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

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Dietary Supplement: Coenzyme Q10
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coenzyme Q10<br>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. | Dietary Supplement: Coenzyme Q10<br>* 300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks<br>|
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br>* Placebo (three chewable tablets) 2 times daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use | Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation of Statin | Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses. | 4 weeks | 
| Percentage of Participants With Improvement in Disability Related to Muscle Pain | Disability improvement was based on patient report of improvement they felt was meaningful to them | 4 weeks | 
| Percentage of Participants With Adverse Effects | serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CoQ10, Statins, Myalgia, Muscle Pain, Muscle Weakness