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研究完成SGLT2抑制剂empagliflozin在急性心衰住院患者中应用的临床试验
2022-03-06 12:37
来源：小柯机器人

荷兰格罗宁根大学Adriaan A. Voors等研究人员完成SGLT2抑制剂empagliflozin在急性心衰住院患者中应用的临床试验。这一研究成果于2022年2月28日在线发表在国际学术期刊《自然—医学》上。

研究人员表示，钠-葡萄糖共转运体2抑制剂empagliflozin可降低慢性心力衰竭患者的心血管死亡或心力衰竭住院的风险，但empagliflozin在因急性心力衰竭住院的患者中启动时是否也能改善临床结果尚不清楚。
 
在研究人员的双盲试验（EMPULSE；NCT04157751）中，530名主要诊断为急性新发或失代偿性慢性心力衰竭的患者，无论左心室射血分数如何，都被随机分配接受empagliflozin 10 mg，每日一次或安慰剂。患者在临床稳定的情况下在医院进行随机分配（从入院到随机分配的中位时间为3天），治疗时间长达90天。试验的主要结果是临床获益，定义为任何原因导致的死亡、心力衰竭事件的数量和首次心力衰竭事件发生的时间的层次综合，或90天时堪萨斯城心肌病问卷总症状评分与基线的变化相差5分或更多，用胜率来评估。
 
与安慰剂相比，更多接受empagliflozin治疗的患者有临床获益（分层胜率，1.36；95%置信区间，1.09-1.68；P=0.0054），符合主要终点。急性新发心力衰竭和失代偿性慢性心力衰竭都能观察到临床获益，而且不论射血分数或是否有糖尿病都能观察到。empagliflozin的耐受性良好；在empagliflozin和安慰剂治疗的患者中，分别有32.3%和43.6%报告了严重不良事件。这些发现表明，因急性心力衰竭而住院的患者开始使用empagliflozin的耐受性良好，并在开始治疗后的90天内产生明显的临床效益。
 
附：英文原文
 
Title: The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial

Author: Voors, Adriaan A., Angermann, Christiane E., Teerlink, John R., Collins, Sean P., Kosiborod, Mikhail, Biegus, Jan, Ferreira, Joo Pedro, Nassif, Michael E., Psotka, Mitchell A., Tromp, Jasper, Borleffs, C. Jan Willem, Ma, Changsheng, Comin-Colet, Joseph, Fu, Michael, Janssens, Stefan P., Kiss, Robert G., Mentz, Robert J., Sakata, Yasushi, Schirmer, Henrik, Schou, Morten, Schulze, P. Christian, Spinarova, Lenka, Volterrani, Maurizio, Wranicz, Jerzy K., Zeymer, Uwe, Zieroth, Shelley, Brueckmann, Martina, Blatchford, Jonathan P., Salsali, Afshin, Ponikowski, Piotr

Issue&Volume: 2022-02-28

Abstract: The sodium–glucose cotransporter 2 inhibitor empagliflozin reduces the risk of cardiovascular death or heart failure hospitalization in patients with chronic heart failure, but whether empagliflozin also improves clinical outcomes when initiated in patients who are hospitalized for acute heart failure is unknown. In this double-blind trial (EMPULSE; NCT04157751), 530 patients with a primary diagnosis of acute de novo or decompensated chronic heart failure regardless of left ventricular ejection fraction were randomly assigned to receive empagliflozin 10mg once daily or placebo. Patients were randomized in-hospital when clinically stable (median time from hospital admission to randomization, 3days) and were treated for up to 90days. The primary outcome of the trial was clinical benefit, defined as a hierarchical composite of death from any cause, number of heart failure events and time to first heart failure event, or a 5point or greater difference in change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score at 90days, as assessed using a win ratio. More patients treated with empagliflozin had clinical benefit compared with placebo (stratified win ratio, 1.36; 95% confidence interval, 1.09–1.68; P=0.0054), meeting the primary endpoint. Clinical benefit was observed for both acute de novo and decompensated chronic heart failure and was observed regardless of ejection fraction or the presence or absence of diabetes. Empagliflozin was well tolerated; serious adverse events were reported in 32.3% and 43.6% of the empagliflozin- and placebo-treated patients, respectively. These findings indicate that initiation of empagliflozin in patients hospitalized for acute heart failure is well tolerated and results in significant clinical benefit in the 90days after starting treatment.

DOI: 10.1038/s41591-021-01659-1

Source: https://www.nature.com/articles/s41591-021-01659-1

Nature Medicine：《自然—医学》，创刊于1995年。隶属于施普林格·自然出版集团，最新IF：87.241
官方网址：https://www.nature.com/nm/
投稿链接：https://mts-nmed.nature.com/cgi-bin/main.plex


本期文章：《自然—医学》：Online/在线发表

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