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Effectiveness of Creatine in Preventing Muscle Aching From Cholesterol-Lowering Statin Drugs

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: NCT00797407
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : November 25, 2008
Information provided by:
The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Hypercholesterolemia Aches Cramps Weakness Dietary Supplement: Creatine

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Creatine Supplementation for the Prevention of Statin Myalgia
Study Start Date : August 2006
Primary Completion Date : December 2006
Study Completion Date : December 2006

Intervention Details:
    Dietary Supplement: Creatine
    Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day
    Other Name: creatine monohydrate

Primary Outcome Measures :
  1. Combined visual analog pain scales (0-10) for aching, cramping and weakness [ Time Frame: 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hypercholesterolemia in need of aggressive treatment, defined as a high risk of a vascular event, thus subjects with diabetes, pre-diabetes, or known vascular disease
  • intolerance (i.e. muscle toxicity symptoms) of at least 3 statin drugs, each confirmed on rechallenge

Exclusion Criteria:

  • history of elevated CPK or rhabdomyolysis while taking a statin,
  • CPK levels elevated above the normal range at baseline,
  • pregnancy.
  • renal insufficiency, defined as a serum creatinine ≥ 2.0 mg/dl.
  • history of congestive heart failure.

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): NCT00797407

United States, Ohio
Wooster Family Health Center, Cleveland Clinic
Wooster, Ohio, United States, 44691
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: David A Shewmon, MD The Cleveland Clinic

Responsible Party: David A. Shewmon MD / Endocrinologist, Cleveland Clinic Foundation Identifier: NCT00797407     History of Changes
Other Study ID Numbers: 06-297
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: November 25, 2008
Last Verified: November 2008

Keywords provided by The Cleveland Clinic:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Adverse Effects
Muscle Toxicity

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents