Effect of Vitamin D on Statin-Associated Muscle Symptoms among New Statin Users
JAMA Cardiology: Published on November, 2022
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Question: Does vitamin D prevent statin-associated muscle
symptoms and reduce statin discontinuation?
This study assessed whether vitamin D supplementation (2000
IU of cholecalciferol) would prevent statin-associated muscle symptoms (SAMS)
and reduce statin discontinuation in 2083 participants from the VITAL trial.
Findings: Over 4.8 years of follow-up, there was no significant
difference in the incidence of SAMS and the rate of statin discontinuation
between participants randomized to vitamin D supplementation and those
randomized to placebo, regardless of pretreatment 25-hydroxy vitamin D levels.
Meaning: The findings suggest that, vitamin D supplementation did not prevent statin-associated muscle symptoms or statin discontinuation.
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Importance Statin-associated muscle symptoms (SAMS) are
common and may lead to discontinuation of indicated statin therapy.
Observational studies suggest that vitamin D therapy is associated with reduced
statin intolerance, but no randomized studies have been reported.
Objective To test whether vitamin D supplementation was associated with
prevention of SAMS and a reduction of statin discontinuation.
Design, Setting, and Participants Men 50 years or older and
women 55 years or older, free of cancer and cardiovascular disease, were
enrolled in a randomized, placebo-controlled, double-blind clinical trial of
vitamin D supplementation. Participants who initiated statin therapy after
randomization were surveyed in early 2016. The data were analyzed in early
2022.
Interventions Daily cholecalciferol (2000 international units)
or placebo with assessment of statin prescriptions during follow-up.
Main Outcomes and Measures Muscle pain or discomfort lasting several
days (primary outcome) and discontinuation of a statin due to SAMS (secondary
outcome).
Results Statins were initiated by 1033 vitamin D–assigned
participants and 1050 placebo-assigned participants; mean (SD) age was 66.8
(6.2) years and 49% were women. Over 4.8 years of follow-up, SAMS were reported
by 317 participants (31%) assigned vitamin D and 325 assigned placebo (31%).
Statins were discontinued by 137 participants (13%) assigned to vitamin D and
133 assigned to placebo (13%). These results were consistent across
pretreatment 25-hydroxy vitamin D levels. Among participants with levels less
than 20 ng/mL, SAMS were reported by 28 of 85 vitamin D–assigned participants
(33%) and 33 of 95 placebo-assigned participants (35%). For those with levels
less than 30 ng/ml, SAMS were reported by 88 of 330 vitamin–D assigned
participants (27%) and 96 of 323 of placebo-assigned participants (30%).
Conclusions and Relevance Vitamin D supplementation did not prevent
SAMS or reduce statin discontinuation. These results were consistent across
pretreatment 25-hydroxy vitamin D levels.
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