utraceuticals in the management of statin associated muscle symptoms (SAMS) in statin-intolerant participants.

Curtin University0 个研究点目标入组 49 人开始时间: 2018年4月24日最近更新: 2021年11月22日

适应症

试验速览

暂无简介。

•Patients who are intolerant to statins and not currently achieving lipid targets (fasting LDL-c >1.8 mmol/L and <7 mmol/L). Statin intolerance will be defined as an inability to tolerate 2 or more statins, one at a low dose, due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued. Low dose statin therapy is defined as an average daily dose of rosuvastatin 5mg, atorvastatin 10mg, simvastatin 10mg, lovastatin 20mg, pravastatin 40mg, fluvastatin 40mg or pitavastatin 2mg. Patients tolerating very low dose statin therapy (rosuvastatin <5mg, atorvastatin <10mg, simvastatin <10mg, lovastatin <20mg, pravastatin <40mg, fluvastatin <40mg or pitavastatin <2mg) are considered to be intolerant to that low dose statin.

•- Participants with pre-existing coronary artery disease (calcium score >0, previous coronary event) who are currently taking Ezetimibe or other cholesterol-lowering medication
•- No documented statin intolerance
•- Abnormal biochemistry at screening suggestive of an additional underlying cause of statin intolerance
•- Pregnant or lactating women
•- Inability to provide informed written consent.

发起方