6533b852fe1ef96bd12ab8c0
RESEARCH PRODUCT
Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial
Paolo CaraceniOliviero RiggioPaolo AngeliCarlo AlessandriaSergio NeriFrancesco G FoschiFabio LevantesiAldo AiroldiSergio BocciaGianluca Svegliati BaroniStefano FagiuoliRoberto G RomanelliRaffaele CozzolongoVito Di MarcoVincenzo SangiovanniFilomena MoriscoPierluigi ToniuttoAnnalisa TortoraRosanna De MarcoMario AngelicoIrene CacciolaGianfranco EliaAlessandro FedericoSara MassironiRiccardo GuariscoAlessandra GaliotoGiorgio BallardiniMaria RendinaSilvia NardelliSalvatore PianoChiara EliaLoredana PrestianniFederica Mirici CappaLucia CesariniLoredana SimoneChiara PasqualeMarta CavallinAlida AndrealliFederica FidoneMatteo RuggeriAndrea RoncadoriMaurizio BaldassarreManuel TufoniGiacomo ZaccheriniMauro BernardiMarco DomenicaliFerdinando A GiannoneManuela MerliStefania GioiaSilvano FasolatoAntonietta SticcaDaniela CampionAlessandro RissoGiorgio M SaraccoDaniela MaiorcaAgostino RizzottoArianna LanziElga NeriAnna VisaniAntonio MastroianniAlberto B AlbertiChiara MazzarelliMarcello VangeliMarco MarzioniFrancesca CaprettiAlba KostandiniGiulia MaginiMaria ColpaniGiacomo LaffiTommaso GabbaniMaria MarsicoMarianna ZappimbulsoJosè PetruzziVincenza CalvarusoGiovanni ParrellaNicola CaporasoFrancesco AuriemmaMaria GuarinoFabio PuglieseAntonio GasbarriniPietro LeoFrancesco De LeonardisAlessandra PecchioliPiera RossiGiovanni RaimondoElisa NegriMarcello DallioCarmelina LoguercioDario ConteNatascia CelliRoberto BringiottiNicola M CastellanetaFrancesco Salerno Answer Study Investigatorssubject
Liver CirrhosisMaleTime FactorsCirrhosisKaplan-Meier Estimatelaw.inventionascites0302 clinical medicineHepatorenal syndromeRandomized controlled trialFurosemidelawAscitesClinical endpointParacentesisDiureticsalbumin decompensated cirrhosiMineralocorticoid Receptor AntagonistsSettore MED/12 - GastroenterologiaMedicine (all)Hazard ratioGeneral MedicineMiddle AgedSurvival RateCirrhosis030220 oncology & carcinogenesisDrug Therapy CombinationFemale030211 gastroenterology & hepatologyQuality-Adjusted Life Yearsmedicine.symptomHyponatremiamedicine.medical_specialty03 medical and health sciencesAlbuminsInternal medicinemedicineHumansSurvival ratealbuminAgedbusiness.industrycirrhosis; albumin; ascitesmedicine.diseaseClinical trialalbumin cirrhosis ascites liver decompensationQuality of LifeHyperkalemiabusinessEsophagus Varices Portal Hypertension Varicosisdescription
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. Copyright © 2018 Elsevier Ltd. All rights reserved.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2018-01-01 |