Patients who take statins to lower their high cholesterol often complain of muscle aches, which can cause them to stop taking this highly effective drug and put them at increased risk of heart attack or stroke.
Some clinicians have recommended vitamin D supplements to relieve muscle pain in patients taking a statin, but a new study by scientists from Northwestern University, Harvard University and Stanford University shows that vitamin does not seem to have a substantial impact.
The study will be published on November 23 in JAMA Cardiology.
Although non-randomized studies have reported vitamin D to be an effective treatment for muscle symptoms associated with statins, the new study, which is the first randomized clinical trial to examine the effect of vitamin D on muscle symptoms associated with statins, was large enough to rule out any significant benefit.
In the randomized, double-blind trial, 2,083 participants ingested either 2,000 units of vitamin D supplements daily or a placebo. The study found that participants in both categories were equally likely to develop muscle symptoms and discontinue statin therapy.
Over 4.8 years of follow-up, statin-related muscle pain was reported by 31% of participants receiving vitamin D and 31% receiving placebo.
“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 statins,” said L. lead author, Dr. Neil Stone, Professor of Medicine in Cardiology and Preventive Medicine at Northwestern University Feinberg School of Medicine and Northwestern Medicine Cardiologist. “So it was very disappointing that vitamin D failed a rigorous test. Nevertheless, it is important to avoid using ineffective treatments and instead focus on research that can provide an answer.”
Statins and vitamin D supplements are two of the most commonly used drugs among American adults. About 30 to 35 million Americans are prescribed statins, and about half of the population age 60 and older takes a vitamin D supplement.
“We took advantage of a large, randomized, placebo-controlled trial to test whether vitamin D would reduce statin-associated muscle symptoms and help patients stay on their statins,” said Dr. Mark Hlatky, lead author of the study, professor of health policy and cardiovascular medicine. at Stanford. “The placebo control in the study was important because if people think vitamin D is supposed to reduce their muscle pain, they might feel better taking it, even if vitamin D doesn’t have a specific effect. ”
The trial was a sub-study of a larger clinical trial
The 2,083 patients were part of the largest cohort of participants in the VITAmin D and Omega-3 Trial (VITAL), which randomized nearly 26,000 participants to receive double-blind vitamin D supplementation to determine whether it would prevent cardiovascular disease and cancer. This provided researchers with a unique opportunity to test whether vitamin D reduces muscle symptoms in participants who started taking statins during the follow-up period of the larger VITAL trial. The average age of study participants was 67 and 51% were female.
“Randomized clinical trials are important because many really good ideas don’t work as well as we hoped when they’re put to the test,” Hlatky said. “Statistical associations do not prove a causal relationship. Low levels of vitamin D are associated with many medical problems, but it turns out that giving people vitamin D usually doesn’t solve these problems.”
For patients who report muscle soreness associated with statins
Dr. Stone noted that sometimes the secret to understanding patients who are having difficulty with statins is to analyze other medications they are taking, determine whether or not they have associated metabolic or inflammatory conditions, advise on their ability to adequately hydrate and, most importantly, discuss “pill anxiety.”
“For those who are having difficulty with statins, a systematic evaluation by a physician experienced in treating these issues is always very important,” Stone said.
The idea for this substudy grew out of 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.