NCT00850460

Quality of Life in Patients With Statin-Associated Myopathy

Quality of Life and Metabolic Alterations in Patients With Statin-Associated Myopathy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The proposed study will focus on possible effects of statins on muscle strength and why they become tired more easily, quality of life, and measurements to understand why muscles are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life. This study hypothesize that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show: 1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36) scores (primary end point) 2. alleviation of muscle symptoms, 3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results 4. decreased intramyocellular lipid (IMCL) 5. improved insulin sensitivity.

Detailed description

The proposed study will focus on possible effects of statins on muscle strength and quality of life, and measurements to understand why muscles of statin users are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life. This study hypothesizes that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show: 1. improved INQoL and SF-36 scores (primary end point) 2. alleviation of muscle symptoms, 3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results 4. decreased IMCL 5. improved insulin sensitivity.

Conditions

• Statin Adverse Reaction

Interventions

Type	Name	Description
DRUG	Statins	Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth.
DRUG	Placebo	Placebo pills will consist of lactose and will be given one capsule once daily

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-02-25
• Last updated: 2016-11-07
• Results posted: 2016-11-07

Locations

1 site across 1 country: United States