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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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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. |
format | Online Article Text |
id | pubmed-8584661 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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