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Is Myopathy Part of Statin Therapy (IMPOSTER-16) - Article


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Clinical Trial: Is Myopathy Part of Statin Therapy (IMPOSTER-16)

This study is not yet open for patient recruitment.
Verified by Scripps Mercy Hospital August 2005

Sponsored by: Scripps Mercy Hospital
Information provided by: Scripps Mercy Hospital
ClinicalTrials.gov Identifier: NCT00127335

Purpose

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 Intervention Phase
Myopathic Conditions
 Drug: Statins
Phase IV

MedlinePlus related topics:  Muscle Disorders

Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study

Official Title: Double Blind, Prospective Randomized, Crossover Study of Patients With Muscle Complaints on Statin Therapy

Further Study Details: 
Primary Outcomes: hip flexion; grip strength; oxygen consumption and anaerobic threshold; muscle pathology score
Secondary Outcomes: ability to identify blinded statin; other aerobic exercise indexes; fatty acid oxidation of myocyte cell cultures
Expected Total Enrollment:  60

Study start: August 2005;  Expected completion: December 2007
Last follow-up: August 2005;  Data entry closure: August 2007

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 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 (CK), 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.

Eligibility

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both
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
  • TSH must be normal
  • Fasting 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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00127335

Paul S Phillips, MD      619-297-0014    phillips.paul@scrippshealth.org
Nancy L Gray, RN      619-260-7278    gray.nancy@scrippshealth.org

California
      Scripps Mercy Hospital, San Diego,  California,  92103,  United States
Paul S Phillips, MD  619-297-0014    Phillips.paul@scripps.org 
Paul S Phillips, MD,  Principal Investigator
Harminder Sikand, PharmD,  Sub-Investigator
Nancy L Gray, RN,  Sub-Investigator
William Davidson, MD,  Sub-Investigator
Theodore P Ciaraldi, Phd,  Sub-Investigator
M A Verity, MD, Phd,  Sub-Investigator

Study chairs or principal investigators

Paul S Phillips, MD,  Principal Investigator,  Scripps Mercy Hospital   
Harminder Sikand, PharmD,  Study Director,  Scripps Mercy   

More Information

Publications

Phillips PS. Ezetimibe and statin-associated myopathy. Ann Intern Med. 2004 Oct 19;141(8):649. No abstract available.

Phillips PS, Phillips CT, Sullivan MJ, Naviaux RK, Haas RH. Statin myotoxicity is associated with changes in the cardiopulmonary function. Atherosclerosis. 2004 Nov;177(1):183-8.

Phillips PS, Haas RH, Bannykh S, Hathaway S, Gray NL, Kimura BJ, Vladutiu GD, England JD; Scripps Mercy Clinical Research Center. Statin-associated myopathy with normal creatine kinase levels. Ann Intern Med. 2002 Oct 1;137(7):581-5.

Study ID Numbers:  M-05-001
Last Updated:  August 22, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00127335
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23

Resources



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Page Updated: September 6, 2005
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