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

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ClinicalTrials.gov Identifier: NCT00609063
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : January 9, 2012
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Hartford Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Hydroxymethylglutaryl-CoA Reductase Inhibitors Muscular Diseases Drug: Atorvastatin Drug: Placebo Not Applicable

Detailed Description:

Statins are the most effective medications for reducing high cholesterol levels. They are extremely well tolerated by the majority of people but can produce a variety of muscle-related side effects in some people. Of these side effects, the most serious is rhabdomyolysis, which involves muscle fiber damage that can begin as muscle pain and progress to a loss of muscle cells, kidney failure, and death. While rhabdomyolysis is extremely rare, some people experience the more common muscle-related side effects of statins, such as muscle pain (known as "myalgia"), cramps, and weakness. These more common side effects warrant attention because they may limit the use of statins, affect mobility, and increase the risk of injury in older individuals. Also, the term "muscle weakness," often used by patients and their doctors, is not well defined and can refer to a wide range of complaints from simple fatigue to an actual inability to perform activities of daily living. It is important to describe and quantify in more detail the muscle-related side effects associated with statins. The purpose of this study is to determine the incidence of statin-induced mild muscle complaints and to determine the effect of statins on skeletal muscle strength, endurance, and aerobic exercise performance.

This study will enroll healthy people who have never received statin medications. First, participants will attend three study visits over a period of 2 weeks. These study visits will include blood collection, questionnaires on physical activity and pain, vital sign measurements, and body measurements, including height, weight, and head circumference. Participants will also complete two cardiopulmonary exercise stress tests on a treadmill and will undergo arm and leg strength testing. Some participants may undergo a muscle biopsy. Participants will then be randomly assigned to receive either 80 mg of atorvastatin or placebo on a daily basis for 6 months. Blood will be collected again at Month 3. At Month 6, participants will attend two study visits for repeat baseline measurements. All participants will be contacted by phone every other week during the 6-month treatment period to monitor adverse events and medication compliance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: The Effect of Statins on Skeletal Muscle Function
Study Start Date : January 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Participants will receive atorvastatin for 6 months.
Drug: Atorvastatin
80-mg atorvastatin capsules taken daily for 6 months
Other Name: Lipitor

Placebo Comparator: 2
Participants will receive matching placebo for 6 months.
Drug: Placebo
Placebo capsules taken daily for 6 months

Primary Outcome Measures :
  1. Myopathy frequency [ Time Frame: Measured every other week ]
  2. Arm isokinetic force at 60 degrees per second [ Time Frame: Measured at Month 6 ]
  3. Leg isokinetic force at 60 degrees per second [ Time Frame: Measured at Month 6 ]
  4. Handgrip isometric force [ Time Frame: Measured at Month 6 ]
  5. Leg dynamic endurance [ Time Frame: Measured at Month 6 ]
  6. Maximal aerobic power [ Time Frame: Measured at Month 6 ]

Secondary Outcome Measures :
  1. Structural differences in the muscle samples obtained from symptomatic and asymptomatic participants [ Time Frame: Measured after 2 weeks of symptom persistence ]
  2. Skeletal muscle gene expression in muscle samples obtained from symptomatic and asymptomatic participants [ Time Frame: Measured after 2 weeks of symptom persistence ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609063

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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
University of Connecticut
Storrs, Connecticut, United States, 06269
United States, Massachusetts
University of Massachusetts
Amherst, Massachusetts, United States, 01003
Sponsors and Collaborators
Hartford Hospital
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Paul D. Thompson, MD Hartford Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00609063    
Other Study ID Numbers: 552
R01HL081893-01A2 ( U.S. NIH Grant/Contract )
1R01HL081893-01A2 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: January 9, 2012
Last Verified: January 2012
Keywords provided by Hartford Hospital:
Muscle Cramp
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors