Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.
研究概览
简要总结
This study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a history of statin-related myopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of muscle symptoms occuring within 3 weeks of starting a statin
- •need for statin therapy to achieve LDL target according to the 2009 Canadian Lipid Guidelines
- •willingness to re-try statin therapy
排除标准
- •currently tolerant of statin therapy
- •metabolic or inflammatory myopathy
- •known neuropathy
- •CK elevation >3 times upper limit of normal (ULN) previously on a statin or history of rhabdomyolysis
- •pregnant, breastfeeding, or wanting to become pregnant in the near future
- •participation in another clinical trial
- •other medical condition associated with decreased life span
- •inability to adhere to stringent regimen
- •unwilling to stop consumption of grapefruit juice
- •Subset of 5 patients also completing neuromuscular testing:
- •Inclusion Criteria:
- •same as above
- •Exclusion Criteria:
- •same as above but also:
- •angina III of IV
- •decompensated heart failure
- •history of orthopedic problems
- •have any skin ulcers or other non-healed skin areas or infections in the arm or leg
研究组 & 干预措施
Statin
Individual-specific statin causing myopathy - i.e., Patients will receive the specific statin previously associated with myopathic symptoms in them (can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the doses causing symptoms previously).
干预措施: Individual-specific statin causing myopathy (Drug)
Placebo
Identical placebo to patient-specific statin
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy.
时间窗: Duration of study September 2010 to August 2013
次要结局
- To delineate the relation of objective changes in non-invasive neuromuscular testing to subjective symptoms during the first exposure to active or placebo therapy, in subset of 5 patients with prior history of statin myopathy.(September 2010 to August 2013)
研究者
Tisha Joy
Assistant Professor, Division of Endocrinology
Lawson Health Research Institute