A randomized clinical trial to assess the effect of statins on skeletal muscle function and performance: rationale and study design.
Hydroxymethylglutaryl-coenzyme A reductase inhibitors or statins are the most effective medications for reducing elevated concentrations of low-density lipoprotein cholesterol (LDL-C). Statins reduce cardiac events in patients with coronary artery disease and previously healthy persons. Current recommendations for LDL-C treatment goals indicate that more patients will be treated with higher doses of these medications. Statins have been extremely well-tolerated in controlled clinical trials but are increasingly recognized to produce skeletal muscle myalgia, cramps, and weakness. The reported frequency of such mild symptoms is not clear, and muscle performance has not been examined with these medications. Accordingly, the present investigation, the Effect of Statins on Skeletal Muscle Function and Performance (STOMP) study, will recruit approximately 440 healthy persons. Participants will be randomly assigned to treatment with atorvastatin 80 mg/d or placebo. Handgrip, elbow and knee isometric and isokinetic strength, knee extensor endurance, and maximal aerobic exercise performance will be determined at baseline. Participants will undergo repeat testing after 6 months of treatment or after meeting the study definition of statin myalgia. This study will determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise performance and may ultimately help clinicians better evaluate statin-related muscle and exercise complaints.
Thompson
Paul D
PD
Division of Cardiology, Henry Low Heart Center, Hartford Hospital, Hartford, CT 06102, USA. pthomps@harthosp.org
Parker
Beth A
BA
Clarkson
Priscilla M
PM
Pescatello
Linda S
LS
White
C Michael
CM
Grimaldi
Adam S
AS
Levine
Benjamin D
BD
Haller
Ronald G
RG
Hoffman
Eric P
EP
D000069059:Atorvastatin; D008078:Cholesterol, LDL / Q000187:drug effects; D003324:Coronary Artery Disease / Q000188:drug therapy; D003402:Creatine Kinase / Q000187:drug effects; D003663:Decision Trees; D004311:Double-Blind Method; D005080:Exercise Test; D005260:Female; D006305:Health Status Indicators; D006538:Heptanoic Acids / Q000009:adverse effects* / Q000494:pharmacology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000494:pharmacology; D006937:Hypercholesterolemia / Q000188:drug therapy; D007537:Isometric Contraction / Q000187:drug effects*; D008297:Male; D009043:Motor Activity; D053580:Muscle Strength / Q000187:drug effects*; D053581:Muscle Strength Dynamometer; D018908:Muscle Weakness / Q000139:chemically induced*; D018482:Muscle, Skeletal / Q000187:drug effects*; D010807:Physical Endurance / Q000187:drug effects; D011758:Pyrroles / Q000009:adverse effects* / Q000494:pharmacology; D012107:Research Design; D011795:Surveys and Questionnaires
D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin; D003402:Creatine Kinase