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Randomized Controlled Trial
. 2018 Jun 16;391(10138):2417-2429.
doi: 10.1016/S0140-6736(18)30840-7. Epub 2018 Jun 1.

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

Paolo Caraceni  1 , Oliviero Riggio  2 , Paolo Angeli  3 , Carlo Alessandria  4 , Sergio Neri  5 , Francesco G Foschi  6 , Fabio Levantesi  7 , Aldo Airoldi  8 , Sergio Boccia  9 , Gianluca Svegliati-Baroni  10 , Stefano Fagiuoli  11 , Roberto G Romanelli  12 , Raffaele Cozzolongo  13 , Vito Di Marco  14 , Vincenzo Sangiovanni  15 , Filomena Morisco  16 , Pierluigi Toniutto  17 , Annalisa Tortora  18 , Rosanna De Marco  19 , Mario Angelico  20 , Irene Cacciola  21 , Gianfranco Elia  22 , Alessandro Federico  23 , Sara Massironi  24 , Riccardo Guarisco  25 , Alessandra Galioto  26 , Giorgio Ballardini  27 , Maria Rendina  28 , Silvia Nardelli  2 , Salvatore Piano  3 , Chiara Elia  4 , Loredana Prestianni  5 , Federica Mirici Cappa  6 , Lucia Cesarini  8 , Loredana Simone  9 , Chiara Pasquale  2 , Marta Cavallin  3 , Alida Andrealli  4 , Federica Fidone  5 , Matteo Ruggeri  29 , Andrea Roncadori  30 , Maurizio Baldassarre  1 , Manuel Tufoni  1 , Giacomo Zaccherini  1 , Mauro Bernardi  31 ; ANSWER Study Investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Paolo Caraceni et al. Lancet. .

Erratum in

  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2018 Aug 4;392(10145):386. doi: 10.1016/S0140-6736(18)31709-4. Lancet. 2018. PMID: 30102172 No abstract available.

Abstract

Background: Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated 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 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical 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 in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, 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 the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 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 related adverse events.

Interpretation: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis.

Funding: Italian Medicine Agency.

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