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Is Myopathy Part of Statin Therapy (IMPOSTER-16)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127335
Recruitment Status : Terminated (Lack of funding)
First Posted : August 5, 2005
Last Update Posted : July 28, 2011
Information provided by:
Scripps Health

Brief 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.

Condition or disease Intervention/treatment Phase
Myopathic Conditions Drug: cellulose placebo vs. atorvastatin Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Double Blind, Prospective Randomized, Crossover Study of Patients With Muscle Complaints on Statin Therapy
Study Start Date : August 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Placebo Comparator: 1 Drug: cellulose placebo vs. atorvastatin
Other Name: atorvastatin

Active Comparator: 2
statin administration
Drug: cellulose placebo vs. atorvastatin
Other Name: atorvastatin

Primary Outcome Measures :
  1. hip flexion [ Time Frame: 8 weeks ]
  2. grip strength [ Time Frame: 8 weeks ]
  3. oxygen consumption and anaerobic threshold [ Time Frame: 8 weeks ]
  4. muscle pathology score [ Time Frame: at entry ]

Secondary Outcome Measures :
  1. ability to identify blinded statin [ Time Frame: 8 weeks ]
  2. other aerobic exercise indexes [ Time Frame: 8 weeks ]
  3. fatty acid oxidation of myocyte cell cultures [ Time Frame: at entry ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127335

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United States, California
Scripps Mercy Hospital
San Diego, California, United States, 92103
Sponsors and Collaborators
Scripps Health
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Principal Investigator: Paul S Phillips, MD Scripps Health
Study Director: Harminder Sikand, PharmD Scripps Mercy
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Responsible Party: Paul Phillips,, MD, Scripps Health - Scripps Mercy Hospital Identifier: NCT00127335    
Other Study ID Numbers: M-05-001 (MER004241)
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011
Keywords provided by Scripps Health:
statin side effects,
fatty acid oxidation
Statin induced Muscle toxicity
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors