The Effect of Statin Medications on Muscle Performance (The STOMP Study)
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.
Hydroxymethylglutaryl-CoA Reductase Inhibitors
|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 ]
|Study Start Date:||January 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Participants will receive atorvastatin for 6 months.
80-mg atorvastatin capsules taken daily for 6 months
Other Name: Lipitor
Placebo Comparator: 2
Participants will receive matching placebo for 6 months.
Placebo capsules taken daily for 6 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609063
|United States, Connecticut|
|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|