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

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00797407
First received: November 24, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David A. Shewmon MD / Endocrinologist, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00797407     History of Changes
Other Study ID Numbers: 06-297
Study First Received: November 24, 2008
Last Updated: November 24, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Asthenia
Hypercholesterolemia
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014