Patients who take statins to lower high levels of cholesterol often complain of muscle pains, which may cause them to stop taking the highly effective medication and put them at greater risk of heart attack or stroke.
Some clinicians have advisable vitamin D supplements to ease the muscle aches of patients taking a statin, but a recent study from scientists at Northwestern University, Harvard University and Stanford University shows the vitamin appears to don’t have any substantial impact.
The study will probably be published Nov. 23 in JAMA Cardiology.
Although non-randomized studies have reported vitamin D to be an efficient treatment for statin-associated muscle symptoms, the brand new study, which is the primary randomized clinical trial to have a look at the effect of vitamin D on statin-associated muscle symptoms, was large enough to rule out any essential advantages.
Within the randomized, double-blind trial, 2,083 participants ingested either 2,000 units of vitamin D supplements day by day or a placebo. The study found participants in each categories were equally prone to develop muscle symptoms and discontinue statin therapy.
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.
“We had high hopes that vitamin D can be effective because in our clinic and across the country, statin-associated muscle symptoms were a serious reason why so many patients stopped taking their statin medication,” said senior creator Dr. Neil Stone, professor of drugs in cardiology and preventive medicine at Northwestern University Feinberg School of Medicine and a Northwestern Medicine cardiologist. “So, it was very disappointing that vitamin D failed a rigorous test. Nevertheless, it is vital to avoid using ineffective treatments and as a substitute deal with research that may provide a solution.”
Statins and vitamin D supplements are two of probably the most commonly used medications in American adults. About 30 to 35 million Americans are prescribed statins, and about half of the population aged 60 and older take a vitamin D complement.
“We took advantage of a big placebo-controlled randomized trial to check whether vitamin D would scale back statin-associated muscle symptoms and help patients keep taking their statins,” said lead study creator Dr. Mark Hlatky, a professor of health policy and cardiovascular medicine at Stanford. “The placebo control within the study was essential because if people think vitamin D is alleged to reduce their muscle pains, they simply might feel higher while taking it, even when vitamin D has no specific effect.”
Trial was a sub study inside a bigger clinical trial
The two,083 patients were among the many larger cohort of participants within the VITamin D and Omega-3 Trial (VITAL), which randomized nearly 26,000 participants to double-blind vitamin D supplementation to find out whether it might prevent heart problems and cancer. This provided researchers a singular opportunity to check whether vitamin D reduces muscle symptoms amongst participants who initiated statins throughout the follow-up period of the larger VITAL trial. The mean age of the study participants was 67, and 51% were women.
“Randomized clinical trials are essential because many superb ideas don’t work in addition to we had hoped once they are put to the test,” Hlatky said. “Statistical associations don’t prove a cause-and-effect relationship. Low levels of vitamin D are related to many medical problems, however it seems that giving people vitamin D doesn’t generally fix those problems.”
For patients who report statin-associated muscle pains
Dr. Stone noted that sometimes the key for understanding patients who’ve difficulty with statins is analyzing other medications they’re taking, determining whether or not they’ve associated metabolic or inflammatory conditions, counseling them on their ability to hydrate adequately and, importantly, discussing “pill anxiety.”
“For many who have difficulties with statins, a scientific appraisal by a physician with experience in coping with these matters continues to be very essential,” Stone said.
The thought for this sub study arose out of conversations between study co-author Dr. Pedro Gonzalez, then a resident at Northwestern Memorial Hospital, and Dr. Stone, who runs a big lipid clinic at Northwestern.
Other authors of the study include 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.
Source:
Journal reference:
10.1001/jamacardio.2022.4250