Is Myopathy Part of Statin Therapy (IMPOSTER-16)

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

There is a significant proportion of patients complaining of muscle symptoms while on statin therapy who have a measurable difference in muscle strength or endurance and whose muscle biopsies are diagnostic for myopathy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Primary doctor's permission

• Patient understands nature of study and has signed consent

• Patient is >21 years of age

• Patient willing to stop statin for up to 12 weeks and remain off CoQ10 for study duration

• Patient able to perform the strength and functional tests required

• Patient complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy

• CK < 350 IU

• Thyroid stimulating hormone (TSH) must be normal

• Fasting respiratory exchange ratio (RER) > 0.80 off statin for at least 4 weeks

Exclusion Criteria:

• Severe underlying illness including: Cr > 3.0, liver failure, unstable angina, symptomatic valvular heart disease, congestive heart failure, or prior cerebrovascular accident (CVA) preventing exercise testing.

• History of muscle damage (CK > 350 IU) on statins

• Underlying musculoskeletal disorder preventing muscle testing

• History of severe depression

• Taking doses of other medicines with statin sufficient to cause myopathy including:

cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily.

• Diabetes requiring other than diet therapy

• Use of thiazolidinediones (TZD's), protease inhibitors or other drugs known to influence RER or fatty acid oxidation.

• Abnormal thyroid status

• Inability to maintain constant exercise, dietary, and drug regimen during the 16 weeks required by the study protocol.