Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study
| Title: | Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study |
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| Authors: | R. Wachter; M. Senni; J. Belohlavek; E. Straburzynska-Migaj; Kl. K. Witte; Z. Kobalava; C. Fonseca; E. Goncalvesova; Y. Cavusoglu; A. Fernandez; S. Chaaban; E- Bøhmer; Anne-C. Pouleur; C. Mueller; C. Tribouilloy; E. Lonn; J. A. L. Buraiki; J. Gniot; M. Mozheiko; M. Lelonek; Ad. Noè; H. Schwende; W. Bao; D. Butylin; D. Pascual-Figal Jacek Gniot; Maria Mozheiko; Malgorzata Lelonek; Antonio Reyes Dominguez; Thomas Horacek; Enrique Garcia Del Rio; Zhanna Kobalava; Christian Eugen Mueller; Yuksel Cavusoglu; Ewa Straburzynska-Migaj; Miroslav Slanina; Juergen Vom Dahl; Michele Senni; Alisdair Ryding; Andrew Moriarty; Manuel Beltran Robles; Julio Nunez Villota; Antonio Garcia Quintana; Thorsten Nitschke; Jose Manuel Garcia Pinilla; Luis Almenar Bonet; Said Chaaban; Samia Filali Zaatari Md; Jindrich Spinar; Wlodzimierz Musial; Khaled Abdelbaki; Jan Belohlavek; Wolfgang Fehske; Michael Carlos Bott; Geir Hoegalmen; Marisa Crespo Leiro; Ismail Turkay Ozcan; Wilfried Mullens; Radim Kryza; Riadh Al-Ani; Krystyna Loboz-Grudzien; Lyudmila Ermoshkina; Silvia Hojerova; Alberto Alfredo Fernandez; Lenka Spinarova; Harald Lapp; Efraim Bulut; Filipa Almeida; Alexander Vishnevsky; Margita Belicova; Domingo Pascual; Klaus Witte; Kenneth Wong; Walter Droogne; Marc Delforge; Martin Peterka; Hans-Georg Olbrich; Stefano Carugo; Jadwiga Nessler; Thao Huynh McGill; Burkhard Huegl; Ibrahim Akin; Ilidio Moreira; Andrey Baglikov; Jeetendra Thambyrajah; Chris Hayes; Marcelo Raul Barrionuevo; Zerrin Yigit; Hakki Kaya; Zdenek Klimsa; Martin Radvan; Christoph Kadel; Ulf Landmesser; Giuseppe Di Tano; Malgorzata Buksinska Lisik; Candida Fonseca; Luis Oliveira; Irene Marques; Luis Miguel Santos; Egon Lenner; Peter Letavay; Manuel Gomez Bueno; Paula Mota; Aaron Wong; Kristian Bailey; Paul Foley; Eduardo Hasbani; Sean Virani; Tony Abdel Massih; Shukri Al-Saif; Milos Taborsky; Marta Kaislerova; Zuzana Motovska; Praha; Aron Ariel Cohen; Damien Logeart; Dierk Endemann; Daniel Ferreira; Dulce Brito; Peter Kycina; Entela Bollano; Enrique Galve Basilio; Lorenzo Facila Rubio; Marcos Garcia Aguado; Lilia Beatriz Schiavi; Daniel Francisco Zivano; Eva Lonn; Ali El Sayed; Anne-Catherine Pouleur; Alex Heyse; Alexandr Schee; Rostislav Polasek; Marek Houra; Christophe Tribouilloy; Marie France Seronde; Michel Galinier; Michel Noutsias; Peter Schwimmbeck; Ingo Voigt; Dirk Westermann; Giovanni Pulignano; Johnny Vegsundvaag; Jose Alexandre Da Silva Antunes; Pedro Monteiro; Jan Stevlik; Eva Goncalvesova; Beata Hulkoova; Antonio Juan Castro Fernandez; Ceri Davies; Iain Squire; Philippe Meyer; Richard Sheppard; Tayfun Sahin; Karel Sochor; Guillaume De Geeter; Rolf Wachter; Alexander Schmeisser; Joachim Weil; Ana Oliveira Soares; Olga Bulashova Vasilevna; Andrey Oshurkov; Shahid Junejo Sunderland; Jason Glover; Tomas Exequiel; Eric Decoulx; Sven Meyer; Thomas Muenzel; Fernando Frioes; Georgy Arbolishvili; Anna Tokarcikova; Patric Karlstrom; Joan Carles Trullas Vila; Gonzalo Pena Perez; Rajiv Sankaranarayanan; Thuraia Nageh; Diego Cristian Alasia; Marwan Refaat; Burcu Demirkan; Jehad Al-Buraiki; Shadi Karabsheh |
| Contributors: | R. Wachter; M. Senni; J. Belohlavek; E. Straburzynska-Migaj; K.K. Witte; Z. Kobalava; C. Fonseca; E. Goncalvesova; Y. Cavusoglu; A. Fernandez; S. Chaaban; E. Bøhmer; A. Pouleur; C. Mueller; C. Tribouilloy; E. Lonn; J.A.L. Buraiki; J. Gniot; M. Mozheiko; M. Lelonek; A. Noè; H. Schwende; W. Bao; D. Butylin; D. Pascual-Figal Jacek Gniot; A. Reyes Dominguez; T. Horacek; E. Garcia Del Rio; C. Eugen Mueller; M. Slanina; J. Vom Dahl; A. Ryding; A. Moriarty; M. Beltran Roble; J. Nunez Villota; A. Garcia Quintana; T. Nitschke; J. Manuel Garcia Pinilla; L. Almenar Bonet; S. Filali Zaatari Md; J. Spinar; W. Musial; K. Abdelbaki; W. Fehske; M. Carlos Bott; G. Hoegalmen; M. Crespo Leiro; I. Turkay Ozcan; W. Mullen; R. Kryza; R. Al-Ani; K. Loboz-Grudzien; L. Ermoshkina; S. Hojerova; A. Alfredo Fernandez; L. Spinarova; H. Lapp; E. Bulut; F. Almeida; A. Vishnevsky; M. Belicova; D. Pascual; K. Witte; K. Wong; W. Droogne; M. Delforge; M. Peterka; H. Olbrich; S. Carugo; J. Nessler; T. Huynh McGill; B. Huegl; I. Akin; I. Moreira; A. Baglikov; J. Thambyrajah; C. Haye; M. Raul Barrionuevo; Z. Yigit; H. Kaya; Z. Klimsa; M. Radvan; C. Kadel; U. Landmesser; G. Di Tano; M. Buksinska Lisik; L. Oliveira; I. Marque; L. Miguel Santo; E. Lenner; P. Letavay |
| Publisher Information: | Elsevier |
| Publication Year: | 2019 |
| Collection: | The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| Subject Terms: | Acute decompensated heart failure; Angiotensin receptor-neprilysin inhibitor; Heart failure; Hospitalisation; Sacubitril; valsartan; Settore MED/11 - Malattie dell'Apparato Cardiovascolare |
| Description: | 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 |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/wos/WOS:000479074300008; volume:21; issue:8; firstpage:998; lastpage:1007; numberofpages:10; journal:EUROPEAN JOURNAL OF HEART FAILURE; https://hdl.handle.net/2434/655549 |
| DOI: | 10.1002/ejhf.1498 |
| Availability: | https://hdl.handle.net/2434/655549; https://doi.org/10.1002/ejhf.1498 |
| Rights: | info:eu-repo/semantics/closedAccess |
| Accession Number: | edsbas.27AE8668 |
| Database: | BASE |