title: A randomized trial of coenzyme Q10 in patients with statin myopathy: rationale and study design.
abstract: BACKGROUND
  Statins are the most commonly prescribed and effective medications for reducing low-density lipoprotein levels. Some patients experience myopathic symptoms during statin treatment. The etiology is not known, but depletion of mevalonate pathway metabolites, including coenzyme Q10 (CoQ10), has been suggested. Despite a lack of conclusive evidence supporting its utility, CoQ10 supplementation has been recommended to patients who experience myalgic symptoms.
  
  
  OBJECTIVE
  The Co-Enzyme Q10 in Statin Myopathy study is designed to examine the effect of CoQ10 supplementation on the extent and intensity of muscle pain during treatment with simvastatin.
  
  
  METHODS
  We will recruit patients with a documented history of myalgia during statin treatment. The presence of statin-related myalgia will be confirmed in a crossover run-in trial during which the presence and absence of symptoms will be documented during statin and placebo treatment, respectively. Individuals experience myalgic symptoms while taking statins but not placebo will be randomized to receive simvastatin 20 mg daily plus either 600 mg daily of CoQ10 or placebo. Muscle pain intensity will be documented during weekly phone calls via use of the Brief Pain Inventory, Short Form. Treatment will continue for 8 weeks or until muscle symptoms are reported continuously for 1 week or become intolerable, and then subjects will crossover to the alternative treatment (CoQ10 or placebo).
  
  
  RESULTS
  This study is an ongoing clinical trial.
  
  
  CONCLUSIONS
  This study will determine the utility of CoQ10 for reducing pain intensity in myalgic patients and will provide guidance for clinicians treating patients with hypercholesterolemia who are intolerant to statins.
authors.affiliation: Division of Cardiology, Henry Low Heart Center, 80 Seymour Street, Hartford Hospital, Hartford, CT 06102, USA.
authors.forename: Beth A
authors.initials: BA
authors.lastname: Parker
authors.forename: Sara M
authors.initials: SM
authors.lastname: Gregory
authors.forename: Lindsay
authors.initials: L
authors.lastname: Lorson
authors.forename: Donna
authors.initials: D
authors.lastname: Polk
authors.forename: C Michael
authors.initials: CM
authors.lastname: White
authors.forename: Paul D
authors.initials: PD
authors.lastname: Thompson
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D009132:Muscles / Q000187:drug effects / Q000473:pathology*; D009135:Muscular Diseases / Q000188:drug therapy*; D019821:Simvastatin / Q000627:therapeutic use*; D014451:Ubiquinone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D014451:Ubiquinone; D019821:Simvastatin; C024989:coenzyme Q10