Knopp R H, Dujovne C A, Le Beaut A, Lipka L J, Suresh R, Veltri E P
Northwest Lipid Research Clinic, University of Washington, 325 Ninth Avenue, Room 465, Mailstop 359720, Seattle, WA 98104, USA.
Int J Clin Pract. 2003 Jun;57(5):363-8.
Ezetimibe is a novel cholesterol absorption inhibitor that blocks intestinal absorption of dietary and biliary cholesterol. Data from 1719 patients who participated in two multicentre, double-blind studies of ezetimibe were pooled to evaluate the drug's efficacy and safety in patients with primary hypercholesterolaemia. Following dietary stabilisation, a two- to 12-week washout period, and a four-week, single-blind, placebo lead-in period, patients were randomised to ezetimibe 10 mg or placebo once daily in the morning for 12 consecutive weeks. The primary efficacy endpoint was percent reduction in plasma low-density lipoprotein (LDL)-cholesterol from baseline at endpoint. Ezetimibe reduced LDL-cholesterol by a mean of 18.2% compared with an increase of 0.9% with placebo (p<0.01) and resulted in favourable, statistically significant changes in HDL-cholesterol, triglycerides and apo B. The response to ezetimibe was consistent across all subgroups analysed. Ezetimibe was well tolerated, with a safety profile similar to placebo.
依折麦布是一种新型胆固醇吸收抑制剂，可阻断膳食和胆汁胆固醇的肠道吸收。汇总了1719名参与两项依折麦布多中心、双盲研究患者的数据，以评估该药物在原发性高胆固醇血症患者中的疗效和安全性。在饮食稳定、为期2至12周的洗脱期以及为期4周的单盲、安慰剂导入期之后，患者被随机分为每日早晨一次服用10 mg依折麦布或安慰剂，连续服用12周。主要疗效终点是终点时血浆低密度脂蛋白（LDL）胆固醇相对于基线的降低百分比。与安慰剂组升高0.9%相比，依折麦布使LDL胆固醇平均降低了18.2%（p<0.01），并使高密度脂蛋白胆固醇、甘油三酯和载脂蛋白B发生了有利的、具有统计学意义的变化。在所有分析的亚组中，对依折麦布的反应是一致的。依折麦布耐受性良好，安全性与安慰剂相似。
