to four open records concurrently.

Citation: Adelman JS et al. Effect of restriction of the number of concurrently open records in an electronic health record on wrong-patient order errors: A randomized clinical trial. JAMA. 2019;32(18):1780-7.

Dr. Field is a hospitalist at Ochsner Health System, New Orleans.

Background: An estimated 600,000 patients in U.S. hospitals had an order placed in their record that was meant for another patient in 2016. The Office of the National Coordinator for Health Information Technology and the Joint Commission recommend that EHRs limit the number of open records to one at a time based on expert opinion only. There is wide variation in the number of open records allowed among EHRs across the United States currently.

Despite the ability to have up to four open records at one time in the unrestricted group, 66% of the order sessions were completed with only one record open in that group. This limited the power of the study to detect a difference in risk of order errors between the restricted and unrestricted groups.

Bottom line: Limiting clinicians to only one open record did not reduce the proportion of wrong-patient orders, compared with allowing up to four open records concurrently.

Citation: Adelman JS et al. Effect of restriction of the number of concurrently open records in an electronic health record on wrong-patient order errors: A randomized clinical trial. JAMA. 2019;32(18):1780-7.

Dr. Field is a hospitalist at Ochsner Health System, New Orleans.

Background: An estimated 600,000 patients in U.S. hospitals had an order placed in their record that was meant for another patient in 2016. The Office of the National Coordinator for Health Information Technology and the Joint Commission recommend that EHRs limit the number of open records to one at a time based on expert opinion only. There is wide variation in the number of open records allowed among EHRs across the United States currently.

Despite the ability to have up to four open records at one time in the unrestricted group, 66% of the order sessions were completed with only one record open in that group. This limited the power of the study to detect a difference in risk of order errors between the restricted and unrestricted groups.

Bottom line: Limiting clinicians to only one open record did not reduce the proportion of wrong-patient orders, compared with allowing up to four open records concurrently.

Citation: Adelman JS et al. Effect of restriction of the number of concurrently open records in an electronic health record on wrong-patient order errors: A randomized clinical trial. JAMA. 2019;32(18):1780-7.

Dr. Field is a hospitalist at Ochsner Health System, New Orleans.

Safe and effective new prescription topical therapies for primary axillary hyperhidrosis took a giant step closer to reaching clinical practice following positive reports from two phase 3, randomized, controlled trials of novel agents presented at the virtual annual meeting of the American Academy of Dermatology.

simarik/iStock/Getty Images

Both investigational topical anticholinergic agents – 5% sofpironium bromide (SPB) gel and 1% glycopyrronium bromide (GPB) cream – met all of the efficacy and safety endpoints required by the Food and Drug Administration.

Primary axillary hyperhidrosis, or symmetrical bilateral excessive armpit sweating, has a prevalence worldwide of 1%-16%, with 5%-6% the most frequently cited numbers. The condition has a strong adverse impact on quality of life. Primary axillary hyperhidrosis is not caused by a disorder of the sweat glands; rather, it’s actually a dysregulation of the autonomic nervous system leading to disproportionate sweating, explained Christoph Abels, MD, PhD, medical director at Dr. August Wolff in Bielefeld, Germany.

“What’s surprising is that more than 50% of patients do not receive appropriate treatment, very likely due to lack of awareness or embarrassment,” he added.

Also, many patients are put off by the systemic side effects of the oral anticholinergic agents, which are the current off-label treatment mainstay for patients with moderate or severe disease, according to Tomoko Fujimoto, MD, PhD, director of Ikebukuro Nishiguchi Fukurou Dermatology, near Tokyo.
 

Sofpironium bromide gel

Dr. Fujimoto presented the results of a phase 3, double-blind, multicenter, 6-week, vehicle-controlled clinical trial conducted in 281 Japanese patients with moderate to severe primary axillary hyperhidrosis as defined by a baseline score of 3 or 4 on the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Participants were randomized to self-application of 5% SPB gel or its vehicle once daily before bedtime.

Sofpironium bromide blocks the cholinergic response mediated by the M3 muscarinic receptor subtype expressed on eccrine sweat glands, thereby inhibiting sweating. The drug then undergoes breakdown into an inactive metabolite after reaching the blood.

An important aspect of both SPB gel and GPB cream is that these agents are rolled onto the axillae using a dedicated applicator. Patients never touch the medications with their hands, thus avoiding accidental exposure to the mucous membranes. This largely prevents problems with mydriasis and blurred vision as anticholinergic side effects, which has been an issue with glycopyrronium tosylate topical cloth wipes (Qbrexza), the first FDA-approved treatment for primary axillary hyperhidrosis.

The primary endpoint in the Japanese study was at least a 1-point improvement on the HDSS plus at least a 50% reduction in gravimetric sweat production between baseline and week 6. This composite outcome was achieved in 53.9% of patients in the active treatment arm, compared with 36.4% of controls.

The secondary endpoint consisting of a week-6 HDSS score of 1 or 2 – that is, underarm sweating that’s either never noticeable or is tolerable – occurred in 60.3% of the sofpironium bromide group and 47.9% of controls, a between-group difference that achieved statistical significance by week 2, when the rates were 46.8% and 28.2%.

The reduction in total gravimetric weight of axillary sweat from a mean baseline of 227 mg collected over 5 minutes was also significantly greater in the SPB group: a decrease of 157.6 mg, compared with 127.6 mg in controls; a between-group difference that also was significant by week 2. The mean Dermatology Life Quality Index score dropped by 6.8 points in the active-treatment arm from a baseline of 11.3, a significant improvement over the mean 4.5-point drop in controls.

A new 5-point measure of subjective symptoms of primary axillary hyperhidrosis – the Hyperhidrosis Disease Severity Measure–Axilla (HDSM-Ax) – improved by 1.41 points in the SPB group, significantly better than the 0.93 points in vehicle-treated controls. About 48% of patients on SBP experienced at least a 1.5-point reduction on the HDSM-Ax, compared with 26% of controls.

Regarding safety, there was a 2% incidence of application-site itch or scale in the SBP group. Anticholinergic side effects consisted of a single case of mydriasis, another of constipation, and two complaints of thirst, all mild, none resulting in treatment discontinuation. There were no reports of headache or blurred vision.

“These results indicate that the safety risks of sofpironium bromide can be considered small and controllable,” Dr. Fujimoto said. “Moreover, sofpironium bromide is a topical agent that patients can use by themselves, so it is highly convenient, unlike, say, botulinum toxin type A injections.”

Glycopyrronium bromide cream

Following on the heels of a recently published dose-ranging study (Br J Dermatol. 2020 Jan;182[1]:229-231), Dr. Abels presented the 4-week outcomes of a phase 3a, double-blind, randomized, five-country trial of once-daily 1% GPB cream or placebo in 171 patients with moderate or severe primary axillary hyperhidrosis. A phase 3b, open-label, 72-week, long-term safety trial is ongoing in 516 patients.

The primary endpoint of the 4-week trial was the reduction in gravimetric sweat production from day 1 to day 29. A reduction of 50% or more was documented in 57.5% of the patients on GBP and 34.5% of controls. A 75% or greater reduction occurred in 32.2% of the active-treatment group and 16.7% of those on placebo. And a decrease of at least 90% was seen in 23% of patients on topical GBP, compared with 9.5% of controls. All these between-group differences were significant.

The FDA now requires a quality of life measurement as a coprimary endpoint in phase 3 hyperhidrosis studies, and the phase 3 GBP trial also served as the successful validation study for a new patient-reported quality of life instrument designed specifically for this purpose. The new tool, known as the Hyperhydrosis Quality of Life questionnaire (HidroQol), proved much more sensitive than the HDSS or DLQI for evaluating clinical improvement in response to treatment (Br J Dermatol. 2020 Jun 8. doi: 10.1111/bjd.19300).

Initial results from the long-term phase 3b safety study should be available this fall on the first 100 patients followed on topical GBP for 1 year and for 300 followed for 6 months, Dr. Abels said.

Dr. Fujimoto reported serving as a paid consultant to and speaker for Kaken Pharmaceutical, which is developing SBP gel with Brickell Biotech. Dr. Abels is an employee of the company that is developing GPB cream.

[email protected]

Safe and effective new prescription topical therapies for primary axillary hyperhidrosis took a giant step closer to reaching clinical practice following positive reports from two phase 3, randomized, controlled trials of novel agents presented at the virtual annual meeting of the American Academy of Dermatology.

simarik/iStock/Getty Images

Both investigational topical anticholinergic agents – 5% sofpironium bromide (SPB) gel and 1% glycopyrronium bromide (GPB) cream – met all of the efficacy and safety endpoints required by the Food and Drug Administration.

Primary axillary hyperhidrosis, or symmetrical bilateral excessive armpit sweating, has a prevalence worldwide of 1%-16%, with 5%-6% the most frequently cited numbers. The condition has a strong adverse impact on quality of life. Primary axillary hyperhidrosis is not caused by a disorder of the sweat glands; rather, it’s actually a dysregulation of the autonomic nervous system leading to disproportionate sweating, explained Christoph Abels, MD, PhD, medical director at Dr. August Wolff in Bielefeld, Germany.

“What’s surprising is that more than 50% of patients do not receive appropriate treatment, very likely due to lack of awareness or embarrassment,” he added.

Also, many patients are put off by the systemic side effects of the oral anticholinergic agents, which are the current off-label treatment mainstay for patients with moderate or severe disease, according to Tomoko Fujimoto, MD, PhD, director of Ikebukuro Nishiguchi Fukurou Dermatology, near Tokyo.
 

Sofpironium bromide gel

Dr. Fujimoto presented the results of a phase 3, double-blind, multicenter, 6-week, vehicle-controlled clinical trial conducted in 281 Japanese patients with moderate to severe primary axillary hyperhidrosis as defined by a baseline score of 3 or 4 on the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Participants were randomized to self-application of 5% SPB gel or its vehicle once daily before bedtime.

Sofpironium bromide blocks the cholinergic response mediated by the M3 muscarinic receptor subtype expressed on eccrine sweat glands, thereby inhibiting sweating. The drug then undergoes breakdown into an inactive metabolite after reaching the blood.

An important aspect of both SPB gel and GPB cream is that these agents are rolled onto the axillae using a dedicated applicator. Patients never touch the medications with their hands, thus avoiding accidental exposure to the mucous membranes. This largely prevents problems with mydriasis and blurred vision as anticholinergic side effects, which has been an issue with glycopyrronium tosylate topical cloth wipes (Qbrexza), the first FDA-approved treatment for primary axillary hyperhidrosis.

The primary endpoint in the Japanese study was at least a 1-point improvement on the HDSS plus at least a 50% reduction in gravimetric sweat production between baseline and week 6. This composite outcome was achieved in 53.9% of patients in the active treatment arm, compared with 36.4% of controls.

The secondary endpoint consisting of a week-6 HDSS score of 1 or 2 – that is, underarm sweating that’s either never noticeable or is tolerable – occurred in 60.3% of the sofpironium bromide group and 47.9% of controls, a between-group difference that achieved statistical significance by week 2, when the rates were 46.8% and 28.2%.

The reduction in total gravimetric weight of axillary sweat from a mean baseline of 227 mg collected over 5 minutes was also significantly greater in the SPB group: a decrease of 157.6 mg, compared with 127.6 mg in controls; a between-group difference that also was significant by week 2. The mean Dermatology Life Quality Index score dropped by 6.8 points in the active-treatment arm from a baseline of 11.3, a significant improvement over the mean 4.5-point drop in controls.

A new 5-point measure of subjective symptoms of primary axillary hyperhidrosis – the Hyperhidrosis Disease Severity Measure–Axilla (HDSM-Ax) – improved by 1.41 points in the SPB group, significantly better than the 0.93 points in vehicle-treated controls. About 48% of patients on SBP experienced at least a 1.5-point reduction on the HDSM-Ax, compared with 26% of controls.

Regarding safety, there was a 2% incidence of application-site itch or scale in the SBP group. Anticholinergic side effects consisted of a single case of mydriasis, another of constipation, and two complaints of thirst, all mild, none resulting in treatment discontinuation. There were no reports of headache or blurred vision.

“These results indicate that the safety risks of sofpironium bromide can be considered small and controllable,” Dr. Fujimoto said. “Moreover, sofpironium bromide is a topical agent that patients can use by themselves, so it is highly convenient, unlike, say, botulinum toxin type A injections.”

Glycopyrronium bromide cream

Following on the heels of a recently published dose-ranging study (Br J Dermatol. 2020 Jan;182[1]:229-231), Dr. Abels presented the 4-week outcomes of a phase 3a, double-blind, randomized, five-country trial of once-daily 1% GPB cream or placebo in 171 patients with moderate or severe primary axillary hyperhidrosis. A phase 3b, open-label, 72-week, long-term safety trial is ongoing in 516 patients.

The primary endpoint of the 4-week trial was the reduction in gravimetric sweat production from day 1 to day 29. A reduction of 50% or more was documented in 57.5% of the patients on GBP and 34.5% of controls. A 75% or greater reduction occurred in 32.2% of the active-treatment group and 16.7% of those on placebo. And a decrease of at least 90% was seen in 23% of patients on topical GBP, compared with 9.5% of controls. All these between-group differences were significant.

The FDA now requires a quality of life measurement as a coprimary endpoint in phase 3 hyperhidrosis studies, and the phase 3 GBP trial also served as the successful validation study for a new patient-reported quality of life instrument designed specifically for this purpose. The new tool, known as the Hyperhydrosis Quality of Life questionnaire (HidroQol), proved much more sensitive than the HDSS or DLQI for evaluating clinical improvement in response to treatment (Br J Dermatol. 2020 Jun 8. doi: 10.1111/bjd.19300).

Initial results from the long-term phase 3b safety study should be available this fall on the first 100 patients followed on topical GBP for 1 year and for 300 followed for 6 months, Dr. Abels said.

Dr. Fujimoto reported serving as a paid consultant to and speaker for Kaken Pharmaceutical, which is developing SBP gel with Brickell Biotech. Dr. Abels is an employee of the company that is developing GPB cream.

[email protected]

Safe and effective new prescription topical therapies for primary axillary hyperhidrosis took a giant step closer to reaching clinical practice following positive reports from two phase 3, randomized, controlled trials of novel agents presented at the virtual annual meeting of the American Academy of Dermatology.

simarik/iStock/Getty Images

Both investigational topical anticholinergic agents – 5% sofpironium bromide (SPB) gel and 1% glycopyrronium bromide (GPB) cream – met all of the efficacy and safety endpoints required by the Food and Drug Administration.

Primary axillary hyperhidrosis, or symmetrical bilateral excessive armpit sweating, has a prevalence worldwide of 1%-16%, with 5%-6% the most frequently cited numbers. The condition has a strong adverse impact on quality of life. Primary axillary hyperhidrosis is not caused by a disorder of the sweat glands; rather, it’s actually a dysregulation of the autonomic nervous system leading to disproportionate sweating, explained Christoph Abels, MD, PhD, medical director at Dr. August Wolff in Bielefeld, Germany.

“What’s surprising is that more than 50% of patients do not receive appropriate treatment, very likely due to lack of awareness or embarrassment,” he added.

Also, many patients are put off by the systemic side effects of the oral anticholinergic agents, which are the current off-label treatment mainstay for patients with moderate or severe disease, according to Tomoko Fujimoto, MD, PhD, director of Ikebukuro Nishiguchi Fukurou Dermatology, near Tokyo.
 

Sofpironium bromide gel

Dr. Fujimoto presented the results of a phase 3, double-blind, multicenter, 6-week, vehicle-controlled clinical trial conducted in 281 Japanese patients with moderate to severe primary axillary hyperhidrosis as defined by a baseline score of 3 or 4 on the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Participants were randomized to self-application of 5% SPB gel or its vehicle once daily before bedtime.

Sofpironium bromide blocks the cholinergic response mediated by the M3 muscarinic receptor subtype expressed on eccrine sweat glands, thereby inhibiting sweating. The drug then undergoes breakdown into an inactive metabolite after reaching the blood.

An important aspect of both SPB gel and GPB cream is that these agents are rolled onto the axillae using a dedicated applicator. Patients never touch the medications with their hands, thus avoiding accidental exposure to the mucous membranes. This largely prevents problems with mydriasis and blurred vision as anticholinergic side effects, which has been an issue with glycopyrronium tosylate topical cloth wipes (Qbrexza), the first FDA-approved treatment for primary axillary hyperhidrosis.

The primary endpoint in the Japanese study was at least a 1-point improvement on the HDSS plus at least a 50% reduction in gravimetric sweat production between baseline and week 6. This composite outcome was achieved in 53.9% of patients in the active treatment arm, compared with 36.4% of controls.

The secondary endpoint consisting of a week-6 HDSS score of 1 or 2 – that is, underarm sweating that’s either never noticeable or is tolerable – occurred in 60.3% of the sofpironium bromide group and 47.9% of controls, a between-group difference that achieved statistical significance by week 2, when the rates were 46.8% and 28.2%.

The reduction in total gravimetric weight of axillary sweat from a mean baseline of 227 mg collected over 5 minutes was also significantly greater in the SPB group: a decrease of 157.6 mg, compared with 127.6 mg in controls; a between-group difference that also was significant by week 2. The mean Dermatology Life Quality Index score dropped by 6.8 points in the active-treatment arm from a baseline of 11.3, a significant improvement over the mean 4.5-point drop in controls.

A new 5-point measure of subjective symptoms of primary axillary hyperhidrosis – the Hyperhidrosis Disease Severity Measure–Axilla (HDSM-Ax) – improved by 1.41 points in the SPB group, significantly better than the 0.93 points in vehicle-treated controls. About 48% of patients on SBP experienced at least a 1.5-point reduction on the HDSM-Ax, compared with 26% of controls.

Regarding safety, there was a 2% incidence of application-site itch or scale in the SBP group. Anticholinergic side effects consisted of a single case of mydriasis, another of constipation, and two complaints of thirst, all mild, none resulting in treatment discontinuation. There were no reports of headache or blurred vision.

“These results indicate that the safety risks of sofpironium bromide can be considered small and controllable,” Dr. Fujimoto said. “Moreover, sofpironium bromide is a topical agent that patients can use by themselves, so it is highly convenient, unlike, say, botulinum toxin type A injections.”

Glycopyrronium bromide cream

Following on the heels of a recently published dose-ranging study (Br J Dermatol. 2020 Jan;182[1]:229-231), Dr. Abels presented the 4-week outcomes of a phase 3a, double-blind, randomized, five-country trial of once-daily 1% GPB cream or placebo in 171 patients with moderate or severe primary axillary hyperhidrosis. A phase 3b, open-label, 72-week, long-term safety trial is ongoing in 516 patients.

The primary endpoint of the 4-week trial was the reduction in gravimetric sweat production from day 1 to day 29. A reduction of 50% or more was documented in 57.5% of the patients on GBP and 34.5% of controls. A 75% or greater reduction occurred in 32.2% of the active-treatment group and 16.7% of those on placebo. And a decrease of at least 90% was seen in 23% of patients on topical GBP, compared with 9.5% of controls. All these between-group differences were significant.

The FDA now requires a quality of life measurement as a coprimary endpoint in phase 3 hyperhidrosis studies, and the phase 3 GBP trial also served as the successful validation study for a new patient-reported quality of life instrument designed specifically for this purpose. The new tool, known as the Hyperhydrosis Quality of Life questionnaire (HidroQol), proved much more sensitive than the HDSS or DLQI for evaluating clinical improvement in response to treatment (Br J Dermatol. 2020 Jun 8. doi: 10.1111/bjd.19300).

Initial results from the long-term phase 3b safety study should be available this fall on the first 100 patients followed on topical GBP for 1 year and for 300 followed for 6 months, Dr. Abels said.

Dr. Fujimoto reported serving as a paid consultant to and speaker for Kaken Pharmaceutical, which is developing SBP gel with Brickell Biotech. Dr. Abels is an employee of the company that is developing GPB cream.

[email protected]

The Diagnosis: Kaposi Varicelliform Eruption (Eczema Herpeticum) 

Polymerase chain reaction confirmed presence of herpes simplex virus (HSV) type 1, and the patient was started on intravenous acyclovir (10 mg/kg every 8 hours). Diagnosis was further supported by histopathologic examination with confirmatory immunohistochemistry (Figure 1). The patient's anemia and thrombocytopenia also were attributed to widespread HSV infection. 

Approximately 8 hours after the patient was started on acyclovir, he developed increasing tremors, confusion, and impaired speech. Lumbar puncture confirmed the presence of HSV-1 in the cerebrospinal fluid. Despite ongoing intravenous antiviral therapy, he required intubation 6 days after hospitalization due to impaired mental status and myoclonic jerking. He remained intubated, unresponsive, and in critical condition for 9 days before he gradually began to demonstrate cognitive recovery. He subsequently was weaned off the ventilator, his mental status returned to normal, and his skin rash slowly resolved (Figure 2). 

Hailey-Hailey disease (HHD), also known as familial benign chronic pemphigus, is a rare autosomal-dominant condition first described by Howard and Hugh Hailey in 1939.¹ It is a chronic blistering process characterized by epidermal fragility, often manifesting as macerated fissured erosions in areas exposed to heat and friction (eg, axillae, groin). Hailey-Hailey disease results from a defective calcium transporter (ATP2C1 gene), leading to impaired keratinocyte adhesion.² 

Eczema herpeticum refers to the dissemination of herpes infection to areas of compromised skin barrier. Although originally used to describe HSV infection in patients with atopic dermatitis, eczema herpeticum has been described in various conditions that affect the skin barrier function, including Darier disease, ichthyosis vulgaris, pemphigus foliaceus, pemphigus vulgaris, and mycosis fungoides, among others.³ When applied to skin conditions other than atopic dermatitis, it sometimes is referred to as Kaposi varicelliform eruption.² 

Hailey-Hailey disease commonly is complicated by a bacterial or fungal infection, including impetigo, tinea, or candidiasis. The first case of HHD complicated by HSV infection was reported in 1973.⁴ A PubMed search of articles indexed for MEDLINE using the terms benign familial pemphigus AND herpes, Hailey-Hailey AND herpes, Hailey-Hailey AND eczema herpeticum, Hailey-Hailey AND Kaposi varicelliform eruption, and Hailey-Hailey herpeticum revealed 15 cases of HHD complicated by eczema herpeticum.^4-6 Herpes simplex virus encephalitis is a rare and life-threatening complication of eczema herpeticum.^7,8 We report a case of HSV encephalitis resulting from eczema herpeticum in a patient with HHD.  

The clinical differential includes a flare of the patient's known HHD, secondary bacterial or fungal infection, or a superimposed viral infection (eg, HSV, zoster). Histologic evidence of herpetic infection would be absent in an uncomplicated flare of HHD. Impetigo is a superficial bacterial infection that can present in 2 clinical forms: a vesiculopustular type and less commonly a bullous type. It is caused by Staphylococcus aureus in most cases. In multiple myeloma with cutaneous dissemination, a monoclonal proliferation of plasma cells would be evident. Lastly, tinea corporis is caused by dermatophytes that can be seen on hematoxylin and eosin or periodic acid-Schiff staining.  

The diagnosis of eczema herpeticum in a patient with HHD should be considered in patients who present with grouped vesicles or hemorrhagic or punched-out erosions in areas of pre-existing HHD. The diagnosis can be confirmed by Tzanck smear, viral culture, polymerase chain reaction, or histopathology (with or without immunohistochemistry).^1,2,6 When eczema herpeticum is suspected, prompt antiviral administration is imperative to limit life-threatening systemic spread. 

The Diagnosis: Kaposi Varicelliform Eruption (Eczema Herpeticum) 

Polymerase chain reaction confirmed presence of herpes simplex virus (HSV) type 1, and the patient was started on intravenous acyclovir (10 mg/kg every 8 hours). Diagnosis was further supported by histopathologic examination with confirmatory immunohistochemistry (Figure 1). The patient's anemia and thrombocytopenia also were attributed to widespread HSV infection. 

Approximately 8 hours after the patient was started on acyclovir, he developed increasing tremors, confusion, and impaired speech. Lumbar puncture confirmed the presence of HSV-1 in the cerebrospinal fluid. Despite ongoing intravenous antiviral therapy, he required intubation 6 days after hospitalization due to impaired mental status and myoclonic jerking. He remained intubated, unresponsive, and in critical condition for 9 days before he gradually began to demonstrate cognitive recovery. He subsequently was weaned off the ventilator, his mental status returned to normal, and his skin rash slowly resolved (Figure 2). 

Hailey-Hailey disease (HHD), also known as familial benign chronic pemphigus, is a rare autosomal-dominant condition first described by Howard and Hugh Hailey in 1939.¹ It is a chronic blistering process characterized by epidermal fragility, often manifesting as macerated fissured erosions in areas exposed to heat and friction (eg, axillae, groin). Hailey-Hailey disease results from a defective calcium transporter (ATP2C1 gene), leading to impaired keratinocyte adhesion.² 

Eczema herpeticum refers to the dissemination of herpes infection to areas of compromised skin barrier. Although originally used to describe HSV infection in patients with atopic dermatitis, eczema herpeticum has been described in various conditions that affect the skin barrier function, including Darier disease, ichthyosis vulgaris, pemphigus foliaceus, pemphigus vulgaris, and mycosis fungoides, among others.³ When applied to skin conditions other than atopic dermatitis, it sometimes is referred to as Kaposi varicelliform eruption.² 

Hailey-Hailey disease commonly is complicated by a bacterial or fungal infection, including impetigo, tinea, or candidiasis. The first case of HHD complicated by HSV infection was reported in 1973.⁴ A PubMed search of articles indexed for MEDLINE using the terms benign familial pemphigus AND herpes, Hailey-Hailey AND herpes, Hailey-Hailey AND eczema herpeticum, Hailey-Hailey AND Kaposi varicelliform eruption, and Hailey-Hailey herpeticum revealed 15 cases of HHD complicated by eczema herpeticum.^4-6 Herpes simplex virus encephalitis is a rare and life-threatening complication of eczema herpeticum.^7,8 We report a case of HSV encephalitis resulting from eczema herpeticum in a patient with HHD.  

The clinical differential includes a flare of the patient's known HHD, secondary bacterial or fungal infection, or a superimposed viral infection (eg, HSV, zoster). Histologic evidence of herpetic infection would be absent in an uncomplicated flare of HHD. Impetigo is a superficial bacterial infection that can present in 2 clinical forms: a vesiculopustular type and less commonly a bullous type. It is caused by Staphylococcus aureus in most cases. In multiple myeloma with cutaneous dissemination, a monoclonal proliferation of plasma cells would be evident. Lastly, tinea corporis is caused by dermatophytes that can be seen on hematoxylin and eosin or periodic acid-Schiff staining.  

The diagnosis of eczema herpeticum in a patient with HHD should be considered in patients who present with grouped vesicles or hemorrhagic or punched-out erosions in areas of pre-existing HHD. The diagnosis can be confirmed by Tzanck smear, viral culture, polymerase chain reaction, or histopathology (with or without immunohistochemistry).^1,2,6 When eczema herpeticum is suspected, prompt antiviral administration is imperative to limit life-threatening systemic spread. 

The Diagnosis: Kaposi Varicelliform Eruption (Eczema Herpeticum) 

Polymerase chain reaction confirmed presence of herpes simplex virus (HSV) type 1, and the patient was started on intravenous acyclovir (10 mg/kg every 8 hours). Diagnosis was further supported by histopathologic examination with confirmatory immunohistochemistry (Figure 1). The patient's anemia and thrombocytopenia also were attributed to widespread HSV infection. 

Approximately 8 hours after the patient was started on acyclovir, he developed increasing tremors, confusion, and impaired speech. Lumbar puncture confirmed the presence of HSV-1 in the cerebrospinal fluid. Despite ongoing intravenous antiviral therapy, he required intubation 6 days after hospitalization due to impaired mental status and myoclonic jerking. He remained intubated, unresponsive, and in critical condition for 9 days before he gradually began to demonstrate cognitive recovery. He subsequently was weaned off the ventilator, his mental status returned to normal, and his skin rash slowly resolved (Figure 2). 

Hailey-Hailey disease (HHD), also known as familial benign chronic pemphigus, is a rare autosomal-dominant condition first described by Howard and Hugh Hailey in 1939.¹ It is a chronic blistering process characterized by epidermal fragility, often manifesting as macerated fissured erosions in areas exposed to heat and friction (eg, axillae, groin). Hailey-Hailey disease results from a defective calcium transporter (ATP2C1 gene), leading to impaired keratinocyte adhesion.² 

Eczema herpeticum refers to the dissemination of herpes infection to areas of compromised skin barrier. Although originally used to describe HSV infection in patients with atopic dermatitis, eczema herpeticum has been described in various conditions that affect the skin barrier function, including Darier disease, ichthyosis vulgaris, pemphigus foliaceus, pemphigus vulgaris, and mycosis fungoides, among others.³ When applied to skin conditions other than atopic dermatitis, it sometimes is referred to as Kaposi varicelliform eruption.² 

Hailey-Hailey disease commonly is complicated by a bacterial or fungal infection, including impetigo, tinea, or candidiasis. The first case of HHD complicated by HSV infection was reported in 1973.⁴ A PubMed search of articles indexed for MEDLINE using the terms benign familial pemphigus AND herpes, Hailey-Hailey AND herpes, Hailey-Hailey AND eczema herpeticum, Hailey-Hailey AND Kaposi varicelliform eruption, and Hailey-Hailey herpeticum revealed 15 cases of HHD complicated by eczema herpeticum.^4-6 Herpes simplex virus encephalitis is a rare and life-threatening complication of eczema herpeticum.^7,8 We report a case of HSV encephalitis resulting from eczema herpeticum in a patient with HHD.  

The clinical differential includes a flare of the patient's known HHD, secondary bacterial or fungal infection, or a superimposed viral infection (eg, HSV, zoster). Histologic evidence of herpetic infection would be absent in an uncomplicated flare of HHD. Impetigo is a superficial bacterial infection that can present in 2 clinical forms: a vesiculopustular type and less commonly a bullous type. It is caused by Staphylococcus aureus in most cases. In multiple myeloma with cutaneous dissemination, a monoclonal proliferation of plasma cells would be evident. Lastly, tinea corporis is caused by dermatophytes that can be seen on hematoxylin and eosin or periodic acid-Schiff staining.  

The diagnosis of eczema herpeticum in a patient with HHD should be considered in patients who present with grouped vesicles or hemorrhagic or punched-out erosions in areas of pre-existing HHD. The diagnosis can be confirmed by Tzanck smear, viral culture, polymerase chain reaction, or histopathology (with or without immunohistochemistry).^1,2,6 When eczema herpeticum is suspected, prompt antiviral administration is imperative to limit life-threatening systemic spread. 

A strategy that includes a urine steroid test along with imaging characteristics and tumor size criteria can significantly improve the challenging diagnosis of adrenocortical cancer, helping to avoid unnecessary, and often unsuccessful, further imaging and even surgery, new research shows.

“A triple-test strategy of tumor diameter, imaging characteristics, and urine steroid metabolomics improves detection of adrenocortical carcinoma, which could shorten time to surgery for patients with ... carcinoma and help to avoid unnecessary surgery in patients with benign tumors,” the authors say in research published online July 23 in The Lancet Diabetes & Endocrinology.

The triple-test strategy can be expected to make its way into international guidelines, notes joint lead author Irina Bancos, MD, an associate professor of endocrinology at the Mayo Clinic, Rochester, Minn., in a press statement issued by the University of Birmingham (England), which also had a number of researchers involved in the study.

“The findings of this study will feed into the next international guidelines on the management of adrenal tumors and the implementation of the new test will hopefully improve the overall outlook for patients diagnosed with adrenal tumors,” Dr. Bancos emphasized.

More imaging has led to detection of more adrenal tumors

Advances in CT and MRI imaging have increased the ability to detect adrenal incidentalomas, which are now picked up on about 5% of scans, and the widespread use of imaging has compounded the prevalence of such findings, particularly in older people.

Adrenocortical carcinomas represent only about 2%-12% of adrenal incidentalomas, but the prognosis is very poor, and early detection and surgery can improve outcomes, so findings of any adrenal tumor typically trigger additional multimodal imaging to rule out malignancy.

Evidence is lacking on the accuracy of imaging in determining whether such masses are truly cancerous, or benign, and such procedures add costs, as well as expose patients to radiation that may ultimately have no benefit. However, a previous proof-of-concept study from the same authors did show that the presence of excess adrenal steroid hormones in the urine is a key indicator of adrenal tumors, and other research has supported the findings.

All three tests together give best predictive value: EURINE-ACT

To further validate this work, the authors conducted the EURINE-ACT trial, a prospective 14-center study that is the first of its kind to evaluate the efficacy of a screening strategy for adrenocortical carcinoma that combines urine steroid profiling with tumor size and imaging characteristics.

The study of 2,017 participants with newly diagnosed adrenal masses, recruited from January 2011 to July 2016 from specialist centers in 11 different countries, assessed the diagnostic accuracy of three components: maximum tumor diameter (≥4 cm vs. <4 cm), imaging characteristics (positive vs. negative), and urine steroid metabolomics (low, medium, or high risk of adrenocortical carcinoma), separately and in combination.

Of the patients, 98 (4.9%) had adrenocortical carcinoma confirmed clinically, histopathologically, or biochemically.

Tumors with diameters of 4 cm or larger were identified in 488 patients (24.2%) and were observed in the vast majority of patients with adrenocortical carcinoma (96 of 98), for a positive predictive value (PPV) of 19.7%.

Likewise, the PPV for imaging characteristics was 19.7%. However, increasing the unenhanced CT tumor attenuation threshold to 20 Hounsfield units (HU) from the recommended 10 HU increased specificity for adrenocortical carcinoma (80.0% vs. 64.0%) while maintaining sensitivity (99.0% vs. 100.0%).

Comparatively, a urine steroid metabolomics result suggesting a high risk of adrenocortical carcinoma had a PPV of 34.6%.

A total of 106 patients (5.3%) met the criteria for all three measures, and the PPV for all three was 76.4%.

Using the criteria, 70 patients (3.5%) were classified as being at moderate risk of adrenocortical carcinoma and 1,841 (91.3%) at low risk, for a negative predictive value (NPV) of 99.7%.

“Use of radiation-free, noninvasive urine steroid metabolomics has a higher PPV than two standard imaging tests, and best performance was seen with the combination of all three tests,” the authors state.

Limit urine test to patients with larger tumors

They note that the use of the combined diagnostic strategy would have led to additional imaging in only 488 (24.2%) of the study’s 2,017 patients, compared with the 2,737 scans that were actually conducted before reaching a diagnostic decision.

“Implementation of urine steroid metabolomics in the routine diagnostic assessment of newly discovered adrenal masses could reduce the number of imaging procedures required to diagnose adrenocortical carcinoma and avoid unnecessary surgery of benign adrenal tumors, potentially yielding beneficial effects with respect to patient burden and health care costs,” they stress.

And regarding imaging parameters, “we also showed that using a cutoff of 20 HU for unenhanced CT tumor attenuation increases the accuracy of imaging characteristic assessment for exclusion of adrenocortical carcinoma, compared with the currently recommended cutoff of 10 HU, which has immediate implications for clinical practice,” they emphasize.

In an accompanying editorial, Adina F. Turcu, MD, of the division of metabolism, endocrinology, and diabetes, University of Michigan, Ann Arbor, and Axel K. Walch, MD, of the Helmholtz Zentrum München–German Research Centre for Environmental Health, agree. “The introduction of urine steroid metabolomics into routine clinical practice would provide major advantages,” they state.

However, they point out that, although the overall negative predictive value of the test was excellent, the specificity was weak.

“Thus, urine steroid metabolomics should be limited to patients who have adrenal nodules larger than 4 cm and have qualitative imaging characteristics suggestive of malignancy,” say Dr. Turcu and Dr. Walch.

The EURINE-ACT study results suggest this subgroup would represent roughly only 12% of all patients with adrenal incidentalomas, they add.

Issues that remain to be addressed with regard to the implementation of the screening strategy include how to best respond to patients who are classified as having intermediate or moderate risk of malignancy, and whether the diagnostic value of steroid metabolomics could be refined by adding analytes or parameters, the editorialists conclude.

The study was funded by the European Commission, U.K. Medical Research Council, Wellcome Trust, U.K. National Institute for Health Research, U.S. National Institutes of Health, the Claire Khan Trust Fund at University Hospitals Birmingham Charities, and the Mayo Clinic Foundation for Medical Education and Research.
 

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

A strategy that includes a urine steroid test along with imaging characteristics and tumor size criteria can significantly improve the challenging diagnosis of adrenocortical cancer, helping to avoid unnecessary, and often unsuccessful, further imaging and even surgery, new research shows.

“A triple-test strategy of tumor diameter, imaging characteristics, and urine steroid metabolomics improves detection of adrenocortical carcinoma, which could shorten time to surgery for patients with ... carcinoma and help to avoid unnecessary surgery in patients with benign tumors,” the authors say in research published online July 23 in The Lancet Diabetes & Endocrinology.

The triple-test strategy can be expected to make its way into international guidelines, notes joint lead author Irina Bancos, MD, an associate professor of endocrinology at the Mayo Clinic, Rochester, Minn., in a press statement issued by the University of Birmingham (England), which also had a number of researchers involved in the study.

“The findings of this study will feed into the next international guidelines on the management of adrenal tumors and the implementation of the new test will hopefully improve the overall outlook for patients diagnosed with adrenal tumors,” Dr. Bancos emphasized.

More imaging has led to detection of more adrenal tumors

Advances in CT and MRI imaging have increased the ability to detect adrenal incidentalomas, which are now picked up on about 5% of scans, and the widespread use of imaging has compounded the prevalence of such findings, particularly in older people.

Adrenocortical carcinomas represent only about 2%-12% of adrenal incidentalomas, but the prognosis is very poor, and early detection and surgery can improve outcomes, so findings of any adrenal tumor typically trigger additional multimodal imaging to rule out malignancy.

Evidence is lacking on the accuracy of imaging in determining whether such masses are truly cancerous, or benign, and such procedures add costs, as well as expose patients to radiation that may ultimately have no benefit. However, a previous proof-of-concept study from the same authors did show that the presence of excess adrenal steroid hormones in the urine is a key indicator of adrenal tumors, and other research has supported the findings.

All three tests together give best predictive value: EURINE-ACT

To further validate this work, the authors conducted the EURINE-ACT trial, a prospective 14-center study that is the first of its kind to evaluate the efficacy of a screening strategy for adrenocortical carcinoma that combines urine steroid profiling with tumor size and imaging characteristics.

The study of 2,017 participants with newly diagnosed adrenal masses, recruited from January 2011 to July 2016 from specialist centers in 11 different countries, assessed the diagnostic accuracy of three components: maximum tumor diameter (≥4 cm vs. <4 cm), imaging characteristics (positive vs. negative), and urine steroid metabolomics (low, medium, or high risk of adrenocortical carcinoma), separately and in combination.

Of the patients, 98 (4.9%) had adrenocortical carcinoma confirmed clinically, histopathologically, or biochemically.

Tumors with diameters of 4 cm or larger were identified in 488 patients (24.2%) and were observed in the vast majority of patients with adrenocortical carcinoma (96 of 98), for a positive predictive value (PPV) of 19.7%.

Likewise, the PPV for imaging characteristics was 19.7%. However, increasing the unenhanced CT tumor attenuation threshold to 20 Hounsfield units (HU) from the recommended 10 HU increased specificity for adrenocortical carcinoma (80.0% vs. 64.0%) while maintaining sensitivity (99.0% vs. 100.0%).

Comparatively, a urine steroid metabolomics result suggesting a high risk of adrenocortical carcinoma had a PPV of 34.6%.

A total of 106 patients (5.3%) met the criteria for all three measures, and the PPV for all three was 76.4%.

Using the criteria, 70 patients (3.5%) were classified as being at moderate risk of adrenocortical carcinoma and 1,841 (91.3%) at low risk, for a negative predictive value (NPV) of 99.7%.

“Use of radiation-free, noninvasive urine steroid metabolomics has a higher PPV than two standard imaging tests, and best performance was seen with the combination of all three tests,” the authors state.

Limit urine test to patients with larger tumors

They note that the use of the combined diagnostic strategy would have led to additional imaging in only 488 (24.2%) of the study’s 2,017 patients, compared with the 2,737 scans that were actually conducted before reaching a diagnostic decision.

“Implementation of urine steroid metabolomics in the routine diagnostic assessment of newly discovered adrenal masses could reduce the number of imaging procedures required to diagnose adrenocortical carcinoma and avoid unnecessary surgery of benign adrenal tumors, potentially yielding beneficial effects with respect to patient burden and health care costs,” they stress.

And regarding imaging parameters, “we also showed that using a cutoff of 20 HU for unenhanced CT tumor attenuation increases the accuracy of imaging characteristic assessment for exclusion of adrenocortical carcinoma, compared with the currently recommended cutoff of 10 HU, which has immediate implications for clinical practice,” they emphasize.

In an accompanying editorial, Adina F. Turcu, MD, of the division of metabolism, endocrinology, and diabetes, University of Michigan, Ann Arbor, and Axel K. Walch, MD, of the Helmholtz Zentrum München–German Research Centre for Environmental Health, agree. “The introduction of urine steroid metabolomics into routine clinical practice would provide major advantages,” they state.

However, they point out that, although the overall negative predictive value of the test was excellent, the specificity was weak.

“Thus, urine steroid metabolomics should be limited to patients who have adrenal nodules larger than 4 cm and have qualitative imaging characteristics suggestive of malignancy,” say Dr. Turcu and Dr. Walch.

The EURINE-ACT study results suggest this subgroup would represent roughly only 12% of all patients with adrenal incidentalomas, they add.

Issues that remain to be addressed with regard to the implementation of the screening strategy include how to best respond to patients who are classified as having intermediate or moderate risk of malignancy, and whether the diagnostic value of steroid metabolomics could be refined by adding analytes or parameters, the editorialists conclude.

The study was funded by the European Commission, U.K. Medical Research Council, Wellcome Trust, U.K. National Institute for Health Research, U.S. National Institutes of Health, the Claire Khan Trust Fund at University Hospitals Birmingham Charities, and the Mayo Clinic Foundation for Medical Education and Research.
 

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

A strategy that includes a urine steroid test along with imaging characteristics and tumor size criteria can significantly improve the challenging diagnosis of adrenocortical cancer, helping to avoid unnecessary, and often unsuccessful, further imaging and even surgery, new research shows.

“A triple-test strategy of tumor diameter, imaging characteristics, and urine steroid metabolomics improves detection of adrenocortical carcinoma, which could shorten time to surgery for patients with ... carcinoma and help to avoid unnecessary surgery in patients with benign tumors,” the authors say in research published online July 23 in The Lancet Diabetes & Endocrinology.

The triple-test strategy can be expected to make its way into international guidelines, notes joint lead author Irina Bancos, MD, an associate professor of endocrinology at the Mayo Clinic, Rochester, Minn., in a press statement issued by the University of Birmingham (England), which also had a number of researchers involved in the study.

“The findings of this study will feed into the next international guidelines on the management of adrenal tumors and the implementation of the new test will hopefully improve the overall outlook for patients diagnosed with adrenal tumors,” Dr. Bancos emphasized.

More imaging has led to detection of more adrenal tumors

Advances in CT and MRI imaging have increased the ability to detect adrenal incidentalomas, which are now picked up on about 5% of scans, and the widespread use of imaging has compounded the prevalence of such findings, particularly in older people.

Adrenocortical carcinomas represent only about 2%-12% of adrenal incidentalomas, but the prognosis is very poor, and early detection and surgery can improve outcomes, so findings of any adrenal tumor typically trigger additional multimodal imaging to rule out malignancy.

Evidence is lacking on the accuracy of imaging in determining whether such masses are truly cancerous, or benign, and such procedures add costs, as well as expose patients to radiation that may ultimately have no benefit. However, a previous proof-of-concept study from the same authors did show that the presence of excess adrenal steroid hormones in the urine is a key indicator of adrenal tumors, and other research has supported the findings.

All three tests together give best predictive value: EURINE-ACT

To further validate this work, the authors conducted the EURINE-ACT trial, a prospective 14-center study that is the first of its kind to evaluate the efficacy of a screening strategy for adrenocortical carcinoma that combines urine steroid profiling with tumor size and imaging characteristics.

The study of 2,017 participants with newly diagnosed adrenal masses, recruited from January 2011 to July 2016 from specialist centers in 11 different countries, assessed the diagnostic accuracy of three components: maximum tumor diameter (≥4 cm vs. <4 cm), imaging characteristics (positive vs. negative), and urine steroid metabolomics (low, medium, or high risk of adrenocortical carcinoma), separately and in combination.

Of the patients, 98 (4.9%) had adrenocortical carcinoma confirmed clinically, histopathologically, or biochemically.

Tumors with diameters of 4 cm or larger were identified in 488 patients (24.2%) and were observed in the vast majority of patients with adrenocortical carcinoma (96 of 98), for a positive predictive value (PPV) of 19.7%.

Likewise, the PPV for imaging characteristics was 19.7%. However, increasing the unenhanced CT tumor attenuation threshold to 20 Hounsfield units (HU) from the recommended 10 HU increased specificity for adrenocortical carcinoma (80.0% vs. 64.0%) while maintaining sensitivity (99.0% vs. 100.0%).

Comparatively, a urine steroid metabolomics result suggesting a high risk of adrenocortical carcinoma had a PPV of 34.6%.

A total of 106 patients (5.3%) met the criteria for all three measures, and the PPV for all three was 76.4%.

Using the criteria, 70 patients (3.5%) were classified as being at moderate risk of adrenocortical carcinoma and 1,841 (91.3%) at low risk, for a negative predictive value (NPV) of 99.7%.

“Use of radiation-free, noninvasive urine steroid metabolomics has a higher PPV than two standard imaging tests, and best performance was seen with the combination of all three tests,” the authors state.

Limit urine test to patients with larger tumors

They note that the use of the combined diagnostic strategy would have led to additional imaging in only 488 (24.2%) of the study’s 2,017 patients, compared with the 2,737 scans that were actually conducted before reaching a diagnostic decision.

“Implementation of urine steroid metabolomics in the routine diagnostic assessment of newly discovered adrenal masses could reduce the number of imaging procedures required to diagnose adrenocortical carcinoma and avoid unnecessary surgery of benign adrenal tumors, potentially yielding beneficial effects with respect to patient burden and health care costs,” they stress.

And regarding imaging parameters, “we also showed that using a cutoff of 20 HU for unenhanced CT tumor attenuation increases the accuracy of imaging characteristic assessment for exclusion of adrenocortical carcinoma, compared with the currently recommended cutoff of 10 HU, which has immediate implications for clinical practice,” they emphasize.

In an accompanying editorial, Adina F. Turcu, MD, of the division of metabolism, endocrinology, and diabetes, University of Michigan, Ann Arbor, and Axel K. Walch, MD, of the Helmholtz Zentrum München–German Research Centre for Environmental Health, agree. “The introduction of urine steroid metabolomics into routine clinical practice would provide major advantages,” they state.

However, they point out that, although the overall negative predictive value of the test was excellent, the specificity was weak.

“Thus, urine steroid metabolomics should be limited to patients who have adrenal nodules larger than 4 cm and have qualitative imaging characteristics suggestive of malignancy,” say Dr. Turcu and Dr. Walch.

The EURINE-ACT study results suggest this subgroup would represent roughly only 12% of all patients with adrenal incidentalomas, they add.

Issues that remain to be addressed with regard to the implementation of the screening strategy include how to best respond to patients who are classified as having intermediate or moderate risk of malignancy, and whether the diagnostic value of steroid metabolomics could be refined by adding analytes or parameters, the editorialists conclude.

The study was funded by the European Commission, U.K. Medical Research Council, Wellcome Trust, U.K. National Institute for Health Research, U.S. National Institutes of Health, the Claire Khan Trust Fund at University Hospitals Birmingham Charities, and the Mayo Clinic Foundation for Medical Education and Research.
 

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

The first-in-class drug belantamab mafodotin (Blenrep, GlaxoSmithKline) has been recommended for conditional marketing approval in the European Union (EU) for use in the treatment of relapsed and refractory multiple myeloma in patients who have already tried other therapies.

The product was accepted into the European Medicines Agency (EMA) PRIME program for medicines that have potential to address unmet medical needs, the agency noted.

Belantamab mafodotin was also recently recommended for U.S. approval when a Food and Drug Administration advisory committee voted 12-0 in favor of the drug’s benefits outweighing risks in this patient population.

Specifically, these patients with refractory or relapsed multiple myeloma should have already tried treatment with one of the three major classes of drugs, namely an immunomodulatory agent, a proteasome inhibitor, and a CD-38 monoclonal antibody.

For patients who no longer respond to these drugs, the outlook is bleak, the EMA said. There is an unmet medical need for new treatments that improve survival of these patients beyond the currently observed 3 months or less.

Belantamab mafodotin has a novel mechanism of action: It targets B-cell maturation antigen (BCMA), a protein present on the surface of virtually all multiple myeloma cells, but is absent from normal B-cells, thus “making it an ideal drug target,” the agency remarked.

The product is an antibody–drug conjugate that combines a monoclonal antibody that targets BCMA with the cytotoxic agent maleimidocaproyl monomethylauristatin F (mcMMAF). It homes in on BCMA on myeloma cell surfaces, and once inside the myeloma cell, the cytotoxic agent is released leading to apoptosis, the “programmed” death of the cancerous plasma cells, the agency explained.

Results from open-label study

The recommendation for conditional marketing authorization comes from the EMA Committee for Medicinal Products for Human Use (CHMP) and was based on a phase 2, open-label, randomized, two-arm study, DREAMM-2.

The study investigated the efficacy and safety of two doses of belantamab mafodotin in patients with multiple myeloma who still had active disease after three or more lines of therapy and who no longer responded to treatment with immunomodulatory drugs, proteasome inhibitors, and an anti-CD38 monoclonal antibody.

Six-month results were published in December in The Lancet Oncology. The overall response rate was 31% in the cohort given a 2.5-mg/kg dose of the drug; 30 of 97 patients had outcomes that met the study’s positive threshold.

Another 99 patients in DREAMM-2 received a dose of 3.4 mg/kg, which was judged to have a less favorable safety profile.

The EMA has requested further clinical data, including final results from the phase 2 study, as well as results from a confirmatory phase 3 trial comparing belantamab mafodotin with pomalidomide plus low-dose dexamethasone (a standard treatment option for relapsed and refractory multiple myeloma).

Ocular toxicity

One of the most common side effects of the new drug experienced by participants in clinical trials was keratopathy, which affects the cornea. This ocular toxicity was seen at both drug doses.

The EMA noted that patients taking the drug would need to undergo specific ophthalmic examinations so that any findings can be promptly and adequately managed. As for all medicines, a risk management plan (RMP) will ensure rigorous safety monitoring of the medicine once authorized across the European Union, it added.

At the FDA advisory committee meeting, it was noted that 44% of patients in the group that received the 2.5-mg/kg dose experienced at least one episode of severe keratopathy. In some patients, the ocular side effects caused severe vision loss that interfered with patients’ activities of daily living, such as driving and reading, FDA staff said.

For the United States, the manufacturer proposed a risk evaluation and mitigation strategy (REMS) for the detection and treatment of potential complications of belantamab. This includes recommendations for ophthalmic examinations, including assessment of best corrected visual acuity prior to each treatment cycle and promptly for patients with worsening symptoms.

One of the FDA advisory committee panelists, Gita Thanarajasingam, MD, assistant professor of medicine at the Mayo Clinic, in Rochester, Minn., said belantamab appeared to be well tolerated with the exception of ocular toxicity. Physicians need to acknowledge how severe this risk may be for patients while keeping in mind that belantamab still may be more tolerable for some than current treatments, she said.

“It’s reasonable to leave open the option for decision-making. Patients can express their values and preferences,” Thanarajasingam said. “There’s adequate, albeit not complete, information to guide this risk–benefit discussion in a REMS program.”

Heidi D. Klepin, MD, a professor at Wake Forest University Health Sciences, Winston Salem, N.C., agreed that the informed consent process should allow patients “to choose whether the trade-off is worth it” with belantamab.
 

This article first appeared on Medscape.com.

The first-in-class drug belantamab mafodotin (Blenrep, GlaxoSmithKline) has been recommended for conditional marketing approval in the European Union (EU) for use in the treatment of relapsed and refractory multiple myeloma in patients who have already tried other therapies.

The product was accepted into the European Medicines Agency (EMA) PRIME program for medicines that have potential to address unmet medical needs, the agency noted.

Belantamab mafodotin was also recently recommended for U.S. approval when a Food and Drug Administration advisory committee voted 12-0 in favor of the drug’s benefits outweighing risks in this patient population.

Specifically, these patients with refractory or relapsed multiple myeloma should have already tried treatment with one of the three major classes of drugs, namely an immunomodulatory agent, a proteasome inhibitor, and a CD-38 monoclonal antibody.

For patients who no longer respond to these drugs, the outlook is bleak, the EMA said. There is an unmet medical need for new treatments that improve survival of these patients beyond the currently observed 3 months or less.

Belantamab mafodotin has a novel mechanism of action: It targets B-cell maturation antigen (BCMA), a protein present on the surface of virtually all multiple myeloma cells, but is absent from normal B-cells, thus “making it an ideal drug target,” the agency remarked.

The product is an antibody–drug conjugate that combines a monoclonal antibody that targets BCMA with the cytotoxic agent maleimidocaproyl monomethylauristatin F (mcMMAF). It homes in on BCMA on myeloma cell surfaces, and once inside the myeloma cell, the cytotoxic agent is released leading to apoptosis, the “programmed” death of the cancerous plasma cells, the agency explained.

Results from open-label study

The recommendation for conditional marketing authorization comes from the EMA Committee for Medicinal Products for Human Use (CHMP) and was based on a phase 2, open-label, randomized, two-arm study, DREAMM-2.

The study investigated the efficacy and safety of two doses of belantamab mafodotin in patients with multiple myeloma who still had active disease after three or more lines of therapy and who no longer responded to treatment with immunomodulatory drugs, proteasome inhibitors, and an anti-CD38 monoclonal antibody.

Six-month results were published in December in The Lancet Oncology. The overall response rate was 31% in the cohort given a 2.5-mg/kg dose of the drug; 30 of 97 patients had outcomes that met the study’s positive threshold.

Another 99 patients in DREAMM-2 received a dose of 3.4 mg/kg, which was judged to have a less favorable safety profile.

The EMA has requested further clinical data, including final results from the phase 2 study, as well as results from a confirmatory phase 3 trial comparing belantamab mafodotin with pomalidomide plus low-dose dexamethasone (a standard treatment option for relapsed and refractory multiple myeloma).

Ocular toxicity

One of the most common side effects of the new drug experienced by participants in clinical trials was keratopathy, which affects the cornea. This ocular toxicity was seen at both drug doses.

The EMA noted that patients taking the drug would need to undergo specific ophthalmic examinations so that any findings can be promptly and adequately managed. As for all medicines, a risk management plan (RMP) will ensure rigorous safety monitoring of the medicine once authorized across the European Union, it added.

At the FDA advisory committee meeting, it was noted that 44% of patients in the group that received the 2.5-mg/kg dose experienced at least one episode of severe keratopathy. In some patients, the ocular side effects caused severe vision loss that interfered with patients’ activities of daily living, such as driving and reading, FDA staff said.

For the United States, the manufacturer proposed a risk evaluation and mitigation strategy (REMS) for the detection and treatment of potential complications of belantamab. This includes recommendations for ophthalmic examinations, including assessment of best corrected visual acuity prior to each treatment cycle and promptly for patients with worsening symptoms.

One of the FDA advisory committee panelists, Gita Thanarajasingam, MD, assistant professor of medicine at the Mayo Clinic, in Rochester, Minn., said belantamab appeared to be well tolerated with the exception of ocular toxicity. Physicians need to acknowledge how severe this risk may be for patients while keeping in mind that belantamab still may be more tolerable for some than current treatments, she said.

“It’s reasonable to leave open the option for decision-making. Patients can express their values and preferences,” Thanarajasingam said. “There’s adequate, albeit not complete, information to guide this risk–benefit discussion in a REMS program.”

Heidi D. Klepin, MD, a professor at Wake Forest University Health Sciences, Winston Salem, N.C., agreed that the informed consent process should allow patients “to choose whether the trade-off is worth it” with belantamab.
 

This article first appeared on Medscape.com.

The first-in-class drug belantamab mafodotin (Blenrep, GlaxoSmithKline) has been recommended for conditional marketing approval in the European Union (EU) for use in the treatment of relapsed and refractory multiple myeloma in patients who have already tried other therapies.

The product was accepted into the European Medicines Agency (EMA) PRIME program for medicines that have potential to address unmet medical needs, the agency noted.

Belantamab mafodotin was also recently recommended for U.S. approval when a Food and Drug Administration advisory committee voted 12-0 in favor of the drug’s benefits outweighing risks in this patient population.

Specifically, these patients with refractory or relapsed multiple myeloma should have already tried treatment with one of the three major classes of drugs, namely an immunomodulatory agent, a proteasome inhibitor, and a CD-38 monoclonal antibody.

For patients who no longer respond to these drugs, the outlook is bleak, the EMA said. There is an unmet medical need for new treatments that improve survival of these patients beyond the currently observed 3 months or less.

Belantamab mafodotin has a novel mechanism of action: It targets B-cell maturation antigen (BCMA), a protein present on the surface of virtually all multiple myeloma cells, but is absent from normal B-cells, thus “making it an ideal drug target,” the agency remarked.

The product is an antibody–drug conjugate that combines a monoclonal antibody that targets BCMA with the cytotoxic agent maleimidocaproyl monomethylauristatin F (mcMMAF). It homes in on BCMA on myeloma cell surfaces, and once inside the myeloma cell, the cytotoxic agent is released leading to apoptosis, the “programmed” death of the cancerous plasma cells, the agency explained.

Results from open-label study

The recommendation for conditional marketing authorization comes from the EMA Committee for Medicinal Products for Human Use (CHMP) and was based on a phase 2, open-label, randomized, two-arm study, DREAMM-2.

The study investigated the efficacy and safety of two doses of belantamab mafodotin in patients with multiple myeloma who still had active disease after three or more lines of therapy and who no longer responded to treatment with immunomodulatory drugs, proteasome inhibitors, and an anti-CD38 monoclonal antibody.

Six-month results were published in December in The Lancet Oncology. The overall response rate was 31% in the cohort given a 2.5-mg/kg dose of the drug; 30 of 97 patients had outcomes that met the study’s positive threshold.

Another 99 patients in DREAMM-2 received a dose of 3.4 mg/kg, which was judged to have a less favorable safety profile.

The EMA has requested further clinical data, including final results from the phase 2 study, as well as results from a confirmatory phase 3 trial comparing belantamab mafodotin with pomalidomide plus low-dose dexamethasone (a standard treatment option for relapsed and refractory multiple myeloma).

Ocular toxicity

One of the most common side effects of the new drug experienced by participants in clinical trials was keratopathy, which affects the cornea. This ocular toxicity was seen at both drug doses.

The EMA noted that patients taking the drug would need to undergo specific ophthalmic examinations so that any findings can be promptly and adequately managed. As for all medicines, a risk management plan (RMP) will ensure rigorous safety monitoring of the medicine once authorized across the European Union, it added.

At the FDA advisory committee meeting, it was noted that 44% of patients in the group that received the 2.5-mg/kg dose experienced at least one episode of severe keratopathy. In some patients, the ocular side effects caused severe vision loss that interfered with patients’ activities of daily living, such as driving and reading, FDA staff said.

For the United States, the manufacturer proposed a risk evaluation and mitigation strategy (REMS) for the detection and treatment of potential complications of belantamab. This includes recommendations for ophthalmic examinations, including assessment of best corrected visual acuity prior to each treatment cycle and promptly for patients with worsening symptoms.

One of the FDA advisory committee panelists, Gita Thanarajasingam, MD, assistant professor of medicine at the Mayo Clinic, in Rochester, Minn., said belantamab appeared to be well tolerated with the exception of ocular toxicity. Physicians need to acknowledge how severe this risk may be for patients while keeping in mind that belantamab still may be more tolerable for some than current treatments, she said.

“It’s reasonable to leave open the option for decision-making. Patients can express their values and preferences,” Thanarajasingam said. “There’s adequate, albeit not complete, information to guide this risk–benefit discussion in a REMS program.”

Heidi D. Klepin, MD, a professor at Wake Forest University Health Sciences, Winston Salem, N.C., agreed that the informed consent process should allow patients “to choose whether the trade-off is worth it” with belantamab.
 

This article first appeared on Medscape.com.