恩格列净治疗射血分数保留的慢性心力衰竭患者的有效性与安全性:EMPEROR-Preserved研究中国亚组分析

Efficacy and safety of empagliflozin in heart failure with preserved ejection fraction:a subgroup analysis for Chinese population of the EMPEROR-Preserved trial

目的EMPEROR-Preserved研究证实了恩格列净(10 mg/d)可以显著降低射血分数保留的心力衰竭(HFpEF)患者的心血管死亡或因心力衰竭(心衰)住院(HHF)的复合终点风险。本亚组分析旨在进一步探索恩格列净在中国人群中的有效性与安全性。方法EMPEROR-Preserved是一项随机、双盲、多国家、平行组、事件驱动的Ⅲ期临床试验,纳入了左心室射血分数>40%且纽约心脏协会心功能分级Ⅱ~Ⅳ级的慢性心衰患者。患者在接受标准治疗的基础上,随机分配(1∶1)接受恩格列净(10 mg/d)或安慰剂。主要终点为至首次发生裁定的心血管死亡或HHF事件的时间。结果共筛选了255例中国患者,随机入组137例(恩格列净组64例,安慰剂组73例)。恩格列净组患者的心血管死亡或HHF的风险发生率低于安慰剂组,分别为15.03/100患者年和21.38/100患者年(风险比0.61,95%可信区间0.32~1.14),两组发生事件的患者比例分别为25%和34.2%。恩格列净组和安慰剂组发生不良事件的患者比例相似(90.6%比90.4%)。结论恩格列净在中国HFpEF患者中的有效性与整体人群一致,相比于安慰剂组,恩格列净组发生心血管死亡或HHF的风险更低,并且未发现新的安全性问题。

Objective EMPEROR-Preserved study demonstrated that empagliflozin reduced the combined risk of cardiovascular(CV)death or hospitalization for heart failure(HHF)in patients with heart failure and preserved ejection fraction(HFpEF).This subgroup study aimed to further analyze the efficacy and safety of empagliflozin in the Chinese population.Method EMPEROR-Preserved was a randomized,double-blind,multi-national,parallel-group,event-driven phaseⅢtrial.Patients with New York Heart Association(NYHA)functional class II-IV heart failure and left ventricular ejection fraction more than 40%were randomized(1:1)to receive empagliflozin(10 mg once daily)or placebo,in addition to standard therapy.The primary endpoint was time to the first adjudicated CV death or HHF.Results A total of 255 Chinese patients were screened,among whom 137 were randomized(empagliflozin:64;placebo:73).The incidence rate of CV death or HHF was lower in the empagliflozin group than that in the placebo group(15.03/100 patient-years vs.21.38/100 patient-years;hazard ratio 0.61;95%confidence interval 0.32-1.14);the proportions of patients with CV death or HHF were 25%and 34.2%,respectively.The proportions of patients with any adverse events(AEs)were similar between the empagliflozin group and the placebo group(90.6%vs.90.4%).Conclusion The efficacy of empagliflozin in the Chinese patients with HFpEF was consistent with that in the entire study population.Empagliflozin reduced the risk of CV death or HHF,compared with placebo.No specific safety concerns were identified in the Chinese population.