Ear, Nose, And Throat Conditions |
ENT |
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
|
Purpose
| 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
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
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
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, 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
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.
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
- A Guide for Parents - Questions and Answers: Fluid in the Middle Ear (Division of Bacterial & Mycotic Diseases, NCID, CDC, OPHS, HHS)
- Age Page: Hearing Loss (National Institute on Aging)

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