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[大学生论坛]:冰片乙酯用于高甘油三酯血症的心血管风险降低

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Sherrylxy 发表于 2019-1-3 22:32:03 | 显示全部楼层 |阅读模式
本帖最后由 Sherrylxy 于 2019-1-3 22:37 编辑

Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia
冰片乙酯用于高甘油三酯血症的心血管风险降低

BACKGROUND
Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its effects on ischemic events.
背景
甘油三酯水平升高的患者发生缺血事件的风险增加。冰片乙酯乙基,一种高度纯化的二十碳五烯酸乙酯,可降低甘油三酯水平,但需要数据来确定其对缺血事件的影响


METHODS
We performed a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter (1.52 to 5.63 mmol per liter) and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter). The patients were randomly assigned to receive 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
方法
我们进行了一项多中心,随机,双盲,安慰剂对照试验,该试验涉及已确诊为心血管疾病或糖尿病及其他危险因素的患者,他们接受过他汀类药物治疗,其甘油三酯水平为每分升135至499毫克(每升1.52至5.63mmol)和低密度脂蛋白胆固醇水平为41至100mg /分升(1.06至2.59mmol / L)。患者被随机分配接受2g每日两次(总日剂量,4g)或安慰剂的冰片乙酯。主要终点是心血管死亡,非致死性心肌梗死,非致死性卒中,冠状动脉血运重建或不稳定型心绞痛的综合。关键的次要终点是心血管死亡,非致死性心肌梗死或非致死性卒中的综合。

RESULTS
A total of 8179 patients were enrolled (70.7% for secondary prevention of cardiovascular events) and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001). The rates of additional ischemic end points, as assessed according to a prespecified hierarchical schema, were significantly lower in the icosapent ethyl group than in the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%; hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P=0.03). A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06).
结果
共招募了8179名患者(70.7%用于心血管事件的二级预防),随访时间中位数为4。9年。在冰片乙基组中,17.2%的患者发生主要终点事件,而安慰剂组患者为22.0%(风险比,0.75; 95%置信区间[CI],0.68至0.83; P <0.001);关键次要终点的相应率分别为11.2%和14.8%(风险比,0.74; 95%CI,0.65至0.83; P <0.001)。根据预先设定的等级方案评估的额外缺血终点的比率在冰片乙基组中显着低于安慰剂组,包括心血管死亡率(4.3%对比5.2%;风险比,0.80; 95%CI,0.66至0.98; P = 0.03)。冰片乙基组患者比安慰剂组患者住院治疗房颤或扑动(3.1%vs。2.1%,P = 0.004)。 冰片乙酯组中2.7%的患者出现严重出血事件,安慰剂组出现2.1%(P = 0.06)。

CONCLUSIONS
Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo.
结论
尽管使用他汀类药物,甘油三酯水平升高的患者中,每天接受2克冰片乙酯治疗的患者缺血事件(包括心血管死亡)的风险显着低于服用安慰剂的患者。


作者:Deepak L. Bhatt, M.D., M.P.H., P. Gabriel Steg, M.D., Michael Miller, M.D., Eliot A. Brinton, M.D., Terry A. Jacobson, M.D., Steven B. Ketchum, Ph.D., Ralph T. Doyle, Jr., B.A., Rebecca A. Juliano, Ph.D., Lixia Jiao, Ph.D., Craig Granowitz, M.D., Ph.D., Jean-Claude Tardif, M.D., and Christie M. Ballantyne, M.D. for the REDUCE-IT Investigators*期刊名称:新英格兰医学杂志发表时间:2019-1-3N Engl J Med 2019; 380:11-22
DOI: 10.1056/NEJMoa1812792

15商务英语班 刘雪怡 3151204010





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