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

Catherine Buettner68 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

Coenzyme Q10DIETARY_SUPPLEMENT

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.