Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes
Articolo
Data di Pubblicazione:
2021
Citazione:
Effect of empagliflozin on exercise ability and symptoms in heart failure patients with reduced and preserved ejection fraction, with and without type 2 diabetes / W.T. Abraham, J. Lindenfeld, P. Ponikowski, P. Agostoni, J. Butler, A.S. Desai, G. Filippatos, J. Gniot, M. Fu, L. Gullestad, J.G. Howlett, S.J. Nicholls, J. Redon, I. Schenkenberger, J. Silva-Cardoso, S. Störk, J. Krzysztof Wranicz, G. Savarese, M. Brueckmann, W. Jamal, M. Nordaby, B. Peil, I. Ritter, A. Ustyugova, C. Zeller, A. Salsali, S.D. Anker. - In: EUROPEAN HEART JOURNAL. - ISSN 0195-668X. - 42:6(2021), pp. 700-710. [10.1093/eurheartj/ehaa943]
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 ofKCCQ-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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Exercise ability; Heart failure; Patient-reported outcomes; Sodium-glucose co-transporter-2 inhibitor; Symptom burden
Elenco autori:
W.T. Abraham, J. Lindenfeld, P. Ponikowski, P. Agostoni, J. Butler, A.S. Desai, G. Filippatos, J. Gniot, M. Fu, L. Gullestad, J.G. Howlett, S.J. Nicholls, J. Redon, I. Schenkenberger, J. Silva-Cardoso, S. Störk, J. Krzysztof Wranicz, G. Savarese, M. Brueckmann, W. Jamal, M. Nordaby, B. Peil, I. Ritter, A. Ustyugova, C. Zeller, A. Salsali, S.D. Anker
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