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

医学 腹水 肝硬化 内科学 危险系数 临床终点 随机对照试验 意向治疗分析 白蛋白 胃肠病学 临床试验 置信区间 外科
作者
Paolo Caraceni,Oliviero Riggio,Paolo Angeli,Carlo Alessandria,Sergio Neri,Francesco Giuseppe Foschi,Fabio Levantesi,Aldo Airoldi,Sergio Boccia,Gianluca Svegliati‐Baroni,S. Fagiuoli,Roberto Giulio Romanelli,Raffaele Cozzolongo,V. Di Marco,Vincenzo Sangiovanni,Filomena Morisco,Pierluigi Toniutto,A. Tortora,Rosanna De Marco,M. Angélico
出处
期刊:The Lancet [Elsevier BV]
卷期号:391 (10138): 2417-2429 被引量:425
标识
DOI:10.1016/s0140-6736(18)30840-7
摘要

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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