恩格列净对急性心肌梗死后心力衰竭结局的影响：来自 EMPACT-MI 试验的见解。

BACKGROUND: Empagliflozin reduces the risk of heart failure (HF) events in patients with type 2 diabetes at high cardiovascular risk, chronic kidney disease, or prevalent HF irrespective of ejection fraction. Whereas the EMPACT-MI trial (Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients With Acute Myocardial Infarction) showed that empagliflozin does not reduce the risk of the composite of hospitalization for HF and all-cause death, the effect of empagliflozin on first and recurrent HF events after myocardial infarction is unknown. METHODS: EMPACT-MI was a double-blind, randomized, placebo-controlled, event-driven trial that randomized 6522 patients hospitalized for acute myocardial infarction at risk for HF on the basis of newly developed left ventricular ejection fraction of <45% or signs or symptoms of congestion to receive empagliflozin 10 mg daily or placebo within 14 days of admission. In prespecified secondary analyses, treatment groups were analyzed for HF outcomes. RESULTS: Over a median follow-up of 17.9 months, the risk for first HF hospitalization and total HF hospitalizations was significantly lower in the empagliflozin compared with the placebo group (118 [3.6%] versus 153 [4.7%] patients with events; hazard ratio, 0.77 [95% CI, 0.60, 0.98]; =0.031, for first HF hospitalization; 148 versus 207 events; rate ratio, 0.67 [95% CI, 0.51, 0.89]; =0.006, for total HF hospitalizations). Subgroup analysis showed consistency of empagliflozin benefit across clinically relevant patient subgroups for first and total HF hospitalizations. The need for new use of diuretics, renin-angiotensin modulators, or mineralocorticoid receptor antagonists after discharge was less in patients randomized to empagliflozin versus placebo (all <0.05). CONCLUSIONS: Empagliflozin reduced the risk of HF in patients with left ventricular dysfunction or congestion after acute myocardial infarction. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04509674.

背景：恩格列净可降低心血管风险高、慢性肾脏病或有心力衰竭病史的 2 型糖尿病患者的心力衰竭（HF）事件风险，而无论射血分数如何。尽管 EMPACT-MI 试验（恩格列净对急性心肌梗死后因心力衰竭住院和全因死亡风险的影响）表明恩格列净不能降低因心力衰竭住院和全因死亡的复合风险，但恩格列净对心肌梗死后首次和复发心力衰竭事件的影响尚不清楚。

方法：EMPACT-MI 是一项双盲、随机、安慰剂对照、事件驱动的试验，纳入了 6522 例因新发左心室射血分数<45%或充血的体征或症状而有 HF 风险的急性心肌梗死后住院患者，在入院后 14 天内随机接受恩格列净 10mg 每日一次或安慰剂治疗。在预先设定的次要分析中，对治疗组进行了 HF 结局分析。

结果：中位随访 17.9 个月期间，与安慰剂组相比，恩格列净组首次 HF 住院和总 HF 住院的风险显著降低（118[3.6%]例患者发生事件，153[4.7%]例患者发生事件；风险比，0.77[95%CI，0.60，0.98]；=0.031，首次 HF 住院；148 例患者 vs 207 例患者；率比，0.67[95%CI，0.51，0.89]；=0.006，总 HF 住院）。亚组分析显示，恩格列净在首次和总 HF 住院的多个临床相关亚组中均有获益的一致性。与安慰剂相比，随机分配到恩格列净组的患者出院后利尿剂、肾素-血管紧张素调节剂或盐皮质激素受体拮抗剂的新使用需求较少（均<0.05）。

结论：恩格列净降低了急性心肌梗死后左心室功能障碍或充血患者的 HF 风险。

登记：网址：https://www.clinicaltrials.gov；唯一标识符：NCT04509674。