The Effect of Statin Medications on Muscle Performance (The STOMP Study)

Completed · Not applicable · Has a placebo group

Conditions studied: Hydroxymethylglutaryl-CoA Reductase Inhibitors, Muscular Diseases

In brief

Statins are a group of medications that are used to lower cholesterol levels. Although serious side effects are rare, some people taking statins experience muscle pain or weakness. This study will evaluate the number of people who experience mild muscle complaints and will determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise performance.

Key facts

Study ID

NCT00609063

Run by

Hartford Hospital

People needed

420

Starts

2008-01-01

Expected to finish

2011-06-01

Last updated by the study team

2012-01-09

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Statin-naive (i.e., has never taken statins before)

You may not qualify if…

• Previous use of statins
• Current treatment with cholesterol- or triglyceride-lowering drugs
• Impaired liver or kidney function
• Untreated hypothyroidism or hyperthyroidism
• Treatment with other medications known to increase risk of myopathy in atorvastatin-treated patients (e.g., cyclosporine, azithromycin, erythromycin, azole antifungals, fusidic acid)
• Existing infection requiring treatment with antibiotic therapy
• Consumption of greater that 1 quart of grapefruit juice per day
• Documented history of neuroleptic malignant syndrome
• Inherited muscle disorders or myopathy
• Known sickle cell trait
• Cancer within the 5 years prior to study entry
• Diabetes
• Currently being treated for high blood pressure
• Coronary artery disease
• Peripheral vascular disease
• Physical disability or previous injury that prevents safe exercise testing
• Pregnant or breastfeeding

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• University of Connecticut — Storrs, Connecticut, United States
• University of Massachusetts — Amherst, Massachusetts, United States

Full record on ClinicalTrials.gov

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