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Randomized Controlled Trial
. 2021 Feb 11;42(6):700-710.
doi: 10.1093/eurheartj/ehaa943.

Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes

William T Abraham  1 , JoAnn Lindenfeld  2 , Piotr Ponikowski  3 , Piergiuseppe Agostoni  4   5 , Javed Butler  6 , Akshay S Desai  7 , Gerasimos Filippatos  8   9 , Jacek Gniot  10 , Michael Fu  11 , Lars Gullestad  12   13   14   15 , Jonathan G Howlett  16 , Stephen J Nicholls  17 , Josep Redon  18 , Isabelle Schenkenberger  19 , José Silva-Cardoso  20 , Stefan Störk  21 , Jerzy Krzysztof Wranicz  22 , Gianluigi Savarese  23 , Martina Brueckmann  24   25 , Waheed Jamal  24 , Matias Nordaby  24 , Barbara Peil  26 , Ivana Ritter  24 , Anastasia Ustyugova  24 , Cordula Zeller  27 , Afshin Salsali  28 , Stefan D Anker  29
Affiliations
Randomized Controlled Trial

Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes

William T Abraham et al. Eur Heart J. .

Abstract

Aims: The EMPERIAL (Effect of EMPagliflozin on ExeRcise ability and HF symptoms In patients with chronic heArt faiLure) trials evaluated the effects of empagliflozin on exercise ability and patient-reported outcomes in heart failure (HF) with reduced and preserved ejection fraction (EF), with and without type 2 diabetes (T2D), reporting, for the first time, the effects of sodium-glucose co-transporter-2 inhibition in HF with preserved EF (HFpEF).

Methods and results: HF patients with reduced EF (HFrEF) (≤40%, N = 312, EMPERIAL-Reduced) or preserved EF (>40%, N = 315, EMPERIAL-Preserved), with and without T2D, were randomized to empagliflozin 10 mg or placebo for 12 weeks. The primary endpoint was 6-minute walk test distance (6MWTD) change to Week 12. Key secondary endpoints included Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnoea score. 6MWTD median (95% confidence interval) differences, empagliflozin vs. placebo, at Week 12 were -4.0 m (-16.0, 6.0; P = 0.42) and 4.0 m (-5.0, 13.0; P = 0.37) in EMPERIAL-Reduced and EMPERIAL-Preserved, respectively. As the primary endpoint was non-significant, all secondary endpoints were considered exploratory. Changes in KCCQ-TSS and CHQ-SAS dyspnoea score were non-significant. Improvements with empagliflozin in exploratory pre-specified analyses of KCCQ-TSS responder rates, congestion score, and diuretic use in EMPERIAL-Reduced are hypothesis generating. Empagliflozin adverse events were consistent with those previously reported.

Conclusion: The primary outcome for both trials was neutral. Empagliflozin was well tolerated in HF patients, with and without T2D, with a safety profile consistent with that previously reported in T2D. Hypothesis-generating improvements in exploratory analyses of secondary endpoints with empagliflozin in HFrEF were observed.

Keywords: Exercise ability; Heart failure; Patient-reported outcomes; Sodium-glucose co-transporter-2 inhibitor; Symptom burden.

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