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
Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study / 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, M. Mozheiko, M. Lelonek, A. Reyes Dominguez, T. Horacek, E. Garcia Del Rio, Z. Kobalava, C. Eugen Mueller, Y. Cavusoglu, E. Straburzynska-Migaj, M. Slanina, J. Vom Dahl, M. Senni, A. Ryding, A. Moriarty, M. Beltran Robles, J. Nunez Villota, A. Garcia Quintana, T. Nitschke, J. Manuel Garcia Pinilla, L. Almenar Bonet, S. Chaaban, S. Filali Zaatari Md, J. Spinar, W. Musial, K. Abdelbaki, J. Belohlavek, W. Fehske, M. Carlos Bott, G. Hoegalmen, M. Crespo Leiro, I. Turkay Ozcan, W. Mullens, 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. Hayes, M. Raul Barrionuevo, Z. Yigit, H. Kaya, Z. Klimsa, M. Radvan, C. Kadel, U. Landmesser, G. Di Tano, M. Buksinska Lisik, C. Fonseca, L. Oliveira, I. Marques, L. Miguel Santos, E. Lenner, P. Letavay, M. Gomez Bueno, P. Mota, A. Wong, K. Bailey, P. Foley, E. Hasbani, S. Virani, T. Abdel Massih, S. Al-Saif, M. Taborsky, M. Kaislerova, Z. Motovska, Praha, A. Ariel Cohen, D. Logeart, D. Endemann, D. Ferreira, D. Brito, P. Kycina, E. Bollano, E. Galve Basilio, L. Facila Rubio, M. Garcia Aguado, L. Beatriz Schiavi, D. Francisco Zivano, E. Lonn, A. El Sayed, A. Pouleur, A. Heyse, A. Schee, R. Polasek, M. Houra, C. Tribouilloy, M. France Seronde, M. Galinier, M. Noutsias, P. Schwimmbeck, I. Voigt, D. Westermann, G. Pulignano, J. Vegsundvaag, J. Alexandre Da Silva Antunes, P. Monteiro, J. Stevlik, E. Goncalvesova, B. Hulkoova, A. Juan Castro Fernandez, C. Davies, I. Squire, P. Meyer, R. Sheppard, T. Sahin, K. Sochor, G. De Geeter, R. Wachter, A. Schmeisser, J. Weil, A. Oliveira Soares, O. Bulashova Vasilevna, A. Oshurkov, S. Junejo Sunderland, J. Glover, T. Exequiel, E. Decoulx, S. Meyer, T. Muenzel, F. Frioes, G. Arbolishvili, A. Tokarcikova, P. Karlstrom, J. Carles Trullas Vila, G. Pena Perez, R. Sankaranarayanan, T. Nageh, D. Cristian Alasia, M. Refaat, B. Demirkan, J. Al-Buraiki, S. Karabsheh. - In: EUROPEAN JOURNAL OF HEART FAILURE. - ISSN 1879-0844. - 21:8(2019), pp. 998-1007. [10.1002/ejhf.1498]
Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study
S. Carugo;
2019
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
| File | Dimensione | Formato | |
|---|---|---|---|
|
TRANSITION 2019.pdf
accesso riservato
Tipologia:
Publisher's version/PDF
Dimensione
764.12 kB
Formato
Adobe PDF
|
764.12 kB | Adobe PDF | Visualizza/Apri Richiedi una copia |
Pubblicazioni consigliate
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
