Diabetologie und Stoffwechsel 2019; 14(S 01): S66
DOI: 10.1055/s-0039-1688298
Poster
Diabetes und Herz
Georg Thieme Verlag KG Stuttgart · New York

Design and rationale of the EMPEROR trials of, empagliflozin 10 mg once daily, in patients with chronic heart failure with reduced ejection fraction (EMPEROR-Reduced) or preserved ejection fraction (EMPEROR-Preserved)

S Anker
1   Charité Universitätsmedizin Berlin, Department of Cardiology (Campus CVK) & Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Berlin, Germany
,
F Zannad
2   Institut Lorrain du Coeur et des Vaisseaux, Cardiology and Centre d'Investigation Clinique, Nancy, France
,
J Butler
3   University of Mississippi, Department of Medicine, Jackson, United States
,
G Filippatos
4   University of Athens, University of Athens, Athens, Greece
,
A Salsali
5   Boehringer Ingelheim Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, United States
,
K Kimura
6   Boehringer Ingelheim Canada Ltd., Boehringer Ingelheim Canada Ltd., Burlington, Ontario, Canada
,
J Schnee
5   Boehringer Ingelheim Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, United States
,
C Zeller
7   Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
,
S Pocock
8   London School of Hygiene and Tropical Medicine, Department of Medical Statistics, London, United Kingdom
,
J George
9   Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Ingelheim, Germany
,
M Brueckmann
9   Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Ingelheim, Germany
,
M Packer
10   Baylor Heart and Vascular Institute, Baylor Heart and Vascular Institute, Dallas, Texas, United States
› Author Affiliations
Further Information

Publication History

Publication Date:
07 May 2019 (online)

Also available at
 

Aims:

In EMPA-REG OUTCOME, empagliflozin reduced the risk of cardiovascular (CV) mortality and hospitalisations for heart failure (HHF), in patients with type 2 diabetes (T2D) and established CV disease, by 38% and 35%, respectively. These findings suggest possible benefits of empagliflozin beyond its blood glucose-lowering effect. Two phase III randomised, double-blind trials, EMPEROR-Reduced and EMPEROR-Preserved, will explore the efficacy and safety of empagliflozin 10 mg versus placebo, in patients with/without T2D, and with chronic heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

Methods:

EMPEROR-Reduced includes patients with left ejection fraction (EF)≤40% and elevated NT-proBNP levels (cut-offs for patients without/with atrial fibrillation [AF] are:

EF 36 – 40%, NT-proBNp ≥2500/5000pg/mL; EF 31 – 35%, ≥1000/2000pg/mL; EF ≤30%, ≥600/1200pg/mL). Patients with EF ≤40% also qualify if they had HHF within 12 months and present with elevated NT-proBNP levels (≥600/≥1200pg/mL). EMPEROR-Preserved includes patients with left ventricular EF > 40% and elevated NT-proBNP levels (> 300/> 900pg/mL without/with AF), and structural heart disease or documented HHF ≤12 months. The composite primary endpoint in both trials is time to first adjudicated CV death or HHF; key secondary endpoints include the incidence of adjudicated HHF and the renal outcome of eGFR slope of change from baseline. Approximately 3350 and 5500 patients are planned for randomisation in EMPEROR-Reduced and EMPEROR-Preserved, respectively (this may be increased based on the accrual of primary outcome events).

Results:

Recruitment started in 2017.

Conclusion:

The EMPEROR trials are expected to deliver conclusive insights regarding the value of empagliflozin treatment for patients with heart failure.