Sufferers who take statins to decrease excessive levels of cholesterol typically complain of muscle pains, which may cause them to cease taking the extremely efficient remedy and put them at higher danger of coronary heart assault or stroke.
Some clinicians have beneficial vitamin D dietary supplements to ease the muscle aches of sufferers taking a statin, however a brand new examine from scientists at Northwestern College, Harvard College and Stanford College reveals the vitamin seems to haven’t any substantial impression.
The examine shall be revealed Nov. 23 in JAMA Cardiology.
Though non-randomized research have reported vitamin D to be an efficient therapy for statin-associated muscle signs, the brand new examine, which is the primary randomized scientific trial to take a look at the impact of vitamin D on statin-associated muscle signs, was giant sufficient to rule out any necessary advantages.
Within the randomized, double-blind trial, 2,083 individuals ingested both 2,000 items of vitamin D dietary supplements every day or a placebo. The examine discovered individuals in each classes have been equally more likely to develop muscle signs and discontinue statin remedy.
Over 4.8 years of follow-up, statin-related muscle ache was reported by 31% of the individuals assigned vitamin D and 31% assigned a placebo.
“We had excessive hopes that vitamin D could be efficient as a result of in our clinic and throughout the nation, statin-associated muscle signs have been a significant purpose why so many sufferers stopped taking their statin remedy,” mentioned senior writer Dr. Neil Stone, professor of medication in cardiology and preventive drugs at Northwestern College Feinberg Faculty of Drugs and a Northwestern Drugs heart specialist. “So, it was very disappointing that vitamin D failed a rigorous check. However, it is necessary to keep away from utilizing ineffective therapies and as an alternative concentrate on analysis that may present a solution.”
Statins and vitamin D dietary supplements are two of essentially the most generally used medicines in American adults. About 30 to 35 million Individuals are prescribed statins, and about half of the inhabitants aged 60 and older take a vitamin D complement.
“We took benefit of a giant placebo-controlled randomized trial to check whether or not vitamin D would cut back statin-associated muscle signs and assist sufferers maintain taking their statins,” mentioned lead examine writer Dr. Mark Hlatky, a professor of well being coverage and cardiovascular drugs at Stanford. “The placebo management within the examine was necessary as a result of if folks assume vitamin D is meant to cut back their muscle pains, they simply may really feel higher whereas taking it, even when vitamin D has no particular impact.”
Trial was a sub examine inside a bigger scientific trial
The two,083 sufferers have been among the many bigger cohort of individuals within the VITamin D and Omega-3 Trial (VITAL), which randomized almost 26,000 individuals to double-blind vitamin D supplementation to find out whether or not it could forestall heart problems and most cancers. This supplied researchers a singular alternative to check whether or not vitamin D reduces muscle signs amongst individuals who initiated statins through the follow-up interval of the bigger VITAL trial. The imply age of the examine individuals was 67, and 51% have been girls.
“Randomized scientific trials are necessary as a result of many superb concepts do not work in addition to we had hoped when they’re put to the check,” Hlatky mentioned. “Statistical associations don’t show a cause-and-effect relationship. Low ranges of vitamin D are related to many medical issues, however it seems that giving folks vitamin D doesn’t typically repair these issues.”
For sufferers who report statin-associated muscle pains
Dr. Stone famous that generally the key for understanding sufferers who’ve problem with statins is analyzing different medicines they’re taking, figuring out whether or not or not they’ve related metabolic or inflammatory circumstances, counseling them on their skill to hydrate adequately and, importantly, discussing “capsule nervousness.”
“For individuals who have difficulties with statins, a scientific appraisal by a doctor with expertise in coping with these issues continues to be essential,” Stone mentioned.
The thought for this sub examine arose out of conversations between examine co-author Dr. Pedro Gonzalez, then a resident at Northwestern Memorial Hospital, and Dr. Stone, who runs a big lipid clinic at Northwestern.
Different authors of the examine embody JoAnn E. Manson and the VITAL examine group at Brigham and Ladies’s Hospital, Harvard Medical Faculty and the Harvard T. H. Chan Faculty of Public Well being.