Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis

Objective: The clinical benefit of ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) has never been reported in absolute measures. The aim of this study was to assess the number needed to treat (NNT) with UDCA to prevent liver transplantation (LT) or death among patients with PBC. Met...

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Autores: Harms, Maren H., Veer, Rozanne C. de, Lammers, Willem J., Corpechot, Christopher, Thorburn, Douglas, Janssen, Harry L. A., Lindor, Keith D., Trivedi, Palak J., Hirschfield, Gideon M., Parés Darnaculleta, Albert, Floreani, Annarosa, Mayo, Marlyn J., Invernizzi, Pietro, Battezzati, Pier Maria, Nevens, Frederick, Ponsioen, Cyriel Y., Mason, Andrew L., Kowdley, Kris V., Hansen, Bettina E., van Buuren, Henk R., van der Meer, Adriaan J.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/173021
Acceso en línea:https://hdl.handle.net/2445/173021
Access Level:acceso abierto
Palabra clave:Cirrosi hepàtica
Mortalitat
Trasplantament hepàtic
Hepatic cirrhosis
Mortality
Hepatic transplantation
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spelling Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitisHarms, Maren H.Veer, Rozanne C. deLammers, Willem J.Corpechot, ChristopherThorburn, DouglasJanssen, Harry L. A.Lindor, Keith D.Trivedi, Palak J.Hirschfield, Gideon M.Parés Darnaculleta, AlbertFloreani, AnnarosaMayo, Marlyn J.Invernizzi, PietroBattezzati, Pier MariaNevens, FrederickPonsioen, Cyriel Y.Mason, Andrew L.Kowdley, Kris V.Hansen, Bettina E.van Buuren, Henk R.van der Meer, Adriaan J.Cirrosi hepàticaMortalitatTrasplantament hepàticHepatic cirrhosisMortalityHepatic transplantationObjective: The clinical benefit of ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) has never been reported in absolute measures. The aim of this study was to assess the number needed to treat (NNT) with UDCA to prevent liver transplantation (LT) or death among patients with PBC. Methods: The NNT was calculated based on the untreated LT-free survival and HR of UDCA with respect to LT or death as derived from inverse probability of treatment weighting-adjusted Cox proportional hazard analyses within the Global PBC Study Group database. Results: We included 3902 patients with a median follow-up of 7.8 (4.1-12.1) years. The overall HR of UDCA was 0.46 (95% CI 0.40 to 0.52) and the 5-year LT-free survival without UDCA was 81% (95% CI 79 to 82). The NNT to prevent one LT or death within 5 years (NNT5y) was 11 (95% CI 9 to 13). Although the HR of UDCA was similar for patients with and without cirrhosis (0.33 vs 0.31), the NNT5y was 4 (95% CI 3 to 5) and 20 (95% CI 14 to 34), respectively. Among patients with low alkaline phosphatase (ALP) (≤2× the upper limit of normal (ULN)), intermediate ALP (2-4× ULN) and high ALP (>4× ULN), the NNT5y to prevent one LT or death was 26 (95% CI 15 to 70), 11 (95% CI 8 to 17) and 5 (95% CI 4 to 8), respectively. Conclusion: The absolute clinical efficacy of UDCA with respect to LT or death varied with baseline prognostic characteristics, but was high throughout. These findings strongly emphasise the incentive to promptly initiate UDCA treatment in all patients with PBC and may improve patient compliance.BMJ Publishing Group2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/173021Articles publicats en revistes (Medicina)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1136/gutjnl-2019-319057Gut, 2020, vol. 69, num. 8, p. 1502-1509https://doi.org/10.1136/gutjnl-2019-319057cc by (c) Harms et al., 2020http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1730212026-05-27T06:46:51Z
dc.title.none.fl_str_mv Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis
title Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis
spellingShingle Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis
Harms, Maren H.
Cirrosi hepàtica
Mortalitat
Trasplantament hepàtic
Hepatic cirrhosis
Mortality
Hepatic transplantation
title_short Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis
title_full Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis
title_fullStr Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis
title_full_unstemmed Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis
title_sort Number needed to treat with ursodeoxycholic acid therapy to prevent liver transplantation or death in primary biliary cholangitis
dc.creator.none.fl_str_mv Harms, Maren H.
Veer, Rozanne C. de
Lammers, Willem J.
Corpechot, Christopher
Thorburn, Douglas
Janssen, Harry L. A.
Lindor, Keith D.
Trivedi, Palak J.
Hirschfield, Gideon M.
Parés Darnaculleta, Albert
Floreani, Annarosa
Mayo, Marlyn J.
Invernizzi, Pietro
Battezzati, Pier Maria
Nevens, Frederick
Ponsioen, Cyriel Y.
Mason, Andrew L.
Kowdley, Kris V.
Hansen, Bettina E.
van Buuren, Henk R.
van der Meer, Adriaan J.
author Harms, Maren H.
author_facet Harms, Maren H.
Veer, Rozanne C. de
Lammers, Willem J.
Corpechot, Christopher
Thorburn, Douglas
Janssen, Harry L. A.
Lindor, Keith D.
Trivedi, Palak J.
Hirschfield, Gideon M.
Parés Darnaculleta, Albert
Floreani, Annarosa
Mayo, Marlyn J.
Invernizzi, Pietro
Battezzati, Pier Maria
Nevens, Frederick
Ponsioen, Cyriel Y.
Mason, Andrew L.
Kowdley, Kris V.
Hansen, Bettina E.
van Buuren, Henk R.
van der Meer, Adriaan J.
author_role author
author2 Veer, Rozanne C. de
Lammers, Willem J.
Corpechot, Christopher
Thorburn, Douglas
Janssen, Harry L. A.
Lindor, Keith D.
Trivedi, Palak J.
Hirschfield, Gideon M.
Parés Darnaculleta, Albert
Floreani, Annarosa
Mayo, Marlyn J.
Invernizzi, Pietro
Battezzati, Pier Maria
Nevens, Frederick
Ponsioen, Cyriel Y.
Mason, Andrew L.
Kowdley, Kris V.
Hansen, Bettina E.
van Buuren, Henk R.
van der Meer, Adriaan J.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Cirrosi hepàtica
Mortalitat
Trasplantament hepàtic
Hepatic cirrhosis
Mortality
Hepatic transplantation
topic Cirrosi hepàtica
Mortalitat
Trasplantament hepàtic
Hepatic cirrhosis
Mortality
Hepatic transplantation
description Objective: The clinical benefit of ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) has never been reported in absolute measures. The aim of this study was to assess the number needed to treat (NNT) with UDCA to prevent liver transplantation (LT) or death among patients with PBC. Methods: The NNT was calculated based on the untreated LT-free survival and HR of UDCA with respect to LT or death as derived from inverse probability of treatment weighting-adjusted Cox proportional hazard analyses within the Global PBC Study Group database. Results: We included 3902 patients with a median follow-up of 7.8 (4.1-12.1) years. The overall HR of UDCA was 0.46 (95% CI 0.40 to 0.52) and the 5-year LT-free survival without UDCA was 81% (95% CI 79 to 82). The NNT to prevent one LT or death within 5 years (NNT5y) was 11 (95% CI 9 to 13). Although the HR of UDCA was similar for patients with and without cirrhosis (0.33 vs 0.31), the NNT5y was 4 (95% CI 3 to 5) and 20 (95% CI 14 to 34), respectively. Among patients with low alkaline phosphatase (ALP) (≤2× the upper limit of normal (ULN)), intermediate ALP (2-4× ULN) and high ALP (>4× ULN), the NNT5y to prevent one LT or death was 26 (95% CI 15 to 70), 11 (95% CI 8 to 17) and 5 (95% CI 4 to 8), respectively. Conclusion: The absolute clinical efficacy of UDCA with respect to LT or death varied with baseline prognostic characteristics, but was high throughout. These findings strongly emphasise the incentive to promptly initiate UDCA treatment in all patients with PBC and may improve patient compliance.
publishDate 2020
dc.date.none.fl_str_mv 2020
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/2445/173021
url https://hdl.handle.net/2445/173021
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/10.1136/gutjnl-2019-319057
Gut, 2020, vol. 69, num. 8, p. 1502-1509
https://doi.org/10.1136/gutjnl-2019-319057
dc.rights.none.fl_str_mv cc by (c) Harms et al., 2020
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Harms et al., 2020
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
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repository.mail.fl_str_mv
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