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首页> 外文期刊>The New England journal of medicine >Effects of dalcetrapib in patients with a recent acute coronary syndrome
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Effects of dalcetrapib in patients with a recent acute coronary syndrome

机译：dalcetrapib在近期急性冠脉综合征患者中的作用

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BACKGROUND:In observational analyses, higher levels of high-density lipoprotein (HDL) cholesterol have been associated with a lower risk of coronary heart disease events. However, whether raising HDL cholesterol levels therapeutically reduces cardiovascular risk remains uncertain. Inhibition of cholesteryl ester transfer protein (CETP) raises HDL cholesterol levels and might therefore improve cardiovascular outcomes. METHODS:We randomly assigned 15,871 patients who had had a recent acute coronary syndrome to receive the CETP inhibitor dalcetrapib, at a dose of 600 mg daily, or placebo, in addition to the best available evidence-based care. The primary efficacy end point was a composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, unstable angina, or cardiac arrest with resuscitation. RESULTS:At the time of randomization, the mean HDL cholesterol level was 42 mg per deciliter (1.1 mmol per liter), and the mean low-density lipoprotein (LDL) cholesterol level was 76 mg per deciliter (2.0 mmol per liter). Over the course of the trial, HDL cholesterol levels increased from baseline by 4 to 11% in the placebo group and by 31 to 40% in the dalcetrapib group. Dalcetrapib had a minimal effect on LDL cholesterol levels. Patients were followed for a median of 31 months. At a prespecified interim analysis that included 1135 primary end-point events (71% of the projected total number), the independent data and safety monitoring board recommended termination of the trial for futility. As compared with placebo, dalcetrapib did not alter the risk of the primary end point (cumulative event rate, 8.0% and 8.3%, respectively; hazard ratio with dalcetrapib, 1.04; 95% confidence interval, 0.93 to 1.16; P = 0.52) and did not have a significant effect on any component of the primary end point or total mortality. The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo (P<0.001 for both comparisons). CONCLUSIONS:In patients who had had a recent acute coronary syndrome, dalcetrapib increased HDL cholesterol levels but did not reduce the risk of recurrent cardiovascular events. (Funded by F. Hoffmann-La Roche; dal-OUTCOMES ClinicalTrials.gov number, NCT00658515.)
机译：背景：在观察性分析中，高密度脂蛋白（HDL）胆固醇水平升高与冠心病事件的风险降低有关。但是，提高HDL胆固醇水平是否可以通过治疗降低心血管疾病的风险尚不确定。抑制胆固醇酯转移蛋白（CETP）会升高HDL胆固醇水平，因此可能会改善心血管疾病的预后。方法：我们随机分配了15871例近期患有急性冠状动脉综合征的患者，除可获得的最佳循证护理外，还接受每日600 mg剂量的CETP抑制剂dalcetrapib或安慰剂。主要疗效终点是由冠心病，非致命性心肌梗死，缺血性中风，不稳定型心绞痛或复苏引起的心脏骤停导致的死亡综合。结果：随机分组时，HDL胆固醇的平均水平为每分升42 mg（1.1 mmol /升），低密度脂蛋白（LDL）的平均胆固醇水平为每分升76 mg（2.0 mmol /升）。在整个试验过程中，安慰剂组的HDL胆固醇水平从基线提高了4％至11％，而达塞曲普组的HDL胆固醇水平从基线提高了31％至40％。 Dalcetrapib对LDL胆固醇水平的影响很小。随访患者中位时间为31个月。在预先指定的包括1135个主要终点事件的临时分析中（占预计总数的71％），独立数据和安全监控委员会建议终止试验，以免徒劳。与安慰剂相比，dalcetrapib不会改变主要终点的风险（累积事件发生率，分别为8.0％和8.3％; dalcetrapib的危险比为1.04; 95％的置信区间为0.93至1.16; P = 0.52）和对主要终点或总死亡率的任何组成部分均无明显影响。与安慰剂相比，dalcetrapib的中位C反应蛋白水平高0.2毫克/升，平均收缩压高0.6毫米汞柱（两个比较均P <0.001）。结论：在患有近期急性冠脉综合征的患者中，dalcetrapib增加了HDL胆固醇水平，但并未降低复发性心血管事件的风险。 （由F. Hoffmann-La Roche资助; dal-OUTCOMES ClinicalTrials.gov编号，NCT00658515。）

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