Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

Catherine Buettner

Status and phase: Completed; Phase 3; Phase 2

Conditions: HMG COA Reductase Inhibitor Adverse Reaction; Weakness; Cramps; Myalgia or Myositis Nos; Pain

Treatments: Other: Placebo; Dietary Supplement: Coenzyme Q10

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01032993

K23AR055664 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced by some individuals who use statin medications.

Full description

This study will recruit individuals who have had muscle symptoms while using a statin. During the first part of the study, volunteers will be given a statin medication to see if their muscle symptoms return. Those who experience muscle symptoms on this statin rechallenge will be invited to continue in the second part of the trial, in which participants will be randomly assigned to receive either CoQ10 or a placebo (sugar pill) to take with statin medication. We hypothesize that those who receive CoQ10 will experience an improvement in their muscle symptoms compared to those who receive placebo, and, secondarily, that those who receive CoQ10 will be more likely to continue taking the statin medication.

Enrollment: 68 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with a history of muscle symptoms (such as aches, pains, cramps and/or weakness) while taking a statin drug that persisted for at least 2 weeks on a statin

Exclusion criteria

• Plasma creatine kinase levels > 3 times the upper normal limit
• Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) > 2 times the upper normal limit
• Pregnancy or breastfeeding (a contraindication for statin use)
• Severe renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min/1.73 m2
• Bleeding disorder, current use of warfarin, an international normalized ratio (INR) greater than 1.5, or a platelet count less than 100,000 mm3
• Contraindication to strength testing, including myocardial infarction, unstable angina, or revascularization procedure within the past six weeks, a history of brain aneurysm or stroke
• Chest or abdominal surgery within the past six weeks
• Severe persistent pain related to other causes
• Unable to complete self-administered questionnaires, or unable to read or converse in English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

Coenzyme Q10

Active Comparator group

Description:

600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily. Study wafers: ChewQ (Tishcon Corp, Westbury, NY) are chewable wafers each containing 100 mg of Coenzyme Q10 (ubidecarenone USP). All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.

Treatment:

Dietary Supplement: Coenzyme Q10

Placebo

Placebo Comparator group

Description:

Placebo was manufactured by the manufacturer of ChewQ, Tishcon Corp (Westbury, NY), included the same excipients, but no active CoQ10, and looked and tasted identical to active agent. All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.

Treatment:

Other: Placebo