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

The Cleveland Clinic12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hypercholesterolemia Aches Cramps Weakness

Interventions

CreatineDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wooster Family Health Center, Cleveland Clinic

Wooster, Ohio, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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