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)
Top Cited Papers
Open Access
- 1 April 2020
- journal article
- research article
- Published by Wiley in European Journal of Heart Failure
- Vol. 22 (4), 713-722
- https://doi.org/10.1002/ejhf.1713
Abstract
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.Funding Information
- Boehringer Ingelheim
This publication has 27 references indexed in Scilit:
- 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failureEuropean Journal of Heart Failure, 2016
- Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME®trialEuropean Heart Journal, 2016
- Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 DiabetesThe New England Journal of Medicine, 2015
- Terminology and definition of changes renal function in heart failureEuropean Heart Journal, 2014
- Diuretic response in acute heart failure: clinical characteristics and prognostic significanceEuropean Heart Journal, 2014
- The Chronic Kidney Disease Epidemiology Collaboration equation outperforms the Modification of Diet in Renal Disease equation for estimating glomerular filtration rate in chronic systolic heart failureEuropean Journal of Heart Failure, 2013
- Timing of Hemoconcentration During Treatment of Acute Decompensated Heart Failure and Subsequent SurvivalJournal of the American College of Cardiology, 2013
- Dapagliflozin a glucose‐regulating drug with diuretic properties in subjects with type 2 diabetesDiabetes, Obesity and Metabolism, 2013
- Diuretic Strategies in Patients with Acute Decompensated Heart FailureThe New England Journal of Medicine, 2011
- Rolofylline, an Adenosine A1−Receptor Antagonist, in Acute Heart FailureThe New England Journal of Medicine, 2010