Muscle Characteristics Associated With Statin Therapy

• Status: Withdrawn
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the mechanism of statin-related myopathy by evaluating muscle samples before and after statin exposure.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scripps Health
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin

Criteria

Inclusion Criteria:

• Primary surgeon's permission.

• Patient is > 21 years of age.

• Patient will go through a two phase surgery with the two procedures one to eight months apart.

• Patient or representative understands the nature of the study.

• Normal thyroid stimulating hormone (TSH).

• LDL-cholesterol > 100 mg/dL or highly sensitive C-reactive protein (hsCRP) > 2.0.

• One of the following risk factors: male > 45 year old or female > 55 year old, smoker, hypertension, first degree family history of coronary artery disease < 55 year old, HDL <40 mg/dL, chronic kidney disease, diabetes mellitus, previous TIA or stroke, previous coronary artery disease.

Exclusion Criteria:

• Has been on a lipid-lowering medication previously.

• Severe illness (e.g. trauma or sepsis) more than 24 hours before obtaining the first biopsy.

• Less than a 10% reduction of LDL after 3 months of therapy (indicative of non-adherence).

• Contraindications to statins such as liver failure.

• History of underlying muscle disorder.

• Taking amiodarone.