Accéder directement au contenu Accéder directement à la navigation
Article dans une revue

Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study

Rolf Wachter 1 Michele Senni 2 Jan Belohlavek 3 Ewa Straburzynska-Migaj Klaus K. Witte Zhanna Kobalava 4 Candida Fonseca Eva Goncalvesova Yuksel Cavusoglu Alberto Fernandez 5 Said Chaabann Ellen Bohmer Anne-Catherine Pouleur 6, 7, 8 Christian Mueller 9, 10 Christophe Tribouilloy 11, 12 Eva Lonn 13 Jehad A. L. Buraiki Jacek Gniot Maria Mozheiko Malgorzata Lelonek Adele Noe Heike Schwende Weibin Bao Dmytro Butylin Domingo Pascual-Figal
1 UMG - University Medical Center Göttingen
2 Ospedale Papa Giovanni XXIII
3 First Faculty of Medicine Charles University [Prague]
4 RUDN - Peoples Friendship University of Russia [RUDN University]
5 URJC - Universidad Rey Juan Carlos [Madrid]
6 CARD - Pôle de Recherche Cardiovasculaire
7 IREC - Institut de Recherche Expérimentale et Clinique
8 Division of Cardiology
9 University Hospital Basel [Basel]
10 Unibas - University of Basel
11 MP3CV - Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517
12 CHU Amiens-Picardie
13 Hamilton General Hospital
Abstract : Aims To assess tolerability and optimal time point for initiation of sacubitril/valsartan in patients stabilised after acute heart failure (AHF). Methods and results TRANSITION was a randomised, multicentre, open-label study comparing two treatment initiation modalities of sacubitril/valsartan. Patients aged >= 18 years, hospitalised for AHF were stratified according to pre-admission use of renin-angiotensin-aldosterone system inhibitors and randomised (n = 1002) after stabilisation to initiate sacubitril/valsartan either >= 12-h pre-discharge or between Days 1-14 post-discharge. Starting dose (as per label) was 24/26 mg or 49/51 mg bid with up- or down-titration based on tolerability. The primary endpoint was the proportion of patients attaining 97/103 mg bid target dose after 10 weeks. Median time of first dose of sacubitril/valsartan from the day of discharge was Day -1 and Day +1 in the pre-discharge group and the post-discharge group, respectively. Comparable proportions of patients in the pre- and post-discharge initiation groups met the primary endpoint [45.4% vs. 50.7%; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.79-1.02]. The proportion of patients who achieved and maintained for >= 2 weeks leading to Week 10, either 49/51 or 97/103 mg bid was 62.1% vs. 68.5% (RR 0.91; 95% CI 0.83-0.99); or any dose was 86.0% vs. 89.6% (RR 0.96; 95% CI 0.92-1.01). Discontinuation due to adverse events occurred in 7.3% vs. 4.9% of patients (RR 1.49; 95% CI 0.90-2.46). Conclusions Initiation of sacubitril/valsartan in a wide range of heart failure with reduced ejection fraction patients stabilised after an AHF event, either in hospital or shortly after discharge, is feasible with about half of the patients achieving target dose within 10 weeks. Clinical Trial Registration: ID: NCT02661217
Type de document :
Article dans une revue
Liste complète des métadonnées
https://hal-u-picardie.archives-ouvertes.fr/hal-03579999
Contributeur : Louise Dessaivre Connectez-vous pour contacter le contributeur
Soumis le : vendredi 18 février 2022 - 14:01:48
Dernière modification le : samedi 19 février 2022 - 03:00:19

Lien texte intégral

openaccess

Identifiants

Collections

MP3CV | U-PICARDIE

Citation

Rolf Wachter, Michele Senni, Jan Belohlavek, Ewa Straburzynska-Migaj, Klaus K. Witte, et al.. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study. EUROPEAN JOURNAL OF HEART FAILURE, 2019, 21 (8), pp.998-1007. ⟨10.1002/ejhf.1498⟩. ⟨hal-03579999⟩

Exporter

BibTeX TEI DC DCterms EndNote Datacite

Partager

Métriques

Consultations de la notice

2