Patients taking statins to treat high cholesterol levels frequently experience muscle soreness, 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 pills to patients using 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 much of an effect.
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 trial, 2,083 individuals took either a placebo or 2,000 units of vitamin D supplements daily. According to the study, participants in both categories had an identical likelihood of experiencing muscle complaints and stopping their statin therapy.
Over 4.8 years of follow-up, 31% of subjects assigned vitamin D and 31% assigned a placebo had statin-related muscle soreness.
“We had high hopes that vitamin D would be effective,” said 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. “Statin-associated muscle symptoms were a major reason why so many patients stopped taking their statin medication in our clinic and across the country.” “Therefore, the fact that vitamin D failed a strict test was highly upsetting.” However, it’s crucial to refrain from employing useless treatments and instead concentrate on research that can offer a solution.
The two drugs that American people use the most frequently 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.
Dr. Mark Hlatky, the study’s lead author and a professor of health policy and cardiovascular medicine at Stanford University, said, “We made use of a sizable placebo-controlled randomized trial to test whether vitamin D would lessen statin-associated muscle symptoms and help patients keep taking their statins. The placebo control in the study was crucial because even if vitamin D has no discernible effects, people may experience relief from their muscle discomfort if they believe it is supposed to do so.
Trial was a sub study within a larger clinical trial
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 rare chance to investigate whether vitamin D alleviates muscular complaints in people who started taking statins during the longer VITAL trial’s follow-up period. The study’s participants had an average age of 67, and 51% of them were female.
“Many very brilliant concepts don’t work as well as we had thought when they are put to the test,” Hlatky added. “Randomized clinical trials are vital.” “Statistics alone cannot establish a cause-and-effect connection.” Numerous medical conditions are linked to low vitamin D levels, yet it turns out that supplementing with vitamin D rarely resolves these muscle pain issues.
For patients who report statin-associated muscle pain
In some cases, according to Dr. Stone, the key to understanding patients who have trouble taking statins is looking at the other medications they are taking, seeing if they have any associated metabolic or inflammatory conditions, giving them advice on how to drink enough water, and, most importantly, talking to them about “pill anxiety.”
According to Stone, a thorough evaluation by a doctor with experience in handling these issues is still crucial for people who struggle with statins.
Conversations between Dr. Stone, who oversees a sizable lipid clinic at Northwestern, and Dr. Pedro Gonzalez, then a resident at Northwestern Memorial Hospital, gave rise to the concept for this sub-research.
JoAnn E. Manson, the VITAL study group at Brigham and Women’s Hospital, Harvard Medical School, and the Harvard T. H. Chan School of Public Health are additional authors of the paper.
