NCT00990834

Muscle Characteristics Associated With Statin Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Statins have been proven to reduce cardiovascular events and mortality in large clinical trials but remain underutilized partly due to the associated myopathy. Severe reactions manifested as rhabdomyolysis are rare but myalgia is commonly noted in clinical practice. The pathophysiology of these events remains obscure. Previous studies suggest that statins block the downstream products (such as cellular signaling molecules) of the mevalonate pathway needed for normal muscle function. Other studies show that statins are associated with gene expressions involved in muscle damage such as atrogin-1. We will quantify these entities pre and post statin therapy to better understand these reactions.

Conditions

• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Myopathy

Interventions

Type	Name	Description
DRUG	simvastatin	simvastatin 80 mg PO daily for one to eight months.

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-10-07
• Last updated: 2015-05-22

Locations

1 site across 1 country: United States