AIMS Inhibition of sodium-glucose co-transporter 2 (SGLT2) reduces the risk of death and heart failure (HF) admissions in patients with chronic HF. However, safety and clinical efficacy of SGLT2 inhibitors in patients with acute decompensated HF are unknown. METHODS AND RESULTS In this randomized, placebo-controlled, double-blind, parallel group, multicentre pilot study, we randomized 80 acute HF patients with and without diabetes to either empagliflozin 10 mg/day or placebo for 30 days. The primary outcomes were change in visual analogue scale (VAS) dyspnoea score, diuretic response (weight change per 40 mg furosemide), change in N-terminal pro brain natriuretic peptide (NT-proBNP), and length of stay. Secondary outcomes included safety and clinical endpoints. Mean age was 76 years, 33% were female, 47% had de novo HF and median NT-proBNP was 5236 pg/mL. No difference was observed in VAS dyspnoea score, diuretic response, length of stay, or change in NT-proBNP between empagliflozin and placebo. Empagliflozin reduced a combined endpoint of in-hospital worsening HF, rehospitalization for HF or death at 60 days compared with placebo [4 (10%) vs. 13 (33%); P = 0.014]. Urinary output up until day 4 was significantly greater with empagliflozin vs. placebo [difference 3449 (95% confidence interval 578-6321) mL; P < 0.01]. Empagliflozin was safe, well tolerated, and had no adverse effects on blood pressure or renal function. CONCLUSIONS In patients with acute HF, treatment with empagliflozin had no effect on change in VAS dyspnoea, diuretic response, NT-proBNP, and length of hospital stay, but was safe, increased urinary output and reduced a combined endpoint of worsening HF, rehospitalization for HF or death at 60 days.

中文翻译：

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恩帕格列净对急性失代偿性心力衰竭（EMPA-RESPONSE-AHF）患者临床结局的影响的随机，双盲，安慰剂对照，多中心先导研究。

AIMS抑制钠-葡萄糖共转运蛋白2（SGLT2）可降低慢性HF患者的死亡和心力衰竭（HF）入院风险。然而，尚不清楚SGLT2抑制剂在急性失代偿性HF患者中的安全性和临床疗效。方法和结果在这项随机，安慰剂对照，双盲，平行组，多中心先导研究中，我们将80例有糖尿病和无糖尿病的急性HF患者随机分为10毫克/天的依帕格列净或30天的安慰剂。主要结局是视觉模拟量表（VAS）呼吸困难评分，利尿反应（每40毫克呋塞米体重改变），N末端脑钠肽（NT-proBNP）改变和住院时间的改变。次要结果包括安全性和临床终点。平均年龄为76岁，女性为33％，47％的患者从头有HF，NT-proBNP中位数为5236 pg / mL。依帕列净与安慰剂之间的VAS呼吸困难评分，利尿反应，住院时间或NT-proBNP的变化无差异。与安慰剂相比，Empagliflozin降低了院内HF恶化，HF再次住院或60天死亡的综合终点[4（10％）vs. 13（33％）；P = 0.014]。依帕列净与安慰剂相比，直到第4天的尿量显着增加[差异3449（95％置信区间578-6321）mL；P <0.01]。Empagliflozin安全，耐受性好，对血压或肾功能无不良影响。结论在急性心力衰竭患者中，依帕格列净治疗对VAS呼吸困难，利尿反应，NT-proBNP和住院时间没有影响，但安全，