Petrie Mark C, Udell Jacob A, Anker Stefan D, Harrington Josephine, Jones W Schuyler, Mattheus Michaela, Gasior Tomasz, van der Meer Peter, Amir Offer, Bahit M Cecilia, Bauersachs Johann, Bayes-Genis Antoni, Chopra Vijay K, Januzzi James L, Lopes Renato D, Ponikowski Piotr, Rossello Xavier, Schou Morten, Zieroth Shelley, Brueckmann Martina, Sumin Mikhail, Bhatt Deepak L, Hernandez Adrian F, Butler Javed
School of Cardiovascular and Medical Sciences, British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Women's College Hospital and Peter Munk Cardiac Centre, Toronto General Hospital, University of Toronto, Toronto, ON, Canada.
Eur J Heart Fail. 2025 Mar;27(3):577-588. doi: 10.1002/ejhf.3548. Epub 2024 Dec 26.
In the EMPACT-MI trial, empagliflozin reduced heart failure (HF) hospitalizations but not mortality in acute myocardial infarction (MI). Contemporary reports of clinical event rates with and without type 2 diabetes mellitus (T2DM) in acute MI trials are sparse. The treatment effect of empagliflozin in those with and without T2DM in acute MI is unknown.
A total of 6522 patients with acute MI with newly reduced left ventricular ejection fraction (LVEF) to <45%, congestion, or both, were randomized to empagliflozin 10 mg or placebo. The primary endpoint was time to first HF hospitalization or all-cause death. Rates of endpoints with and without T2DM and the efficacy and safety of empagliflozin according to T2DM status were assessed. Overall, 32% had T2DM; 14% had pre-diabetes; 16% were normoglycaemic; 38% had unknown glycaemic status. Patients with T2DM, compared to those without T2DM, were at higher risk of time to first HF hospitalization or all-cause death (hazard ratio [HR] 1.44; 95% confidence interval [CI] 1.06-1.95) and all-cause death (HR 1.70; 95% CI 1.13-2.56). T2DM did not confer a higher risk of first HF hospitalization (HR 1.22, 95% CI 0.82-1.83). Empagliflozin reduced first and total HF hospitalizations, but not all-cause mortality, regardless of presence or absence of T2DM. The safety profile of empagliflozin was the same with and without T2DM.
Patients with acute MI, LVEF <45% and/or congestion who had T2DM were at a higher risk of mortality than those without T2DM. Empagliflozin reduced first and total HF hospitalizations regardless of the presence or absence of T2DM.
在EMPACT-MI试验中，恩格列净可减少急性心肌梗死（MI）患者的心力衰竭（HF）住院率，但不能降低死亡率。目前关于急性心肌梗死试验中伴有和不伴有2型糖尿病（T2DM）的临床事件发生率的报道较少。恩格列净在急性心肌梗死伴有和不伴有T2DM患者中的治疗效果尚不清楚。
共有6522例急性心肌梗死患者，其左心室射血分数（LVEF）新降低至<45%、出现充血或两者兼有，被随机分为恩格列净10毫克组或安慰剂组。主要终点是首次HF住院或全因死亡的时间。评估了伴有和不伴有T2DM的终点事件发生率以及根据T2DM状态评估恩格列净的疗效和安全性。总体而言，32%的患者患有T2DM；14%的患者患有糖尿病前期；16%的患者血糖正常；38%的患者血糖状态未知。与不患有T2DM的患者相比，患有T2DM的患者首次HF住院或全因死亡的风险更高（风险比[HR]1.44；95%置信区间[CI]1.06-1.95）以及全因死亡风险更高（HR 1.70；95%CI 1.13-2.56）。T2DM并未使首次HF住院风险更高（HR 1.22，95%CI 0.82-1.83）。无论是否存在T2DM，恩格列净均可减少首次和总的HF住院率，但不能降低全因死亡率。恩格列净在伴有和不伴有T2DM患者中的安全性特征相同。
急性心肌梗死、LVEF<45%和/或出现充血且患有T2DM的患者比不患有T2DM的患者死亡风险更高。无论是否存在T2DM，恩格列净均可减少首次和总的HF住院率。
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