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

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Aches; Cramps; Weakness

• Registration Number: NCT00797407
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-08
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-11
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Last Update Submitted: 2008-11-24
• Study First Posted: 2008-11-25
• Last Update Posted: 2008-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wooster Family Health Center, Cleveland Clinic; 🇺🇸 Wooster, Ohio, United States