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Outcomes with empagliflozin in heart failure with preserved ejection fraction using DELIVER‐like endpoint definitions

AIMS: To report data from EMPEROR‐Preserved according to prespecified endpoints of DELIVER. METHODS AND RESULTS: In order to assess the impact of DELIVER‐like definition on EMPEROR‐Preserved outcomes, the following differences were reconciled: (1) the primary outcome in DELIVER added urgent heart fa...

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Autores principales: Anker, Stefan D., Siddiqi, Tariq Jamal, Filippatos, Gerasimos, Zannad, Faiez, Ferreira, João Pedro, Pocock, Stuart J., Brueckmann, Martina, Zeller, Cordula, Packer, Milton, Butler, Javed
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Ltd. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9544587/
https://www.ncbi.nlm.nih.gov/pubmed/35604680
http://dx.doi.org/10.1002/ejhf.2558
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author Anker, Stefan D.
Siddiqi, Tariq Jamal
Filippatos, Gerasimos
Zannad, Faiez
Ferreira, João Pedro
Pocock, Stuart J.
Brueckmann, Martina
Zeller, Cordula
Packer, Milton
Butler, Javed
author_facet Anker, Stefan D.
Siddiqi, Tariq Jamal
Filippatos, Gerasimos
Zannad, Faiez
Ferreira, João Pedro
Pocock, Stuart J.
Brueckmann, Martina
Zeller, Cordula
Packer, Milton
Butler, Javed
author_sort Anker, Stefan D.
collection PubMed
description AIMS: To report data from EMPEROR‐Preserved according to prespecified endpoints of DELIVER. METHODS AND RESULTS: In order to assess the impact of DELIVER‐like definition on EMPEROR‐Preserved outcomes, the following differences were reconciled: (1) the primary outcome in DELIVER added urgent heart failure (HF) visits to cardiovascular death or HF hospitalizations; (2) the EMPEROR‐Preserved trial did not require documentation of physical findings or laboratory tests for confirming a HF hospitalization and it included events of 12–24 h if intensification of treatment was not only oral diuretics; (3) DELIVER excluded undetermined causes of deaths from the primary endpoint; (4) the composite renal endpoint in DELIVER included a sustained ≥50% decline in estimated glomerular filtration rate and incorporated renal death; and (5) DELIVER will assess outcomes in the overall population and in patients with ejection fraction (EF) <60% separately. Using the endpoint definitions from DELIVER, the primary outcome overall occurred in 13.1% in the empagliflozin and 16.8% in the placebo group (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.67–0.87; p < 0.0001). The relative risk reduction (RRR) changed from 21% to 24% when urgent HF visits were added, and undetermined death was eliminated. Compared to overall population RRR of 24%, it was 28% in patients with EF <60%. Death from cardiovascular causes excluding undetermined causes occurred in 6.2% in the empagliflozin and in 7.1% in the placebo group (HR 0.88, 95% CI 0.73–1.07). The RRR for the composite renal endpoint changed from 22% in the overall population (HR 0.78, 95% CI 0.54–1.13) to 40% when patients with EF <60% were assessed (p = 0.037). CONCLUSION: Findings from EMPEROR‐Preserved were modestly altered when analysed using cardiovascular trial endpoint definitions of the DELIVER trial. For the composite renal endpoint, the effect of empagliflozin became statistically significant in patients with EF <60% using the DELIVER definition.
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spelling pubmed-95445872022-10-14 Outcomes with empagliflozin in heart failure with preserved ejection fraction using DELIVER‐like endpoint definitions Anker, Stefan D. Siddiqi, Tariq Jamal Filippatos, Gerasimos Zannad, Faiez Ferreira, João Pedro Pocock, Stuart J. Brueckmann, Martina Zeller, Cordula Packer, Milton Butler, Javed Eur J Heart Fail Clinical Trials AIMS: To report data from EMPEROR‐Preserved according to prespecified endpoints of DELIVER. METHODS AND RESULTS: In order to assess the impact of DELIVER‐like definition on EMPEROR‐Preserved outcomes, the following differences were reconciled: (1) the primary outcome in DELIVER added urgent heart failure (HF) visits to cardiovascular death or HF hospitalizations; (2) the EMPEROR‐Preserved trial did not require documentation of physical findings or laboratory tests for confirming a HF hospitalization and it included events of 12–24 h if intensification of treatment was not only oral diuretics; (3) DELIVER excluded undetermined causes of deaths from the primary endpoint; (4) the composite renal endpoint in DELIVER included a sustained ≥50% decline in estimated glomerular filtration rate and incorporated renal death; and (5) DELIVER will assess outcomes in the overall population and in patients with ejection fraction (EF) <60% separately. Using the endpoint definitions from DELIVER, the primary outcome overall occurred in 13.1% in the empagliflozin and 16.8% in the placebo group (hazard ratio [HR] 0.76, 95% confidence interval [CI] 0.67–0.87; p < 0.0001). The relative risk reduction (RRR) changed from 21% to 24% when urgent HF visits were added, and undetermined death was eliminated. Compared to overall population RRR of 24%, it was 28% in patients with EF <60%. Death from cardiovascular causes excluding undetermined causes occurred in 6.2% in the empagliflozin and in 7.1% in the placebo group (HR 0.88, 95% CI 0.73–1.07). The RRR for the composite renal endpoint changed from 22% in the overall population (HR 0.78, 95% CI 0.54–1.13) to 40% when patients with EF <60% were assessed (p = 0.037). CONCLUSION: Findings from EMPEROR‐Preserved were modestly altered when analysed using cardiovascular trial endpoint definitions of the DELIVER trial. For the composite renal endpoint, the effect of empagliflozin became statistically significant in patients with EF <60% using the DELIVER definition. John Wiley & Sons, Ltd. 2022-06-05 2022-08 /pmc/articles/PMC9544587/ /pubmed/35604680 http://dx.doi.org/10.1002/ejhf.2558 Text en © 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Clinical Trials
Anker, Stefan D.
Siddiqi, Tariq Jamal
Filippatos, Gerasimos
Zannad, Faiez
Ferreira, João Pedro
Pocock, Stuart J.
Brueckmann, Martina
Zeller, Cordula
Packer, Milton
Butler, Javed
Outcomes with empagliflozin in heart failure with preserved ejection fraction using DELIVER‐like endpoint definitions
title Outcomes with empagliflozin in heart failure with preserved ejection fraction using DELIVER‐like endpoint definitions
title_full Outcomes with empagliflozin in heart failure with preserved ejection fraction using DELIVER‐like endpoint definitions
title_fullStr Outcomes with empagliflozin in heart failure with preserved ejection fraction using DELIVER‐like endpoint definitions
title_full_unstemmed Outcomes with empagliflozin in heart failure with preserved ejection fraction using DELIVER‐like endpoint definitions
title_short Outcomes with empagliflozin in heart failure with preserved ejection fraction using DELIVER‐like endpoint definitions
title_sort outcomes with empagliflozin in heart failure with preserved ejection fraction using deliver‐like endpoint definitions
topic Clinical Trials
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9544587/
https://www.ncbi.nlm.nih.gov/pubmed/35604680
http://dx.doi.org/10.1002/ejhf.2558
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