Clinical trial NCT01032993: Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Official title: Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Weakness
Cramps
Myalgia or Myositis Nos
HMG COA Reductase Inhibitor Adverse Reaction
Keywords: CoQ10
Statins
Myalgia
Muscle Pain
Muscle Weakness
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2009-12-16
Enrollment: 68
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use
timeFrame: 4 weeks
Secondary outcomes:
measure: Continuation of Statin
timeFrame: 4 weeks
measure: Percentage of Participants With Improvement in Disability Related to Muscle Pain
timeFrame: 4 weeks
measure: Percentage of Participants With Adverse Effects
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Catherine Buettner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: