Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial.

Vincenza Calvaruso, Vito Di Marco, Loredana Simone, Nicola M Castellaneta, Chiara Mazzarelli, Vincenzo Sangiovanni, Vincenza Calvaruso, Ferdinando A Giannone, Alida Andrealli, Maria Colpani, Matteo Ruggeri, Maurizio Baldassarre, Paolo Angeli, Mario Angelico, Daniela Maiorca, Giacomo Zaccherini, Annalisa Tortora, Elisa Negri, Chiara Pasquale, Silvia NardelliCarmelina Loguercio, Fabio Levantesi, Sergio Boccia, Agostino Rizzotto, Marta Cavallin, Salvatore Piano, Federica Fidone, Alessandra Pecchioli, Alessandro Risso, Giovanni Parrella, Antonio Gasbarrini, Manuel Tufoni, Francesco Auriemma, Stefania Gioia, Marcello Dallio, Carlo Alessandria, Tommaso Gabbani, Maria Guarino, Andrea Roncadori, Alba Kostandini, Daniela Campion, Arianna Lanzi, Maria Marsico, Marianna Zappimbulso, Antonio Mastroianni, Antonio Gasbarrini, Elga Neri, Fabio Pugliese, Giovanni Raimondo, Rosanna De Marco, Piera Rossi, Gianluca Svegliati-Baroni, Roberto Bringiotti, Francesco De Leonardis, Marco Marzioni, Anna Visani, Francesca Capretti, Pietro Leo, Francesco G Foschi, Josè Petruzzi, Giorgio Ballardini, Natascia Celli, Agostino Rizzotto, Daniela Maiorca, Giovanni Parrella, Alberto B Alberti, Silvano Fasolato, Antonietta Sticca, Marcello Vangeli, Lucia Cesarini, Marco Domenicali, Sara Massironi, Raffaele Cozzolongo, Irene Cacciola, Natascia Celli, Maria Rendina, Filomena Morisco, Paolo Caraceni, Aldo Airoldi, Pierluigi Toniutto, Stefano Fagiuoli, Roberto G Romanelli, Gianfranco Elia, Giacomo Laffi, Francesco Salerno, Antonio Mastroianni, Sergio Neri, Manuela Merli, Oliviero Riggio, Nicola Caporaso, Giorgio M Saracco, Alberto B Alberti, Mauro Bernardi, Loredana Prestianni, Alessandra Galioto, Dario Conte, Giulia Magini, Alessandro Federico, Federica Mirici Cappa, Chiara Elia, Riccardo Guarisco

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Abstract

Background Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients withdecompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis(ANSWER) study was designed to clarify this issue.Methods We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academicand non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites whowere treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standardmedical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months.The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time inpatients included in the modified intention-to-treat and per-protocol populations. This study is registered withEudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794.Findings From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in themodified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMTgroup. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meierestimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]).46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver relatedadverse events.Interpretation In this trial, long-term HA administration prolongs overall survival and might act as a diseasemodifying treatment in patients with decompensated cirrhosis.Funding Italian Medicine Agency.Copyright © 2018 Elsevier Ltd. All rights reserved.
Lingua originaleEnglish
pagine (da-a)2417-2429
Numero di pagine13
RivistaTHE LANCET
Volume391
Stato di pubblicazionePublished - 2018

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Calvaruso, V., Di Marco, V., Simone, L., Castellaneta, N. M., Mazzarelli, C., Sangiovanni, V., Calvaruso, V., Giannone, F. A., Andrealli, A., Colpani, M., Ruggeri, M., Baldassarre, M., Angeli, P., Angelico, M., Maiorca, D., Zaccherini, G., Tortora, A., Negri, E., Pasquale, C., ... Guarisco, R. (2018). Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial. THE LANCET, 391, 2417-2429.