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Eur J Heart Fail. 2019 Aug;21(8):998-1007. doi: 10.1002/ejhf.1498. Epub 2019 May 27.

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

Collaborators (155)

Gniot J, Mozheiko M, Lelonek M, Dominguez AR, Horacek T, Del Rio EG, Kobalava Z, Mueller CE, Cavusoglu Y, Straburzynska-Migaj E, Slanina M, Vom Dahl J, Senni M, Ryding A, Moriarty A, Robles MB, Villota JN, Quintana AG, Nitschke T, Manuel Garcia Pinilla J, Bonet LA, Chaaban S, Filali Zaatari Md S, Spinar J, Musial W, Abdelbaki K, Belohlavek J, Fehske W, Bott MC, Hoegalmen G, Leiro MC, Ozcan IT, Mullens W, Kryza R, Al-Ani R, Loboz-Grudzien K, Ermoshkina L, Hojerova S, Fernandez AA, Spinarova L, Lapp H, Bulut E, Almeida F, Vishnevsky A, Belicova M, Pascual D, Witte K, Wong K, Droogne W, Delforge M, Peterka M, Olbrich HG, Carugo S, Nessler J, McGill TH, Huegl B, Akin I, Moreira I, Baglikov A, Thambyrajah J, Hayes C, Barrionuevo MR, Yigit Z, Kaya H, Klimsa Z, Radvan M, Kadel C, Landmesser U, Di Tano G, Lisik MB, Fonseca C, Oliveira L, Marques I, Santos LM, Lenner E, Letavay P, Bueno MG, Mota P, Wong A, Bailey K, Foley P, Hasbani E, Virani S, Massih TA, Al-Saif S, Taborsky M, Kaislerova M, Motovska Z, Praha, Cohen AA, Logeart D, Endemann D, Ferreira D, Brito D, Kycina P, Bollano E, Basilio EG, Rubio LF, Aguado MG, Schiavi LB, Zivano DF, Lonn E, Sayed AE, Pouleur AC, Heyse A, Schee A, Polasek R, Houra M, Tribouilloy C, Seronde MF, Galinier M, Noutsias M, Schwimmbeck P, Voigt I, Westermann D, Pulignano G, Vegsundvaag J, Alexandre Da Silva Antunes J, Monteiro P, Stevlik J, Goncalvesova E, Hulkoova B, Juan Castro Fernandez A, Davies C, Squire I, Meyer P, Sheppard R, Sahin T, Sochor K, De Geeter G, Wachter R, Schmeisser A, Weil J, Soares AO, Vasilevna OB, Oshurkov A, Sunderland SJ, Glover J, Exequiel T, Decoulx E, Meyer S, Muenzel T, Frioes F, Arbolishvili G, Tokarcikova A, Karlstrom P, Carles Trullas Vila J, Perez GP, Sankaranarayanan R, Nageh T, Alasia DC, Refaat M, Demirkan B, Al-Buraiki J, Karabsheh S.

Author information

1
Clinic and Policlinic for Cardiology, University Hospital Leipzig, and Clinic for Cardiology, University Medicine Göttingen and German Cardiovascular Research Center, Partner Site, Göttingen, Germany.
2
Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.
3
General Teaching Hospital, Charles University in Prague, Prague, Czech Republic.
4
First Department of Cardiology, University of Medical Sciences, Poznan, Poland.
5
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
6
Peoples' Friendship University of Russia (RUDN University), Moscow, Russia.
7
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.
8
Odd. Srdcovehozlyhavania a Transplantacie, Bratislava, Slovakia.
9
Eskişehir Osmangazi University Medical Faculty, Eskişehir, Turkey.
10
Sanatorio Modelo Quilmes, Buenos Aires, Argentina.
11
Hammoud Hospital University Medical Center, Saida, Lebanon.
12
Innlandet Hospital Trust, Lillehammer, Norway.
13
Cardiology Division, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
14
University Hospital Basel, University of Basel, Basel, Switzerland.
15
Department of Cardiology, Amiens University Hospital, Amiens, France.
16
McMaster University and Hamilton Health Sciences, Hamilton, Canada.
17
King Faisal Specialist Hospital, Riyadh, Saudi Arabia.
18
SP ZOZ Szpital Specjalistyczny, Pulawy, Poland.
19
Yaroslavl Regional Hospital of Veterans of Wars, Yaroslavl, Russia.
20
Department of Noninvasive Cardiology, Medical University of Lodz, Lodz, Poland.
21
Novartis Pharma AG, Basel, Switzerland.
22
Novartis Pharmaceuticals, East Hanover, NJ, USA.
23
Cardiology Department, Hospital Universitario Virgen de la Arrixaca, Universidad de Murcia, Murcia, Spain.

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.

KEYWORDS:

Acute decompensated heart failure; Angiotensin receptor-neprilysin inhibitor; Heart failure; Hospitalisation; Sacubitril/valsartan

PMID:
31134724
DOI:
10.1002/ejhf.1498
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