On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites

• DOI: 10.1016/j.jhep.2020.08.021
• Publication Date: 2020-08-24T15:26:28Z
• Authors: Paolo Caraceni; Manuel Tufoni; Giacomo Zaccherini; Oliviero Riggio; Paolo Angeli; Carlo Alessandria; Sergio Neri; Francesco G. Foschi; Fabio Levantesi; Aldo Airoldi; Loredana Simone; Gianluca Svegliat...; Stefano Fagiuoli; Giacomo Laffi; Raffaele Cozzolongo; Vito Di Marco; Vincenzo Sangiovanni; Filomena Morisco; Pierluigi Toniutto; Antonio Gasbarrini; Rosanna De Marco; Salvatore Piano; Silvia Nardelli; Chiara Elia; Andrea Roncadori; Maurizio Baldassarre; Mauro Bernardi; Marco Domenicali; Ferdinando A. Gia...; Agnese Antognoli; Manuela Merli; Chiara Pasquale; Stefania Gioia; Silvano Fasolato; Antonietta Sticca; Daniela Campion; Alessandro Risso; Giorgio M. Saracco; Loredana Prestianni; Federica Fidone; Daniela Maiorca; Agostino Rizzotto; Federica Mirici C...; Arianna Lanzi; Elga Neri; Anna Visani; Antonio Mastroianni; Giovanni Perricone; Alberto B. Alberti; Lucia Cesarini; Chiara Mazzarelli; Marcello Vangeli; Raffaella Viganò; Marco Marzioni; Francesca Capretti; Alba Kostandini; Giulia Magini; Maria Colpani; Tommaso Gabbani; Maria Marsico; Marianna Zappimbulso; Josè Petruzzi; Vincenza Calvaruso; Giovanni Parrella; Nicola Caporaso; Francesco Auriemma; Maria Guarino; Fabio Pugliese; Annalisa Tortora; Pietro Leo; Mario Angelico; Francesco De Leon...; Alessandra Pecchioli; Piera Rossi; Giovanni Raimondo; Irene Cacciola; Gianfranco Elia; Elisa Negri; Marcello Dallio; Carmelina Loguercio; Alessandro Federico; Dario Conte; Sara Massironi; Giorgio Ballardin...; Maria Rendina; Roberto Bringiotti; Nicola Maurizio C...; Francesco Salerno; Sergio Boccia; Riccardo Guarisco; Alessandra Galioto; Marta Cavallin; Alida Andrealli
• Keywords: Liver Cirrhosis; Male; ascites; complications; liver cirrhosis; serum albumin; survival; Complications; complications; Survival; Ascites; Cirrhosis; Complications; Serum albumin; Survival;; Ascites, Cirrhosis, Complications, Serum albumin, Survival; liver cirrhosis; serum albumin; Serum albumin; Serum Albumin, Human; survival; Biomarkers, Pharmacological; Ascites; Cirrhosis; Complications; Serum albumin; Survival; ascites; 03 medical and health sciences; 0302 clinical medicine; Predictive Value of Tests; Humans; Serum Albumin; Biological Products; Ascites; ascites; cirrhosis; complications; serum albumin; survival; Middle Aged; Long-Term Care; Survival Analysis; Intention to Treat Analysis; 3. Good health; Treatment Outcome; Cirrhosis; Female; Drug Monitoring

The ANSWER study reported that long-term albumin administration in patients with cirrhosis and uncomplicated ascites improves survival. During treatment, serum albumin increased within a month and remained stable thereafter. In this post hoc analysis, we aimed to determine whether on-treatment serum albumin levels could guide therapy.Logistic regression was used to assess the association between baseline serum albumin and mortality, as well as to determine on-treatment factors associated with mortality and to predict the achievement of a given on-treatment serum albumin level. Survival was assessed by Kaplan-Meier estimates and second-order polynomial regression. Patients whose on-treatment serum albumin remained below normal were compared with a subset of patients from the control arm matched by principal score.Baseline serum albumin was closely associated with 18-month mortality in untreated patients; albumin treatment almost effaced this relationship. On-treatment serum albumin and MELD-Na at month 1 were the sole independent variables associated with mortality. Second-order polynomial regression revealed that survival improved in parallel with increased 1-month on-treatment serum albumin. Kaplan-Meier estimations showed that any value of 1-month on-treatment serum albumin (0.1 g/dl intervals) in the range 2.5-4.5 g/dl discriminated patient survival. In the normal range of serum albumin, the best discriminant value was 4.0 g/dl. Compared to untreated patients, survival even improved in patients whose on-treatment serum albumin remained below normal.Baseline serum albumin per se should not guide the decision to start albumin therapy. Conversely, 1-month on-treatment serum albumin levels are strongly associated with outcomes and could guide the use of albumin - 4.0 g/dl being the target threshold. However, even patients whose serum albumin remains below normal benefit from long-term albumin administration.The ANSWER study has shown that long-term albumin administration improves survival and prevents the occurrence of major complications in patients with cirrhosis and ascites. This study shows that the achievement of these beneficial effects is related to a significant increase in serum albumin concentration. Even though the best results follow the achievement of a serum albumin concentration of 4 g/dl, a survival benefit is also achieved in patients who fail to normalise serum albumin.