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Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis

No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The...

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Autores principales: Ventura-Cots, Meritxell, Simón-Talero, Macarena, Poca, Maria, Ariza, Xavier, Masnou, Helena, Sanchez, Jordi, Llop, Elba, Cañete, Núria, Martín-Llahí, Marta, Amador, Alberto, Martínez, Javier, Clemente-Sanchez, Ana, Puente, Angela, Torrens, Maria, Alvarado-Tapias, Edilmar, Napoleone, Laura, Miquel-Planas, Mireia, Ardèvol, Alba, Casas Rodrigo, Meritxell, Calleja, Jose Luís, Solé, Cristina, Soriano, German, Genescà, Joan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8584661/
https://www.ncbi.nlm.nih.gov/pubmed/34768404
http://dx.doi.org/10.3390/jcm10214885
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author Ventura-Cots, Meritxell
Simón-Talero, Macarena
Poca, Maria
Ariza, Xavier
Masnou, Helena
Sanchez, Jordi
Llop, Elba
Cañete, Núria
Martín-Llahí, Marta
Amador, Alberto
Martínez, Javier
Clemente-Sanchez, Ana
Puente, Angela
Torrens, Maria
Alvarado-Tapias, Edilmar
Napoleone, Laura
Miquel-Planas, Mireia
Ardèvol, Alba
Casas Rodrigo, Meritxell
Calleja, Jose Luís
Solé, Cristina
Soriano, German
Genescà, Joan
author_facet Ventura-Cots, Meritxell
Simón-Talero, Macarena
Poca, Maria
Ariza, Xavier
Masnou, Helena
Sanchez, Jordi
Llop, Elba
Cañete, Núria
Martín-Llahí, Marta
Amador, Alberto
Martínez, Javier
Clemente-Sanchez, Ana
Puente, Angela
Torrens, Maria
Alvarado-Tapias, Edilmar
Napoleone, Laura
Miquel-Planas, Mireia
Ardèvol, Alba
Casas Rodrigo, Meritxell
Calleja, Jose Luís
Solé, Cristina
Soriano, German
Genescà, Joan
author_sort Ventura-Cots, Meritxell
collection PubMed
description No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient’s data for survival including two clinical trials (BETA and ALFAE) was performed. Results: In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, p = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo (p = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21–0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, p = 0.02). Conclusions: Repeated doses of albumin might be beneficial for patient’s survival as an add-on therapy after an HE episode, but an adequately powered trial is needed.
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spelling pubmed-85846612021-11-12 Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis Ventura-Cots, Meritxell Simón-Talero, Macarena Poca, Maria Ariza, Xavier Masnou, Helena Sanchez, Jordi Llop, Elba Cañete, Núria Martín-Llahí, Marta Amador, Alberto Martínez, Javier Clemente-Sanchez, Ana Puente, Angela Torrens, Maria Alvarado-Tapias, Edilmar Napoleone, Laura Miquel-Planas, Mireia Ardèvol, Alba Casas Rodrigo, Meritxell Calleja, Jose Luís Solé, Cristina Soriano, German Genescà, Joan J Clin Med Article No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient’s data for survival including two clinical trials (BETA and ALFAE) was performed. Results: In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, p = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo (p = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21–0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, p = 0.02). Conclusions: Repeated doses of albumin might be beneficial for patient’s survival as an add-on therapy after an HE episode, but an adequately powered trial is needed. MDPI 2021-10-23 /pmc/articles/PMC8584661/ /pubmed/34768404 http://dx.doi.org/10.3390/jcm10214885 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Ventura-Cots, Meritxell
Simón-Talero, Macarena
Poca, Maria
Ariza, Xavier
Masnou, Helena
Sanchez, Jordi
Llop, Elba
Cañete, Núria
Martín-Llahí, Marta
Amador, Alberto
Martínez, Javier
Clemente-Sanchez, Ana
Puente, Angela
Torrens, Maria
Alvarado-Tapias, Edilmar
Napoleone, Laura
Miquel-Planas, Mireia
Ardèvol, Alba
Casas Rodrigo, Meritxell
Calleja, Jose Luís
Solé, Cristina
Soriano, German
Genescà, Joan
Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_full Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_fullStr Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_full_unstemmed Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_short Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
title_sort effects of albumin on survival after a hepatic encephalopathy episode: randomized double-blind trial and meta-analysis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8584661/
https://www.ncbi.nlm.nih.gov/pubmed/34768404
http://dx.doi.org/10.3390/jcm10214885
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