Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes2型糖尿病：依帕列净、心血管转归和死亡 The effects of empagliflozin, an inhibitor of sodium–glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. 依帕列净是一种钠离子-葡萄糖协同转运蛋白2抑制剂。对于高心血管风险的2型糖尿病患者，该药物联合常规治疗对心血管疾病风险和死亡风险的影响仍然未知。 We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. 我们随机招募了2型糖尿病患者参与本研究，所有受试者每天服用10 mg或25 mg的依帕列净或安慰剂。研究的主要复合终点为心因性死亡、非致死性心肌梗塞或非致死性脑卒中，相关结果通过比较依帕列净组和安慰剂组之间的差异得出。次要研究终点为主要终点+不稳定型心绞痛住院。 A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P=0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events. 共计7020名患者纳入本研究（中位观察时间3.1年）。依帕列净组的4687名受试者中，共有490人达到研究终点（10.5%），而安慰剂组为282人/2333人（12.1%）。两个组别之间的心肌梗塞或脑卒中发生率并无明显差异，但依帕列净组的下列几个指标明显更低：心因性死亡率（3.7%, vs. 5.9%；相对危险降低率38%）、心衰入院率（2.7%和4.1%；相对危险降低率35%）、全因死亡率（5.7%和8.3%；相对危险降低率32%）。次要研究终点并无显著差异。依帕列净组受试者的生殖道感染风险更高，但其余不良事件发生率并无差异。 Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care. 对于高心血管风险的2型糖尿病患者而言，常规药物治疗联合依帕列净可降低主要心血管复合终点风险和全因死亡风险。 参考文献 Zinman, B., et al., Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine, 2015. 373(22): p. 2117-2128. |
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