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The purpose of this study is to determine of creatine will prevent or treat the muscle toxicity side effect of statin drug therapy, whose symptoms are aching, cramping, and weakness. This is tested in patients who have had this side effect from 3 different statin drugs.
Muscle toxicity is the most common limiting side effect of statin therapy. Biochemical studies have suggested the presence of intramuscular creatine deficiency in patients with muscle toxicity. This is a test of oral creatine supplementation in statin intolerant subjects as a method of preventing the onset of this side effect as well as resolving these symptoms when present during statin therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creatine | Dietary Supplement | Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined visual analog pain scales (0-10) for aching, cramping and weakness | baseline, after 5 days of creatine loading, after 6 weeks of creatine+statin, after up to 6 weeks on statin without creatine, after 4 days of rechallenge with creatine while still on statin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Shewmon, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wooster Family Health Center, Cleveland Clinic | Wooster | Ohio | 44691 | United States |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D010146 | Pain |
| D009120 | Muscle Cramp |
| D001247 | Asthenia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003401 | Creatine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |