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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pain; Weakness; Cramps; Myalgia or Myositis Nos; HMG COA Reductase Inhibitor Adverse Reaction	Dietary Supplement: Coenzyme Q10; Other: Placebo	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	68 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Study Start Date :	December 2009
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	May 2016

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 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.	Dietary Supplement: Coenzyme Q10; 300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks
Placebo Comparator: 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.	Other: Placebo; Placebo (three chewable tablets) 2 times daily for 4 weeks

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use [ Time Frame: 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 :

1. Continuation of Statin [ Time Frame: 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.
2. Percentage of Participants With Improvement in Disability Related to Muscle Pain [ Time Frame: 4 weeks ]
   Disability improvement was based on patient report of improvement they felt was meaningful to them
3. Percentage of Participants With Adverse Effects [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Catherine Buettner

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:	Catherine Buettner, MD, MPH	Beth Israel Deaconess Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Catherine Buettner, Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01032993 History of Changes
Other Study ID Numbers:	K23AR055664 ( U.S. NIH Grant/Contract )
First Posted:	December 16, 2009
Results First Posted:	January 23, 2017
Last Update Posted:	January 23, 2017
Last Verified:	November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	No consent for sharing IPD from trial participants was obtained when this clinical trial began

Keywords provided by Catherine Buettner, Beth Israel Deaconess Medical Center:

CoQ10; Statins; Myalgia; Muscle Pain; Muscle Weakness

Additional relevant MeSH terms:

Myositis; Myalgia; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Coenzyme Q10	Ubiquinone; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Micronutrients; Growth Substances; Physiological Effects of Drugs; Vitamins