Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction in Low density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.
详细描述
Ezetimibe, a cholesterol-absorption inhibitor, significantly lowers low-density lipoprotein cholesterol (LDL-C) when administered in addition to statin treatment. The effect of ezetimibe on the incidence and progression of vascular disease is elusive. Therefore, our objective was to examine the effects of fluvastatin and fluvastatin plus ezetimibe on lipoprotein subfractions in patients with diabetes mellitus and/or coronary heart disease.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CHD or CHD equivalent with LDL 100-160 mg/dl
- •Male or female sex
- •Normal values of CK, AST and ALT
- •Normal kidney function
排除标准
- •CHD Stage III-IV
- •St. p. myocardial infarction or coronary artery bypass grafting
- •Pregnancy or breastfeeding
- •Premenopausal women without certain contraception
- •Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib
研究组 & 干预措施
Fluvastatin
Fluvastatin 80 mg MR
干预措施: fluvastatin (Drug)
Fluvastatin + Ezetimibe
Fluvastatin MR 80 mg plus Ezetimibe 10 mg
干预措施: Fluvastatin plus ezetimibe (Drug)
结局指标
主要结局
Reduction in Low density lipoprotein cholesterol (LDL-C)
时间窗: week 6 and 12
次要结局
- Total cholesterol, triglycerides, HDL-C, lipoprotein subfractions, hs-CRP(week 6 and 12)
- adverse events, CK elevation, liver enzyme elevation(week 6, 12)