The Effect of Statin Medications on Muscle Performance (The STOMP Study)
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Purpose
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 | Intervention |
|---|---|
|
Hydroxymethylglutaryl-CoA Reductase Inhibitors Muscular Diseases |
Drug: Atorvastatin Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | The Effect of Statins on Skeletal Muscle Function |
- Myopathy frequency [ Time Frame: Measured every other week ] [ Designated as safety issue: Yes ]
- Arm isokinetic force at 60 degrees per second [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
- Leg isokinetic force at 60 degrees per second [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
- Handgrip isometric force [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
- Leg dynamic endurance [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
- Maximal aerobic power [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
- Structural differences in the muscle samples obtained from symptomatic and asymptomatic participants [ Time Frame: Measured after 2 weeks of symptom persistence ] [ Designated as safety issue: No ]
- Skeletal muscle gene expression in muscle samples obtained from symptomatic and asymptomatic participants [ Time Frame: Measured after 2 weeks of symptom persistence ] [ Designated as safety issue: No ]
| Enrollment: | 420 |
| Study Start Date: | January 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 | |
| Principal Investigator: | Paul D. Thompson, MD | Hartford Hospital |
More Information
No publications provided by Hartford Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hartford Hospital |
| ClinicalTrials.gov Identifier: | NCT00609063 History of Changes |
| Other Study ID Numbers: | 552, R01HL081893-01A2, 1 R01 HL081893-01A2, 105-0342 |
| Study First Received: | January 25, 2008 |
| Last Updated: | January 5, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Hartford Hospital:
|
Statins Myalgia Muscle Cramp |
Additional relevant MeSH terms:
|
Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013