Federal Practitioner

A pair of dueling editorials in the journal Hypertension debate whether our focus should be on sodium or its often neglected partner, potassium.

Should we cut sodium from our diet or eat more potassium to lower blood pressure? The answer requires an intricate understanding of renal physiology that is fascinating. To nephrologists. A meta-analysis of 85 trials showed a consistent and linear. It may also depend on where you live and whether your concern is treating individuals or implementing effective food policy.

The Case for Sodium Restriction

Stephen Juraschek, MD, PhD, of the Beth Israel Deaconess Medical Center, Boston, Massachusetts, co-author of one editorial, told me in a zoom interview that he believes his side of the debate clearly has the stronger argument. Of the two cations in question, there has been infinitely more ink spilled about sodium.

Studies such as INTERSALT, the DASH diet, and TOHP may be the most well-known, but there are many, many intervention studies of sodium restriction’s effect on blood pressure. A meta-analysis of 85 trials of showed a consistent and linear relationship between sodium reduction and blood pressure. In contrast, the evidence base for potassium is more limited and less consistent. There are half as many trials with potassium, and its ability to lower blood pressure may depend on how much sodium is present in the diet.

An outlier in the sodium restriction evidence base is the PURE study, which suggested that extreme sodium restriction could increase cardiovascular mortality, but the trial suffered from two potential issues. First, it used a single spot urine specimen to measure sodium rather than the generally accepted more accurate 24-hour urine collection. A reanalysis of the TOHP study using a spot urine rather than a 24-hour urine collection changed the relationship between sodium intake and mortality and possibly explained the U-shaped association observed in PURE. Second, PURE was an observational cohort and was prone to confounding, or in this case, reverse causation. Why did people who consumed very little salt have an increased risk for cardiovascular disease? It is very possible that people with a high risk for cardiovascular disease were told to consume less salt to begin with. Hence B led to A rather than A leading to B.

The debate on sodium restriction has been bitter at times. Opposing camps formed, and people took sides in the “salt wars.” A group of researchers, termed the Jackson 6, met and decided to end the controversy by running a randomized trial in US prisons (having discounted the options of long-term care homes and military bases). They detailed their plan in an editorial in Hypertension. The study never came to fruition for two reasons: the obvious ethical problems of experimenting on prisoners and the revelation of undisclosed salt industry funding.

More recent studies have mercifully been more conventional. The SSaSS study, a randomized controlled trial of a salt substitute, provided the cardiovascular outcomes data that many were waiting for. And CARDIA-SSBP, a cross-over randomized trial recently presented at the American Heart Association meeting, showed that reducing dietary sodium was on par with medication when it came to lowering blood pressure.

For Dr. Juraschek, the evidence is clear: “If you were going to choose one, I would say the weight of the evidence is still really heavily on the sodium side.”

The Case for Potassium Supplementation

The evidence for salt restriction notwithstanding, Swapnil Hiremath, MD, MPH, from the University of Ottawa, Ontario, Canada, argued in his editorial that potassium supplementation has gotten short shrift. Though he admits the studies for potassium supplementation have been smaller and sometimes rely on observational evidence, the evidence is there. In the distal convoluted tubule, the sodium chloride cotransporter (NCC), aka the potassium switch, is turned on by low potassium levels and leads to sodium reabsorption by the kidney even in settings of high sodium intake (Figure). To nonnephrologists, renal physiology may be a black box. But if you quickly brush up on the mechanism of action of thiazide diuretics, the preceding descriptor will make more sense.

Medscape

Realistic Diets and Taste Issues

“We know that increasing potassium, decreasing sodium is useful. The question is how do we do that?” says Dr. Hiremath. Should we encourage fruit and vegetable consumption in a healthy diet, give potassium supplements, or encourage the use of low-sodium salt substitutes?

Recommending a healthier diet with more fruits and vegetables is a no-brainer. But getting people to do it is hard. In a world where fruit is more expensive than junk food is, economic realities may drive food choice regardless of our best efforts. The 4700 mg of potassium in the DASH eating plan is the equivalent of eleven bananas daily; although not impossible, it would require a substantive shift in eating patterns for most people.

Given that we prescribe iron, vitamin B12, calcium, and vitamin D to patients who need them, why not potassium tablets to help with blood pressure? Granted, there are concerns about inducing hyperkalemia. Also, why not just prescribe a proven anti-hypertensive, such as ramipril, which has the added benefit of helping with renal protection or cardiac remodeling? Dr. Hiremath points out that patients are far less reluctant to take dietary supplements. Medication is something you take when sick. A supplement is seen as “natural” and “healthy” and might be more attractive to people resistant to prescription meds.

Another drawback of oral potassium supplementation is taste. In a Consumer Reports taste test, potassium chloride fared poorly. It was bitter and had a metallic aftertaste. At least one tester wouldn’t ever consume it again. Potassium citrate is slightly more palpable.

Salt substitutes, like the 75:25 ratio of sodium to potassium used in SSaSS, may be as high as you can go for potassium in any low-sodium salt alternative. If you go any higher than that, the taste will just turn people off, suggests Dr. Hiremath.

But SsaSS, which was done in China, may not be relevant to North America. In China, most sodium is added during cooking at home, and the consumption of processed foods is low. For the typical North American, roughly three quarters of the sodium eaten is added to their food by someone else; only about 15% is added during cooking at home or at the dinner table. If you aren’t someone who cooks, buying a salt substitute is probably not going to have much impact.

Given that reality, Dr. Juraschek thinks we need to target the sodium in processed foods. “There’s just so much sodium in so many products,” he says. “When you think about public policy, it’s most expeditious for there to be more regulation about how much is added to our food supply vs trying to get people to consume eight to 12 servings of fruit.”

No Salt War Here

Despite their different editorial takes, Dr. Hiremath and Dr. Juraschek largely agree on the broad strokes of the problem. This isn’t X (or Twitter) after all. Potassium supplementation may be useful in some parts of the world but may not address the underlying problem in countries where processed foods are the source of most dietary sodium.

The CARDIA-SSBP trial showed that a very low–sodium diet had the same blood pressure–lowering effect as a first-line antihypertensive, but most people will not be able to limit themselves to 500 mg of dietary sodium per day. In CARDIA-SSBP, just as in DASH, participants were provided with meals from study kitchens. They were not just told to eat less salt, which would almost certainly have failed.

“We should aim for stuff that is practical and doable rather than aim for stuff that cannot be done,” according to Dr. Hiremath. Whether that should be salt substitutes or policy change may depend on which part of the planet you live on.

One recent positive change may herald the beginning of a policy change, at least in the United States. In March 2023, the US Food and Drug Administration proposed a rule change to allow salt substitutes to be labeled as salt. This would make it easier for food manufacturers to swap out sodium chloride for a low-sodium alternative and reduce the amount of sodium in the US diet without having a large impact on taste and consumer uptake. Both Dr. Hiremath and Dr. Juraschek agree that it may not be enough on its own but that it’s a start.

Christopher Labos is a cardiologist with a degree in epidemiology. He spends most of his time doing things that he doesn’t get paid for, like research, teaching, and podcasting. Occasionally, he finds time to practice cardiology to pay the rent. He realizes that half of his research findings will be disproved in 5 years; he just doesn’t know which half. He is a regular contributor to the Montreal Gazette, CJAD radio, and CTV television in Montreal, and is host of the award-winning podcast The Body of Evidence.

A version of this article appeared on Medscape.com.

A pair of dueling editorials in the journal Hypertension debate whether our focus should be on sodium or its often neglected partner, potassium.

Should we cut sodium from our diet or eat more potassium to lower blood pressure? The answer requires an intricate understanding of renal physiology that is fascinating. To nephrologists. A meta-analysis of 85 trials showed a consistent and linear. It may also depend on where you live and whether your concern is treating individuals or implementing effective food policy.

The Case for Sodium Restriction

Stephen Juraschek, MD, PhD, of the Beth Israel Deaconess Medical Center, Boston, Massachusetts, co-author of one editorial, told me in a zoom interview that he believes his side of the debate clearly has the stronger argument. Of the two cations in question, there has been infinitely more ink spilled about sodium.

Studies such as INTERSALT, the DASH diet, and TOHP may be the most well-known, but there are many, many intervention studies of sodium restriction’s effect on blood pressure. A meta-analysis of 85 trials of showed a consistent and linear relationship between sodium reduction and blood pressure. In contrast, the evidence base for potassium is more limited and less consistent. There are half as many trials with potassium, and its ability to lower blood pressure may depend on how much sodium is present in the diet.

An outlier in the sodium restriction evidence base is the PURE study, which suggested that extreme sodium restriction could increase cardiovascular mortality, but the trial suffered from two potential issues. First, it used a single spot urine specimen to measure sodium rather than the generally accepted more accurate 24-hour urine collection. A reanalysis of the TOHP study using a spot urine rather than a 24-hour urine collection changed the relationship between sodium intake and mortality and possibly explained the U-shaped association observed in PURE. Second, PURE was an observational cohort and was prone to confounding, or in this case, reverse causation. Why did people who consumed very little salt have an increased risk for cardiovascular disease? It is very possible that people with a high risk for cardiovascular disease were told to consume less salt to begin with. Hence B led to A rather than A leading to B.

The debate on sodium restriction has been bitter at times. Opposing camps formed, and people took sides in the “salt wars.” A group of researchers, termed the Jackson 6, met and decided to end the controversy by running a randomized trial in US prisons (having discounted the options of long-term care homes and military bases). They detailed their plan in an editorial in Hypertension. The study never came to fruition for two reasons: the obvious ethical problems of experimenting on prisoners and the revelation of undisclosed salt industry funding.

More recent studies have mercifully been more conventional. The SSaSS study, a randomized controlled trial of a salt substitute, provided the cardiovascular outcomes data that many were waiting for. And CARDIA-SSBP, a cross-over randomized trial recently presented at the American Heart Association meeting, showed that reducing dietary sodium was on par with medication when it came to lowering blood pressure.

For Dr. Juraschek, the evidence is clear: “If you were going to choose one, I would say the weight of the evidence is still really heavily on the sodium side.”

The Case for Potassium Supplementation

The evidence for salt restriction notwithstanding, Swapnil Hiremath, MD, MPH, from the University of Ottawa, Ontario, Canada, argued in his editorial that potassium supplementation has gotten short shrift. Though he admits the studies for potassium supplementation have been smaller and sometimes rely on observational evidence, the evidence is there. In the distal convoluted tubule, the sodium chloride cotransporter (NCC), aka the potassium switch, is turned on by low potassium levels and leads to sodium reabsorption by the kidney even in settings of high sodium intake (Figure). To nonnephrologists, renal physiology may be a black box. But if you quickly brush up on the mechanism of action of thiazide diuretics, the preceding descriptor will make more sense.

Medscape

Realistic Diets and Taste Issues

“We know that increasing potassium, decreasing sodium is useful. The question is how do we do that?” says Dr. Hiremath. Should we encourage fruit and vegetable consumption in a healthy diet, give potassium supplements, or encourage the use of low-sodium salt substitutes?

Recommending a healthier diet with more fruits and vegetables is a no-brainer. But getting people to do it is hard. In a world where fruit is more expensive than junk food is, economic realities may drive food choice regardless of our best efforts. The 4700 mg of potassium in the DASH eating plan is the equivalent of eleven bananas daily; although not impossible, it would require a substantive shift in eating patterns for most people.

Given that we prescribe iron, vitamin B12, calcium, and vitamin D to patients who need them, why not potassium tablets to help with blood pressure? Granted, there are concerns about inducing hyperkalemia. Also, why not just prescribe a proven anti-hypertensive, such as ramipril, which has the added benefit of helping with renal protection or cardiac remodeling? Dr. Hiremath points out that patients are far less reluctant to take dietary supplements. Medication is something you take when sick. A supplement is seen as “natural” and “healthy” and might be more attractive to people resistant to prescription meds.

Another drawback of oral potassium supplementation is taste. In a Consumer Reports taste test, potassium chloride fared poorly. It was bitter and had a metallic aftertaste. At least one tester wouldn’t ever consume it again. Potassium citrate is slightly more palpable.

Salt substitutes, like the 75:25 ratio of sodium to potassium used in SSaSS, may be as high as you can go for potassium in any low-sodium salt alternative. If you go any higher than that, the taste will just turn people off, suggests Dr. Hiremath.

But SsaSS, which was done in China, may not be relevant to North America. In China, most sodium is added during cooking at home, and the consumption of processed foods is low. For the typical North American, roughly three quarters of the sodium eaten is added to their food by someone else; only about 15% is added during cooking at home or at the dinner table. If you aren’t someone who cooks, buying a salt substitute is probably not going to have much impact.

Given that reality, Dr. Juraschek thinks we need to target the sodium in processed foods. “There’s just so much sodium in so many products,” he says. “When you think about public policy, it’s most expeditious for there to be more regulation about how much is added to our food supply vs trying to get people to consume eight to 12 servings of fruit.”

No Salt War Here

Despite their different editorial takes, Dr. Hiremath and Dr. Juraschek largely agree on the broad strokes of the problem. This isn’t X (or Twitter) after all. Potassium supplementation may be useful in some parts of the world but may not address the underlying problem in countries where processed foods are the source of most dietary sodium.

The CARDIA-SSBP trial showed that a very low–sodium diet had the same blood pressure–lowering effect as a first-line antihypertensive, but most people will not be able to limit themselves to 500 mg of dietary sodium per day. In CARDIA-SSBP, just as in DASH, participants were provided with meals from study kitchens. They were not just told to eat less salt, which would almost certainly have failed.

“We should aim for stuff that is practical and doable rather than aim for stuff that cannot be done,” according to Dr. Hiremath. Whether that should be salt substitutes or policy change may depend on which part of the planet you live on.

One recent positive change may herald the beginning of a policy change, at least in the United States. In March 2023, the US Food and Drug Administration proposed a rule change to allow salt substitutes to be labeled as salt. This would make it easier for food manufacturers to swap out sodium chloride for a low-sodium alternative and reduce the amount of sodium in the US diet without having a large impact on taste and consumer uptake. Both Dr. Hiremath and Dr. Juraschek agree that it may not be enough on its own but that it’s a start.

Christopher Labos is a cardiologist with a degree in epidemiology. He spends most of his time doing things that he doesn’t get paid for, like research, teaching, and podcasting. Occasionally, he finds time to practice cardiology to pay the rent. He realizes that half of his research findings will be disproved in 5 years; he just doesn’t know which half. He is a regular contributor to the Montreal Gazette, CJAD radio, and CTV television in Montreal, and is host of the award-winning podcast The Body of Evidence.

A version of this article appeared on Medscape.com.

A pair of dueling editorials in the journal Hypertension debate whether our focus should be on sodium or its often neglected partner, potassium.

Should we cut sodium from our diet or eat more potassium to lower blood pressure? The answer requires an intricate understanding of renal physiology that is fascinating. To nephrologists. A meta-analysis of 85 trials showed a consistent and linear. It may also depend on where you live and whether your concern is treating individuals or implementing effective food policy.

The Case for Sodium Restriction

Stephen Juraschek, MD, PhD, of the Beth Israel Deaconess Medical Center, Boston, Massachusetts, co-author of one editorial, told me in a zoom interview that he believes his side of the debate clearly has the stronger argument. Of the two cations in question, there has been infinitely more ink spilled about sodium.

Studies such as INTERSALT, the DASH diet, and TOHP may be the most well-known, but there are many, many intervention studies of sodium restriction’s effect on blood pressure. A meta-analysis of 85 trials of showed a consistent and linear relationship between sodium reduction and blood pressure. In contrast, the evidence base for potassium is more limited and less consistent. There are half as many trials with potassium, and its ability to lower blood pressure may depend on how much sodium is present in the diet.

An outlier in the sodium restriction evidence base is the PURE study, which suggested that extreme sodium restriction could increase cardiovascular mortality, but the trial suffered from two potential issues. First, it used a single spot urine specimen to measure sodium rather than the generally accepted more accurate 24-hour urine collection. A reanalysis of the TOHP study using a spot urine rather than a 24-hour urine collection changed the relationship between sodium intake and mortality and possibly explained the U-shaped association observed in PURE. Second, PURE was an observational cohort and was prone to confounding, or in this case, reverse causation. Why did people who consumed very little salt have an increased risk for cardiovascular disease? It is very possible that people with a high risk for cardiovascular disease were told to consume less salt to begin with. Hence B led to A rather than A leading to B.

The debate on sodium restriction has been bitter at times. Opposing camps formed, and people took sides in the “salt wars.” A group of researchers, termed the Jackson 6, met and decided to end the controversy by running a randomized trial in US prisons (having discounted the options of long-term care homes and military bases). They detailed their plan in an editorial in Hypertension. The study never came to fruition for two reasons: the obvious ethical problems of experimenting on prisoners and the revelation of undisclosed salt industry funding.

More recent studies have mercifully been more conventional. The SSaSS study, a randomized controlled trial of a salt substitute, provided the cardiovascular outcomes data that many were waiting for. And CARDIA-SSBP, a cross-over randomized trial recently presented at the American Heart Association meeting, showed that reducing dietary sodium was on par with medication when it came to lowering blood pressure.

For Dr. Juraschek, the evidence is clear: “If you were going to choose one, I would say the weight of the evidence is still really heavily on the sodium side.”

The Case for Potassium Supplementation

The evidence for salt restriction notwithstanding, Swapnil Hiremath, MD, MPH, from the University of Ottawa, Ontario, Canada, argued in his editorial that potassium supplementation has gotten short shrift. Though he admits the studies for potassium supplementation have been smaller and sometimes rely on observational evidence, the evidence is there. In the distal convoluted tubule, the sodium chloride cotransporter (NCC), aka the potassium switch, is turned on by low potassium levels and leads to sodium reabsorption by the kidney even in settings of high sodium intake (Figure). To nonnephrologists, renal physiology may be a black box. But if you quickly brush up on the mechanism of action of thiazide diuretics, the preceding descriptor will make more sense.

Medscape

Realistic Diets and Taste Issues

“We know that increasing potassium, decreasing sodium is useful. The question is how do we do that?” says Dr. Hiremath. Should we encourage fruit and vegetable consumption in a healthy diet, give potassium supplements, or encourage the use of low-sodium salt substitutes?

Recommending a healthier diet with more fruits and vegetables is a no-brainer. But getting people to do it is hard. In a world where fruit is more expensive than junk food is, economic realities may drive food choice regardless of our best efforts. The 4700 mg of potassium in the DASH eating plan is the equivalent of eleven bananas daily; although not impossible, it would require a substantive shift in eating patterns for most people.

Given that we prescribe iron, vitamin B12, calcium, and vitamin D to patients who need them, why not potassium tablets to help with blood pressure? Granted, there are concerns about inducing hyperkalemia. Also, why not just prescribe a proven anti-hypertensive, such as ramipril, which has the added benefit of helping with renal protection or cardiac remodeling? Dr. Hiremath points out that patients are far less reluctant to take dietary supplements. Medication is something you take when sick. A supplement is seen as “natural” and “healthy” and might be more attractive to people resistant to prescription meds.

Another drawback of oral potassium supplementation is taste. In a Consumer Reports taste test, potassium chloride fared poorly. It was bitter and had a metallic aftertaste. At least one tester wouldn’t ever consume it again. Potassium citrate is slightly more palpable.

Salt substitutes, like the 75:25 ratio of sodium to potassium used in SSaSS, may be as high as you can go for potassium in any low-sodium salt alternative. If you go any higher than that, the taste will just turn people off, suggests Dr. Hiremath.

But SsaSS, which was done in China, may not be relevant to North America. In China, most sodium is added during cooking at home, and the consumption of processed foods is low. For the typical North American, roughly three quarters of the sodium eaten is added to their food by someone else; only about 15% is added during cooking at home or at the dinner table. If you aren’t someone who cooks, buying a salt substitute is probably not going to have much impact.

Given that reality, Dr. Juraschek thinks we need to target the sodium in processed foods. “There’s just so much sodium in so many products,” he says. “When you think about public policy, it’s most expeditious for there to be more regulation about how much is added to our food supply vs trying to get people to consume eight to 12 servings of fruit.”

No Salt War Here

Despite their different editorial takes, Dr. Hiremath and Dr. Juraschek largely agree on the broad strokes of the problem. This isn’t X (or Twitter) after all. Potassium supplementation may be useful in some parts of the world but may not address the underlying problem in countries where processed foods are the source of most dietary sodium.

The CARDIA-SSBP trial showed that a very low–sodium diet had the same blood pressure–lowering effect as a first-line antihypertensive, but most people will not be able to limit themselves to 500 mg of dietary sodium per day. In CARDIA-SSBP, just as in DASH, participants were provided with meals from study kitchens. They were not just told to eat less salt, which would almost certainly have failed.

“We should aim for stuff that is practical and doable rather than aim for stuff that cannot be done,” according to Dr. Hiremath. Whether that should be salt substitutes or policy change may depend on which part of the planet you live on.

One recent positive change may herald the beginning of a policy change, at least in the United States. In March 2023, the US Food and Drug Administration proposed a rule change to allow salt substitutes to be labeled as salt. This would make it easier for food manufacturers to swap out sodium chloride for a low-sodium alternative and reduce the amount of sodium in the US diet without having a large impact on taste and consumer uptake. Both Dr. Hiremath and Dr. Juraschek agree that it may not be enough on its own but that it’s a start.

Christopher Labos is a cardiologist with a degree in epidemiology. He spends most of his time doing things that he doesn’t get paid for, like research, teaching, and podcasting. Occasionally, he finds time to practice cardiology to pay the rent. He realizes that half of his research findings will be disproved in 5 years; he just doesn’t know which half. He is a regular contributor to the Montreal Gazette, CJAD radio, and CTV television in Montreal, and is host of the award-winning podcast The Body of Evidence.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

From the year 2000 until around 2016, the incidence of breast cancer among young women — those under age 50 — rose steadily, if slowly.

JAMA Network Open

JAMA Network Open

JAMA Network Open

Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

From the year 2000 until around 2016, the incidence of breast cancer among young women — those under age 50 — rose steadily, if slowly.

JAMA Network Open

JAMA Network Open

JAMA Network Open

Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

From the year 2000 until around 2016, the incidence of breast cancer among young women — those under age 50 — rose steadily, if slowly.

JAMA Network Open

JAMA Network Open

JAMA Network Open

Dr. F. Perry Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Have patients who want to lose weight? Tell them to put on their dancing shoes. 

Dancing can be an effective fat-loss tool for people who are overweight or have obesity, according to a recent meta-analysis in PLOS One. People who danced regularly lost about four more pounds — including three and a half pounds of fat — than those who didn’t dance. They also shaved an extra inch off their waists. 

Participants who danced three times a week for at least 3 months reaped maximum benefits. And the more they let loose, the better — more creative dance forms led to more pronounced improvements in body composition. 

The study builds on previous research that suggests dance can be beneficial for weight loss and overall health. A 2017 meta-analysis found that dance significantly improved body composition, blood biomarkers, and musculoskeletal function. Other research has linked dance with improvements in cognitive function, mental health, and quality of life.  

What makes dance special? It’s a full-body workout that might be easier to stick with than other exercises. “Enjoyment” is key for sustainability, the researchers wrote: “As a form of physical activity that integrates exercise, entertainment, and sociality, dance possesses innate advantages in fostering motivation for exercise.”

“The best exercise is the one you’ll do every day, and something that you like to do,” said Nicholas Pennings, DO, chair and associate professor of family medicine at Campbell University, Buies Creek, NC. (Dr. Pennings was not involved in the study.) For patients who enjoy dancing, dance could be that thing — or at least one workout to add to the mix. 

Help your patients get started with these tips. 

Frame it as a hobby, not exercise. Ask what hobbies they used to enjoy in high school, suggests Deirdre Mattina, MD, a cardiologist at the Cleveland Clinic and a former professional dancer. “ This can sometimes evoke happy memories of younger years and perhaps hobbies that they’d given up because they thought they were too old,” she said. If they used to play sports or dance, that’s your in. “I usually talk about hot yoga as a transition to get back their flexibility and then something like a dance aerobics or Zumba class to start.”

Recommend a group class. “Any intervention promoting social relationships is expected to increase adherence,” said Giulio Marchesini Reggiani, MD, a recently retired professor of internal medicine and dietetics at the University of Bologna in Italy. “You are motivated by the group, and you create a relationship among participants, and this means that you are no longer alone.” Try local gyms, health clubs, or even dance studios (yes, where kids go — they offer adult classes, too).

Help patients find their unique groove. Dr. Mattina has some patients who take cardio dance classes, some who line dance, and others who pole dance or heels dance. “Those are the things that keep it fun,” she said. “It doesn’t seem like exercise. It seems more like going out and hanging out.” 

Encourage those who “don’t know how to dance.” You don’t need fancy choreography or the grace of a prima ballerina.”Simply move aided by the music,” said Dr. Reggiani. “As long as you start engaging in physical activity, you improve your health, and you improve your movement.” Suggest patients start with beginner Zumba or a step class to get the hang of moving to a beat. Or try a home dance video, like Barre Blend by BODi (which offers a 14-day free trial). “You can try taking a couple classes in the privacy of your own home first, so you feel comfortable getting out there and doing it with a group,” said Dr. Mattina.

Modify as needed. If a patient has mobility limitations or lower-body pain, they can still dance — just do the upper-body portion of the moves. “Dance involves both upper and lower body movement, and so many dance activities could easily be performed in a chair,” said Dr. Pennings. A good joint-friendly option: Some health clubs offer dance classes that take place in a swimming pool.

Involve the whole family. Support from a partner can help patients stick with exercise, said Dr. Reggiani, and dance can also help a couple strengthen their bond. Invite kids and grandparents to join, too. “Dancing is something that can be done at any age,” said Dr. Reggiani. “For kids, it is important to make it fun,” said Dr. Pennings. “Start when they are young with music they are familiar with and enjoy.” For skeptical partners? “Keep it simple and nonjudgmental,” he said.

Remind patients to warm up. We lose flexibility with age, so ease into it, said Dr. Mattina. Many classes include warmups, but if you’re at home, do a few minutes of light, low-impact cardio — jumping jacks, mountain climbers, jogging, or brisk walking — before stretching. Or just put on a slow song and start lightly bouncing to the beat or stepping your feet to one side, together, then to the other side and together.

Tell them to take dance breaks. No time to join a class? Break up the workday with a few 10-minute dance parties. (That’s about three songs.) “Short bursts of exercise throughout the day, like if you do 10 minutes of exercise six times a day, actually has a greater health benefit than doing 60 minutes of continuous exercise,” said Dr. Pennings. It helps counter the negative effects of prolonged sitting “by increasing blood flow and increasing utilization of your muscles.”

Manage expectations about weight loss. Patients often have outsized expectations about how much weight they’ll lose when starting a new exercise regimen, Dr. Pennings said. Dancing burns about 300 calories per hour, so it takes roughly 12 hours to lose one pound. Consistency over time is the key. “My goal is to both emphasize the health benefits of exercise while maintaining realistic expectations about weight loss,” said Dr. Pennings. Focus less on the weight part and highlight other benefits: Dancing builds strength, balance, and coordination, said Dr. Pennings. It can help improve blood pressure and other heart health markers and boost cognition in older adults. And it’s fun.  
 

A version of this article appeared on Medscape.com.

Have patients who want to lose weight? Tell them to put on their dancing shoes. 

Dancing can be an effective fat-loss tool for people who are overweight or have obesity, according to a recent meta-analysis in PLOS One. People who danced regularly lost about four more pounds — including three and a half pounds of fat — than those who didn’t dance. They also shaved an extra inch off their waists. 

Participants who danced three times a week for at least 3 months reaped maximum benefits. And the more they let loose, the better — more creative dance forms led to more pronounced improvements in body composition. 

The study builds on previous research that suggests dance can be beneficial for weight loss and overall health. A 2017 meta-analysis found that dance significantly improved body composition, blood biomarkers, and musculoskeletal function. Other research has linked dance with improvements in cognitive function, mental health, and quality of life.  

What makes dance special? It’s a full-body workout that might be easier to stick with than other exercises. “Enjoyment” is key for sustainability, the researchers wrote: “As a form of physical activity that integrates exercise, entertainment, and sociality, dance possesses innate advantages in fostering motivation for exercise.”

“The best exercise is the one you’ll do every day, and something that you like to do,” said Nicholas Pennings, DO, chair and associate professor of family medicine at Campbell University, Buies Creek, NC. (Dr. Pennings was not involved in the study.) For patients who enjoy dancing, dance could be that thing — or at least one workout to add to the mix. 

Help your patients get started with these tips. 

Frame it as a hobby, not exercise. Ask what hobbies they used to enjoy in high school, suggests Deirdre Mattina, MD, a cardiologist at the Cleveland Clinic and a former professional dancer. “ This can sometimes evoke happy memories of younger years and perhaps hobbies that they’d given up because they thought they were too old,” she said. If they used to play sports or dance, that’s your in. “I usually talk about hot yoga as a transition to get back their flexibility and then something like a dance aerobics or Zumba class to start.”

Recommend a group class. “Any intervention promoting social relationships is expected to increase adherence,” said Giulio Marchesini Reggiani, MD, a recently retired professor of internal medicine and dietetics at the University of Bologna in Italy. “You are motivated by the group, and you create a relationship among participants, and this means that you are no longer alone.” Try local gyms, health clubs, or even dance studios (yes, where kids go — they offer adult classes, too).

Help patients find their unique groove. Dr. Mattina has some patients who take cardio dance classes, some who line dance, and others who pole dance or heels dance. “Those are the things that keep it fun,” she said. “It doesn’t seem like exercise. It seems more like going out and hanging out.” 

Encourage those who “don’t know how to dance.” You don’t need fancy choreography or the grace of a prima ballerina.”Simply move aided by the music,” said Dr. Reggiani. “As long as you start engaging in physical activity, you improve your health, and you improve your movement.” Suggest patients start with beginner Zumba or a step class to get the hang of moving to a beat. Or try a home dance video, like Barre Blend by BODi (which offers a 14-day free trial). “You can try taking a couple classes in the privacy of your own home first, so you feel comfortable getting out there and doing it with a group,” said Dr. Mattina.

Modify as needed. If a patient has mobility limitations or lower-body pain, they can still dance — just do the upper-body portion of the moves. “Dance involves both upper and lower body movement, and so many dance activities could easily be performed in a chair,” said Dr. Pennings. A good joint-friendly option: Some health clubs offer dance classes that take place in a swimming pool.

Involve the whole family. Support from a partner can help patients stick with exercise, said Dr. Reggiani, and dance can also help a couple strengthen their bond. Invite kids and grandparents to join, too. “Dancing is something that can be done at any age,” said Dr. Reggiani. “For kids, it is important to make it fun,” said Dr. Pennings. “Start when they are young with music they are familiar with and enjoy.” For skeptical partners? “Keep it simple and nonjudgmental,” he said.

Remind patients to warm up. We lose flexibility with age, so ease into it, said Dr. Mattina. Many classes include warmups, but if you’re at home, do a few minutes of light, low-impact cardio — jumping jacks, mountain climbers, jogging, or brisk walking — before stretching. Or just put on a slow song and start lightly bouncing to the beat or stepping your feet to one side, together, then to the other side and together.

Tell them to take dance breaks. No time to join a class? Break up the workday with a few 10-minute dance parties. (That’s about three songs.) “Short bursts of exercise throughout the day, like if you do 10 minutes of exercise six times a day, actually has a greater health benefit than doing 60 minutes of continuous exercise,” said Dr. Pennings. It helps counter the negative effects of prolonged sitting “by increasing blood flow and increasing utilization of your muscles.”

Manage expectations about weight loss. Patients often have outsized expectations about how much weight they’ll lose when starting a new exercise regimen, Dr. Pennings said. Dancing burns about 300 calories per hour, so it takes roughly 12 hours to lose one pound. Consistency over time is the key. “My goal is to both emphasize the health benefits of exercise while maintaining realistic expectations about weight loss,” said Dr. Pennings. Focus less on the weight part and highlight other benefits: Dancing builds strength, balance, and coordination, said Dr. Pennings. It can help improve blood pressure and other heart health markers and boost cognition in older adults. And it’s fun.  
 

A version of this article appeared on Medscape.com.

Have patients who want to lose weight? Tell them to put on their dancing shoes. 

Dancing can be an effective fat-loss tool for people who are overweight or have obesity, according to a recent meta-analysis in PLOS One. People who danced regularly lost about four more pounds — including three and a half pounds of fat — than those who didn’t dance. They also shaved an extra inch off their waists. 

Participants who danced three times a week for at least 3 months reaped maximum benefits. And the more they let loose, the better — more creative dance forms led to more pronounced improvements in body composition. 

The study builds on previous research that suggests dance can be beneficial for weight loss and overall health. A 2017 meta-analysis found that dance significantly improved body composition, blood biomarkers, and musculoskeletal function. Other research has linked dance with improvements in cognitive function, mental health, and quality of life.  

What makes dance special? It’s a full-body workout that might be easier to stick with than other exercises. “Enjoyment” is key for sustainability, the researchers wrote: “As a form of physical activity that integrates exercise, entertainment, and sociality, dance possesses innate advantages in fostering motivation for exercise.”

“The best exercise is the one you’ll do every day, and something that you like to do,” said Nicholas Pennings, DO, chair and associate professor of family medicine at Campbell University, Buies Creek, NC. (Dr. Pennings was not involved in the study.) For patients who enjoy dancing, dance could be that thing — or at least one workout to add to the mix. 

Help your patients get started with these tips. 

Frame it as a hobby, not exercise. Ask what hobbies they used to enjoy in high school, suggests Deirdre Mattina, MD, a cardiologist at the Cleveland Clinic and a former professional dancer. “ This can sometimes evoke happy memories of younger years and perhaps hobbies that they’d given up because they thought they were too old,” she said. If they used to play sports or dance, that’s your in. “I usually talk about hot yoga as a transition to get back their flexibility and then something like a dance aerobics or Zumba class to start.”

Recommend a group class. “Any intervention promoting social relationships is expected to increase adherence,” said Giulio Marchesini Reggiani, MD, a recently retired professor of internal medicine and dietetics at the University of Bologna in Italy. “You are motivated by the group, and you create a relationship among participants, and this means that you are no longer alone.” Try local gyms, health clubs, or even dance studios (yes, where kids go — they offer adult classes, too).

Help patients find their unique groove. Dr. Mattina has some patients who take cardio dance classes, some who line dance, and others who pole dance or heels dance. “Those are the things that keep it fun,” she said. “It doesn’t seem like exercise. It seems more like going out and hanging out.” 

Encourage those who “don’t know how to dance.” You don’t need fancy choreography or the grace of a prima ballerina.”Simply move aided by the music,” said Dr. Reggiani. “As long as you start engaging in physical activity, you improve your health, and you improve your movement.” Suggest patients start with beginner Zumba or a step class to get the hang of moving to a beat. Or try a home dance video, like Barre Blend by BODi (which offers a 14-day free trial). “You can try taking a couple classes in the privacy of your own home first, so you feel comfortable getting out there and doing it with a group,” said Dr. Mattina.

Modify as needed. If a patient has mobility limitations or lower-body pain, they can still dance — just do the upper-body portion of the moves. “Dance involves both upper and lower body movement, and so many dance activities could easily be performed in a chair,” said Dr. Pennings. A good joint-friendly option: Some health clubs offer dance classes that take place in a swimming pool.

Involve the whole family. Support from a partner can help patients stick with exercise, said Dr. Reggiani, and dance can also help a couple strengthen their bond. Invite kids and grandparents to join, too. “Dancing is something that can be done at any age,” said Dr. Reggiani. “For kids, it is important to make it fun,” said Dr. Pennings. “Start when they are young with music they are familiar with and enjoy.” For skeptical partners? “Keep it simple and nonjudgmental,” he said.

Remind patients to warm up. We lose flexibility with age, so ease into it, said Dr. Mattina. Many classes include warmups, but if you’re at home, do a few minutes of light, low-impact cardio — jumping jacks, mountain climbers, jogging, or brisk walking — before stretching. Or just put on a slow song and start lightly bouncing to the beat or stepping your feet to one side, together, then to the other side and together.

Tell them to take dance breaks. No time to join a class? Break up the workday with a few 10-minute dance parties. (That’s about three songs.) “Short bursts of exercise throughout the day, like if you do 10 minutes of exercise six times a day, actually has a greater health benefit than doing 60 minutes of continuous exercise,” said Dr. Pennings. It helps counter the negative effects of prolonged sitting “by increasing blood flow and increasing utilization of your muscles.”

Manage expectations about weight loss. Patients often have outsized expectations about how much weight they’ll lose when starting a new exercise regimen, Dr. Pennings said. Dancing burns about 300 calories per hour, so it takes roughly 12 hours to lose one pound. Consistency over time is the key. “My goal is to both emphasize the health benefits of exercise while maintaining realistic expectations about weight loss,” said Dr. Pennings. Focus less on the weight part and highlight other benefits: Dancing builds strength, balance, and coordination, said Dr. Pennings. It can help improve blood pressure and other heart health markers and boost cognition in older adults. And it’s fun.  
 

A version of this article appeared on Medscape.com.

TOPLINE:

A daily low dose of colchicine significantly reduces ischemic cardiovascular events in patients with type 2 diabetes (T2D) and a recent myocardial infarction (MI). 

METHODOLOGY:

• After an MI, patients with vs without T2D have a higher risk for another cardiovascular event.
• The Colchicine Cardiovascular Outcomes Trial (COLCOT), a randomized, double-blinded trial, found a lower risk for ischemic cardiovascular events with 0.5 mg colchicine taken daily vs placebo, initiated within 30 days of an MI.
• Researchers conducted a prespecified subgroup analysis of 959 adult patients with T2D (mean age, 62.4 years; 22.2% women) in COLCOT (462 patients in colchicine and 497 patients in placebo groups).
• The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization within a median 23 months.
• The patients were taking a variety of appropriate medications, including aspirin and another antiplatelet agent and a statin (98%-99%) and metformin (75%-76%).

TAKEAWAY:

• The risk for the primary endpoint was reduced by 35% in patients with T2D who received colchicine than in those who received placebo (hazard ratio, 0.65; P = .03).
• The primary endpoint event rate per 100 patient-months was significantly lower in the colchicine group than in the placebo group (rate ratio, 0.53; P = .01).
• The frequencies of adverse events were similar in both the treatment and placebo groups (14.6% and 12.8%, respectively; P = .41), with gastrointestinal adverse events being the most common.
• In COLCOT, patients with T2D had a 1.86-fold higher risk for a primary endpoint cardiovascular event, but there was no significant difference in the primary endpoint between those with and without T2D on colchicine.

IN PRACTICE:

“Patients with both T2D and a recent MI derive a large benefit from inflammation-reducing therapy with colchicine,” the authors noted.

SOURCE:

This study, led by François Roubille, University Hospital of Montpellier, France, was published online on January 5, 2024, in Diabetes Care. 

LIMITATIONS:

Patients were not stratified at inclusion for the presence of diabetes. Also, the study did not evaluate the role of glycated hemoglobin and low-density lipoprotein cholesterol, as well as the effects of different glucose-lowering medications or possible hypoglycemic episodes.

DISCLOSURES:

The COLCOT study was funded by the Government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Coauthors Jean-Claude Tardif and Wolfgang Koenig declared receiving research grants, honoraria, advisory board fees, and lecture fees from pharmaceutical companies, as well as having other ties with various sources.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A daily low dose of colchicine significantly reduces ischemic cardiovascular events in patients with type 2 diabetes (T2D) and a recent myocardial infarction (MI). 

METHODOLOGY:

• After an MI, patients with vs without T2D have a higher risk for another cardiovascular event.
• The Colchicine Cardiovascular Outcomes Trial (COLCOT), a randomized, double-blinded trial, found a lower risk for ischemic cardiovascular events with 0.5 mg colchicine taken daily vs placebo, initiated within 30 days of an MI.
• Researchers conducted a prespecified subgroup analysis of 959 adult patients with T2D (mean age, 62.4 years; 22.2% women) in COLCOT (462 patients in colchicine and 497 patients in placebo groups).
• The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization within a median 23 months.
• The patients were taking a variety of appropriate medications, including aspirin and another antiplatelet agent and a statin (98%-99%) and metformin (75%-76%).

TAKEAWAY:

• The risk for the primary endpoint was reduced by 35% in patients with T2D who received colchicine than in those who received placebo (hazard ratio, 0.65; P = .03).
• The primary endpoint event rate per 100 patient-months was significantly lower in the colchicine group than in the placebo group (rate ratio, 0.53; P = .01).
• The frequencies of adverse events were similar in both the treatment and placebo groups (14.6% and 12.8%, respectively; P = .41), with gastrointestinal adverse events being the most common.
• In COLCOT, patients with T2D had a 1.86-fold higher risk for a primary endpoint cardiovascular event, but there was no significant difference in the primary endpoint between those with and without T2D on colchicine.

IN PRACTICE:

“Patients with both T2D and a recent MI derive a large benefit from inflammation-reducing therapy with colchicine,” the authors noted.

SOURCE:

This study, led by François Roubille, University Hospital of Montpellier, France, was published online on January 5, 2024, in Diabetes Care. 

LIMITATIONS:

Patients were not stratified at inclusion for the presence of diabetes. Also, the study did not evaluate the role of glycated hemoglobin and low-density lipoprotein cholesterol, as well as the effects of different glucose-lowering medications or possible hypoglycemic episodes.

DISCLOSURES:

The COLCOT study was funded by the Government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Coauthors Jean-Claude Tardif and Wolfgang Koenig declared receiving research grants, honoraria, advisory board fees, and lecture fees from pharmaceutical companies, as well as having other ties with various sources.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A daily low dose of colchicine significantly reduces ischemic cardiovascular events in patients with type 2 diabetes (T2D) and a recent myocardial infarction (MI). 

METHODOLOGY:

• After an MI, patients with vs without T2D have a higher risk for another cardiovascular event.
• The Colchicine Cardiovascular Outcomes Trial (COLCOT), a randomized, double-blinded trial, found a lower risk for ischemic cardiovascular events with 0.5 mg colchicine taken daily vs placebo, initiated within 30 days of an MI.
• Researchers conducted a prespecified subgroup analysis of 959 adult patients with T2D (mean age, 62.4 years; 22.2% women) in COLCOT (462 patients in colchicine and 497 patients in placebo groups).
• The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization within a median 23 months.
• The patients were taking a variety of appropriate medications, including aspirin and another antiplatelet agent and a statin (98%-99%) and metformin (75%-76%).

TAKEAWAY:

• The risk for the primary endpoint was reduced by 35% in patients with T2D who received colchicine than in those who received placebo (hazard ratio, 0.65; P = .03).
• The primary endpoint event rate per 100 patient-months was significantly lower in the colchicine group than in the placebo group (rate ratio, 0.53; P = .01).
• The frequencies of adverse events were similar in both the treatment and placebo groups (14.6% and 12.8%, respectively; P = .41), with gastrointestinal adverse events being the most common.
• In COLCOT, patients with T2D had a 1.86-fold higher risk for a primary endpoint cardiovascular event, but there was no significant difference in the primary endpoint between those with and without T2D on colchicine.

IN PRACTICE:

“Patients with both T2D and a recent MI derive a large benefit from inflammation-reducing therapy with colchicine,” the authors noted.

SOURCE:

This study, led by François Roubille, University Hospital of Montpellier, France, was published online on January 5, 2024, in Diabetes Care. 

LIMITATIONS:

Patients were not stratified at inclusion for the presence of diabetes. Also, the study did not evaluate the role of glycated hemoglobin and low-density lipoprotein cholesterol, as well as the effects of different glucose-lowering medications or possible hypoglycemic episodes.

DISCLOSURES:

The COLCOT study was funded by the Government of Quebec, the Canadian Institutes of Health Research, and philanthropic foundations. Coauthors Jean-Claude Tardif and Wolfgang Koenig declared receiving research grants, honoraria, advisory board fees, and lecture fees from pharmaceutical companies, as well as having other ties with various sources.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.

The FDA previously approved the drug for EoE in persons aged 12 years or older and weighing ≥ 40 kg in May 2022, as reported by this news organization.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating. 

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. 
 

EoE KIDS Trial

The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts. 

Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.

At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.

In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.

Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment. 

Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.

The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE. 

The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.

Full prescribing information is available online.

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

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.

The FDA previously approved the drug for EoE in persons aged 12 years or older and weighing ≥ 40 kg in May 2022, as reported by this news organization.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating. 

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. 
 

EoE KIDS Trial

The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts. 

Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.

At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.

In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.

Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment. 

Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.

The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE. 

The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.

Full prescribing information is available online.

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

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.

The FDA previously approved the drug for EoE in persons aged 12 years or older and weighing ≥ 40 kg in May 2022, as reported by this news organization.

EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating. 

Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. 
 

EoE KIDS Trial

The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts. 

Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.

At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.

In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.

Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment. 

Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.

The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE. 

The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.

Full prescribing information is available online.

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

This transcript has been edited for clarity.

Neha Pathak, MD: Hello. Today, we’re talking to Dr. Daniel Clauw, a professor at the University of Michigan in Ann Arbor, who is running a major trial on treatments for chronic back pain. We’re talking today about managing back pain in the post-opioid world. Thank you so much, Dr. Clauw, for taking the time to be our resident pain consultant today. Managing chronic pain can lead to a large amount of burnout and helplessness in the clinic setting. That’s the reality with some of the modalities that patients are requesting; there is still confusion about what is optimal for a particular type of patient, this feeling that we’re not really helping people get better, and whenever patients come in, that’s always still their chief complaint.

How would you advise providers to think about that and to settle into their role as communicators about better strategies without the burnout?

Daniel Clauw, MD: The first thing is to broaden the number of other providers that you get involved in these individuals’ care as the evidence base for all of these nonpharmacologic therapies being effective in chronic pain increases and increases. As third-party payers begin to reimburse for more and more of these therapies, it’s really difficult to manage chronic pain patients if you’re trying to do it alone on an island.

If you can, identify the good physical therapists in your community that are going to really work with people to give them an exercise program that they can use at home; find a pain psychologist that can offer some cognitive-behavioral therapy (CBT) for insomnia and some CBT for pain; and in the subset of patients with trauma, give them the emotional awareness of the neural reprocessing therapy for that specific subset.

As you start to identify more and more of these nonpharmacologic therapies that you want your patients to try, each of those has a set of providers and they can be incredibly helpful so that you, as the primary care provider (PCP), don’t really feel overwhelmed that you’re it, that you’re the only one.

Many of these individuals have more time to spend, and they have more one-on-one in-person time than you do as a primary care physician in the current healthcare system. Many of those providers have become really good at doing amateur CBT, goal-setting, and some of the other things that you need to do when you manage chronic pain patients. Try to find that other group of people that you can send your patients to that are going to be offering some of these nonpharmacologic therapies, and they’ll really help you manage these individuals.

Dr. Pathak: I think a couple of things come up for me. One is that we have to maybe broaden thinking about pain management, not only as multimodal strategies but also as multidisciplinary strategies. To your point, I think that’s really important. I also worry and wonder about health equity concerns, because just as overburdened as many PCPs are, we’re seeing it’s very difficult to get into physical therapy or to get into a setting where you’d be able to receive CBT for your pain. Any thoughts on those types of considerations?

Dr. Clauw: That’s a huge problem. Our group and many other groups in the pain space are developing websites, smartphone apps, and things like that to try to get some of these things directly to individuals with pain, not only for the reasons that you stated but also so that persons with pain don’t have to become patients. Our healthcare systems often make pain worse rather than better.

There were some great articles in The Lancet about 5 years ago talking about low back pain and that in different countries, the healthcare systems, for different reasons, have a tendency to actually make low back pain worse because they do too much surgery, immobilize people, or things like that rather than just not make them better. I think we’ve overmedicalized chronic pain in some settings, and much of what we’re trying to lead people to are things that are parts of wellness programs. The NIH National Center for Complementary and Integrative Health director talks about whole person health often.

I think that these interdisciplinary, integrative approaches are what we have to be using for chronic pain patients. I tell pain patients that, among acupuncture, acupressure, mindfulness, five different forms of CBT, yoga, and tai chi, I don’t know which of those is going to work, but I know that about 1 in 3 individuals that tries each of those therapies gets a benefit. What I really should be doing most is incentivizing people and motivating people to keep trying some of those nonpharmacologic approaches that they haven’t yet tried, because when they find one that works for them, then they will integrate it into their day-to-day life.

The other trick I would use for primary care physicians or anyone managing chronic pain patients is, don’t try to incentivize a pain patient to go try a new nonpharmacologic therapy or start an exercise program because you want their pain score to go from a 6 to a 3. Incentivize them by asking them, what are two or three things that you’re not able to do now because you have chronic pain that you’d really like to be able to do?

You’d like to play nine holes of golf; you’d like to be able to hug your grandchild; or you’d like to be able to do something else. Use those functional goals that are patient0driven to motivate your patients to do these things, because that will work much better. Again, any of us are inherently more likely to take the time and the effort to do some of these nonpharmacologic therapies if it’s for a reason that internally motivates us.

Dr. Pathak: I think that’s great. I’m very privileged to work within the Veterans Affairs (VA) healthcare system. I think that there’s been a huge shift within VA healthcare to provide these ancillary services, whether it’s yoga, tai chi, or acupuncture, as an adjunct to the pain management strategy.

Also, what comes up for me, as you’re saying, is grounding the point that instead of relying on a pain score — which can be objective and different from patient to patient and even within a patient — we should choose a smart goal that is almost more objective when it’s functional. Your goal is to walk two blocks to the mailbox. Can we achieve that as part of your pain control strategy?

I so appreciate your taking the time to be our pain consultant today. I really appreciate our discussion, and I’d like to hand it over to you for any final thoughts.

Dr. Clauw: I’d add that when you’re seeing chronic pain patients, many of them are going to have comorbid sleep problems. They’re going to have comorbid problems with fatigue and memory problems, especially the central nervous system–driven forms of pain that we now call nociplastic pain. Look at those as therapeutic targets.

If you’re befuddled because you’ve tried many different things for pain in this individual you’ve been seeing for a while, focus on their sleep and focus on getting them more active. Don’t use the word exercise — because that scares chronic pain patients — but focus on getting them more active.

There are many different tactics and strategies that you can use to motivate the patients to try some of these new nonpharmacologic approaches as the evidence base continues to increase.

Dr. Pathak: Thank you so much, again, to Dr. Clauw for joining us and being our pain consultant, really helping us to think about managing back pain in the postopioid world.
 

Dr. Pathak is Chief Physician Editor, Health and Lifestyle Medicine, WebMD. She has disclosed no relevant financial relationships. Dr. Clauw is Director, Chronic Pain and Fatigue Research Center, Department of Anesthesia, University of Michigan, Ann Arbor. He disclosed ties with Tonix and Viatris.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Neha Pathak, MD: Hello. Today, we’re talking to Dr. Daniel Clauw, a professor at the University of Michigan in Ann Arbor, who is running a major trial on treatments for chronic back pain. We’re talking today about managing back pain in the post-opioid world. Thank you so much, Dr. Clauw, for taking the time to be our resident pain consultant today. Managing chronic pain can lead to a large amount of burnout and helplessness in the clinic setting. That’s the reality with some of the modalities that patients are requesting; there is still confusion about what is optimal for a particular type of patient, this feeling that we’re not really helping people get better, and whenever patients come in, that’s always still their chief complaint.

How would you advise providers to think about that and to settle into their role as communicators about better strategies without the burnout?

Daniel Clauw, MD: The first thing is to broaden the number of other providers that you get involved in these individuals’ care as the evidence base for all of these nonpharmacologic therapies being effective in chronic pain increases and increases. As third-party payers begin to reimburse for more and more of these therapies, it’s really difficult to manage chronic pain patients if you’re trying to do it alone on an island.

If you can, identify the good physical therapists in your community that are going to really work with people to give them an exercise program that they can use at home; find a pain psychologist that can offer some cognitive-behavioral therapy (CBT) for insomnia and some CBT for pain; and in the subset of patients with trauma, give them the emotional awareness of the neural reprocessing therapy for that specific subset.

As you start to identify more and more of these nonpharmacologic therapies that you want your patients to try, each of those has a set of providers and they can be incredibly helpful so that you, as the primary care provider (PCP), don’t really feel overwhelmed that you’re it, that you’re the only one.

Many of these individuals have more time to spend, and they have more one-on-one in-person time than you do as a primary care physician in the current healthcare system. Many of those providers have become really good at doing amateur CBT, goal-setting, and some of the other things that you need to do when you manage chronic pain patients. Try to find that other group of people that you can send your patients to that are going to be offering some of these nonpharmacologic therapies, and they’ll really help you manage these individuals.

Dr. Pathak: I think a couple of things come up for me. One is that we have to maybe broaden thinking about pain management, not only as multimodal strategies but also as multidisciplinary strategies. To your point, I think that’s really important. I also worry and wonder about health equity concerns, because just as overburdened as many PCPs are, we’re seeing it’s very difficult to get into physical therapy or to get into a setting where you’d be able to receive CBT for your pain. Any thoughts on those types of considerations?

Dr. Clauw: That’s a huge problem. Our group and many other groups in the pain space are developing websites, smartphone apps, and things like that to try to get some of these things directly to individuals with pain, not only for the reasons that you stated but also so that persons with pain don’t have to become patients. Our healthcare systems often make pain worse rather than better.

There were some great articles in The Lancet about 5 years ago talking about low back pain and that in different countries, the healthcare systems, for different reasons, have a tendency to actually make low back pain worse because they do too much surgery, immobilize people, or things like that rather than just not make them better. I think we’ve overmedicalized chronic pain in some settings, and much of what we’re trying to lead people to are things that are parts of wellness programs. The NIH National Center for Complementary and Integrative Health director talks about whole person health often.

I think that these interdisciplinary, integrative approaches are what we have to be using for chronic pain patients. I tell pain patients that, among acupuncture, acupressure, mindfulness, five different forms of CBT, yoga, and tai chi, I don’t know which of those is going to work, but I know that about 1 in 3 individuals that tries each of those therapies gets a benefit. What I really should be doing most is incentivizing people and motivating people to keep trying some of those nonpharmacologic approaches that they haven’t yet tried, because when they find one that works for them, then they will integrate it into their day-to-day life.

The other trick I would use for primary care physicians or anyone managing chronic pain patients is, don’t try to incentivize a pain patient to go try a new nonpharmacologic therapy or start an exercise program because you want their pain score to go from a 6 to a 3. Incentivize them by asking them, what are two or three things that you’re not able to do now because you have chronic pain that you’d really like to be able to do?

You’d like to play nine holes of golf; you’d like to be able to hug your grandchild; or you’d like to be able to do something else. Use those functional goals that are patient0driven to motivate your patients to do these things, because that will work much better. Again, any of us are inherently more likely to take the time and the effort to do some of these nonpharmacologic therapies if it’s for a reason that internally motivates us.

Dr. Pathak: I think that’s great. I’m very privileged to work within the Veterans Affairs (VA) healthcare system. I think that there’s been a huge shift within VA healthcare to provide these ancillary services, whether it’s yoga, tai chi, or acupuncture, as an adjunct to the pain management strategy.

Also, what comes up for me, as you’re saying, is grounding the point that instead of relying on a pain score — which can be objective and different from patient to patient and even within a patient — we should choose a smart goal that is almost more objective when it’s functional. Your goal is to walk two blocks to the mailbox. Can we achieve that as part of your pain control strategy?

I so appreciate your taking the time to be our pain consultant today. I really appreciate our discussion, and I’d like to hand it over to you for any final thoughts.

Dr. Clauw: I’d add that when you’re seeing chronic pain patients, many of them are going to have comorbid sleep problems. They’re going to have comorbid problems with fatigue and memory problems, especially the central nervous system–driven forms of pain that we now call nociplastic pain. Look at those as therapeutic targets.

If you’re befuddled because you’ve tried many different things for pain in this individual you’ve been seeing for a while, focus on their sleep and focus on getting them more active. Don’t use the word exercise — because that scares chronic pain patients — but focus on getting them more active.

There are many different tactics and strategies that you can use to motivate the patients to try some of these new nonpharmacologic approaches as the evidence base continues to increase.

Dr. Pathak: Thank you so much, again, to Dr. Clauw for joining us and being our pain consultant, really helping us to think about managing back pain in the postopioid world.
 

Dr. Pathak is Chief Physician Editor, Health and Lifestyle Medicine, WebMD. She has disclosed no relevant financial relationships. Dr. Clauw is Director, Chronic Pain and Fatigue Research Center, Department of Anesthesia, University of Michigan, Ann Arbor. He disclosed ties with Tonix and Viatris.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Neha Pathak, MD: Hello. Today, we’re talking to Dr. Daniel Clauw, a professor at the University of Michigan in Ann Arbor, who is running a major trial on treatments for chronic back pain. We’re talking today about managing back pain in the post-opioid world. Thank you so much, Dr. Clauw, for taking the time to be our resident pain consultant today. Managing chronic pain can lead to a large amount of burnout and helplessness in the clinic setting. That’s the reality with some of the modalities that patients are requesting; there is still confusion about what is optimal for a particular type of patient, this feeling that we’re not really helping people get better, and whenever patients come in, that’s always still their chief complaint.

How would you advise providers to think about that and to settle into their role as communicators about better strategies without the burnout?

Daniel Clauw, MD: The first thing is to broaden the number of other providers that you get involved in these individuals’ care as the evidence base for all of these nonpharmacologic therapies being effective in chronic pain increases and increases. As third-party payers begin to reimburse for more and more of these therapies, it’s really difficult to manage chronic pain patients if you’re trying to do it alone on an island.

If you can, identify the good physical therapists in your community that are going to really work with people to give them an exercise program that they can use at home; find a pain psychologist that can offer some cognitive-behavioral therapy (CBT) for insomnia and some CBT for pain; and in the subset of patients with trauma, give them the emotional awareness of the neural reprocessing therapy for that specific subset.

As you start to identify more and more of these nonpharmacologic therapies that you want your patients to try, each of those has a set of providers and they can be incredibly helpful so that you, as the primary care provider (PCP), don’t really feel overwhelmed that you’re it, that you’re the only one.

Many of these individuals have more time to spend, and they have more one-on-one in-person time than you do as a primary care physician in the current healthcare system. Many of those providers have become really good at doing amateur CBT, goal-setting, and some of the other things that you need to do when you manage chronic pain patients. Try to find that other group of people that you can send your patients to that are going to be offering some of these nonpharmacologic therapies, and they’ll really help you manage these individuals.

Dr. Pathak: I think a couple of things come up for me. One is that we have to maybe broaden thinking about pain management, not only as multimodal strategies but also as multidisciplinary strategies. To your point, I think that’s really important. I also worry and wonder about health equity concerns, because just as overburdened as many PCPs are, we’re seeing it’s very difficult to get into physical therapy or to get into a setting where you’d be able to receive CBT for your pain. Any thoughts on those types of considerations?

Dr. Clauw: That’s a huge problem. Our group and many other groups in the pain space are developing websites, smartphone apps, and things like that to try to get some of these things directly to individuals with pain, not only for the reasons that you stated but also so that persons with pain don’t have to become patients. Our healthcare systems often make pain worse rather than better.

There were some great articles in The Lancet about 5 years ago talking about low back pain and that in different countries, the healthcare systems, for different reasons, have a tendency to actually make low back pain worse because they do too much surgery, immobilize people, or things like that rather than just not make them better. I think we’ve overmedicalized chronic pain in some settings, and much of what we’re trying to lead people to are things that are parts of wellness programs. The NIH National Center for Complementary and Integrative Health director talks about whole person health often.

I think that these interdisciplinary, integrative approaches are what we have to be using for chronic pain patients. I tell pain patients that, among acupuncture, acupressure, mindfulness, five different forms of CBT, yoga, and tai chi, I don’t know which of those is going to work, but I know that about 1 in 3 individuals that tries each of those therapies gets a benefit. What I really should be doing most is incentivizing people and motivating people to keep trying some of those nonpharmacologic approaches that they haven’t yet tried, because when they find one that works for them, then they will integrate it into their day-to-day life.

The other trick I would use for primary care physicians or anyone managing chronic pain patients is, don’t try to incentivize a pain patient to go try a new nonpharmacologic therapy or start an exercise program because you want their pain score to go from a 6 to a 3. Incentivize them by asking them, what are two or three things that you’re not able to do now because you have chronic pain that you’d really like to be able to do?

You’d like to play nine holes of golf; you’d like to be able to hug your grandchild; or you’d like to be able to do something else. Use those functional goals that are patient0driven to motivate your patients to do these things, because that will work much better. Again, any of us are inherently more likely to take the time and the effort to do some of these nonpharmacologic therapies if it’s for a reason that internally motivates us.

Dr. Pathak: I think that’s great. I’m very privileged to work within the Veterans Affairs (VA) healthcare system. I think that there’s been a huge shift within VA healthcare to provide these ancillary services, whether it’s yoga, tai chi, or acupuncture, as an adjunct to the pain management strategy.

Also, what comes up for me, as you’re saying, is grounding the point that instead of relying on a pain score — which can be objective and different from patient to patient and even within a patient — we should choose a smart goal that is almost more objective when it’s functional. Your goal is to walk two blocks to the mailbox. Can we achieve that as part of your pain control strategy?

I so appreciate your taking the time to be our pain consultant today. I really appreciate our discussion, and I’d like to hand it over to you for any final thoughts.

Dr. Clauw: I’d add that when you’re seeing chronic pain patients, many of them are going to have comorbid sleep problems. They’re going to have comorbid problems with fatigue and memory problems, especially the central nervous system–driven forms of pain that we now call nociplastic pain. Look at those as therapeutic targets.

If you’re befuddled because you’ve tried many different things for pain in this individual you’ve been seeing for a while, focus on their sleep and focus on getting them more active. Don’t use the word exercise — because that scares chronic pain patients — but focus on getting them more active.

There are many different tactics and strategies that you can use to motivate the patients to try some of these new nonpharmacologic approaches as the evidence base continues to increase.

Dr. Pathak: Thank you so much, again, to Dr. Clauw for joining us and being our pain consultant, really helping us to think about managing back pain in the postopioid world.
 

Dr. Pathak is Chief Physician Editor, Health and Lifestyle Medicine, WebMD. She has disclosed no relevant financial relationships. Dr. Clauw is Director, Chronic Pain and Fatigue Research Center, Department of Anesthesia, University of Michigan, Ann Arbor. He disclosed ties with Tonix and Viatris.

A version of this article appeared on Medscape.com.

UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.

TOPLINE:

Among adults motivated to quit smoking, electronic cigarettes are more effective than nicotine chewing gum and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers. 

METHODOLOGY:

• The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
• They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.

TAKEAWAY: 

• At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
• At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
• Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
• In the varenicline group, 8.8% experienced nausea.
• No serious adverse events were reported.

IN PRACTICE:

“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary. 

SOURCE:

Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine. 

LIMITATIONS:

The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.

The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.

More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.

Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.

DISCLOSURES:

The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.

A version of this article appeared on Medscape.com.

UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.

TOPLINE:

Among adults motivated to quit smoking, electronic cigarettes are more effective than nicotine chewing gum and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers. 

METHODOLOGY:

• The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
• They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.

TAKEAWAY: 

• At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
• At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
• Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
• In the varenicline group, 8.8% experienced nausea.
• No serious adverse events were reported.

IN PRACTICE:

“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary. 

SOURCE:

Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine. 

LIMITATIONS:

The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.

The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.

More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.

Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.

DISCLOSURES:

The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.

A version of this article appeared on Medscape.com.

UPDATE: On March 29, 2024, the authors of this study published in JAMA Internal Medicine issued a formal retraction of their article. "Unfortunately, we have found significant coding errors that are difficult to rectify," the author wrote. "We also discovered discrepancies in the calculation process that cast doubt on the accuracy and reliability of the reported findings." The CHEST Physician® Editorial Board apologizes for any confusion this may have caused.

TOPLINE:

Among adults motivated to quit smoking, electronic cigarettes are more effective than nicotine chewing gum and as effective as varenicline in achieving sustained abstinence at 6 months, a randomized trial found. Questions about the long-term safety of e-cigarettes remain, however, according to the researchers. 

METHODOLOGY:

• The study included 1068 participants in China who were smoking at least 10 cigarettes per day.
• They were randomly assigned to undergo 12 weeks of treatment with a cartridge-based e-cigarette, varenicline, or nicotine chewing gum.

TAKEAWAY: 

• At 6 months, the biochemically validated rate of quitting was 15.7% for those who received e-cigarettes, 14.2% for those who received varenicline, and 8.8% for those who chewed nicotine gum.
• At 6 months, 62.8% of participants in the e-cigarette arm were still using the devices, whereas those in the other study arms had not continued their treatments.
• Adverse reactions with e-cigarettes and nicotine chewing gum included irritation of the throat and mouth, which occurred in 7%-8% of participants.
• In the varenicline group, 8.8% experienced nausea.
• No serious adverse events were reported.

IN PRACTICE:

“A moderate approach would be to recommend approved medications as the first step and, if that fails, then inform the patient of the evidence regarding the use of electronic cigarettes as a possible approach, acknowledging all its caveats,” Dorothy K. Hatsukami, PhD, with the University of Minnesota in Minneapolis, and Judith J. Prochaska, PhD, MPH, with Stanford (California) University, wrote in an invited commentary. 

SOURCE:

Zhao Liu, PhD, with the China-Japan Friendship Hospital in Beijing, was the corresponding author for the study. The study was published online on January 29, 2024, in JAMA Internal Medicine. 

LIMITATIONS:

The trial had an open-label design, so participants’ expectations about their assigned treatment may have influenced the results.

The study did not include participants older than 45 years, so it is unclear how the results apply to older populations.

More studies are needed to see whether continued use of e-cigarettes is beneficial or harmful, the researchers wrote.

Combining forms of nicotine replacement therapy, such as gum plus a patch, may be more effective than a single form, but the trial did not assess a combined approach, the commentary authors noted. The dose of nicotine gum for some participants may have been suboptimal, they added.

DISCLOSURES:

The study was supported by the Scientific Research Project Fund of China-Japan Friendship Hospital. The researchers had no conflict of interest disclosures. Dr. Prochaska disclosed receiving fees from Achieve Life Sciences, OneLeaf, and attorneys who are involved in litigation against tobacco companies.

A version of this article appeared on Medscape.com.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The vaccine Cervarix was effective in protecting women from cervical cancer when administered between ages 12 and 13 years, according to a new study published in Journal of the National Cancer Institute.

METHODOLOGY:

• Cervical cancer is the fourth most common cancer among women worldwide.
• Programs to provide Cervarix, a bivalent vaccine, began in the United Kingdom in 2007.
• After the initiation of the programs, administering the vaccine became part of routine care for girls starting at age 12 years.
• Researchers collected data in 2020 from 447,845 women born between 1988 and 1996 from the Scottish cervical cancer screening system to assess the efficacy of Cervarix in lowering rates of cervical cancer.
• They correlated the rate of cervical cancer per 100,000 person-years with data on women regarding vaccination status, age when vaccinated, and deprivation in areas like income, housing, and health.

TAKEAWAY:

• No cases of cervical cancer were found among women who were immunized at ages 12 or 13 years, no matter how many doses they received. 
• Women who were immunized between ages 14 and 18 years and received three doses had fewer instances of cervical cancer compared with unvaccinated women regardless of deprivation status (3.2 cases per 100,00 women vs 8.4 cases per 100,000). 

IN PRACTICE:

“Continued participation in screening and monitoring of outcomes is required, however, to assess the effects of changes in vaccines used and dosage schedules since the start of vaccination in Scotland in 2008 and the longevity of protection the vaccines offer.”

SOURCE:

The study was led by Timothy J. Palmer, PhD, Scottish Clinical Lead for Cervical Screening at Public Health Scotland.

LIMITATIONS:

Only 14,645 women had received just one or two doses, which may have affected the statistical analysis. 

DISCLOSURES:

The study was funded by Public Health Scotland. A coauthor reports attending an advisory board meeting for HOLOGIC and Vaccitech. Her institution received research funding or gratis support funding from Cepheid, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene, Roche, Hologic, and Vaccitech in the past 3 years.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Using olaparib alone or in combination with durvalumab as a chemotherapy-free maintenance treatment can extend progression-free survival (PFS) in patients with advanced triple-negative breast cancer (TNBC).

METHODOLOGY:

• First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
• The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
• The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
• The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.

TAKEAWAY:

• After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
• Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
• Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
• Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.

IN PRACTICE:

“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.

SOURCE:

This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.

LIMITATIONS:

The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.

DISCLOSURES:

AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Using olaparib alone or in combination with durvalumab as a chemotherapy-free maintenance treatment can extend progression-free survival (PFS) in patients with advanced triple-negative breast cancer (TNBC).

METHODOLOGY:

• First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
• The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
• The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
• The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.

TAKEAWAY:

• After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
• Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
• Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
• Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.

IN PRACTICE:

“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.

SOURCE:

This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.

LIMITATIONS:

The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.

DISCLOSURES:

AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Using olaparib alone or in combination with durvalumab as a chemotherapy-free maintenance treatment can extend progression-free survival (PFS) in patients with advanced triple-negative breast cancer (TNBC).

METHODOLOGY:

• First-line standard therapy for advanced TNBC generally includes taxane- or platinum-based chemotherapy which poses challenging toxicities. Exploring chemotherapy-free maintenance strategies may provide adequate disease control and improve patient quality of life.
• The researchers evaluated 45 patients, at five sites in the Republic of Korea, the United States, and Singapore, with TNBC who had ongoing stable disease or complete/partial response from first- or second-line platinum-based chemotherapy.
• The patients were randomized 1:1 to receive olaparib 300 mg twice daily with or without durvalumab 1500 mg on day 1 every 4 weeks.
• The authors compared PFS with a historical control of continued platinum-based therapy. An improvement to 4 months with maintenance therapy was considered clinically significant.

TAKEAWAY:

• After a follow-up of 9.8 months, patients who received olaparib alone demonstrated median PFS of 4.0 months, and those who received the combination therapy had median PFS of 6.1 months.
• Clinical benefit rates, defined as stable disease for at least 24 weeks or complete/partial response, were reported in 44% of the monotherapy group and 36% of the combination therapy group.
• Sustained clinical benefit was evident irrespective of germline BRCA mutation or programmed death-ligand 1 status, although it tended to be associated with complete or partial response to prior platinum.
• Grade 3-4 adverse events were reported in nine patients (39%) in the olaparib arm and eight patients (36%) in the combination arm. No treatment-related deaths or new safety signals were observed.

IN PRACTICE:

“Maintenance regimens are rarely used in [triple-negative breast cancer] but offer the possibility of more tolerable long-term treatment avoiding some of the chemotherapy-related side effects of more aggressive regimens, as is standard in the first-line treatment of HER2-positive advanced breast cancer,” the researchers concluded.

SOURCE:

This study, led by Tira J. Tan from Duke-NUS Medical School, Singapore, was published online on January 18, 2024, in Clinical Cancer Research.

LIMITATIONS:

The main limitations were the small sample size and lack of a standard control arm. Most patients (76%) were Asian, limiting generalizability. The trial was not designed to compare olaparib monotherapy and olaparib plus durvalumab regimens.

DISCLOSURES:

AstraZeneca Pharmaceuticals LP supported this study. Several authors reported financial support from various sources.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The sequence of systematic therapies for unresectable or metastatic pancreatic ductal adenocarcinoma may have an impact on patient survival, a new retrospective analysis suggests.

METHODOLOGY:

• Despite therapeutic advances, survival among patients with unresectable and/or metastatic pancreatic ductal adenocarcinoma has not markedly improved in recent years.
• In the current analysis, researchers evaluated whether treatment sequence could affect survival outcomes in this patient population.
• To this end , researchers conducted a single institution, retrospective analysis of patients who received different lines of treatment between January 2015 and December 2021.
• The most common first-line therapy was nab-paclitaxel plus S-1 (58%), followed by FOLFIRINOX (10%), nab-paclitaxel plus gemcitabine (8%), gemcitabine alone (7%), gemcitabine plus oxaliplatin (6%); second-line therapies, in order of frequency, included gemcitabine combination therapy (48%), nab-paclitaxel combination therapy (19%), FOLFIRINOX (10%), and gemcitabine alone (7%); third-line treatments consisted of FOLFIRINOX (31%), irinotecan or oxaliplatin combination therapy (23%), immunotherapy (19%), and gemcitabine combination therapy (10%).