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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00609063
First received: January 25, 2008
Last updated: January 5, 2012
Last verified: January 2012
  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

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609063

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
Sponsors and Collaborators
Hartford Hospital
Investigators
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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014