Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study. (27th May 2019)

• Record Type: Journal Article
• Authors: Wachter, Rolf; Senni, Michele; Belohlavek, Jan; Straburzynska‐Migaj, Ewa; Witte, Klaus K.; Kobalava, Zhanna; Fonseca, Candida; Goncalvesova, Eva; Cavusoglu, Yuksel; Fernandez, Alberto; Chaaban, Said; Bøhmer, Ellen; Pouleur, Anne‐Catherine; Mueller, Christian; Tribouilloy, Christophe; Lonn, Eva; A.L. Buraiki, Jehad; Gniot, Jacek; Mozheiko, Maria; Lelonek, Malgorzata; Noè, Adele; Schwende, Heike; Bao, Weibin; Butylin, Dmytro; Pascual‐Figal, Domingo
• Other Names: Gniot Jacek investigator.; Mozheiko Maria investigator.; Lelonek Malgorzata investigator.; Dominguez Antonio Reyes investigator.; Horacek Thomas investigator.; del Rio Enrique Garcia investigator.; Kobalava Zhanna investigator.; Mueller Christian Eugen investigator.; Cavusoglu Yuksel investigator.; Straburzynska-Migaj Ewa investigator.; Slanina Miroslav investigator.; vom Dahl Juergen investigator.; Senni Michele investigator.; Ryding Alisdair investigator.; Moriarty Andrew investigator.; Robles Manuel Beltran investigator.; Villota Julio Nunez investigator.; Quintana Antonio Garcia investigator.; Nitschke Thorsten investigator.; Manuel Garcia Pinilla Jose investigator.; Bonet Luis Almenar investigator.; Chaaban Said investigator.; Filali zaatari, MD Samia investigator.; Spinar Jindrich investigator.; Musial Wlodzimierz investigator.; Abdelbaki Khaled investigator.; Belohlavek Jan investigator.; Fehske Wolfgang investigator.; Bott Michael Carlos investigator.; Hoegalmen Geir investigator.; Leiro Marisa Crespo investigator.; Ozcan Ismail Turkay investigator.; Mullens Wilfried investigator.; Kryza Radim investigator.; Al-Ani Riadh investigator.; Loboz-Grudzien Krystyna investigator.; Ermoshkina Lyudmila investigator.; Hojerova Silvia investigator.; Fernandez Alberto Alfredo investigator.; Spinarova Lenka investigator.; Lapp Harald investigator.; Bulut Efraim investigator.; Almeida Filipa investigator.; Vishnevsky Alexander investigator.; Belicova Margita investigator.; Pascual Domingo investigator.; Witte Klaus investigator.; Wong Kenneth investigator.; Droogne Walter investigator.; Delforge Marc investigator.; Peterka Martin investigator.; Olbrich Hans‐Georg investigator.; Carugo Stefano investigator.; Nessler Jadwiga investigator.; McGill Thao Huynh investigator.; Huegl Burkhard investigator.; Akin Ibrahim investigator.; Moreira Ilidio investigator.; Baglikov Andrey investigator.; Thambyrajah Jeetendra investigator.; Hayes Chris investigator.; Barrionuevo Marcelo Raul investigator.; Yigit Zerrin investigator.; Kaya Hakki investigator.; Klimsa Zdenek investigator.; Radvan Martin investigator.; Kadel Christoph investigator.; Landmesser Ulf investigator.; Di Tano Giuseppe investigator.; Lisik Malgorzata Buksinska investigator.; Fonseca Candida investigator.; Oliveira Luis investigator.; Marques Irene investigator.; Santos Luis Miguel investigator.; Lenner Egon investigator.; Letavay Peter investigator.; Bueno Manuel Gomez investigator.; Mota Paula investigator.; Wong Aaron investigator.; Bailey Kristian investigator.; Foley Paul investigator.; Hasbani Eduardo investigator.; Virani Sean investigator.; Massih Tony Abdel investigator.; Al‐Saif Shukri investigator.; Taborsky Milos investigator.; Kaislerova Marta investigator.; Motovska Zuzana investigator.; Praha investigator.; Cohen Aron Ariel investigator.; Logeart Damien investigator.; Endemann Dierk investigator.; Ferreira Daniel investigator.; Brito Dulce investigator.; Kycina Peter investigator.; Bollano Entela investigator.; Basilio Enrique Galve investigator.; Rubio Lorenzo Facila investigator.; Aguado Marcos Garcia investigator.; Schiavi Lilia Beatriz investigator.; Zivano Daniel Francisco investigator.; Lonn Eva investigator.; Sayed Ali El investigator.; Pouleur Anne‐Catherine investigator.; Heyse Alex investigator.; Schee Alexandr investigator.; Polasek Rostislav investigator.; Houra Marek investigator.; Tribouilloy Christophe investigator.; Seronde Marie France investigator.; Galinier Michel investigator.; Noutsias Michel investigator.; Schwimmbeck Peter investigator.; Voigt Ingo investigator.; Westermann Dirk investigator.; Pulignano Giovanni investigator.; Vegsundvaag Johnny investigator.; Alexandre Da Silva Antunes Jose investigator.; Monteiro Pedro investigator.; Stevlik Jan investigator.; Goncalvesova Eva investigator.; Hulkoova Beata investigator.; Juan Castro Fernandez Antonio investigator.; Davies Ceri investigator.; Squire Iain investigator.; Meyer Philippe investigator.; Sheppard Richard investigator.; Sahin Tayfun investigator.; Sochor Karel investigator.; De Geeter Guillaume investigator.; Wachter Rolf investigator.; Schmeisser Alexander investigator.; Weil Joachim investigator.; Soares Ana Oliveira investigator.; Vasilevna Olga Bulashova investigator.; Oshurkov Andrey investigator.; Sunderland Shahid Junejo investigator.; Glover Jason investigator.; Exequiel Tomas investigator.; Decoulx Eric investigator.; Meyer Sven investigator.; Muenzel Thomas investigator.; Frioes Fernando investigator.; Arbolishvili Georgy investigator.; Tokarcikova Anna investigator.; Karlstrom Patric investigator.; Carles Trullas Vila Joan investigator.; Perez Gonzalo Pena investigator.; Sankaranarayanan Rajiv investigator.; Nageh Thuraia investigator.; Alasia Diego Cristian investigator.; Refaat Marwan investigator.; Demirkan Burcu investigator.; Al-Buraiki Jehad investigator.; Karabsheh Shadi investigator.;
• Is Part Of: European journal of heart failure. Volume 21:Number 8(2019)
• Page Start: 998
• Page End: 1007
• Publication Date: 2019-05-27
• Subjects: Acute decompensated heart failure -- Angiotensin receptor–neprilysin inhibitor -- Heart failure -- Hospitalisation -- Sacubitril/valsartan; Heart failure -- Periodicals; Heart Failure -- Periodicals; Insuffisance cardiaque -- Périodiques; Heart failure; Periodicals; 616.129005
• DOI: 10.1002/ejhf.1498
• Languages: English
• ISSNs: 1388-9842

Abstract

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: ClinicalTrials.gov ID: NCT02661217