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

January 5, 2012 updated by: Hartford Hospital

The Effect of Statins on Skeletal Muscle Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Storrs, Connecticut, United States, 06269
        • University of Connecticut
    • Massachusetts
      • Amherst, Massachusetts, United States, 01003
        • University of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive atorvastatin for 6 months.
Drug: Atorvastatin
80-mg atorvastatin capsules taken daily for 6 months
Other Names:
  • Lipitor
Placebo Comparator: 2
Participants will receive matching placebo for 6 months.
Drug: Placebo
Placebo capsules taken daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myopathy frequency
Time Frame: Measured every other week
Measured every other week
Arm isokinetic force at 60 degrees per second
Time Frame: Measured at Month 6
Measured at Month 6
Leg isokinetic force at 60 degrees per second
Time Frame: Measured at Month 6
Measured at Month 6
Handgrip isometric force
Time Frame: Measured at Month 6
Measured at Month 6
Leg dynamic endurance
Time Frame: Measured at Month 6
Measured at Month 6
Maximal aerobic power
Time Frame: Measured at Month 6
Measured at Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Structural differences in the muscle samples obtained from symptomatic and asymptomatic participants
Time Frame: Measured after 2 weeks of symptom persistence
Measured after 2 weeks of symptom persistence
Skeletal muscle gene expression in muscle samples obtained from symptomatic and asymptomatic participants
Time Frame: Measured after 2 weeks of symptom persistence
Measured after 2 weeks of symptom persistence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Paul D. Thompson, MD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 25, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2012

Last Update Submitted That Met QC Criteria

January 5, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 552
  • R01HL081893-01A2 (U.S. NIH Grant/Contract)
  • 1R01HL081893-01A2 (U.S. NIH Grant/Contract)
  • 105-0342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Muscular Diseases

Clinical Trials on Atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe