Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis

Background & Aims: Total bilirubin is a predictor of survival in primary biliary cholangitis, with the main elevated component being direct bilirubin. The purpose of this post hoc analysis was to assess the efficacy and safety of obeticholic acid across quartiles of varying baseline levels of di...

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Autores: Parés Darnaculleta, Albert, Shiffman, Mitchell L., Vargas, Víctor, Invernizzi, Pietro, Malecha, Elizabeth S., Liberman, Alexander, MacConell, Leigh, Hirschfield, Gideon
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/173011
Acceso en línea:https://hdl.handle.net/2445/173011
Access Level:acceso abierto
Palabra clave:Cirrosi hepàtica
Malalties del tracte biliar
Hepatic cirrhosis
Bilious diseases and biliousness
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spelling Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitisParés Darnaculleta, AlbertShiffman, Mitchell L.Vargas, VíctorInvernizzi, PietroMalecha, Elizabeth S.Liberman, AlexanderMacConell, LeighHirschfield, GideonCirrosi hepàticaMalalties del tracte biliarHepatic cirrhosisBilious diseases and biliousnessBackground & Aims: Total bilirubin is a predictor of survival in primary biliary cholangitis, with the main elevated component being direct bilirubin. The purpose of this post hoc analysis was to assess the efficacy and safety of obeticholic acid across quartiles of varying baseline levels of direct bilirubin in the phase 3, randomized, placebo‐controlled Primary Biliary Cholangitis Obeticholic Acid International Study of Efficacy. Methods: This analysis assessed patients on the basis of their baseline direct bilirubin level (divided by quartile). Biochemistry and safety outcomes were evaluated within each quartile over time. Results: In the quartile with the highest baseline direct bilirubin (>5.47 µmol/L), there was a significant reduction in both direct and total bilirubin at Month 12 compared with placebo. Least squares mean (standard error) change from baseline in direct bilirubin at Month 12 was 4.17 (1.42) µmol/L for placebo, −3.48 (1.63) µmol/L for obeticholic acid 5‐10 mg and −3.66 (1.51) µmol/L for obeticholic acid 10 mg (P < .0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, −4.53 (1.83) µmol/L for obeticholic acid 5‐10 mg and −5.06 (1.64) µmol/L for obeticholic acid 10 mg (P < .0001, obeticholic acid vs placebo). Conclusions: Obeticholic acid treatment was associated with significant reductions in total and direct bilirubin, particularly in patients with high baseline direct bilirubin. Because raised direct bilirubin levels, even within the normal range, are predictive of survival in primary biliary cholangitis, these results suggest substantial benefits of obeticholic acid in at‐risk patients.John Wiley & Sons2021202120202021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion9 p.application/pdfhttps://hdl.handle.net/2445/173011Articles publicats en revistes (Medicina)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1111/liv.14429Liver International, 2020, vol. 40, num. 5, p. 1121-1129https://doi.org/10.1111/liv.14429cc by (c) Parés Darnaculleta et al., 2020http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/1730112026-05-29T05:05:01Z
dc.title.none.fl_str_mv Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
title Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
spellingShingle Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
Parés Darnaculleta, Albert
Cirrosi hepàtica
Malalties del tracte biliar
Hepatic cirrhosis
Bilious diseases and biliousness
title_short Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
title_full Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
title_fullStr Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
title_full_unstemmed Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
title_sort Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
dc.creator.none.fl_str_mv Parés Darnaculleta, Albert
Shiffman, Mitchell L.
Vargas, Víctor
Invernizzi, Pietro
Malecha, Elizabeth S.
Liberman, Alexander
MacConell, Leigh
Hirschfield, Gideon
author Parés Darnaculleta, Albert
author_facet Parés Darnaculleta, Albert
Shiffman, Mitchell L.
Vargas, Víctor
Invernizzi, Pietro
Malecha, Elizabeth S.
Liberman, Alexander
MacConell, Leigh
Hirschfield, Gideon
author_role author
author2 Shiffman, Mitchell L.
Vargas, Víctor
Invernizzi, Pietro
Malecha, Elizabeth S.
Liberman, Alexander
MacConell, Leigh
Hirschfield, Gideon
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Cirrosi hepàtica
Malalties del tracte biliar
Hepatic cirrhosis
Bilious diseases and biliousness
topic Cirrosi hepàtica
Malalties del tracte biliar
Hepatic cirrhosis
Bilious diseases and biliousness
description Background & Aims: Total bilirubin is a predictor of survival in primary biliary cholangitis, with the main elevated component being direct bilirubin. The purpose of this post hoc analysis was to assess the efficacy and safety of obeticholic acid across quartiles of varying baseline levels of direct bilirubin in the phase 3, randomized, placebo‐controlled Primary Biliary Cholangitis Obeticholic Acid International Study of Efficacy. Methods: This analysis assessed patients on the basis of their baseline direct bilirubin level (divided by quartile). Biochemistry and safety outcomes were evaluated within each quartile over time. Results: In the quartile with the highest baseline direct bilirubin (>5.47 µmol/L), there was a significant reduction in both direct and total bilirubin at Month 12 compared with placebo. Least squares mean (standard error) change from baseline in direct bilirubin at Month 12 was 4.17 (1.42) µmol/L for placebo, −3.48 (1.63) µmol/L for obeticholic acid 5‐10 mg and −3.66 (1.51) µmol/L for obeticholic acid 10 mg (P < .0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, −4.53 (1.83) µmol/L for obeticholic acid 5‐10 mg and −5.06 (1.64) µmol/L for obeticholic acid 10 mg (P < .0001, obeticholic acid vs placebo). Conclusions: Obeticholic acid treatment was associated with significant reductions in total and direct bilirubin, particularly in patients with high baseline direct bilirubin. Because raised direct bilirubin levels, even within the normal range, are predictive of survival in primary biliary cholangitis, these results suggest substantial benefits of obeticholic acid in at‐risk patients.
publishDate 2020
dc.date.none.fl_str_mv 2020
2021
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/173011
url https://hdl.handle.net/2445/173011
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1111/liv.14429
Liver International, 2020, vol. 40, num. 5, p. 1121-1129
https://doi.org/10.1111/liv.14429
dc.rights.none.fl_str_mv cc by (c) Parés Darnaculleta et al., 2020
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Parés Darnaculleta et al., 2020
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 9 p.
application/pdf
dc.publisher.none.fl_str_mv John Wiley & Sons
publisher.none.fl_str_mv John Wiley & Sons
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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