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Statin-Associated Muscle Symptoms and Vitamin D Supplementation
Quick Takes
- Vitamin D supplementation was not associated with statin-associated symptoms among VITAL study participants who initiated statins during follow-up.
- These results were consistent across pretreatment 25-hydroxy vitamin D levels.
- Participants randomized to vitamin D supplementation and those randomized to placebo who initiated statin therapy were equally likely to discontinue statin therapy during follow-up.
Study Questions:
Does vitamin D supplementation prevent statin-associated muscle symptoms (SAMS)?
Methods:
Data from the VITAL (Vitamin D and Omega-3 Trial) study were used to examine the occurrence of SAMS among adults using statin therapy for the first time. The VITAL study included men aged ≥50 years and women aged ≥55 years who were free from cardiovascular disease or cancer at baseline and were enrolled in a randomized, placebo-controlled, double-blind clinical trial of vitamin D supplementation. Participants were randomized to vitamin D supplement (2000 IU of cholecalciferol) versus placebo and omega-3 fatty acid supplements versus placebo in a 2 x 2 factorial design. Participants not taking a statin at baseline who initiated a statin during follow-up were included in the present study. The primary outcome of interest was muscle pain or discomfort lasting several days, with discontinuation of a statin due to SAMS as the secondary outcome.
Results:
The VITAL study randomized a total of 25,871 participants between November 2011 and March 2014 (mean age 67.1 years; 51% women). A total of 2,083 participants initiated statin therapy (1,033 randomized to vitamin D and 1,050 randomized to placebo) during a mean follow-up of 4.8 years (mean age 66.8 years; 49% women). Baseline characteristics were similar between participants randomized to vitamin D supplementation and those randomized to placebo. SAMS were reported by 317 participants (31%) assigned to vitamin D and 325 assigned to placebo (31%). The adjusted odds ratio (OR) was 0.97 (95% confidence interval [CI], 0.80-1.18; p = 0.78). Statins were discontinued by 137 participants (13%) assigned to vitamin D and 133 assigned to placebo (13%) with an adjusted OR of 1.04 (95% CI, 0.80-1.35; p = 0.78). These results were consistent across pretreatment 25-hydroxy vitamin D levels, including participants with levels <20 ng/mL.
Conclusions:
The investigators concluded that vitamin D supplementation did not prevent SAMS or reduce statin discontinuation. These results were consistent across pretreatment 25-hydroxy vitamin D levels.
Perspective:
These data from a secondary analysis of a large randomized controlled trial suggest that vitamin D supplementation is not associated with the prevention of SAMS.
Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Diet
Keywords: Cholecalciferol, Dietary Supplements, Dyslipidemias, Fatty Acids, Omega-3, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Muscles, Myalgia, Neoplasms, Primary Prevention, Vitamin D
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