Creatine Supplementation for the Prevention of Statin Myalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Combined visual analog pain scales (0-10) for aching, cramping and weakness
研究概览
简要总结
The purpose of this study is to determine of creatine will prevent or treat the muscle toxicity side effect of statin drug therapy, whose symptoms are aching, cramping, and weakness. This is tested in patients who have had this side effect from 3 different statin drugs.
详细描述
Muscle toxicity is the most common limiting side effect of statin therapy. Biochemical studies have suggested the presence of intramuscular creatine deficiency in patients with muscle toxicity. This is a test of oral creatine supplementation in statin intolerant subjects as a method of preventing the onset of this side effect as well as resolving these symptoms when present during statin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypercholesterolemia in need of aggressive treatment, defined as a high risk of a vascular event, thus subjects with diabetes, pre-diabetes, or known vascular disease
- •intolerance (i.e. muscle toxicity symptoms) of at least 3 statin drugs, each confirmed on rechallenge
排除标准
- •history of elevated CPK or rhabdomyolysis while taking a statin,
- •CPK levels elevated above the normal range at baseline,
- •pregnancy.
- •renal insufficiency, defined as a serum creatinine ≥ 2.0 mg/dl.
- •history of congestive heart failure.
结局指标
主要结局
Combined visual analog pain scales (0-10) for aching, cramping and weakness
时间窗: baseline, after 5 days of creatine loading, after 6 weeks of creatine+statin, after up to 6 weeks on statin without creatine, after 4 days of rechallenge with creatine while still on statin
次要结局
未报告次要终点