title: A randomized trial of coenzyme Q10 in patients with confirmed statin myopathy.
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.
authors.affiliation: Division of Cardiology, Henry Low Heart Center, Hartford Hospital, Hartford, CT, USA; Department of Health Sciences, University of Hartford, West Hartford, CT, USA; University of Connecticut School of Medicine, Farmington, CT, USA. Electronic address: Beth.taylor@hhchealth.org.
authors.forename: Beth A
authors.initials: BA
authors.lastname: Taylor
authors.affiliation: Division of Cardiology, Henry Low Heart Center, Hartford Hospital, Hartford, CT, USA.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Lorson
authors.affiliation: Division of Cardiology, Henry Low Heart Center, Hartford Hospital, Hartford, CT, USA; University of Connecticut School of Medicine, Farmington, CT, USA.
authors.forename: C Michael
authors.initials: CM
authors.lastname: White
authors.affiliation: Division of Cardiology, Henry Low Heart Center, Hartford Hospital, Hartford, CT, USA; University of Connecticut School of Medicine, Farmington, CT, USA.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Thompson
mesh_terms: D000368:Aged; D003237:Connecticut; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength / Q000187:drug effects; D018482:Muscle, Skeletal / Q000187:drug effects* / Q000503:physiopathology; D063806:Myalgia / Q000139:chemically induced / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D010101:Oxygen Consumption / Q000187:drug effects; D010147:Pain Measurement; D012720:Severity of Illness Index; D019821:Simvastatin / Q000009:adverse effects*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014451:Ubiquinone / Q000627:therapeutic use*
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014451:Ubiquinone; D019821:Simvastatin
keywords: Aerobic performance; CoQ10; Exercise; Muscle pain; Muscle strength; Myalgia; Statin; Ubiquinol