Clinician Reviews

Stable slate gray to blue lesions that are asymptomatic raise the possibility of a blue nevus, also known as dermal dendritic melanocytic proliferations. In this case, dermoscopy confirmed a uniform dark color with no signs suggestive of melanoma or pigmented basal cell carcinoma (BCC).

Blue nevi are the result of a benign localized proliferation of dermal dendritic melanocytes. The blue color is due to the increased pigment deep in the dermis that reflects the blue shorter wavelength light while absorbing longer wavelengths.¹ In this author’s experience, these “blue” lesions usually appear to be more gray (as was the case with this individual). Dermoscopy shows a steel blue homogenous pigmentation.²

It is helpful to use dermoscopy to screen for an atypical pigment network, regression of pigmentation, or abnormal pigmentation; these are signs of atypical nevi and melanoma. It is also important to look for arborizing blood vessels and leaf-like structures that can be seen in pigmented BCCs. Both melanoma and pigmented BCCs can appear as circumscribed dark lesions.

Reassuring factors for blue nevi are lesions that are stable in size and color over time, asymptomatic, and have not bled nor shown signs of erosion. If the diagnosis is in doubt, excise the lesion in its entirety for definitive pathology. Since the melanocytes are typically deeper in blue nevi than in most other nevi, a deep shave technique may not remove the lesion in its entirety. A deeper than usual shave (or, if feasible, a full-thickness excision) may return better results with quicker healing.

This patient was advised of the benign nature of a blue nevus. He was counseled to watch for any changes in the lesion and to return for reevaluation if symptoms or changes occurred.

‌

Image and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Stable slate gray to blue lesions that are asymptomatic raise the possibility of a blue nevus, also known as dermal dendritic melanocytic proliferations. In this case, dermoscopy confirmed a uniform dark color with no signs suggestive of melanoma or pigmented basal cell carcinoma (BCC).

Blue nevi are the result of a benign localized proliferation of dermal dendritic melanocytes. The blue color is due to the increased pigment deep in the dermis that reflects the blue shorter wavelength light while absorbing longer wavelengths.¹ In this author’s experience, these “blue” lesions usually appear to be more gray (as was the case with this individual). Dermoscopy shows a steel blue homogenous pigmentation.²

It is helpful to use dermoscopy to screen for an atypical pigment network, regression of pigmentation, or abnormal pigmentation; these are signs of atypical nevi and melanoma. It is also important to look for arborizing blood vessels and leaf-like structures that can be seen in pigmented BCCs. Both melanoma and pigmented BCCs can appear as circumscribed dark lesions.

Reassuring factors for blue nevi are lesions that are stable in size and color over time, asymptomatic, and have not bled nor shown signs of erosion. If the diagnosis is in doubt, excise the lesion in its entirety for definitive pathology. Since the melanocytes are typically deeper in blue nevi than in most other nevi, a deep shave technique may not remove the lesion in its entirety. A deeper than usual shave (or, if feasible, a full-thickness excision) may return better results with quicker healing.

This patient was advised of the benign nature of a blue nevus. He was counseled to watch for any changes in the lesion and to return for reevaluation if symptoms or changes occurred.

‌

Image and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Stable slate gray to blue lesions that are asymptomatic raise the possibility of a blue nevus, also known as dermal dendritic melanocytic proliferations. In this case, dermoscopy confirmed a uniform dark color with no signs suggestive of melanoma or pigmented basal cell carcinoma (BCC).

Blue nevi are the result of a benign localized proliferation of dermal dendritic melanocytes. The blue color is due to the increased pigment deep in the dermis that reflects the blue shorter wavelength light while absorbing longer wavelengths.¹ In this author’s experience, these “blue” lesions usually appear to be more gray (as was the case with this individual). Dermoscopy shows a steel blue homogenous pigmentation.²

It is helpful to use dermoscopy to screen for an atypical pigment network, regression of pigmentation, or abnormal pigmentation; these are signs of atypical nevi and melanoma. It is also important to look for arborizing blood vessels and leaf-like structures that can be seen in pigmented BCCs. Both melanoma and pigmented BCCs can appear as circumscribed dark lesions.

Reassuring factors for blue nevi are lesions that are stable in size and color over time, asymptomatic, and have not bled nor shown signs of erosion. If the diagnosis is in doubt, excise the lesion in its entirety for definitive pathology. Since the melanocytes are typically deeper in blue nevi than in most other nevi, a deep shave technique may not remove the lesion in its entirety. A deeper than usual shave (or, if feasible, a full-thickness excision) may return better results with quicker healing.

This patient was advised of the benign nature of a blue nevus. He was counseled to watch for any changes in the lesion and to return for reevaluation if symptoms or changes occurred.

‌

Image and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

You can get all the exercise you need in just 8 minutes a day if you work out a bit harder, according to a new study in the European Heart Journal.

Just 54 minutes of vigorous exercise per week provides the most bang for your buck, researchers found, lowering the risk of early death from any cause by 36%, and your chances of getting heart disease by 35%.

Scientists examined data from fitness trackers worn by more than 71,000 people studied in the United Kingdom, then analyzed their health over the next several years.

While more time spent exercising unsurprisingly led to better health, the protective effects of exercise start to plateau after a certain point, according to the study.

A tough, short workout improves blood pressure, shrinks artery-clogging plaques, and boosts your overall fitness.

Vigorous exercise helps your body adapt better than moderate exercise does, leading to more notable benefits, says study author Matthew Ahmadi, PhD, a postdoctoral research fellow at the University of Sydney.

“Collectively, these will lower a person’s risk of cardiovascular disease. Exercise can also lower body inflammation, which will in turn lower the risk for certain cancers,” he says.

The CDC recommends at least 150 minutes of “moderate intensity” exercise each week, such as walking at a brisk pace. Or you could spend 75 minutes each week doing vigorous exercise, like running, it says. The CDC also recommends muscle strengthening activities, like lifting weights, at least 2 days per week.

But only 54% of Americans actually manage to get their 150 minutes of aerobic activity in each week, according to the most recent data from the National Center for Health Statistics. Even fewer – just 24% – also squeeze in the two recommended strength workouts.

So 8 minutes a day instead of 30 minutes could persuade busy people to get the exercise they need.

“Lack of time is one of the main reasons people have reported for not engaging in exercise,” says Dr. Ahmadi.

Vigorous exercise doesn’t mean you have to run, bike, or lift weights. Scientists consider a physical activity “vigorous” if it’s greater than 6 times your resting metabolic rate, or MET. That includes all kinds of strenuous movement, including dancing in a nightclub or carrying groceries upstairs.

“All of these activities are equally beneficial,” says Dr. Ahmadi.

He recommends aiming for 2-minute bouts of a heart-pumping activity, spread throughout the day for the most benefit in the least amount of time. If you wear a smartwatch or other device that tracks your heart rate, you’ll be above the threshold if your heart is pumping at 77% or more of your max heart rate (which most fitness trackers help you calculate).

No smartwatch? “The easiest way a person can infer if they are doing vigorous activity is if they are breathing hard enough that it’s difficult to have a conversation or speak in a full sentence while doing the activity,” Dr. Ahmadi says. In other words, if you’re huffing and puffing, then you’re in the zone.

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

You can get all the exercise you need in just 8 minutes a day if you work out a bit harder, according to a new study in the European Heart Journal.

Just 54 minutes of vigorous exercise per week provides the most bang for your buck, researchers found, lowering the risk of early death from any cause by 36%, and your chances of getting heart disease by 35%.

Scientists examined data from fitness trackers worn by more than 71,000 people studied in the United Kingdom, then analyzed their health over the next several years.

While more time spent exercising unsurprisingly led to better health, the protective effects of exercise start to plateau after a certain point, according to the study.

A tough, short workout improves blood pressure, shrinks artery-clogging plaques, and boosts your overall fitness.

Vigorous exercise helps your body adapt better than moderate exercise does, leading to more notable benefits, says study author Matthew Ahmadi, PhD, a postdoctoral research fellow at the University of Sydney.

“Collectively, these will lower a person’s risk of cardiovascular disease. Exercise can also lower body inflammation, which will in turn lower the risk for certain cancers,” he says.

The CDC recommends at least 150 minutes of “moderate intensity” exercise each week, such as walking at a brisk pace. Or you could spend 75 minutes each week doing vigorous exercise, like running, it says. The CDC also recommends muscle strengthening activities, like lifting weights, at least 2 days per week.

But only 54% of Americans actually manage to get their 150 minutes of aerobic activity in each week, according to the most recent data from the National Center for Health Statistics. Even fewer – just 24% – also squeeze in the two recommended strength workouts.

So 8 minutes a day instead of 30 minutes could persuade busy people to get the exercise they need.

“Lack of time is one of the main reasons people have reported for not engaging in exercise,” says Dr. Ahmadi.

Vigorous exercise doesn’t mean you have to run, bike, or lift weights. Scientists consider a physical activity “vigorous” if it’s greater than 6 times your resting metabolic rate, or MET. That includes all kinds of strenuous movement, including dancing in a nightclub or carrying groceries upstairs.

“All of these activities are equally beneficial,” says Dr. Ahmadi.

He recommends aiming for 2-minute bouts of a heart-pumping activity, spread throughout the day for the most benefit in the least amount of time. If you wear a smartwatch or other device that tracks your heart rate, you’ll be above the threshold if your heart is pumping at 77% or more of your max heart rate (which most fitness trackers help you calculate).

No smartwatch? “The easiest way a person can infer if they are doing vigorous activity is if they are breathing hard enough that it’s difficult to have a conversation or speak in a full sentence while doing the activity,” Dr. Ahmadi says. In other words, if you’re huffing and puffing, then you’re in the zone.

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

You can get all the exercise you need in just 8 minutes a day if you work out a bit harder, according to a new study in the European Heart Journal.

Just 54 minutes of vigorous exercise per week provides the most bang for your buck, researchers found, lowering the risk of early death from any cause by 36%, and your chances of getting heart disease by 35%.

Scientists examined data from fitness trackers worn by more than 71,000 people studied in the United Kingdom, then analyzed their health over the next several years.

While more time spent exercising unsurprisingly led to better health, the protective effects of exercise start to plateau after a certain point, according to the study.

A tough, short workout improves blood pressure, shrinks artery-clogging plaques, and boosts your overall fitness.

Vigorous exercise helps your body adapt better than moderate exercise does, leading to more notable benefits, says study author Matthew Ahmadi, PhD, a postdoctoral research fellow at the University of Sydney.

“Collectively, these will lower a person’s risk of cardiovascular disease. Exercise can also lower body inflammation, which will in turn lower the risk for certain cancers,” he says.

The CDC recommends at least 150 minutes of “moderate intensity” exercise each week, such as walking at a brisk pace. Or you could spend 75 minutes each week doing vigorous exercise, like running, it says. The CDC also recommends muscle strengthening activities, like lifting weights, at least 2 days per week.

But only 54% of Americans actually manage to get their 150 minutes of aerobic activity in each week, according to the most recent data from the National Center for Health Statistics. Even fewer – just 24% – also squeeze in the two recommended strength workouts.

So 8 minutes a day instead of 30 minutes could persuade busy people to get the exercise they need.

“Lack of time is one of the main reasons people have reported for not engaging in exercise,” says Dr. Ahmadi.

Vigorous exercise doesn’t mean you have to run, bike, or lift weights. Scientists consider a physical activity “vigorous” if it’s greater than 6 times your resting metabolic rate, or MET. That includes all kinds of strenuous movement, including dancing in a nightclub or carrying groceries upstairs.

“All of these activities are equally beneficial,” says Dr. Ahmadi.

He recommends aiming for 2-minute bouts of a heart-pumping activity, spread throughout the day for the most benefit in the least amount of time. If you wear a smartwatch or other device that tracks your heart rate, you’ll be above the threshold if your heart is pumping at 77% or more of your max heart rate (which most fitness trackers help you calculate).

No smartwatch? “The easiest way a person can infer if they are doing vigorous activity is if they are breathing hard enough that it’s difficult to have a conversation or speak in a full sentence while doing the activity,” Dr. Ahmadi says. In other words, if you’re huffing and puffing, then you’re in the zone.

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

Vitamin D supplements do not prevent muscle symptoms in new statin users or affect the likelihood of discontinuing a statin due to muscle pain and discomfort, a substudy of the VITAL trial indicates.

Among more than 2,000 randomized participants, statin-associated muscle symptoms (SAMS) were reported by 31% assigned to vitamin D and 31% assigned to placebo.

copyright Joss/Fotolia.com

The two groups were equally likely to stop taking a statin due to muscle symptoms, at 13%.

No significant difference was observed in SAMS (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.80-1.18) or statin discontinuations (OR, 1.04; 95% CI, 0.80-1.35) after adjustment for baseline variables and other characteristics, namely age, sex, and African-American race, previously found to be associated with SAMS in VITAL.

“We actually thought when we started out that maybe we were going to show something, that maybe it was going to be that the people who got the vitamin D were least likely to have a problem with a statin than all those who didn’t get vitamin D, but that is not what we showed,” senior author Neil J. Stone, MD, Northwestern University, Chicago, told this news organization.

He noted that patients in the clinic with low levels of vitamin D often have muscle pain and discomfort and that previous unblinded studies suggested vitamin D might benefit patients with SAMS and reduce statin intolerance.

As previously reported, the double-blind VITAL trial showed no difference in the primary prevention of cardiovascular disease or cancer at 5 years among 25,871 middle-aged adults randomized to vitamin D3 at 2000 IU/d or placebo, regardless of their baseline vitamin D level.

Unlike previous studies showing a benefit with vitamin D on SAMS, importantly, VITAL participants were unaware of whether they were taking vitamin D or placebo and were not expecting any help with their muscle symptoms, first author Mark A. Hlatky, MD, Stanford (Calif.) University, pointed out in an interview.

As to how many statin users turn to the popular supplement for SAMS, he said that number couldn’t be pinned down, despite a lengthy search. “But I think it’s very common, because up to half of people stop taking their statins within a year and many of these do so because of statin-associated muscle symptoms, and we found it in about 30% of people who have them. I have them myself and was motivated to study it because I thought this was an interesting question.”

The results were published online in JAMA Cardiology.
 

SAMS by baseline 25-OHD

The substudy included 2,083 patients who initiated statin therapy after randomization and were surveyed in early 2016 about their statin use and muscle symptoms.

Two-thirds, or 1,397 patients, had 25-hydroxy vitamin D (25-OHD) measured at baseline, with 47% having levels < 30 ng/mL and 13% levels < 20 ng/mL.

Serum 25-OHD levels were virtually identical in the two treatment groups (mean, 30.4 ng/mL; median, 30.0 ng/mL). The frequency of SAMS did not differ between those assigned to vitamin D or placebo (28% vs. 31%).

The odds ratios for the association with vitamin D on SAMS were:

• 0.86 in all respondents with 25-OHD measured (95% CI, 0.69-1.09).
• 0.87 in those with levels ≥ 30 ng/mL (95% CI, 0.64-1.19).
• 0.85 with levels of 20-30 ng/mL (95% CI, 0.56-1.28).
• 0.93 with levels < 20 ng/mL (95% CI, 0.50-1.74).

The test for treatment effect modification by baseline serum 25-OHD level was not significant (P for interaction = .83).

In addition, the rate of muscle symptoms was similar between participants randomized to vitamin D and placebo when researchers used a cutpoint to define low 25-OHD of < 30 ng/mL (27% vs. 30%) or < 20 ng/mL (33% vs. 35%).

“We didn’t find any evidence at all that the people who came into the study with low levels of vitamin D did better with the supplement in this case,” Dr. Hlatky said. “So that wasn’t the reason we didn’t see anything.”

Critics may suggest the trial didn’t use a high enough dose of vitamin D, but both Dr. Hlatky and Dr. Stone say that’s unlikely to be a factor in the results because 2,000 IU/d is a substantial dose and well above the recommended adult daily dose of 600-800 IU.

They caution that the substudy wasn’t prespecified, was smaller than the parent trial, and did not have a protocol in place to detail SAMS. They also can’t rule out the possibility that vitamin D may have an effect in patients who have confirmed intolerance to multiple statins, especially after adjustment for the statin type and dose.

“If you’re taking vitamin D to keep from having statin-associated muscle symptoms, this very carefully done substudy with the various caveats doesn’t support that and that’s not something I would give my patients,” Dr. Stone said.

“The most important thing from a negative study is that it allows you to focus your attention on things that may be much more productive rather than assuming that just giving everybody vitamin D will take care of the statin issue,” he added. “Maybe the answer is going to be somewhere else, and there’ll be a lot of people I’m sure who will offer their advice as what the answer is but, I would argue, we want to see more studies to pin it down. So people can get some science behind what they do to try to reduce statin-associated muscle symptoms.”

Paul D. Thompson, MD, chief of cardiology emeritus at Hartford (Conn.) Hospital, and a SAMS expert who was not involved with the research, said, “This is a useful publication, and it’s smart in that it took advantage of a study that was already done.”

He acknowledged being skeptical of a beneficial effect of vitamin D supplementation on SAMS, because some previous data have been retracted, but said that potential treatments are best tested in patients with confirmed statin myalgia, as was the case in his team’s negative trial of CoQ10 supplementation.

That said, the present “study was able to at least give some of the best evidence so far that vitamin D doesn’t do anything to improve symptoms,” Dr. Thompson said. “So maybe it will cut down on so many vitamin D levels [being measured] and use of vitamin D when you don’t really need it.”

The study was sponsored by the Hyperlipidemia Research Fund at Northwestern University. The VITAL trial was supported by grants from the National Institutes of Health, and Quest Diagnostics performed the laboratory measurements at no additional costs. Dr. Hlatky reports no relevant financial relationships. Dr. Stone reports a grant from the Hyperlipidemia Research Fund at Northwestern and honorarium for educational activity for Knowledge to Practice. Dr. Thompson is on the executive committee for a study examining bempedoic acid in patients with statin-associated muscle symptoms.

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

Vitamin D supplements do not prevent muscle symptoms in new statin users or affect the likelihood of discontinuing a statin due to muscle pain and discomfort, a substudy of the VITAL trial indicates.

Among more than 2,000 randomized participants, statin-associated muscle symptoms (SAMS) were reported by 31% assigned to vitamin D and 31% assigned to placebo.

copyright Joss/Fotolia.com

The two groups were equally likely to stop taking a statin due to muscle symptoms, at 13%.

No significant difference was observed in SAMS (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.80-1.18) or statin discontinuations (OR, 1.04; 95% CI, 0.80-1.35) after adjustment for baseline variables and other characteristics, namely age, sex, and African-American race, previously found to be associated with SAMS in VITAL.

“We actually thought when we started out that maybe we were going to show something, that maybe it was going to be that the people who got the vitamin D were least likely to have a problem with a statin than all those who didn’t get vitamin D, but that is not what we showed,” senior author Neil J. Stone, MD, Northwestern University, Chicago, told this news organization.

He noted that patients in the clinic with low levels of vitamin D often have muscle pain and discomfort and that previous unblinded studies suggested vitamin D might benefit patients with SAMS and reduce statin intolerance.

As previously reported, the double-blind VITAL trial showed no difference in the primary prevention of cardiovascular disease or cancer at 5 years among 25,871 middle-aged adults randomized to vitamin D3 at 2000 IU/d or placebo, regardless of their baseline vitamin D level.

Unlike previous studies showing a benefit with vitamin D on SAMS, importantly, VITAL participants were unaware of whether they were taking vitamin D or placebo and were not expecting any help with their muscle symptoms, first author Mark A. Hlatky, MD, Stanford (Calif.) University, pointed out in an interview.

As to how many statin users turn to the popular supplement for SAMS, he said that number couldn’t be pinned down, despite a lengthy search. “But I think it’s very common, because up to half of people stop taking their statins within a year and many of these do so because of statin-associated muscle symptoms, and we found it in about 30% of people who have them. I have them myself and was motivated to study it because I thought this was an interesting question.”

The results were published online in JAMA Cardiology.
 

SAMS by baseline 25-OHD

The substudy included 2,083 patients who initiated statin therapy after randomization and were surveyed in early 2016 about their statin use and muscle symptoms.

Two-thirds, or 1,397 patients, had 25-hydroxy vitamin D (25-OHD) measured at baseline, with 47% having levels < 30 ng/mL and 13% levels < 20 ng/mL.

Serum 25-OHD levels were virtually identical in the two treatment groups (mean, 30.4 ng/mL; median, 30.0 ng/mL). The frequency of SAMS did not differ between those assigned to vitamin D or placebo (28% vs. 31%).

The odds ratios for the association with vitamin D on SAMS were:

• 0.86 in all respondents with 25-OHD measured (95% CI, 0.69-1.09).
• 0.87 in those with levels ≥ 30 ng/mL (95% CI, 0.64-1.19).
• 0.85 with levels of 20-30 ng/mL (95% CI, 0.56-1.28).
• 0.93 with levels < 20 ng/mL (95% CI, 0.50-1.74).

The test for treatment effect modification by baseline serum 25-OHD level was not significant (P for interaction = .83).

In addition, the rate of muscle symptoms was similar between participants randomized to vitamin D and placebo when researchers used a cutpoint to define low 25-OHD of < 30 ng/mL (27% vs. 30%) or < 20 ng/mL (33% vs. 35%).

“We didn’t find any evidence at all that the people who came into the study with low levels of vitamin D did better with the supplement in this case,” Dr. Hlatky said. “So that wasn’t the reason we didn’t see anything.”

Critics may suggest the trial didn’t use a high enough dose of vitamin D, but both Dr. Hlatky and Dr. Stone say that’s unlikely to be a factor in the results because 2,000 IU/d is a substantial dose and well above the recommended adult daily dose of 600-800 IU.

They caution that the substudy wasn’t prespecified, was smaller than the parent trial, and did not have a protocol in place to detail SAMS. They also can’t rule out the possibility that vitamin D may have an effect in patients who have confirmed intolerance to multiple statins, especially after adjustment for the statin type and dose.

“If you’re taking vitamin D to keep from having statin-associated muscle symptoms, this very carefully done substudy with the various caveats doesn’t support that and that’s not something I would give my patients,” Dr. Stone said.

“The most important thing from a negative study is that it allows you to focus your attention on things that may be much more productive rather than assuming that just giving everybody vitamin D will take care of the statin issue,” he added. “Maybe the answer is going to be somewhere else, and there’ll be a lot of people I’m sure who will offer their advice as what the answer is but, I would argue, we want to see more studies to pin it down. So people can get some science behind what they do to try to reduce statin-associated muscle symptoms.”

Paul D. Thompson, MD, chief of cardiology emeritus at Hartford (Conn.) Hospital, and a SAMS expert who was not involved with the research, said, “This is a useful publication, and it’s smart in that it took advantage of a study that was already done.”

He acknowledged being skeptical of a beneficial effect of vitamin D supplementation on SAMS, because some previous data have been retracted, but said that potential treatments are best tested in patients with confirmed statin myalgia, as was the case in his team’s negative trial of CoQ10 supplementation.

That said, the present “study was able to at least give some of the best evidence so far that vitamin D doesn’t do anything to improve symptoms,” Dr. Thompson said. “So maybe it will cut down on so many vitamin D levels [being measured] and use of vitamin D when you don’t really need it.”

The study was sponsored by the Hyperlipidemia Research Fund at Northwestern University. The VITAL trial was supported by grants from the National Institutes of Health, and Quest Diagnostics performed the laboratory measurements at no additional costs. Dr. Hlatky reports no relevant financial relationships. Dr. Stone reports a grant from the Hyperlipidemia Research Fund at Northwestern and honorarium for educational activity for Knowledge to Practice. Dr. Thompson is on the executive committee for a study examining bempedoic acid in patients with statin-associated muscle symptoms.

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

Vitamin D supplements do not prevent muscle symptoms in new statin users or affect the likelihood of discontinuing a statin due to muscle pain and discomfort, a substudy of the VITAL trial indicates.

Among more than 2,000 randomized participants, statin-associated muscle symptoms (SAMS) were reported by 31% assigned to vitamin D and 31% assigned to placebo.

copyright Joss/Fotolia.com

The two groups were equally likely to stop taking a statin due to muscle symptoms, at 13%.

No significant difference was observed in SAMS (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.80-1.18) or statin discontinuations (OR, 1.04; 95% CI, 0.80-1.35) after adjustment for baseline variables and other characteristics, namely age, sex, and African-American race, previously found to be associated with SAMS in VITAL.

“We actually thought when we started out that maybe we were going to show something, that maybe it was going to be that the people who got the vitamin D were least likely to have a problem with a statin than all those who didn’t get vitamin D, but that is not what we showed,” senior author Neil J. Stone, MD, Northwestern University, Chicago, told this news organization.

He noted that patients in the clinic with low levels of vitamin D often have muscle pain and discomfort and that previous unblinded studies suggested vitamin D might benefit patients with SAMS and reduce statin intolerance.

As previously reported, the double-blind VITAL trial showed no difference in the primary prevention of cardiovascular disease or cancer at 5 years among 25,871 middle-aged adults randomized to vitamin D3 at 2000 IU/d or placebo, regardless of their baseline vitamin D level.

Unlike previous studies showing a benefit with vitamin D on SAMS, importantly, VITAL participants were unaware of whether they were taking vitamin D or placebo and were not expecting any help with their muscle symptoms, first author Mark A. Hlatky, MD, Stanford (Calif.) University, pointed out in an interview.

As to how many statin users turn to the popular supplement for SAMS, he said that number couldn’t be pinned down, despite a lengthy search. “But I think it’s very common, because up to half of people stop taking their statins within a year and many of these do so because of statin-associated muscle symptoms, and we found it in about 30% of people who have them. I have them myself and was motivated to study it because I thought this was an interesting question.”

The results were published online in JAMA Cardiology.
 

SAMS by baseline 25-OHD

The substudy included 2,083 patients who initiated statin therapy after randomization and were surveyed in early 2016 about their statin use and muscle symptoms.

Two-thirds, or 1,397 patients, had 25-hydroxy vitamin D (25-OHD) measured at baseline, with 47% having levels < 30 ng/mL and 13% levels < 20 ng/mL.

Serum 25-OHD levels were virtually identical in the two treatment groups (mean, 30.4 ng/mL; median, 30.0 ng/mL). The frequency of SAMS did not differ between those assigned to vitamin D or placebo (28% vs. 31%).

The odds ratios for the association with vitamin D on SAMS were:

• 0.86 in all respondents with 25-OHD measured (95% CI, 0.69-1.09).
• 0.87 in those with levels ≥ 30 ng/mL (95% CI, 0.64-1.19).
• 0.85 with levels of 20-30 ng/mL (95% CI, 0.56-1.28).
• 0.93 with levels < 20 ng/mL (95% CI, 0.50-1.74).

The test for treatment effect modification by baseline serum 25-OHD level was not significant (P for interaction = .83).

In addition, the rate of muscle symptoms was similar between participants randomized to vitamin D and placebo when researchers used a cutpoint to define low 25-OHD of < 30 ng/mL (27% vs. 30%) or < 20 ng/mL (33% vs. 35%).

“We didn’t find any evidence at all that the people who came into the study with low levels of vitamin D did better with the supplement in this case,” Dr. Hlatky said. “So that wasn’t the reason we didn’t see anything.”

Critics may suggest the trial didn’t use a high enough dose of vitamin D, but both Dr. Hlatky and Dr. Stone say that’s unlikely to be a factor in the results because 2,000 IU/d is a substantial dose and well above the recommended adult daily dose of 600-800 IU.

They caution that the substudy wasn’t prespecified, was smaller than the parent trial, and did not have a protocol in place to detail SAMS. They also can’t rule out the possibility that vitamin D may have an effect in patients who have confirmed intolerance to multiple statins, especially after adjustment for the statin type and dose.

“If you’re taking vitamin D to keep from having statin-associated muscle symptoms, this very carefully done substudy with the various caveats doesn’t support that and that’s not something I would give my patients,” Dr. Stone said.

“The most important thing from a negative study is that it allows you to focus your attention on things that may be much more productive rather than assuming that just giving everybody vitamin D will take care of the statin issue,” he added. “Maybe the answer is going to be somewhere else, and there’ll be a lot of people I’m sure who will offer their advice as what the answer is but, I would argue, we want to see more studies to pin it down. So people can get some science behind what they do to try to reduce statin-associated muscle symptoms.”

Paul D. Thompson, MD, chief of cardiology emeritus at Hartford (Conn.) Hospital, and a SAMS expert who was not involved with the research, said, “This is a useful publication, and it’s smart in that it took advantage of a study that was already done.”

He acknowledged being skeptical of a beneficial effect of vitamin D supplementation on SAMS, because some previous data have been retracted, but said that potential treatments are best tested in patients with confirmed statin myalgia, as was the case in his team’s negative trial of CoQ10 supplementation.

That said, the present “study was able to at least give some of the best evidence so far that vitamin D doesn’t do anything to improve symptoms,” Dr. Thompson said. “So maybe it will cut down on so many vitamin D levels [being measured] and use of vitamin D when you don’t really need it.”

The study was sponsored by the Hyperlipidemia Research Fund at Northwestern University. The VITAL trial was supported by grants from the National Institutes of Health, and Quest Diagnostics performed the laboratory measurements at no additional costs. Dr. Hlatky reports no relevant financial relationships. Dr. Stone reports a grant from the Hyperlipidemia Research Fund at Northwestern and honorarium for educational activity for Knowledge to Practice. Dr. Thompson is on the executive committee for a study examining bempedoic acid in patients with statin-associated muscle symptoms.

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

A newly discovered genetic variant that is associated with type 2 diabetes (T2D) is responsible for almost 7% of all diabetes cases in Greenland, according to a whole-genome sequencing analysis of 448 Greenlandic Inuit individuals.

The variant, identified as c.1108G>T, “has the largest population impact of any previously reported variant” within the HNF1A gene – a gene that can cause maturity-onset diabetes of the young (MODY), reported senior author Torben Hansen, MD, PhD, of the University of Copenhagen, and colleagues in The Lancet Regional Health–Europe. The c.1108G>T variant does not cause MODY, but other variants within the HNF1A gene do. However, carriers of this variant, which is present in 1.9% of the Greenlandic Inuit population and has not been found elsewhere, have normal insulin sensitivity, but decreased beta-cell function and a more than fourfold risk of developing type 2 diabetes. “This adds to a previous discovery that about 11% of all diabetes in Greenlandic Inuit is explained by a mutation in the TBC1D4 variant,” Dr. Hansen told this publication. “Thus 1 in 5 patients diagnosed with type 2 diabetes in Greenland have a specific mutation explaining their diabetes. In European populations only about 1%-2% of patients diagnosed with type 2 diabetes have a known genetic etiology.”

The finding “provides new avenues to subgroup patients, detect diabetes in family members, and pursue precision treatment trials,” noted the authors, although they acknowledged that treatment choices for individuals with this variant still need to be explored. “We know from HNF1A-mutation carriers with European ancestry that they benefit from sulfonylurea treatment,” said Dr. Hansen. “However, we have not yet done treatment studies in Inuit.” The investigators noted that “it is not always the case that variants in HNF1A result in an increased insulin secretory response to sulfonylurea. ... Whether carriers of the c.1108G>T variant could benefit from treatment with sulfonylurea should be pursued within the context of a randomized clinical trial establishing both short- and long-term efficacy of sulfonylurea in these patients.”

A total of 4,497 study participants were randomly sampled from two cross-sectional cohorts in an adult Greenlandic population health survey. Among 448 participants who had whole genome sequencing, 14 known MODY genes were screened for both previously identified as well as novel variants. This identified the c.1108G>T variant, which was then genotyped in the full cohort in order to estimate an allele frequency of 1.3% in the general Greenlandic population, and 1.9% in the Inuit component. The variant was not found in genome sequences of other populations.

The researchers then tested the association of the variant with T2D and showed strong association with T2D (odds ratio, 4.35) and higher hemoglobin A1c levels.

“This is very well-conducted and exciting research that highlights the importance of studying the genetics of diverse populations,” said Miriam Udler, MD, PhD, director of the Massachusetts General Diabetes Genetics Clinic, and assistant professor at Harvard University, both in Boston. “This manuscript builds on prior work from the researchers identifying another genetic variant specific to the Greenlandic Inuit population in the gene TBC1D4,” she added. “About 3.8% of people in this population carry two copies of the TBC1D4 variant and have about a 10-fold increased risk of diabetes. Together the two variants affect 18% of Greenlanders with diabetes.”

With its fourfold increased risk of diabetes, the new variant falls into “an ever-growing category” of “intermediate risk” genetic variants, explained Dr. Udler – “meaning that they have a large impact on diabetes risk, but cannot fully predict whether someone will get diabetes. The contribution of additional risk factors is particularly important for ‘intermediate risk’ genetic variants,” she added. “Thus, clinically, we can tell patients who have variants such as HNF1A c.1108>T that they are at substantial increased risk of diabetes, but that many will not develop diabetes. And for those who do develop diabetes, we are not yet able to advise on particular therapeutic strategies.”

Still, she emphasized, the importance of studying diverse populations with specific genetic risk factors is the end-goal of precision medicine. “An active area of research is determining whether and how to return such information about ‘intermediate risk’ variants to patients who get clinical genetic testing for diabetes, since typically only variants that are very high risk ... are returned in clinical testing reports.” Dr. Udler added that “many more such “intermediate risk’ variants likely exist in all populations, but have yet to be characterized because they are less common than HNF1A c.1108>T; however, ongoing worldwide efforts to increase the sample sizes of human genetic studies will facilitate such discovery.”

The study was funded by Novo Nordisk Foundation, Independent Research Fund Denmark, and Karen Elise Jensen’s Foundation. Dr. Hansen and Dr. Udler had no disclosures.
 

A newly discovered genetic variant that is associated with type 2 diabetes (T2D) is responsible for almost 7% of all diabetes cases in Greenland, according to a whole-genome sequencing analysis of 448 Greenlandic Inuit individuals.

The variant, identified as c.1108G>T, “has the largest population impact of any previously reported variant” within the HNF1A gene – a gene that can cause maturity-onset diabetes of the young (MODY), reported senior author Torben Hansen, MD, PhD, of the University of Copenhagen, and colleagues in The Lancet Regional Health–Europe. The c.1108G>T variant does not cause MODY, but other variants within the HNF1A gene do. However, carriers of this variant, which is present in 1.9% of the Greenlandic Inuit population and has not been found elsewhere, have normal insulin sensitivity, but decreased beta-cell function and a more than fourfold risk of developing type 2 diabetes. “This adds to a previous discovery that about 11% of all diabetes in Greenlandic Inuit is explained by a mutation in the TBC1D4 variant,” Dr. Hansen told this publication. “Thus 1 in 5 patients diagnosed with type 2 diabetes in Greenland have a specific mutation explaining their diabetes. In European populations only about 1%-2% of patients diagnosed with type 2 diabetes have a known genetic etiology.”

The finding “provides new avenues to subgroup patients, detect diabetes in family members, and pursue precision treatment trials,” noted the authors, although they acknowledged that treatment choices for individuals with this variant still need to be explored. “We know from HNF1A-mutation carriers with European ancestry that they benefit from sulfonylurea treatment,” said Dr. Hansen. “However, we have not yet done treatment studies in Inuit.” The investigators noted that “it is not always the case that variants in HNF1A result in an increased insulin secretory response to sulfonylurea. ... Whether carriers of the c.1108G>T variant could benefit from treatment with sulfonylurea should be pursued within the context of a randomized clinical trial establishing both short- and long-term efficacy of sulfonylurea in these patients.”

A total of 4,497 study participants were randomly sampled from two cross-sectional cohorts in an adult Greenlandic population health survey. Among 448 participants who had whole genome sequencing, 14 known MODY genes were screened for both previously identified as well as novel variants. This identified the c.1108G>T variant, which was then genotyped in the full cohort in order to estimate an allele frequency of 1.3% in the general Greenlandic population, and 1.9% in the Inuit component. The variant was not found in genome sequences of other populations.

The researchers then tested the association of the variant with T2D and showed strong association with T2D (odds ratio, 4.35) and higher hemoglobin A1c levels.

“This is very well-conducted and exciting research that highlights the importance of studying the genetics of diverse populations,” said Miriam Udler, MD, PhD, director of the Massachusetts General Diabetes Genetics Clinic, and assistant professor at Harvard University, both in Boston. “This manuscript builds on prior work from the researchers identifying another genetic variant specific to the Greenlandic Inuit population in the gene TBC1D4,” she added. “About 3.8% of people in this population carry two copies of the TBC1D4 variant and have about a 10-fold increased risk of diabetes. Together the two variants affect 18% of Greenlanders with diabetes.”

With its fourfold increased risk of diabetes, the new variant falls into “an ever-growing category” of “intermediate risk” genetic variants, explained Dr. Udler – “meaning that they have a large impact on diabetes risk, but cannot fully predict whether someone will get diabetes. The contribution of additional risk factors is particularly important for ‘intermediate risk’ genetic variants,” she added. “Thus, clinically, we can tell patients who have variants such as HNF1A c.1108>T that they are at substantial increased risk of diabetes, but that many will not develop diabetes. And for those who do develop diabetes, we are not yet able to advise on particular therapeutic strategies.”

Still, she emphasized, the importance of studying diverse populations with specific genetic risk factors is the end-goal of precision medicine. “An active area of research is determining whether and how to return such information about ‘intermediate risk’ variants to patients who get clinical genetic testing for diabetes, since typically only variants that are very high risk ... are returned in clinical testing reports.” Dr. Udler added that “many more such “intermediate risk’ variants likely exist in all populations, but have yet to be characterized because they are less common than HNF1A c.1108>T; however, ongoing worldwide efforts to increase the sample sizes of human genetic studies will facilitate such discovery.”

The study was funded by Novo Nordisk Foundation, Independent Research Fund Denmark, and Karen Elise Jensen’s Foundation. Dr. Hansen and Dr. Udler had no disclosures.
 

A newly discovered genetic variant that is associated with type 2 diabetes (T2D) is responsible for almost 7% of all diabetes cases in Greenland, according to a whole-genome sequencing analysis of 448 Greenlandic Inuit individuals.

The variant, identified as c.1108G>T, “has the largest population impact of any previously reported variant” within the HNF1A gene – a gene that can cause maturity-onset diabetes of the young (MODY), reported senior author Torben Hansen, MD, PhD, of the University of Copenhagen, and colleagues in The Lancet Regional Health–Europe. The c.1108G>T variant does not cause MODY, but other variants within the HNF1A gene do. However, carriers of this variant, which is present in 1.9% of the Greenlandic Inuit population and has not been found elsewhere, have normal insulin sensitivity, but decreased beta-cell function and a more than fourfold risk of developing type 2 diabetes. “This adds to a previous discovery that about 11% of all diabetes in Greenlandic Inuit is explained by a mutation in the TBC1D4 variant,” Dr. Hansen told this publication. “Thus 1 in 5 patients diagnosed with type 2 diabetes in Greenland have a specific mutation explaining their diabetes. In European populations only about 1%-2% of patients diagnosed with type 2 diabetes have a known genetic etiology.”

The finding “provides new avenues to subgroup patients, detect diabetes in family members, and pursue precision treatment trials,” noted the authors, although they acknowledged that treatment choices for individuals with this variant still need to be explored. “We know from HNF1A-mutation carriers with European ancestry that they benefit from sulfonylurea treatment,” said Dr. Hansen. “However, we have not yet done treatment studies in Inuit.” The investigators noted that “it is not always the case that variants in HNF1A result in an increased insulin secretory response to sulfonylurea. ... Whether carriers of the c.1108G>T variant could benefit from treatment with sulfonylurea should be pursued within the context of a randomized clinical trial establishing both short- and long-term efficacy of sulfonylurea in these patients.”

A total of 4,497 study participants were randomly sampled from two cross-sectional cohorts in an adult Greenlandic population health survey. Among 448 participants who had whole genome sequencing, 14 known MODY genes were screened for both previously identified as well as novel variants. This identified the c.1108G>T variant, which was then genotyped in the full cohort in order to estimate an allele frequency of 1.3% in the general Greenlandic population, and 1.9% in the Inuit component. The variant was not found in genome sequences of other populations.

The researchers then tested the association of the variant with T2D and showed strong association with T2D (odds ratio, 4.35) and higher hemoglobin A1c levels.

“This is very well-conducted and exciting research that highlights the importance of studying the genetics of diverse populations,” said Miriam Udler, MD, PhD, director of the Massachusetts General Diabetes Genetics Clinic, and assistant professor at Harvard University, both in Boston. “This manuscript builds on prior work from the researchers identifying another genetic variant specific to the Greenlandic Inuit population in the gene TBC1D4,” she added. “About 3.8% of people in this population carry two copies of the TBC1D4 variant and have about a 10-fold increased risk of diabetes. Together the two variants affect 18% of Greenlanders with diabetes.”

With its fourfold increased risk of diabetes, the new variant falls into “an ever-growing category” of “intermediate risk” genetic variants, explained Dr. Udler – “meaning that they have a large impact on diabetes risk, but cannot fully predict whether someone will get diabetes. The contribution of additional risk factors is particularly important for ‘intermediate risk’ genetic variants,” she added. “Thus, clinically, we can tell patients who have variants such as HNF1A c.1108>T that they are at substantial increased risk of diabetes, but that many will not develop diabetes. And for those who do develop diabetes, we are not yet able to advise on particular therapeutic strategies.”

Still, she emphasized, the importance of studying diverse populations with specific genetic risk factors is the end-goal of precision medicine. “An active area of research is determining whether and how to return such information about ‘intermediate risk’ variants to patients who get clinical genetic testing for diabetes, since typically only variants that are very high risk ... are returned in clinical testing reports.” Dr. Udler added that “many more such “intermediate risk’ variants likely exist in all populations, but have yet to be characterized because they are less common than HNF1A c.1108>T; however, ongoing worldwide efforts to increase the sample sizes of human genetic studies will facilitate such discovery.”

The study was funded by Novo Nordisk Foundation, Independent Research Fund Denmark, and Karen Elise Jensen’s Foundation. Dr. Hansen and Dr. Udler had no disclosures.
 

TAMPA – People living with HIV (PLWH) were more likely than other populations to get vaccinated for flu and COVID-19, to seek reputable sources of information, and to be connected through essential community organizations that share essential health and wellness information, according to the results of a large survey.

PLWH, therefore, would have been an ideal model population for creating and disseminating effective messaging around COVID-19 immunizations earlier in the pandemic, said Kathleen Gallagher, MPH, an epidemiologist, researcher, and health services administrator at the Patient Advocate Foundation.

The PLWH community can still offer valuable insights into effective ways to reach out to people, to disseminate correct information, and to link people with resources, Ms. Gallagher said during a poster presentation at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

In addition, the PLWH response to the pandemic illustrates the importance of community. Local, community-based organizations “are the people that these individuals trust, they are people entrenched in their community, and they have existing relationships with them in terms of getting vaccinated and listening to their concerns,” Ms. Gallagher said.

“It’s a missed opportunity.”
 

A highly compliant group

The July 2021 survey of 271 PLWH was part of a larger, longitudinal survey of 1,400 people with any chronic illness asked about attitudes and barriers to vaccination. The PLWH population was important to focus on, the researchers note, because they could be potentially high risk for more serious COVID-19 outcomes.

The PLWH group was 81% White and 90% male, and 83% were age 56 or older. In addition, 86% had an annual household income below $48,000.

Ninety-three percent of the PLWH group had had flu vaccination in the prior 3 years and received at least one COVID-19 vaccination.
 

Unable vs. unwilling to vaccinate

Ms. Gallagher and colleagues found 12 people (4%) in the PLWH group did not get vaccinated against COVID-19. It’s a small number, “so you have to take this with a grain of salt,” she said. “But we asked them why they were hesitant. They either were unable or unwilling – and the unable part is not surprising.”

Those who were unable to get vaccinated were either homebound or had concerns about being in a clinic where they could be exposed to COVID while waiting to get the vaccine.

“And then there were some who were just not willing” to get vaccinated, Ms. Gallagher said. She added most cited vaccine safety concerns and “a lot of the misinformation or confusing information around efficacy.”
 

Trusted information sources

Although people reported getting COVID-19 vaccine information from multiple sources, including online and from television, 64% or nearly two-thirds sought information from their doctors or health care teams.

In fact, doctors emerged as the most trusted source, as indicated by 72% of PLWH.

“I was a little surprised that doctors scored so highly because, sometimes in other cohorts that we looked at, it wasn’t the case,” Ms. Gallagher said. However, she added, a lot of PLWH “have a very strong trust bond with their provider because this is a very personal, very sensitive diagnosis.”

How did social media score? “A whopping 1%,” she said. “So at least this was a savvy group, and they realized that that was not the place to go for vaccination information.”
 

Overcoming barriers

A lack of vaccine availability at the time of their appointment was the number one barrier to immunization. Also, a small number of people said knowing someone who had an adverse reaction to COVID-19 vaccination was a barrier for them. Ms. Gallagher explained that, by definition in the survey, an adverse reaction to vaccination had to be serious enough to drive people to seek medical care.

When asked to comment on the poster, Andrew Komensky, RN, told this news organization that he found the results “interesting, because I’m an infection preventionist, in addition to being an HIV nurse.” He is director of infection prevention and control at CharterCARE Health Partners, Providence, R.I.

Mr. Komensky said he was surprised that a high proportion of PLWH cited their doctor – and not their nurse – as the most trusted source of information. “In my experience in COVID care ... it was a nursing staff who had most of the contact with patients, who did most of the education, and provided most of the information surrounding vaccination and potential side effects.”

It made sense to Mr. Komensky that the PLWH population would be compliant with vaccinations. “People who are living with HIV do everything they possibly can just to stay healthy.”

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

TAMPA – People living with HIV (PLWH) were more likely than other populations to get vaccinated for flu and COVID-19, to seek reputable sources of information, and to be connected through essential community organizations that share essential health and wellness information, according to the results of a large survey.

PLWH, therefore, would have been an ideal model population for creating and disseminating effective messaging around COVID-19 immunizations earlier in the pandemic, said Kathleen Gallagher, MPH, an epidemiologist, researcher, and health services administrator at the Patient Advocate Foundation.

The PLWH community can still offer valuable insights into effective ways to reach out to people, to disseminate correct information, and to link people with resources, Ms. Gallagher said during a poster presentation at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

In addition, the PLWH response to the pandemic illustrates the importance of community. Local, community-based organizations “are the people that these individuals trust, they are people entrenched in their community, and they have existing relationships with them in terms of getting vaccinated and listening to their concerns,” Ms. Gallagher said.

“It’s a missed opportunity.”
 

A highly compliant group

The July 2021 survey of 271 PLWH was part of a larger, longitudinal survey of 1,400 people with any chronic illness asked about attitudes and barriers to vaccination. The PLWH population was important to focus on, the researchers note, because they could be potentially high risk for more serious COVID-19 outcomes.

The PLWH group was 81% White and 90% male, and 83% were age 56 or older. In addition, 86% had an annual household income below $48,000.

Ninety-three percent of the PLWH group had had flu vaccination in the prior 3 years and received at least one COVID-19 vaccination.
 

Unable vs. unwilling to vaccinate

Ms. Gallagher and colleagues found 12 people (4%) in the PLWH group did not get vaccinated against COVID-19. It’s a small number, “so you have to take this with a grain of salt,” she said. “But we asked them why they were hesitant. They either were unable or unwilling – and the unable part is not surprising.”

Those who were unable to get vaccinated were either homebound or had concerns about being in a clinic where they could be exposed to COVID while waiting to get the vaccine.

“And then there were some who were just not willing” to get vaccinated, Ms. Gallagher said. She added most cited vaccine safety concerns and “a lot of the misinformation or confusing information around efficacy.”
 

Trusted information sources

Although people reported getting COVID-19 vaccine information from multiple sources, including online and from television, 64% or nearly two-thirds sought information from their doctors or health care teams.

In fact, doctors emerged as the most trusted source, as indicated by 72% of PLWH.

“I was a little surprised that doctors scored so highly because, sometimes in other cohorts that we looked at, it wasn’t the case,” Ms. Gallagher said. However, she added, a lot of PLWH “have a very strong trust bond with their provider because this is a very personal, very sensitive diagnosis.”

How did social media score? “A whopping 1%,” she said. “So at least this was a savvy group, and they realized that that was not the place to go for vaccination information.”
 

Overcoming barriers

A lack of vaccine availability at the time of their appointment was the number one barrier to immunization. Also, a small number of people said knowing someone who had an adverse reaction to COVID-19 vaccination was a barrier for them. Ms. Gallagher explained that, by definition in the survey, an adverse reaction to vaccination had to be serious enough to drive people to seek medical care.

When asked to comment on the poster, Andrew Komensky, RN, told this news organization that he found the results “interesting, because I’m an infection preventionist, in addition to being an HIV nurse.” He is director of infection prevention and control at CharterCARE Health Partners, Providence, R.I.

Mr. Komensky said he was surprised that a high proportion of PLWH cited their doctor – and not their nurse – as the most trusted source of information. “In my experience in COVID care ... it was a nursing staff who had most of the contact with patients, who did most of the education, and provided most of the information surrounding vaccination and potential side effects.”

It made sense to Mr. Komensky that the PLWH population would be compliant with vaccinations. “People who are living with HIV do everything they possibly can just to stay healthy.”

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

TAMPA – People living with HIV (PLWH) were more likely than other populations to get vaccinated for flu and COVID-19, to seek reputable sources of information, and to be connected through essential community organizations that share essential health and wellness information, according to the results of a large survey.

PLWH, therefore, would have been an ideal model population for creating and disseminating effective messaging around COVID-19 immunizations earlier in the pandemic, said Kathleen Gallagher, MPH, an epidemiologist, researcher, and health services administrator at the Patient Advocate Foundation.

The PLWH community can still offer valuable insights into effective ways to reach out to people, to disseminate correct information, and to link people with resources, Ms. Gallagher said during a poster presentation at the annual meeting of the Association of Nurses in AIDS Care (ANAC).

In addition, the PLWH response to the pandemic illustrates the importance of community. Local, community-based organizations “are the people that these individuals trust, they are people entrenched in their community, and they have existing relationships with them in terms of getting vaccinated and listening to their concerns,” Ms. Gallagher said.

“It’s a missed opportunity.”
 

A highly compliant group

The July 2021 survey of 271 PLWH was part of a larger, longitudinal survey of 1,400 people with any chronic illness asked about attitudes and barriers to vaccination. The PLWH population was important to focus on, the researchers note, because they could be potentially high risk for more serious COVID-19 outcomes.

The PLWH group was 81% White and 90% male, and 83% were age 56 or older. In addition, 86% had an annual household income below $48,000.

Ninety-three percent of the PLWH group had had flu vaccination in the prior 3 years and received at least one COVID-19 vaccination.
 

Unable vs. unwilling to vaccinate

Ms. Gallagher and colleagues found 12 people (4%) in the PLWH group did not get vaccinated against COVID-19. It’s a small number, “so you have to take this with a grain of salt,” she said. “But we asked them why they were hesitant. They either were unable or unwilling – and the unable part is not surprising.”

Those who were unable to get vaccinated were either homebound or had concerns about being in a clinic where they could be exposed to COVID while waiting to get the vaccine.

“And then there were some who were just not willing” to get vaccinated, Ms. Gallagher said. She added most cited vaccine safety concerns and “a lot of the misinformation or confusing information around efficacy.”
 

Trusted information sources

Although people reported getting COVID-19 vaccine information from multiple sources, including online and from television, 64% or nearly two-thirds sought information from their doctors or health care teams.

In fact, doctors emerged as the most trusted source, as indicated by 72% of PLWH.

“I was a little surprised that doctors scored so highly because, sometimes in other cohorts that we looked at, it wasn’t the case,” Ms. Gallagher said. However, she added, a lot of PLWH “have a very strong trust bond with their provider because this is a very personal, very sensitive diagnosis.”

How did social media score? “A whopping 1%,” she said. “So at least this was a savvy group, and they realized that that was not the place to go for vaccination information.”
 

Overcoming barriers

A lack of vaccine availability at the time of their appointment was the number one barrier to immunization. Also, a small number of people said knowing someone who had an adverse reaction to COVID-19 vaccination was a barrier for them. Ms. Gallagher explained that, by definition in the survey, an adverse reaction to vaccination had to be serious enough to drive people to seek medical care.

When asked to comment on the poster, Andrew Komensky, RN, told this news organization that he found the results “interesting, because I’m an infection preventionist, in addition to being an HIV nurse.” He is director of infection prevention and control at CharterCARE Health Partners, Providence, R.I.

Mr. Komensky said he was surprised that a high proportion of PLWH cited their doctor – and not their nurse – as the most trusted source of information. “In my experience in COVID care ... it was a nursing staff who had most of the contact with patients, who did most of the education, and provided most of the information surrounding vaccination and potential side effects.”

It made sense to Mr. Komensky that the PLWH population would be compliant with vaccinations. “People who are living with HIV do everything they possibly can just to stay healthy.”

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

TAMPA – Screening and recommending preexposure prophylaxis (PrEP) to people at risk for HIV exposure could be more successful if education and access to the preventive protocol is offered during testing for sexually transmitted infections (STIs).

It comes down to numbers, said Gabriela Brito, MSN, RN, ACRN, a researcher at nonprofit CAN Community Health, headquartered in Sarasota, Fla. More people seek screening for STIs compared with those who actively seek PrEP for HIV prevention.

“One out of five individuals got tested and were diagnosed with an STI in 2021, so we can capture a huge amount of people just from STI testing and direct them to PrEP programs,” Ms. Brito said in an interview during a poster presentation here at the annual meeting of the Association of Nurses in AIDS Care (ANAC). “So our initiative is pretty much about capturing people” at the point of care.

Ms. Brito reported that as of September 30, 2022, 2,174 patients were receiving PrEP services through one of 40 CAN Community Health clinics. Nearly one-third, 32%, were initially seen for free STI screening.
 

Striving for better adherence

In some cases, the issue is not starting people on PrEP, it’s keeping them on the regimen over time. The study revealed that 61% of the people were still taking the medication at 6 months.

This figure might have been even lower without CAN Community Health PrEP navigators. Of the 2,174 patients, 63% work with a “PrEP navigator.” These navigators help people access the medication and check in with them on a regular basis to address any questions or reasons behind a lack of adherence.

“If we’re seeing someone’s missing their appointments, our PrEP navigator will start reaching out to them to see what’s going on,” study coauthor Cheryl Netherly, BSW, LPN, ACLPN, said in an interview.

“It could be they moved to a different area or entered a mutually monogamous relationship. They don’t realize they can continue through telehealth if they need to, because sometimes it is hard to get off of work to go [see] the doctor,” Ms. Netherly added. “So we find ways to break those barriers.”
 

More education needed

Greater awareness around PrEP is another issue. “I think educating people and educating professionals, it’s really crucial. It can also help diminish the stigma around PrEP,” Ms. Brito said.

An analogy is when birth control pills first came out, and some providers would not prescribe them because they were concerned women would be promiscuous, Ms. Netherly said.

“When PrEP first came out, there was a lot of that same mindset,” Ms. Netherly added. “But PrEP does not change your behavior. It’s just adding a layer of protection to the behavior, so you can understand how to keep yourself healthy.”
 

A primary care tenet

The strategy of identifying potential PrEP candidates during STI screening is “extremely important,” Myra L. Rutland, CPN, DNP, FNP-BC, a family nurse practitioner and director for infectious disease and community outreach at Spectrum Community Health Center in Philadelphia, said when asked to comment. Ms. Rutland was not involved in the CAN Community Health study.

“This is primary care at its most generic level. Primary care means that you intervene before there’s a problem,” Ms. Rutland said.

“We have great medications. Now if patients are adherent to the medication, they are not just a little bit effective – they are between 95% and 99% effective at preventing HIV,” she added.

The goal is to increase awareness that “if you contract any type of sexual transmitted infection ... that means that perhaps you may have come in contact with HIV,” Ms. Rutland said. “So why not offer PrEP? I do that with all of my patients.”

The study was independently supported. Ms. Brito and Ms. Rutland report no relevant financial relationships.

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

Patients with mild to moderate atopic dermatitis (AD) who were treated with topical brepocitinib had a significant improvement in their Eczema Area and Severity Index score at 6 weeks compared with a group that received vehicle, in a recently published study..

The investigators said that brepocitinib, an investigational dual tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) inhibitor, was effective and well tolerated in patients with mild to moderate AD based on improvements in multiple measures, including Eczema Area and Severity Index (EASI) total score and Investigator Global Assessment (IGA) responder rates. Brepocitinib also reduced pruritus symptoms as early as 2 days after the start of treatment, they noted.

“This study supports the further evaluation of topical brepocitinib as a novel treatment for mild to moderate AD,” Megan N. Landis, MD, of the department of medicine at the University of Louisville (Ky.) and colleagues wrote in the study published in the British Journal of Dermatology.

They evaluated brepocitinib in a phase 2b, double-blind, dose-ranging study where 292 patients were randomized to receive brepocitinib once daily (brepocitinib 0.1%, 0.3%, 1.0%, 3.0%) or twice daily (brepocitinib 0.3%, 1.0%), or vehicle for 6 weeks. At 6 weeks, the researchers assessed EASI total score as a primary outcome, an IGA score of 0 or 1 as a secondary outcome. The mean age of the patients was 40 years (range, 13-74), almost 60% were White, 17.5% were Black, and about 20% were Asian.

Compared with the corresponding once-daily vehicle group (least squares mean reduction of –44.4; 90% confidence interval, –57.3 to –31.6) and the twice-daily vehicle group (LSM, –47.6; 90% CI, –57.5 to –37.7) , the brepocitinib 1% once-daily group (LSM, –70.1; 90% CI, –82.1 to –58.0) and twice-daily group (LSM, –75.0; 90% CI, –83.8 to –66.2) had significant percentage reductions in EASI total score compared with baseline at 6 weeks. Patients in the other brepocitinib dose groups had nonsignificant reductions in EASI from baseline.

Regarding secondary outcomes, a significantly higher percentage of patients in five of the six active treatment groups achieved an IGA score of 0 or 1 and at least a 2-point reduction in IGA score in the once-daily brepocitinib 0.1% group (29.7%; 90% CI, 18.5%-43.3%), 0.3% group (33.3%; 90% CI, 21.3%-47.0%), 1.0% group (40.5%; 90% CI, 28.0%-54.4%), 3.0% group (44.4%; 90% CI, 30.2%-59.1%), and brepocitinib 0.3% twice-daily group (33.3%; 90% CI, 21.3%-47.0%) compared with the once-daily (10.8%; 90% CI, 4.8%-22.2%) and twice-daily (13.9%; 90% CI, 6.9%-25.4%) vehicle groups.

The study authors noted that 37.0% of patients overall experienced treatment-emergent adverse events (TEAEs), with most TEAEs occurring in the once-daily vehicle (48.6%), twice-daily vehicle (47.2%), and brepocitinib 0.1% (45.9%) groups. Adverse events were not considered dose dependent, and no group had any serious TEAEs or deaths.

Nasopharyngitis and worsening AD were the most common TEAEs reported, with about 8% of those in the vehicle groups experiencing worsening AD.

Brepocitinib is also currently being developed as a treatment for dermatomyositis, systemic lupus erythematosus, hidradenitis suppurativa, and noninfectious uveitis by Priovant Therapeutics, a company founded by Pfizer and Roivant Sciences.

In September 2021, the Food and Drug Administration approved topical ruxolitinib cream for the treatment of patients with mild to moderate atopic dermatitis aged 12 years and older, the first topical JAK inhibitor approved for AD.

This study was sponsored by Pfizer. The authors reported personal and institutional relationships in the form of investigator positions, fees, honoraria, research grants, employee positions, and holding stock or shares for a variety of pharmaceutical, life science, and biotechnology companies.

Patients with mild to moderate atopic dermatitis (AD) who were treated with topical brepocitinib had a significant improvement in their Eczema Area and Severity Index score at 6 weeks compared with a group that received vehicle, in a recently published study..

The investigators said that brepocitinib, an investigational dual tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) inhibitor, was effective and well tolerated in patients with mild to moderate AD based on improvements in multiple measures, including Eczema Area and Severity Index (EASI) total score and Investigator Global Assessment (IGA) responder rates. Brepocitinib also reduced pruritus symptoms as early as 2 days after the start of treatment, they noted.

“This study supports the further evaluation of topical brepocitinib as a novel treatment for mild to moderate AD,” Megan N. Landis, MD, of the department of medicine at the University of Louisville (Ky.) and colleagues wrote in the study published in the British Journal of Dermatology.

They evaluated brepocitinib in a phase 2b, double-blind, dose-ranging study where 292 patients were randomized to receive brepocitinib once daily (brepocitinib 0.1%, 0.3%, 1.0%, 3.0%) or twice daily (brepocitinib 0.3%, 1.0%), or vehicle for 6 weeks. At 6 weeks, the researchers assessed EASI total score as a primary outcome, an IGA score of 0 or 1 as a secondary outcome. The mean age of the patients was 40 years (range, 13-74), almost 60% were White, 17.5% were Black, and about 20% were Asian.

Compared with the corresponding once-daily vehicle group (least squares mean reduction of –44.4; 90% confidence interval, –57.3 to –31.6) and the twice-daily vehicle group (LSM, –47.6; 90% CI, –57.5 to –37.7) , the brepocitinib 1% once-daily group (LSM, –70.1; 90% CI, –82.1 to –58.0) and twice-daily group (LSM, –75.0; 90% CI, –83.8 to –66.2) had significant percentage reductions in EASI total score compared with baseline at 6 weeks. Patients in the other brepocitinib dose groups had nonsignificant reductions in EASI from baseline.

Regarding secondary outcomes, a significantly higher percentage of patients in five of the six active treatment groups achieved an IGA score of 0 or 1 and at least a 2-point reduction in IGA score in the once-daily brepocitinib 0.1% group (29.7%; 90% CI, 18.5%-43.3%), 0.3% group (33.3%; 90% CI, 21.3%-47.0%), 1.0% group (40.5%; 90% CI, 28.0%-54.4%), 3.0% group (44.4%; 90% CI, 30.2%-59.1%), and brepocitinib 0.3% twice-daily group (33.3%; 90% CI, 21.3%-47.0%) compared with the once-daily (10.8%; 90% CI, 4.8%-22.2%) and twice-daily (13.9%; 90% CI, 6.9%-25.4%) vehicle groups.

The study authors noted that 37.0% of patients overall experienced treatment-emergent adverse events (TEAEs), with most TEAEs occurring in the once-daily vehicle (48.6%), twice-daily vehicle (47.2%), and brepocitinib 0.1% (45.9%) groups. Adverse events were not considered dose dependent, and no group had any serious TEAEs or deaths.

Nasopharyngitis and worsening AD were the most common TEAEs reported, with about 8% of those in the vehicle groups experiencing worsening AD.

Brepocitinib is also currently being developed as a treatment for dermatomyositis, systemic lupus erythematosus, hidradenitis suppurativa, and noninfectious uveitis by Priovant Therapeutics, a company founded by Pfizer and Roivant Sciences.

In September 2021, the Food and Drug Administration approved topical ruxolitinib cream for the treatment of patients with mild to moderate atopic dermatitis aged 12 years and older, the first topical JAK inhibitor approved for AD.

This study was sponsored by Pfizer. The authors reported personal and institutional relationships in the form of investigator positions, fees, honoraria, research grants, employee positions, and holding stock or shares for a variety of pharmaceutical, life science, and biotechnology companies.

Patients with mild to moderate atopic dermatitis (AD) who were treated with topical brepocitinib had a significant improvement in their Eczema Area and Severity Index score at 6 weeks compared with a group that received vehicle, in a recently published study..

The investigators said that brepocitinib, an investigational dual tyrosine kinase 2 (TYK2) and Janus kinase 1 (JAK1) inhibitor, was effective and well tolerated in patients with mild to moderate AD based on improvements in multiple measures, including Eczema Area and Severity Index (EASI) total score and Investigator Global Assessment (IGA) responder rates. Brepocitinib also reduced pruritus symptoms as early as 2 days after the start of treatment, they noted.

“This study supports the further evaluation of topical brepocitinib as a novel treatment for mild to moderate AD,” Megan N. Landis, MD, of the department of medicine at the University of Louisville (Ky.) and colleagues wrote in the study published in the British Journal of Dermatology.

They evaluated brepocitinib in a phase 2b, double-blind, dose-ranging study where 292 patients were randomized to receive brepocitinib once daily (brepocitinib 0.1%, 0.3%, 1.0%, 3.0%) or twice daily (brepocitinib 0.3%, 1.0%), or vehicle for 6 weeks. At 6 weeks, the researchers assessed EASI total score as a primary outcome, an IGA score of 0 or 1 as a secondary outcome. The mean age of the patients was 40 years (range, 13-74), almost 60% were White, 17.5% were Black, and about 20% were Asian.

Compared with the corresponding once-daily vehicle group (least squares mean reduction of –44.4; 90% confidence interval, –57.3 to –31.6) and the twice-daily vehicle group (LSM, –47.6; 90% CI, –57.5 to –37.7) , the brepocitinib 1% once-daily group (LSM, –70.1; 90% CI, –82.1 to –58.0) and twice-daily group (LSM, –75.0; 90% CI, –83.8 to –66.2) had significant percentage reductions in EASI total score compared with baseline at 6 weeks. Patients in the other brepocitinib dose groups had nonsignificant reductions in EASI from baseline.

Regarding secondary outcomes, a significantly higher percentage of patients in five of the six active treatment groups achieved an IGA score of 0 or 1 and at least a 2-point reduction in IGA score in the once-daily brepocitinib 0.1% group (29.7%; 90% CI, 18.5%-43.3%), 0.3% group (33.3%; 90% CI, 21.3%-47.0%), 1.0% group (40.5%; 90% CI, 28.0%-54.4%), 3.0% group (44.4%; 90% CI, 30.2%-59.1%), and brepocitinib 0.3% twice-daily group (33.3%; 90% CI, 21.3%-47.0%) compared with the once-daily (10.8%; 90% CI, 4.8%-22.2%) and twice-daily (13.9%; 90% CI, 6.9%-25.4%) vehicle groups.

The study authors noted that 37.0% of patients overall experienced treatment-emergent adverse events (TEAEs), with most TEAEs occurring in the once-daily vehicle (48.6%), twice-daily vehicle (47.2%), and brepocitinib 0.1% (45.9%) groups. Adverse events were not considered dose dependent, and no group had any serious TEAEs or deaths.

Nasopharyngitis and worsening AD were the most common TEAEs reported, with about 8% of those in the vehicle groups experiencing worsening AD.

Brepocitinib is also currently being developed as a treatment for dermatomyositis, systemic lupus erythematosus, hidradenitis suppurativa, and noninfectious uveitis by Priovant Therapeutics, a company founded by Pfizer and Roivant Sciences.

In September 2021, the Food and Drug Administration approved topical ruxolitinib cream for the treatment of patients with mild to moderate atopic dermatitis aged 12 years and older, the first topical JAK inhibitor approved for AD.

This study was sponsored by Pfizer. The authors reported personal and institutional relationships in the form of investigator positions, fees, honoraria, research grants, employee positions, and holding stock or shares for a variety of pharmaceutical, life science, and biotechnology companies.

Nearly 1 in 7 U.S. adults reported bloating symptoms in the past week, yet most didn’t seek help from a gastroenterologist or other health care professional, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.

The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.

“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.

Results of the survey are published online in Clinical Gastroenterology and Hepatology.
 

Common problem, incompletely understood

To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.

Altogether, 12,324 (14%) respondents reported bloating in the past week.

The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.

The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.

Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.

Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
 

Suffering in silence?

Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.

About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.

“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.

Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.

A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.

Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.

Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.

“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.

“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.

Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.

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

Nearly 1 in 7 U.S. adults reported bloating symptoms in the past week, yet most didn’t seek help from a gastroenterologist or other health care professional, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.

The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.

“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.

Results of the survey are published online in Clinical Gastroenterology and Hepatology.
 

Common problem, incompletely understood

To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.

Altogether, 12,324 (14%) respondents reported bloating in the past week.

The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.

The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.

Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.

Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
 

Suffering in silence?

Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.

About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.

“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.

Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.

A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.

Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.

Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.

“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.

“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.

Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.

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

Nearly 1 in 7 U.S. adults reported bloating symptoms in the past week, yet most didn’t seek help from a gastroenterologist or other health care professional, some of whom said they weren’t comfortable discussing it with their doctor, according to a large national survey.

The findings suggest doctors should “proactively” ask about bloating, especially in adults at increased risk, including women and those with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), the researchers say.

“Bloating is common because it usually has multifactorial causes and can also be a secondary symptom to another gastrointestinal (GI) symptom or condition. Its mechanisms are complex and individualized, making it difficult for providers to identify and treat each patient,” Janice E. Oh, MD, department of medicine, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“Thus, many adults may be persistently suffering without proper diagnosis or management,” Dr. Oh added.

Results of the survey are published online in Clinical Gastroenterology and Hepatology.
 

Common problem, incompletely understood

To get a better handle on the nationwide prevalence and health-related impact of bloating in the United States, Dr. Oh and her colleagues conducted an online survey of a nationally representative group of 88,795 adults aged 18 years or older.

Altogether, 12,324 (14%) respondents reported bloating in the past week.

The likelihood of bloating was significantly higher in women (odds ratio, 2.56) and in those with certain comorbid conditions, especially IBS, chronic constipation, and ulcerative colitis, the authors write.

The odds of bloating were also higher in adults with other concomitant GI symptoms, especially abdominal pain and excess gas.

Factors associated with more severe bloating included the presence of IBS, IBD, celiac disease, bowel incontinence, abdominal pain, constipation (functional and opioid-induced), and excess gas.

Bloating severity increased with age up to 59 years and then decreased in people aged 60 years or older.
 

Suffering in silence?

Notably, more than half (59%) of people who reported recent bloating never sought care for the problem. About one-third of them reported that bloating resolved on its own, and 30% said the symptoms were not bothersome.

About 1 in 5 adults who did not seek care said that they were managing symptoms on their own with over-the-counter medications or lifestyle modifications. And 9% of those who did not seek care said that they were uncomfortable discussing the problem with their doctor.

“The hesitancy in seeking health care or discussing bloating in patients may be attributed to lack of routine screening for bloating, lack of focus on bloating complaints by providers, or patients’ dissatisfaction with management of bloating symptoms,” the researchers say.

Adults most apt to seek care for bloating were those older than 29 years; non-Hispanic Black persons; those with comorbid conditions, such as celiac disease, IBD, and IBS; and those with more severe bloating symptoms.

A limitation is that individuals with GI symptoms or conditions may be more likely to participate in a GI-focused survey, leading to a possible overestimation of the prevalence of bloating.

Also, the survey was conducted during the COVID-19 pandemic, which has the potential to overestimate the prevalence or severity of bloating because COVID-19 is known to affect the GI system.

Despite these limitations, the researchers encourage health care professionals to routinely ask their patients about bloating as a first step in appropriate management.

“Bloating can be associated with nutrition/diet, the gut microbiome, anatomical issues, or underlying conditions that range from neurologic to gynecologic disorders. And, the majority of the time, it is usually more than one distinct issue that is attributing to the bloating,” Dr. Oh said.

“Understanding the patterns of bloating occurrence, psychosocial factors, past medical history, and nutrition can help providers determine the causes. We hope to identify a more standardized method to identify causes of bloating,” Dr. Oh added.

Support for the survey was provided by Ironwood Pharmaceuticals in the form of an institutional research grant to Cedars-Sinai. The authors have no relevant disclosures.

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

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

For the first time, the majority of people dying from COVID-19 in America have been vaccinated.

“We can no longer say this is a pandemic of the unvaccinated,” Kaiser Family Foundation Vice President Cynthia Cox, who conducted the analysis, told The Washington Post.

People who had been vaccinated or boosted made up 58% of COVID-19 deaths in August, the analysis showed. The rate has been on the rise: 23% of coronavirus deaths were among vaccinated people in September 2021, and the vaccinated made up 42% of deaths in January and February 2022, the Post reported.

Research continues to show that people who are vaccinated or boosted have a lower risk of death. The rise in deaths among the vaccinated is the result of three factors, Ms. Cox said.

• A large majority of people in the United States have been vaccinated (267 million people, the  said).
• People who are at the greatest risk of dying from COVID-19 are more likely to be vaccinated and boosted, such as the elderly.
• Vaccines lose their effectiveness over time; the virus changes to avoid vaccines; and people need to choose to get boosters to continue to be protected.

The case for the effectiveness of vaccines and boosters versus skipping the shots remains strong. People age 6 months and older who are unvaccinated are six times more likely to die of COVID-19, compared to those who got the primary series of shots, the Post reported. Survival rates were even better with additional booster shots, particularly among older people.

“I feel very confident that if people continue to get vaccinated at good numbers, if people get boosted, we can absolutely have a very safe and healthy holiday season,” Ashish Jha, White House coronavirus czar, said on Nov. 22.

The number of Americans who have gotten the most recent booster has been increasing ahead of the holidays. CDC data show that 12% of the U.S. population age 5 and older has received a booster.

A new study by a team of researchers from Harvard University and Yale University estimates that 94% of the U.S. population has been infected with COVID-19 at least once, leaving just 1 in 20 people who have never had the virus.

“Despite these high exposure numbers, there is still substantial population susceptibility to infection with an Omicron variant,” the authors wrote.

They said that if all states achieved the vaccination levels of Vermont, where 55% of people had at least one booster and 22% got a second one, there would be “an appreciable improvement in population immunity, with greater relative impact for protection against infection versus severe disease. This additional protection results from both the recovery of immunity lost due to waning and the increased effectiveness of the bivalent booster against Omicron infections.”

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

Strength training is the most effective form of exercise for reducing migraine, with high-intensity aerobics coming in second, and both beating top-line migraine medications topiramate and amitriptyline, new research suggests.

The new results should encourage clinicians to recommend patients with migraine engage in strength-training exercise whenever possible, study investigator Yohannes W. Woldeamanuel, MD, a physician-scientist and instructor, department of neurology and neurological sciences, Stanford (Calif.) University, told this news organization.

“Exercise is something patients can do all their lives and use it to prevent migraine attacks instead of taking daily medications or repetitive injections that have several adverse effects.”

The findings were published online in the Journal of Headache and Pain.
 

Head-to-head comparison

Several clinical trials have shown exercise is effective for migraine management, but to date, there have been no head-to-head comparisons of strength training and aerobic exercise, said Dr. Woldeamanuel.

This new study used a systematic review with network meta-analysis (NMA), which compares multiple interventions and ranks the efficacy of each one.

After a literature search, researchers included 21 clinical trials with an exercise regimen arm and a comparison control arm. All study data reported monthly frequency of migraine at baseline and at the end of the intervention.

The total combined sample size was 1,195 patients with migraine, who were a mean age of 35.5 years, with a female-to-male ratio of 6.7:1. All studies used International Classification of Headache Disorders (ICHD) criteria for migraine diagnosis.

The NMA provided 27 pairwise comparisons and 8 indirect comparisons. The pairwise comparisons provided direct evidence between the different interventions.

Researchers combined strength training, including weightlifting, with resistance training. Both modalities target muscles, while aerobic exercise targets cardiovascular health.

The average number of weeks was 9.3, 9.3, and 10.7, and the average number of hours per session for strength/resistance training, high-intensity aerobic exercise, and moderate-intensity aerobic exercise interventions was 50, 56, and 45.3, respectively.

The analysis showed all exercise interventions were more effective than the placebo groups in reducing the frequency of migraine. In terms of ranking, strength training came out on top, with a mean difference in monthly migraine days of −3.55 (95% confidence interval, −6.15 to −0.95) between the active and placebo groups.

Next was high-intensity aerobic exercise (−3.13; 95% CI, −5.28 to −0.97) and moderate-intensity aerobic exercise (−2.18; 95% CI, −3.25 to −1.11), followed by topiramate, placebo, and then amitriptyline.

Strength/resistance training was superior possibly because it targets muscle strengthening, particularly major muscles in the neck and shoulder area, which can be a source of the pain trigger, said Dr. Woldeamanuel. He added neck pain is highly comorbid with migraine.

Interestingly, patients doing exercises that focus on unaffected muscles – for example, squats – still get the benefits of less migraine burden, said Dr. Woldeamanuel.
 

Training recommendations

Strength training also increases or preserves lean muscle mass, which is associated with reduced migraine frequency. Research shows preservation of lean body mass combats central sensitization in various pain syndromes, said Dr. Woldeamanuel.

The superior effects of high- versus moderate-intensity aerobic exercise may be due to recruitment of endogenous molecules involved in exercise-mediated hypoalgesia (pain reduction).

The most common pathways are the opioid and endocannabinoid systems, although other systems are also likely involved, said Dr. Woldeamanuel. He noted migraine has been linked to a deficiency of both opioidergic and endocannabinoidergic signaling.

Dr. Woldeamanuel commented on the difficulty of comparing exercise interventions for patients with chronic versus episodic migraine, as many studies include both.

However, the two studies with moderate-intensity aerobic exercise exclusively involving patients with chronic migraine showed large effect sizes (Cohen’s d) of 0.80 and 1.10 in reducing monthly headache frequency.

Based on these new results and their own experience, the researchers recommend strength training start with 50% of repetition maximum (RM) with 2-3 sets of 12-15 repetitions three times a week along with 10 minutes of warm-up, stretching, and cool-down, totaling 45-60 minutes per session. Weight/resistance load can then be increased weekly by 5% of RM if the patient is capable of successfully completing three sets.

They also recommend including active recovery days (low-intensity exercise) between training days. All major muscles, including neck, shoulder, and upper limb muscles, should be trained in a rotation.

For high-intensity aerobic exercise, the authors recommend starting with interval training at 55% VO_2max (maximum respiratory capacity), or 50% HRmax (maximal heart rate) for 45-60 minutes per session, including 10 minutes of warm-up and cool-down, three times per week. The intensity can then be increased by 5%-10% each week to reach a maximum target of 80%-90% by week 12.

It is best for patients to start with a trainer for guidance and supervision, but once they master the routines, they can do the exercises independently, said Dr. Woldeamanuel.
 

Managing flare-ups

Headache flare-ups are normal during exercise, which may be caused by “boom and bust cycles” – exercising excessively when feeling good then completely stopping when feeling bad, said Dr. Woldeamanuel. He noted these flare-ups don’t mean “there’s something wrong with the brain or there’s some injury to muscles.”

The best way to manage such flare-ups is to use a pacing strategy that involves “not going overboard on good days and avoiding excessive rest on bad days,” the investigators note.

Dr. Woldeamanuel noted exercise is a lifestyle-based intervention; it not only helps reduce migraine attacks but also helps control other known comorbidities such as obesity and hypertension.

In a comment, Elizabeth Loder, MD, vice-chair, academic affairs, department of neurology, Brigham and Women’s Hospital, and professor of neurology, Harvard Medical School, both in Boston, said, “It’s useful to collect and summarize all of these studies, and to focus on helping patients and doctors understand the possible value of different kinds of exercise.”

The review was “well done,” said Dr. Loder, adding the researchers “have looked carefully at the quality of included studies.”

The study received support from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health. Dr. Woldeamanuel has reported no relevant financial relationships.

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

Strength training is the most effective form of exercise for reducing migraine, with high-intensity aerobics coming in second, and both beating top-line migraine medications topiramate and amitriptyline, new research suggests.

The new results should encourage clinicians to recommend patients with migraine engage in strength-training exercise whenever possible, study investigator Yohannes W. Woldeamanuel, MD, a physician-scientist and instructor, department of neurology and neurological sciences, Stanford (Calif.) University, told this news organization.

“Exercise is something patients can do all their lives and use it to prevent migraine attacks instead of taking daily medications or repetitive injections that have several adverse effects.”

The findings were published online in the Journal of Headache and Pain.
 

Head-to-head comparison

Several clinical trials have shown exercise is effective for migraine management, but to date, there have been no head-to-head comparisons of strength training and aerobic exercise, said Dr. Woldeamanuel.

This new study used a systematic review with network meta-analysis (NMA), which compares multiple interventions and ranks the efficacy of each one.

After a literature search, researchers included 21 clinical trials with an exercise regimen arm and a comparison control arm. All study data reported monthly frequency of migraine at baseline and at the end of the intervention.

The total combined sample size was 1,195 patients with migraine, who were a mean age of 35.5 years, with a female-to-male ratio of 6.7:1. All studies used International Classification of Headache Disorders (ICHD) criteria for migraine diagnosis.

The NMA provided 27 pairwise comparisons and 8 indirect comparisons. The pairwise comparisons provided direct evidence between the different interventions.

Researchers combined strength training, including weightlifting, with resistance training. Both modalities target muscles, while aerobic exercise targets cardiovascular health.

The average number of weeks was 9.3, 9.3, and 10.7, and the average number of hours per session for strength/resistance training, high-intensity aerobic exercise, and moderate-intensity aerobic exercise interventions was 50, 56, and 45.3, respectively.

The analysis showed all exercise interventions were more effective than the placebo groups in reducing the frequency of migraine. In terms of ranking, strength training came out on top, with a mean difference in monthly migraine days of −3.55 (95% confidence interval, −6.15 to −0.95) between the active and placebo groups.

Next was high-intensity aerobic exercise (−3.13; 95% CI, −5.28 to −0.97) and moderate-intensity aerobic exercise (−2.18; 95% CI, −3.25 to −1.11), followed by topiramate, placebo, and then amitriptyline.

Strength/resistance training was superior possibly because it targets muscle strengthening, particularly major muscles in the neck and shoulder area, which can be a source of the pain trigger, said Dr. Woldeamanuel. He added neck pain is highly comorbid with migraine.

Interestingly, patients doing exercises that focus on unaffected muscles – for example, squats – still get the benefits of less migraine burden, said Dr. Woldeamanuel.
 

Training recommendations

Strength training also increases or preserves lean muscle mass, which is associated with reduced migraine frequency. Research shows preservation of lean body mass combats central sensitization in various pain syndromes, said Dr. Woldeamanuel.

The superior effects of high- versus moderate-intensity aerobic exercise may be due to recruitment of endogenous molecules involved in exercise-mediated hypoalgesia (pain reduction).

The most common pathways are the opioid and endocannabinoid systems, although other systems are also likely involved, said Dr. Woldeamanuel. He noted migraine has been linked to a deficiency of both opioidergic and endocannabinoidergic signaling.

Dr. Woldeamanuel commented on the difficulty of comparing exercise interventions for patients with chronic versus episodic migraine, as many studies include both.

However, the two studies with moderate-intensity aerobic exercise exclusively involving patients with chronic migraine showed large effect sizes (Cohen’s d) of 0.80 and 1.10 in reducing monthly headache frequency.

Based on these new results and their own experience, the researchers recommend strength training start with 50% of repetition maximum (RM) with 2-3 sets of 12-15 repetitions three times a week along with 10 minutes of warm-up, stretching, and cool-down, totaling 45-60 minutes per session. Weight/resistance load can then be increased weekly by 5% of RM if the patient is capable of successfully completing three sets.

They also recommend including active recovery days (low-intensity exercise) between training days. All major muscles, including neck, shoulder, and upper limb muscles, should be trained in a rotation.

For high-intensity aerobic exercise, the authors recommend starting with interval training at 55% VO_2max (maximum respiratory capacity), or 50% HRmax (maximal heart rate) for 45-60 minutes per session, including 10 minutes of warm-up and cool-down, three times per week. The intensity can then be increased by 5%-10% each week to reach a maximum target of 80%-90% by week 12.

It is best for patients to start with a trainer for guidance and supervision, but once they master the routines, they can do the exercises independently, said Dr. Woldeamanuel.
 

Managing flare-ups

Headache flare-ups are normal during exercise, which may be caused by “boom and bust cycles” – exercising excessively when feeling good then completely stopping when feeling bad, said Dr. Woldeamanuel. He noted these flare-ups don’t mean “there’s something wrong with the brain or there’s some injury to muscles.”

The best way to manage such flare-ups is to use a pacing strategy that involves “not going overboard on good days and avoiding excessive rest on bad days,” the investigators note.

Dr. Woldeamanuel noted exercise is a lifestyle-based intervention; it not only helps reduce migraine attacks but also helps control other known comorbidities such as obesity and hypertension.

In a comment, Elizabeth Loder, MD, vice-chair, academic affairs, department of neurology, Brigham and Women’s Hospital, and professor of neurology, Harvard Medical School, both in Boston, said, “It’s useful to collect and summarize all of these studies, and to focus on helping patients and doctors understand the possible value of different kinds of exercise.”

The review was “well done,” said Dr. Loder, adding the researchers “have looked carefully at the quality of included studies.”

The study received support from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health. Dr. Woldeamanuel has reported no relevant financial relationships.

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

Strength training is the most effective form of exercise for reducing migraine, with high-intensity aerobics coming in second, and both beating top-line migraine medications topiramate and amitriptyline, new research suggests.

The new results should encourage clinicians to recommend patients with migraine engage in strength-training exercise whenever possible, study investigator Yohannes W. Woldeamanuel, MD, a physician-scientist and instructor, department of neurology and neurological sciences, Stanford (Calif.) University, told this news organization.

“Exercise is something patients can do all their lives and use it to prevent migraine attacks instead of taking daily medications or repetitive injections that have several adverse effects.”

The findings were published online in the Journal of Headache and Pain.
 

Head-to-head comparison

Several clinical trials have shown exercise is effective for migraine management, but to date, there have been no head-to-head comparisons of strength training and aerobic exercise, said Dr. Woldeamanuel.

This new study used a systematic review with network meta-analysis (NMA), which compares multiple interventions and ranks the efficacy of each one.

After a literature search, researchers included 21 clinical trials with an exercise regimen arm and a comparison control arm. All study data reported monthly frequency of migraine at baseline and at the end of the intervention.

The total combined sample size was 1,195 patients with migraine, who were a mean age of 35.5 years, with a female-to-male ratio of 6.7:1. All studies used International Classification of Headache Disorders (ICHD) criteria for migraine diagnosis.

The NMA provided 27 pairwise comparisons and 8 indirect comparisons. The pairwise comparisons provided direct evidence between the different interventions.

Researchers combined strength training, including weightlifting, with resistance training. Both modalities target muscles, while aerobic exercise targets cardiovascular health.

The average number of weeks was 9.3, 9.3, and 10.7, and the average number of hours per session for strength/resistance training, high-intensity aerobic exercise, and moderate-intensity aerobic exercise interventions was 50, 56, and 45.3, respectively.

The analysis showed all exercise interventions were more effective than the placebo groups in reducing the frequency of migraine. In terms of ranking, strength training came out on top, with a mean difference in monthly migraine days of −3.55 (95% confidence interval, −6.15 to −0.95) between the active and placebo groups.

Next was high-intensity aerobic exercise (−3.13; 95% CI, −5.28 to −0.97) and moderate-intensity aerobic exercise (−2.18; 95% CI, −3.25 to −1.11), followed by topiramate, placebo, and then amitriptyline.

Strength/resistance training was superior possibly because it targets muscle strengthening, particularly major muscles in the neck and shoulder area, which can be a source of the pain trigger, said Dr. Woldeamanuel. He added neck pain is highly comorbid with migraine.

Interestingly, patients doing exercises that focus on unaffected muscles – for example, squats – still get the benefits of less migraine burden, said Dr. Woldeamanuel.
 

Training recommendations

Strength training also increases or preserves lean muscle mass, which is associated with reduced migraine frequency. Research shows preservation of lean body mass combats central sensitization in various pain syndromes, said Dr. Woldeamanuel.

The superior effects of high- versus moderate-intensity aerobic exercise may be due to recruitment of endogenous molecules involved in exercise-mediated hypoalgesia (pain reduction).

The most common pathways are the opioid and endocannabinoid systems, although other systems are also likely involved, said Dr. Woldeamanuel. He noted migraine has been linked to a deficiency of both opioidergic and endocannabinoidergic signaling.

Dr. Woldeamanuel commented on the difficulty of comparing exercise interventions for patients with chronic versus episodic migraine, as many studies include both.

However, the two studies with moderate-intensity aerobic exercise exclusively involving patients with chronic migraine showed large effect sizes (Cohen’s d) of 0.80 and 1.10 in reducing monthly headache frequency.

Based on these new results and their own experience, the researchers recommend strength training start with 50% of repetition maximum (RM) with 2-3 sets of 12-15 repetitions three times a week along with 10 minutes of warm-up, stretching, and cool-down, totaling 45-60 minutes per session. Weight/resistance load can then be increased weekly by 5% of RM if the patient is capable of successfully completing three sets.

They also recommend including active recovery days (low-intensity exercise) between training days. All major muscles, including neck, shoulder, and upper limb muscles, should be trained in a rotation.

For high-intensity aerobic exercise, the authors recommend starting with interval training at 55% VO_2max (maximum respiratory capacity), or 50% HRmax (maximal heart rate) for 45-60 minutes per session, including 10 minutes of warm-up and cool-down, three times per week. The intensity can then be increased by 5%-10% each week to reach a maximum target of 80%-90% by week 12.

It is best for patients to start with a trainer for guidance and supervision, but once they master the routines, they can do the exercises independently, said Dr. Woldeamanuel.
 

Managing flare-ups

Headache flare-ups are normal during exercise, which may be caused by “boom and bust cycles” – exercising excessively when feeling good then completely stopping when feeling bad, said Dr. Woldeamanuel. He noted these flare-ups don’t mean “there’s something wrong with the brain or there’s some injury to muscles.”

The best way to manage such flare-ups is to use a pacing strategy that involves “not going overboard on good days and avoiding excessive rest on bad days,” the investigators note.

Dr. Woldeamanuel noted exercise is a lifestyle-based intervention; it not only helps reduce migraine attacks but also helps control other known comorbidities such as obesity and hypertension.

In a comment, Elizabeth Loder, MD, vice-chair, academic affairs, department of neurology, Brigham and Women’s Hospital, and professor of neurology, Harvard Medical School, both in Boston, said, “It’s useful to collect and summarize all of these studies, and to focus on helping patients and doctors understand the possible value of different kinds of exercise.”

The review was “well done,” said Dr. Loder, adding the researchers “have looked carefully at the quality of included studies.”

The study received support from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health. Dr. Woldeamanuel has reported no relevant financial relationships.

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