Miami Research Associates, Coral Gables, Florida.
Metab Syndr Relat Disord. 2007 Spring;5(1):13-21. doi: 10.1089/met.2006.0033.
The combination of ezetimibe and simvastatin (EZE/SIMVA) inhibits intestinal absorption and hepatic synthesis of cholesterol, providing significantly greater LDL-C-lowering compared to either drug alone. We examined the efficacy and safety of EZE/SIMVAin hypercholesterolemic patients with metabolic syndrome (MetS).
We evaluated pooled data from three similarly designed, randomized, doubleblinded, placebo-controlled studies in patients with primary hypercholesterolemia. After a 6- to 8-week washout and a 4-week diet/placebo run-in, patients received one of the following 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. For this analysis, the efficacy of EZE/SIMVA versus SIMVA was evaluated in patients with and without MetS. The primary endpoint was mean percent change from baseline in LDL-C for EZE/SIMVA (pooled across doses) versus SIMVA (pooled across doses).
Of 2394 patients who received SIMVA or EZE/SIMVA and for whom MetS status at baseline could be determined, 31% were identified as having MetS. In the entire cohort, treatment with EZE/SIMVA led to a significant incremental reduction in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B, triglyceride (TG), and C-reactive protein compared to SIMVA and these effects were similar across the MetS and non-MetS subgroups. EZE/SIMVA was well tolerated in both the MetS and non-MetS subgroups.
EZE/SIMVA significantly improved the lipid and inflammatory profiles of hypercholesterolemic patients with MetS and was well tolerated. Thus, EZE/SIMVA offers an efficacious and safe treatment option for these patients.
依折麦布与辛伐他汀（EZE/SIMVA）联合抑制胆固醇的肠吸收和肝脏合成，与单独使用任一药物相比，能显著降低 LDL-C。我们评估了 EZE/SIMVA 在代谢综合征（MetS）合并高胆固醇血症患者中的疗效和安全性。
我们对三项设计相似、随机、双盲、安慰剂对照的原发性高胆固醇血症患者研究的数据进行了汇总分析。在 6-8 周洗脱期和 4 周饮食/安慰剂导入期后，患者接受以下治疗之一，持续 12 周：EZE/SIMVA（10/10、10/20、10/40 或 10/80mg）；SIMVA（10、20、40 或 80mg）；EZE 10mg；或安慰剂。在这项分析中，评估了 EZE/SIMVA 相对于 SIMVA 在有和无 MetS 的患者中的疗效。主要终点是 EZE/SIMVA（各剂量组汇总）与 SIMVA（各剂量组汇总）相比，LDL-C 自基线的平均百分比变化。
在接受 SIMVA 或 EZE/SIMVA 治疗且基线时 MetS 状态可确定的 2394 例患者中，31%被确定为患有 MetS。在整个队列中，与 SIMVA 相比，EZE/SIMVA 治疗导致低密度脂蛋白胆固醇（LDL-C）、非高密度脂蛋白胆固醇（非-HDL-C）、载脂蛋白 B、甘油三酯（TG）和 C 反应蛋白显著降低，这些作用在 MetS 和非 MetS 亚组中相似。EZE/SIMVA 在 MetS 和非 MetS 亚组中均耐受良好。
EZE/SIMVA 显著改善了 MetS 合并高胆固醇血症患者的血脂和炎症谱，且耐受良好。因此，EZE/SIMVA 为这些患者提供了一种有效且安全的治疗选择。
