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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00797407
First Posted: November 25, 2008
Last Update Posted: November 25, 2008
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.
Information provided by:
The Cleveland Clinic
  Purpose
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 Intervention
Hypercholesterolemia Aches Cramps Weakness Dietary Supplement: Creatine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Creatine Supplementation for the Prevention of Statin Myalgia

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: August 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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
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.
  Eligibility

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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00797407


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

Responsible Party: David A. Shewmon MD / Endocrinologist, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00797407     History of Changes
Other Study ID Numbers: 06-297
First Submitted: November 24, 2008
First Posted: November 25, 2008
Last Update Posted: November 25, 2008
Last Verified: November 2008

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

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