Could vitamin D Reduce Muscle Pain Associated With Statin? This is what the first placebo-controlled, randomized clinical trial shows.
Patients taking statins to treat high cholesterol levels frequently experience muscle pain, which can cause them to quit taking the extremely effective drug and increase their chance of having a heart attack or stroke.
Some doctors have suggested vitamin D supplements to patients on statins to help with muscle pain, but a recent study by researchers at Northwestern University, Harvard University, and Stanford University reveals the vitamin doesn’t seem to have any significant effect.
The findings were published in JAMA Cardiology today.
The new study, which is the first randomized clinical trial to examine the effect of vitamin D on statin-associated muscle symptoms, was large enough to rule out any significant advantages, despite non-randomized studies suggesting that vitamin D is an effective treatment for statin-associated muscle symptoms.
In the randomized, double-blind study, 2,083 participants received either 2,000 units of vitamin D or a placebo everyday. According to the study, participants in both groups were equally likely to experience muscle problems and quit statin therapy.
Over 4.8 years of follow-up, 31% of subjects assigned vitamin D and 31% assigned a placebo had 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,” adds senior author Dr. Neil Stone.
But “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.”
The most often used drugs among American adults are statins and vitamin D pills. Statins are prescribed to roughly 30 to 35 million Americans, and over half of people over 60 take a vitamin D pill.
“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,” explains lead study author Dr. Mark Hlatky. “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.”
This trial was part of a bigger clinical investigation
The VITamin D and Omega-3 Trial (VITAL), which randomized over 26,000 volunteers to double-blind vitamin D treatment in an effort to investigate if it would prevent cancer and cardiovascular disease, included the 2,083 patients as part of its wider cohort of participants. This gave researchers a one-of-a-kind opportunity to see if vitamin D decreases muscle complaints in people who started taking statins during the follow-up phase of the broader VITAL study. The average age of the study participants was 67, with 51% being female.
“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 adds. “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.”
Patients who complain of statin-related muscle pain
Dr. Stone noted that sometimes the key to understanding patients who have difficulty with statins is analyzing other medications they are taking, determining whether or not they have associated metabolic or inflammatory conditions, counseling them on their ability to adequately hydrate, and most importantly, discussing “pill anxiety.”
“For those who have difficulties with statins, a systematic appraisal by a physician with experience in dealing with these matters is still very important,” Stone adds.
Source: RSNA.org/press22
Image Credit: Getty