A Randomized Trial of Coenzyme Q10 in Patients With Confirmed Statin Myopathy

Atherosclerosis. 2015 Feb;238(2):329-35. doi: 10.1016/j.atherosclerosis.2014.12.016. Epub 2014 Dec 17.

Abstract

Background: Coenzyme Q10 (CoQ10) supplementation is the most popular therapy for statin myalgia among both physicians and patients despite limited and conflicting evidence of its efficacy.

Objective: This study examined the effect of coenzyme Q10 (CoQ10) supplementation on simvastatin-associated muscle pain, muscle strength and aerobic performance in patients with confirmed statin myalgia.

Methods: Statin myalgia was confirmed in 120 patients with prior symptoms of statin myalgia using an 8-week randomized, double-blind crossover trial of simvastatin 20 mg/d and placebo. Forty-one subjects developed muscle pain with simvastatin but not with placebo and were randomized to simvastatin 20 mg/d combined with CoQ10 (600 mg/d ubiquinol) or placebo for 8 weeks. Muscle pain (Brief Pain Inventory [BPI]), time to pain onset, arm and leg muscle strength, and maximal oxygen uptake (VO2max) were measured before and after each treatment.

Results: Serum CoQ10 increased from 1.3 ± 0.4 to 5.2 ± 2.3 mcg/mL with simvastatin and CoQ10, but did not increase with simvastatin and placebo (1.3 ± 0.3 to 0.8 ± 0.2) (p < 0.05). BPI pain severity and interference scores increased with simvastatin therapy (both p < 0.01), irrespective of CoQ10 assignment (p = 0.53 and 0.56). There were no changes in muscle strength or VO2max with simvastatin with or without CoQ10 (all p > 0.10). Marginally more subjects reported pain with CoQ10 (14 of 20 vs 7 of 18; p = 0.05). There was no difference in time to pain onset in the CoQ10 (3.0 ± 2.0 weeks) vs. placebo (2.4 ± 2.1 wks) groups (p = 0.55). A similar lack of CoQ10 effect was observed in 24 subjects who were then crossed over to the alternative treatment.

Conclusions: Only 36% of patients complaining of statin myalgia develop symptoms during a randomized, double-blind crossover of statin vs placebo. CoQ10 supplementation does not reduce muscle pain in patients with statin myalgia. Trial RegistrationNCT01140308; www.clinicaltrials.gov.

Keywords: Aerobic performance; CoQ10; Exercise; Muscle pain; Muscle strength; Myalgia; Statin; Ubiquinol.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Connecticut
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Male
  • Middle Aged
  • Muscle Strength / drug effects
  • Muscle, Skeletal / drug effects*
  • Muscle, Skeletal / physiopathology
  • Myalgia / chemically induced
  • Myalgia / diagnosis
  • Myalgia / physiopathology
  • Myalgia / prevention & control*
  • Oxygen Consumption / drug effects
  • Pain Measurement
  • Severity of Illness Index
  • Simvastatin / adverse effects*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Ubiquinone / therapeutic use*

Substances

  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Ubiquinone
  • Simvastatin

Associated data

  • ClinicalTrials.gov/NCT01140308