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

NCT01032993 | Completed Phase 2 Results

• 1 other identifier: K23AR055664
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

CoQ10; Statins; Myalgia; Muscle Pain; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Continuation of Statin

  4 weeks

• Percentage of Participants With Improvement in Disability Related to Muscle Pain

  4 weeks

• Percentage of Participants With Adverse Effects

  4 weeks

Study Arms (2)

Coenzyme Q10

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Coenzyme Q10 DIETARY_SUPPLEMENT

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

Coenzyme Q10

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catherine Buettner: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pain; Asthenia; Muscle Cramp; Myalgia; Myositis, Inclusion Body; Muscle Weakness

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Nervous System Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myositis; Pathologic Processes

Limitations and Caveats

100 participants were planned to achieve \>50 randomized. However, due to slow recruiting, the CoQ10 and placebo expired and we were unable to obtain more. Therefore only 68 participants were enrolled and ultimately 39 participants were randomized.

Results Point of Contact

• Title: Catherine Buettner, MD MPH, Assistant Professor of Medicine
• Organization: BIDMC

cbuettne@bidmc.harvard.edu

617-754-9600

Study Officials

• Catherine Buettner, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 23, 2017
• Results First Posted: January 23, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)