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A randomized clinical trial to assess the effect of statins on skeletal muscle function and performance: rationale and study design.
Prev Cardiol. 2010 Summer; 13(3):104-11.PC

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 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.

Authors+Show Affiliations

Division of Cardiology, Henry Low Heart Center, Hartford Hospital, Hartford, CT 06102, USA. pthomps@harthosp.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

20626664

Citation

Thompson, Paul D., et al. "A Randomized Clinical Trial to Assess the Effect of Statins On Skeletal Muscle Function and Performance: Rationale and Study Design." Preventive Cardiology, vol. 13, no. 3, 2010, pp. 104-11.
Thompson PD, Parker BA, Clarkson PM, et al. A randomized clinical trial to assess the effect of statins on skeletal muscle function and performance: rationale and study design. Prev Cardiol. 2010;13(3):104-11.
Thompson, P. D., Parker, B. A., Clarkson, P. M., Pescatello, L. S., White, C. M., Grimaldi, A. S., Levine, B. D., Haller, R. G., & 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), 104-11. https://doi.org/10.1111/j.1751-7141.2009.00063.x
Thompson PD, et al. A Randomized Clinical Trial to Assess the Effect of Statins On Skeletal Muscle Function and Performance: Rationale and Study Design. Prev Cardiol. 2010;13(3):104-11. PubMed PMID: 20626664.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized clinical trial to assess the effect of statins on skeletal muscle function and performance: rationale and study design. AU - Thompson,Paul D, AU - Parker,Beth A, AU - Clarkson,Priscilla M, AU - Pescatello,Linda S, AU - White,C Michael, AU - Grimaldi,Adam S, AU - Levine,Benjamin D, AU - Haller,Ronald G, AU - Hoffman,Eric P, PY - 2010/7/15/entrez PY - 2010/7/16/pubmed PY - 2011/6/3/medline SP - 104 EP - 11 JF - Preventive cardiology JO - Prev Cardiol VL - 13 IS - 3 N2 - 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. SN - 1751-7141 UR - https://www.unboundmedicine.com/medline/citation/20626664/A_randomized_clinical_trial_to_assess_the_effect_of_statins_on_skeletal_muscle_function_and_performance:_rationale_and_study_design_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=1520-037X&date=2010&volume=13&issue=3&spage=104 DB - PRIME DP - Unbound Medicine ER -