Is Myopathy Part of Statin Therapy (IMPOSTER-16)

Scripps Health

Status and phase

Withdrawn

Phase 4

Conditions

Myopathic Conditions

Treatments

Drug: cellulose placebo vs. atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00127335

M-05-001 (MER004241)

Details and patient eligibility

About

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.

Full description

This is a double-blinded, randomized, placebo-controlled, crossover trial. Sixty patients who are identified by their physician as having muscle pain or weakness while on statin therapy and in whom creatine kinase (CK) enzyme determinations have been normal will be enrolled voluntarily. All patients will have a percutaneous muscle biopsy prior to enrollment into the trial. These patients will be randomized in a blinded crossover fashion to either standardized statin therapy or placebo in eight week intervals. After eight weeks of drug or placebo the patients will be assessed for signs and symptoms of muscle weakness by:

Dynamometry of grip and hip strength
An exercise test with exhaled gas analysis
Blood tests for cholesterol, creatine kinase, lactate
Urine tests for organic acids

Following the first eight-week study and testing period, each patient will serve as their own control and they will enter a second eight-week study period. During the second phase they will take the opposite therapy, either drug or placebo, which they have not yet received. Sub-studies will include ten controls who have never previously received statins and ten subjects who have suffered statin-induced rhabdomyolysis. Subjects in these sub-studies will not be exposed to statin therapy and will only undergo limited testing.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.