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An analysis of the VITAL trial suggests vitamin D supplementation does not prevent perceived muscle symptoms or reduce statin discontinuation among older adults using statins in the US.
Using data from 2083 participants who initiated statin therapy during follow-up in the trial, investigators determined daily vitamin D supplementation failed to prevent muscle pain or discomfort among statin users in the trial and did not contribute to a reduction in discontinuation of statin therapy due to these symptoms.
“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,” said senior investigator Neil Stone, MD, professor of medicine in cardiology and preventive medicine at Northwestern University Feinberg School of Medicine and a Northwestern Medicine cardiologist, in a statement. “So, 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.”
A randomized clinical trial of vitamin D in the form of vitamin D3 (cholecalciferol 2000 IU) and omega-3 fatty acid supplements in the primary prevention of cancer and cardiovascular disease, the Vitamin D and Omega-3 Trial (VITAL) is an ongoing research effort led by Brigham and Women’s Hospital that randomized 25,871 participants to vitamin D supplementation or placebo therapy. The current analysis was designed with the intent of assessing the impact of vitamin D supplementation on statin-associated muscle symptoms (SAMS) in those who initiated statin therapy during the follow-up of the trial.
Among the 12,927 randomized to vitamin D, 1033 initiated statin therapy during follow-up and provided responses to a follow-up survey assessing SAMS and discontinuation. Among the 12,924 randomized to placebo, 1050 initiated statin therapy during follow-up and provided responses to the aforementioned survey. With this in mind, muscle pain or discomfort lasting days was used as the primary outcome of interest for the trial. Discontinuation of statin therapy was used as a secondary outcome of interest.
Investigators pointed out associations of vitamin D supplementation with the outcomes of interest were assessed using multivariable logistic regression models adjusted for baseline characteristics previously found to be associated with SAMS in VITAL participants, including age, sex, race, and BMI as well as any other baseline variables that were found to differ significantly between the 2 randomized groups. The cohort included in the current study had a mean age of 66.8 (SD, 6.2) years and 49% were women.
Over a follow-up period lasting a mean of 4.8 years, SAMS were reported by 31% of those randomized to vitamin D and 31% of those randomized to placebo therapy (aOR, 0.97 [95% CI , 0.80-1.18]; P=.78). Statin discontinuation was reported by 13% of the vitamin D arm and 13% of the placebo arm (aOR, 1.04 [95% CI, 0.80-1.35]; P=.78). Investigators noted these results were consistent across patient subgroups defined by pretreatment 25-hydroxy vitamin D levels (P=.83).
Further analysis among a subgroup of patients with levels less than 20 ng/mL indicated SAMS were reported by 33% of patients in this subgroup receiving vitamin D and 35% of patients in these subgroups receiving placebo therapy. Among those with levels less than 30 ng/mL, SAMS were reported by 27% of those receiving vitamin D and 30% of those receiving placebo therapy.
“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,” said lead investigator Mark Hlatky, MD, a professor of health policy and cardiovascular medicine at Stanford, in the aforementioned statement. “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 study, “Statin-Associated Muscle Symptoms Among New Statin Users Randomly Assigned to Vitamin D or Placebo,” was published in JAMA Cardiology.