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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hartford Hospital
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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