本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2314051

摘要内容如下：

背景

恩帕格列嗪可改善心力衰竭患者、心血管高危的2型糖尿病患者和慢性肾病患者的心血管结局。恩帕格列嗪在急性心肌梗死患者中的安全性和有效性尚不清楚。

方法

在这项事件驱动、双盲、随机、安慰剂对照试验中，我们以1:1的比例将因急性心肌梗死住院且有心力衰竭风险的患者在入院后14天内除接受标准治疗外，还接受恩帕格列嗪（剂量为10 mg/日）或安慰剂治疗。主要终点是在首次事件时间分析中评估的因心力衰竭住院或任何原因死亡的复合终点。

结果

共有3260名患者接受恩帕格列嗪治疗，3262名患者接受安慰剂治疗。在中位数为17.9个月的随访期间，恩帕格列嗪组和安慰剂组分别有267例（8.2%）和298例（9.1%）患者首次因心力衰竭或任何原因死亡而住院，事件发生率分别为5.9和6.6/100患者-年（风险比为0.90；95%置信区间[CI]，0.76至1.06；P=0.21）。就主要终点的各个组成部分而言，恩帕格列嗪组中有118名患者（3.6%）首次因心力衰竭住院，安慰剂组中有153名患者（4.7%）首次因心力衰竭住院（风险比为0.77；95%CI为0.60-0.98），169例（5.2%）和178例（5.5%）患者因任何原因死亡（风险比为0.96；95%置信区间，0.78至1.19）。不良事件与恩帕格列嗪的已知安全性一致，并且在两个试验组中相似。

结论

在急性心肌梗死后心力衰竭风险增加的患者中，与安慰剂相比，恩帕格列嗪治疗并未显著降低首次因心力衰竭住院或因任何原因死亡的风险。（由勃林格殷格翰（Boehringer Ingelheim）和礼来（Eli Lilly）资助；EMPACT-MI ClinicalTrials.gov编号，NCT04509674。）

英文原文如下：

Abstracts

BACKGROUND  Empagliflozin improves cardiovascular outcomes in patients with heart failure, patients with type 2 diabetes who are at high cardiovascular risk, and patients with chronic kidney disease. The safety and efficacy of empagliflozin in patients who have had acute myocardial infarction are unknown.

METHODS  In this event-driven, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, patients who had been hospitalized for acute myocardial infarction and were at risk for heart failure to receive empagliflozin at a dose of 10 mg daily or placebo in addition to standard care within 14 days after admission. The primary end point was a composite of hospitalization for heart failure or death from any cause as assessed in a time-to-first-event analysis.

RESULTS  A total of 3260 patients were assigned to receive empagliflozin and 3262 to receive placebo. During a median follow-up of 17.9 months, a first hospitalization for heart failure or death from any cause occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years (hazard ratio, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P = 0.21). With respect to the individual components of the primary end point, a first hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and in 153 patients (4.7%) in the placebo group (hazard ratio, 0.77; 95% CI, 0.60 to 0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (hazard ratio, 0.96; 95% CI, 0.78 to 1.19). Adverse events were consistent with the known safety profile of empagliflozin and were similar in the two trial groups.

CONCLUSIONS  Among patients at increased risk for heart failure after acute myocardial infarction, treatment with empagliflozin did not lead to a significantly lower risk of a first hospitalization for heart failure or death from any cause than placebo. (Funded by Boehringer Ingelheim and Eli Lilly; EMPACT-MI ClinicalTrials.gov number, NCT04509674.).

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