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

Sponsored by:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00797407

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Cholest-5-en-3-ol (3beta)- Creatine Creatine monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Creatine Supplementation for the Prevention of Statin Myalgia

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:

Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day

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

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

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

Keywords provided by The Cleveland Clinic:

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Creatine
Adverse Effects
Muscle Toxicity

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Asthenia
Pain
Metabolic disorder

Muscle Cramp
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009