Study is the first randomized, placebo-controlled clinical trial to examine this – ScienceDaily


Patients taking statins to lower high cholesterol levels often complain of muscle pain, which can lead them to stop taking highly effective medications and put them at risk of a heart attack or stroke.

Some doctors have recommended vitamin D supplements to relieve muscle pain in patients taking statins, but a new study by scientists at Northwestern University, Harvard University and Stanford University shows that the vitamin doesn’t seem to have much of an effect.

The study will be published November 23 in heart gamma.

Although non-randomized studies have reported vitamin D as an effective treatment for statin-related muscle symptoms, the new study, the first randomized clinical trial to look at the effect of vitamin D on statin-related muscle symptoms, was large enough to rule out any benefits. a task.

In the randomized, double-blind trial, 2,083 participants took either 2,000 units of vitamin D supplement daily or a placebo. The study found that participants in both groups were equally likely to develop muscle symptoms and stop statin therapy.

Over 4,8 years of follow-up, statins-related muscle pain was reported by 31% of the participants prescribed vitamin D and 31% prescribing a placebo.

“We had high hopes that vitamin D would be effective because in our clinic and across the country, statins-related muscle symptoms were a major reason many patients stopped taking,” said senior author Dr. Neil Stone, a professor at the University of California, Berkeley. their statin drugs. Medicine in Cardiology and Preventive Medicine at Northwestern University Feinberg School of Medicine and a Cardiologist in Medicine at Northwestern University. “Therefore, it was very disappointing that vitamin D failed a rigorous test. However, it is important to avoid the use of ineffective treatments and instead focus on research that can provide an answer.”

Statins and vitamin D supplements are two of the most commonly prescribed medications among American adults. About 30 to 35 million Americans are prescribed statins, and half of the population ages 60 and older take vitamin D supplements.

“We took advantage of a large, randomized, placebo-controlled trial to test whether vitamin D would reduce statin-related muscle symptoms and help patients stay on statins,” said study senior author Dr. Mark Hlatky, professor of health policy and cardiovascular medicine. . at Stanford. “The placebo control in the study was important because if people believed that vitamin D was supposed to reduce their muscle pain, they might feel better while taking it, even if vitamin D had no specific effect.”

The trial was a sub-study within a larger clinical trial

The 2,083 patients were among the largest cohort of participants in the Vitamin D and Omega-3 Trial (VITAL), which randomized nearly 26,000 participants to double vitamin D supplementation to determine whether it would prevent cardiovascular disease and cancer. This provided the researchers with a unique opportunity to test whether vitamin D reduces muscle symptoms among participants who started statins during the follow-up period of the larger VITAL trial. The average age of the study participants was 67, and 51% were women.

“Randomized clinical trials are important because many very good ideas don’t work as well as we hoped when they are tested,” Hlatky said. “The statistical correlations do not prove a cause-and-effect relationship. Low levels of vitamin D are associated with many medical problems, but it turns out that giving people vitamin D does not generally solve these problems.”

For patients reporting statins-related muscle pain

Dr. Stone noted that sometimes the secret to understanding patients who have difficulty taking statins is to analyze what other medications they’re taking, determine whether or not they have associated metabolic or inflammatory conditions, and advise them on their ability to hydrate adequately, Most importantly, discuss “pill anxiety”.

“For those who have difficulties taking statins, regular evaluation by a physician experienced in dealing with these issues is still very important,” Stone said.

The idea for this substudy arose from conversations between study co-author Dr. Pedro Gonzalez, then a resident at Northwestern Memorial Hospital, and Dr. Stone, who runs a large lipid clinic at Northwestern.

Other study authors include JoAnn E. Manson and the Vital Study Group at Brigham and Women’s Hospital, Harvard Medical School and Harvard TH Chan School of Public Health.


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