恩格列净对射血分数保留的心力衰竭患者心力衰竭恶化事件的影响：EMPEROR-Preserved 试验。

Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction: EMPEROR-Preserved Trial.

机构信息

Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).

Imperial College, London, United Kingdom (M.P.).

出版信息

Circulation. 2021 Oct 19;144(16):1284-1294. doi: 10.1161/CIRCULATIONAHA.121.056824. Epub 2021 Aug 29.

DOI:10.1161/CIRCULATIONAHA.121.056824

PMID:34459213

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8522627/

Abstract

BACKGROUND

Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with preserved ejection fraction, but additional data are needed about its effect on inpatient and outpatient heart failure events.

METHODS

We randomly assigned 5988 patients with class II through IV heart failure with an ejection fraction of >40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to usual therapy, for a median of 26 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite end points.

RESULTS

Empagliflozin reduced the combined risk of cardiovascular death, hospitalization for heart failure, or an emergency or urgent heart failure visit requiring intravenous treatment (432 versus 546 patients [empagliflozin versus placebo, respectively]; hazard ratio, 0.77 [95% CI, 0.67-0.87]; <0.0001). This benefit reached statistical significance at 18 days after randomization. Empagliflozin reduced the total number of heart failure hospitalizations that required intensive care (hazard ratio, 0.71 [95% CI, 0.52-0.96]; =0.028) and the total number of all hospitalizations that required a vasopressor or positive inotropic drug (hazard ratio, 0.73 [95% CI, 0.55-0.97]; =0.033). Compared with patients in the placebo group, fewer patients in the empagliflozin group reported outpatient intensification of diuretics (482 versus 610; hazard ratio, 0.76 [95% CI, 0.67-0.86]; <0.0001), and patients assigned to empagliflozin were 20% to 50% more likely to have a better New York Heart Association functional class, with significant effects at 12 weeks that were maintained for at least 2 years. The benefit on total heart failure hospitalizations was similar in patients with an ejection fraction of >40% to <50% and 50% to <60%, but was attenuated at higher ejection fractions.

CONCLUSIONS

In patients with heart failure with preserved ejection fraction, empagliflozin produced a meaningful, early, and sustained reduction in the risk and severity of a broad range of inpatient and outpatient worsening heart failure events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057977.

摘要

背景

恩格列净可降低射血分数保留型心力衰竭患者的心血管死亡或心力衰竭住院风险，但仍需要更多数据来评估其对住院和门诊心力衰竭事件的影响。

方法

我们将 5988 例射血分数＞40%的 II 级至 IV 级心力衰竭患者随机分为两组，接受安慰剂或恩格列净（10mg 每日 1 次）联合标准治疗，中位随访时间 26 个月。我们前瞻性地收集了反映心力衰竭恶化的住院和门诊事件信息，并在个体和复合终点中预先设定了分析方案。

结果

恩格列净降低了心血管死亡、心力衰竭住院或紧急或紧急心力衰竭就诊需静脉治疗（432 例 vs. 546 例[恩格列净组 vs. 安慰剂组]；风险比，0.77[95%CI，0.67-0.87]；<0.0001）的复合风险。该获益在随机分组后 18 天即达到统计学显著性。恩格列净降低了需要重症监护的心力衰竭住院总数（风险比，0.71[95%CI，0.52-0.96]；=0.028）和需要血管加压素或正性肌力药物的所有住院总数（风险比，0.73[95%CI，0.55-0.97]；=0.033）。与安慰剂组相比，恩格列净组更少患者报告门诊利尿剂强化治疗（482 例 vs. 610 例；风险比，0.76[95%CI，0.67-0.86]；<0.0001），并且接受恩格列净治疗的患者纽约心脏协会心功能分级改善的可能性高 20%至 50%，至少在 2 年内保持显著效果。在射血分数＞40%至＜50%和 50%至＜60%的患者中，总心力衰竭住院治疗的获益相似，但在射血分数较高时有所减弱。