A Randomized Clinical Trial to Assess the Effect of Statins on Skeletal Muscle Function and Performance: Rationale and Study Design

Paul D. Thompson, Beth A. Parker, Priscilla M. Clarkson, Linda S. Pescatello, C. Michael White, Adam S. Grimaldi, Benjamin D. Levine, Ronald G. Haller, Eric P. Hoffman

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

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 mgd 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.

Original languageEnglish (US)
Pages (from-to)104-111
Number of pages8
JournalPreventive Cardiology
Volume13
Issue number3
DOIs
StatePublished - Jun 2010

Fingerprint

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Skeletal Muscle
Randomized Controlled Trials
Myalgia
Exercise
LDL Cholesterol
Knee
Muscle Cramp
Muscles
Muscle Weakness
Controlled Clinical Trials
Muscle Strength
Elbow
Coronary Artery Disease
Oxidoreductases
Therapeutics
Placebos

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Public Health, Environmental and Occupational Health

Cite this

Thompson, P. D., Parker, B. A., Clarkson, P. M., Pescatello, L. S., Michael White, C., Grimaldi, A. S., ... Hoffman, E. P. (2010). A Randomized Clinical Trial to Assess the Effect of Statins on Skeletal Muscle Function and Performance: Rationale and Study Design. Preventive Cardiology, 13(3), 104-111. https://doi.org/10.1111/j.1751-7141.2009.00063.x

A Randomized Clinical Trial to Assess the Effect of Statins on Skeletal Muscle Function and Performance : Rationale and Study Design. / Thompson, Paul D.; Parker, Beth A.; Clarkson, Priscilla M.; Pescatello, Linda S.; Michael White, C.; Grimaldi, Adam S.; Levine, Benjamin D.; Haller, Ronald G.; Hoffman, Eric P.

In: Preventive Cardiology, Vol. 13, No. 3, 06.2010, p. 104-111.

Research output: Contribution to journalArticle

Thompson, Paul D. ; Parker, Beth A. ; Clarkson, Priscilla M. ; Pescatello, Linda S. ; Michael White, C. ; Grimaldi, Adam S. ; Levine, Benjamin D. ; Haller, Ronald G. ; Hoffman, Eric P. / A Randomized Clinical Trial to Assess the Effect of Statins on Skeletal Muscle Function and Performance : Rationale and Study Design. In: Preventive Cardiology. 2010 ; Vol. 13, No. 3. pp. 104-111.
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