It is a great day when a patient shows up at clinical appointment already motivated to make lifestyle behavior changes. Often, they have been inspired by health information they consumed elsewhere, such as from a book, movie, documentary, TV show, a friend, or something out in the community.

Currently, one of the more public representations of health and longevity promotion is Blue Zones. The organization, named for specific areas of the world — the so-called blue zones, where people experience less disease and live longer lives — has created considerable public awareness for healthy living. Today, there are more than 75 Blue Zones Project communities across the United States, where community leaders, businesses, organizations, and citizens collaborate to make healthier choices the easier choices. A recent Netflix special, Live to 100: Secrets of the Blue Zones, further propelled blue zones into the public consciousness.

For clinicians trained in lifestyle medicine, Blue Zones’ consumer awareness is an opportunity. There is considerable crossover between the lifestyle habits advocated by Blue Zones, known as the Power9, and the six pillars of lifestyle medicine. The Blue Zones emphasis on “plant-slant” diet, natural movement, purpose and contribution, downshifting, and family and community intersect with the lifestyle medicine pillars of whole-food, plant-predominant eating patterns, regular physical activity, stress management, restorative sleep, and positive social connections. Both Blue Zones and lifestyle medicine share a goal of creating healthier and stronger individuals and communities.

For those reasons, it made perfect sense that Blue Zones and the American College of Lifestyle Medicine (ACLM) recently announced a partnership to synergize both organizations’ strengths and resources. Among other things, the collaboration will establish a new certification status of Blue Zones–Certified Physician or Blue Zones–Certified Healthcare Professional, available in 2025 exclusively to clinicians who already are or become certified in lifestyle medicine.

Because of Blue Zones’ considerable consumer awareness, physicians and other health professionals who earn the certification will stand out to potential patients as clinicians with the training and knowledge to help them make sustainable lifestyle behavior changes. A challenging part of any clinician’s job is educating and convincing patients on the proven health benefits of lifestyle behavior change within the time restraints of a routine clinical visit. Patients familiar with Blue Zones are more likely to arrive already interested in changing lifestyle behavior, and clinicians should have the skills to help them achieve their goals.

In addition, community infrastructure developed through Blue Zones that supports healthful lifestyle choices is significant for patients. Lack of resources in their home, work, and community environments is a common obstacle that patients cite when discussing lifestyle change with a clinician. Bicycle lanes for commuting, parks with exercise equipment, accessible healthy food options, and community events to facilitate positive social connections enhance lifestyle-medicine prescriptions. Workplaces, restaurants, places of worship, and grocery stores are examples of community stakeholders that collaborate in Blue Zones communities to promote healthy lifestyle decisions. Although lifestyle medicine clinicians can and do identify creative ways to support patients in communities without strong healthy choice infrastructure, the Blue Zones road map is a welcome companion.

The timing is right for this synthesis of Blue Zones and lifestyle medicine. As consumer interest in Blue Zones has risen, so has clinician interest in evidence-based lifestyle medicine. Since certification in lifestyle medicine began in 2017, almost 6700 physicians and other health professionals have become certified worldwide. More than 43,000 health care professionals have registered for ACLM’s complimentary lifestyle and food-as-medicine courses highlighted by the White House Conference on Hunger, Nutrition, and Health. 

What if more patients came to us motivated to make lifestyle changes because of awareness infused in their work and supported in their surrounding community? Matching lifestyle medicine certification with Blue Zone communities equips clinicians to help these patients achieve what they really want: to live longer and better.

Dr. Collings is Director of Lifestyle Medicine, Silicon Valley Medical Development, and Past President, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

It is a great day when a patient shows up at clinical appointment already motivated to make lifestyle behavior changes. Often, they have been inspired by health information they consumed elsewhere, such as from a book, movie, documentary, TV show, a friend, or something out in the community.

Currently, one of the more public representations of health and longevity promotion is Blue Zones. The organization, named for specific areas of the world — the so-called blue zones, where people experience less disease and live longer lives — has created considerable public awareness for healthy living. Today, there are more than 75 Blue Zones Project communities across the United States, where community leaders, businesses, organizations, and citizens collaborate to make healthier choices the easier choices. A recent Netflix special, Live to 100: Secrets of the Blue Zones, further propelled blue zones into the public consciousness.

For clinicians trained in lifestyle medicine, Blue Zones’ consumer awareness is an opportunity. There is considerable crossover between the lifestyle habits advocated by Blue Zones, known as the Power9, and the six pillars of lifestyle medicine. The Blue Zones emphasis on “plant-slant” diet, natural movement, purpose and contribution, downshifting, and family and community intersect with the lifestyle medicine pillars of whole-food, plant-predominant eating patterns, regular physical activity, stress management, restorative sleep, and positive social connections. Both Blue Zones and lifestyle medicine share a goal of creating healthier and stronger individuals and communities.

For those reasons, it made perfect sense that Blue Zones and the American College of Lifestyle Medicine (ACLM) recently announced a partnership to synergize both organizations’ strengths and resources. Among other things, the collaboration will establish a new certification status of Blue Zones–Certified Physician or Blue Zones–Certified Healthcare Professional, available in 2025 exclusively to clinicians who already are or become certified in lifestyle medicine.

Because of Blue Zones’ considerable consumer awareness, physicians and other health professionals who earn the certification will stand out to potential patients as clinicians with the training and knowledge to help them make sustainable lifestyle behavior changes. A challenging part of any clinician’s job is educating and convincing patients on the proven health benefits of lifestyle behavior change within the time restraints of a routine clinical visit. Patients familiar with Blue Zones are more likely to arrive already interested in changing lifestyle behavior, and clinicians should have the skills to help them achieve their goals.

In addition, community infrastructure developed through Blue Zones that supports healthful lifestyle choices is significant for patients. Lack of resources in their home, work, and community environments is a common obstacle that patients cite when discussing lifestyle change with a clinician. Bicycle lanes for commuting, parks with exercise equipment, accessible healthy food options, and community events to facilitate positive social connections enhance lifestyle-medicine prescriptions. Workplaces, restaurants, places of worship, and grocery stores are examples of community stakeholders that collaborate in Blue Zones communities to promote healthy lifestyle decisions. Although lifestyle medicine clinicians can and do identify creative ways to support patients in communities without strong healthy choice infrastructure, the Blue Zones road map is a welcome companion.

The timing is right for this synthesis of Blue Zones and lifestyle medicine. As consumer interest in Blue Zones has risen, so has clinician interest in evidence-based lifestyle medicine. Since certification in lifestyle medicine began in 2017, almost 6700 physicians and other health professionals have become certified worldwide. More than 43,000 health care professionals have registered for ACLM’s complimentary lifestyle and food-as-medicine courses highlighted by the White House Conference on Hunger, Nutrition, and Health. 

What if more patients came to us motivated to make lifestyle changes because of awareness infused in their work and supported in their surrounding community? Matching lifestyle medicine certification with Blue Zone communities equips clinicians to help these patients achieve what they really want: to live longer and better.

Dr. Collings is Director of Lifestyle Medicine, Silicon Valley Medical Development, and Past President, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

It is a great day when a patient shows up at clinical appointment already motivated to make lifestyle behavior changes. Often, they have been inspired by health information they consumed elsewhere, such as from a book, movie, documentary, TV show, a friend, or something out in the community.

Currently, one of the more public representations of health and longevity promotion is Blue Zones. The organization, named for specific areas of the world — the so-called blue zones, where people experience less disease and live longer lives — has created considerable public awareness for healthy living. Today, there are more than 75 Blue Zones Project communities across the United States, where community leaders, businesses, organizations, and citizens collaborate to make healthier choices the easier choices. A recent Netflix special, Live to 100: Secrets of the Blue Zones, further propelled blue zones into the public consciousness.

For clinicians trained in lifestyle medicine, Blue Zones’ consumer awareness is an opportunity. There is considerable crossover between the lifestyle habits advocated by Blue Zones, known as the Power9, and the six pillars of lifestyle medicine. The Blue Zones emphasis on “plant-slant” diet, natural movement, purpose and contribution, downshifting, and family and community intersect with the lifestyle medicine pillars of whole-food, plant-predominant eating patterns, regular physical activity, stress management, restorative sleep, and positive social connections. Both Blue Zones and lifestyle medicine share a goal of creating healthier and stronger individuals and communities.

For those reasons, it made perfect sense that Blue Zones and the American College of Lifestyle Medicine (ACLM) recently announced a partnership to synergize both organizations’ strengths and resources. Among other things, the collaboration will establish a new certification status of Blue Zones–Certified Physician or Blue Zones–Certified Healthcare Professional, available in 2025 exclusively to clinicians who already are or become certified in lifestyle medicine.

Because of Blue Zones’ considerable consumer awareness, physicians and other health professionals who earn the certification will stand out to potential patients as clinicians with the training and knowledge to help them make sustainable lifestyle behavior changes. A challenging part of any clinician’s job is educating and convincing patients on the proven health benefits of lifestyle behavior change within the time restraints of a routine clinical visit. Patients familiar with Blue Zones are more likely to arrive already interested in changing lifestyle behavior, and clinicians should have the skills to help them achieve their goals.

In addition, community infrastructure developed through Blue Zones that supports healthful lifestyle choices is significant for patients. Lack of resources in their home, work, and community environments is a common obstacle that patients cite when discussing lifestyle change with a clinician. Bicycle lanes for commuting, parks with exercise equipment, accessible healthy food options, and community events to facilitate positive social connections enhance lifestyle-medicine prescriptions. Workplaces, restaurants, places of worship, and grocery stores are examples of community stakeholders that collaborate in Blue Zones communities to promote healthy lifestyle decisions. Although lifestyle medicine clinicians can and do identify creative ways to support patients in communities without strong healthy choice infrastructure, the Blue Zones road map is a welcome companion.

The timing is right for this synthesis of Blue Zones and lifestyle medicine. As consumer interest in Blue Zones has risen, so has clinician interest in evidence-based lifestyle medicine. Since certification in lifestyle medicine began in 2017, almost 6700 physicians and other health professionals have become certified worldwide. More than 43,000 health care professionals have registered for ACLM’s complimentary lifestyle and food-as-medicine courses highlighted by the White House Conference on Hunger, Nutrition, and Health. 

What if more patients came to us motivated to make lifestyle changes because of awareness infused in their work and supported in their surrounding community? Matching lifestyle medicine certification with Blue Zone communities equips clinicians to help these patients achieve what they really want: to live longer and better.

Dr. Collings is Director of Lifestyle Medicine, Silicon Valley Medical Development, and Past President, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

“You had to pay the fee, or the doctor wasn’t going to see you anymore.”

That was the takeaway for Terri Marroquin of Midland, Texas, when her longtime physician began charging a membership fee in 2019. She found out about the change when someone at the physician’s front desk pointed to a posted notice.

At first, she stuck with the practice; in her area, she said, it is now tough to find a primary care doctor who doesn’t charge an annual membership fee from $350 to $500.

But last year, Ms. Marroquin finally left to join a practice with no membership fee where she sees a physician assistant rather than a doctor. “I had had enough. The concierge fee kept going up, and the doctor’s office kept getting nicer and nicer,” she said, referring to the décor.

With the national shortage of primary care physicians reaching 17,637 in 2023 and projected to worsen, more Americans are paying for the privilege of seeing a doctor — on top of insurance premiums that cover most services a doctor might provide or order. Many people seeking a new doctor are calling a long list of primary care practices only to be told they’re not taking new patients.

“Concierge medicine potentially leads to disproportionately richer people being able to pay for the scarce resource of physician time and crowding out people who have lower incomes and are sicker,” said Adam Leive, PhD, lead author of a 2023 study on concierge medicine and researcher at the University of California, Berkeley.

Dr. Leive’s research showed no decrease in mortality for concierge patients compared with similar patients who saw nonconcierge physicians, suggesting concierge care may not notably improve some health outcomes.

A 2005 study showed concierge physicians had smaller proportions of patients with diabetes than their nonconcierge counterparts and provided care for fewer Black and Hispanic patients.

There’s little reliable data available on the size of the concierge medicine market. But one market research firm projects that concierge medicine revenue will grow about 10.4% annually through 2030. About 5,000 to 7,000 physicians and practices provide concierge care in the United States, most of whom are primary care providers, according to Concierge Medicine Today. (Yes, the burgeoning field already has a trade publication.)

The concierge pitch is simple: More time with your doctor, in-person or remotely, promptly and at your convenience. With many primary care physicians caring for thousands of patients each in appointments of 15 minutes or less, some people who can afford the fee say they feel forced to pay it just to maintain adequate access to their doctor.

As primary care providers convert to concierge medicine, many patients could face the financial and health consequences of a potentially lengthy search for a new provider. With fewer physicians in nonconcierge practices, the pool available to people who can’t or won’t pay is smaller. For them, it is harder to find a doctor.

Concierge care models vary widely, but all involve paying a periodic fee to be a patient of the practice.

These fees are generally not covered by insurance nor payable with a tax-advantaged flexible spending account or health savings account. Annual fees range from $199 for Amazon’s One Medical (with a discount available for Prime members) to low four figures for companies like MDVIP and SignatureMD that partner with physicians, to $10,000 or more for top-branded practices like Massachusetts General Hospital’s.

Many patients are exasperated with the prospect of pay-to-play primary care. For one thing, under the Affordable Care Act, insurers are required to cover a variety of preventive services without a patient paying out of pocket. “Your annual physical should be free,” said Caitlin Donovan, a spokesperson for the National Patient Advocate Foundation. “Why are you paying $2,000 for it?”

Liz Glatzer felt her doctor in Providence, Rhode Island, was competent but didn’t have time to absorb her full health history. “I had double mastectomy 25 years ago,” she said. “At my first physical, the doctor ran through my meds and whatever else, and she said, ‘Oh, you haven’t had a mammogram.’ I said, ‘I don’t have breasts to have mammography.’ ”

In 2023, after repeating that same exchange during her next two physicals, Ms. Glatzer signed up to pay $1,900 a year for MDVIP, a concierge staffing service that contracts with her new doctor, who is also a friend’s husband. In her first couple of visits, Ms. Glatzer’s new physician took hours to get to know her, she said.

For the growing numbers of Americans who can’t or won’t pay when their doctor switches to concierge care, finding new primary care can mean frustration, delayed or missed tests or treatments, and fragmented health care.

“I’ve met so many patients who couldn’t afford the concierge services and needed to look for a new primary care physician,” said Yalda Jabbarpour, director of the Robert Graham Center and a practicing family physician. Separating from a doctor who’s transitioning to concierge care “breaks the continuity with the provider that we know is so important for good health outcomes.” .

That disruption has consequences. “People don’t get the preventive services that they should, and they use more expensive and inefficient avenues for care that could have otherwise been provided by their doctor,” said Abbie Leibowitz, chief medical officer at Health Advocate, a company that helps patients find care and resolve insurance issues.

What happens to patients who find themselves at loose ends when a physician transitions to concierge practice?

Patients who lose their doctors often give up on having an ongoing relationship with a primary care clinician. They may rely solely on a pharmacy-based clinic or urgent care center or even a hospital emergency department for primary care.

Some concierge providers say they are responding to concerns about access and equity by allowing patients to opt out of concierge care but stay with the practice group at a lower tier of service. This might entail longer waits for shorter appointments, fewer visits with a physician, and more visits with mid-level providers, for example.

Deb Gordon of Cambridge, Massachusetts, said she is searching for a new primary care doctor after hers switched to concierge medicine — a challenge that involves finding someone in her network who has admitting privileges at her preferred hospitals and is accepting new patients.

Ms. Gordon, who is codirector of the Alliance of Professional Health Advocates, which provides support services to patient advocates, said the practice that her doctor left has not assigned her a new provider, and her health plan said it was OK if she went without one. “I was shocked that they literally said, ‘You can go to urgent care.’ ”

Some patients find themselves turning to physician assistants and other mid-level providers. But those clinicians have much less training than physicians with board certification in family medicine or internal medicine and so may not be fully qualified to treat patients with complex health problems. “The expertise of physician assistants and nurse practitioners can really vary widely,” said Russell Phillips, director of the Harvard Medical School Center for Primary Care.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

“You had to pay the fee, or the doctor wasn’t going to see you anymore.”

That was the takeaway for Terri Marroquin of Midland, Texas, when her longtime physician began charging a membership fee in 2019. She found out about the change when someone at the physician’s front desk pointed to a posted notice.

At first, she stuck with the practice; in her area, she said, it is now tough to find a primary care doctor who doesn’t charge an annual membership fee from $350 to $500.

But last year, Ms. Marroquin finally left to join a practice with no membership fee where she sees a physician assistant rather than a doctor. “I had had enough. The concierge fee kept going up, and the doctor’s office kept getting nicer and nicer,” she said, referring to the décor.

With the national shortage of primary care physicians reaching 17,637 in 2023 and projected to worsen, more Americans are paying for the privilege of seeing a doctor — on top of insurance premiums that cover most services a doctor might provide or order. Many people seeking a new doctor are calling a long list of primary care practices only to be told they’re not taking new patients.

“Concierge medicine potentially leads to disproportionately richer people being able to pay for the scarce resource of physician time and crowding out people who have lower incomes and are sicker,” said Adam Leive, PhD, lead author of a 2023 study on concierge medicine and researcher at the University of California, Berkeley.

Dr. Leive’s research showed no decrease in mortality for concierge patients compared with similar patients who saw nonconcierge physicians, suggesting concierge care may not notably improve some health outcomes.

A 2005 study showed concierge physicians had smaller proportions of patients with diabetes than their nonconcierge counterparts and provided care for fewer Black and Hispanic patients.

There’s little reliable data available on the size of the concierge medicine market. But one market research firm projects that concierge medicine revenue will grow about 10.4% annually through 2030. About 5,000 to 7,000 physicians and practices provide concierge care in the United States, most of whom are primary care providers, according to Concierge Medicine Today. (Yes, the burgeoning field already has a trade publication.)

The concierge pitch is simple: More time with your doctor, in-person or remotely, promptly and at your convenience. With many primary care physicians caring for thousands of patients each in appointments of 15 minutes or less, some people who can afford the fee say they feel forced to pay it just to maintain adequate access to their doctor.

As primary care providers convert to concierge medicine, many patients could face the financial and health consequences of a potentially lengthy search for a new provider. With fewer physicians in nonconcierge practices, the pool available to people who can’t or won’t pay is smaller. For them, it is harder to find a doctor.

Concierge care models vary widely, but all involve paying a periodic fee to be a patient of the practice.

These fees are generally not covered by insurance nor payable with a tax-advantaged flexible spending account or health savings account. Annual fees range from $199 for Amazon’s One Medical (with a discount available for Prime members) to low four figures for companies like MDVIP and SignatureMD that partner with physicians, to $10,000 or more for top-branded practices like Massachusetts General Hospital’s.

Many patients are exasperated with the prospect of pay-to-play primary care. For one thing, under the Affordable Care Act, insurers are required to cover a variety of preventive services without a patient paying out of pocket. “Your annual physical should be free,” said Caitlin Donovan, a spokesperson for the National Patient Advocate Foundation. “Why are you paying $2,000 for it?”

Liz Glatzer felt her doctor in Providence, Rhode Island, was competent but didn’t have time to absorb her full health history. “I had double mastectomy 25 years ago,” she said. “At my first physical, the doctor ran through my meds and whatever else, and she said, ‘Oh, you haven’t had a mammogram.’ I said, ‘I don’t have breasts to have mammography.’ ”

In 2023, after repeating that same exchange during her next two physicals, Ms. Glatzer signed up to pay $1,900 a year for MDVIP, a concierge staffing service that contracts with her new doctor, who is also a friend’s husband. In her first couple of visits, Ms. Glatzer’s new physician took hours to get to know her, she said.

For the growing numbers of Americans who can’t or won’t pay when their doctor switches to concierge care, finding new primary care can mean frustration, delayed or missed tests or treatments, and fragmented health care.

“I’ve met so many patients who couldn’t afford the concierge services and needed to look for a new primary care physician,” said Yalda Jabbarpour, director of the Robert Graham Center and a practicing family physician. Separating from a doctor who’s transitioning to concierge care “breaks the continuity with the provider that we know is so important for good health outcomes.” .

That disruption has consequences. “People don’t get the preventive services that they should, and they use more expensive and inefficient avenues for care that could have otherwise been provided by their doctor,” said Abbie Leibowitz, chief medical officer at Health Advocate, a company that helps patients find care and resolve insurance issues.

What happens to patients who find themselves at loose ends when a physician transitions to concierge practice?

Patients who lose their doctors often give up on having an ongoing relationship with a primary care clinician. They may rely solely on a pharmacy-based clinic or urgent care center or even a hospital emergency department for primary care.

Some concierge providers say they are responding to concerns about access and equity by allowing patients to opt out of concierge care but stay with the practice group at a lower tier of service. This might entail longer waits for shorter appointments, fewer visits with a physician, and more visits with mid-level providers, for example.

Deb Gordon of Cambridge, Massachusetts, said she is searching for a new primary care doctor after hers switched to concierge medicine — a challenge that involves finding someone in her network who has admitting privileges at her preferred hospitals and is accepting new patients.

Ms. Gordon, who is codirector of the Alliance of Professional Health Advocates, which provides support services to patient advocates, said the practice that her doctor left has not assigned her a new provider, and her health plan said it was OK if she went without one. “I was shocked that they literally said, ‘You can go to urgent care.’ ”

Some patients find themselves turning to physician assistants and other mid-level providers. But those clinicians have much less training than physicians with board certification in family medicine or internal medicine and so may not be fully qualified to treat patients with complex health problems. “The expertise of physician assistants and nurse practitioners can really vary widely,” said Russell Phillips, director of the Harvard Medical School Center for Primary Care.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

“You had to pay the fee, or the doctor wasn’t going to see you anymore.”

That was the takeaway for Terri Marroquin of Midland, Texas, when her longtime physician began charging a membership fee in 2019. She found out about the change when someone at the physician’s front desk pointed to a posted notice.

At first, she stuck with the practice; in her area, she said, it is now tough to find a primary care doctor who doesn’t charge an annual membership fee from $350 to $500.

But last year, Ms. Marroquin finally left to join a practice with no membership fee where she sees a physician assistant rather than a doctor. “I had had enough. The concierge fee kept going up, and the doctor’s office kept getting nicer and nicer,” she said, referring to the décor.

With the national shortage of primary care physicians reaching 17,637 in 2023 and projected to worsen, more Americans are paying for the privilege of seeing a doctor — on top of insurance premiums that cover most services a doctor might provide or order. Many people seeking a new doctor are calling a long list of primary care practices only to be told they’re not taking new patients.

“Concierge medicine potentially leads to disproportionately richer people being able to pay for the scarce resource of physician time and crowding out people who have lower incomes and are sicker,” said Adam Leive, PhD, lead author of a 2023 study on concierge medicine and researcher at the University of California, Berkeley.

Dr. Leive’s research showed no decrease in mortality for concierge patients compared with similar patients who saw nonconcierge physicians, suggesting concierge care may not notably improve some health outcomes.

A 2005 study showed concierge physicians had smaller proportions of patients with diabetes than their nonconcierge counterparts and provided care for fewer Black and Hispanic patients.

There’s little reliable data available on the size of the concierge medicine market. But one market research firm projects that concierge medicine revenue will grow about 10.4% annually through 2030. About 5,000 to 7,000 physicians and practices provide concierge care in the United States, most of whom are primary care providers, according to Concierge Medicine Today. (Yes, the burgeoning field already has a trade publication.)

The concierge pitch is simple: More time with your doctor, in-person or remotely, promptly and at your convenience. With many primary care physicians caring for thousands of patients each in appointments of 15 minutes or less, some people who can afford the fee say they feel forced to pay it just to maintain adequate access to their doctor.

As primary care providers convert to concierge medicine, many patients could face the financial and health consequences of a potentially lengthy search for a new provider. With fewer physicians in nonconcierge practices, the pool available to people who can’t or won’t pay is smaller. For them, it is harder to find a doctor.

Concierge care models vary widely, but all involve paying a periodic fee to be a patient of the practice.

These fees are generally not covered by insurance nor payable with a tax-advantaged flexible spending account or health savings account. Annual fees range from $199 for Amazon’s One Medical (with a discount available for Prime members) to low four figures for companies like MDVIP and SignatureMD that partner with physicians, to $10,000 or more for top-branded practices like Massachusetts General Hospital’s.

Many patients are exasperated with the prospect of pay-to-play primary care. For one thing, under the Affordable Care Act, insurers are required to cover a variety of preventive services without a patient paying out of pocket. “Your annual physical should be free,” said Caitlin Donovan, a spokesperson for the National Patient Advocate Foundation. “Why are you paying $2,000 for it?”

Liz Glatzer felt her doctor in Providence, Rhode Island, was competent but didn’t have time to absorb her full health history. “I had double mastectomy 25 years ago,” she said. “At my first physical, the doctor ran through my meds and whatever else, and she said, ‘Oh, you haven’t had a mammogram.’ I said, ‘I don’t have breasts to have mammography.’ ”

In 2023, after repeating that same exchange during her next two physicals, Ms. Glatzer signed up to pay $1,900 a year for MDVIP, a concierge staffing service that contracts with her new doctor, who is also a friend’s husband. In her first couple of visits, Ms. Glatzer’s new physician took hours to get to know her, she said.

For the growing numbers of Americans who can’t or won’t pay when their doctor switches to concierge care, finding new primary care can mean frustration, delayed or missed tests or treatments, and fragmented health care.

“I’ve met so many patients who couldn’t afford the concierge services and needed to look for a new primary care physician,” said Yalda Jabbarpour, director of the Robert Graham Center and a practicing family physician. Separating from a doctor who’s transitioning to concierge care “breaks the continuity with the provider that we know is so important for good health outcomes.” .

That disruption has consequences. “People don’t get the preventive services that they should, and they use more expensive and inefficient avenues for care that could have otherwise been provided by their doctor,” said Abbie Leibowitz, chief medical officer at Health Advocate, a company that helps patients find care and resolve insurance issues.

What happens to patients who find themselves at loose ends when a physician transitions to concierge practice?

Patients who lose their doctors often give up on having an ongoing relationship with a primary care clinician. They may rely solely on a pharmacy-based clinic or urgent care center or even a hospital emergency department for primary care.

Some concierge providers say they are responding to concerns about access and equity by allowing patients to opt out of concierge care but stay with the practice group at a lower tier of service. This might entail longer waits for shorter appointments, fewer visits with a physician, and more visits with mid-level providers, for example.

Deb Gordon of Cambridge, Massachusetts, said she is searching for a new primary care doctor after hers switched to concierge medicine — a challenge that involves finding someone in her network who has admitting privileges at her preferred hospitals and is accepting new patients.

Ms. Gordon, who is codirector of the Alliance of Professional Health Advocates, which provides support services to patient advocates, said the practice that her doctor left has not assigned her a new provider, and her health plan said it was OK if she went without one. “I was shocked that they literally said, ‘You can go to urgent care.’ ”

Some patients find themselves turning to physician assistants and other mid-level providers. But those clinicians have much less training than physicians with board certification in family medicine or internal medicine and so may not be fully qualified to treat patients with complex health problems. “The expertise of physician assistants and nurse practitioners can really vary widely,” said Russell Phillips, director of the Harvard Medical School Center for Primary Care.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Strict sodium intake — with or without restrictions on fluid intake — is unlikely to confer clinical benefits on patients with heart failure, reported investigators.

Their review of studies showed sodium should only be moderately restricted because “patients are more likely to follow instructions that are not too draconian, and there is no evidence that severe sodium restriction saves lives or delays hospital admissions.”

In fact, moderate daily intake of sodium (3.0-4.5 g) may improve the quality of life and functional status of these patients, even if it will not improve life expectancy or the hospitalization rate, Paolo Raggi, MD, from the University of Alberta, Edmonton, Alberta, Canada, explained in his narrative review published online in the European Journal of Clinical Investigation.

“It is always a little hard to give up long-held beliefs, and you try to find fault in the new evidence before your eyes,” he said.

Dr. Raggi, who is also coeditor of Atherosclerosis, explained this work was prompted in part by the large, multicenter SODIUM-HF study, which showed that sodium restriction did not reduce the composite outcome of all-cause mortality, cardiovascular hospitalization, and cardiovascular-related emergency department visits, although it did improve quality of life and New York Heart Association class.

And “excessive fluid restriction — typically we were taught to restrict fluid intake to 1 L/d or, at the most, 1.5 L — does not reduce mortality or hospitalization rates and inflicts unnecessary strain and pain on patients,” he said. “Clinicians need to get on board with this novel information.”
 

Examining the Evidence

For the narrative review, the researchers conducted a literature search for the terms heart failure, salt, sodium, and fluid intake to identify relevant reports.

Most randomized trials were small and examined widely heterogeneous interventions. The identified trials published from 2000 to 2021 had populations that ranged from 12 to 203 participants, had inpatients and outpatients, and included people with reduced and preserved ejection fraction. Sodium interventions varied from extreme reductions (< 800 mg/d) to more moderate approaches (2-3 g/d). No study, regardless of the level of restriction, showed a reduction in mortality or hospitalization rates.

Notably, SODIUM-HF — the randomized clinical trial of sodium restriction to a target of 1.5 g/d — was stopped early after an interim analysis demonstrated the futility of the intervention, and the COVID pandemic made it difficult to continue the trial.

Although a moderate sodium intake of 3-4.5 g/d “seems prudent” for patients with recurrent hospital admissions and fluid overload, an intake of 2-3 g/d may be a more acceptable level. “A more aggressive sodium restriction may be necessary in the presence of chronic kidney disease, where the handling of sodium by the kidneys is hampered,” Dr. Raggi reported.

“The debate on tight sodium restriction in heart failure continues to appear in major medical journals, yet it would seem that after many years of controversy, the time has come to close it,” he said.
 

‘One Approach Does Not Fit All’

Sodium restriction is difficult to quantify in a large cohort of patients because many studies are based on recall questionnaires and qualitative measurements, said Johanna Contreras, MD, an advanced heart failure and transplant cardiologist at the Mount Sinai Fuster Heart Hospital in New York City.

“Many patients are not aware that processed and precooked foods are very high in sodium and don’t count them as sodium-rich foods,” she said.

Nevertheless, heart failure has many etiologies and stages, so “one approach does not fit all,” she said. For example, patients with stage C heart failure “will clearly get more decompensated when they consume sodium-rich diets, which will increase water absorption.” And patients with heart failure secondary to hypertension are “particularly susceptible” and are likely to become more symptomatic and acutely congestive on diets high in sodium and water, which can increase both morbidity and mortality.

“It is important to understand the kinds of patients we are referring to, how advanced they are, and what comorbidities the patients have,” she said. “We also know that there are race, ethnicity, and gender differences in sensitivity to sodium.”

We should aim for a moderate sodium intake, she said, but patients with high sensitivity, multiple comorbidities, kidney disease, and certain demographic characteristics “need to be more careful.”

Overall, “patients should aim to consume fresh fruits and vegetables and [be aware of] processed foods and adding salt at the table when they are eating,” Dr. Contreras said.

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

Strict sodium intake — with or without restrictions on fluid intake — is unlikely to confer clinical benefits on patients with heart failure, reported investigators.

Their review of studies showed sodium should only be moderately restricted because “patients are more likely to follow instructions that are not too draconian, and there is no evidence that severe sodium restriction saves lives or delays hospital admissions.”

In fact, moderate daily intake of sodium (3.0-4.5 g) may improve the quality of life and functional status of these patients, even if it will not improve life expectancy or the hospitalization rate, Paolo Raggi, MD, from the University of Alberta, Edmonton, Alberta, Canada, explained in his narrative review published online in the European Journal of Clinical Investigation.

“It is always a little hard to give up long-held beliefs, and you try to find fault in the new evidence before your eyes,” he said.

Dr. Raggi, who is also coeditor of Atherosclerosis, explained this work was prompted in part by the large, multicenter SODIUM-HF study, which showed that sodium restriction did not reduce the composite outcome of all-cause mortality, cardiovascular hospitalization, and cardiovascular-related emergency department visits, although it did improve quality of life and New York Heart Association class.

And “excessive fluid restriction — typically we were taught to restrict fluid intake to 1 L/d or, at the most, 1.5 L — does not reduce mortality or hospitalization rates and inflicts unnecessary strain and pain on patients,” he said. “Clinicians need to get on board with this novel information.”
 

Examining the Evidence

For the narrative review, the researchers conducted a literature search for the terms heart failure, salt, sodium, and fluid intake to identify relevant reports.

Most randomized trials were small and examined widely heterogeneous interventions. The identified trials published from 2000 to 2021 had populations that ranged from 12 to 203 participants, had inpatients and outpatients, and included people with reduced and preserved ejection fraction. Sodium interventions varied from extreme reductions (< 800 mg/d) to more moderate approaches (2-3 g/d). No study, regardless of the level of restriction, showed a reduction in mortality or hospitalization rates.

Notably, SODIUM-HF — the randomized clinical trial of sodium restriction to a target of 1.5 g/d — was stopped early after an interim analysis demonstrated the futility of the intervention, and the COVID pandemic made it difficult to continue the trial.

Although a moderate sodium intake of 3-4.5 g/d “seems prudent” for patients with recurrent hospital admissions and fluid overload, an intake of 2-3 g/d may be a more acceptable level. “A more aggressive sodium restriction may be necessary in the presence of chronic kidney disease, where the handling of sodium by the kidneys is hampered,” Dr. Raggi reported.

“The debate on tight sodium restriction in heart failure continues to appear in major medical journals, yet it would seem that after many years of controversy, the time has come to close it,” he said.
 

‘One Approach Does Not Fit All’

Sodium restriction is difficult to quantify in a large cohort of patients because many studies are based on recall questionnaires and qualitative measurements, said Johanna Contreras, MD, an advanced heart failure and transplant cardiologist at the Mount Sinai Fuster Heart Hospital in New York City.

“Many patients are not aware that processed and precooked foods are very high in sodium and don’t count them as sodium-rich foods,” she said.

Nevertheless, heart failure has many etiologies and stages, so “one approach does not fit all,” she said. For example, patients with stage C heart failure “will clearly get more decompensated when they consume sodium-rich diets, which will increase water absorption.” And patients with heart failure secondary to hypertension are “particularly susceptible” and are likely to become more symptomatic and acutely congestive on diets high in sodium and water, which can increase both morbidity and mortality.

“It is important to understand the kinds of patients we are referring to, how advanced they are, and what comorbidities the patients have,” she said. “We also know that there are race, ethnicity, and gender differences in sensitivity to sodium.”

We should aim for a moderate sodium intake, she said, but patients with high sensitivity, multiple comorbidities, kidney disease, and certain demographic characteristics “need to be more careful.”

Overall, “patients should aim to consume fresh fruits and vegetables and [be aware of] processed foods and adding salt at the table when they are eating,” Dr. Contreras said.

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

Strict sodium intake — with or without restrictions on fluid intake — is unlikely to confer clinical benefits on patients with heart failure, reported investigators.

Their review of studies showed sodium should only be moderately restricted because “patients are more likely to follow instructions that are not too draconian, and there is no evidence that severe sodium restriction saves lives or delays hospital admissions.”

In fact, moderate daily intake of sodium (3.0-4.5 g) may improve the quality of life and functional status of these patients, even if it will not improve life expectancy or the hospitalization rate, Paolo Raggi, MD, from the University of Alberta, Edmonton, Alberta, Canada, explained in his narrative review published online in the European Journal of Clinical Investigation.

“It is always a little hard to give up long-held beliefs, and you try to find fault in the new evidence before your eyes,” he said.

Dr. Raggi, who is also coeditor of Atherosclerosis, explained this work was prompted in part by the large, multicenter SODIUM-HF study, which showed that sodium restriction did not reduce the composite outcome of all-cause mortality, cardiovascular hospitalization, and cardiovascular-related emergency department visits, although it did improve quality of life and New York Heart Association class.

And “excessive fluid restriction — typically we were taught to restrict fluid intake to 1 L/d or, at the most, 1.5 L — does not reduce mortality or hospitalization rates and inflicts unnecessary strain and pain on patients,” he said. “Clinicians need to get on board with this novel information.”
 

Examining the Evidence

For the narrative review, the researchers conducted a literature search for the terms heart failure, salt, sodium, and fluid intake to identify relevant reports.

Most randomized trials were small and examined widely heterogeneous interventions. The identified trials published from 2000 to 2021 had populations that ranged from 12 to 203 participants, had inpatients and outpatients, and included people with reduced and preserved ejection fraction. Sodium interventions varied from extreme reductions (< 800 mg/d) to more moderate approaches (2-3 g/d). No study, regardless of the level of restriction, showed a reduction in mortality or hospitalization rates.

Notably, SODIUM-HF — the randomized clinical trial of sodium restriction to a target of 1.5 g/d — was stopped early after an interim analysis demonstrated the futility of the intervention, and the COVID pandemic made it difficult to continue the trial.

Although a moderate sodium intake of 3-4.5 g/d “seems prudent” for patients with recurrent hospital admissions and fluid overload, an intake of 2-3 g/d may be a more acceptable level. “A more aggressive sodium restriction may be necessary in the presence of chronic kidney disease, where the handling of sodium by the kidneys is hampered,” Dr. Raggi reported.

“The debate on tight sodium restriction in heart failure continues to appear in major medical journals, yet it would seem that after many years of controversy, the time has come to close it,” he said.
 

‘One Approach Does Not Fit All’

Sodium restriction is difficult to quantify in a large cohort of patients because many studies are based on recall questionnaires and qualitative measurements, said Johanna Contreras, MD, an advanced heart failure and transplant cardiologist at the Mount Sinai Fuster Heart Hospital in New York City.

“Many patients are not aware that processed and precooked foods are very high in sodium and don’t count them as sodium-rich foods,” she said.

Nevertheless, heart failure has many etiologies and stages, so “one approach does not fit all,” she said. For example, patients with stage C heart failure “will clearly get more decompensated when they consume sodium-rich diets, which will increase water absorption.” And patients with heart failure secondary to hypertension are “particularly susceptible” and are likely to become more symptomatic and acutely congestive on diets high in sodium and water, which can increase both morbidity and mortality.

“It is important to understand the kinds of patients we are referring to, how advanced they are, and what comorbidities the patients have,” she said. “We also know that there are race, ethnicity, and gender differences in sensitivity to sodium.”

We should aim for a moderate sodium intake, she said, but patients with high sensitivity, multiple comorbidities, kidney disease, and certain demographic characteristics “need to be more careful.”

Overall, “patients should aim to consume fresh fruits and vegetables and [be aware of] processed foods and adding salt at the table when they are eating,” Dr. Contreras said.

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

Eight commonly used antidepressants have been ranked by their weight gain potential. 

Results of a large observational study showed small differences in short- and long-term weight change in patients prescribed one of eight antidepressants, with bupropion associated with the lowest weight gain and escitalopram, paroxetine, and duloxetine associated with the greatest. 

Escitalopram, paroxetine, and duloxetine users were 10%-15% more likely to gain at least 5% of their baseline weight compared with those taking sertraline, which was used as a comparator. 

Investigators noted that the more clinicians and patients know about how a particular antidepressant may affect patients’ weight, the better informed they can be about which antidepressants to prescribe. 

“Patients and their clinicians often have several options when starting an antidepressant for the first time. This study provides important real-world evidence regarding the amount of weight gain that should be expected after starting some of the most common antidepressants,” lead author Joshua Petimar, ScD, assistant professor of population medicine in the Harvard Pilgrim Health Care Institute at Harvard Medical School, Boston, said in a press release. 

The findings were published online in Annals of Internal Medicine. 


 

Real-World Data

Though weight gain is a commonly reported side effect of antidepressant use and may lead to medication nonadherence and worse outcomes, there is a lack of real-world data about weight change across specific medications. 

Investigators used electronic health records from eight health care systems across the United States spanning from 2010 to 2019. The analysis included information on 183,118 adults aged 20-80 years who were new users of one of eight common first-line antidepressants. Investigators measured their weight at baseline and at 6, 12, and 24 months after initiation to estimate intention-to-treat (ITT) effects of weight change.

At baseline, participants were randomly assigned to begin sertraline, citalopram, escitalopram, fluoxetine, paroxetine, bupropion, duloxetine, or venlafaxine. 

The most common antidepressants prescribed were sertraline, citalopram, and bupropion. Approximately 36% of participants had a diagnosis of depression, and 39% were diagnosed with anxiety.

Among selective serotonin reuptake inhibitors (SSRIs), escitalopram and paroxetine were associated with the greatest 6-month weight gain, whereas bupropion was associated with the least weight gain across all analyses.

Using sertraline as a comparator, 6-month weight change was lower for bupropion (difference, 0.22 kg) and higher for escitalopram (difference, 0.41 kg), duloxetine (difference, 0.34 kg), paroxetine (difference, 0.37 kg), and venlafaxine (difference, 0.17 kg).

Escitalopram, paroxetine, and duloxetine users were 10%-15% more likely to gain at least 5% of their baseline weight compared with sertraline users.

Investigators noted little difference in adherence levels between medications during the study except at 6 months, when it was higher for those who took bupropion (41%) than for those taking other antidepressants (28%-36%).

The study included data only on prescriptions and investigators could not verify whether the medications were dispensed or taken as prescribed. Other limitations included missing weight information because most patients did not encounter the health system at exactly 6, 12, and 24 months; only 15%-30% had weight measurements in those months. 

Finally, the low adherence rates made it difficult to attribute relative weight change at the 12- and 24-month time points to the specific medications of interest.

“Clinicians and patients could consider these differences when making decisions about specific antidepressants, especially given the complex relationships of obesity and depression with health, quality of life, and stigma,” the authors wrote. 

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Disclosures are noted in the original article. 

A version of this article appeared on Medscape.com.

Eight commonly used antidepressants have been ranked by their weight gain potential. 

Results of a large observational study showed small differences in short- and long-term weight change in patients prescribed one of eight antidepressants, with bupropion associated with the lowest weight gain and escitalopram, paroxetine, and duloxetine associated with the greatest. 

Escitalopram, paroxetine, and duloxetine users were 10%-15% more likely to gain at least 5% of their baseline weight compared with those taking sertraline, which was used as a comparator. 

Investigators noted that the more clinicians and patients know about how a particular antidepressant may affect patients’ weight, the better informed they can be about which antidepressants to prescribe. 

“Patients and their clinicians often have several options when starting an antidepressant for the first time. This study provides important real-world evidence regarding the amount of weight gain that should be expected after starting some of the most common antidepressants,” lead author Joshua Petimar, ScD, assistant professor of population medicine in the Harvard Pilgrim Health Care Institute at Harvard Medical School, Boston, said in a press release. 

The findings were published online in Annals of Internal Medicine. 


 

Real-World Data

Though weight gain is a commonly reported side effect of antidepressant use and may lead to medication nonadherence and worse outcomes, there is a lack of real-world data about weight change across specific medications. 

Investigators used electronic health records from eight health care systems across the United States spanning from 2010 to 2019. The analysis included information on 183,118 adults aged 20-80 years who were new users of one of eight common first-line antidepressants. Investigators measured their weight at baseline and at 6, 12, and 24 months after initiation to estimate intention-to-treat (ITT) effects of weight change.

At baseline, participants were randomly assigned to begin sertraline, citalopram, escitalopram, fluoxetine, paroxetine, bupropion, duloxetine, or venlafaxine. 

The most common antidepressants prescribed were sertraline, citalopram, and bupropion. Approximately 36% of participants had a diagnosis of depression, and 39% were diagnosed with anxiety.

Among selective serotonin reuptake inhibitors (SSRIs), escitalopram and paroxetine were associated with the greatest 6-month weight gain, whereas bupropion was associated with the least weight gain across all analyses.

Using sertraline as a comparator, 6-month weight change was lower for bupropion (difference, 0.22 kg) and higher for escitalopram (difference, 0.41 kg), duloxetine (difference, 0.34 kg), paroxetine (difference, 0.37 kg), and venlafaxine (difference, 0.17 kg).

Escitalopram, paroxetine, and duloxetine users were 10%-15% more likely to gain at least 5% of their baseline weight compared with sertraline users.

Investigators noted little difference in adherence levels between medications during the study except at 6 months, when it was higher for those who took bupropion (41%) than for those taking other antidepressants (28%-36%).

The study included data only on prescriptions and investigators could not verify whether the medications were dispensed or taken as prescribed. Other limitations included missing weight information because most patients did not encounter the health system at exactly 6, 12, and 24 months; only 15%-30% had weight measurements in those months. 

Finally, the low adherence rates made it difficult to attribute relative weight change at the 12- and 24-month time points to the specific medications of interest.

“Clinicians and patients could consider these differences when making decisions about specific antidepressants, especially given the complex relationships of obesity and depression with health, quality of life, and stigma,” the authors wrote. 

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Disclosures are noted in the original article. 

A version of this article appeared on Medscape.com.

Eight commonly used antidepressants have been ranked by their weight gain potential. 

Results of a large observational study showed small differences in short- and long-term weight change in patients prescribed one of eight antidepressants, with bupropion associated with the lowest weight gain and escitalopram, paroxetine, and duloxetine associated with the greatest. 

Escitalopram, paroxetine, and duloxetine users were 10%-15% more likely to gain at least 5% of their baseline weight compared with those taking sertraline, which was used as a comparator. 

Investigators noted that the more clinicians and patients know about how a particular antidepressant may affect patients’ weight, the better informed they can be about which antidepressants to prescribe. 

“Patients and their clinicians often have several options when starting an antidepressant for the first time. This study provides important real-world evidence regarding the amount of weight gain that should be expected after starting some of the most common antidepressants,” lead author Joshua Petimar, ScD, assistant professor of population medicine in the Harvard Pilgrim Health Care Institute at Harvard Medical School, Boston, said in a press release. 

The findings were published online in Annals of Internal Medicine. 


 

Real-World Data

Though weight gain is a commonly reported side effect of antidepressant use and may lead to medication nonadherence and worse outcomes, there is a lack of real-world data about weight change across specific medications. 

Investigators used electronic health records from eight health care systems across the United States spanning from 2010 to 2019. The analysis included information on 183,118 adults aged 20-80 years who were new users of one of eight common first-line antidepressants. Investigators measured their weight at baseline and at 6, 12, and 24 months after initiation to estimate intention-to-treat (ITT) effects of weight change.

At baseline, participants were randomly assigned to begin sertraline, citalopram, escitalopram, fluoxetine, paroxetine, bupropion, duloxetine, or venlafaxine. 

The most common antidepressants prescribed were sertraline, citalopram, and bupropion. Approximately 36% of participants had a diagnosis of depression, and 39% were diagnosed with anxiety.

Among selective serotonin reuptake inhibitors (SSRIs), escitalopram and paroxetine were associated with the greatest 6-month weight gain, whereas bupropion was associated with the least weight gain across all analyses.

Using sertraline as a comparator, 6-month weight change was lower for bupropion (difference, 0.22 kg) and higher for escitalopram (difference, 0.41 kg), duloxetine (difference, 0.34 kg), paroxetine (difference, 0.37 kg), and venlafaxine (difference, 0.17 kg).

Escitalopram, paroxetine, and duloxetine users were 10%-15% more likely to gain at least 5% of their baseline weight compared with sertraline users.

Investigators noted little difference in adherence levels between medications during the study except at 6 months, when it was higher for those who took bupropion (41%) than for those taking other antidepressants (28%-36%).

The study included data only on prescriptions and investigators could not verify whether the medications were dispensed or taken as prescribed. Other limitations included missing weight information because most patients did not encounter the health system at exactly 6, 12, and 24 months; only 15%-30% had weight measurements in those months. 

Finally, the low adherence rates made it difficult to attribute relative weight change at the 12- and 24-month time points to the specific medications of interest.

“Clinicians and patients could consider these differences when making decisions about specific antidepressants, especially given the complex relationships of obesity and depression with health, quality of life, and stigma,” the authors wrote. 

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Disclosures are noted in the original article. 

A version of this article appeared on Medscape.com.

TOPLINE: 

Patients with type 2 diabetes, overweight, or obesity taking the glucagon-like peptide receptor agonist (GLP-1 RA) semaglutide appear to have an increased risk for an uncommon condition that can cause vision loss. 
 

METHODOLOGY:

• Researchers conducted a retrospective study of 16,827 patients at Massachusetts Eye and Ear in Boston.
• Their analysis focused on 710 patients with type 2 diabetes (194 of whom had been prescribed semaglutide) and 979 patients with overweight or obesity (361 prescribed semaglutide).
• The researchers compared patients prescribed semaglutide with those prescribed a medication other than a GLP-1 agent. They matched patients by factors such as age and sex and whether they had hypertension, obstructive sleep apnea, or coronary artery disease.
• They assessed the cumulative incidence of nonarteritic anterior ischemic optic neuropathy (NAION) during 36 months of follow-up. 
•  

TAKEAWAY: 

• Semaglutide use was associated with a higher risk for NAION in patients with type 2 diabetes (hazard ratio [HR], 4.28; 95% CI, 1.62-11.29).
• In patients with overweight or obesity, semaglutide again was linked to a higher risk for NAION (HR, 7.64; 95% CI, 2.21-26.36).
• Among patients with type 2 diabetes, the cumulative incidence of NAION over 36 months was 8.9% for those prescribed semaglutide vs 1.8% among those taking non–GLP-1 medications.
• For patients with overweight or obesity, the cumulative incidence of NAION over 36 months was 6.7% for the semaglutide cohort vs 0.8% for those in the other group. 

IN PRACTICE:

Semaglutide has “provided very significant benefits in many ways, but future discussions between a patient and their physician should include NAION as a potential risk,” study leader Joseph Rizzo, MD, with Mass Eye and Ear and Harvard Medical School, said in a news release about the findings. “It is important to appreciate, however, that the increased risk relates to a disorder that is relatively uncommon.”

“Given the numbers of participants who have been recruited to clinical trials and the large number of people globally who use GLP-1 RAs, we should be confident that if corroborated, the absolute risk of developing NAION in direct relation to taking semaglutide must indeed be rare,” Susan P. Mollan, MBcHB, of University Hospitals Birmingham NHS Foundation Trust, in England, wrote in a commentary published with the study. 
 

SOURCE:

The study was published online on July 3 in JAMA Ophthalmology.
 

LIMITATIONS: 

The patients were seen at a hospital that specializes in ophthalmology and has a specialized neuro-ophthalmology service, so the results may not fully apply to other settings. The results were driven by a relatively small number of NAION cases in the patients exposed to semaglutide. The study does not establish that semaglutide directly causes NAION, the researchers noted. “The best approaches to confirm, refute, or refine our findings would be to conduct a much larger, retrospective, multicenter population-based cohort study; a prospective, randomized clinical study; or a postmarket analysis of all GLP-1 RA drugs,” they wrote.

DISCLOSURES:

The study was supported by a grant from Research to Prevent Blindness. 
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE: 

Patients with type 2 diabetes, overweight, or obesity taking the glucagon-like peptide receptor agonist (GLP-1 RA) semaglutide appear to have an increased risk for an uncommon condition that can cause vision loss. 
 

METHODOLOGY:

• Researchers conducted a retrospective study of 16,827 patients at Massachusetts Eye and Ear in Boston.
• Their analysis focused on 710 patients with type 2 diabetes (194 of whom had been prescribed semaglutide) and 979 patients with overweight or obesity (361 prescribed semaglutide).
• The researchers compared patients prescribed semaglutide with those prescribed a medication other than a GLP-1 agent. They matched patients by factors such as age and sex and whether they had hypertension, obstructive sleep apnea, or coronary artery disease.
• They assessed the cumulative incidence of nonarteritic anterior ischemic optic neuropathy (NAION) during 36 months of follow-up. 
•  

TAKEAWAY: 

• Semaglutide use was associated with a higher risk for NAION in patients with type 2 diabetes (hazard ratio [HR], 4.28; 95% CI, 1.62-11.29).
• In patients with overweight or obesity, semaglutide again was linked to a higher risk for NAION (HR, 7.64; 95% CI, 2.21-26.36).
• Among patients with type 2 diabetes, the cumulative incidence of NAION over 36 months was 8.9% for those prescribed semaglutide vs 1.8% among those taking non–GLP-1 medications.
• For patients with overweight or obesity, the cumulative incidence of NAION over 36 months was 6.7% for the semaglutide cohort vs 0.8% for those in the other group. 

IN PRACTICE:

Semaglutide has “provided very significant benefits in many ways, but future discussions between a patient and their physician should include NAION as a potential risk,” study leader Joseph Rizzo, MD, with Mass Eye and Ear and Harvard Medical School, said in a news release about the findings. “It is important to appreciate, however, that the increased risk relates to a disorder that is relatively uncommon.”

“Given the numbers of participants who have been recruited to clinical trials and the large number of people globally who use GLP-1 RAs, we should be confident that if corroborated, the absolute risk of developing NAION in direct relation to taking semaglutide must indeed be rare,” Susan P. Mollan, MBcHB, of University Hospitals Birmingham NHS Foundation Trust, in England, wrote in a commentary published with the study. 
 

SOURCE:

The study was published online on July 3 in JAMA Ophthalmology.
 

LIMITATIONS: 

The patients were seen at a hospital that specializes in ophthalmology and has a specialized neuro-ophthalmology service, so the results may not fully apply to other settings. The results were driven by a relatively small number of NAION cases in the patients exposed to semaglutide. The study does not establish that semaglutide directly causes NAION, the researchers noted. “The best approaches to confirm, refute, or refine our findings would be to conduct a much larger, retrospective, multicenter population-based cohort study; a prospective, randomized clinical study; or a postmarket analysis of all GLP-1 RA drugs,” they wrote.

DISCLOSURES:

The study was supported by a grant from Research to Prevent Blindness. 
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE: 

Patients with type 2 diabetes, overweight, or obesity taking the glucagon-like peptide receptor agonist (GLP-1 RA) semaglutide appear to have an increased risk for an uncommon condition that can cause vision loss. 
 

METHODOLOGY:

• Researchers conducted a retrospective study of 16,827 patients at Massachusetts Eye and Ear in Boston.
• Their analysis focused on 710 patients with type 2 diabetes (194 of whom had been prescribed semaglutide) and 979 patients with overweight or obesity (361 prescribed semaglutide).
• The researchers compared patients prescribed semaglutide with those prescribed a medication other than a GLP-1 agent. They matched patients by factors such as age and sex and whether they had hypertension, obstructive sleep apnea, or coronary artery disease.
• They assessed the cumulative incidence of nonarteritic anterior ischemic optic neuropathy (NAION) during 36 months of follow-up. 
•  

TAKEAWAY: 

• Semaglutide use was associated with a higher risk for NAION in patients with type 2 diabetes (hazard ratio [HR], 4.28; 95% CI, 1.62-11.29).
• In patients with overweight or obesity, semaglutide again was linked to a higher risk for NAION (HR, 7.64; 95% CI, 2.21-26.36).
• Among patients with type 2 diabetes, the cumulative incidence of NAION over 36 months was 8.9% for those prescribed semaglutide vs 1.8% among those taking non–GLP-1 medications.
• For patients with overweight or obesity, the cumulative incidence of NAION over 36 months was 6.7% for the semaglutide cohort vs 0.8% for those in the other group. 

IN PRACTICE:

Semaglutide has “provided very significant benefits in many ways, but future discussions between a patient and their physician should include NAION as a potential risk,” study leader Joseph Rizzo, MD, with Mass Eye and Ear and Harvard Medical School, said in a news release about the findings. “It is important to appreciate, however, that the increased risk relates to a disorder that is relatively uncommon.”

“Given the numbers of participants who have been recruited to clinical trials and the large number of people globally who use GLP-1 RAs, we should be confident that if corroborated, the absolute risk of developing NAION in direct relation to taking semaglutide must indeed be rare,” Susan P. Mollan, MBcHB, of University Hospitals Birmingham NHS Foundation Trust, in England, wrote in a commentary published with the study. 
 

SOURCE:

The study was published online on July 3 in JAMA Ophthalmology.
 

LIMITATIONS: 

The patients were seen at a hospital that specializes in ophthalmology and has a specialized neuro-ophthalmology service, so the results may not fully apply to other settings. The results were driven by a relatively small number of NAION cases in the patients exposed to semaglutide. The study does not establish that semaglutide directly causes NAION, the researchers noted. “The best approaches to confirm, refute, or refine our findings would be to conduct a much larger, retrospective, multicenter population-based cohort study; a prospective, randomized clinical study; or a postmarket analysis of all GLP-1 RA drugs,” they wrote.

DISCLOSURES:

The study was supported by a grant from Research to Prevent Blindness. 
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Compared with placebo, administration of vocacapsaicin during bunionectomy reduces pain and decreases opioid consumption in the first 96 hours after surgery, with no local or systemic toxicity.

METHODOLOGY:

• This triple-blind, randomized, placebo-controlled trial included 147 patients undergoing bunionectomy.
• Patients were randomly assigned to receive 14 mL of either 0.05 mg/mL vocacapsaicin, 0.15 mg/mL vocacapsaicin, 0.30 mg/mL vocacapsaicin, or placebo at the surgical site during wound closure. Except for the study drug, all patients received identical perioperative analgesics.
• Patients were observed for 96 hours post-surgery, with follow-up visits on days 8, 15, and 29 to monitor for pain and adverse events.
• The primary endpoint was overall levels of pain at rest through the first 96 hours after surgery for the 0.30-mg/mL vocacapsaicin group.
• The secondary endpoints included the percentage of patients who did not require opioids and total opioid consumption through 96 hours, as well as pain scores during the first postoperative week.

TAKEAWAY:

• Vocacapsaicin (0.30 mg/mL) reduced pain at rest by 33% over the first 96 hours, compared with placebo (P = .005).
• Overall, 26% of patients who received the 0.30-mg/mL dose of vocacapsaicin did not require opioids through 96 hours compared with 5% of patients receiving placebo (P = .025).
• The researchers reported no difference in the rate, type, or severity of adverse events in the four study groups, consistent with typical recovery from bunionectomy.

IN PRACTICE:

“These data suggest that intraoperative administration of vocacapsaicin may provide substantial benefits in other surgical procedures,” the authors wrote.

SOURCE:

The study was led by Steven L. Shafer, MD, of the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University in Stanford, California, and published in the June 2024 issue of Anesthesiology.

LIMITATIONS:

The use of opioids was restricted from 0 to 96 hours after surgery, which did not reflect typical clinical practice. The range of vocacapsaicin concentrations tested may not have been extensive enough, as concentrations > 0.30 mg/mL might have provided better analgesia.

DISCLOSURES:

The study was supported by Concentric Analgesics. Two authors declared being employed by Concentric Analgesics. Other authors declared having several ties with many sources, including the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Compared with placebo, administration of vocacapsaicin during bunionectomy reduces pain and decreases opioid consumption in the first 96 hours after surgery, with no local or systemic toxicity.

METHODOLOGY:

• This triple-blind, randomized, placebo-controlled trial included 147 patients undergoing bunionectomy.
• Patients were randomly assigned to receive 14 mL of either 0.05 mg/mL vocacapsaicin, 0.15 mg/mL vocacapsaicin, 0.30 mg/mL vocacapsaicin, or placebo at the surgical site during wound closure. Except for the study drug, all patients received identical perioperative analgesics.
• Patients were observed for 96 hours post-surgery, with follow-up visits on days 8, 15, and 29 to monitor for pain and adverse events.
• The primary endpoint was overall levels of pain at rest through the first 96 hours after surgery for the 0.30-mg/mL vocacapsaicin group.
• The secondary endpoints included the percentage of patients who did not require opioids and total opioid consumption through 96 hours, as well as pain scores during the first postoperative week.

TAKEAWAY:

• Vocacapsaicin (0.30 mg/mL) reduced pain at rest by 33% over the first 96 hours, compared with placebo (P = .005).
• Overall, 26% of patients who received the 0.30-mg/mL dose of vocacapsaicin did not require opioids through 96 hours compared with 5% of patients receiving placebo (P = .025).
• The researchers reported no difference in the rate, type, or severity of adverse events in the four study groups, consistent with typical recovery from bunionectomy.

IN PRACTICE:

“These data suggest that intraoperative administration of vocacapsaicin may provide substantial benefits in other surgical procedures,” the authors wrote.

SOURCE:

The study was led by Steven L. Shafer, MD, of the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University in Stanford, California, and published in the June 2024 issue of Anesthesiology.

LIMITATIONS:

The use of opioids was restricted from 0 to 96 hours after surgery, which did not reflect typical clinical practice. The range of vocacapsaicin concentrations tested may not have been extensive enough, as concentrations > 0.30 mg/mL might have provided better analgesia.

DISCLOSURES:

The study was supported by Concentric Analgesics. Two authors declared being employed by Concentric Analgesics. Other authors declared having several ties with many sources, including the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Compared with placebo, administration of vocacapsaicin during bunionectomy reduces pain and decreases opioid consumption in the first 96 hours after surgery, with no local or systemic toxicity.

METHODOLOGY:

• This triple-blind, randomized, placebo-controlled trial included 147 patients undergoing bunionectomy.
• Patients were randomly assigned to receive 14 mL of either 0.05 mg/mL vocacapsaicin, 0.15 mg/mL vocacapsaicin, 0.30 mg/mL vocacapsaicin, or placebo at the surgical site during wound closure. Except for the study drug, all patients received identical perioperative analgesics.
• Patients were observed for 96 hours post-surgery, with follow-up visits on days 8, 15, and 29 to monitor for pain and adverse events.
• The primary endpoint was overall levels of pain at rest through the first 96 hours after surgery for the 0.30-mg/mL vocacapsaicin group.
• The secondary endpoints included the percentage of patients who did not require opioids and total opioid consumption through 96 hours, as well as pain scores during the first postoperative week.

TAKEAWAY:

• Vocacapsaicin (0.30 mg/mL) reduced pain at rest by 33% over the first 96 hours, compared with placebo (P = .005).
• Overall, 26% of patients who received the 0.30-mg/mL dose of vocacapsaicin did not require opioids through 96 hours compared with 5% of patients receiving placebo (P = .025).
• The researchers reported no difference in the rate, type, or severity of adverse events in the four study groups, consistent with typical recovery from bunionectomy.

IN PRACTICE:

“These data suggest that intraoperative administration of vocacapsaicin may provide substantial benefits in other surgical procedures,” the authors wrote.

SOURCE:

The study was led by Steven L. Shafer, MD, of the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University in Stanford, California, and published in the June 2024 issue of Anesthesiology.

LIMITATIONS:

The use of opioids was restricted from 0 to 96 hours after surgery, which did not reflect typical clinical practice. The range of vocacapsaicin concentrations tested may not have been extensive enough, as concentrations > 0.30 mg/mL might have provided better analgesia.

DISCLOSURES:

The study was supported by Concentric Analgesics. Two authors declared being employed by Concentric Analgesics. Other authors declared having several ties with many sources, including the funding agency.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

Hello. I’m Mark Lewis, director of gastrointestinal (GI) oncology at Intermountain Health in Utah. I’m speaking from the 2024 ASCO Annual Meeting in Chicago, where we’ve seen some interesting, new data in GI cancers.

If you allow me, I’d like to go in a craniocaudal fashion. It’s my anatomic mnemonic. I think that’s appropriate because our plenary session yesterday kicked off with some exciting data in esophageal cancer, specifically esophageal adenocarcinoma. 

This was the long-awaited ESOPEC trial. It’s a phase 3 study looking at perioperative FLOT (5-FU/leucovorin/oxaliplatin/docetaxel), a chemo triplet, vs the CROSS protocol, which is neoadjuvant chemoradiation with carboplatin and paclitaxel. The primary endpoint was overall survival, and at first blush, FLOT looked to be the true winner. There were some really remarkable milestones in this study, and I have some reservations about the FLOT arm that I’ll raise in just a second. 

The investigators are to be commended because in a truly deadly disease, they reported a 5-year overall survival in half of the patients who were receiving FLOT. That is truly commendable and really a milestone in our field. The reason I take a little bit of issue with the trial is that I still have some questions about methodology.

It wasn’t that long ago at ASCO GI that there was a really heated debate called “FLOT or Not” — not in this precise setting, but asking the question, do we think that patients with upper GI malignancy are even fit enough to handle a chemo triplet like FLOT? 

The reason I bring that up now in 2024 is that, to my surprise, and I think to many others’, there was a lower-than-expected completion rate of the patients in this trial who were receiving the CROSS regimen. The number of people who were able to complete that in full was about two-thirds, which compared with a historical control from a trial scheme that first emerged over a decade ago that used to be over 90% completion. I found that quite strange. 

I also think this trial suffers a little bit, and unavoidably, from the evolution of care that’s happened since it was first enrolling. Of course, I refer to adjuvant immunotherapy. Now, the real question is whether there is synergy between patients who receive radiation upfront and then adjuvant nivolumab, as per CheckMate 577. 

In her plenary discussion, I thought Dr. Karyn Goodman did a masterful job — I would encourage you to watch it on ASCO’s website —discussing how we can take all these data and reconcile them for optimal patient outcome. She ultimately suggested that we might deploy all four modalities in the management of these people. 

She proposed a paradigm with a PET-adapted, upfront induction chemotherapy, then moving to chemoradiation, then moving to surgery, and finally moving to immunotherapy. That is all four of the traditional arms of oncology. I find that really rather remarkable. Watch that space. This is a great trial with really remarkable survival data, but I’m not entirely convinced that the CROSS arm was given its due. 

Next up, I want to talk about pancreas cancer, which is something near and dear to my heart. It affects about one in four of my patients and it remains, unfortunately, a highly lethal disease. I think the top-line news from this meeting is that the KRAS mutation is druggable. I’m probably showing my age, but when I did my fellowship in 2009 through 2012, I was taught that KRAS was sort of the undruggable mutation par excellence. At this meeting, we’ve seen maturing data in regard to targeting KRAS G12C with both sotorasib and adagrasib. The disease control rates are astounding, at 80% and more, which is really remarkable. I wouldn’t have believed that even a few years ago. 

I’m even more excited about how we bring a rising tide that can lift all boats and apply this to other KRAS mutations, and not just KRAS G12C but all KRAS mutations. I think that’s coming, hopefully, with the pan-RAS inhibitors, because once that happens — if that happens; I’ll try not to be irrationally exuberant — that would take the traditional mutation found in almost all pancreas cancers and really make it its own Achilles heel. I think that could be such a huge leap forward. 

Another matter, however, that remains unresolved at this meeting is in the neoadjuvant setting with pancreatic ductal adenocarcinoma. There’s still equipoise, actually, between neoadjuvant gemcitabine, paclitaxel, and FOLFIRINOX. I thought that that was very well spelled out by some of our Dutch colleagues, who continue to do great work in a variety of cancers, including colorectal. 

Where I’d like to move next is colorectal cancer. Of course, immunotherapy remains a hot topic at all of these conferences. There were three different aspects of immunotherapy I’d like to highlight at this conference in regard to colon and rectal cancer. 

First, Dr. Heinz-Josef Lenz presented updated data from CheckMate 8HW, which looked at nivolumab and ipilimumab (nivo/ipi) vs chemotherapy in the first line for MSI-high or mismatch repair–deficient colon cancer. Once again, the data we’ve had now for several years at the 2-year mark are incredibly impressive. The 2-year progression-free survival (PFS) rates for nivo/ipi are above 70% and down at around 14% for chemo. 

What was impressive about this meeting is that Dr. Lenz presented PFS2, trying to determine the impact, if any, of subsequent therapy. What was going on here, which I think was ethically responsible by the investigators, was crossover. About two-thirds of the chemo arm crossed over to any form of immuno-oncology (IO), and just under a half crossed over to nivo and ipi. The PFS benefits continued with up-front IO. The way that Dr. Lenz phrased it is that you really never get the chance to win back the benefit that you would derive by giving immunotherapy first line to someone who has MSI-high or mismatch repair–deficient metastatic colon cancer. 

One thing that’s still not settled in my mind, though, is, does this really dethrone single-agent immunotherapy, such as pembrolizumab in KEYNOTE-177? What I’m really driving at is the ipilimumab. Is the juice worth the squeeze? Is the addition of an anti-CTLA4 agent worth the toxicity that we know comes along with that mechanism of action? Watch this space. 

I was also really interested in NEOPRISM-CRC, which looked at the role of immunotherapy in neoadjuvant down-staging of radiographically high-risk stage II or stage III colon cancer. Here, the investigators really make a strong case that, up front in these potentially respectable cases, not only should we know about mismatch repair deficiency but we should actually be interrogating further for tumor mutational burden (TMB). 

They had TMB-high patients. In fact, the median TMB was 42 mutations per megabase, with really impressive down-staging using three cycles of every-3-week pembrolizumab before surgery. Again, I really think we’re at an exciting time where, even for colon cancer that looks operable up front, we might actually have the opportunity to improve pathologic and clinical complete responses before and after surgery. 

Finally, I want to bring up what continues to amaze me. Two years ago, at ASCO 2022, we heard from Dr. Andrea Cercek and the Memorial Sloan Kettering group about the incredible experience they were having with neoadjuvant, or frankly, definitive dostarlimab in mismatch repair–deficient locally advanced rectal cancer. 

I remember being at the conference and there was simultaneous publication of that abstract in The New York Times because it was so remarkable. There was a 100% clinical complete response. The patients didn’t require radiation, they didn’t require chemotherapy, and they didn’t require surgery for locally advanced rectal cancer, provided there was this vulnerability of mismatch-repair deficiency. 

Now, 2 years later, Dr. Cercek and her group have updated those data with more than 40 patients, and again, a 100% clinical complete response, including mature, complete responses at over a year in about 20 patients. Again, we are really doing our rectal cancer patients a disservice if we’re not checking for mismatch-repair deficiency upfront, and especially if we’re not talking about them in multidisciplinary conferences. 

One of the things that absolutely blows my mind about rectal cancer is just how complicated it’s becoming. I think it is the standard of care to discuss these cases upfront with radiation oncology, surgical oncology, medical oncology, and pathology. 

Maybe the overarching message I would take from everything I’ve said today is that the oncologist without the pathologist is blind. It’s really a dyad, a partnership that guides optimal medical oncology care. As much as I love ASCO, I often wish we had more of our pathology colleagues here. I look forward to taking all the findings from this meeting back to the tumor board and really having a dynamic dialogue.

Dr. Lewis is director, Department of Gastrointestinal Oncology, Intermountain Health, Salt Lake City, Utah. He has disclosed no relevant financial relationships. 

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

Hello. I’m Mark Lewis, director of gastrointestinal (GI) oncology at Intermountain Health in Utah. I’m speaking from the 2024 ASCO Annual Meeting in Chicago, where we’ve seen some interesting, new data in GI cancers.

If you allow me, I’d like to go in a craniocaudal fashion. It’s my anatomic mnemonic. I think that’s appropriate because our plenary session yesterday kicked off with some exciting data in esophageal cancer, specifically esophageal adenocarcinoma. 

This was the long-awaited ESOPEC trial. It’s a phase 3 study looking at perioperative FLOT (5-FU/leucovorin/oxaliplatin/docetaxel), a chemo triplet, vs the CROSS protocol, which is neoadjuvant chemoradiation with carboplatin and paclitaxel. The primary endpoint was overall survival, and at first blush, FLOT looked to be the true winner. There were some really remarkable milestones in this study, and I have some reservations about the FLOT arm that I’ll raise in just a second. 

The investigators are to be commended because in a truly deadly disease, they reported a 5-year overall survival in half of the patients who were receiving FLOT. That is truly commendable and really a milestone in our field. The reason I take a little bit of issue with the trial is that I still have some questions about methodology.

It wasn’t that long ago at ASCO GI that there was a really heated debate called “FLOT or Not” — not in this precise setting, but asking the question, do we think that patients with upper GI malignancy are even fit enough to handle a chemo triplet like FLOT? 

The reason I bring that up now in 2024 is that, to my surprise, and I think to many others’, there was a lower-than-expected completion rate of the patients in this trial who were receiving the CROSS regimen. The number of people who were able to complete that in full was about two-thirds, which compared with a historical control from a trial scheme that first emerged over a decade ago that used to be over 90% completion. I found that quite strange. 

I also think this trial suffers a little bit, and unavoidably, from the evolution of care that’s happened since it was first enrolling. Of course, I refer to adjuvant immunotherapy. Now, the real question is whether there is synergy between patients who receive radiation upfront and then adjuvant nivolumab, as per CheckMate 577. 

In her plenary discussion, I thought Dr. Karyn Goodman did a masterful job — I would encourage you to watch it on ASCO’s website —discussing how we can take all these data and reconcile them for optimal patient outcome. She ultimately suggested that we might deploy all four modalities in the management of these people. 

She proposed a paradigm with a PET-adapted, upfront induction chemotherapy, then moving to chemoradiation, then moving to surgery, and finally moving to immunotherapy. That is all four of the traditional arms of oncology. I find that really rather remarkable. Watch that space. This is a great trial with really remarkable survival data, but I’m not entirely convinced that the CROSS arm was given its due. 

Next up, I want to talk about pancreas cancer, which is something near and dear to my heart. It affects about one in four of my patients and it remains, unfortunately, a highly lethal disease. I think the top-line news from this meeting is that the KRAS mutation is druggable. I’m probably showing my age, but when I did my fellowship in 2009 through 2012, I was taught that KRAS was sort of the undruggable mutation par excellence. At this meeting, we’ve seen maturing data in regard to targeting KRAS G12C with both sotorasib and adagrasib. The disease control rates are astounding, at 80% and more, which is really remarkable. I wouldn’t have believed that even a few years ago. 

I’m even more excited about how we bring a rising tide that can lift all boats and apply this to other KRAS mutations, and not just KRAS G12C but all KRAS mutations. I think that’s coming, hopefully, with the pan-RAS inhibitors, because once that happens — if that happens; I’ll try not to be irrationally exuberant — that would take the traditional mutation found in almost all pancreas cancers and really make it its own Achilles heel. I think that could be such a huge leap forward. 

Another matter, however, that remains unresolved at this meeting is in the neoadjuvant setting with pancreatic ductal adenocarcinoma. There’s still equipoise, actually, between neoadjuvant gemcitabine, paclitaxel, and FOLFIRINOX. I thought that that was very well spelled out by some of our Dutch colleagues, who continue to do great work in a variety of cancers, including colorectal. 

Where I’d like to move next is colorectal cancer. Of course, immunotherapy remains a hot topic at all of these conferences. There were three different aspects of immunotherapy I’d like to highlight at this conference in regard to colon and rectal cancer. 

First, Dr. Heinz-Josef Lenz presented updated data from CheckMate 8HW, which looked at nivolumab and ipilimumab (nivo/ipi) vs chemotherapy in the first line for MSI-high or mismatch repair–deficient colon cancer. Once again, the data we’ve had now for several years at the 2-year mark are incredibly impressive. The 2-year progression-free survival (PFS) rates for nivo/ipi are above 70% and down at around 14% for chemo. 

What was impressive about this meeting is that Dr. Lenz presented PFS2, trying to determine the impact, if any, of subsequent therapy. What was going on here, which I think was ethically responsible by the investigators, was crossover. About two-thirds of the chemo arm crossed over to any form of immuno-oncology (IO), and just under a half crossed over to nivo and ipi. The PFS benefits continued with up-front IO. The way that Dr. Lenz phrased it is that you really never get the chance to win back the benefit that you would derive by giving immunotherapy first line to someone who has MSI-high or mismatch repair–deficient metastatic colon cancer. 

One thing that’s still not settled in my mind, though, is, does this really dethrone single-agent immunotherapy, such as pembrolizumab in KEYNOTE-177? What I’m really driving at is the ipilimumab. Is the juice worth the squeeze? Is the addition of an anti-CTLA4 agent worth the toxicity that we know comes along with that mechanism of action? Watch this space. 

I was also really interested in NEOPRISM-CRC, which looked at the role of immunotherapy in neoadjuvant down-staging of radiographically high-risk stage II or stage III colon cancer. Here, the investigators really make a strong case that, up front in these potentially respectable cases, not only should we know about mismatch repair deficiency but we should actually be interrogating further for tumor mutational burden (TMB). 

They had TMB-high patients. In fact, the median TMB was 42 mutations per megabase, with really impressive down-staging using three cycles of every-3-week pembrolizumab before surgery. Again, I really think we’re at an exciting time where, even for colon cancer that looks operable up front, we might actually have the opportunity to improve pathologic and clinical complete responses before and after surgery. 

Finally, I want to bring up what continues to amaze me. Two years ago, at ASCO 2022, we heard from Dr. Andrea Cercek and the Memorial Sloan Kettering group about the incredible experience they were having with neoadjuvant, or frankly, definitive dostarlimab in mismatch repair–deficient locally advanced rectal cancer. 

I remember being at the conference and there was simultaneous publication of that abstract in The New York Times because it was so remarkable. There was a 100% clinical complete response. The patients didn’t require radiation, they didn’t require chemotherapy, and they didn’t require surgery for locally advanced rectal cancer, provided there was this vulnerability of mismatch-repair deficiency. 

Now, 2 years later, Dr. Cercek and her group have updated those data with more than 40 patients, and again, a 100% clinical complete response, including mature, complete responses at over a year in about 20 patients. Again, we are really doing our rectal cancer patients a disservice if we’re not checking for mismatch-repair deficiency upfront, and especially if we’re not talking about them in multidisciplinary conferences. 

One of the things that absolutely blows my mind about rectal cancer is just how complicated it’s becoming. I think it is the standard of care to discuss these cases upfront with radiation oncology, surgical oncology, medical oncology, and pathology. 

Maybe the overarching message I would take from everything I’ve said today is that the oncologist without the pathologist is blind. It’s really a dyad, a partnership that guides optimal medical oncology care. As much as I love ASCO, I often wish we had more of our pathology colleagues here. I look forward to taking all the findings from this meeting back to the tumor board and really having a dynamic dialogue.

Dr. Lewis is director, Department of Gastrointestinal Oncology, Intermountain Health, Salt Lake City, Utah. He has disclosed no relevant financial relationships. 

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity. 

Hello. I’m Mark Lewis, director of gastrointestinal (GI) oncology at Intermountain Health in Utah. I’m speaking from the 2024 ASCO Annual Meeting in Chicago, where we’ve seen some interesting, new data in GI cancers.

If you allow me, I’d like to go in a craniocaudal fashion. It’s my anatomic mnemonic. I think that’s appropriate because our plenary session yesterday kicked off with some exciting data in esophageal cancer, specifically esophageal adenocarcinoma. 

This was the long-awaited ESOPEC trial. It’s a phase 3 study looking at perioperative FLOT (5-FU/leucovorin/oxaliplatin/docetaxel), a chemo triplet, vs the CROSS protocol, which is neoadjuvant chemoradiation with carboplatin and paclitaxel. The primary endpoint was overall survival, and at first blush, FLOT looked to be the true winner. There were some really remarkable milestones in this study, and I have some reservations about the FLOT arm that I’ll raise in just a second. 

The investigators are to be commended because in a truly deadly disease, they reported a 5-year overall survival in half of the patients who were receiving FLOT. That is truly commendable and really a milestone in our field. The reason I take a little bit of issue with the trial is that I still have some questions about methodology.

It wasn’t that long ago at ASCO GI that there was a really heated debate called “FLOT or Not” — not in this precise setting, but asking the question, do we think that patients with upper GI malignancy are even fit enough to handle a chemo triplet like FLOT? 

The reason I bring that up now in 2024 is that, to my surprise, and I think to many others’, there was a lower-than-expected completion rate of the patients in this trial who were receiving the CROSS regimen. The number of people who were able to complete that in full was about two-thirds, which compared with a historical control from a trial scheme that first emerged over a decade ago that used to be over 90% completion. I found that quite strange. 

I also think this trial suffers a little bit, and unavoidably, from the evolution of care that’s happened since it was first enrolling. Of course, I refer to adjuvant immunotherapy. Now, the real question is whether there is synergy between patients who receive radiation upfront and then adjuvant nivolumab, as per CheckMate 577. 

In her plenary discussion, I thought Dr. Karyn Goodman did a masterful job — I would encourage you to watch it on ASCO’s website —discussing how we can take all these data and reconcile them for optimal patient outcome. She ultimately suggested that we might deploy all four modalities in the management of these people. 

She proposed a paradigm with a PET-adapted, upfront induction chemotherapy, then moving to chemoradiation, then moving to surgery, and finally moving to immunotherapy. That is all four of the traditional arms of oncology. I find that really rather remarkable. Watch that space. This is a great trial with really remarkable survival data, but I’m not entirely convinced that the CROSS arm was given its due. 

Next up, I want to talk about pancreas cancer, which is something near and dear to my heart. It affects about one in four of my patients and it remains, unfortunately, a highly lethal disease. I think the top-line news from this meeting is that the KRAS mutation is druggable. I’m probably showing my age, but when I did my fellowship in 2009 through 2012, I was taught that KRAS was sort of the undruggable mutation par excellence. At this meeting, we’ve seen maturing data in regard to targeting KRAS G12C with both sotorasib and adagrasib. The disease control rates are astounding, at 80% and more, which is really remarkable. I wouldn’t have believed that even a few years ago. 

I’m even more excited about how we bring a rising tide that can lift all boats and apply this to other KRAS mutations, and not just KRAS G12C but all KRAS mutations. I think that’s coming, hopefully, with the pan-RAS inhibitors, because once that happens — if that happens; I’ll try not to be irrationally exuberant — that would take the traditional mutation found in almost all pancreas cancers and really make it its own Achilles heel. I think that could be such a huge leap forward. 

Another matter, however, that remains unresolved at this meeting is in the neoadjuvant setting with pancreatic ductal adenocarcinoma. There’s still equipoise, actually, between neoadjuvant gemcitabine, paclitaxel, and FOLFIRINOX. I thought that that was very well spelled out by some of our Dutch colleagues, who continue to do great work in a variety of cancers, including colorectal. 

Where I’d like to move next is colorectal cancer. Of course, immunotherapy remains a hot topic at all of these conferences. There were three different aspects of immunotherapy I’d like to highlight at this conference in regard to colon and rectal cancer. 

First, Dr. Heinz-Josef Lenz presented updated data from CheckMate 8HW, which looked at nivolumab and ipilimumab (nivo/ipi) vs chemotherapy in the first line for MSI-high or mismatch repair–deficient colon cancer. Once again, the data we’ve had now for several years at the 2-year mark are incredibly impressive. The 2-year progression-free survival (PFS) rates for nivo/ipi are above 70% and down at around 14% for chemo. 

What was impressive about this meeting is that Dr. Lenz presented PFS2, trying to determine the impact, if any, of subsequent therapy. What was going on here, which I think was ethically responsible by the investigators, was crossover. About two-thirds of the chemo arm crossed over to any form of immuno-oncology (IO), and just under a half crossed over to nivo and ipi. The PFS benefits continued with up-front IO. The way that Dr. Lenz phrased it is that you really never get the chance to win back the benefit that you would derive by giving immunotherapy first line to someone who has MSI-high or mismatch repair–deficient metastatic colon cancer. 

One thing that’s still not settled in my mind, though, is, does this really dethrone single-agent immunotherapy, such as pembrolizumab in KEYNOTE-177? What I’m really driving at is the ipilimumab. Is the juice worth the squeeze? Is the addition of an anti-CTLA4 agent worth the toxicity that we know comes along with that mechanism of action? Watch this space. 

I was also really interested in NEOPRISM-CRC, which looked at the role of immunotherapy in neoadjuvant down-staging of radiographically high-risk stage II or stage III colon cancer. Here, the investigators really make a strong case that, up front in these potentially respectable cases, not only should we know about mismatch repair deficiency but we should actually be interrogating further for tumor mutational burden (TMB). 

They had TMB-high patients. In fact, the median TMB was 42 mutations per megabase, with really impressive down-staging using three cycles of every-3-week pembrolizumab before surgery. Again, I really think we’re at an exciting time where, even for colon cancer that looks operable up front, we might actually have the opportunity to improve pathologic and clinical complete responses before and after surgery. 

Finally, I want to bring up what continues to amaze me. Two years ago, at ASCO 2022, we heard from Dr. Andrea Cercek and the Memorial Sloan Kettering group about the incredible experience they were having with neoadjuvant, or frankly, definitive dostarlimab in mismatch repair–deficient locally advanced rectal cancer. 

I remember being at the conference and there was simultaneous publication of that abstract in The New York Times because it was so remarkable. There was a 100% clinical complete response. The patients didn’t require radiation, they didn’t require chemotherapy, and they didn’t require surgery for locally advanced rectal cancer, provided there was this vulnerability of mismatch-repair deficiency. 

Now, 2 years later, Dr. Cercek and her group have updated those data with more than 40 patients, and again, a 100% clinical complete response, including mature, complete responses at over a year in about 20 patients. Again, we are really doing our rectal cancer patients a disservice if we’re not checking for mismatch-repair deficiency upfront, and especially if we’re not talking about them in multidisciplinary conferences. 

One of the things that absolutely blows my mind about rectal cancer is just how complicated it’s becoming. I think it is the standard of care to discuss these cases upfront with radiation oncology, surgical oncology, medical oncology, and pathology. 

Maybe the overarching message I would take from everything I’ve said today is that the oncologist without the pathologist is blind. It’s really a dyad, a partnership that guides optimal medical oncology care. As much as I love ASCO, I often wish we had more of our pathology colleagues here. I look forward to taking all the findings from this meeting back to the tumor board and really having a dynamic dialogue.

Dr. Lewis is director, Department of Gastrointestinal Oncology, Intermountain Health, Salt Lake City, Utah. He has disclosed no relevant financial relationships. 

A version of this article appeared on Medscape.com.

Replacing meat with plant-based meat alternatives (PBMAs) can improve cardiovascular disease risk factors, including low-density lipoprotein cholesterol (LDL-C), a review of randomized controlled trials suggested.

Long-term randomized controlled trials and prospective cohort studies that evaluate cardiovascular disease events such as myocardial infarction and stroke are needed to draw definitive conclusions, according to the authors.

“Our take-home is that plant-based meats are a healthy alternative to animal meat, based on intermediate cardiovascular endpoints such as lipids, triglycerides, blood pressure, and other cardiovascular disease risk factors,” said senior author Ehud Ur, MB, professor of medicine at the University of British Columbia, Vancouver, in Canada, and an endocrinologist at St. Paul’s Hospital in Vancouver.

“However, we also found that there’s a lack of clinical outcome trials that would determine definitively whether plant-based meats are healthy. But certainly, everything points in the direction of cardiovascular benefit,” said Dr. Ur.

The review was published on June 25 in the Canadian Journal of Cardiology.
 

Ultraprocessed Foods

PBMAs are foods that mimic meats and contain ingredients such as protein derivatives from soy, pea, wheat, and fungi. A growing number of Canadians are limiting meat or excluding it from their diets. Some are opting to eat PBMAs instead.

But most PBMAs are classified as ultraprocessed foods. Such foods are produced primarily from substances extracted from whole food sources, such as sugar, salt, oil, and protein. Alternatively, they may be created in a laboratory using flavor enhancers and food coloring. This classification has caused the public and health professionals to question the potential health implications of PBMAs, said Dr. Ur.

“One of the concerns is that these products are highly processed, and things that are highly processed are considered bad. And so, are you swapping one set of risks for another?” he said.

To shed more light on this question, Dr. Ur’s team, which was led by Matthew Nagra, ND, of the Vancouver Naturopathic Clinic, assessed the literature on PBMAs and their impact on health.

“While the plant-based meat market has experienced significant growth in recent years and more and more Canadians are enjoying plant-based burgers, surprisingly little is known about how these meat alternatives may impact health and, in particular, cardiovascular disease risk,” Dr. Nagra said in a statement. “Thus, we sought to review the available literature on the topic to identify what is currently known and to provide direction for future research.”
 

Less Saturated Fat, Cholesterol

The researchers assessed the literature that was published from 1970 to 2023 on PBMAs, their contents, nutritional profiles, and impact on cardiovascular disease risk factors, such as cholesterol levels and blood pressure.

They found that, compared with meat, PBMAs had less saturated fat, less cholesterol, more fiber, more carbohydrates, fewer calories, less monounsaturated fat, more polyunsaturated fat, and more sodium.

In addition, several randomized controlled trials showed that PBMAs reduced total cholesterol and LDL-C, as well as apolipoprotein B-100, body weight, and waist circumference. PBMAs were not shown to raise blood pressure, despite some products’ high sodium content.

“No currently available evidence suggests that the concerning aspects of PBMAs (eg, food processing and high sodium content) negate the potential cardiovascular benefits,” wrote the researchers.

Unfortunately, no long-term research has evaluated how these alternatives may affect the risk of developing a myocardial infarction or stroke. Similarly, there is little research on the healthfulness of some common components of PBMAs, such as vital wheat gluten.

To shed light on these important issues would require large clinical trials, involving many patients, and great expense, said Dr. Ur. “Drug companies can afford to do large clinical trials, even if they are expensive to do, because they must do them to get approval for their drug. But these plant-based meats are produced by companies that most likely are not able to do clinical outcome trials. Such trials would have to be done by the National Institutes of Health in the United States, or in Canada, the National Research Council,” he said.

There are many reasons to avoid meat, Dr. Ur added. “There are ethical reasons against killing animals. Then there is the issue of global warming. Meat is a very expensive source of food energy. As an individual, the biggest impact you can make on global warming is to not eat meat. Then there is the argument about personal health, which is where our study comes in. For those people who like the taste of meat and who struggle with giving it up, the PBMAs allow them to have a reasonably diverse diet,” he said.
 

Are Eggs Healthy?

Meat substitutes are helpful for people who want to reduce their cardiovascular disease risk, J. David Spence, MD, professor emeritus of neurology and clinical pharmacology at the University of Western Ontario in London, Canada, wrote in an accompanying editorial.

“Eating too much meat and egg yolk increases cardiovascular risk, and it’s a challenge for patients to learn to eat less meat and cut out egg yolks. If we can find good substitutes that are tasty and enjoyable, that’s a good thing,” Dr. Spence told this news organization.

“Besides plant-based meat substitutes, there is great potential for reduction of cardiovascular risk with the use of egg substitutes,” he said.

Dr. Spence pointed out that two large egg yolks contain 474 mg of cholesterol, almost twice the amount contained in a Hardee’s Monster Thickburger (265 mg).

Cholesterol elevates plasma levels of toxic metabolites of the intestinal microbiome, such as trimethylamine N-oxide (TMAO). Plasma levels of TMAO increase in a linear fashion with egg consumption, and TMAO is bad for the arteries, said Dr. Spence.

“Eggs are terrible and should not be eaten by people at risk for cardiovascular disease. But people don’t understand that because the egg marketing propaganda has been so effective. The yolk is terrible. The egg marketing board is extremely effective in persuading people that eggs are healthy, and they’re not.”

Dr. Spence recommends using egg substitutes, such as Egg Beaters or Better’n Eggs, instead of whole eggs, and says it’s never too late to switch. “That’s the mistake people make, but the arteries can actually improve,” he said.

No funding source for the study was reported. Dr. Ur and Dr. Spence reported having no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Replacing meat with plant-based meat alternatives (PBMAs) can improve cardiovascular disease risk factors, including low-density lipoprotein cholesterol (LDL-C), a review of randomized controlled trials suggested.

Long-term randomized controlled trials and prospective cohort studies that evaluate cardiovascular disease events such as myocardial infarction and stroke are needed to draw definitive conclusions, according to the authors.

“Our take-home is that plant-based meats are a healthy alternative to animal meat, based on intermediate cardiovascular endpoints such as lipids, triglycerides, blood pressure, and other cardiovascular disease risk factors,” said senior author Ehud Ur, MB, professor of medicine at the University of British Columbia, Vancouver, in Canada, and an endocrinologist at St. Paul’s Hospital in Vancouver.

“However, we also found that there’s a lack of clinical outcome trials that would determine definitively whether plant-based meats are healthy. But certainly, everything points in the direction of cardiovascular benefit,” said Dr. Ur.

The review was published on June 25 in the Canadian Journal of Cardiology.
 

Ultraprocessed Foods

PBMAs are foods that mimic meats and contain ingredients such as protein derivatives from soy, pea, wheat, and fungi. A growing number of Canadians are limiting meat or excluding it from their diets. Some are opting to eat PBMAs instead.

But most PBMAs are classified as ultraprocessed foods. Such foods are produced primarily from substances extracted from whole food sources, such as sugar, salt, oil, and protein. Alternatively, they may be created in a laboratory using flavor enhancers and food coloring. This classification has caused the public and health professionals to question the potential health implications of PBMAs, said Dr. Ur.

“One of the concerns is that these products are highly processed, and things that are highly processed are considered bad. And so, are you swapping one set of risks for another?” he said.

To shed more light on this question, Dr. Ur’s team, which was led by Matthew Nagra, ND, of the Vancouver Naturopathic Clinic, assessed the literature on PBMAs and their impact on health.

“While the plant-based meat market has experienced significant growth in recent years and more and more Canadians are enjoying plant-based burgers, surprisingly little is known about how these meat alternatives may impact health and, in particular, cardiovascular disease risk,” Dr. Nagra said in a statement. “Thus, we sought to review the available literature on the topic to identify what is currently known and to provide direction for future research.”
 

Less Saturated Fat, Cholesterol

The researchers assessed the literature that was published from 1970 to 2023 on PBMAs, their contents, nutritional profiles, and impact on cardiovascular disease risk factors, such as cholesterol levels and blood pressure.

They found that, compared with meat, PBMAs had less saturated fat, less cholesterol, more fiber, more carbohydrates, fewer calories, less monounsaturated fat, more polyunsaturated fat, and more sodium.

In addition, several randomized controlled trials showed that PBMAs reduced total cholesterol and LDL-C, as well as apolipoprotein B-100, body weight, and waist circumference. PBMAs were not shown to raise blood pressure, despite some products’ high sodium content.

“No currently available evidence suggests that the concerning aspects of PBMAs (eg, food processing and high sodium content) negate the potential cardiovascular benefits,” wrote the researchers.

Unfortunately, no long-term research has evaluated how these alternatives may affect the risk of developing a myocardial infarction or stroke. Similarly, there is little research on the healthfulness of some common components of PBMAs, such as vital wheat gluten.

To shed light on these important issues would require large clinical trials, involving many patients, and great expense, said Dr. Ur. “Drug companies can afford to do large clinical trials, even if they are expensive to do, because they must do them to get approval for their drug. But these plant-based meats are produced by companies that most likely are not able to do clinical outcome trials. Such trials would have to be done by the National Institutes of Health in the United States, or in Canada, the National Research Council,” he said.

There are many reasons to avoid meat, Dr. Ur added. “There are ethical reasons against killing animals. Then there is the issue of global warming. Meat is a very expensive source of food energy. As an individual, the biggest impact you can make on global warming is to not eat meat. Then there is the argument about personal health, which is where our study comes in. For those people who like the taste of meat and who struggle with giving it up, the PBMAs allow them to have a reasonably diverse diet,” he said.
 

Are Eggs Healthy?

Meat substitutes are helpful for people who want to reduce their cardiovascular disease risk, J. David Spence, MD, professor emeritus of neurology and clinical pharmacology at the University of Western Ontario in London, Canada, wrote in an accompanying editorial.

“Eating too much meat and egg yolk increases cardiovascular risk, and it’s a challenge for patients to learn to eat less meat and cut out egg yolks. If we can find good substitutes that are tasty and enjoyable, that’s a good thing,” Dr. Spence told this news organization.

“Besides plant-based meat substitutes, there is great potential for reduction of cardiovascular risk with the use of egg substitutes,” he said.

Dr. Spence pointed out that two large egg yolks contain 474 mg of cholesterol, almost twice the amount contained in a Hardee’s Monster Thickburger (265 mg).

Cholesterol elevates plasma levels of toxic metabolites of the intestinal microbiome, such as trimethylamine N-oxide (TMAO). Plasma levels of TMAO increase in a linear fashion with egg consumption, and TMAO is bad for the arteries, said Dr. Spence.

“Eggs are terrible and should not be eaten by people at risk for cardiovascular disease. But people don’t understand that because the egg marketing propaganda has been so effective. The yolk is terrible. The egg marketing board is extremely effective in persuading people that eggs are healthy, and they’re not.”

Dr. Spence recommends using egg substitutes, such as Egg Beaters or Better’n Eggs, instead of whole eggs, and says it’s never too late to switch. “That’s the mistake people make, but the arteries can actually improve,” he said.

No funding source for the study was reported. Dr. Ur and Dr. Spence reported having no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Replacing meat with plant-based meat alternatives (PBMAs) can improve cardiovascular disease risk factors, including low-density lipoprotein cholesterol (LDL-C), a review of randomized controlled trials suggested.

Long-term randomized controlled trials and prospective cohort studies that evaluate cardiovascular disease events such as myocardial infarction and stroke are needed to draw definitive conclusions, according to the authors.

“Our take-home is that plant-based meats are a healthy alternative to animal meat, based on intermediate cardiovascular endpoints such as lipids, triglycerides, blood pressure, and other cardiovascular disease risk factors,” said senior author Ehud Ur, MB, professor of medicine at the University of British Columbia, Vancouver, in Canada, and an endocrinologist at St. Paul’s Hospital in Vancouver.

“However, we also found that there’s a lack of clinical outcome trials that would determine definitively whether plant-based meats are healthy. But certainly, everything points in the direction of cardiovascular benefit,” said Dr. Ur.

The review was published on June 25 in the Canadian Journal of Cardiology.
 

Ultraprocessed Foods

PBMAs are foods that mimic meats and contain ingredients such as protein derivatives from soy, pea, wheat, and fungi. A growing number of Canadians are limiting meat or excluding it from their diets. Some are opting to eat PBMAs instead.

But most PBMAs are classified as ultraprocessed foods. Such foods are produced primarily from substances extracted from whole food sources, such as sugar, salt, oil, and protein. Alternatively, they may be created in a laboratory using flavor enhancers and food coloring. This classification has caused the public and health professionals to question the potential health implications of PBMAs, said Dr. Ur.

“One of the concerns is that these products are highly processed, and things that are highly processed are considered bad. And so, are you swapping one set of risks for another?” he said.

To shed more light on this question, Dr. Ur’s team, which was led by Matthew Nagra, ND, of the Vancouver Naturopathic Clinic, assessed the literature on PBMAs and their impact on health.

“While the plant-based meat market has experienced significant growth in recent years and more and more Canadians are enjoying plant-based burgers, surprisingly little is known about how these meat alternatives may impact health and, in particular, cardiovascular disease risk,” Dr. Nagra said in a statement. “Thus, we sought to review the available literature on the topic to identify what is currently known and to provide direction for future research.”
 

Less Saturated Fat, Cholesterol

The researchers assessed the literature that was published from 1970 to 2023 on PBMAs, their contents, nutritional profiles, and impact on cardiovascular disease risk factors, such as cholesterol levels and blood pressure.

They found that, compared with meat, PBMAs had less saturated fat, less cholesterol, more fiber, more carbohydrates, fewer calories, less monounsaturated fat, more polyunsaturated fat, and more sodium.

In addition, several randomized controlled trials showed that PBMAs reduced total cholesterol and LDL-C, as well as apolipoprotein B-100, body weight, and waist circumference. PBMAs were not shown to raise blood pressure, despite some products’ high sodium content.

“No currently available evidence suggests that the concerning aspects of PBMAs (eg, food processing and high sodium content) negate the potential cardiovascular benefits,” wrote the researchers.

Unfortunately, no long-term research has evaluated how these alternatives may affect the risk of developing a myocardial infarction or stroke. Similarly, there is little research on the healthfulness of some common components of PBMAs, such as vital wheat gluten.

To shed light on these important issues would require large clinical trials, involving many patients, and great expense, said Dr. Ur. “Drug companies can afford to do large clinical trials, even if they are expensive to do, because they must do them to get approval for their drug. But these plant-based meats are produced by companies that most likely are not able to do clinical outcome trials. Such trials would have to be done by the National Institutes of Health in the United States, or in Canada, the National Research Council,” he said.

There are many reasons to avoid meat, Dr. Ur added. “There are ethical reasons against killing animals. Then there is the issue of global warming. Meat is a very expensive source of food energy. As an individual, the biggest impact you can make on global warming is to not eat meat. Then there is the argument about personal health, which is where our study comes in. For those people who like the taste of meat and who struggle with giving it up, the PBMAs allow them to have a reasonably diverse diet,” he said.
 

Are Eggs Healthy?

Meat substitutes are helpful for people who want to reduce their cardiovascular disease risk, J. David Spence, MD, professor emeritus of neurology and clinical pharmacology at the University of Western Ontario in London, Canada, wrote in an accompanying editorial.

“Eating too much meat and egg yolk increases cardiovascular risk, and it’s a challenge for patients to learn to eat less meat and cut out egg yolks. If we can find good substitutes that are tasty and enjoyable, that’s a good thing,” Dr. Spence told this news organization.

“Besides plant-based meat substitutes, there is great potential for reduction of cardiovascular risk with the use of egg substitutes,” he said.

Dr. Spence pointed out that two large egg yolks contain 474 mg of cholesterol, almost twice the amount contained in a Hardee’s Monster Thickburger (265 mg).

Cholesterol elevates plasma levels of toxic metabolites of the intestinal microbiome, such as trimethylamine N-oxide (TMAO). Plasma levels of TMAO increase in a linear fashion with egg consumption, and TMAO is bad for the arteries, said Dr. Spence.

“Eggs are terrible and should not be eaten by people at risk for cardiovascular disease. But people don’t understand that because the egg marketing propaganda has been so effective. The yolk is terrible. The egg marketing board is extremely effective in persuading people that eggs are healthy, and they’re not.”

Dr. Spence recommends using egg substitutes, such as Egg Beaters or Better’n Eggs, instead of whole eggs, and says it’s never too late to switch. “That’s the mistake people make, but the arteries can actually improve,” he said.

No funding source for the study was reported. Dr. Ur and Dr. Spence reported having no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of patients with difficult-to-treat rheumatoid arthritis (D2T RA) no longer met the criteria for that status at the end of a 5-year period by achieving disease remission or low disease activity with additional treatment modifications.

METHODOLOGY:

• This retrospective cohort study included 150 patients with D2T RA, as defined by the European Alliance of Associations for Rheumatology, in 2018 at Keio University Hospital, Tokyo.
• The researchers followed patients until 2023 and collected data on demographics, treatment changes, disease activity, and outcomes.
• D2T RA resolution was defined as achieving remission or low disease activity for ≥ 3 consecutive months.

TAKEAWAY:

• Overall, 45% of patients achieved resolution of D2T RA at a mean duration of 24.1 months.
• Treatment changes were more frequent in patients with resolved disease vs those with persistent D2T RA (83.6% vs 58.7%; P = .002).
• Patients with resolved D2T RA were more frequently treated with interleukin-6 receptor inhibitors in 2023 vs 2018 (35.8% vs 20.0%; P = .04) and less often treated with prednisolone (14.9% vs 38.7%; P < .001).
• Over 5 years, 5% of the patients died; increased glucocorticoid doses were linked to mortality (P = .002).

IN PRACTICE:

“Although a treatment strategy for difficult-to-treat RA has not yet been established, our study suggests that the optimal treatment choice for patients with difficult-to-treat RA is distinct, based on the causes,” wrote the authors.

SOURCE:

The study was led by Satoshi Takanashi, MD, PhD, from Keio University School of Medicine in Tokyo. It was published online in Rheumatology.

LIMITATIONS:

The study’s single-center design and relatively small sample size may limit the generalizability of the findings. Treatment changes were decided by attending doctors, which could introduce bias. The investigators were also unable to determine the impact of any comorbid fibromyalgia in the patients.

DISCLOSURES:

The study was supported by the JCR Grant for Promoting Research for Difficult-to-Treat Rheumatoid Arthritis, a KAKENHI grant from the Japan Society for the Promotion of Science, and Keio University Medical Science Fund. Each of the study’s three authors reported financial relationships with various manufacturers of drugs for RA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of patients with difficult-to-treat rheumatoid arthritis (D2T RA) no longer met the criteria for that status at the end of a 5-year period by achieving disease remission or low disease activity with additional treatment modifications.

METHODOLOGY:

• This retrospective cohort study included 150 patients with D2T RA, as defined by the European Alliance of Associations for Rheumatology, in 2018 at Keio University Hospital, Tokyo.
• The researchers followed patients until 2023 and collected data on demographics, treatment changes, disease activity, and outcomes.
• D2T RA resolution was defined as achieving remission or low disease activity for ≥ 3 consecutive months.

TAKEAWAY:

• Overall, 45% of patients achieved resolution of D2T RA at a mean duration of 24.1 months.
• Treatment changes were more frequent in patients with resolved disease vs those with persistent D2T RA (83.6% vs 58.7%; P = .002).
• Patients with resolved D2T RA were more frequently treated with interleukin-6 receptor inhibitors in 2023 vs 2018 (35.8% vs 20.0%; P = .04) and less often treated with prednisolone (14.9% vs 38.7%; P < .001).
• Over 5 years, 5% of the patients died; increased glucocorticoid doses were linked to mortality (P = .002).

IN PRACTICE:

“Although a treatment strategy for difficult-to-treat RA has not yet been established, our study suggests that the optimal treatment choice for patients with difficult-to-treat RA is distinct, based on the causes,” wrote the authors.

SOURCE:

The study was led by Satoshi Takanashi, MD, PhD, from Keio University School of Medicine in Tokyo. It was published online in Rheumatology.

LIMITATIONS:

The study’s single-center design and relatively small sample size may limit the generalizability of the findings. Treatment changes were decided by attending doctors, which could introduce bias. The investigators were also unable to determine the impact of any comorbid fibromyalgia in the patients.

DISCLOSURES:

The study was supported by the JCR Grant for Promoting Research for Difficult-to-Treat Rheumatoid Arthritis, a KAKENHI grant from the Japan Society for the Promotion of Science, and Keio University Medical Science Fund. Each of the study’s three authors reported financial relationships with various manufacturers of drugs for RA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Nearly half of patients with difficult-to-treat rheumatoid arthritis (D2T RA) no longer met the criteria for that status at the end of a 5-year period by achieving disease remission or low disease activity with additional treatment modifications.

METHODOLOGY:

• This retrospective cohort study included 150 patients with D2T RA, as defined by the European Alliance of Associations for Rheumatology, in 2018 at Keio University Hospital, Tokyo.
• The researchers followed patients until 2023 and collected data on demographics, treatment changes, disease activity, and outcomes.
• D2T RA resolution was defined as achieving remission or low disease activity for ≥ 3 consecutive months.

TAKEAWAY:

• Overall, 45% of patients achieved resolution of D2T RA at a mean duration of 24.1 months.
• Treatment changes were more frequent in patients with resolved disease vs those with persistent D2T RA (83.6% vs 58.7%; P = .002).
• Patients with resolved D2T RA were more frequently treated with interleukin-6 receptor inhibitors in 2023 vs 2018 (35.8% vs 20.0%; P = .04) and less often treated with prednisolone (14.9% vs 38.7%; P < .001).
• Over 5 years, 5% of the patients died; increased glucocorticoid doses were linked to mortality (P = .002).

IN PRACTICE:

“Although a treatment strategy for difficult-to-treat RA has not yet been established, our study suggests that the optimal treatment choice for patients with difficult-to-treat RA is distinct, based on the causes,” wrote the authors.

SOURCE:

The study was led by Satoshi Takanashi, MD, PhD, from Keio University School of Medicine in Tokyo. It was published online in Rheumatology.

LIMITATIONS:

The study’s single-center design and relatively small sample size may limit the generalizability of the findings. Treatment changes were decided by attending doctors, which could introduce bias. The investigators were also unable to determine the impact of any comorbid fibromyalgia in the patients.

DISCLOSURES:

The study was supported by the JCR Grant for Promoting Research for Difficult-to-Treat Rheumatoid Arthritis, a KAKENHI grant from the Japan Society for the Promotion of Science, and Keio University Medical Science Fund. Each of the study’s three authors reported financial relationships with various manufacturers of drugs for RA.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Hepatitis B (Hep B) is a liver infection against which vaccination was previously recommended for certain eligible risk groups. However, in 2022, the Centers for Disease Control and Prevention (CDC) switched from recommending vaccination for at-risk persons to recommending universal vaccination for children and adults.

That includes infants, children 18 years of age and younger, adults aged 19-59, and people aged 60 and up with risk factors for this viral infection. Even those aged 60 and older without known risk factors for hepatitis B may receive Hep B vaccines.

Risk factors under prior recommendations included potential criminal or stigmatizing behaviors such as injection-drug use, incarceration, or multiple sex partners, which limited risk assessment by providers. The CDC points out that universal adult Hep B vaccination through age 59 obviates the need for the previous approach of risk-factor screening and sensitive disclosures to determine eligibility and could increase vaccination coverage and reduce cases.

“A universal recommendation for Hep B vaccination could increase the number of persons who receive vaccination before the onset of chronic liver disease and other comorbidities (e.g., obesity or diabetes) that might make vaccination less effective,” the CDC stated, noting that patients with chronic liver disease have a reduced immune response to Hep B vaccination. Hep B vaccination also protects against hepatitis D.

“Most people born in the US are vaccinated during infancy, beginning on the first day of life,” Lauren D. Block, MD, an internist at Northwell Health and an assistant professor in the Institute of Health System Science at the Feinstein Institutes for Medical Research at sites in metropolitan New York City, said in an interview.

Feinstein Institute for Medical Research

Typically, Dr. Block added, at-risk persons will have titers drawn to make sure they are immune to Hep B. “Titers can wane over the decades in healthy people, in which case a booster shot may be needed, or a restart of the three-part vaccination series if a person is not sure if they were vaccinated previously.” Those at greater risk include people with weakened immune systems, people with diabetes or on immunosuppressives, healthcare workers, travelers to higher-risk countries, people with multiple sexual partners, and IV drug users.

Although Hep B vaccines have demonstrated safety, immunogenicity, and efficacy during the past four decades, coverage among US adults has been suboptimal, limiting further reduction in infections, the CDC noted.

Hepatitis A

Though not widely endemic to North America, Hep A can be acquired during travel abroad, particularly to developing countries, or through exposure to unsanitary conditions and contaminated food or water.

The CDC recommends routine Hep A vaccination for all children aged 12-23 months, all unvaccinated children and adolescents 2-18 years, and all persons, including those who are pregnant, with increased risk factors for this orally and fecally transmitted infection or at risk for severe disease from it. At-risk groups include international travelers to affected regions, men who have sex with men, incarcerated individuals or group-home residents, injection and non-injection drug users, and homeless persons.
 

Hepatitis C and E

There is no vaccine for Hep C, and no FDA-approved vaccine in the United States for hepatitis E, although a vaccine for the latter was approved in China in 2012.

As with Hep A, observing strict water, food, and sanitation standards is essential for preventing infection with hepatitis E.

Dr. Block disclosed no competing interests relevant to her comments.

Hepatitis B (Hep B) is a liver infection against which vaccination was previously recommended for certain eligible risk groups. However, in 2022, the Centers for Disease Control and Prevention (CDC) switched from recommending vaccination for at-risk persons to recommending universal vaccination for children and adults.

That includes infants, children 18 years of age and younger, adults aged 19-59, and people aged 60 and up with risk factors for this viral infection. Even those aged 60 and older without known risk factors for hepatitis B may receive Hep B vaccines.

Risk factors under prior recommendations included potential criminal or stigmatizing behaviors such as injection-drug use, incarceration, or multiple sex partners, which limited risk assessment by providers. The CDC points out that universal adult Hep B vaccination through age 59 obviates the need for the previous approach of risk-factor screening and sensitive disclosures to determine eligibility and could increase vaccination coverage and reduce cases.

“A universal recommendation for Hep B vaccination could increase the number of persons who receive vaccination before the onset of chronic liver disease and other comorbidities (e.g., obesity or diabetes) that might make vaccination less effective,” the CDC stated, noting that patients with chronic liver disease have a reduced immune response to Hep B vaccination. Hep B vaccination also protects against hepatitis D.

“Most people born in the US are vaccinated during infancy, beginning on the first day of life,” Lauren D. Block, MD, an internist at Northwell Health and an assistant professor in the Institute of Health System Science at the Feinstein Institutes for Medical Research at sites in metropolitan New York City, said in an interview.

Feinstein Institute for Medical Research

Typically, Dr. Block added, at-risk persons will have titers drawn to make sure they are immune to Hep B. “Titers can wane over the decades in healthy people, in which case a booster shot may be needed, or a restart of the three-part vaccination series if a person is not sure if they were vaccinated previously.” Those at greater risk include people with weakened immune systems, people with diabetes or on immunosuppressives, healthcare workers, travelers to higher-risk countries, people with multiple sexual partners, and IV drug users.

Although Hep B vaccines have demonstrated safety, immunogenicity, and efficacy during the past four decades, coverage among US adults has been suboptimal, limiting further reduction in infections, the CDC noted.

Hepatitis A

Though not widely endemic to North America, Hep A can be acquired during travel abroad, particularly to developing countries, or through exposure to unsanitary conditions and contaminated food or water.

The CDC recommends routine Hep A vaccination for all children aged 12-23 months, all unvaccinated children and adolescents 2-18 years, and all persons, including those who are pregnant, with increased risk factors for this orally and fecally transmitted infection or at risk for severe disease from it. At-risk groups include international travelers to affected regions, men who have sex with men, incarcerated individuals or group-home residents, injection and non-injection drug users, and homeless persons.
 

Hepatitis C and E

There is no vaccine for Hep C, and no FDA-approved vaccine in the United States for hepatitis E, although a vaccine for the latter was approved in China in 2012.

As with Hep A, observing strict water, food, and sanitation standards is essential for preventing infection with hepatitis E.

Dr. Block disclosed no competing interests relevant to her comments.

Hepatitis B (Hep B) is a liver infection against which vaccination was previously recommended for certain eligible risk groups. However, in 2022, the Centers for Disease Control and Prevention (CDC) switched from recommending vaccination for at-risk persons to recommending universal vaccination for children and adults.

That includes infants, children 18 years of age and younger, adults aged 19-59, and people aged 60 and up with risk factors for this viral infection. Even those aged 60 and older without known risk factors for hepatitis B may receive Hep B vaccines.

Risk factors under prior recommendations included potential criminal or stigmatizing behaviors such as injection-drug use, incarceration, or multiple sex partners, which limited risk assessment by providers. The CDC points out that universal adult Hep B vaccination through age 59 obviates the need for the previous approach of risk-factor screening and sensitive disclosures to determine eligibility and could increase vaccination coverage and reduce cases.

“A universal recommendation for Hep B vaccination could increase the number of persons who receive vaccination before the onset of chronic liver disease and other comorbidities (e.g., obesity or diabetes) that might make vaccination less effective,” the CDC stated, noting that patients with chronic liver disease have a reduced immune response to Hep B vaccination. Hep B vaccination also protects against hepatitis D.

“Most people born in the US are vaccinated during infancy, beginning on the first day of life,” Lauren D. Block, MD, an internist at Northwell Health and an assistant professor in the Institute of Health System Science at the Feinstein Institutes for Medical Research at sites in metropolitan New York City, said in an interview.

Feinstein Institute for Medical Research

Typically, Dr. Block added, at-risk persons will have titers drawn to make sure they are immune to Hep B. “Titers can wane over the decades in healthy people, in which case a booster shot may be needed, or a restart of the three-part vaccination series if a person is not sure if they were vaccinated previously.” Those at greater risk include people with weakened immune systems, people with diabetes or on immunosuppressives, healthcare workers, travelers to higher-risk countries, people with multiple sexual partners, and IV drug users.

Although Hep B vaccines have demonstrated safety, immunogenicity, and efficacy during the past four decades, coverage among US adults has been suboptimal, limiting further reduction in infections, the CDC noted.

Hepatitis A

Though not widely endemic to North America, Hep A can be acquired during travel abroad, particularly to developing countries, or through exposure to unsanitary conditions and contaminated food or water.

The CDC recommends routine Hep A vaccination for all children aged 12-23 months, all unvaccinated children and adolescents 2-18 years, and all persons, including those who are pregnant, with increased risk factors for this orally and fecally transmitted infection or at risk for severe disease from it. At-risk groups include international travelers to affected regions, men who have sex with men, incarcerated individuals or group-home residents, injection and non-injection drug users, and homeless persons.
 

Hepatitis C and E

There is no vaccine for Hep C, and no FDA-approved vaccine in the United States for hepatitis E, although a vaccine for the latter was approved in China in 2012.

As with Hep A, observing strict water, food, and sanitation standards is essential for preventing infection with hepatitis E.

Dr. Block disclosed no competing interests relevant to her comments.