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Brews, Bubbles, & Booze: Stroke Risk and Patients’ Favorite Drinks

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Changed
Tue, 11/05/2024 - 13:25

A growing body of research explores the link between stroke risk and regular consumption of coffee, tea, soda, and alcohol. This research roundup reviews the latest findings, highlighting both promising insights and remaining uncertainties to help guide discussions with your patients.

Coffee and Tea: Good or Bad? 

In the INTERSTROKE study, high coffee consumption (> 4 cups daily) was associated with an significantly increased risk for all strokes (odds ratio [OR], 1.37) or ischemic stroke (OR, 1.31), while low to moderate coffee had no link to increased stroke risk. In contrast, tea consumption was associated with lower odds of all stroke (OR, 0.81 for highest intake) or ischemic stroke (OR, 0.81). 

In a recent UK Biobank study, consumption of coffee or tea was associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages. 

Specifically, the investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia versus those who did not.

A recent systematic review and dose-response meta-analysis showed that each daily cup increase in tea was associated with an average 4% reduced risk for stroke and a 2% reduced risk for cardiovascular disease (CVD) events. 

The protective effect of coffee and tea on stroke risk may be driven, in part, by flavonoids, which have antioxidant and anti-inflammatory properties, as well as positive effects on vascular function.

“The advice to patients should be that coffee and tea may protect against stroke, but that sweetening either beverage with sugar probably should be minimized,” said Cheryl Bushnell, MD, MHS, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, and chair of the American Stroke Association (ASA) 2024 Guideline for the Primary Prevention of Stroke

Taylor Wallace, PhD, a certified food scientist, said, “most people should consume a cup or two of unsweetened tea per day in moderation for cardiometabolic health. It is an easy step in the right direction for good health but not a cure-all.”

When it comes to coffee, adults who like it should drink it “in moderation — just lay off the cream and sugar,” said Wallace, adjunct associate professor at George Washington University, Washington, DC, and Tufts University, Boston, Massachusetts.

“A cup or two of black coffee with low-fat or nonfat milk with breakfast is a healthy way to start the day, especially when you’re like me and have an 8-year-old that is full of energy!” Wallace said. 
 

The Skinny on Soda

When it comes to sugar-sweetened and diet beverages, data from the Nurses’ Health Study and Health Professionals Follow-Up Study, showed a 16% increased risk for stroke with one or more daily servings of sugar-sweetened or low-calorie soda per day (vs none), independent of established dietary and nondietary cardiovascular risk factors. 

In the Women’s Health Initiative Observational Study of postmenopausal women, a higher intake of artificially sweetened beverages was associated with increased risk for all stroke (adjusted hazard ratio [aHR], 1.23), ischemic stroke (aHR, 1.31), coronary heart disease (aHR, 1.29) and all-cause mortality (aHR, 1.16).

In the Framingham Heart Study Offspring cohort, consumption of one can of diet soda or more each day (vs none) was associated with a nearly threefold increased risk for stroke and dementia over a 10-year follow-up period. 

A separate French study showed that total artificial sweetener intake from all sources was associated with increased overall risk for cardiovascular and cerebrovascular disease.

However, given the limitations of these studies, it’s hard to draw any firm conclusions, Wallace cautioned. 

“We know that sugar-sweetened beverages are correlated with weight gain and cardiometabolic dysfunction promotion in children and adults,” he said. 

Yet, “there really isn’t any convincing evidence that diet soda has much impact on human health at all. Most observational studies are mixed and likely very confounded by other diet and lifestyle factors. That doesn’t mean go overboard; a daily diet soda is probably fine, but that doesn’t mean go drink 10 of them every day,” he added. 
 

 

 

Alcohol: Moderation or Abstinence?

Evidence on alcohol use and stroke risk have been mixed over the years. For decades, the evidence was suggestive that a moderate amount of alcohol daily (one to two drinks in men and one drink in women) may be beneficial at reducing major vascular outcomes.

Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. And the detrimental effects of excessive alcohol use are clear. 

large meta-analysis showed that light to moderate alcohol consumption (up to one drink per day) was associated with a reduced risk for ischemic stroke. However, heavy drinking (more than two drinks per day) significantly increased the risk for both ischemic and hemorrhagic stroke.

A separate study showed young adults who are moderate to heavy drinkers are at increased risk for stroke — and the risk increases with more years of imbibing.

In the INTERSTROKE study, high to moderate alcohol consumption was associated with increased stroke risk, whereas low alcohol consumption conferred no increased risk. 

However, Bushnell pointed out that the study data was derived from based on self-report, and that other healthy behaviors may counteract the risk for alcohol consumption.

“For alcohol, regardless of stroke risk, the most important data shows that any alcohol consumption is associated with worse cognitive function, so generally, the lower the alcohol consumption the better,” Bushnell said. 

She noted that, currently, the American Heart Association (AHA)/ASA recommend a maximum of two drinks per day for men and one drink per day for women to reduce stroke risk.

“However, the data for the risk for cognitive impairment with any alcohol is convincing and should be kept in mind in addition to the maximum alcohol recommended by the AHA/ASA,” Bushnell advised. 

“We know excessive intake puts you at major risk for CVD, cancer, cognitive decline, and a whole host of other health ailments — no question there,” said Wallace.

The impact of moderate intake, on the other hand, is less clear. “Alcohol is a highly biased and political issue and the evidence (or lack thereof) on both sides is shoddy at best,” Wallace added.

A key challenge is that accurate self-reporting of alcohol intake is difficult, even for scientists, and most studies rely on self-reported data from observational cohorts. These often include limited dietary assessments, which provide only a partial picture of long-term consumption patterns, Wallace noted. 

“The short answer is we don’t know if moderation is beneficial, detrimental, or null with respect to health,” he said.

Bushnell reports no relevant disclosures. Wallace (www.drtaylorwallace.com) is CEO of Think Healthy Group; editor of The Journal of Dietary Supplements, deputy editor of The Journal of the American Nutrition Association (www.nutrition.org), nutrition section editor of Annals of Medicine, and an advisory board member with Forbes Health.

A version of this article appeared on Medscape.com.

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A growing body of research explores the link between stroke risk and regular consumption of coffee, tea, soda, and alcohol. This research roundup reviews the latest findings, highlighting both promising insights and remaining uncertainties to help guide discussions with your patients.

Coffee and Tea: Good or Bad? 

In the INTERSTROKE study, high coffee consumption (> 4 cups daily) was associated with an significantly increased risk for all strokes (odds ratio [OR], 1.37) or ischemic stroke (OR, 1.31), while low to moderate coffee had no link to increased stroke risk. In contrast, tea consumption was associated with lower odds of all stroke (OR, 0.81 for highest intake) or ischemic stroke (OR, 0.81). 

In a recent UK Biobank study, consumption of coffee or tea was associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages. 

Specifically, the investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia versus those who did not.

A recent systematic review and dose-response meta-analysis showed that each daily cup increase in tea was associated with an average 4% reduced risk for stroke and a 2% reduced risk for cardiovascular disease (CVD) events. 

The protective effect of coffee and tea on stroke risk may be driven, in part, by flavonoids, which have antioxidant and anti-inflammatory properties, as well as positive effects on vascular function.

“The advice to patients should be that coffee and tea may protect against stroke, but that sweetening either beverage with sugar probably should be minimized,” said Cheryl Bushnell, MD, MHS, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, and chair of the American Stroke Association (ASA) 2024 Guideline for the Primary Prevention of Stroke

Taylor Wallace, PhD, a certified food scientist, said, “most people should consume a cup or two of unsweetened tea per day in moderation for cardiometabolic health. It is an easy step in the right direction for good health but not a cure-all.”

When it comes to coffee, adults who like it should drink it “in moderation — just lay off the cream and sugar,” said Wallace, adjunct associate professor at George Washington University, Washington, DC, and Tufts University, Boston, Massachusetts.

“A cup or two of black coffee with low-fat or nonfat milk with breakfast is a healthy way to start the day, especially when you’re like me and have an 8-year-old that is full of energy!” Wallace said. 
 

The Skinny on Soda

When it comes to sugar-sweetened and diet beverages, data from the Nurses’ Health Study and Health Professionals Follow-Up Study, showed a 16% increased risk for stroke with one or more daily servings of sugar-sweetened or low-calorie soda per day (vs none), independent of established dietary and nondietary cardiovascular risk factors. 

In the Women’s Health Initiative Observational Study of postmenopausal women, a higher intake of artificially sweetened beverages was associated with increased risk for all stroke (adjusted hazard ratio [aHR], 1.23), ischemic stroke (aHR, 1.31), coronary heart disease (aHR, 1.29) and all-cause mortality (aHR, 1.16).

In the Framingham Heart Study Offspring cohort, consumption of one can of diet soda or more each day (vs none) was associated with a nearly threefold increased risk for stroke and dementia over a 10-year follow-up period. 

A separate French study showed that total artificial sweetener intake from all sources was associated with increased overall risk for cardiovascular and cerebrovascular disease.

However, given the limitations of these studies, it’s hard to draw any firm conclusions, Wallace cautioned. 

“We know that sugar-sweetened beverages are correlated with weight gain and cardiometabolic dysfunction promotion in children and adults,” he said. 

Yet, “there really isn’t any convincing evidence that diet soda has much impact on human health at all. Most observational studies are mixed and likely very confounded by other diet and lifestyle factors. That doesn’t mean go overboard; a daily diet soda is probably fine, but that doesn’t mean go drink 10 of them every day,” he added. 
 

 

 

Alcohol: Moderation or Abstinence?

Evidence on alcohol use and stroke risk have been mixed over the years. For decades, the evidence was suggestive that a moderate amount of alcohol daily (one to two drinks in men and one drink in women) may be beneficial at reducing major vascular outcomes.

Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. And the detrimental effects of excessive alcohol use are clear. 

large meta-analysis showed that light to moderate alcohol consumption (up to one drink per day) was associated with a reduced risk for ischemic stroke. However, heavy drinking (more than two drinks per day) significantly increased the risk for both ischemic and hemorrhagic stroke.

A separate study showed young adults who are moderate to heavy drinkers are at increased risk for stroke — and the risk increases with more years of imbibing.

In the INTERSTROKE study, high to moderate alcohol consumption was associated with increased stroke risk, whereas low alcohol consumption conferred no increased risk. 

However, Bushnell pointed out that the study data was derived from based on self-report, and that other healthy behaviors may counteract the risk for alcohol consumption.

“For alcohol, regardless of stroke risk, the most important data shows that any alcohol consumption is associated with worse cognitive function, so generally, the lower the alcohol consumption the better,” Bushnell said. 

She noted that, currently, the American Heart Association (AHA)/ASA recommend a maximum of two drinks per day for men and one drink per day for women to reduce stroke risk.

“However, the data for the risk for cognitive impairment with any alcohol is convincing and should be kept in mind in addition to the maximum alcohol recommended by the AHA/ASA,” Bushnell advised. 

“We know excessive intake puts you at major risk for CVD, cancer, cognitive decline, and a whole host of other health ailments — no question there,” said Wallace.

The impact of moderate intake, on the other hand, is less clear. “Alcohol is a highly biased and political issue and the evidence (or lack thereof) on both sides is shoddy at best,” Wallace added.

A key challenge is that accurate self-reporting of alcohol intake is difficult, even for scientists, and most studies rely on self-reported data from observational cohorts. These often include limited dietary assessments, which provide only a partial picture of long-term consumption patterns, Wallace noted. 

“The short answer is we don’t know if moderation is beneficial, detrimental, or null with respect to health,” he said.

Bushnell reports no relevant disclosures. Wallace (www.drtaylorwallace.com) is CEO of Think Healthy Group; editor of The Journal of Dietary Supplements, deputy editor of The Journal of the American Nutrition Association (www.nutrition.org), nutrition section editor of Annals of Medicine, and an advisory board member with Forbes Health.

A version of this article appeared on Medscape.com.

A growing body of research explores the link between stroke risk and regular consumption of coffee, tea, soda, and alcohol. This research roundup reviews the latest findings, highlighting both promising insights and remaining uncertainties to help guide discussions with your patients.

Coffee and Tea: Good or Bad? 

In the INTERSTROKE study, high coffee consumption (> 4 cups daily) was associated with an significantly increased risk for all strokes (odds ratio [OR], 1.37) or ischemic stroke (OR, 1.31), while low to moderate coffee had no link to increased stroke risk. In contrast, tea consumption was associated with lower odds of all stroke (OR, 0.81 for highest intake) or ischemic stroke (OR, 0.81). 

In a recent UK Biobank study, consumption of coffee or tea was associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages. 

Specifically, the investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia versus those who did not.

A recent systematic review and dose-response meta-analysis showed that each daily cup increase in tea was associated with an average 4% reduced risk for stroke and a 2% reduced risk for cardiovascular disease (CVD) events. 

The protective effect of coffee and tea on stroke risk may be driven, in part, by flavonoids, which have antioxidant and anti-inflammatory properties, as well as positive effects on vascular function.

“The advice to patients should be that coffee and tea may protect against stroke, but that sweetening either beverage with sugar probably should be minimized,” said Cheryl Bushnell, MD, MHS, of Wake Forest University School of Medicine in Winston-Salem, North Carolina, and chair of the American Stroke Association (ASA) 2024 Guideline for the Primary Prevention of Stroke

Taylor Wallace, PhD, a certified food scientist, said, “most people should consume a cup or two of unsweetened tea per day in moderation for cardiometabolic health. It is an easy step in the right direction for good health but not a cure-all.”

When it comes to coffee, adults who like it should drink it “in moderation — just lay off the cream and sugar,” said Wallace, adjunct associate professor at George Washington University, Washington, DC, and Tufts University, Boston, Massachusetts.

“A cup or two of black coffee with low-fat or nonfat milk with breakfast is a healthy way to start the day, especially when you’re like me and have an 8-year-old that is full of energy!” Wallace said. 
 

The Skinny on Soda

When it comes to sugar-sweetened and diet beverages, data from the Nurses’ Health Study and Health Professionals Follow-Up Study, showed a 16% increased risk for stroke with one or more daily servings of sugar-sweetened or low-calorie soda per day (vs none), independent of established dietary and nondietary cardiovascular risk factors. 

In the Women’s Health Initiative Observational Study of postmenopausal women, a higher intake of artificially sweetened beverages was associated with increased risk for all stroke (adjusted hazard ratio [aHR], 1.23), ischemic stroke (aHR, 1.31), coronary heart disease (aHR, 1.29) and all-cause mortality (aHR, 1.16).

In the Framingham Heart Study Offspring cohort, consumption of one can of diet soda or more each day (vs none) was associated with a nearly threefold increased risk for stroke and dementia over a 10-year follow-up period. 

A separate French study showed that total artificial sweetener intake from all sources was associated with increased overall risk for cardiovascular and cerebrovascular disease.

However, given the limitations of these studies, it’s hard to draw any firm conclusions, Wallace cautioned. 

“We know that sugar-sweetened beverages are correlated with weight gain and cardiometabolic dysfunction promotion in children and adults,” he said. 

Yet, “there really isn’t any convincing evidence that diet soda has much impact on human health at all. Most observational studies are mixed and likely very confounded by other diet and lifestyle factors. That doesn’t mean go overboard; a daily diet soda is probably fine, but that doesn’t mean go drink 10 of them every day,” he added. 
 

 

 

Alcohol: Moderation or Abstinence?

Evidence on alcohol use and stroke risk have been mixed over the years. For decades, the evidence was suggestive that a moderate amount of alcohol daily (one to two drinks in men and one drink in women) may be beneficial at reducing major vascular outcomes.

Yet, over the past few years, some research has found no evidence of benefit with moderate alcohol intake. And the detrimental effects of excessive alcohol use are clear. 

large meta-analysis showed that light to moderate alcohol consumption (up to one drink per day) was associated with a reduced risk for ischemic stroke. However, heavy drinking (more than two drinks per day) significantly increased the risk for both ischemic and hemorrhagic stroke.

A separate study showed young adults who are moderate to heavy drinkers are at increased risk for stroke — and the risk increases with more years of imbibing.

In the INTERSTROKE study, high to moderate alcohol consumption was associated with increased stroke risk, whereas low alcohol consumption conferred no increased risk. 

However, Bushnell pointed out that the study data was derived from based on self-report, and that other healthy behaviors may counteract the risk for alcohol consumption.

“For alcohol, regardless of stroke risk, the most important data shows that any alcohol consumption is associated with worse cognitive function, so generally, the lower the alcohol consumption the better,” Bushnell said. 

She noted that, currently, the American Heart Association (AHA)/ASA recommend a maximum of two drinks per day for men and one drink per day for women to reduce stroke risk.

“However, the data for the risk for cognitive impairment with any alcohol is convincing and should be kept in mind in addition to the maximum alcohol recommended by the AHA/ASA,” Bushnell advised. 

“We know excessive intake puts you at major risk for CVD, cancer, cognitive decline, and a whole host of other health ailments — no question there,” said Wallace.

The impact of moderate intake, on the other hand, is less clear. “Alcohol is a highly biased and political issue and the evidence (or lack thereof) on both sides is shoddy at best,” Wallace added.

A key challenge is that accurate self-reporting of alcohol intake is difficult, even for scientists, and most studies rely on self-reported data from observational cohorts. These often include limited dietary assessments, which provide only a partial picture of long-term consumption patterns, Wallace noted. 

“The short answer is we don’t know if moderation is beneficial, detrimental, or null with respect to health,” he said.

Bushnell reports no relevant disclosures. Wallace (www.drtaylorwallace.com) is CEO of Think Healthy Group; editor of The Journal of Dietary Supplements, deputy editor of The Journal of the American Nutrition Association (www.nutrition.org), nutrition section editor of Annals of Medicine, and an advisory board member with Forbes Health.

A version of this article appeared on Medscape.com.

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Silent Epidemic: Loneliness a Serious Threat to Both Brain and Body

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Changed
Fri, 11/08/2024 - 02:18

In a world that is more connected than ever, a silent epidemic is taking its toll. Overall, one in three US adults report chronic loneliness — a condition so detrimental that it rivals smoking and obesity with respect to its negative effect on health and well-being. From anxiety and depression to life-threatening conditions like cardiovascular disease, stroke, and Alzheimer’s and Parkinson’s diseases, loneliness is more than an emotion — it’s a serious threat to both the brain and body.

In 2023, a US Surgeon General advisory raised the alarm about the national problem of loneliness and isolation, describing it as an epidemic.

“Given the significant health consequences of loneliness and isolation, we must prioritize building social connection in the same way we have prioritized other critical public health issues such as tobacco, obesity, and substance use disorders. Together, we can build a country that’s healthier, more resilient, less lonely, and more connected,” the report concluded.

But how, exactly, does chronic loneliness affect the physiology and function of the brain? What does the latest research reveal about the link between loneliness and neurologic and psychiatric illness, and what can clinicians do to address the issue?

This news organization spoke to multiple experts in the field to explore these issues.
 

A Major Risk Factor

Anna Finley, PhD, assistant professor of psychology at North Dakota State University, Fargo, explained that loneliness and social isolation are different entities. Social isolation is an objective measure of the number of people someone interacts with on a regular basis, whereas loneliness is a subjective feeling that occurs when close connections are lacking.

“These two things are not actually as related as you think they would be. People can feel lonely in a crowd or feel well connected with only a few friendships. It’s more about the quality of the connection and the quality of your perception of it. So someone could be in some very supportive relationships but still feel that there’s something missing,” she said in an interview.

So what do we know about how loneliness affects health? Evidence supporting the hypothesis that loneliness is an emerging risk factor for many diseases is steadily building.

Recently, the American Heart Association published a statement summarizing the evidence for a direct association between social isolation and loneliness and coronary heart disease and stroke mortality.

In addition, many studies have shown that individuals experiencing social isolation or loneliness have an increased risk for anxiety and depression, dementia, infectious disease, hospitalization, and all-cause death, even after adjusting for age and many other traditional risk factors.

One study revealed that eliminating loneliness has the potential to prevent nearly 20% of cases of depression in adults aged 50 years or older.

Indu Subramanian, MD, professor of neurology at the University of California, Los Angeles, and colleagues conducted a study involving patients with Parkinson’s disease, which showed that the negative impact of loneliness on disease severity was as significant as the positive effects of 30 minutes of daily exercise.

“The importance of loneliness is under-recognized and undervalued, and it poses a major risk for health outcomes and quality of life,” said Subramanian.

Subramanian noted that loneliness is stigmatizing, causing people to feel unlikable and blame themselves, which prevents them from opening up to doctors or loved ones about their struggle. At the same time, healthcare providers may not think to ask about loneliness or know about potential interventions. She emphasized that much more work is needed to address this issue.
 

 

 

Early Mortality Risk

Julianne Holt-Lunstad, PhD, professor of psychology and neuroscience at Brigham Young University in Provo, Utah, is the author of two large meta-analyses that suggest loneliness, social isolation, or living alone are independent risk factors for early mortality, increasing this risk by about a third — the equivalent to the risk of smoking 15 cigarettes per day.

“We have quite robust evidence across a number of health outcomes implicating the harmful effects of loneliness and social isolation. While these are observational studies and show mainly associations, we do have evidence from longitudinal studies that show lacking social connection, whether that be loneliness or social isolation, predicts subsequent worse outcomes, and most of these studies have adjusted for alternative kinds of explanations, like age, initial health status, lifestyle factors,” Holt-Lunstad said.

There is some evidence to suggest that isolation is more predictive of physical health outcomes, whereas loneliness is more predictive of mental health outcomes. That said, both isolation and loneliness have significant effects on mental and physical health outcomes, she noted.

There is also the question of whether loneliness is causing poor health or whether people who are in poor health feel lonely because poor health can lead to social isolation.

Finley said there’s probably a bit of both going on, but longitudinal studies, where loneliness is measured at a fixed timepoint then health outcomes are reported a few years later, suggest that loneliness is contributing to these adverse outcomes.

She added that there is also some evidence in animal models to suggest that loneliness is a causal risk factor for adverse health outcomes. “But you can’t ask a mouse or rat how lonely they’re feeling. All you can do is house them individually — removing them from social connection. This isn’t necessarily the same thing as loneliness in humans.”

Finley is studying mechanisms in the brain that may be involved in mediating the adverse health consequences of loneliness.

“What I’ve been seeing in the data so far is that it tends to be the self-report of how lonely folks are feeling that has the associations with differences in the brain, as opposed to the number of social connections people have. It does seem to be the more subjective, emotional perception of loneliness that is important.”

In a review of potential mechanisms involved, she concluded that it is dysregulated emotions and altered perceptions of social interactions that has profound impacts on the brain, suggesting that people who are lonely may have a tendency to interpret social cues in a negative way, preventing them from forming productive positive relationships.
 

Lack of Trust

One researcher who has studied this phenomenon is Dirk Scheele, PhD, professor of social neuroscience at Ruhr University Bochum in Germany.

“We were interested to find out why people remained lonely,” he said in an interview. “Loneliness is an unpleasant experience, and there are so many opportunities for social contacts nowadays, it’s not really clear at first sight why people are chronically lonely.”

To examine this question, Scheele and his team conducted a study in which functional MRI was used to examine the brain in otherwise healthy individuals with high or low loneliness scores while they played a trust game.

They also simulated a positive social interaction between participants and researchers, in which they talked about plans for a fictitious lottery win, and about their hobbies and interests, during which mood was measured with questionnaires, and saliva samples were collected to measure hormone levels.

Results showed that the high-lonely individuals had reduced activation in the insula cortex during the trust decisions. “This area of the brain is involved in the processing of bodily signals, such as ‘gut feelings.’ So reduced activity here could be interpreted as fewer gut feelings on who can be trusted,” Scheele explained.

The high-lonely individuals also had reduced responsiveness to the positive social interaction with a lower release of oxytocin and a smaller elevation in mood compared with the control individuals.

Scheele pointed out that there is some evidence that oxytocin might increase trust, and there is reduced release of endogenous oxytocin in high loneliness.

“Our results are consistent with the idea that loneliness is associated with negative biases about other people. So if we expect negative things from other people — for instance, that they cannot be trusted — then that would hamper further social interactions and could lead to loneliness,” he added.
 

 

 

A Role for Oxytocin?

In another study, the same researchers tested short-term (five weekly sessions) group psychotherapy to reduce loneliness using established techniques to target these negative biases. They also investigated whether the effects of this group psychotherapy could be augmented by administering intranasal oxytocin (vs placebo) before the group psychotherapy sessions.

Results showed that the group psychotherapy intervention reduced trait loneliness (loneliness experienced over a prolonged period). The oxytocin did not show a significant effect on trait loneliness, but there was a suggestion that it may enhance the reduction in state loneliness (how someone is feeling at a specific time) brought about by the psychotherapy sessions.

“We found that bonding within the groups was experienced as more positive in the oxytocin treated groups. It is possible that a longer intervention would be helpful for longer-term results,” Scheele concluded. “It’s not going to be a quick fix for loneliness, but there may be a role for oxytocin as an adjunct to psychotherapy.”
 

A Basic Human Need

Another loneliness researcher, Livia Tomova, PhD, assistant professor of psychology at Cardiff University in Wales, has used social isolation to induce loneliness in young people and found that this intervention was linked to brain patterns similar to those associated with hunger.

“We know that the drive to eat food is a very basic human need. We know quite well how it is represented in the brain,” she explained.

The researchers tested how the brains of the participants responded to seeing pictures of social interactions after they underwent a prolonged period of social isolation. In a subsequent session, the same people were asked to undergo food fasting and then underwent brain scans when looking at pictures of food. Results showed that the neural patterns were similar in the two situations with increased activity in the substantia nigra area within the midbrain.

“This area of the brain processes rewards and motivation. It consists primarily of dopamine neurons and increased activity corresponds to a feeling of craving something. So this area of the brain that controls essential homeostatic needs is activated when people feel lonely, suggesting that our need for social contact with others is potentially a very basic need similar to eating,” Tomova said.
 

Lower Gray Matter Volumes in Key Brain Areas

And another group from Germany has found that higher loneliness scores are negatively associated with specific brain regions responsible for memory, emotion regulation, and social processing.

Sandra Düzel, PhD, and colleagues from the Max Planck Institute for Human Development and the Charité – Universitätsmedizin Berlin, both in Berlin, Germany, reported a study in which individuals who reported higher loneliness had smaller gray matter volumes in brain regions such as the left amygdala, anterior hippocampus, and cerebellum, regions which are crucial for both emotional regulation and higher-order cognitive processes, such as self-reflection and executive function.

Düzel believes that possible mechanisms behind the link between loneliness and brain volume differences could include stress-related damage, with prolonged loneliness associated with elevated levels of stress hormones, which can damage the hippocampus over time, and reduced cognitive and social stimulation, which may contribute to brain volume reductions in regions critical for memory and emotional processing.

“Loneliness is often characterized by reduced social and environmental diversity, leading to less engagement with novel experiences and potentially lower hippocampal-striatal connectivity.

Since novelty-seeking and environmental diversity are associated with positive emotional states, individuals experiencing loneliness might benefit from increased exposure to new environments which could stimulate the brain’s reward circuits, fostering positive affect and potentially mitigating the emotional burden of loneliness,” she said.
 

 

 

Is Social Prescribing the Answer?

So are there enough data now to act and attempt to develop interventions to reduce loneliness? Most of these researchers believe so.

“I think we have enough information to act on this now. There are a number of national academies consensus reports, which suggest that, while certainly there are still gaps in our evidence and more to be learned, there is sufficient evidence that a concerning portion of the population seems to lack connection, and that the consequences are serious enough that we need to do something about it,” said Holt-Lunstad.

Some countries have introduced social prescribing where doctors can prescribe a group activity or a regular visit or telephone conversation with a supportive person.

Subramanian pointed out that it’s easier to implement in countries with national health services and may be more difficult to embrace in the US healthcare system.

“We are not so encouraged from a financial perspective to think about preventive care in the US. We don’t have an easy way to recognize in any tangible way the downstream of such activities in terms of preventing future problems. That is something we need to work on,” she said.

Finley cautioned that to work well, social prescribing will require an understanding of each person’s individual situation.

“Some people may only receive benefit of interacting with others if they are also getting some sort of support to address the social and emotional concerns that are tagging along with loneliness. I’m not sure that just telling people to go join their local gardening club or whatever will be the correct answer for everyone.”

She pointed out that many people will have issues in their life that are making it hard for them to be social. These could be mobility or financial challenges, care responsibilities, or concerns about illnesses or life events. “We need to figure out what would have the most bang for the person’s buck, so to speak, as an intervention. That could mean connecting them to a group relevant to their individual situation.”
 

Opportunity to Connect Not Enough?

Tomova believes that training people in social skills may be a better option. “It appears that some people who are chronically lonely seem to struggle to make relationships with others. So just encouraging them to interact with others more will not necessarily help. We need to better understand the pathways involved and who are the people who become ill. We can then develop and target better interventions and teach people coping strategies for that situation.”

Scheele agreed. “While just giving people the opportunity to connect may work for some, others who are experiencing really chronic loneliness may not benefit very much from this unless their negative belief systems are addressed.” He suggested some sort of psychotherapy may be helpful in this situation.

But at least all seem to agree that healthcare providers need to be more aware of loneliness as a health risk factor, try to identify people at risk, and to think about how best to support them.

Holt-Lunstad noted that one of the recommendations in the US Surgeon General’s advisory was to increase the education, training, and resources on loneliness for healthcare providers.

“If we want this to be addressed, we need to give healthcare providers the time, resources, and training in order to do that, otherwise, we are adding one more thing to an already overburdened system. They need to understand how important it is, and how it might help them take care of the patient.”

“Our hope is that we can start to reverse some of the trends that we are seeing, both in terms of the prevalence rates of loneliness, but also that we could start seeing improvements in health and other kinds of outcomes,” she concluded.

Progress is being made in increasing awareness about the dangers of chronic loneliness. It’s now recognized as a serious health risk, but there are actionable steps that can help. Loneliness doesn’t have to be a permanent condition for anyone, said Scheele.

Holt-Lunstad served as an adviser for Foundation for Social Connection, Global Initiative on Loneliness and Connection, and Nextdoor Neighborhood Vitality Board and received research grants/income from Templeton Foundation, Eventbrite, Foundation for Social Connection, and Triple-S Foundation. Subramanian served as a speaker bureau for Acorda Pharma. The other researchers reported no disclosures.

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

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In a world that is more connected than ever, a silent epidemic is taking its toll. Overall, one in three US adults report chronic loneliness — a condition so detrimental that it rivals smoking and obesity with respect to its negative effect on health and well-being. From anxiety and depression to life-threatening conditions like cardiovascular disease, stroke, and Alzheimer’s and Parkinson’s diseases, loneliness is more than an emotion — it’s a serious threat to both the brain and body.

In 2023, a US Surgeon General advisory raised the alarm about the national problem of loneliness and isolation, describing it as an epidemic.

“Given the significant health consequences of loneliness and isolation, we must prioritize building social connection in the same way we have prioritized other critical public health issues such as tobacco, obesity, and substance use disorders. Together, we can build a country that’s healthier, more resilient, less lonely, and more connected,” the report concluded.

But how, exactly, does chronic loneliness affect the physiology and function of the brain? What does the latest research reveal about the link between loneliness and neurologic and psychiatric illness, and what can clinicians do to address the issue?

This news organization spoke to multiple experts in the field to explore these issues.
 

A Major Risk Factor

Anna Finley, PhD, assistant professor of psychology at North Dakota State University, Fargo, explained that loneliness and social isolation are different entities. Social isolation is an objective measure of the number of people someone interacts with on a regular basis, whereas loneliness is a subjective feeling that occurs when close connections are lacking.

“These two things are not actually as related as you think they would be. People can feel lonely in a crowd or feel well connected with only a few friendships. It’s more about the quality of the connection and the quality of your perception of it. So someone could be in some very supportive relationships but still feel that there’s something missing,” she said in an interview.

So what do we know about how loneliness affects health? Evidence supporting the hypothesis that loneliness is an emerging risk factor for many diseases is steadily building.

Recently, the American Heart Association published a statement summarizing the evidence for a direct association between social isolation and loneliness and coronary heart disease and stroke mortality.

In addition, many studies have shown that individuals experiencing social isolation or loneliness have an increased risk for anxiety and depression, dementia, infectious disease, hospitalization, and all-cause death, even after adjusting for age and many other traditional risk factors.

One study revealed that eliminating loneliness has the potential to prevent nearly 20% of cases of depression in adults aged 50 years or older.

Indu Subramanian, MD, professor of neurology at the University of California, Los Angeles, and colleagues conducted a study involving patients with Parkinson’s disease, which showed that the negative impact of loneliness on disease severity was as significant as the positive effects of 30 minutes of daily exercise.

“The importance of loneliness is under-recognized and undervalued, and it poses a major risk for health outcomes and quality of life,” said Subramanian.

Subramanian noted that loneliness is stigmatizing, causing people to feel unlikable and blame themselves, which prevents them from opening up to doctors or loved ones about their struggle. At the same time, healthcare providers may not think to ask about loneliness or know about potential interventions. She emphasized that much more work is needed to address this issue.
 

 

 

Early Mortality Risk

Julianne Holt-Lunstad, PhD, professor of psychology and neuroscience at Brigham Young University in Provo, Utah, is the author of two large meta-analyses that suggest loneliness, social isolation, or living alone are independent risk factors for early mortality, increasing this risk by about a third — the equivalent to the risk of smoking 15 cigarettes per day.

“We have quite robust evidence across a number of health outcomes implicating the harmful effects of loneliness and social isolation. While these are observational studies and show mainly associations, we do have evidence from longitudinal studies that show lacking social connection, whether that be loneliness or social isolation, predicts subsequent worse outcomes, and most of these studies have adjusted for alternative kinds of explanations, like age, initial health status, lifestyle factors,” Holt-Lunstad said.

There is some evidence to suggest that isolation is more predictive of physical health outcomes, whereas loneliness is more predictive of mental health outcomes. That said, both isolation and loneliness have significant effects on mental and physical health outcomes, she noted.

There is also the question of whether loneliness is causing poor health or whether people who are in poor health feel lonely because poor health can lead to social isolation.

Finley said there’s probably a bit of both going on, but longitudinal studies, where loneliness is measured at a fixed timepoint then health outcomes are reported a few years later, suggest that loneliness is contributing to these adverse outcomes.

She added that there is also some evidence in animal models to suggest that loneliness is a causal risk factor for adverse health outcomes. “But you can’t ask a mouse or rat how lonely they’re feeling. All you can do is house them individually — removing them from social connection. This isn’t necessarily the same thing as loneliness in humans.”

Finley is studying mechanisms in the brain that may be involved in mediating the adverse health consequences of loneliness.

“What I’ve been seeing in the data so far is that it tends to be the self-report of how lonely folks are feeling that has the associations with differences in the brain, as opposed to the number of social connections people have. It does seem to be the more subjective, emotional perception of loneliness that is important.”

In a review of potential mechanisms involved, she concluded that it is dysregulated emotions and altered perceptions of social interactions that has profound impacts on the brain, suggesting that people who are lonely may have a tendency to interpret social cues in a negative way, preventing them from forming productive positive relationships.
 

Lack of Trust

One researcher who has studied this phenomenon is Dirk Scheele, PhD, professor of social neuroscience at Ruhr University Bochum in Germany.

“We were interested to find out why people remained lonely,” he said in an interview. “Loneliness is an unpleasant experience, and there are so many opportunities for social contacts nowadays, it’s not really clear at first sight why people are chronically lonely.”

To examine this question, Scheele and his team conducted a study in which functional MRI was used to examine the brain in otherwise healthy individuals with high or low loneliness scores while they played a trust game.

They also simulated a positive social interaction between participants and researchers, in which they talked about plans for a fictitious lottery win, and about their hobbies and interests, during which mood was measured with questionnaires, and saliva samples were collected to measure hormone levels.

Results showed that the high-lonely individuals had reduced activation in the insula cortex during the trust decisions. “This area of the brain is involved in the processing of bodily signals, such as ‘gut feelings.’ So reduced activity here could be interpreted as fewer gut feelings on who can be trusted,” Scheele explained.

The high-lonely individuals also had reduced responsiveness to the positive social interaction with a lower release of oxytocin and a smaller elevation in mood compared with the control individuals.

Scheele pointed out that there is some evidence that oxytocin might increase trust, and there is reduced release of endogenous oxytocin in high loneliness.

“Our results are consistent with the idea that loneliness is associated with negative biases about other people. So if we expect negative things from other people — for instance, that they cannot be trusted — then that would hamper further social interactions and could lead to loneliness,” he added.
 

 

 

A Role for Oxytocin?

In another study, the same researchers tested short-term (five weekly sessions) group psychotherapy to reduce loneliness using established techniques to target these negative biases. They also investigated whether the effects of this group psychotherapy could be augmented by administering intranasal oxytocin (vs placebo) before the group psychotherapy sessions.

Results showed that the group psychotherapy intervention reduced trait loneliness (loneliness experienced over a prolonged period). The oxytocin did not show a significant effect on trait loneliness, but there was a suggestion that it may enhance the reduction in state loneliness (how someone is feeling at a specific time) brought about by the psychotherapy sessions.

“We found that bonding within the groups was experienced as more positive in the oxytocin treated groups. It is possible that a longer intervention would be helpful for longer-term results,” Scheele concluded. “It’s not going to be a quick fix for loneliness, but there may be a role for oxytocin as an adjunct to psychotherapy.”
 

A Basic Human Need

Another loneliness researcher, Livia Tomova, PhD, assistant professor of psychology at Cardiff University in Wales, has used social isolation to induce loneliness in young people and found that this intervention was linked to brain patterns similar to those associated with hunger.

“We know that the drive to eat food is a very basic human need. We know quite well how it is represented in the brain,” she explained.

The researchers tested how the brains of the participants responded to seeing pictures of social interactions after they underwent a prolonged period of social isolation. In a subsequent session, the same people were asked to undergo food fasting and then underwent brain scans when looking at pictures of food. Results showed that the neural patterns were similar in the two situations with increased activity in the substantia nigra area within the midbrain.

“This area of the brain processes rewards and motivation. It consists primarily of dopamine neurons and increased activity corresponds to a feeling of craving something. So this area of the brain that controls essential homeostatic needs is activated when people feel lonely, suggesting that our need for social contact with others is potentially a very basic need similar to eating,” Tomova said.
 

Lower Gray Matter Volumes in Key Brain Areas

And another group from Germany has found that higher loneliness scores are negatively associated with specific brain regions responsible for memory, emotion regulation, and social processing.

Sandra Düzel, PhD, and colleagues from the Max Planck Institute for Human Development and the Charité – Universitätsmedizin Berlin, both in Berlin, Germany, reported a study in which individuals who reported higher loneliness had smaller gray matter volumes in brain regions such as the left amygdala, anterior hippocampus, and cerebellum, regions which are crucial for both emotional regulation and higher-order cognitive processes, such as self-reflection and executive function.

Düzel believes that possible mechanisms behind the link between loneliness and brain volume differences could include stress-related damage, with prolonged loneliness associated with elevated levels of stress hormones, which can damage the hippocampus over time, and reduced cognitive and social stimulation, which may contribute to brain volume reductions in regions critical for memory and emotional processing.

“Loneliness is often characterized by reduced social and environmental diversity, leading to less engagement with novel experiences and potentially lower hippocampal-striatal connectivity.

Since novelty-seeking and environmental diversity are associated with positive emotional states, individuals experiencing loneliness might benefit from increased exposure to new environments which could stimulate the brain’s reward circuits, fostering positive affect and potentially mitigating the emotional burden of loneliness,” she said.
 

 

 

Is Social Prescribing the Answer?

So are there enough data now to act and attempt to develop interventions to reduce loneliness? Most of these researchers believe so.

“I think we have enough information to act on this now. There are a number of national academies consensus reports, which suggest that, while certainly there are still gaps in our evidence and more to be learned, there is sufficient evidence that a concerning portion of the population seems to lack connection, and that the consequences are serious enough that we need to do something about it,” said Holt-Lunstad.

Some countries have introduced social prescribing where doctors can prescribe a group activity or a regular visit or telephone conversation with a supportive person.

Subramanian pointed out that it’s easier to implement in countries with national health services and may be more difficult to embrace in the US healthcare system.

“We are not so encouraged from a financial perspective to think about preventive care in the US. We don’t have an easy way to recognize in any tangible way the downstream of such activities in terms of preventing future problems. That is something we need to work on,” she said.

Finley cautioned that to work well, social prescribing will require an understanding of each person’s individual situation.

“Some people may only receive benefit of interacting with others if they are also getting some sort of support to address the social and emotional concerns that are tagging along with loneliness. I’m not sure that just telling people to go join their local gardening club or whatever will be the correct answer for everyone.”

She pointed out that many people will have issues in their life that are making it hard for them to be social. These could be mobility or financial challenges, care responsibilities, or concerns about illnesses or life events. “We need to figure out what would have the most bang for the person’s buck, so to speak, as an intervention. That could mean connecting them to a group relevant to their individual situation.”
 

Opportunity to Connect Not Enough?

Tomova believes that training people in social skills may be a better option. “It appears that some people who are chronically lonely seem to struggle to make relationships with others. So just encouraging them to interact with others more will not necessarily help. We need to better understand the pathways involved and who are the people who become ill. We can then develop and target better interventions and teach people coping strategies for that situation.”

Scheele agreed. “While just giving people the opportunity to connect may work for some, others who are experiencing really chronic loneliness may not benefit very much from this unless their negative belief systems are addressed.” He suggested some sort of psychotherapy may be helpful in this situation.

But at least all seem to agree that healthcare providers need to be more aware of loneliness as a health risk factor, try to identify people at risk, and to think about how best to support them.

Holt-Lunstad noted that one of the recommendations in the US Surgeon General’s advisory was to increase the education, training, and resources on loneliness for healthcare providers.

“If we want this to be addressed, we need to give healthcare providers the time, resources, and training in order to do that, otherwise, we are adding one more thing to an already overburdened system. They need to understand how important it is, and how it might help them take care of the patient.”

“Our hope is that we can start to reverse some of the trends that we are seeing, both in terms of the prevalence rates of loneliness, but also that we could start seeing improvements in health and other kinds of outcomes,” she concluded.

Progress is being made in increasing awareness about the dangers of chronic loneliness. It’s now recognized as a serious health risk, but there are actionable steps that can help. Loneliness doesn’t have to be a permanent condition for anyone, said Scheele.

Holt-Lunstad served as an adviser for Foundation for Social Connection, Global Initiative on Loneliness and Connection, and Nextdoor Neighborhood Vitality Board and received research grants/income from Templeton Foundation, Eventbrite, Foundation for Social Connection, and Triple-S Foundation. Subramanian served as a speaker bureau for Acorda Pharma. The other researchers reported no disclosures.

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

In a world that is more connected than ever, a silent epidemic is taking its toll. Overall, one in three US adults report chronic loneliness — a condition so detrimental that it rivals smoking and obesity with respect to its negative effect on health and well-being. From anxiety and depression to life-threatening conditions like cardiovascular disease, stroke, and Alzheimer’s and Parkinson’s diseases, loneliness is more than an emotion — it’s a serious threat to both the brain and body.

In 2023, a US Surgeon General advisory raised the alarm about the national problem of loneliness and isolation, describing it as an epidemic.

“Given the significant health consequences of loneliness and isolation, we must prioritize building social connection in the same way we have prioritized other critical public health issues such as tobacco, obesity, and substance use disorders. Together, we can build a country that’s healthier, more resilient, less lonely, and more connected,” the report concluded.

But how, exactly, does chronic loneliness affect the physiology and function of the brain? What does the latest research reveal about the link between loneliness and neurologic and psychiatric illness, and what can clinicians do to address the issue?

This news organization spoke to multiple experts in the field to explore these issues.
 

A Major Risk Factor

Anna Finley, PhD, assistant professor of psychology at North Dakota State University, Fargo, explained that loneliness and social isolation are different entities. Social isolation is an objective measure of the number of people someone interacts with on a regular basis, whereas loneliness is a subjective feeling that occurs when close connections are lacking.

“These two things are not actually as related as you think they would be. People can feel lonely in a crowd or feel well connected with only a few friendships. It’s more about the quality of the connection and the quality of your perception of it. So someone could be in some very supportive relationships but still feel that there’s something missing,” she said in an interview.

So what do we know about how loneliness affects health? Evidence supporting the hypothesis that loneliness is an emerging risk factor for many diseases is steadily building.

Recently, the American Heart Association published a statement summarizing the evidence for a direct association between social isolation and loneliness and coronary heart disease and stroke mortality.

In addition, many studies have shown that individuals experiencing social isolation or loneliness have an increased risk for anxiety and depression, dementia, infectious disease, hospitalization, and all-cause death, even after adjusting for age and many other traditional risk factors.

One study revealed that eliminating loneliness has the potential to prevent nearly 20% of cases of depression in adults aged 50 years or older.

Indu Subramanian, MD, professor of neurology at the University of California, Los Angeles, and colleagues conducted a study involving patients with Parkinson’s disease, which showed that the negative impact of loneliness on disease severity was as significant as the positive effects of 30 minutes of daily exercise.

“The importance of loneliness is under-recognized and undervalued, and it poses a major risk for health outcomes and quality of life,” said Subramanian.

Subramanian noted that loneliness is stigmatizing, causing people to feel unlikable and blame themselves, which prevents them from opening up to doctors or loved ones about their struggle. At the same time, healthcare providers may not think to ask about loneliness or know about potential interventions. She emphasized that much more work is needed to address this issue.
 

 

 

Early Mortality Risk

Julianne Holt-Lunstad, PhD, professor of psychology and neuroscience at Brigham Young University in Provo, Utah, is the author of two large meta-analyses that suggest loneliness, social isolation, or living alone are independent risk factors for early mortality, increasing this risk by about a third — the equivalent to the risk of smoking 15 cigarettes per day.

“We have quite robust evidence across a number of health outcomes implicating the harmful effects of loneliness and social isolation. While these are observational studies and show mainly associations, we do have evidence from longitudinal studies that show lacking social connection, whether that be loneliness or social isolation, predicts subsequent worse outcomes, and most of these studies have adjusted for alternative kinds of explanations, like age, initial health status, lifestyle factors,” Holt-Lunstad said.

There is some evidence to suggest that isolation is more predictive of physical health outcomes, whereas loneliness is more predictive of mental health outcomes. That said, both isolation and loneliness have significant effects on mental and physical health outcomes, she noted.

There is also the question of whether loneliness is causing poor health or whether people who are in poor health feel lonely because poor health can lead to social isolation.

Finley said there’s probably a bit of both going on, but longitudinal studies, where loneliness is measured at a fixed timepoint then health outcomes are reported a few years later, suggest that loneliness is contributing to these adverse outcomes.

She added that there is also some evidence in animal models to suggest that loneliness is a causal risk factor for adverse health outcomes. “But you can’t ask a mouse or rat how lonely they’re feeling. All you can do is house them individually — removing them from social connection. This isn’t necessarily the same thing as loneliness in humans.”

Finley is studying mechanisms in the brain that may be involved in mediating the adverse health consequences of loneliness.

“What I’ve been seeing in the data so far is that it tends to be the self-report of how lonely folks are feeling that has the associations with differences in the brain, as opposed to the number of social connections people have. It does seem to be the more subjective, emotional perception of loneliness that is important.”

In a review of potential mechanisms involved, she concluded that it is dysregulated emotions and altered perceptions of social interactions that has profound impacts on the brain, suggesting that people who are lonely may have a tendency to interpret social cues in a negative way, preventing them from forming productive positive relationships.
 

Lack of Trust

One researcher who has studied this phenomenon is Dirk Scheele, PhD, professor of social neuroscience at Ruhr University Bochum in Germany.

“We were interested to find out why people remained lonely,” he said in an interview. “Loneliness is an unpleasant experience, and there are so many opportunities for social contacts nowadays, it’s not really clear at first sight why people are chronically lonely.”

To examine this question, Scheele and his team conducted a study in which functional MRI was used to examine the brain in otherwise healthy individuals with high or low loneliness scores while they played a trust game.

They also simulated a positive social interaction between participants and researchers, in which they talked about plans for a fictitious lottery win, and about their hobbies and interests, during which mood was measured with questionnaires, and saliva samples were collected to measure hormone levels.

Results showed that the high-lonely individuals had reduced activation in the insula cortex during the trust decisions. “This area of the brain is involved in the processing of bodily signals, such as ‘gut feelings.’ So reduced activity here could be interpreted as fewer gut feelings on who can be trusted,” Scheele explained.

The high-lonely individuals also had reduced responsiveness to the positive social interaction with a lower release of oxytocin and a smaller elevation in mood compared with the control individuals.

Scheele pointed out that there is some evidence that oxytocin might increase trust, and there is reduced release of endogenous oxytocin in high loneliness.

“Our results are consistent with the idea that loneliness is associated with negative biases about other people. So if we expect negative things from other people — for instance, that they cannot be trusted — then that would hamper further social interactions and could lead to loneliness,” he added.
 

 

 

A Role for Oxytocin?

In another study, the same researchers tested short-term (five weekly sessions) group psychotherapy to reduce loneliness using established techniques to target these negative biases. They also investigated whether the effects of this group psychotherapy could be augmented by administering intranasal oxytocin (vs placebo) before the group psychotherapy sessions.

Results showed that the group psychotherapy intervention reduced trait loneliness (loneliness experienced over a prolonged period). The oxytocin did not show a significant effect on trait loneliness, but there was a suggestion that it may enhance the reduction in state loneliness (how someone is feeling at a specific time) brought about by the psychotherapy sessions.

“We found that bonding within the groups was experienced as more positive in the oxytocin treated groups. It is possible that a longer intervention would be helpful for longer-term results,” Scheele concluded. “It’s not going to be a quick fix for loneliness, but there may be a role for oxytocin as an adjunct to psychotherapy.”
 

A Basic Human Need

Another loneliness researcher, Livia Tomova, PhD, assistant professor of psychology at Cardiff University in Wales, has used social isolation to induce loneliness in young people and found that this intervention was linked to brain patterns similar to those associated with hunger.

“We know that the drive to eat food is a very basic human need. We know quite well how it is represented in the brain,” she explained.

The researchers tested how the brains of the participants responded to seeing pictures of social interactions after they underwent a prolonged period of social isolation. In a subsequent session, the same people were asked to undergo food fasting and then underwent brain scans when looking at pictures of food. Results showed that the neural patterns were similar in the two situations with increased activity in the substantia nigra area within the midbrain.

“This area of the brain processes rewards and motivation. It consists primarily of dopamine neurons and increased activity corresponds to a feeling of craving something. So this area of the brain that controls essential homeostatic needs is activated when people feel lonely, suggesting that our need for social contact with others is potentially a very basic need similar to eating,” Tomova said.
 

Lower Gray Matter Volumes in Key Brain Areas

And another group from Germany has found that higher loneliness scores are negatively associated with specific brain regions responsible for memory, emotion regulation, and social processing.

Sandra Düzel, PhD, and colleagues from the Max Planck Institute for Human Development and the Charité – Universitätsmedizin Berlin, both in Berlin, Germany, reported a study in which individuals who reported higher loneliness had smaller gray matter volumes in brain regions such as the left amygdala, anterior hippocampus, and cerebellum, regions which are crucial for both emotional regulation and higher-order cognitive processes, such as self-reflection and executive function.

Düzel believes that possible mechanisms behind the link between loneliness and brain volume differences could include stress-related damage, with prolonged loneliness associated with elevated levels of stress hormones, which can damage the hippocampus over time, and reduced cognitive and social stimulation, which may contribute to brain volume reductions in regions critical for memory and emotional processing.

“Loneliness is often characterized by reduced social and environmental diversity, leading to less engagement with novel experiences and potentially lower hippocampal-striatal connectivity.

Since novelty-seeking and environmental diversity are associated with positive emotional states, individuals experiencing loneliness might benefit from increased exposure to new environments which could stimulate the brain’s reward circuits, fostering positive affect and potentially mitigating the emotional burden of loneliness,” she said.
 

 

 

Is Social Prescribing the Answer?

So are there enough data now to act and attempt to develop interventions to reduce loneliness? Most of these researchers believe so.

“I think we have enough information to act on this now. There are a number of national academies consensus reports, which suggest that, while certainly there are still gaps in our evidence and more to be learned, there is sufficient evidence that a concerning portion of the population seems to lack connection, and that the consequences are serious enough that we need to do something about it,” said Holt-Lunstad.

Some countries have introduced social prescribing where doctors can prescribe a group activity or a regular visit or telephone conversation with a supportive person.

Subramanian pointed out that it’s easier to implement in countries with national health services and may be more difficult to embrace in the US healthcare system.

“We are not so encouraged from a financial perspective to think about preventive care in the US. We don’t have an easy way to recognize in any tangible way the downstream of such activities in terms of preventing future problems. That is something we need to work on,” she said.

Finley cautioned that to work well, social prescribing will require an understanding of each person’s individual situation.

“Some people may only receive benefit of interacting with others if they are also getting some sort of support to address the social and emotional concerns that are tagging along with loneliness. I’m not sure that just telling people to go join their local gardening club or whatever will be the correct answer for everyone.”

She pointed out that many people will have issues in their life that are making it hard for them to be social. These could be mobility or financial challenges, care responsibilities, or concerns about illnesses or life events. “We need to figure out what would have the most bang for the person’s buck, so to speak, as an intervention. That could mean connecting them to a group relevant to their individual situation.”
 

Opportunity to Connect Not Enough?

Tomova believes that training people in social skills may be a better option. “It appears that some people who are chronically lonely seem to struggle to make relationships with others. So just encouraging them to interact with others more will not necessarily help. We need to better understand the pathways involved and who are the people who become ill. We can then develop and target better interventions and teach people coping strategies for that situation.”

Scheele agreed. “While just giving people the opportunity to connect may work for some, others who are experiencing really chronic loneliness may not benefit very much from this unless their negative belief systems are addressed.” He suggested some sort of psychotherapy may be helpful in this situation.

But at least all seem to agree that healthcare providers need to be more aware of loneliness as a health risk factor, try to identify people at risk, and to think about how best to support them.

Holt-Lunstad noted that one of the recommendations in the US Surgeon General’s advisory was to increase the education, training, and resources on loneliness for healthcare providers.

“If we want this to be addressed, we need to give healthcare providers the time, resources, and training in order to do that, otherwise, we are adding one more thing to an already overburdened system. They need to understand how important it is, and how it might help them take care of the patient.”

“Our hope is that we can start to reverse some of the trends that we are seeing, both in terms of the prevalence rates of loneliness, but also that we could start seeing improvements in health and other kinds of outcomes,” she concluded.

Progress is being made in increasing awareness about the dangers of chronic loneliness. It’s now recognized as a serious health risk, but there are actionable steps that can help. Loneliness doesn’t have to be a permanent condition for anyone, said Scheele.

Holt-Lunstad served as an adviser for Foundation for Social Connection, Global Initiative on Loneliness and Connection, and Nextdoor Neighborhood Vitality Board and received research grants/income from Templeton Foundation, Eventbrite, Foundation for Social Connection, and Triple-S Foundation. Subramanian served as a speaker bureau for Acorda Pharma. The other researchers reported no disclosures.

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

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Men Wanted: New Efforts to Attract Male Nurses

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Tue, 11/05/2024 - 11:34

Only 12% of the nurses providing patient care at hospitals and health clinics today are men. Although the percentage of nurses has increased — men made up just 2.7% of nurses in 1970 — nursing is still considered a “pink collar” profession, a female-dominated field.

“We’ve made strides over the last couple of decades, but [the number of men pursuing nursing careers] is leveling out,” said Jason Dunne, DNP, MSN, RN, chief academic officer at the Arizona College of Nursing, Phoenix. “There continues to be persistent gender stereotypes that [have] discouraged men from entering the profession.”

A nationwide nursing shortage has led to increased efforts to attract more men to the profession and ensure that men in nursing feel valued and supported and want to continue their careers long term.

“The nursing shortage is very real,” Dunne said. “We need to be highly focused on the shortage and look at opportunities to bring diversity into the profession, and one big way to solve it is bringing more men into nursing.”
 

Representation Matters

Colleges recognize the need to diversify their nursing student population and have turned their attention to increasing the number of men attending informational sessions and career days. Dunne believes, “There is a general lack of awareness of nursing as a career choice [for men].”

The Nursing Consortium of Florida hosts a “Day in the Life of a Nurse” program to introduce high school students to nursing careers, and the University of Virginia School of Nursing invites male nursing students to speak at educational events to promote workforce diversity.

“When I was growing up, the males wouldn’t have been included in those sessions,” said Melissa Gilbert Gomes, PhD, APRN, PMHNP-BC, FNAP, FAAN, associate dean for diversity, equity, and inclusion at the University of Virginia School of Nursing, Charlottesville, Virginia. “It was nice to see their interest and to have a male student there for them to ask questions and to help them see that this could be a place for them.”

Nursing schools have also engaged in other efforts to encourage more men to consider nursing careers, from highlighting male nurses in marketing materials and engaging with men at career fairs to updating course curriculum to include content on men’s health and connecting male nursing students with men in nursing faculty or clinical settings.

Focusing on nursing as a lucrative career choice could also attract more men to the profession. On average, male registered nurses (RNs) make $7300 per year more than their female counterparts due to the gender pay gap. The median wage for male RNs in acute care, cardiology, and perioperative specialties is $90,000 annually.

At the University of Virginia School of Nursing, which the American Association for Men in Nursing (AAMN) named “Best School for Men in Nursing” in 2023, 20% of nursing students are men.

The school has a Men Advancing Nursing club and is in the process of chartering a new AAMN chapter. The goal, according to Gomes, is to create an environment where male nursing students feel represented and supported.

“Valuing the perspective that men bring [to nursing] is important,” she said. “Coming together [and] having that camaraderie and intrinsic motivation to specifically speak to areas that impact men ... is important.”
 

 

 

Promoting Patient Care

Highlighting the diversity of career options within the nursing profession is also essential. RNs can pursue careers in specialties ranging from pediatrics, orthopedics, and occupational health to anesthesia, cardiology, and nephrology. The specialty with the highest number of male RNs tends to be acute care, which encompasses emergency/trauma and medical-surgical.

John Schmidt, DNP, MSN, BSN, faculty member and program lead for the acute care nurse practitioner program at Purdue Global School of Nursing, refers to these specialties as having a high excitement factor.

“Men gravitate to nursing to help people,” he said. “In critical care, there is instant gratification. You see patients get better. It’s the same in the [intensive care unit] and the emergency department. We take care of them and can see how we made a difference.”

When hospitals and health systems create environments that support men in nursing, patients also benefit. Research shows that patients often prefer nurses of the same gender, and a more diverse healthcare workforce has been linked to improved patient outcomes. Reducing gender inequities among nursing staff could also improve job satisfaction and retention rates for men in nursing.

“When you’re in a vulnerable space as a patient ... it’s important to know that your care provider understands you [and] having men as nurses is a part of that,” said Gomes. “Even though patients might not be used to having a male nurse at the bedside, once they have the experience, it challenges preconceived notions [and] that connection is important.”

Hospitals must proactively support men in nursing to achieve the benefits of greater gender diversity in the nursing workforce. Male nurses have fewer role models and report higher levels of loneliness, isolation, and role strain.

Groups such as NYC Men in Nursing and mentorship programs such as Men in Nursing at RUSH University College of Nursing and RUSH University Medical Center, and the North Carolina Healthcare Association Diverse Healthcare Leaders Mentorship Program were designed to provide coaching, education, and networking opportunities and connect men in nursing.

Male nurses, Dunne added, must be role models and must take the lead in changing the conversations about gender roles in nursing. Establishing support systems and mentorship opportunities is instrumental in inspiring men to pursue nursing careers and creating visibility into the profession and “would create a level of parity for men in the profession and encourage them to want to stay in nursing as a long-term career.”

He told this news organization that creating scholarships for men enrolled in nursing school, increasing the involvement of male nurse leaders in recruitment efforts, and updating curriculum to ensure men are reflected in the materials is also essential.

“We’ve got to be willing and open to having the conversations to end the stereotypes that have plagued the profession,” said Dunne. “And we’ve got to push men in nursing to be front and center so folks see that there are opportunities for men in nursing.”
 

A version of this article appeared on Medscape.com.

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Only 12% of the nurses providing patient care at hospitals and health clinics today are men. Although the percentage of nurses has increased — men made up just 2.7% of nurses in 1970 — nursing is still considered a “pink collar” profession, a female-dominated field.

“We’ve made strides over the last couple of decades, but [the number of men pursuing nursing careers] is leveling out,” said Jason Dunne, DNP, MSN, RN, chief academic officer at the Arizona College of Nursing, Phoenix. “There continues to be persistent gender stereotypes that [have] discouraged men from entering the profession.”

A nationwide nursing shortage has led to increased efforts to attract more men to the profession and ensure that men in nursing feel valued and supported and want to continue their careers long term.

“The nursing shortage is very real,” Dunne said. “We need to be highly focused on the shortage and look at opportunities to bring diversity into the profession, and one big way to solve it is bringing more men into nursing.”
 

Representation Matters

Colleges recognize the need to diversify their nursing student population and have turned their attention to increasing the number of men attending informational sessions and career days. Dunne believes, “There is a general lack of awareness of nursing as a career choice [for men].”

The Nursing Consortium of Florida hosts a “Day in the Life of a Nurse” program to introduce high school students to nursing careers, and the University of Virginia School of Nursing invites male nursing students to speak at educational events to promote workforce diversity.

“When I was growing up, the males wouldn’t have been included in those sessions,” said Melissa Gilbert Gomes, PhD, APRN, PMHNP-BC, FNAP, FAAN, associate dean for diversity, equity, and inclusion at the University of Virginia School of Nursing, Charlottesville, Virginia. “It was nice to see their interest and to have a male student there for them to ask questions and to help them see that this could be a place for them.”

Nursing schools have also engaged in other efforts to encourage more men to consider nursing careers, from highlighting male nurses in marketing materials and engaging with men at career fairs to updating course curriculum to include content on men’s health and connecting male nursing students with men in nursing faculty or clinical settings.

Focusing on nursing as a lucrative career choice could also attract more men to the profession. On average, male registered nurses (RNs) make $7300 per year more than their female counterparts due to the gender pay gap. The median wage for male RNs in acute care, cardiology, and perioperative specialties is $90,000 annually.

At the University of Virginia School of Nursing, which the American Association for Men in Nursing (AAMN) named “Best School for Men in Nursing” in 2023, 20% of nursing students are men.

The school has a Men Advancing Nursing club and is in the process of chartering a new AAMN chapter. The goal, according to Gomes, is to create an environment where male nursing students feel represented and supported.

“Valuing the perspective that men bring [to nursing] is important,” she said. “Coming together [and] having that camaraderie and intrinsic motivation to specifically speak to areas that impact men ... is important.”
 

 

 

Promoting Patient Care

Highlighting the diversity of career options within the nursing profession is also essential. RNs can pursue careers in specialties ranging from pediatrics, orthopedics, and occupational health to anesthesia, cardiology, and nephrology. The specialty with the highest number of male RNs tends to be acute care, which encompasses emergency/trauma and medical-surgical.

John Schmidt, DNP, MSN, BSN, faculty member and program lead for the acute care nurse practitioner program at Purdue Global School of Nursing, refers to these specialties as having a high excitement factor.

“Men gravitate to nursing to help people,” he said. “In critical care, there is instant gratification. You see patients get better. It’s the same in the [intensive care unit] and the emergency department. We take care of them and can see how we made a difference.”

When hospitals and health systems create environments that support men in nursing, patients also benefit. Research shows that patients often prefer nurses of the same gender, and a more diverse healthcare workforce has been linked to improved patient outcomes. Reducing gender inequities among nursing staff could also improve job satisfaction and retention rates for men in nursing.

“When you’re in a vulnerable space as a patient ... it’s important to know that your care provider understands you [and] having men as nurses is a part of that,” said Gomes. “Even though patients might not be used to having a male nurse at the bedside, once they have the experience, it challenges preconceived notions [and] that connection is important.”

Hospitals must proactively support men in nursing to achieve the benefits of greater gender diversity in the nursing workforce. Male nurses have fewer role models and report higher levels of loneliness, isolation, and role strain.

Groups such as NYC Men in Nursing and mentorship programs such as Men in Nursing at RUSH University College of Nursing and RUSH University Medical Center, and the North Carolina Healthcare Association Diverse Healthcare Leaders Mentorship Program were designed to provide coaching, education, and networking opportunities and connect men in nursing.

Male nurses, Dunne added, must be role models and must take the lead in changing the conversations about gender roles in nursing. Establishing support systems and mentorship opportunities is instrumental in inspiring men to pursue nursing careers and creating visibility into the profession and “would create a level of parity for men in the profession and encourage them to want to stay in nursing as a long-term career.”

He told this news organization that creating scholarships for men enrolled in nursing school, increasing the involvement of male nurse leaders in recruitment efforts, and updating curriculum to ensure men are reflected in the materials is also essential.

“We’ve got to be willing and open to having the conversations to end the stereotypes that have plagued the profession,” said Dunne. “And we’ve got to push men in nursing to be front and center so folks see that there are opportunities for men in nursing.”
 

A version of this article appeared on Medscape.com.

Only 12% of the nurses providing patient care at hospitals and health clinics today are men. Although the percentage of nurses has increased — men made up just 2.7% of nurses in 1970 — nursing is still considered a “pink collar” profession, a female-dominated field.

“We’ve made strides over the last couple of decades, but [the number of men pursuing nursing careers] is leveling out,” said Jason Dunne, DNP, MSN, RN, chief academic officer at the Arizona College of Nursing, Phoenix. “There continues to be persistent gender stereotypes that [have] discouraged men from entering the profession.”

A nationwide nursing shortage has led to increased efforts to attract more men to the profession and ensure that men in nursing feel valued and supported and want to continue their careers long term.

“The nursing shortage is very real,” Dunne said. “We need to be highly focused on the shortage and look at opportunities to bring diversity into the profession, and one big way to solve it is bringing more men into nursing.”
 

Representation Matters

Colleges recognize the need to diversify their nursing student population and have turned their attention to increasing the number of men attending informational sessions and career days. Dunne believes, “There is a general lack of awareness of nursing as a career choice [for men].”

The Nursing Consortium of Florida hosts a “Day in the Life of a Nurse” program to introduce high school students to nursing careers, and the University of Virginia School of Nursing invites male nursing students to speak at educational events to promote workforce diversity.

“When I was growing up, the males wouldn’t have been included in those sessions,” said Melissa Gilbert Gomes, PhD, APRN, PMHNP-BC, FNAP, FAAN, associate dean for diversity, equity, and inclusion at the University of Virginia School of Nursing, Charlottesville, Virginia. “It was nice to see their interest and to have a male student there for them to ask questions and to help them see that this could be a place for them.”

Nursing schools have also engaged in other efforts to encourage more men to consider nursing careers, from highlighting male nurses in marketing materials and engaging with men at career fairs to updating course curriculum to include content on men’s health and connecting male nursing students with men in nursing faculty or clinical settings.

Focusing on nursing as a lucrative career choice could also attract more men to the profession. On average, male registered nurses (RNs) make $7300 per year more than their female counterparts due to the gender pay gap. The median wage for male RNs in acute care, cardiology, and perioperative specialties is $90,000 annually.

At the University of Virginia School of Nursing, which the American Association for Men in Nursing (AAMN) named “Best School for Men in Nursing” in 2023, 20% of nursing students are men.

The school has a Men Advancing Nursing club and is in the process of chartering a new AAMN chapter. The goal, according to Gomes, is to create an environment where male nursing students feel represented and supported.

“Valuing the perspective that men bring [to nursing] is important,” she said. “Coming together [and] having that camaraderie and intrinsic motivation to specifically speak to areas that impact men ... is important.”
 

 

 

Promoting Patient Care

Highlighting the diversity of career options within the nursing profession is also essential. RNs can pursue careers in specialties ranging from pediatrics, orthopedics, and occupational health to anesthesia, cardiology, and nephrology. The specialty with the highest number of male RNs tends to be acute care, which encompasses emergency/trauma and medical-surgical.

John Schmidt, DNP, MSN, BSN, faculty member and program lead for the acute care nurse practitioner program at Purdue Global School of Nursing, refers to these specialties as having a high excitement factor.

“Men gravitate to nursing to help people,” he said. “In critical care, there is instant gratification. You see patients get better. It’s the same in the [intensive care unit] and the emergency department. We take care of them and can see how we made a difference.”

When hospitals and health systems create environments that support men in nursing, patients also benefit. Research shows that patients often prefer nurses of the same gender, and a more diverse healthcare workforce has been linked to improved patient outcomes. Reducing gender inequities among nursing staff could also improve job satisfaction and retention rates for men in nursing.

“When you’re in a vulnerable space as a patient ... it’s important to know that your care provider understands you [and] having men as nurses is a part of that,” said Gomes. “Even though patients might not be used to having a male nurse at the bedside, once they have the experience, it challenges preconceived notions [and] that connection is important.”

Hospitals must proactively support men in nursing to achieve the benefits of greater gender diversity in the nursing workforce. Male nurses have fewer role models and report higher levels of loneliness, isolation, and role strain.

Groups such as NYC Men in Nursing and mentorship programs such as Men in Nursing at RUSH University College of Nursing and RUSH University Medical Center, and the North Carolina Healthcare Association Diverse Healthcare Leaders Mentorship Program were designed to provide coaching, education, and networking opportunities and connect men in nursing.

Male nurses, Dunne added, must be role models and must take the lead in changing the conversations about gender roles in nursing. Establishing support systems and mentorship opportunities is instrumental in inspiring men to pursue nursing careers and creating visibility into the profession and “would create a level of parity for men in the profession and encourage them to want to stay in nursing as a long-term career.”

He told this news organization that creating scholarships for men enrolled in nursing school, increasing the involvement of male nurse leaders in recruitment efforts, and updating curriculum to ensure men are reflected in the materials is also essential.

“We’ve got to be willing and open to having the conversations to end the stereotypes that have plagued the profession,” said Dunne. “And we’ve got to push men in nursing to be front and center so folks see that there are opportunities for men in nursing.”
 

A version of this article appeared on Medscape.com.

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Lawmakers Rush to Stave Off Doctor Pay Cuts as Medicare Finalizes 2025 Rates

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Changed
Tue, 11/05/2024 - 11:04

Federal lawmakers are rushing to soften the blow of Medicare’s 2025 effective pay cut for doctors in 2025, introducing a bill that could limit the cut. But they have little time to act.

In 2025, the conversion factor used to calculate payment to doctors and hospitals caring for Medicare patients will drop to $32.35, a nearly 3% decrease from the current level. 

Congress likely will act before the cuts take effect, said Rep. Larry Bucshon, MD (R-IN), who specialized in cardiothoracic surgery before joining Congress. Lawmakers in past years have typically tinkered with the Medicare physician fee schedule at the last minute, tucking in fixes to December legislative packages and spending bills. 

“I’m pretty optimistic that a good portion of the fee cuts will be mitigated and they won’t go through,” Bucshon told this news organization in an interview.

Bruce A. Scott, MD, president of the American Medical Association (AMA) said in a statement that CMS’ release of the final fee schedule on November 1 should trigger serious work on a change to the 2025 Medicare physician fee schedule.

“The fee schedule rule released [on November 1] starts the clock — with January 1 looming,” Scott said. “A legislative remedy will require hard work and compromise. The 66 million patients who rely on Medicare are counting on that.”

Both Bucshon and Scott also joined many lawmakers and medical associations in calling on Congress for a larger overhaul of the Medicare physician fee schedule, well beyond whatever temporary adjustment may be made in the months ahead to avoid or soften the 2025 cuts.

The physician fee schedule sets formulas and rules regarding how the largest US buyer of health services pays the almost 1.3 million clinicians who bill Medicare. Of these, 51% are physicians. The physician fee schedule also covers payments for nurse practitioners, physician assistants, physical therapists, and other health professionals.
 

Last Major Overhaul Unpopular

There’s broad dissatisfaction with Congress’ last major overhaul of the Medicare physician fee schedule. The 2015 Medicare Access and CHIP Reauthorization Act (MACRA) aimed to shift clinicians toward programs tying pay increases to quality measures. But the implementation of that aim through the Merit-based Incentive Payment System is widely considered a disappointment.

MACRA was intended to end the need for annual “doc fixes,” as Congress’ last-minute Medicare adjustments are known. Seventeen such tweaks passed before MACRA took effect. 

But MACRA did not include a broad-based inflation adjuster, and some clinicians’ incomes are lagging as inflation rates — and practice costs — have risen. Scott said the Medicare Economic Index, which is a measure used to gauge increases in practice costs for clinicians, is expected to rise by 3.5%.

“To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” Scott said. “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas.”

In a statement, Jen Brull, MD, president of the American Academy of Family Physicians, noted that this likely will be the fifth year in a row that Congress will need to do a patch to prevent cuts in pay to clinicians. 

Bucshon, who will retire from the House in January, said he expects Congress to pass legislation tying Medicare payment rates to inflation — eventually.

“People want to find a way to fix this problem, but also do it in a way that does not cut benefits to anyone, and that’s the key,” Bucshon said. “We’re going to have to find a way to make sure that providers are properly reimbursed.”

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

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Federal lawmakers are rushing to soften the blow of Medicare’s 2025 effective pay cut for doctors in 2025, introducing a bill that could limit the cut. But they have little time to act.

In 2025, the conversion factor used to calculate payment to doctors and hospitals caring for Medicare patients will drop to $32.35, a nearly 3% decrease from the current level. 

Congress likely will act before the cuts take effect, said Rep. Larry Bucshon, MD (R-IN), who specialized in cardiothoracic surgery before joining Congress. Lawmakers in past years have typically tinkered with the Medicare physician fee schedule at the last minute, tucking in fixes to December legislative packages and spending bills. 

“I’m pretty optimistic that a good portion of the fee cuts will be mitigated and they won’t go through,” Bucshon told this news organization in an interview.

Bruce A. Scott, MD, president of the American Medical Association (AMA) said in a statement that CMS’ release of the final fee schedule on November 1 should trigger serious work on a change to the 2025 Medicare physician fee schedule.

“The fee schedule rule released [on November 1] starts the clock — with January 1 looming,” Scott said. “A legislative remedy will require hard work and compromise. The 66 million patients who rely on Medicare are counting on that.”

Both Bucshon and Scott also joined many lawmakers and medical associations in calling on Congress for a larger overhaul of the Medicare physician fee schedule, well beyond whatever temporary adjustment may be made in the months ahead to avoid or soften the 2025 cuts.

The physician fee schedule sets formulas and rules regarding how the largest US buyer of health services pays the almost 1.3 million clinicians who bill Medicare. Of these, 51% are physicians. The physician fee schedule also covers payments for nurse practitioners, physician assistants, physical therapists, and other health professionals.
 

Last Major Overhaul Unpopular

There’s broad dissatisfaction with Congress’ last major overhaul of the Medicare physician fee schedule. The 2015 Medicare Access and CHIP Reauthorization Act (MACRA) aimed to shift clinicians toward programs tying pay increases to quality measures. But the implementation of that aim through the Merit-based Incentive Payment System is widely considered a disappointment.

MACRA was intended to end the need for annual “doc fixes,” as Congress’ last-minute Medicare adjustments are known. Seventeen such tweaks passed before MACRA took effect. 

But MACRA did not include a broad-based inflation adjuster, and some clinicians’ incomes are lagging as inflation rates — and practice costs — have risen. Scott said the Medicare Economic Index, which is a measure used to gauge increases in practice costs for clinicians, is expected to rise by 3.5%.

“To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” Scott said. “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas.”

In a statement, Jen Brull, MD, president of the American Academy of Family Physicians, noted that this likely will be the fifth year in a row that Congress will need to do a patch to prevent cuts in pay to clinicians. 

Bucshon, who will retire from the House in January, said he expects Congress to pass legislation tying Medicare payment rates to inflation — eventually.

“People want to find a way to fix this problem, but also do it in a way that does not cut benefits to anyone, and that’s the key,” Bucshon said. “We’re going to have to find a way to make sure that providers are properly reimbursed.”

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

Federal lawmakers are rushing to soften the blow of Medicare’s 2025 effective pay cut for doctors in 2025, introducing a bill that could limit the cut. But they have little time to act.

In 2025, the conversion factor used to calculate payment to doctors and hospitals caring for Medicare patients will drop to $32.35, a nearly 3% decrease from the current level. 

Congress likely will act before the cuts take effect, said Rep. Larry Bucshon, MD (R-IN), who specialized in cardiothoracic surgery before joining Congress. Lawmakers in past years have typically tinkered with the Medicare physician fee schedule at the last minute, tucking in fixes to December legislative packages and spending bills. 

“I’m pretty optimistic that a good portion of the fee cuts will be mitigated and they won’t go through,” Bucshon told this news organization in an interview.

Bruce A. Scott, MD, president of the American Medical Association (AMA) said in a statement that CMS’ release of the final fee schedule on November 1 should trigger serious work on a change to the 2025 Medicare physician fee schedule.

“The fee schedule rule released [on November 1] starts the clock — with January 1 looming,” Scott said. “A legislative remedy will require hard work and compromise. The 66 million patients who rely on Medicare are counting on that.”

Both Bucshon and Scott also joined many lawmakers and medical associations in calling on Congress for a larger overhaul of the Medicare physician fee schedule, well beyond whatever temporary adjustment may be made in the months ahead to avoid or soften the 2025 cuts.

The physician fee schedule sets formulas and rules regarding how the largest US buyer of health services pays the almost 1.3 million clinicians who bill Medicare. Of these, 51% are physicians. The physician fee schedule also covers payments for nurse practitioners, physician assistants, physical therapists, and other health professionals.
 

Last Major Overhaul Unpopular

There’s broad dissatisfaction with Congress’ last major overhaul of the Medicare physician fee schedule. The 2015 Medicare Access and CHIP Reauthorization Act (MACRA) aimed to shift clinicians toward programs tying pay increases to quality measures. But the implementation of that aim through the Merit-based Incentive Payment System is widely considered a disappointment.

MACRA was intended to end the need for annual “doc fixes,” as Congress’ last-minute Medicare adjustments are known. Seventeen such tweaks passed before MACRA took effect. 

But MACRA did not include a broad-based inflation adjuster, and some clinicians’ incomes are lagging as inflation rates — and practice costs — have risen. Scott said the Medicare Economic Index, which is a measure used to gauge increases in practice costs for clinicians, is expected to rise by 3.5%.

“To put it bluntly, Medicare plans to pay us less while costs go up. You don’t have to be an economist to know that is an unsustainable trend, though one that has been going on for decades,” Scott said. “For physician practices operating on small margins already, this means it is harder to acquire new equipment, harder to retain staff, harder to take on new Medicare patients, and harder to keep the doors open, particularly in rural and underserved areas.”

In a statement, Jen Brull, MD, president of the American Academy of Family Physicians, noted that this likely will be the fifth year in a row that Congress will need to do a patch to prevent cuts in pay to clinicians. 

Bucshon, who will retire from the House in January, said he expects Congress to pass legislation tying Medicare payment rates to inflation — eventually.

“People want to find a way to fix this problem, but also do it in a way that does not cut benefits to anyone, and that’s the key,” Bucshon said. “We’re going to have to find a way to make sure that providers are properly reimbursed.”

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

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Can We Repurpose Obesity Drugs to Reverse Liver Disease?

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Mon, 11/11/2024 - 12:31

 

Metabolic dysfunction–associated steatotic liver disease (MASLD) has become the most common liver disease worldwide, with a global prevalence of 32.4%. Its growth over the past three decades has occurred in tandem with increasing rates of obesity and type 2 diabetes — two cornerstones of MASLD.

Higher rates of MASLD and metabolic dysfunction–associated steatohepatitis (MASH) with fibrosis are present in adults with obesity and diabetes, noted Arun Sanyal, MD, professor and director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, Richmond, Virginia.

The success surrounding the medications for obesity and type 2 diabetes, including glucagon-like peptide 1 receptor agonists (GLP-1 RAs), has sparked studies investigating whether they could also be an effective treatment for liver disease.

In particular, GLP-1 RAs help patients lose weight and/or control diabetes by mimicking the function of the gut hormone GLP-1, released in response to nutrient intake, and are able to increase insulin secretion and reduce glucagon secretion, delay gastric emptying, and reduce appetite and caloric intake.

The studies for MASLD are testing whether these functions will also work against liver disease, either directly or indirectly, through obesity and diabetes control. The early results are promising.
 

More Than One Risk Factor in Play

MASLD is defined by the presence of hepatic steatosis and at least one of five cardiometabolic risk factors: Overweight/obesity, hypertension, hyperglycemia, dyslipidemia with either low-plasma high-density lipoprotein cholesterol or high triglycerides, or treatment for these conditions.

It is a grim trajectory if the disease progresses to MASH, as the patient may accumulate hepatic fibrosis and go on to develop cirrhosis and/or hepatocellular carcinoma.

Typically, more than one risk factor is at play in MASLD, noted Adnan Said, MD, chief of the Division of Gastroenterology and Hepatology at the William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.

“It most commonly occurs in the setting of weight gain and obesity, which are epidemics in the United States and worldwide, as well as the associated condition — metabolic syndrome — which goes along with obesity and includes type 2 diabetes, hyperlipidemia, hypertension, and sleep apnea,” Said, a hepatology and gastroenterology professor at the University of Wisconsin–Madison, told this news organization.

The research surrounding MASLD is investigating GLP-1 RAs as single agents and in combination with other drugs.

Finding treatment is critical, as there is only one drug — resmetirom — approved for the treatment of MASH with moderate to advanced fibrosis. But because it’s not approved for earlier stages, a treatment gap exists. The drug also doesn’t produce weight loss, which is key to treating MASLD. And while GLP-1 RAs help patients with the weight loss that is critical to MASLD, they are only approved by the US Food and Drug Administration (FDA) for obesity and type 2 diabetes.
 

Single Agents

The GLP-1 RAs liraglutide and semaglutide, both approved for diabetes and weight loss, are being studied as single agents against liver disease, Said said.

“Their action in the setting of MASLD and MASH is primarily indirect, through systemic pathways, improving these conditions via weight loss, as well as by improving insulin sensitivity and reducing lipotoxicity,” he added.

One of the first trials of these agents for liver disease was in 2016. In that double-blind, randomized, 48-week clinical trial of liraglutide in patients with MASH and overweight, 39% of patients who received liraglutide had a resolution of MASH compared with only 9% of those who received placebo. Moreover, only 9% vs 36% of patients in the treatment vs placebo group had progression of fibrosis.

Since then, a 72-week phase 2 trial in patients with MASH, liver fibrosis (stages F1-F3), and overweight or obesity found that once-daily subcutaneous semaglutide (0.1, 0.2, or 0.4 mg) outperformed placebo on MASH resolution without worsening of fibrosis (36%-59% vs 17%) and on weight loss (5%-13% vs 1%), with the greatest benefits at the largest dose. However, neoplasms were reported in 15% of patients receiving semaglutide vs 8% of those receiving placebo.

A phase 1 trial involving patients with liver stiffness, steatosis, and overweight or obesity found significantly greater reductions in liver fat at 48 weeks with semaglutide vs placebo, as well as decreases in liver enzymes, body weight, and A1c. There was no significant difference in liver stiffness.

Furthermore, a meta-analysis of eight studies found that treatment with 24 weeks of semaglutide significantly improved liver enzymes, reduced liver stiffness, and improved metabolic parameters in patients with MASLD/MASH. The authors cautioned that gastrointestinal adverse effects “could be a major concern.”

Several studies have found other GLP-1 RAs, including exenatide and dulaglutide, have a beneficial impact on liver injury indices and liver steatosis.

A new retrospective observational study offers evidence that GLP-1 RAs may have a direct impact on MASLD, independent of weight loss. Among the 28% of patients with type 2 diabetes and MASLD who received a GLP-1 RA, there was a significant reduction not only in body mass index but also in A1c, liver enzymes, and controlled attenuation parameter scores. A beneficial impact on liver parameters was observed even in patients who didn’t lose weight. While there was no difference in liver stiffness measurement, the median 60-month follow-up time may not have been long enough to capture such changes.

Another study indicated that the apparent benefits of GLP-1 RAs, in this case semaglutide, may not extend to patients whose disease has progressed to cirrhosis.
 

 

 

Dual and Triple Mechanisms of Action

Newer agents with double or triple mechanisms of action appear to have a more direct effect on the liver.

“Dual agents may have an added effect by improving MASLD directly through adipose regulation and thermogenesis, thereby improving fibrosis,” Said said.

An example is tirzepatide, a GLP-1 RA and an agonist of glucose-dependent insulinotropic polypeptide (GIP). Like GLP-1, GIP is an incretin. When used together as co-agonists, GLP-1 and GIP have been shown to increase insulin and glucagonostatic response and may work synergistically.

A new phase 2 trial that randomly assigned patients with biopsy-confirmed MASH and moderate or severe fibrosis to receive either once-weekly subcutaneous tirzepatide at one of three doses (5, 10, or 15 mg) or placebo found that tirzepatide at each dosage outperformed placebo in resolution of MASH without worsening of fibrosis.

“These findings were encouraging,” Said said. “We’ll see if the results continue into phase 3 trials.”

The combination of GLP-1 RAs with glucagon (GCG) receptor agonists also has garnered interest.

In a phase 2 trial, adults with biopsy-confirmed MASH and fibrosis stages F1-F3 were randomly assigned to receive either one of three doses of the GLP-1/GCG RA survodutide (2.4, 4.8, or 6 mg) or placebo. Survodutide at each dose was found to be superior to placebo in improving MASH without the worsening of fibrosis, reducing liver fat content by at least 30%, and decreasing liver fibrosis by at least one stage, with the 4.8-mg dose showing the best performance for each measure. However, adverse events, including nausea, diarrhea, and vomiting, were more frequent with survodutide than with placebo.

Trials of triple-action agents (GLP-1/GIP/GCG RAs) are underway too.

The hope is the triple agonists could deliver greater reduction in hepatic fat in patients with MASLD, Sanyal said. 

Sanyal further noted that a reduction in liver fat is important, citing a meta-analysis that showed ≥ 30% relative decline in liver fat is associated with higher odds of histologic response and MASH resolution.

Sanyal pointed to efocipegtrutide (HM15211), a GLP-1/GIP/GCG RA, which demonstrated significant liver fat reduction after 12 weeks in patients with MASLD in a phase 1b/2a randomized, placebo-controlled trial and is now in phase 2 development.

Another example is retatrutide (LY3437943), a once-weekly injectable, that was associated with up to a 24.2% reduction in body weight at 48 weeks, compared with 2.1% with placebo, in a phase 2 trial involving patients with obesity.

A sub-study assessed the mean relative change from baseline in liver fat at 24 weeks. These participants, who also had MASLD and ≥ 10% of liver fat content, were randomly assigned to receive either retatrutide in one of four doses (1, 4, 8, or 12 mg) or placebo for 48 weeks. All doses of retatrutide showed significantly greater reduction in liver fat content compared with placebo in weeks 24-48, with a mean relative liver fat reduction > 80% at the two higher doses. Moreover, ≥ 80% of participants on the higher retatrutide doses experienced ≥ 70% reduction in liver fat at 48 weeks, compared with 0% reduction in those on placebo, and hepatic steatosis resolved in > 85% of these participants.

This space “continues to evolve at a rapid rate,” Sanyal said. For example, oral dual-action agents are under development.
 

 

 

Obstacles and Warnings

Sanyal warned that GLP-1 RAs can cause nausea, so they have to be introduced at a low dose and slowly titrated upward. They should be used with caution in people with a history of multiple endocrine neoplasia. There is also a small but increased risk for gallstone formation and gallstone-induced pancreatitis with rapid weight loss.

GLP-1 RAs may increase the risk for suicidal ideation, with the authors of a recent study calling for “urgent clarification” regarding this possibility.

Following reports of suicidality submitted through its Adverse Events Reporting System, the FDA concluded that it could find no causal relationship between these agents and increased risk for suicidal ideation but also that it could not “definitively rule out that a small risk may exist” and would continue to investigate.

Access to GLP-1 RAs is an obstacle as well. Semaglutide continues to be on the FDA’s shortage list.

“This is improving, but there are still issues around getting approval from insurance companies,” Sanyal said.

Many patients discontinue use because of tolerability or access issues, which is problematic because most regain the weight they had lost while on the medication.

“Right now, we see GLP-1 RAs as a long-term therapeutic commitment, but there is a lot of research interest in figuring out if there’s a more modest benefit — almost an induction-remission maintenance approach to weight loss,” Sanyal said. These are “evolving trends,” and it’s unclear how they will unfold.

“As of now, you have to decide that if you’re putting your patient on these medications, they will have to take them on a long-term basis and include that consideration in your risk-benefit analysis, together with any concerns about adverse effects,” he said.

Sanyal reported consulting for Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Said received research support from Exact Sciences, Boehringer Ingelheim, and Mallinckrodt.
 

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

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Metabolic dysfunction–associated steatotic liver disease (MASLD) has become the most common liver disease worldwide, with a global prevalence of 32.4%. Its growth over the past three decades has occurred in tandem with increasing rates of obesity and type 2 diabetes — two cornerstones of MASLD.

Higher rates of MASLD and metabolic dysfunction–associated steatohepatitis (MASH) with fibrosis are present in adults with obesity and diabetes, noted Arun Sanyal, MD, professor and director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, Richmond, Virginia.

The success surrounding the medications for obesity and type 2 diabetes, including glucagon-like peptide 1 receptor agonists (GLP-1 RAs), has sparked studies investigating whether they could also be an effective treatment for liver disease.

In particular, GLP-1 RAs help patients lose weight and/or control diabetes by mimicking the function of the gut hormone GLP-1, released in response to nutrient intake, and are able to increase insulin secretion and reduce glucagon secretion, delay gastric emptying, and reduce appetite and caloric intake.

The studies for MASLD are testing whether these functions will also work against liver disease, either directly or indirectly, through obesity and diabetes control. The early results are promising.
 

More Than One Risk Factor in Play

MASLD is defined by the presence of hepatic steatosis and at least one of five cardiometabolic risk factors: Overweight/obesity, hypertension, hyperglycemia, dyslipidemia with either low-plasma high-density lipoprotein cholesterol or high triglycerides, or treatment for these conditions.

It is a grim trajectory if the disease progresses to MASH, as the patient may accumulate hepatic fibrosis and go on to develop cirrhosis and/or hepatocellular carcinoma.

Typically, more than one risk factor is at play in MASLD, noted Adnan Said, MD, chief of the Division of Gastroenterology and Hepatology at the William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.

“It most commonly occurs in the setting of weight gain and obesity, which are epidemics in the United States and worldwide, as well as the associated condition — metabolic syndrome — which goes along with obesity and includes type 2 diabetes, hyperlipidemia, hypertension, and sleep apnea,” Said, a hepatology and gastroenterology professor at the University of Wisconsin–Madison, told this news organization.

The research surrounding MASLD is investigating GLP-1 RAs as single agents and in combination with other drugs.

Finding treatment is critical, as there is only one drug — resmetirom — approved for the treatment of MASH with moderate to advanced fibrosis. But because it’s not approved for earlier stages, a treatment gap exists. The drug also doesn’t produce weight loss, which is key to treating MASLD. And while GLP-1 RAs help patients with the weight loss that is critical to MASLD, they are only approved by the US Food and Drug Administration (FDA) for obesity and type 2 diabetes.
 

Single Agents

The GLP-1 RAs liraglutide and semaglutide, both approved for diabetes and weight loss, are being studied as single agents against liver disease, Said said.

“Their action in the setting of MASLD and MASH is primarily indirect, through systemic pathways, improving these conditions via weight loss, as well as by improving insulin sensitivity and reducing lipotoxicity,” he added.

One of the first trials of these agents for liver disease was in 2016. In that double-blind, randomized, 48-week clinical trial of liraglutide in patients with MASH and overweight, 39% of patients who received liraglutide had a resolution of MASH compared with only 9% of those who received placebo. Moreover, only 9% vs 36% of patients in the treatment vs placebo group had progression of fibrosis.

Since then, a 72-week phase 2 trial in patients with MASH, liver fibrosis (stages F1-F3), and overweight or obesity found that once-daily subcutaneous semaglutide (0.1, 0.2, or 0.4 mg) outperformed placebo on MASH resolution without worsening of fibrosis (36%-59% vs 17%) and on weight loss (5%-13% vs 1%), with the greatest benefits at the largest dose. However, neoplasms were reported in 15% of patients receiving semaglutide vs 8% of those receiving placebo.

A phase 1 trial involving patients with liver stiffness, steatosis, and overweight or obesity found significantly greater reductions in liver fat at 48 weeks with semaglutide vs placebo, as well as decreases in liver enzymes, body weight, and A1c. There was no significant difference in liver stiffness.

Furthermore, a meta-analysis of eight studies found that treatment with 24 weeks of semaglutide significantly improved liver enzymes, reduced liver stiffness, and improved metabolic parameters in patients with MASLD/MASH. The authors cautioned that gastrointestinal adverse effects “could be a major concern.”

Several studies have found other GLP-1 RAs, including exenatide and dulaglutide, have a beneficial impact on liver injury indices and liver steatosis.

A new retrospective observational study offers evidence that GLP-1 RAs may have a direct impact on MASLD, independent of weight loss. Among the 28% of patients with type 2 diabetes and MASLD who received a GLP-1 RA, there was a significant reduction not only in body mass index but also in A1c, liver enzymes, and controlled attenuation parameter scores. A beneficial impact on liver parameters was observed even in patients who didn’t lose weight. While there was no difference in liver stiffness measurement, the median 60-month follow-up time may not have been long enough to capture such changes.

Another study indicated that the apparent benefits of GLP-1 RAs, in this case semaglutide, may not extend to patients whose disease has progressed to cirrhosis.
 

 

 

Dual and Triple Mechanisms of Action

Newer agents with double or triple mechanisms of action appear to have a more direct effect on the liver.

“Dual agents may have an added effect by improving MASLD directly through adipose regulation and thermogenesis, thereby improving fibrosis,” Said said.

An example is tirzepatide, a GLP-1 RA and an agonist of glucose-dependent insulinotropic polypeptide (GIP). Like GLP-1, GIP is an incretin. When used together as co-agonists, GLP-1 and GIP have been shown to increase insulin and glucagonostatic response and may work synergistically.

A new phase 2 trial that randomly assigned patients with biopsy-confirmed MASH and moderate or severe fibrosis to receive either once-weekly subcutaneous tirzepatide at one of three doses (5, 10, or 15 mg) or placebo found that tirzepatide at each dosage outperformed placebo in resolution of MASH without worsening of fibrosis.

“These findings were encouraging,” Said said. “We’ll see if the results continue into phase 3 trials.”

The combination of GLP-1 RAs with glucagon (GCG) receptor agonists also has garnered interest.

In a phase 2 trial, adults with biopsy-confirmed MASH and fibrosis stages F1-F3 were randomly assigned to receive either one of three doses of the GLP-1/GCG RA survodutide (2.4, 4.8, or 6 mg) or placebo. Survodutide at each dose was found to be superior to placebo in improving MASH without the worsening of fibrosis, reducing liver fat content by at least 30%, and decreasing liver fibrosis by at least one stage, with the 4.8-mg dose showing the best performance for each measure. However, adverse events, including nausea, diarrhea, and vomiting, were more frequent with survodutide than with placebo.

Trials of triple-action agents (GLP-1/GIP/GCG RAs) are underway too.

The hope is the triple agonists could deliver greater reduction in hepatic fat in patients with MASLD, Sanyal said. 

Sanyal further noted that a reduction in liver fat is important, citing a meta-analysis that showed ≥ 30% relative decline in liver fat is associated with higher odds of histologic response and MASH resolution.

Sanyal pointed to efocipegtrutide (HM15211), a GLP-1/GIP/GCG RA, which demonstrated significant liver fat reduction after 12 weeks in patients with MASLD in a phase 1b/2a randomized, placebo-controlled trial and is now in phase 2 development.

Another example is retatrutide (LY3437943), a once-weekly injectable, that was associated with up to a 24.2% reduction in body weight at 48 weeks, compared with 2.1% with placebo, in a phase 2 trial involving patients with obesity.

A sub-study assessed the mean relative change from baseline in liver fat at 24 weeks. These participants, who also had MASLD and ≥ 10% of liver fat content, were randomly assigned to receive either retatrutide in one of four doses (1, 4, 8, or 12 mg) or placebo for 48 weeks. All doses of retatrutide showed significantly greater reduction in liver fat content compared with placebo in weeks 24-48, with a mean relative liver fat reduction > 80% at the two higher doses. Moreover, ≥ 80% of participants on the higher retatrutide doses experienced ≥ 70% reduction in liver fat at 48 weeks, compared with 0% reduction in those on placebo, and hepatic steatosis resolved in > 85% of these participants.

This space “continues to evolve at a rapid rate,” Sanyal said. For example, oral dual-action agents are under development.
 

 

 

Obstacles and Warnings

Sanyal warned that GLP-1 RAs can cause nausea, so they have to be introduced at a low dose and slowly titrated upward. They should be used with caution in people with a history of multiple endocrine neoplasia. There is also a small but increased risk for gallstone formation and gallstone-induced pancreatitis with rapid weight loss.

GLP-1 RAs may increase the risk for suicidal ideation, with the authors of a recent study calling for “urgent clarification” regarding this possibility.

Following reports of suicidality submitted through its Adverse Events Reporting System, the FDA concluded that it could find no causal relationship between these agents and increased risk for suicidal ideation but also that it could not “definitively rule out that a small risk may exist” and would continue to investigate.

Access to GLP-1 RAs is an obstacle as well. Semaglutide continues to be on the FDA’s shortage list.

“This is improving, but there are still issues around getting approval from insurance companies,” Sanyal said.

Many patients discontinue use because of tolerability or access issues, which is problematic because most regain the weight they had lost while on the medication.

“Right now, we see GLP-1 RAs as a long-term therapeutic commitment, but there is a lot of research interest in figuring out if there’s a more modest benefit — almost an induction-remission maintenance approach to weight loss,” Sanyal said. These are “evolving trends,” and it’s unclear how they will unfold.

“As of now, you have to decide that if you’re putting your patient on these medications, they will have to take them on a long-term basis and include that consideration in your risk-benefit analysis, together with any concerns about adverse effects,” he said.

Sanyal reported consulting for Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Said received research support from Exact Sciences, Boehringer Ingelheim, and Mallinckrodt.
 

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

 

Metabolic dysfunction–associated steatotic liver disease (MASLD) has become the most common liver disease worldwide, with a global prevalence of 32.4%. Its growth over the past three decades has occurred in tandem with increasing rates of obesity and type 2 diabetes — two cornerstones of MASLD.

Higher rates of MASLD and metabolic dysfunction–associated steatohepatitis (MASH) with fibrosis are present in adults with obesity and diabetes, noted Arun Sanyal, MD, professor and director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, Richmond, Virginia.

The success surrounding the medications for obesity and type 2 diabetes, including glucagon-like peptide 1 receptor agonists (GLP-1 RAs), has sparked studies investigating whether they could also be an effective treatment for liver disease.

In particular, GLP-1 RAs help patients lose weight and/or control diabetes by mimicking the function of the gut hormone GLP-1, released in response to nutrient intake, and are able to increase insulin secretion and reduce glucagon secretion, delay gastric emptying, and reduce appetite and caloric intake.

The studies for MASLD are testing whether these functions will also work against liver disease, either directly or indirectly, through obesity and diabetes control. The early results are promising.
 

More Than One Risk Factor in Play

MASLD is defined by the presence of hepatic steatosis and at least one of five cardiometabolic risk factors: Overweight/obesity, hypertension, hyperglycemia, dyslipidemia with either low-plasma high-density lipoprotein cholesterol or high triglycerides, or treatment for these conditions.

It is a grim trajectory if the disease progresses to MASH, as the patient may accumulate hepatic fibrosis and go on to develop cirrhosis and/or hepatocellular carcinoma.

Typically, more than one risk factor is at play in MASLD, noted Adnan Said, MD, chief of the Division of Gastroenterology and Hepatology at the William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.

“It most commonly occurs in the setting of weight gain and obesity, which are epidemics in the United States and worldwide, as well as the associated condition — metabolic syndrome — which goes along with obesity and includes type 2 diabetes, hyperlipidemia, hypertension, and sleep apnea,” Said, a hepatology and gastroenterology professor at the University of Wisconsin–Madison, told this news organization.

The research surrounding MASLD is investigating GLP-1 RAs as single agents and in combination with other drugs.

Finding treatment is critical, as there is only one drug — resmetirom — approved for the treatment of MASH with moderate to advanced fibrosis. But because it’s not approved for earlier stages, a treatment gap exists. The drug also doesn’t produce weight loss, which is key to treating MASLD. And while GLP-1 RAs help patients with the weight loss that is critical to MASLD, they are only approved by the US Food and Drug Administration (FDA) for obesity and type 2 diabetes.
 

Single Agents

The GLP-1 RAs liraglutide and semaglutide, both approved for diabetes and weight loss, are being studied as single agents against liver disease, Said said.

“Their action in the setting of MASLD and MASH is primarily indirect, through systemic pathways, improving these conditions via weight loss, as well as by improving insulin sensitivity and reducing lipotoxicity,” he added.

One of the first trials of these agents for liver disease was in 2016. In that double-blind, randomized, 48-week clinical trial of liraglutide in patients with MASH and overweight, 39% of patients who received liraglutide had a resolution of MASH compared with only 9% of those who received placebo. Moreover, only 9% vs 36% of patients in the treatment vs placebo group had progression of fibrosis.

Since then, a 72-week phase 2 trial in patients with MASH, liver fibrosis (stages F1-F3), and overweight or obesity found that once-daily subcutaneous semaglutide (0.1, 0.2, or 0.4 mg) outperformed placebo on MASH resolution without worsening of fibrosis (36%-59% vs 17%) and on weight loss (5%-13% vs 1%), with the greatest benefits at the largest dose. However, neoplasms were reported in 15% of patients receiving semaglutide vs 8% of those receiving placebo.

A phase 1 trial involving patients with liver stiffness, steatosis, and overweight or obesity found significantly greater reductions in liver fat at 48 weeks with semaglutide vs placebo, as well as decreases in liver enzymes, body weight, and A1c. There was no significant difference in liver stiffness.

Furthermore, a meta-analysis of eight studies found that treatment with 24 weeks of semaglutide significantly improved liver enzymes, reduced liver stiffness, and improved metabolic parameters in patients with MASLD/MASH. The authors cautioned that gastrointestinal adverse effects “could be a major concern.”

Several studies have found other GLP-1 RAs, including exenatide and dulaglutide, have a beneficial impact on liver injury indices and liver steatosis.

A new retrospective observational study offers evidence that GLP-1 RAs may have a direct impact on MASLD, independent of weight loss. Among the 28% of patients with type 2 diabetes and MASLD who received a GLP-1 RA, there was a significant reduction not only in body mass index but also in A1c, liver enzymes, and controlled attenuation parameter scores. A beneficial impact on liver parameters was observed even in patients who didn’t lose weight. While there was no difference in liver stiffness measurement, the median 60-month follow-up time may not have been long enough to capture such changes.

Another study indicated that the apparent benefits of GLP-1 RAs, in this case semaglutide, may not extend to patients whose disease has progressed to cirrhosis.
 

 

 

Dual and Triple Mechanisms of Action

Newer agents with double or triple mechanisms of action appear to have a more direct effect on the liver.

“Dual agents may have an added effect by improving MASLD directly through adipose regulation and thermogenesis, thereby improving fibrosis,” Said said.

An example is tirzepatide, a GLP-1 RA and an agonist of glucose-dependent insulinotropic polypeptide (GIP). Like GLP-1, GIP is an incretin. When used together as co-agonists, GLP-1 and GIP have been shown to increase insulin and glucagonostatic response and may work synergistically.

A new phase 2 trial that randomly assigned patients with biopsy-confirmed MASH and moderate or severe fibrosis to receive either once-weekly subcutaneous tirzepatide at one of three doses (5, 10, or 15 mg) or placebo found that tirzepatide at each dosage outperformed placebo in resolution of MASH without worsening of fibrosis.

“These findings were encouraging,” Said said. “We’ll see if the results continue into phase 3 trials.”

The combination of GLP-1 RAs with glucagon (GCG) receptor agonists also has garnered interest.

In a phase 2 trial, adults with biopsy-confirmed MASH and fibrosis stages F1-F3 were randomly assigned to receive either one of three doses of the GLP-1/GCG RA survodutide (2.4, 4.8, or 6 mg) or placebo. Survodutide at each dose was found to be superior to placebo in improving MASH without the worsening of fibrosis, reducing liver fat content by at least 30%, and decreasing liver fibrosis by at least one stage, with the 4.8-mg dose showing the best performance for each measure. However, adverse events, including nausea, diarrhea, and vomiting, were more frequent with survodutide than with placebo.

Trials of triple-action agents (GLP-1/GIP/GCG RAs) are underway too.

The hope is the triple agonists could deliver greater reduction in hepatic fat in patients with MASLD, Sanyal said. 

Sanyal further noted that a reduction in liver fat is important, citing a meta-analysis that showed ≥ 30% relative decline in liver fat is associated with higher odds of histologic response and MASH resolution.

Sanyal pointed to efocipegtrutide (HM15211), a GLP-1/GIP/GCG RA, which demonstrated significant liver fat reduction after 12 weeks in patients with MASLD in a phase 1b/2a randomized, placebo-controlled trial and is now in phase 2 development.

Another example is retatrutide (LY3437943), a once-weekly injectable, that was associated with up to a 24.2% reduction in body weight at 48 weeks, compared with 2.1% with placebo, in a phase 2 trial involving patients with obesity.

A sub-study assessed the mean relative change from baseline in liver fat at 24 weeks. These participants, who also had MASLD and ≥ 10% of liver fat content, were randomly assigned to receive either retatrutide in one of four doses (1, 4, 8, or 12 mg) or placebo for 48 weeks. All doses of retatrutide showed significantly greater reduction in liver fat content compared with placebo in weeks 24-48, with a mean relative liver fat reduction > 80% at the two higher doses. Moreover, ≥ 80% of participants on the higher retatrutide doses experienced ≥ 70% reduction in liver fat at 48 weeks, compared with 0% reduction in those on placebo, and hepatic steatosis resolved in > 85% of these participants.

This space “continues to evolve at a rapid rate,” Sanyal said. For example, oral dual-action agents are under development.
 

 

 

Obstacles and Warnings

Sanyal warned that GLP-1 RAs can cause nausea, so they have to be introduced at a low dose and slowly titrated upward. They should be used with caution in people with a history of multiple endocrine neoplasia. There is also a small but increased risk for gallstone formation and gallstone-induced pancreatitis with rapid weight loss.

GLP-1 RAs may increase the risk for suicidal ideation, with the authors of a recent study calling for “urgent clarification” regarding this possibility.

Following reports of suicidality submitted through its Adverse Events Reporting System, the FDA concluded that it could find no causal relationship between these agents and increased risk for suicidal ideation but also that it could not “definitively rule out that a small risk may exist” and would continue to investigate.

Access to GLP-1 RAs is an obstacle as well. Semaglutide continues to be on the FDA’s shortage list.

“This is improving, but there are still issues around getting approval from insurance companies,” Sanyal said.

Many patients discontinue use because of tolerability or access issues, which is problematic because most regain the weight they had lost while on the medication.

“Right now, we see GLP-1 RAs as a long-term therapeutic commitment, but there is a lot of research interest in figuring out if there’s a more modest benefit — almost an induction-remission maintenance approach to weight loss,” Sanyal said. These are “evolving trends,” and it’s unclear how they will unfold.

“As of now, you have to decide that if you’re putting your patient on these medications, they will have to take them on a long-term basis and include that consideration in your risk-benefit analysis, together with any concerns about adverse effects,” he said.

Sanyal reported consulting for Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Said received research support from Exact Sciences, Boehringer Ingelheim, and Mallinckrodt.
 

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

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ATA: Updates on Risk, Diagnosis, and Treatment of Thyroid Cancer

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Wed, 11/27/2024 - 04:49

— Patients who are new users of glucagon-like peptide 1 (GLP-1) receptor agonists have a low absolute risk of thyroid cancer, according to a new study presented at the annual meeting of the American Thyroid Association (ATA).

The study, presented by Juan Brito Campana, MBBS, of the Mayo Clinic in Rochester, Minnesota, used Medicare records to perform a secondary analysis of 41,000 adults with type 2 diabetes and moderate cardiovascular risk who were new users of GLP-1 receptor agonists, compared to users of other diabetes medications. 

“We took the innovative approach of applying the methodological rigor of a randomized clinical trial to the very large dataset of observational studies,” said Brito Campana.

The results showed a low absolute risk of thyroid cancer, with only 0.17% of patients in the GLP-1 group developing the disease. However, the data also showed a potential relative increase in risk during the first year of GLP-1 receptor agonist use. 

“This is likely due to increased detection rather than true incidence, as the latency period for thyroid cancer development is typically longer,” Brito Campana said. 

“We also note the limitations of the observational study design, including the short follow-up period and lack of detailed histological data. However, we believe the benefits of GLP-1 receptor agonists likely outweigh the risk of thyroid cancer.”
 

Malignancy in Bethesda III and IV Thyroid Nodules

At the same ATA session, Sapir Nachum Goldberg, MD, of the University of Pennsylvania, Philadelphia, presented the results of a retrospective record review that examined the prevalence of malignancy in Bethesda III and IV thyroid nodules with negative Thyrogen Receptor Signaling (ThyroSeq) version 3 molecular testing results.

Goldberg reported that 87% of patients with ThyroSeq negative subtype results were managed nonoperatively. “Based on our data, the true prevalence of malignancy likely lies between our low and high estimates of 3% and 23%,” she said. “We believe that the prevalence of malignancy may be higher in real-world practice than validation studies.”

Additionally, nodules with “currently negative” or “negative but limited” ThyroSeq results had a higher prevalence of malignancy (7%), compared with those with a “negative” result (2%). Factors like immediate vs delayed surgery, nodule size, and ultrasound pattern did not significantly impact malignancy prevalence.

The study results also indicated that surveillance ultrasonography is not routinely performed in up to one-third of patients, Goldberg said.

She closed by suggesting that colleagues consider the negative subtype in clinical decision-making. For “negative but limited” nodules, repeat the fine needle aspiration and, for “negative” and “currently negative” nodules, consider ultrasound follow-up as per ATA guidelines for Bethesda II cytology, she said.
 

RET-Mutated Medullary Thyroid Cancer

For patients with RET-mutated medullary thyroid cancer, Julien Hadoux, MD, PhD, of Institut de Cancérologie Gustave Roussy, Villejuif, France, presented a combined analysis of the efficacy of the RET inhibitor selpercatinib from the phase 1/2 LIBRETTO-001 and phase 3 LIBRETTO-531 trials.

This post hoc analysis used a combined cohort of 509 patients with RET-mutated advanced or metastatic medullary thyroid cancer who had received selpercatinib in the two trials.

Hadoux reported that robust and durable responses were seen across all mutation groups, including M918T, extracellular cysteine, and an “other” group composed of various uncommon RET mutations. “The median [progression-free survival] PFS was not reached for either the M918T or extracellular groups and it was 51.4 months for the Other group,” he said. 

“Selpercatinib showed superior median PFS vs control, regardless of the RET mutation. This analysis constitutes the largest catalog of RET mutations in medullary thyroid cancers treated with RET-specific inhibitors.”
 

 

 

TRK-Fusion Differentiated Thyroid Cancer

Steven Waguespack, MD, of the University of Texas MD Anderson Cancer Center, Houston, shared updated efficacy and safety data from three phase 1/2 pooled clinical trials of the tropomyosin kinase receptor (TRK) inhibitor larotrectinib in thyroid cancer. These data updated results initially published in 2022.

“Larotrectinib continues to demonstrate rapid and durable responses, extended survival, and offers a favorable safety profile in patients with TRK fusion differentiated thyroid cancer, with limited activity in anaplastic thyroid cancer,” Waguespack said. 

“Additionally, in a subset of patients, we identified some acquired on-target NTRK mutations and off-target GNAS and TP53 mutations that may give further insight into mechanisms of resistance.”

The primary endpoint was the investigator-assessed objective response rate (ORR); at 48 months, the ORR was 79% by independent review. The median PFS in patients with TRK fusion differentiated thyroid cancer was 44 months, while the median duration of response was 41 months. The 4-year overall survival rate was 86%.

Waguespack closed with a cautionary note to colleagues: “While circulating tumor DNA next-generation sequencing (NGS) analysis can be used to test for NTRK gene fusions, negative results should be followed up with tissue-based NGS,” he said.

Brito Campana and Goldberg disclosed no relevant financial relationships. Hadoux reported receiving honoraria for speaker engagements, advisory roles, or funding for CME from Eli Lilly, AAA, IPSEN, Roche, Pharma Mar, and EISAI, and research grants from Novartis, Sanofi, and Eli Lilly.

A version of this article appeared on Medscape.com.

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— Patients who are new users of glucagon-like peptide 1 (GLP-1) receptor agonists have a low absolute risk of thyroid cancer, according to a new study presented at the annual meeting of the American Thyroid Association (ATA).

The study, presented by Juan Brito Campana, MBBS, of the Mayo Clinic in Rochester, Minnesota, used Medicare records to perform a secondary analysis of 41,000 adults with type 2 diabetes and moderate cardiovascular risk who were new users of GLP-1 receptor agonists, compared to users of other diabetes medications. 

“We took the innovative approach of applying the methodological rigor of a randomized clinical trial to the very large dataset of observational studies,” said Brito Campana.

The results showed a low absolute risk of thyroid cancer, with only 0.17% of patients in the GLP-1 group developing the disease. However, the data also showed a potential relative increase in risk during the first year of GLP-1 receptor agonist use. 

“This is likely due to increased detection rather than true incidence, as the latency period for thyroid cancer development is typically longer,” Brito Campana said. 

“We also note the limitations of the observational study design, including the short follow-up period and lack of detailed histological data. However, we believe the benefits of GLP-1 receptor agonists likely outweigh the risk of thyroid cancer.”
 

Malignancy in Bethesda III and IV Thyroid Nodules

At the same ATA session, Sapir Nachum Goldberg, MD, of the University of Pennsylvania, Philadelphia, presented the results of a retrospective record review that examined the prevalence of malignancy in Bethesda III and IV thyroid nodules with negative Thyrogen Receptor Signaling (ThyroSeq) version 3 molecular testing results.

Goldberg reported that 87% of patients with ThyroSeq negative subtype results were managed nonoperatively. “Based on our data, the true prevalence of malignancy likely lies between our low and high estimates of 3% and 23%,” she said. “We believe that the prevalence of malignancy may be higher in real-world practice than validation studies.”

Additionally, nodules with “currently negative” or “negative but limited” ThyroSeq results had a higher prevalence of malignancy (7%), compared with those with a “negative” result (2%). Factors like immediate vs delayed surgery, nodule size, and ultrasound pattern did not significantly impact malignancy prevalence.

The study results also indicated that surveillance ultrasonography is not routinely performed in up to one-third of patients, Goldberg said.

She closed by suggesting that colleagues consider the negative subtype in clinical decision-making. For “negative but limited” nodules, repeat the fine needle aspiration and, for “negative” and “currently negative” nodules, consider ultrasound follow-up as per ATA guidelines for Bethesda II cytology, she said.
 

RET-Mutated Medullary Thyroid Cancer

For patients with RET-mutated medullary thyroid cancer, Julien Hadoux, MD, PhD, of Institut de Cancérologie Gustave Roussy, Villejuif, France, presented a combined analysis of the efficacy of the RET inhibitor selpercatinib from the phase 1/2 LIBRETTO-001 and phase 3 LIBRETTO-531 trials.

This post hoc analysis used a combined cohort of 509 patients with RET-mutated advanced or metastatic medullary thyroid cancer who had received selpercatinib in the two trials.

Hadoux reported that robust and durable responses were seen across all mutation groups, including M918T, extracellular cysteine, and an “other” group composed of various uncommon RET mutations. “The median [progression-free survival] PFS was not reached for either the M918T or extracellular groups and it was 51.4 months for the Other group,” he said. 

“Selpercatinib showed superior median PFS vs control, regardless of the RET mutation. This analysis constitutes the largest catalog of RET mutations in medullary thyroid cancers treated with RET-specific inhibitors.”
 

 

 

TRK-Fusion Differentiated Thyroid Cancer

Steven Waguespack, MD, of the University of Texas MD Anderson Cancer Center, Houston, shared updated efficacy and safety data from three phase 1/2 pooled clinical trials of the tropomyosin kinase receptor (TRK) inhibitor larotrectinib in thyroid cancer. These data updated results initially published in 2022.

“Larotrectinib continues to demonstrate rapid and durable responses, extended survival, and offers a favorable safety profile in patients with TRK fusion differentiated thyroid cancer, with limited activity in anaplastic thyroid cancer,” Waguespack said. 

“Additionally, in a subset of patients, we identified some acquired on-target NTRK mutations and off-target GNAS and TP53 mutations that may give further insight into mechanisms of resistance.”

The primary endpoint was the investigator-assessed objective response rate (ORR); at 48 months, the ORR was 79% by independent review. The median PFS in patients with TRK fusion differentiated thyroid cancer was 44 months, while the median duration of response was 41 months. The 4-year overall survival rate was 86%.

Waguespack closed with a cautionary note to colleagues: “While circulating tumor DNA next-generation sequencing (NGS) analysis can be used to test for NTRK gene fusions, negative results should be followed up with tissue-based NGS,” he said.

Brito Campana and Goldberg disclosed no relevant financial relationships. Hadoux reported receiving honoraria for speaker engagements, advisory roles, or funding for CME from Eli Lilly, AAA, IPSEN, Roche, Pharma Mar, and EISAI, and research grants from Novartis, Sanofi, and Eli Lilly.

A version of this article appeared on Medscape.com.

— Patients who are new users of glucagon-like peptide 1 (GLP-1) receptor agonists have a low absolute risk of thyroid cancer, according to a new study presented at the annual meeting of the American Thyroid Association (ATA).

The study, presented by Juan Brito Campana, MBBS, of the Mayo Clinic in Rochester, Minnesota, used Medicare records to perform a secondary analysis of 41,000 adults with type 2 diabetes and moderate cardiovascular risk who were new users of GLP-1 receptor agonists, compared to users of other diabetes medications. 

“We took the innovative approach of applying the methodological rigor of a randomized clinical trial to the very large dataset of observational studies,” said Brito Campana.

The results showed a low absolute risk of thyroid cancer, with only 0.17% of patients in the GLP-1 group developing the disease. However, the data also showed a potential relative increase in risk during the first year of GLP-1 receptor agonist use. 

“This is likely due to increased detection rather than true incidence, as the latency period for thyroid cancer development is typically longer,” Brito Campana said. 

“We also note the limitations of the observational study design, including the short follow-up period and lack of detailed histological data. However, we believe the benefits of GLP-1 receptor agonists likely outweigh the risk of thyroid cancer.”
 

Malignancy in Bethesda III and IV Thyroid Nodules

At the same ATA session, Sapir Nachum Goldberg, MD, of the University of Pennsylvania, Philadelphia, presented the results of a retrospective record review that examined the prevalence of malignancy in Bethesda III and IV thyroid nodules with negative Thyrogen Receptor Signaling (ThyroSeq) version 3 molecular testing results.

Goldberg reported that 87% of patients with ThyroSeq negative subtype results were managed nonoperatively. “Based on our data, the true prevalence of malignancy likely lies between our low and high estimates of 3% and 23%,” she said. “We believe that the prevalence of malignancy may be higher in real-world practice than validation studies.”

Additionally, nodules with “currently negative” or “negative but limited” ThyroSeq results had a higher prevalence of malignancy (7%), compared with those with a “negative” result (2%). Factors like immediate vs delayed surgery, nodule size, and ultrasound pattern did not significantly impact malignancy prevalence.

The study results also indicated that surveillance ultrasonography is not routinely performed in up to one-third of patients, Goldberg said.

She closed by suggesting that colleagues consider the negative subtype in clinical decision-making. For “negative but limited” nodules, repeat the fine needle aspiration and, for “negative” and “currently negative” nodules, consider ultrasound follow-up as per ATA guidelines for Bethesda II cytology, she said.
 

RET-Mutated Medullary Thyroid Cancer

For patients with RET-mutated medullary thyroid cancer, Julien Hadoux, MD, PhD, of Institut de Cancérologie Gustave Roussy, Villejuif, France, presented a combined analysis of the efficacy of the RET inhibitor selpercatinib from the phase 1/2 LIBRETTO-001 and phase 3 LIBRETTO-531 trials.

This post hoc analysis used a combined cohort of 509 patients with RET-mutated advanced or metastatic medullary thyroid cancer who had received selpercatinib in the two trials.

Hadoux reported that robust and durable responses were seen across all mutation groups, including M918T, extracellular cysteine, and an “other” group composed of various uncommon RET mutations. “The median [progression-free survival] PFS was not reached for either the M918T or extracellular groups and it was 51.4 months for the Other group,” he said. 

“Selpercatinib showed superior median PFS vs control, regardless of the RET mutation. This analysis constitutes the largest catalog of RET mutations in medullary thyroid cancers treated with RET-specific inhibitors.”
 

 

 

TRK-Fusion Differentiated Thyroid Cancer

Steven Waguespack, MD, of the University of Texas MD Anderson Cancer Center, Houston, shared updated efficacy and safety data from three phase 1/2 pooled clinical trials of the tropomyosin kinase receptor (TRK) inhibitor larotrectinib in thyroid cancer. These data updated results initially published in 2022.

“Larotrectinib continues to demonstrate rapid and durable responses, extended survival, and offers a favorable safety profile in patients with TRK fusion differentiated thyroid cancer, with limited activity in anaplastic thyroid cancer,” Waguespack said. 

“Additionally, in a subset of patients, we identified some acquired on-target NTRK mutations and off-target GNAS and TP53 mutations that may give further insight into mechanisms of resistance.”

The primary endpoint was the investigator-assessed objective response rate (ORR); at 48 months, the ORR was 79% by independent review. The median PFS in patients with TRK fusion differentiated thyroid cancer was 44 months, while the median duration of response was 41 months. The 4-year overall survival rate was 86%.

Waguespack closed with a cautionary note to colleagues: “While circulating tumor DNA next-generation sequencing (NGS) analysis can be used to test for NTRK gene fusions, negative results should be followed up with tissue-based NGS,” he said.

Brito Campana and Goldberg disclosed no relevant financial relationships. Hadoux reported receiving honoraria for speaker engagements, advisory roles, or funding for CME from Eli Lilly, AAA, IPSEN, Roche, Pharma Mar, and EISAI, and research grants from Novartis, Sanofi, and Eli Lilly.

A version of this article appeared on Medscape.com.

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Social Adversity Increases Mortality Risk in Patients With Pulmonary Hypertension

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— Social adversity is associated with worse survival among patients with pulmonary hypertension (PH), according to a new retrospective study of a New York City population. Among HIV+ patients with heart failure, PH was associated with about a threefold increase in all-cause mortality, but that risk increased to about sevenfold when social adversity, identified by a licensed social worker, was also present.

A sub-analysis of both HIV+ and HIV– patients showed worse mortality outcomes with social adversity in both groups.

“Almost the majority of patients that we treat have either some social adversity or no insurance or are undocumented, so as a group of residents, we decided to study the impact of these factors on their health and the care that can be provided. We started using the two cohorts and now we keep it going with every new resident,” said Luca Biavati, MD, who presented the study at the CHEST Annual Meeting.

“The presence of any form of socioeconomic disadvantage is negatively impacting care and for a large part of the population, there are some factors that could probably be addressed by either an institutional or hospital policy,” said Dr. Biavati, who is an internal medicine resident at Jacobi Medical Center, New York.

Other factors are more difficult to address, such as lack of education. “[Some patients] don’t understand the gravity of their issue and medical condition until it’s too late, and then they’re not fit enough for the treatment, or just because of the social situation, they cannot qualify for advanced therapies,” said Dr. Biavati.

The researchers established two cohorts: One consisting of patients with HIV and heart failure who may or may not have had PH and one comprising patients with PH with or without HIV and heart failure. In the HIV/heart failure group, PH without social adversity was associated with a nearly threefold increase in all-cause mortality (hazard ratio [HR], 2.83; P = .004), whereas PH with social adversity was linked to a more than sevenfold increase in all-cause mortality (HR, 7.14; P < .001). Social adversity without PA was associated with a more than fourfold increase (HR, 4.47; P < .001).

Within the PH cohort, social adversity was associated with lower survival (P < .001). When the researchers broke down the results by types of social adversity, they found statistically significant relationships between greater mortality risk and economic instability within the HIV+ population (HR, 2.59; P = .040), transportation issues within the HIV– population (HR, 12.8; P < .001), and lack of social or family support within both the HIV– (HR, 5.49; P < .001) and the HIV+ population (HR, 2.03; P = .028). 

The research has prompted interventions, which are now being studied at the institution, according to Dr. Biavati. “We have a policy of giving medications in bags when we discharge a patient with a social adversity. We literally go to the pharmacy, bring up the bag of medication, and we [put it] in their hands before they leave the hospital. They get a 1- or 3-month supply, depending on the medication, and then we usually discharge them with a clinical appointment already scheduled with either a pulmonary or primary care provider, and we usually call them before every appointment to confirm that they’re coming. That increases the chances of some success, but there’s still a very long way to go,” said Dr. Biavati.

Dr. Biavati was blinded to the results of the intervention, so he could not report on whether it was working. “But I can tell you that I’ve had busier clinics, so hopefully that means that they’re showing up more,” he said.

The problem is complex, according to Sandeep Jain, MD, who moderated the session. “Social adversity means lack of education. Lack of education means lack of compliance. Lack of compliance means what can you do if people are not taking medications? So it’s all matched together. It’s all lack of education and lack of money, lack of family support. And these drugs they have to take every single day. It’s not that easy. It’s very easy for us to say I had antiretroviral treatment for 6 months. It is almost impossible to continue regular treatment for that long [for a patient with social adversity]. You can’t blame them if they aren’t taking treatments. It’s very difficult for them,” said Dr. Jain.

That underscores the need for interventions that can address the needs of patients with social adversity. “We have to [practice] medicine considering the social situation of the patient and not just the medicine that we study in books. That’s kind of what we are faced with every day. We have therapies, and then life happens. It’s much harder to care for those patients,” said Dr. Biavati.

Dr. Biavati and Dr. Jain reported no relevant financial relationships.
 

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

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— Social adversity is associated with worse survival among patients with pulmonary hypertension (PH), according to a new retrospective study of a New York City population. Among HIV+ patients with heart failure, PH was associated with about a threefold increase in all-cause mortality, but that risk increased to about sevenfold when social adversity, identified by a licensed social worker, was also present.

A sub-analysis of both HIV+ and HIV– patients showed worse mortality outcomes with social adversity in both groups.

“Almost the majority of patients that we treat have either some social adversity or no insurance or are undocumented, so as a group of residents, we decided to study the impact of these factors on their health and the care that can be provided. We started using the two cohorts and now we keep it going with every new resident,” said Luca Biavati, MD, who presented the study at the CHEST Annual Meeting.

“The presence of any form of socioeconomic disadvantage is negatively impacting care and for a large part of the population, there are some factors that could probably be addressed by either an institutional or hospital policy,” said Dr. Biavati, who is an internal medicine resident at Jacobi Medical Center, New York.

Other factors are more difficult to address, such as lack of education. “[Some patients] don’t understand the gravity of their issue and medical condition until it’s too late, and then they’re not fit enough for the treatment, or just because of the social situation, they cannot qualify for advanced therapies,” said Dr. Biavati.

The researchers established two cohorts: One consisting of patients with HIV and heart failure who may or may not have had PH and one comprising patients with PH with or without HIV and heart failure. In the HIV/heart failure group, PH without social adversity was associated with a nearly threefold increase in all-cause mortality (hazard ratio [HR], 2.83; P = .004), whereas PH with social adversity was linked to a more than sevenfold increase in all-cause mortality (HR, 7.14; P < .001). Social adversity without PA was associated with a more than fourfold increase (HR, 4.47; P < .001).

Within the PH cohort, social adversity was associated with lower survival (P < .001). When the researchers broke down the results by types of social adversity, they found statistically significant relationships between greater mortality risk and economic instability within the HIV+ population (HR, 2.59; P = .040), transportation issues within the HIV– population (HR, 12.8; P < .001), and lack of social or family support within both the HIV– (HR, 5.49; P < .001) and the HIV+ population (HR, 2.03; P = .028). 

The research has prompted interventions, which are now being studied at the institution, according to Dr. Biavati. “We have a policy of giving medications in bags when we discharge a patient with a social adversity. We literally go to the pharmacy, bring up the bag of medication, and we [put it] in their hands before they leave the hospital. They get a 1- or 3-month supply, depending on the medication, and then we usually discharge them with a clinical appointment already scheduled with either a pulmonary or primary care provider, and we usually call them before every appointment to confirm that they’re coming. That increases the chances of some success, but there’s still a very long way to go,” said Dr. Biavati.

Dr. Biavati was blinded to the results of the intervention, so he could not report on whether it was working. “But I can tell you that I’ve had busier clinics, so hopefully that means that they’re showing up more,” he said.

The problem is complex, according to Sandeep Jain, MD, who moderated the session. “Social adversity means lack of education. Lack of education means lack of compliance. Lack of compliance means what can you do if people are not taking medications? So it’s all matched together. It’s all lack of education and lack of money, lack of family support. And these drugs they have to take every single day. It’s not that easy. It’s very easy for us to say I had antiretroviral treatment for 6 months. It is almost impossible to continue regular treatment for that long [for a patient with social adversity]. You can’t blame them if they aren’t taking treatments. It’s very difficult for them,” said Dr. Jain.

That underscores the need for interventions that can address the needs of patients with social adversity. “We have to [practice] medicine considering the social situation of the patient and not just the medicine that we study in books. That’s kind of what we are faced with every day. We have therapies, and then life happens. It’s much harder to care for those patients,” said Dr. Biavati.

Dr. Biavati and Dr. Jain reported no relevant financial relationships.
 

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

 

— Social adversity is associated with worse survival among patients with pulmonary hypertension (PH), according to a new retrospective study of a New York City population. Among HIV+ patients with heart failure, PH was associated with about a threefold increase in all-cause mortality, but that risk increased to about sevenfold when social adversity, identified by a licensed social worker, was also present.

A sub-analysis of both HIV+ and HIV– patients showed worse mortality outcomes with social adversity in both groups.

“Almost the majority of patients that we treat have either some social adversity or no insurance or are undocumented, so as a group of residents, we decided to study the impact of these factors on their health and the care that can be provided. We started using the two cohorts and now we keep it going with every new resident,” said Luca Biavati, MD, who presented the study at the CHEST Annual Meeting.

“The presence of any form of socioeconomic disadvantage is negatively impacting care and for a large part of the population, there are some factors that could probably be addressed by either an institutional or hospital policy,” said Dr. Biavati, who is an internal medicine resident at Jacobi Medical Center, New York.

Other factors are more difficult to address, such as lack of education. “[Some patients] don’t understand the gravity of their issue and medical condition until it’s too late, and then they’re not fit enough for the treatment, or just because of the social situation, they cannot qualify for advanced therapies,” said Dr. Biavati.

The researchers established two cohorts: One consisting of patients with HIV and heart failure who may or may not have had PH and one comprising patients with PH with or without HIV and heart failure. In the HIV/heart failure group, PH without social adversity was associated with a nearly threefold increase in all-cause mortality (hazard ratio [HR], 2.83; P = .004), whereas PH with social adversity was linked to a more than sevenfold increase in all-cause mortality (HR, 7.14; P < .001). Social adversity without PA was associated with a more than fourfold increase (HR, 4.47; P < .001).

Within the PH cohort, social adversity was associated with lower survival (P < .001). When the researchers broke down the results by types of social adversity, they found statistically significant relationships between greater mortality risk and economic instability within the HIV+ population (HR, 2.59; P = .040), transportation issues within the HIV– population (HR, 12.8; P < .001), and lack of social or family support within both the HIV– (HR, 5.49; P < .001) and the HIV+ population (HR, 2.03; P = .028). 

The research has prompted interventions, which are now being studied at the institution, according to Dr. Biavati. “We have a policy of giving medications in bags when we discharge a patient with a social adversity. We literally go to the pharmacy, bring up the bag of medication, and we [put it] in their hands before they leave the hospital. They get a 1- or 3-month supply, depending on the medication, and then we usually discharge them with a clinical appointment already scheduled with either a pulmonary or primary care provider, and we usually call them before every appointment to confirm that they’re coming. That increases the chances of some success, but there’s still a very long way to go,” said Dr. Biavati.

Dr. Biavati was blinded to the results of the intervention, so he could not report on whether it was working. “But I can tell you that I’ve had busier clinics, so hopefully that means that they’re showing up more,” he said.

The problem is complex, according to Sandeep Jain, MD, who moderated the session. “Social adversity means lack of education. Lack of education means lack of compliance. Lack of compliance means what can you do if people are not taking medications? So it’s all matched together. It’s all lack of education and lack of money, lack of family support. And these drugs they have to take every single day. It’s not that easy. It’s very easy for us to say I had antiretroviral treatment for 6 months. It is almost impossible to continue regular treatment for that long [for a patient with social adversity]. You can’t blame them if they aren’t taking treatments. It’s very difficult for them,” said Dr. Jain.

That underscores the need for interventions that can address the needs of patients with social adversity. “We have to [practice] medicine considering the social situation of the patient and not just the medicine that we study in books. That’s kind of what we are faced with every day. We have therapies, and then life happens. It’s much harder to care for those patients,” said Dr. Biavati.

Dr. Biavati and Dr. Jain reported no relevant financial relationships.
 

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

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AF Burden Increases Around Time of COPD Hospitalizations

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Mon, 11/04/2024 - 12:11

— Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

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— Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

— Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

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Minor Progress in Gender Pay Equity, But a Big Gap Persists

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Mon, 11/04/2024 - 11:33

Despite some recent progress in compensation equity, women in medicine continue to be paid significantly lower salaries than men.

According to the Female Compensation Report 2024 by Medscape, male doctors of any kind earned an average salary of about $400,000, whereas female doctors earned approximately $309,000 — a 29% gap.

The report analyzed survey data from 7000 practicing physicians who were recruited over a 4-month period starting in October 2023. The respondents comprised roughly 60% women representing over 29 specialties.

In the 2022 report, the pay gap between the genders was 32%. But some women in the field argued substantial headway is still needed.

“You can try and pick apart the data, but I’d say we’re not really making progress,” said Susan T. Hingle, MD, an internist in Illinois and president of the American Medical Women’s Association. “A decline by a couple of percentage points is not significantly addressing this pay gap that over a lifetime is huge, can be millions of dollars.”

The gender gap was narrower among female primary care physicians (PCPs) vs medical specialists. Female PCPs earned around $253,000 per year, whereas male PCPs earned about $295,000 per year. Hingle suggested that female PCPs may enjoy more pay equity because health systems have a harder time filling these positions.

On the other hand, the gap for specialists rose from 27% in 2022 to 31% in 2023. Differences in how aggressively women and men negotiate compensation packages may play a role, said Hingle.

“Taking negotiation out of the equation would be progress to me,” said Hingle.

Pay disparity did not appear to be the result of time spent on the job — female doctors reported an average of 49 work hours per week, whereas their male counterparts reported 50 work hours per week.

Meanwhile, the pay gap progressively worsened over time. Among doctors aged 28-34 years, men earned an average of $53,000 more than women. By ages 46-49, men earned an average of $157,000 more than women.

“I had to take my employer to court to get equal compensation, sad as it is to say,” said a hospitalist in North Carolina.

Nearly 60% of women surveyed felt they were not being paid fairly for their efforts, up from less than half reported in Medscape’s 2021 report. Hingle said that this figure may not only reflect sentiments about the compensation gap, but also less support on the job, including fewer physician assistants (PAs), nurses, and administrative staff.

“At my job, I do the work of multiple people,” said a survey respondent. “Junior resident, senior resident, social worker, nurse practitioner, PA — as well as try to be a teacher, researcher, [and] an excellent doctor and have the time to make patients feel as if they are not in a rush.”

Roughly 30% of women physicians said they would not choose to go into medicine again if given the chance compared with 26% of male physicians.

“Gender inequities in our profession have a direct impact,” said Shikha Jain, MD, an oncologist in Chicago and founder of the Women in Medicine nonprofit. “I think women in general don’t feel valued in the care they’re providing.” 

Jain cited bullying, harassment, and fewer opportunities for leadership and recognition as factors beyond pay that affect female physicians’ feelings of being valued.

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

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Despite some recent progress in compensation equity, women in medicine continue to be paid significantly lower salaries than men.

According to the Female Compensation Report 2024 by Medscape, male doctors of any kind earned an average salary of about $400,000, whereas female doctors earned approximately $309,000 — a 29% gap.

The report analyzed survey data from 7000 practicing physicians who were recruited over a 4-month period starting in October 2023. The respondents comprised roughly 60% women representing over 29 specialties.

In the 2022 report, the pay gap between the genders was 32%. But some women in the field argued substantial headway is still needed.

“You can try and pick apart the data, but I’d say we’re not really making progress,” said Susan T. Hingle, MD, an internist in Illinois and president of the American Medical Women’s Association. “A decline by a couple of percentage points is not significantly addressing this pay gap that over a lifetime is huge, can be millions of dollars.”

The gender gap was narrower among female primary care physicians (PCPs) vs medical specialists. Female PCPs earned around $253,000 per year, whereas male PCPs earned about $295,000 per year. Hingle suggested that female PCPs may enjoy more pay equity because health systems have a harder time filling these positions.

On the other hand, the gap for specialists rose from 27% in 2022 to 31% in 2023. Differences in how aggressively women and men negotiate compensation packages may play a role, said Hingle.

“Taking negotiation out of the equation would be progress to me,” said Hingle.

Pay disparity did not appear to be the result of time spent on the job — female doctors reported an average of 49 work hours per week, whereas their male counterparts reported 50 work hours per week.

Meanwhile, the pay gap progressively worsened over time. Among doctors aged 28-34 years, men earned an average of $53,000 more than women. By ages 46-49, men earned an average of $157,000 more than women.

“I had to take my employer to court to get equal compensation, sad as it is to say,” said a hospitalist in North Carolina.

Nearly 60% of women surveyed felt they were not being paid fairly for their efforts, up from less than half reported in Medscape’s 2021 report. Hingle said that this figure may not only reflect sentiments about the compensation gap, but also less support on the job, including fewer physician assistants (PAs), nurses, and administrative staff.

“At my job, I do the work of multiple people,” said a survey respondent. “Junior resident, senior resident, social worker, nurse practitioner, PA — as well as try to be a teacher, researcher, [and] an excellent doctor and have the time to make patients feel as if they are not in a rush.”

Roughly 30% of women physicians said they would not choose to go into medicine again if given the chance compared with 26% of male physicians.

“Gender inequities in our profession have a direct impact,” said Shikha Jain, MD, an oncologist in Chicago and founder of the Women in Medicine nonprofit. “I think women in general don’t feel valued in the care they’re providing.” 

Jain cited bullying, harassment, and fewer opportunities for leadership and recognition as factors beyond pay that affect female physicians’ feelings of being valued.

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

Despite some recent progress in compensation equity, women in medicine continue to be paid significantly lower salaries than men.

According to the Female Compensation Report 2024 by Medscape, male doctors of any kind earned an average salary of about $400,000, whereas female doctors earned approximately $309,000 — a 29% gap.

The report analyzed survey data from 7000 practicing physicians who were recruited over a 4-month period starting in October 2023. The respondents comprised roughly 60% women representing over 29 specialties.

In the 2022 report, the pay gap between the genders was 32%. But some women in the field argued substantial headway is still needed.

“You can try and pick apart the data, but I’d say we’re not really making progress,” said Susan T. Hingle, MD, an internist in Illinois and president of the American Medical Women’s Association. “A decline by a couple of percentage points is not significantly addressing this pay gap that over a lifetime is huge, can be millions of dollars.”

The gender gap was narrower among female primary care physicians (PCPs) vs medical specialists. Female PCPs earned around $253,000 per year, whereas male PCPs earned about $295,000 per year. Hingle suggested that female PCPs may enjoy more pay equity because health systems have a harder time filling these positions.

On the other hand, the gap for specialists rose from 27% in 2022 to 31% in 2023. Differences in how aggressively women and men negotiate compensation packages may play a role, said Hingle.

“Taking negotiation out of the equation would be progress to me,” said Hingle.

Pay disparity did not appear to be the result of time spent on the job — female doctors reported an average of 49 work hours per week, whereas their male counterparts reported 50 work hours per week.

Meanwhile, the pay gap progressively worsened over time. Among doctors aged 28-34 years, men earned an average of $53,000 more than women. By ages 46-49, men earned an average of $157,000 more than women.

“I had to take my employer to court to get equal compensation, sad as it is to say,” said a hospitalist in North Carolina.

Nearly 60% of women surveyed felt they were not being paid fairly for their efforts, up from less than half reported in Medscape’s 2021 report. Hingle said that this figure may not only reflect sentiments about the compensation gap, but also less support on the job, including fewer physician assistants (PAs), nurses, and administrative staff.

“At my job, I do the work of multiple people,” said a survey respondent. “Junior resident, senior resident, social worker, nurse practitioner, PA — as well as try to be a teacher, researcher, [and] an excellent doctor and have the time to make patients feel as if they are not in a rush.”

Roughly 30% of women physicians said they would not choose to go into medicine again if given the chance compared with 26% of male physicians.

“Gender inequities in our profession have a direct impact,” said Shikha Jain, MD, an oncologist in Chicago and founder of the Women in Medicine nonprofit. “I think women in general don’t feel valued in the care they’re providing.” 

Jain cited bullying, harassment, and fewer opportunities for leadership and recognition as factors beyond pay that affect female physicians’ feelings of being valued.

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

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Which Specialists Should Lead BP Control Efforts?

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Fri, 11/01/2024 - 12:40

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

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Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

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