Gagné Claude, Bays Harold E, Weiss Stuart R, Mata Pedro, Quinto Katherine, Melino Michael, Cho Meehyung, Musliner Thomas A, Gumbiner Barry
Chul du Chuq, Ste-Foy, Quebec, Canada.
Am J Cardiol. 2002 Nov 15;90(10):1084-91. doi: 10.1016/s0002-9149(02)02774-1.
Ezetimibe is a lipid-lowering drug that inhibits the intestinal absorption of dietary and biliary cholesterol by blocking passage across the intestinal wall. The efficacy and safety of adding ezetimibe to ongoing statin therapy in patients with primary hypercholesterolemia was evaluated in a randomized, double-blind, placebo-controlled study. The study group included 769 adults (aged > or =18 years) with primary hypercholesterolemia who had not achieved National Cholesterol Education Program (NCEP) Adult Treatment Panel II goals with dietary alteration and statin monotherapy. Patients receiving a stable dose of a statin for > or =6 weeks were randomized to receive concurrent treatment with placebo (n = 390) or ezetimibe (n = 379), 10 mg/day, in addition to continuing their open-label statin for 8 weeks. The primary efficacy variable was the percent change in low-density lipoprotein (LDL) cholesterol from baseline with statin monotherapy to end point after intervention (secondary variables: high-density lipoprotein [HDL] cholesterol and triglycerides). Ongoing statin therapy plus ezetimibe led to changes of -25.1% for LDL cholesterol (HDL cholesterol +2.7%; triglycerides -14.0%) compared with LDL cholesterol -3.7% (p <0.001), HDL cholesterol +1.0% (p <0.05), and triglycerides -2.9% (p <0.001) for placebo added to ongoing statin therapy. Among patients not at LDL cholesterol goal at on-statin baseline, 71.5% receiving statin plus ezetimibe versus 18.9% receiving statin plus placebo reached goal at end point (odds ratio 23.7; p <0.001). The co-administration of statin and ezetimibe was generally well tolerated. Adding ezetimibe to ongoing statin therapy led to substantial additional reduction in LDL cholesterol levels, facilitating attainment of NCEP goals. Ezetimibe offers a new therapeutic option for patients receiving statins who require further reduction in LDL cholesterol.
依折麦布是一种降脂药物，它通过阻断肠道壁的通道来抑制膳食和胆汁胆固醇的肠道吸收。在一项随机、双盲、安慰剂对照研究中，评估了在原发性高胆固醇血症患者中，将依折麦布添加到正在进行的他汀类药物治疗中的疗效和安全性。研究组包括769名年龄≥18岁的原发性高胆固醇血症成年人，他们通过饮食改变和他汀类药物单药治疗未达到美国国家胆固醇教育计划（NCEP）成人治疗小组II的目标。接受稳定剂量他汀类药物≥6周的患者被随机分配接受安慰剂（n = 390）或依折麦布（n = 379），10毫克/天的联合治疗，同时继续开放标签的他汀类药物治疗8周。主要疗效变量是从他汀类药物单药治疗的基线到干预后终点的低密度脂蛋白（LDL）胆固醇的百分比变化（次要变量：高密度脂蛋白[HDL]胆固醇和甘油三酯）。与正在进行的他汀类药物治疗加安慰剂相比，正在进行的他汀类药物治疗加依折麦布导致LDL胆固醇变化为-25.1%（HDL胆固醇+2.7%；甘油三酯-14.0%），而LDL胆固醇为-3.7%（p<0.001），HDL胆固醇为+1.0%（p<0.05），甘油三酯为-2.9%（p<0.001）。在他汀类药物治疗基线时未达到LDL胆固醇目标的患者中，71.5%接受他汀类药物加依折麦布的患者与18.9%接受他汀类药物加安慰剂的患者在终点时达到目标（优势比23.7；p<0.001）。他汀类药物和依折麦布的联合给药一般耐受性良好。在正在进行的他汀类药物治疗中添加依折麦布可导致LDL胆固醇水平大幅进一步降低，有助于实现NCEP目标。依折麦布为接受他汀类药物治疗且需要进一步降低LDL胆固醇的患者提供了一种新的治疗选择。
