Randomized, double-blind, placebo-controlled, multicentre pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure (EMPA-RESPONSE-AHF)
Randomized, double-blind, placebo-controlled, multicentre pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure (EMPA-RESPONSE-AHF)
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DOI：
10.1002/ejhf.1713
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发表时间：
2020-04-01
影响因子：
18.2
通讯作者：
Voors, Adriaan A.
中科院分区：
文献类型：
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作者：
Damman, Kevin;Beusekamp, Joost C.;Voors, Adriaan A.
目的：抑制钠-葡萄糖协同转运蛋白2（SGLT 2）可降低慢性心力衰竭（HF）患者的死亡和HF住院风险。然而，急性失代偿性HF.Methods和结果在这个随机，安慰剂对照，双盲，平行组，多中心的试点研究中，SGLT 2抑制剂的安全性和临床疗效急性hf. Methods和结果，我们随机80例急性HF患者与糖尿病和非恩格列净10 mg/天或安慰剂30天。主要结局为视觉模拟量表（VAS）呼吸困难评分的变化、利尿反应（每40 mg呋塞米的体重变化）、N末端脑钠肽前体（NT-proBNP）的变化和住院时间。次要结局包括安全性和临床终点。平均年龄为76岁，33%为女性，47%患有新发HF，中位NT-proBNP为5236 pg/mL。恩格列净和安慰剂之间在VAS呼吸困难评分、利尿反应、住院时间或NT-proBNP变化方面未观察到差异。与安慰剂相比，恩格列净降低了院内HF恶化、因HF再次住院或60天时死亡的联合终点[4（10%）vs. 13（33%）; P = 0.014]。恩格列净组直至第4天的尿量显著高于安慰剂组[差异3449（95%置信区间578-6321）mL; P < 0.01]。恩格列净是安全的，耐受性良好，对血压或肾功能没有不良影响。结论在急性HF患者中，恩格列净治疗对VAS呼吸困难，利尿反应，NT-proBNP和住院时间的变化没有影响，但安全，增加尿量，减少HF恶化，HF再住院或60天死亡的联合终点。
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.