Abstract 9941: Baseline Vitamin D Levels, Vitamin D Deficiency and Changes in Vitamin D With Statin Therapy Do Not Predict Statin Myalgia
Background and Objective: Low Vitamin D levels have been implicated as contributing to statin myalgia, but studies on the relationship between Vitamin D and statin-associated muscle side effects (SAMS) have produced discrepant results. We examined the influence of baseline and change in Vitamin D levels in patients with self-reported statin myalgia who developed muscle symptoms during a statin-placebo cross-over trial.
Methods: Statin myalgia was verified in 120 patients with prior statin muscle complaints using an 8-week randomized, double-blind crossover trial of simvastatin (SIMVA) 20 mg/d and placebo. Anthropometrics, medical histories, demographics and serologic data (including 25 (OH)Vitamin D) were measured at each phase of the trial.
Results: Forty three (35.8%) patients met the study criteria for myalgia, experiencing muscle pain on SIMVA but not placebo. Serum Vitamin D levels (mean ± standard deviation) prior to simvastatin treatment were not different between patients who did (31.7 ±12.1 ng/mL) or did not (31.6 ±10.3 ng/mL) develop myalgia and did not predict SAMS (r2 = 0.00; p = 0.96). The change in Vitamin D with SIMVA (post-pre treatment) was also not different between myalgic and non-myalgic patients (0.3 ± 5.9 vs. 0.2 ±8.3 ng/mL, respectively) and again did not predict SAMS (r2 = 0.00; p = 0.96). In addition, the proportion of patients classified as Vitamin D deficient (< 20 ng/mL) did not differ between myalgics and non-myalgics (n=7 vs. n=8; χ2=1.45; p = 0.23), nor did the proportion of patients classified as Vitamin D insufficient (< 30 ng/mL) (n=18 vs. n=37; χ2 < 0.01 and p = 0.94, respectively).
Conclusions: Our results suggest that baseline levels of Vitamin D, Vitamin D deficiency/insufficiency and changes in Vitamin D with statin therapy do not predict statin myalgia in patients in whom SAMS are verified using a rigorous double-blind, cross-over study design. The failure to verify SAMS in other studies may explain the discordant results on Vitamin D as a risk factor and potential treatment for statin myalgia.
Trial Registration: NCT01140308
Author Disclosures: B. Taylor: None. H. Swales: None. L. Lorson: None. C. White: None. P.D. Thompson: Other Research Support; Modest; Genomas, Roche, Sanolfi, Regeneron, Esperion, Amarin and Pfizer. Honoraria; Modest; Merck, Astra Zenica, Kowa, and Amarin. Expert Witness; Modest; has provided expert legal testimony on exercise-related cardiac events and statin myopathy. Consultant/Advisory Board; Modest; Amgen, Regeneron, Merck, Genomas, Runners World, Sanolfi, Esperion, and Amarin. Other; Modest; Stock in Abbvie, Abbott Labs, General Electric , J&J.
- © 2015 by American Heart Association, Inc.