Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use
时间窗: 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
次要结局
- 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)
研究者
Catherine Buettner
Physician
Beth Israel Deaconess Medical Center