Patients who take statins to lower high cholesterol levels often complain of muscle pains, which can lead them to stop taking the highly effective medication and put them at greater risk of heart attack or stroke.
Some clinicians have recommended vitamin D to ease the muscle aches of patients taking a statin, but a new study shows the vitamin appears to have no real impact.
Vitamin D has been reported in non-randomized studies to be an effective treatment for statin-associated muscle symptoms, but the first randomized clinical trial to look at the effect of vitamin D on statin-associated muscle symptoms was large enough to rule out any important benefits.
The 2,083 participants in a randomized, double-blind trial of vitamin D supplements who started taking a statin therapy were equally likely to develop muscle symptoms and discontinue statin therapy whether they were assigned to vitamin D or to a placebo.
“We took advantage of a large placebo controlled randomized trial to test whether vitamin D would reduce statin associated muscle symptoms, and help patients keep taking their statins,” said Mark Hlatky, MD, a professor of health policy and cardiovascular medicine at Stanford, and lead author of the study published in JAMA Cardiology on November 23. Contrary to their hypothesis, vitamin D had no effect at all.
“We had high hopes that vitamin D would be effective, because statin-associated muscle symptoms are a major reason why so many patients stop taking the statin they need,” said Hlatky. “So it was very disappointing that vitamin D failed a rigorous test. Nevertheless, it’s important to avoid using ineffective treatments, even if the clinical problem is big.”
Over 4.8 years of follow-up, statin-related muscle pain was reported by 31% of the participants assigned vitamin D and 31% assigned a placebo.
The 2,083 patients were among the larger cohort of participants in the VITamin D and Omega-3 Trial (VITAL) which randomized nearly 25,900 participants to double-blind vitamin D supplementation to determine whether it would prevent cardiovascular disease and cancer. This provided researchers a unique opportunity to test whether vitamin D reduces muscle symptoms among participants who initiated statins during the follow-up period of the larger VITAL study. The mean age of the study participants was 67 years and 49% were women.
“The placebo control in the study was important, because if people think vitamin D is supposed to reduce their muscle pains, they just might feel better while taking it, even if vitamin D has no specific effect,” Hlatky said.
He noted that some 30 to 35 million Americans are prescribed statins. Though there is no data about how many clinicians recommend vitamin D for statin-related muscle pain, another large VITAL trial found that the vitamin does not prevenet bone fractures in most people.
“Randomized clinical trials are important because many very good ideas don’t work as well as we had hoped when they are put to the test. Statistical associations 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 fix those problems.”
Other authors of the study include senior author Neil J. Stone of Northwestern University, and JoAnn E. Manson and the VITAL study group at Brigham and Women’s Hospital, Harvard Medical School, and the Harvard T. H. Chan School of Public Health.