About this trial

Statins lower low-density lipoprotein cholesterol (LDL-C) and help prevent atherosclerotic cardiovascular disease, but some users develop statin-associated muscle symptoms (SAMS) such as soreness, stiffness, weakness, or elevated creatine kinase (CK). These symptoms may be more noticeable during exercise. Regular long-distance running improves cardiopulmonary fitness-VO₂max, aerobic threshold (AT), and respiratory compensation point (RCP)-mainly through mitochondrial and metabolic adaptations. Prior studies suggest that lipophilic statins like simvastatin may blunt these adaptations, while hydrophilic statins such as rosuvastatin may have a smaller impact. However, prospective data in habitual endurance runners are limited.

This randomized controlled trial will examine how rosuvastatin affects cardiopulmonary fitness improvements and muscle tolerance in individuals who run at least three times per week and meet clinical criteria for statin therapy. After informed consent and baseline cardiopulmonary exercise testing (CPET), participants will be randomized to rosuvastatin 10 mg daily or no statin therapy for three months. Both groups will maintain their usual training routines, and training load will be recorded using heart-rate-based TRIMP. CPET will be repeated monthly to assess changes in VO₂max, AT, and RCP, and muscle enzymes and SAMS will be evaluated at each visit.

The study aims to clarify whether rosuvastatin influences endurance-related physiological adaptations or increases muscle symptoms in regular long-distance runners.

Eligibility criteria

Qualifiers

Age ≥ 18 years.

Family history of hyperlipidemia.

LDL-C ≥ 160 mg/dL.

10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk ≥ 7.5%

Disqualifiers

Known allergy or intolerance to statins or rosuvastatin.

History of severe statin-related adverse events, including rhabdomyolysis or marked creatine kinase (CK) elevation.

Liver dysfunction with AST or ALT > 3× upper limit of normal.

Moderate to severe renal impairment (eGFR < 30 mL/min/1.73 m²).

Trial design

Treatments tested in this trial

  • Rosuvastatin

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

1
Taipei medical university116, Taipei Taiwan

Sponsors and collaborators

Taipei Medical University WanFang Hospital

Lead sponsor