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

This study has been completed.

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Catherine Buettner, Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT01032993

First received: December 15, 2009

Last updated: November 29, 2016

Last verified: November 2016

History of Changes

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

Resource links provided by NLM:

Genetics Home Reference related topics: idiopathic inflammatory myopathy

MedlinePlus related topics: Statins

Drug Information available for: Ubidecarenone

Genetic and Rare Diseases Information Center resources: Idiopathic Inflammatory Myopathy

U.S. FDA Resources

Further study details as provided by Catherine Buettner, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

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:

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.
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
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.


Enrollment:	68
Study Start Date:	December 2009
Study Completion Date:	May 2016
Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032993

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


Responsible Party:	Catherine Buettner, Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT01032993 History of Changes
Other Study ID Numbers:	K23AR055664 ( US NIH Grant/Contract Award Number )
Study First Received:	December 15, 2009
Results First Received:	October 7, 2016
Last Updated:	November 29, 2016
Individual Participant Data
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 Coenzyme Q10 Ubiquinone Micronutrients Growth Substances Physiological Effects of Drugs Vitamins

ClinicalTrials.gov processed this record on June 23, 2017

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