Impact of Statin Therapy on Adaptations to Aerobic Exercise

University of Kansas

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Exercise Program; Drug: Placebo; Drug: Lipitor 20Mg Tablet; Drug: Lipitor 80Mg Tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03360916

R01AR071263 (U.S. NIH Grant/Contract)

STUDY00140791

Details and patient eligibility

About

The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

Full description

High cholesterol and cardiovascular disease (CVD) is currently prevented and treated with statin therapy. Statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase with dose and duration of statin use. Statins may also change the ability to exercise.

This study is testing how different doses of a statin, Lipitor, affect muscle health and exercise. The doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol.

This study is expected to last about 14 weeks.

Enrollment: 52 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) between 25-43 kg^m2

• Sedentary (less than 150 min of physical activity/week during last 6 months)

• Weight stable (no more than 5% change in body weight the previous 3 months)

  • >5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension).

• Stable doses of medications for 90 days

• Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy

Exclusion criteria

• Smoking
• Use of statins in the last 6 months
• Use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil)
• Diagnosis of chronic diseases including CVD, diabetes, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
• History of abnormal bleeding problems
• Currently taking (within the last 10 days) anti-platelet medication (Plavix), Warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications
• >2 fold upper normal limit (UNL) for alanine aminotransferase (ALT) or creatinine
• Women who are pregnant or breastfeeding
• Individuals with polymorphisms known to be associated with susceptibility for statin induced myopathies (tested at screening)
• Currently enrolled in another research study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 3 patient groups, including a placebo group

Placebo & Exercise Group

Placebo Comparator group

Description:

Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.

Treatment:

Drug: Placebo

Behavioral: Exercise Program

Low Statin & Exercise Group

Experimental group

Description:

Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.

Treatment:

Drug: Lipitor 20Mg Tablet

Behavioral: Exercise Program

High Statin & Exercise Group

Experimental group

Description:

Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.

Treatment:

Drug: Lipitor 80Mg Tablet

Behavioral: Exercise Program