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

NeuroTherapia, Inc.

Status: Completed

Conditions: Weakness; Aches; Hypercholesterolemia; Cramps

Treatments: Dietary Supplement: Creatine

Study type: Interventional

Funder types: Other

Identifiers

NCT00797407

06-297

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)