Muscle pain is a significant reason why many patients fail to remain adherent to their statin medication regimen.
Vitamin D supplementation was not found to have a significant impact in reducing muscle pain in patients taking statins to lower high cholesterol, according to a study published in JAMA Cardiology.
Prior non-randomized studies suggested that vitamin D may be effective treating statin-associated muscle soreness. However, the current study is the first randomized clinical trial to examine the impact of vitamin D on statin-associated muscle symptoms and was large enough to rule out important benefits, according to the authors.
The double-blind trial randomized 2083 individuals to receive either 2000 daily units of vitamin D supplements or a placebo. The results showed that participants in both cohorts were equally as likely to experience muscle symptoms and fail to remain adherent to statin therapy.
Over 4.8 years of follow-up, 31% of individuals in the vitamin D cohort and 31% in the placebo cohort reported statin-related muscle pain.
“We had high hopes that vitamin D would be effective because in our clinic and across the country, statin-associated muscle symptoms were a major reason why so many patients stopped taking their statin medication,” senior author Dr. Neil Stone, professor of medicine in cardiology and preventive medicine at Northwestern University Feinberg School of Medicine and a Northwestern Medicine cardiologist, said in a press release. “So, it was very disappointing that vitamin D failed a rigorous test. Nevertheless, it’s important to avoid using ineffective treatments and instead focus on research that can provide an answer.”
Statins and vitamin D supplements are among the most frequently used medications in US adults, with approximately 35 million individuals prescribed statins and approximately one-half of the population 60 years of age and older taking a vitamin D supplement, according to the study authors.
“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,” lead study author Dr. Mark Hlatky, a professor of health policy and cardiovascular medicine at Stanford, said in a press release. “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.”
Patients in this trial were among a larger group of participants in the VITamin D and Omega-3 Trial (VITAL), which randomized approximately 26,000 individuals to vitamin D supplementation to evaluate whether it can prevent cardiovascular disease and cancer. This trial allowed investigators to also evaluate whether vitamin D decreases muscle symptoms among those initiating statins during the follow-up period of the larger VITAL trial. The mean age of the study participants was 67 years and 51% were women.
“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,” Hlatky said in the press release. “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.”
Vitamin D fails to reduce statin-associated muscle pain. Northwestern University. News release. November 23, 2022. https://www.eurekalert.org/news-releases/972043