Empagliflozin, irrespective of blood pressure, improves outcomes in heart failure with preserved ejection fraction: the EMPEROR-Preserved trial : clinical research : heart failure and cardiomyopathies

Empagliflozin reduces the risk of cardiovascular death or heart failure (HF) hospitalization in patients with HF and preserved ejection fraction. This study aims to evaluate if systolic blood pressure (SBP) moderates these effects.The association of SBP and the treatment effects of empagliflozin in...

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Main Authors: Böhm, Michael (Author) , Anker, Stefan (Author) , Mahfoud, Felix (Author) , Lauder, Lucas (Author) , Filippatos, Gerasimos (Author) , Ferreira, João Pedro (Author) , Pocock, Stuart J (Author) , Brückmann, Martina (Author) , Saloustros, Ilias (Author) , Schüler, Elke (Author) , Wanner, Christoph (Author) , Zannad, Faiez (Author) , Packer, Milton (Author) , Butler, Javed (Author)
Format: Article (Journal)
Language:English
Published: 1 February 2023
In: European heart journal
Year: 2023, Volume: 44, Issue: 5, Pages: 396-407
ISSN:1522-9645
DOI:10.1093/eurheartj/ehac693
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/eurheartj/ehac693
Verlag, lizenzpflichtig, Volltext: https://academic.oup.com/eurheartj/article/44/5/396/6881121?login=true
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Author Notes:Michael Böhm, Stefan Anker, Felix Mahfoud, Lucas Lauder, Gerasimos Filippatos, João Pedro Ferreira, Stuart J. Pocock, Martina Brueckmann, Ilias Saloustros, Elke Schüler, Christoph Wanner, Faiez Zannad, Milton Packer, and Javed Butler, on behalf of the EMPEROR-Preserved Trial Committees and Investigators
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Summary:Empagliflozin reduces the risk of cardiovascular death or heart failure (HF) hospitalization in patients with HF and preserved ejection fraction. This study aims to evaluate if systolic blood pressure (SBP) moderates these effects.The association of SBP and the treatment effects of empagliflozin in EMPEROR-Preserved (empagliflozin outcome trial in patients with chronic heart failure with preserved ejection fraction) was evaluated. Randomized patients (n = 5988) were grouped according to SBP at baseline (<110 mmHg, n = 455; 110-130 mmHg, n = 2415; > 130 mmHg, n = 3118). The effect of empagliflozin on blood pressure, cardiovascular death or HF hospitalization (primary outcome), total HF hospitalizations, and rate of decline in estimated glomerular filtration rate was studied. Over a median of 26.2 months, the placebo-corrected decline was small and not significantly different across baseline SBP. On placebo, the risk of cardiovascular death or hospitalization for HF was 8.58 at >130 mmHg, 8.26 at 110-130 mmHg, and 11.59 events per 100 patient-years at <110 mmHg (P = 0.12 vs. > 130 mmHg, P = 0.08 vs. 110-130 mmHg). There was no evidence for baseline SBP moderating the effect of empagliflozin on risk of HF events (primary endpoint interaction P = 0.69, recurrent HF hospitalizations interaction P = 0.55). When comparing empagliflozin with placebo, SBP did not meaningfully associate with adverse events such as hypotension, volume depletion, and acute renal failure.In EMPEROR-Preserved, empagliflozin was effective and safe without SBP meaningfully moderating empagliflozin’s treatment effects. This analysis of EMPEROR-Preserved shows that empagliflozin can be used safely and effectively without blood pressure being a meaningful moderator of the drug benefit.URL: https://www.clinicaltrials.gov Unique identifier: NCT03057951
Item Description:Online veröffentlicht: 07. Dezember 2022
Gesehen am 17.06.2024
Physical Description:Online Resource
ISSN:1522-9645
DOI:10.1093/eurheartj/ehac693