Vitamin D3 may not help with statin-related muscle pain
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Vitamin D3 supplementation was not associated with reduced statin-associated muscle symptoms compared with placebo among new statin users enrolled in the VITAL trial, according to a trial subanalysis published in JAMA Cardiology.
“Statin-associated muscle symptoms (SAMS) are common and often lead to discontinuation of statins. Several observational studies have shown that low levels of vitamin D are associated with the development of SAMS and plausible mechanisms have been proposed that link low levels of vitamin D to development of SAMS,” Mark A. Hlatky, MD, professor of health policy, cardiovascular medicine and, by courtesy, of epidemiology and population health at Stanford University, and colleagues wrote. “To our knowledge, no randomized, placebo-controlled clinical trials of vitamin D supplementation to prevent or treat SAMS have been reported.”
For the placebo-controlled, NIH-funded VITAL trial, 25,871 participants were randomly assigned vitamin D3 (cholecalciferol) 2,000 IU per day or placebo and omega-3 fatty acids 1 g per day or placebo for the prevention of major CV events and invasive cancer of any type.
As Healio previously reported, neither omega-3 nor vitamin D3 supplements for primary prevention reduced major CV events or development of invasive cancers compared with placebo at 5 years, but some secondary endpoints showed promising signals.
For the present substudy, researchers assessed whether vitamin D3 was associated with reduction in SAMS among new statin users in the VITAL trial and whether vitamin D3 supplementation would be especially effective in participants with low levels of serum 25-hydroxyvitamin D at study baseline.
The primary endpoint was SAMS, defined as muscle pain or discomfort lasting several days. The secondary outcome was statin discontinuation due to the primary outcome.
In VITAL, statins were initiated in 1,033 participants assigned to the vitamin D3 group and 1,050 assigned to the placebo group (mean age, 67 years; 49% women).
During 4.8 years of follow-up, SAMS were reported by 31% of the vitamin D3 arm compared with 31% of the placebo arm (adjusted OR = 0.97; 95% CI, 0.8-1.18; P = .78).
The secondary outcome of statin discontinuation due to the primary outcome occurred in 13% of the vitamin D3 arm compared with 13% of the placebo arm (aOR = 1.04; 95% CI, 0.8-1.35; P = .78).
Moreover, these findings were consistent regardless of baseline 25-hydroxyvitamin D levels (P for interaction = .83).
“This study took advantage of the large double-blind, placebo-controlled VITAL trial, which randomized patients to vitamin D supplementation for primary prevention of cardiovascular disease and cancer to test whether vitamin D was associated with a reduction in SAMS among new statin users,” the researchers wrote. “It was not: We found essentially the same frequency of SAMS among the 1,033 participants randomized to vitamin D as among the 1,050 randomized to placebo and no difference in the frequency of statin discontinuation due to SAMS. These null results in a large, contemporary randomized clinical trial suggest that vitamin D has little, if any, association with preventing SAMS.”
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