Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia
Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia
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DOI：
10.1016/s0195-668x(02)00807-2
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发表时间：
2003-04-01
影响因子：
39.3
通讯作者：
Veltri, EP
中科院分区：
文献类型：
--
作者：
Knopp, RH;Gitter, H;Veltri, EP
这项随机、双盲、安慰剂对照的研究。平行组研究评估了依zetimibe 10mg /天治疗原发性高胆固醇血症患者的安全性和有效性。方法和结果在饮食稳定、2-12周的洗脱期和4周的单盲安慰剂引入期后，827例基线低密度脂蛋白胆固醇（LDL-C）大于或等于3.36 mmol/l （130 mg/dl）至小于或等于6.47 mmol/l （250 mg/dl）、甘油三酯小于或等于3.95 mmol/l （350 mg/dl）的患者按3:1随机分组，接受依zetimibe 10 mg或安慰剂治疗，每天早上口服一次，持续12周。主要疗效终点是直接血浆LDL-C降低百分比。依zetimibe从基线到终点平均降低了17.7%的直接LDL-C，而安慰剂则增加了0.8%
Aims This randomized, double-blind, placebo-controlled,. parallel-group study evaluated the safety and efficacy of ezetimibe 10 mg/day in patients with primary hypercholesterolemia.Methods and results Following dietary stabilization, a 2-12-week washout period, and a 4-week, single-blind, placebo lead-in period, 827 patients with baseline low-density lipoprotein cholesterol (LDL-C) greater than or equal to3.36 mmol/l (130 mg/dl) to less than or equal to6.47 mmol/l (250 mg/dl) and triglycerides less than or equal to3.95 mmol/l (350 mg/dl) were randomized 3:1 to receive ezetimibe 10 mg or placebo orally once daily in the morning for 12 weeks. The primary efficacy endpoint was percentage reduction in direct plasma LDL-C. Ezetimibe reduced direct LDL-C by a mean of 17.7% from baseline to endpoint, compared with an increase of 0.8% with placebo (P