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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Coenzyme Q10

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.

Group Type ACTIVE_COMPARATOR

Coenzyme Q10

Intervention Type DIETARY_SUPPLEMENT

300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo (three chewable tablets) 2 times daily for 4 weeks

Interventions

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Coenzyme Q10

300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (three chewable tablets) 2 times daily for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes