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

Phase 2

Completed

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

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Coenzyme Q10	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use	4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Continuation of Statin	4 weeks	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.
Percentage of Participants With Improvement in Disability Related to Muscle Pain	4 weeks	Disability improvement was based on patient report of improvement they felt was meaningful to them
Percentage of Participants With Adverse Effects	4 weeks	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.