Department of Internal Medicine, Division of Cardiology, Medical University of Graz, Auenbruggerplatz 15, 8036 Graz, Austria.
Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Auenbruggerplatz 15, 8036 Graz, Austria.
Eur Heart J. 2022 Nov 1;43(41):4421-4432. doi: 10.1093/eurheartj/ehac494.
Sodium-glucose co-transporter 2 inhibition reduces the risk of hospitalization for heart failure and for death in patients with symptomatic heart failure. However, trials investigating the effects of this drug class in patients following acute myocardial infarction are lacking.
In this academic, multicentre, double-blind trial, patients (n = 476) with acute myocardial infarction accompanied by a large creatine kinase elevation (>800 IU/L) were randomly assigned to empagliflozin 10 mg or matching placebo once daily within 72 h of percutaneous coronary intervention. The primary outcome was the N-terminal pro-hormone of brain natriuretic peptide (NT-proBNP) change over 26 weeks. Secondary outcomes included changes in echocardiographic parameters. Baseline median (interquartile range) NT-proBNP was 1294 (757-2246) pg/mL. NT-proBNP reduction was significantly greater in the empagliflozin group, compared with placebo, being 15% lower [95% confidence interval (CI) -4.4% to -23.6%] after adjusting for baseline NT-proBNP, sex, and diabetes status (P = 0.026). Absolute left-ventricular ejection fraction improvement was significantly greater (1.5%, 95% CI 0.2-2.9%, P = 0.029), mean E/e' reduction was 6.8% (95% CI 1.3-11.3%, P = 0.015) greater, and left-ventricular end-systolic and end-diastolic volumes were lower by 7.5 mL (95% CI 3.4-11.5 mL, P = 0.0003) and 9.7 mL (95% CI 3.7-15.7 mL, P = 0.0015), respectively, in the empagliflozin group, compared with placebo. Seven patients were hospitalized for heart failure (three in the empagliflozin group). Other predefined serious adverse events were rare and did not differ significantly between groups.
In patients with a recent myocardial infarction, empagliflozin was associated with a significantly greater NT-proBNP reduction over 26 weeks, accompanied by a significant improvement in echocardiographic functional and structural parameters.
CLINICALTRIALS.GOV REGISTRATION: NCT03087773.
钠-葡萄糖协同转运蛋白 2 抑制剂可降低有症状心力衰竭患者因心力衰竭住院和死亡的风险。然而，缺乏此类药物治疗急性心肌梗死后患者的研究。
在这项学术性、多中心、双盲试验中，伴有肌酸激酶升高（>800 IU/L）的急性心肌梗死患者（n=476）在经皮冠状动脉介入治疗后 72 小时内随机接受恩格列净 10mg 或匹配的安慰剂每日一次治疗。主要终点是 26 周时 N 端脑钠肽前体（NT-proBNP）的变化。次要终点包括超声心动图参数的变化。基线中位数（四分位间距）NT-proBNP 为 1294（757-2246）pg/mL。与安慰剂相比，恩格列净组 NT-proBNP 降低更显著，校正基线 NT-proBNP、性别和糖尿病状态后，降低 15%[95%置信区间（CI）-4.4%至-23.6%]，差异有统计学意义（P=0.026）。左心室射血分数的绝对改善明显更大（1.5%，95%CI 0.2-2.9%，P=0.029），平均 E/e'降低 6.8%（95%CI 1.3-11.3%，P=0.015），左心室收缩末期和舒张末期容积分别降低 7.5mL（95%CI 3.4-11.5mL，P=0.0003）和 9.7mL（95%CI 3.7-15.7mL，P=0.0015），与安慰剂组相比，恩格列净组差异有统计学意义。7 例患者因心力衰竭住院（恩格列净组 3 例）。其他预先定义的严重不良事件罕见，两组间无显著差异。
在近期心肌梗死后患者中，恩格列净可显著降低 26 周时的 NT-proBNP，同时显著改善超声心动图功能和结构参数。
临床试验.gov 注册号：NCT03087773。
