BACKGROUND AND PURPOSE Moderate-intensity statin plus ezetimibe versus high-intensity statin alone may provide a greater low-density lipoprotein cholesterol (LDL-C) reduction in patients with recent ischemic stroke. METHODS This randomized, open-label, controlled trial assigned patients with recent ischemic stroke <90 days to rosuvastatin/ezetimibe 10/10 mg once daily (ROS10/EZT10) or to rosuvastatin 20 mg once daily (ROS20). The primary endpoint was LDL-C reduction ≥50% from baseline at 90 days. Key secondary endpoints were LDL-C <70 mg/dL and multiple lipid goal achievement, and composite of major vascular events. RESULTS Of 584 randomized, 530 were included in the modified intention-to-treat analysis. The baseline LDL-C level was 130.2±34.7 mg/dL in the ROS10/EZT10 group and 131.0±33.9 mg/dL in the ROS20 group. The primary endpoint was achieved in 198 patients (72.5%) in the ROS10/EZT10 group and 148 (57.6%) in the ROS20 group (odds ratio [95% confidence interval], 1.944 [1.352-2.795]; P= 0.0003). LDL-C level <70 mg/dL was achieved in 80.2% and 65.4% in the ROS10/EZT10 and ROS20 groups (P=0.0001). Multiple lipid goal achievement rate was 71.1% and 53.7% in the ROS10/EZT10 and ROS20 groups (P<0.0001). Major vascular events occurred in 1 patient in the ROS10/EZT10 group and 9 in the ROS20 group (P=0.0091). The adverse event rates did not differ between the two groups. CONCLUSION Moderate-intensity rosuvastatin plus ezetimibe was superior to high-intensity rosuvastatin alone for intensive LDL-C reduction in patients with recent ischemic stroke. With the combination therapy, more than 70% of patients achieved LDL-C reduction ≥50% and 80% had an LDL-C <70 mg/dL at 90 days.

中文翻译：

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中等强度瑞舒伐他汀加依折麦布与高强度瑞舒伐他汀对近期缺血性中风患者目标低密度脂蛋白胆固醇目标的影响：一项随机对照试验。

背景和目的 与单独使用高强度他汀类药物相比，中等强度他汀类药物加依折麦布可使近期缺血性卒中患者的低密度脂蛋白胆固醇 (LDL-C) 降低更多。方法 该随机、开放标签、对照试验将近期发生 <90 天的缺血性卒中患者分配至瑞舒伐他汀/依折麦布 10/10 mg 每日一次 (ROS10/EZT10) 或瑞舒伐他汀 20 mg 每日一次 (ROS20)。主要终点是 90 天时 LDL-C 较基线降低≥50%。关键的次要终点是 LDL-C <70 mg/dL 和多重脂质目标实现，以及主要血管事件的复合。结果 在 584 例随机分组中，530 例被纳入改良意向治疗分析。ROS10/EZT10组的基线LDL-C水平为130.2±34.7 mg/dL，ROS20组为131.0±33.9 mg/dL。ROS10/EZT10 组的 198 名患者 (72.5%) 和 ROS20 组的 148 名患者 (57.6%) 达到了主要终点（比值比 [95% 置信区间]，1.944 [1.352-2.795]；P = 0.0003）。在 ROS10/EZT10 和 ROS20 组中，80.2% 和 65.4% 的 LDL-C 水平 <70 mg/dL (P=0.0001)。ROS10/EZT10 和 ROS20 组的多重脂质目标达成率分别为 71.1% 和 53.7% (P<0.0001)。ROS10/EZT10 组 1 例患者和 ROS20 组 9 例患者发生主要血管事件 (P=0.0091)。不良事件发生率在两组之间没有差异。结论 中等强度瑞舒伐他汀加依折麦布在近期缺血性卒中患者强化 LDL-C 降低方面优于单独高强度瑞舒伐他汀。通过联合治疗，