Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study.

Autor: Senni M; Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy., Wachter R; Clinic and Policlinic for Cardiology, University Hospital Leipzig, Leipzig, Germany.; Clinic for Cardiology and Pneumology, University Medicine Göttingen, Germany and German Cardiovascular Research Center, partner site Göttingen, Göttingen, Germany., Witte KK; Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK., Straburzynska-Migaj E; 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland., Belohlavek J; General Teaching Hospital, Charles University in Prague, Prague, Czech Republic., Fonseca C; Heart Failure Unit, Internal Medicine Department, Hospital de São Francisco Xavier, CHLO, NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal., Mueller C; University Hospital Basel, University of Basel, Basel, Switzerland., Lonn E; McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada., Chakrabarti A; Novartis Pharmaceuticals, Hyderabad, India., Bao W; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Noe A; Novartis Pharma AG, Basel, Switzerland., Schwende H; Novartis Pharma AG, Basel, Switzerland., Butylin D; Novartis Pharma AG, Basel, Switzerland., Pascual-Figal D; Cardiology Department, Hospital Universitario Virgen de la Arrixaca, Universidad de Murcia, Murcia, Spain.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2020 Feb; Vol. 22 (2), pp. 303-312. Date of Electronic Publication: 2019 Dec 09.
DOI: 10.1002/ejhf.1670
Abstrakt: Aims: Sacubitril/valsartan has shown efficacy and tolerability in patients with heart failure (HF) and reduced ejection fraction (HFrEF) in the ambulatory setting (PARADIGM-HF), and following stabilisation of acutely decompensated HF (ADHF) (PIONEER-HF and TRANSITION). However, data are lacking for the initiation of sacubitril/valsartan in newly diagnosed (de novo) HFrEF. Here, we assess the tolerability of initiating sacubitril/valsartan following ADHF in TRANSITION subgroups of patients with a de novo vs. prior diagnosis of HFrEF.
Methods and Results: TRANSITION randomised 1002 patients to pre- and post-discharge initiation of sacubitril/valsartan (analysis set n = 991, following exclusions for mis-randomisation). In this post-hoc analysis, tolerability to sacubitril/valsartan [proportion of patients achieving target dose (97/103 mg b.i.d.) at 10 weeks post-randomisation], adverse events (AEs) and serious AEs (SAEs) were compared in de novo (n = 286) and prior HFrEF (n = 705) subgroups. More de novo than prior HFrEF patients achieved target dose at Week 10 (56% vs. 45%; relative risk ratio 1.30, 95% confidence interval 1.12-1.52, P < 0.001), and fewer had SAEs and permanent treatment discontinuations. Initiation of sacubitril/valsartan did not prevent the concomitant initiation and up-titration of guideline-directed HF therapies. De novo patients showed faster and greater decreases in N-terminal pro-B-type natriuretic peptide and high-sensitivity troponin-T, and lower rates of HF and all-cause rehospitalisation vs. prior HFrEF.
Conclusions: After ADHF, first-line initiation of sacubitril/valsartan in de novo HFrEF, alongside the initiation of other guideline-directed therapies, is feasible and is associated with a better risk-benefit profile than in patients with prior HFrEF. Early intervention with sacubitril/valsartan may be considered to delay disease progression in patients with de novo HFrEF.
Clinical Trial Registration: ClinicalTrials.gov, NCT02661217.
(© 2019 The Authors. European Journal of Heart Failure © 2019 European Society of Cardiology.)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje