A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia
A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia
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DOI：
10.1016/j.clinthera.2004.11.016
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发表时间：
2004-11-01
影响因子：
3.2
通讯作者：
Donahue, SR
中科院分区：
文献类型：
--
作者：
Bays, HE;Ose, L;Donahue, SR
目标：本研究的目的是评价依折麦布/辛伐他汀的疗效和安全性相对于依折麦布（埃泽）和辛伐他汀（SIMVA）单药治疗，（埃泽/SIMVA）联合片剂治疗原发性高胆固醇血症患者。方法：这是一项随机、多中心、双盲、安慰剂对照、析因设计研究。经过6- 8周的洗脱期和4周的单盲安慰剂导入期后，高胆固醇血症患者（低密度脂蛋白胆固醇[LDL-C]，145-250 mg/dL;甘油三酯[TG]，小于或等于350 mg/dL）随机平均分配至10种每日治疗之一，持续12周：埃泽/SIMVA 10/10、10/20、10/40或10/80 mg; SIMVA 10、20、40或80 mg;埃泽10 mg;或安慰剂。主要疗效分析为LDL-C自基线至研究终点的平均百分比变化。次要终点包括其他血脂变量和C-反应蛋白[CRP]的百分比变化。结果：共有1528例患者随机接受治疗（792例女性，736例男性）;合并治疗组的平均（SD）年龄范围为54.9（11.2）岁至56.4（10.6）岁。治疗组的基线人口统计学分布均衡。合并埃泽/SIMVA与合并SIMVA或单独埃泽相比，LDL-C降低更大（P < 0.001）。根据剂量，埃泽/SIMVA与LDL-C降低-44.8%至-60.2%、非高密度脂蛋白胆固醇降低-40.5%至-55.7%和TG降低-22.5%至-30.7%相关;高密度脂蛋白胆固醇升高5.5%至9.8%。埃泽/SIMVA与CRP和残粒样胆固醇的降低相关性大于SIMVA单独治疗（P < 0.001）。与SIMVA相比，接受埃泽/SIMVA治疗的患者中达到LDL-C浓度的患者更多
Objective: The purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin (EZE/SIMVA) combination tablet, relative to ezetimibe (EZE) and simvastatin (SIMVA) monotherapy, in patients with primary hypercholesterolemia.Methods: This was a randomized, multicenter, double-blind, placebo-controlled, factorial design study After a 6- to 8-week washout period and 4-week, single-blind, placebo run in, hypercholesterolemic patients (low-density lipoprotein cholesterol [LDL-C], 145-250 mg/dL; triglycerides [TG], less than or equal to350 mg/dL) were randomized equally to 1 of 10 daily treatments for 12 weeks: EZE/SIMVA 10/10, 10/20, 10/40, or 10/80 mg; SIMVA 10, 20, 40, or 80 mg; EZE 10 mg; or placebo. The primary efficacy analysis was mean percent change from baseline in LDL-C to study end point. Secondary end points included percent changes in other lipid variables and C-reactive protein [CRP].Results: There were 1528 patients randomized to treatment (792 women, 736 men); mean (SD) age ranged from 54.9 (11.2) years to 56.4 (10.6) years across pooled treatment groups. The treatment groups were well balanced for baseline demographics. Pooled EZE/SIMVA was associated with greater reductions in LDL-C than pooled SIMVA or EZE alone (P < 0.001). Depending on dose, EZE/SIMVA was associated with reductions in LDL-C of -44.8% to -60.2%, non-high-density lipoprotein cholesterol of -40.5% to -55.7%, and TG of -22.5% to -30.7%; high-density lipoprotein cholesterol increased by 5.5% to 9.8%. EZE/SIMVA was associated with greater reductions in CRP and remnant-like particle-cholesterol than SIMVA alone (P < 0.001). More patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations