Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry
Background & Aims: Prospective drug-induced liver injury (DILI) registries are important sources of information on idiosyncratic DILI. We aimed to present a comprehensive analysis of 843 patients with DILI enrolled into the Spanish DILI Registry over a 20-year time period. Methods: Cases were id...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | artículo |
| Fecha de publicación: | 2021 |
| País: | España |
| Recursos: | Universitat Autònoma de Barcelona |
| Repositorio: | Dipòsit Digital de Documents de la UAB |
| Idioma: | inglés |
| OAI Identifier: | oai:ddd.uab.cat:271904 |
| Acesso em linha: | https://ddd.uab.cat/record/271904 https://dx.doi.org/urn:doi:10.1016/j.jhep.2021.01.029 |
| Access Level: | acceso abierto |
| Palavra-chave: | Hepatotoxicity DILI Epidemiology Liver-related death Causative agents Outcome Risk factors Therapy in DILI Drug-induced autoimmune hepatitis |
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oai:ddd.uab.cat:271904 |
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España |
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| dc.title.none.fl_str_mv |
Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry |
| title |
Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry |
| spellingShingle |
Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry Stephens, Camilla|||0000-0002-0796-9610 Hepatotoxicity DILI Epidemiology Liver-related death Causative agents Outcome Risk factors Therapy in DILI Drug-induced autoimmune hepatitis |
| title_short |
Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry |
| title_full |
Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry |
| title_fullStr |
Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry |
| title_full_unstemmed |
Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry |
| title_sort |
Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry |
| dc.creator.none.fl_str_mv |
Stephens, Camilla|||0000-0002-0796-9610 Robles Díaz, Mercedes|||0000-0002-2365-2787 Medina-Cáliz, Inmaculada|||0000-0003-0471-6658 Garcia-Cortes, Miren|||0000-0003-0410-8273 Ortega-Alonso, Aida|||0000-0002-8999-4093 Sanabria-Cabrera, Judith|||0000-0002-7769-7008 Gonzalez-Jimenez, Andrés Alvarez-Alvarez, Ismael Slim, Mahmoud|||0000-0003-2455-1432 Jimenez-Perez, Miguel Gonzalez-Grande, Rocio Fernández, M.Carmen Casado, Marta Soriano, German|||0000-0002-9267-6811 Roman, Eva|||0000-0001-9084-8555 Hallal, Hacibe Romero-Gómez, Manuel|||0000-0001-8494-8947 Castiella, Agustin Conde, Isabel|||0000-0001-7863-2233 Prieto, Martin Moreno-Planas, Jose Maria Giraldez, Alvaro Moreno-Sanfiel, J.Miguel Kaplowitz, Neil Lucena, M. Isabel|||0000-0001-9586-4896 Andrade, Raúl J. Cortés, M.G. Pinazo, Jose García Muñoz, B. Alcántara, Ramiro Hernández, Andrés Escaño, M.D.García del Campo, E. González-Jiménez, A. Sanjuán Jiménez, Rocío Cueto, Alejandro Bonilla, Elvira Di Zeo, D. Niu, H. Villanueva-Paz, Marina|||0000-0003-4728-201X Papineau, A. Pérez Hernández, Manuel José González-Grande, Rocío|||0000-0002-7691-5755 López Ortega, S. Santaella, I. Ocaña, A. Palomino, P. Fernández, Maria Carmen Peláez, Gloria Porcel, A. Casado, M. González Sánchez, Mara Millán-Domínguez, R. Fombuena, Blanca Gallego, Rocío Ampuero, Javier|||0000-0002-8332-2122 Del Campo, José Antonio Calle-Sanz, R. Rojas, Lourdes Rojas, Ángela|||0000-0003-0853-4800 Gil Gómez, Alexandra Vilar, Eduardo Guarner, Carlos|||0000-0001-5957-9481 Quijada-Manuitt, María Ángeles|||0000-0002-9624-0177 Antonijoan Arbós, Rosa Ma (Rosa María)|||0000-0002-7099-5125 Sánchez Delgado, Jordi|||0000-0002-5217-6492 Vergara Gómez, Mariano Hallal, H. García Oltra, Ester Titos Arcos, J.C. Pérez Martínez, Alfonso Sánchez Cobarro, C. Egea Caparrós, J.M. Zapata, Eva María Arenas, Juan Ignacio Gómez García, Alexandra Esandi, F.J. Blanco, Sonia Martínez Odriozola, Pedro Crespo García, Javier|||0000-0001-8248-0172 Iruzubieta, Paula|||0000-0001-9476-1801 Cabezas González, Joaquín|||0000-0003-0012-484X Giráldez Gallego, Álvaro Rodríguez Seguel, Elisa Cuaresma, María González-Gallego, Javier|||0000-0002-4386-9342 Jorquera, Francisco|||0000-0002-1799-2881 Sánchez Campos, S. Otazua, Pedro de Juan Gómez, A. Salmerón, Javier Gila, Ana Quiles, Rosa González, José Manuel Lorenzo, Sara Prieto, Martín Conde Amiel, I. Berenguer, Marina|||0000-0001-9246-4264 García-Eliz, María Primo, Joaquín Molés, José Ramón Garayoa, Ana Carrascosa, Miguel Gómez Domínguez, Elena Cuevas, L. Farré Albaladejo, Magí|||0000-0001-8338-7543 Montané Esteva, Eva|||0000-0002-1691-7652 Barriocanal, Ana María|||0000-0002-4159-519X Arellano, Ana Lucía|||0000-0001-8601-3504 Sanz, Yolanda Morillas Cunill, Rosa Ma|||0000-0001-9117-5049 Sala, Margarita Masnou Ridaura, H. Bruguera, Miquel Ginès, Pere|||0000-0003-4657-4504 Lens, Sabela|||0000-0003-4900-411X Mariño, Zoe|||0000-0001-6321-9534 Hernández Guerra, Manuel Moreno Sanfiel, J.M. Fernández del Campo, C.Boada Tejedor, Martián González Ferrer, Ruth Fernández, Conrado Fernández Gil, Marta Montero, José Luís de la Mata, Manuel Fuentes Olmo, J. Fernández Bonilla, E.M. Moreno, Julián M. Martínez-Ródenas, Ponciano Gómez Garrido, M. Oliva, C. Rendón, Paloma|||0000-0002-6521-3766 García Samaniego, Javier Madejón, Antonio Calleja, Jose Luis|||0000-0002-2265-6591 Martínez Porras, J.L. Cabriada, José Luis|||0000-0002-3068-5659 Pérez-Moreno, José Manuel Lara, Carmen |
| author |
Stephens, Camilla|||0000-0002-0796-9610 |
| author_facet |
Stephens, Camilla|||0000-0002-0796-9610 Robles Díaz, Mercedes|||0000-0002-2365-2787 Medina-Cáliz, Inmaculada|||0000-0003-0471-6658 Garcia-Cortes, Miren|||0000-0003-0410-8273 Ortega-Alonso, Aida|||0000-0002-8999-4093 Sanabria-Cabrera, Judith|||0000-0002-7769-7008 Gonzalez-Jimenez, Andrés Alvarez-Alvarez, Ismael Slim, Mahmoud|||0000-0003-2455-1432 Jimenez-Perez, Miguel Gonzalez-Grande, Rocio Fernández, M.Carmen Casado, Marta Soriano, German|||0000-0002-9267-6811 Roman, Eva|||0000-0001-9084-8555 Hallal, Hacibe Romero-Gómez, Manuel|||0000-0001-8494-8947 Castiella, Agustin Conde, Isabel|||0000-0001-7863-2233 Prieto, Martin Moreno-Planas, Jose Maria Giraldez, Alvaro Moreno-Sanfiel, J.Miguel Kaplowitz, Neil Lucena, M. Isabel|||0000-0001-9586-4896 Andrade, Raúl J. Cortés, M.G. Pinazo, Jose García Muñoz, B. Alcántara, Ramiro Hernández, Andrés Escaño, M.D.García del Campo, E. González-Jiménez, A. Sanjuán Jiménez, Rocío Cueto, Alejandro Bonilla, Elvira Di Zeo, D. Niu, H. Villanueva-Paz, Marina|||0000-0003-4728-201X Papineau, A. Pérez Hernández, Manuel José González-Grande, Rocío|||0000-0002-7691-5755 López Ortega, S. Santaella, I. Ocaña, A. Palomino, P. Fernández, Maria Carmen Peláez, Gloria Porcel, A. Casado, M. González Sánchez, Mara Millán-Domínguez, R. Fombuena, Blanca Gallego, Rocío Ampuero, Javier|||0000-0002-8332-2122 Del Campo, José Antonio Calle-Sanz, R. Rojas, Lourdes Rojas, Ángela|||0000-0003-0853-4800 Gil Gómez, Alexandra Vilar, Eduardo Guarner, Carlos|||0000-0001-5957-9481 Quijada-Manuitt, María Ángeles|||0000-0002-9624-0177 Antonijoan Arbós, Rosa Ma (Rosa María)|||0000-0002-7099-5125 Sánchez Delgado, Jordi|||0000-0002-5217-6492 Vergara Gómez, Mariano Hallal, H. García Oltra, Ester Titos Arcos, J.C. Pérez Martínez, Alfonso Sánchez Cobarro, C. Egea Caparrós, J.M. Zapata, Eva María Arenas, Juan Ignacio Gómez García, Alexandra Esandi, F.J. Blanco, Sonia Martínez Odriozola, Pedro Crespo García, Javier|||0000-0001-8248-0172 Iruzubieta, Paula|||0000-0001-9476-1801 Cabezas González, Joaquín|||0000-0003-0012-484X Giráldez Gallego, Álvaro Rodríguez Seguel, Elisa Cuaresma, María González-Gallego, Javier|||0000-0002-4386-9342 Jorquera, Francisco|||0000-0002-1799-2881 Sánchez Campos, S. Otazua, Pedro de Juan Gómez, A. Salmerón, Javier Gila, Ana Quiles, Rosa González, José Manuel Lorenzo, Sara Prieto, Martín Conde Amiel, I. Berenguer, Marina|||0000-0001-9246-4264 García-Eliz, María Primo, Joaquín Molés, José Ramón Garayoa, Ana Carrascosa, Miguel Gómez Domínguez, Elena Cuevas, L. Farré Albaladejo, Magí|||0000-0001-8338-7543 Montané Esteva, Eva|||0000-0002-1691-7652 Barriocanal, Ana María|||0000-0002-4159-519X Arellano, Ana Lucía|||0000-0001-8601-3504 Sanz, Yolanda Morillas Cunill, Rosa Ma|||0000-0001-9117-5049 Sala, Margarita Masnou Ridaura, H. Bruguera, Miquel Ginès, Pere|||0000-0003-4657-4504 Lens, Sabela|||0000-0003-4900-411X Mariño, Zoe|||0000-0001-6321-9534 Hernández Guerra, Manuel Moreno Sanfiel, J.M. Fernández del Campo, C.Boada Tejedor, Martián González Ferrer, Ruth Fernández, Conrado Fernández Gil, Marta Montero, José Luís de la Mata, Manuel Fuentes Olmo, J. Fernández Bonilla, E.M. Moreno, Julián M. Martínez-Ródenas, Ponciano Gómez Garrido, M. Oliva, C. Rendón, Paloma|||0000-0002-6521-3766 García Samaniego, Javier Madejón, Antonio Calleja, Jose Luis|||0000-0002-2265-6591 Martínez Porras, J.L. Cabriada, José Luis|||0000-0002-3068-5659 Pérez-Moreno, José Manuel Lara, Carmen |
| author_role |
author |
| author2 |
Robles Díaz, Mercedes|||0000-0002-2365-2787 Medina-Cáliz, Inmaculada|||0000-0003-0471-6658 Garcia-Cortes, Miren|||0000-0003-0410-8273 Ortega-Alonso, Aida|||0000-0002-8999-4093 Sanabria-Cabrera, Judith|||0000-0002-7769-7008 Gonzalez-Jimenez, Andrés Alvarez-Alvarez, Ismael Slim, Mahmoud|||0000-0003-2455-1432 Jimenez-Perez, Miguel Gonzalez-Grande, Rocio Fernández, M.Carmen Casado, Marta Soriano, German|||0000-0002-9267-6811 Roman, Eva|||0000-0001-9084-8555 Hallal, Hacibe Romero-Gómez, Manuel|||0000-0001-8494-8947 Castiella, Agustin Conde, Isabel|||0000-0001-7863-2233 Prieto, Martin Moreno-Planas, Jose Maria Giraldez, Alvaro Moreno-Sanfiel, J.Miguel Kaplowitz, Neil Lucena, M. Isabel|||0000-0001-9586-4896 Andrade, Raúl J. Cortés, M.G. Pinazo, Jose García Muñoz, B. Alcántara, Ramiro Hernández, Andrés Escaño, M.D.García del Campo, E. González-Jiménez, A. Sanjuán Jiménez, Rocío Cueto, Alejandro Bonilla, Elvira Di Zeo, D. Niu, H. Villanueva-Paz, Marina|||0000-0003-4728-201X Papineau, A. Pérez Hernández, Manuel José González-Grande, Rocío|||0000-0002-7691-5755 López Ortega, S. Santaella, I. Ocaña, A. Palomino, P. Fernández, Maria Carmen Peláez, Gloria Porcel, A. Casado, M. González Sánchez, Mara Millán-Domínguez, R. Fombuena, Blanca Gallego, Rocío Ampuero, Javier|||0000-0002-8332-2122 Del Campo, José Antonio Calle-Sanz, R. Rojas, Lourdes Rojas, Ángela|||0000-0003-0853-4800 Gil Gómez, Alexandra Vilar, Eduardo Guarner, Carlos|||0000-0001-5957-9481 Quijada-Manuitt, María Ángeles|||0000-0002-9624-0177 Antonijoan Arbós, Rosa Ma (Rosa María)|||0000-0002-7099-5125 Sánchez Delgado, Jordi|||0000-0002-5217-6492 Vergara Gómez, Mariano Hallal, H. García Oltra, Ester Titos Arcos, J.C. Pérez Martínez, Alfonso Sánchez Cobarro, C. Egea Caparrós, J.M. Zapata, Eva María Arenas, Juan Ignacio Gómez García, Alexandra Esandi, F.J. Blanco, Sonia Martínez Odriozola, Pedro Crespo García, Javier|||0000-0001-8248-0172 Iruzubieta, Paula|||0000-0001-9476-1801 Cabezas González, Joaquín|||0000-0003-0012-484X Giráldez Gallego, Álvaro Rodríguez Seguel, Elisa Cuaresma, María González-Gallego, Javier|||0000-0002-4386-9342 Jorquera, Francisco|||0000-0002-1799-2881 Sánchez Campos, S. Otazua, Pedro de Juan Gómez, A. Salmerón, Javier Gila, Ana Quiles, Rosa González, José Manuel Lorenzo, Sara Prieto, Martín Conde Amiel, I. Berenguer, Marina|||0000-0001-9246-4264 García-Eliz, María Primo, Joaquín Molés, José Ramón Garayoa, Ana Carrascosa, Miguel Gómez Domínguez, Elena Cuevas, L. Farré Albaladejo, Magí|||0000-0001-8338-7543 Montané Esteva, Eva|||0000-0002-1691-7652 Barriocanal, Ana María|||0000-0002-4159-519X Arellano, Ana Lucía|||0000-0001-8601-3504 Sanz, Yolanda Morillas Cunill, Rosa Ma|||0000-0001-9117-5049 Sala, Margarita Masnou Ridaura, H. Bruguera, Miquel Ginès, Pere|||0000-0003-4657-4504 Lens, Sabela|||0000-0003-4900-411X Mariño, Zoe|||0000-0001-6321-9534 Hernández Guerra, Manuel Moreno Sanfiel, J.M. Fernández del Campo, C.Boada Tejedor, Martián González Ferrer, Ruth Fernández, Conrado Fernández Gil, Marta Montero, José Luís de la Mata, Manuel Fuentes Olmo, J. Fernández Bonilla, E.M. Moreno, Julián M. Martínez-Ródenas, Ponciano Gómez Garrido, M. Oliva, C. Rendón, Paloma|||0000-0002-6521-3766 García Samaniego, Javier Madejón, Antonio Calleja, Jose Luis|||0000-0002-2265-6591 Martínez Porras, J.L. Cabriada, José Luis|||0000-0002-3068-5659 Pérez-Moreno, José Manuel Lara, Carmen |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Universitat Autònoma de Barcelona |
| dc.subject.none.fl_str_mv |
Hepatotoxicity DILI Epidemiology Liver-related death Causative agents Outcome Risk factors Therapy in DILI Drug-induced autoimmune hepatitis |
| topic |
Hepatotoxicity DILI Epidemiology Liver-related death Causative agents Outcome Risk factors Therapy in DILI Drug-induced autoimmune hepatitis |
| description |
Background & Aims: Prospective drug-induced liver injury (DILI) registries are important sources of information on idiosyncratic DILI. We aimed to present a comprehensive analysis of 843 patients with DILI enrolled into the Spanish DILI Registry over a 20-year time period. Methods: Cases were identified, diagnosed and followed prospectively. Clinical features, drug information and outcome data were collected. Results: A total of 843 patients, with a mean age of 54 years (48% females), were enrolled up to 2018. Hepatocellular injury was associated with younger age (adjusted odds ratio [aOR] per year 0.983; 95% CI 0.974-0.991) and lower platelet count (aOR per unit 0.996; 95% CI 0.994-0.998). Anti-infectives were the most common causative drug class (40%). Liver-related mortality was more frequent in patients with hepatocellular damage aged ≥65 years (p = 0.0083) and in patients with underlying liver disease (p = 0.0221). Independent predictors of liver-related death/transplantation included nR-based hepatocellular injury, female sex, higher onset aspartate aminotransferase (AST) and bilirubin values. nR-based hepatocellular injury was not associated with 6-month overall mortality, for which comorbidity burden played a more important role. The prognostic capacity of Hy's law varied between causative agents. Empirical therapy (corticosteroids, ursodeoxycholic acid and MARS) was prescribed to 20% of patients. Drug-induced autoimmune hepatitis patients (26 cases) were mainly females (62%) with hepatocellular damage (92%), who more frequently received immunosuppressive therapy (58%). Conclusions: AST elevation at onset is a strong predictor of poor outcome and should be routinely assessed in DILI evaluation. Mortality is higher in older patients with hepatocellular damage and patients with underlying hepatic conditions. The Spanish DILI Registry is a valuable tool in the identification of causative drugs, clinical signatures and prognostic risk factors in DILI and can aid physicians in DILI characterisation and management. Lay summary: Clinical information on drug-induced liver injury (DILI) collected from enrolled patients in the Spanish DILI Registry can guide physicians in the decision-making process. We have found that older patients with hepatocellular type liver injury and patients with additional liver conditions are at a higher risk of mortality. The type of liver injury, patient sex and analytical values of aspartate aminotransferase and total bilirubin can also help predict clinical outcomes. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2 2021-01-01 2021 2021-01-01 |
| dc.type.none.fl_str_mv |
Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| dc.identifier.none.fl_str_mv |
https://ddd.uab.cat/record/271904 https://dx.doi.org/urn:doi:10.1016/j.jhep.2021.01.029 |
| url |
https://ddd.uab.cat/record/271904 https://dx.doi.org/urn:doi:10.1016/j.jhep.2021.01.029 |
| dc.language.none.fl_str_mv |
Inglés eng |
| language_invalid_str_mv |
Inglés |
| language |
eng |
| dc.relation.none.fl_str_mv |
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI19/00883 Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI16/01748 Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI18/00901 Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI18/01804 Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI-0285-2016 Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI-0274-2016 Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI-0310-2018 Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PT17/0017/0020 Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 JR16/00015 Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 B-0002-2019 Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 CM17/00243 |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
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application/pdf |
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reponame:Dipòsit Digital de Documents de la UAB instname:Universitat Autònoma de Barcelona |
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Universitat Autònoma de Barcelona |
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Dipòsit Digital de Documents de la UAB |
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Dipòsit Digital de Documents de la UAB |
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Comprehensive analysis and insights gained from long-term experience of the Spanish DILI RegistryStephens, Camilla|||0000-0002-0796-9610Robles Díaz, Mercedes|||0000-0002-2365-2787Medina-Cáliz, Inmaculada|||0000-0003-0471-6658Garcia-Cortes, Miren|||0000-0003-0410-8273Ortega-Alonso, Aida|||0000-0002-8999-4093Sanabria-Cabrera, Judith|||0000-0002-7769-7008Gonzalez-Jimenez, AndrésAlvarez-Alvarez, IsmaelSlim, Mahmoud|||0000-0003-2455-1432Jimenez-Perez, MiguelGonzalez-Grande, RocioFernández, M.CarmenCasado, MartaSoriano, German|||0000-0002-9267-6811Roman, Eva|||0000-0001-9084-8555Hallal, HacibeRomero-Gómez, Manuel|||0000-0001-8494-8947Castiella, AgustinConde, Isabel|||0000-0001-7863-2233Prieto, MartinMoreno-Planas, Jose MariaGiraldez, AlvaroMoreno-Sanfiel, J.MiguelKaplowitz, NeilLucena, M. Isabel|||0000-0001-9586-4896Andrade, Raúl J.Cortés, M.G.Pinazo, JoseGarcía Muñoz, B.Alcántara, RamiroHernández, AndrésEscaño, M.D.Garcíadel Campo, E.González-Jiménez, A.Sanjuán Jiménez, RocíoCueto, AlejandroBonilla, ElviraDi Zeo, D.Niu, H.Villanueva-Paz, Marina|||0000-0003-4728-201XPapineau, A.Pérez Hernández, Manuel JoséGonzález-Grande, Rocío|||0000-0002-7691-5755López Ortega, S.Santaella, I.Ocaña, A.Palomino, P.Fernández, Maria CarmenPeláez, GloriaPorcel, A.Casado, M.González Sánchez, MaraMillán-Domínguez, R.Fombuena, BlancaGallego, RocíoAmpuero, Javier|||0000-0002-8332-2122Del Campo, José AntonioCalle-Sanz, R.Rojas, LourdesRojas, Ángela|||0000-0003-0853-4800Gil Gómez, AlexandraVilar, EduardoGuarner, Carlos|||0000-0001-5957-9481Quijada-Manuitt, María Ángeles|||0000-0002-9624-0177Antonijoan Arbós, Rosa Ma (Rosa María)|||0000-0002-7099-5125Sánchez Delgado, Jordi|||0000-0002-5217-6492Vergara Gómez, MarianoHallal, H.García Oltra, EsterTitos Arcos, J.C.Pérez Martínez, AlfonsoSánchez Cobarro, C.Egea Caparrós, J.M.Zapata, Eva MaríaArenas, Juan IgnacioGómez García, AlexandraEsandi, F.J.Blanco, SoniaMartínez Odriozola, PedroCrespo García, Javier|||0000-0001-8248-0172Iruzubieta, Paula|||0000-0001-9476-1801Cabezas González, Joaquín|||0000-0003-0012-484XGiráldez Gallego, ÁlvaroRodríguez Seguel, ElisaCuaresma, MaríaGonzález-Gallego, Javier|||0000-0002-4386-9342Jorquera, Francisco|||0000-0002-1799-2881Sánchez Campos, S.Otazua, Pedrode Juan Gómez, A.Salmerón, JavierGila, AnaQuiles, RosaGonzález, José ManuelLorenzo, SaraPrieto, MartínConde Amiel, I.Berenguer, Marina|||0000-0001-9246-4264García-Eliz, MaríaPrimo, JoaquínMolés, José RamónGarayoa, AnaCarrascosa, MiguelGómez Domínguez, ElenaCuevas, L.Farré Albaladejo, Magí|||0000-0001-8338-7543Montané Esteva, Eva|||0000-0002-1691-7652Barriocanal, Ana María|||0000-0002-4159-519XArellano, Ana Lucía|||0000-0001-8601-3504Sanz, YolandaMorillas Cunill, Rosa Ma|||0000-0001-9117-5049Sala, MargaritaMasnou Ridaura, H.Bruguera, MiquelGinès, Pere|||0000-0003-4657-4504Lens, Sabela|||0000-0003-4900-411XMariño, Zoe|||0000-0001-6321-9534Hernández Guerra, ManuelMoreno Sanfiel, J.M.Fernández del Campo, C.BoadaTejedor, MartiánGonzález Ferrer, RuthFernández, ConradoFernández Gil, MartaMontero, José Luísde la Mata, ManuelFuentes Olmo, J.Fernández Bonilla, E.M.Moreno, Julián M.Martínez-Ródenas, PoncianoGómez Garrido, M.Oliva, C.Rendón, Paloma|||0000-0002-6521-3766García Samaniego, JavierMadejón, AntonioCalleja, Jose Luis|||0000-0002-2265-6591Martínez Porras, J.L.Cabriada, José Luis|||0000-0002-3068-5659Pérez-Moreno, José ManuelLara, CarmenHepatotoxicityDILIEpidemiologyLiver-related deathCausative agentsOutcomeRisk factorsTherapy in DILIDrug-induced autoimmune hepatitisBackground & Aims: Prospective drug-induced liver injury (DILI) registries are important sources of information on idiosyncratic DILI. We aimed to present a comprehensive analysis of 843 patients with DILI enrolled into the Spanish DILI Registry over a 20-year time period. Methods: Cases were identified, diagnosed and followed prospectively. Clinical features, drug information and outcome data were collected. Results: A total of 843 patients, with a mean age of 54 years (48% females), were enrolled up to 2018. Hepatocellular injury was associated with younger age (adjusted odds ratio [aOR] per year 0.983; 95% CI 0.974-0.991) and lower platelet count (aOR per unit 0.996; 95% CI 0.994-0.998). Anti-infectives were the most common causative drug class (40%). Liver-related mortality was more frequent in patients with hepatocellular damage aged ≥65 years (p = 0.0083) and in patients with underlying liver disease (p = 0.0221). Independent predictors of liver-related death/transplantation included nR-based hepatocellular injury, female sex, higher onset aspartate aminotransferase (AST) and bilirubin values. nR-based hepatocellular injury was not associated with 6-month overall mortality, for which comorbidity burden played a more important role. The prognostic capacity of Hy's law varied between causative agents. Empirical therapy (corticosteroids, ursodeoxycholic acid and MARS) was prescribed to 20% of patients. Drug-induced autoimmune hepatitis patients (26 cases) were mainly females (62%) with hepatocellular damage (92%), who more frequently received immunosuppressive therapy (58%). Conclusions: AST elevation at onset is a strong predictor of poor outcome and should be routinely assessed in DILI evaluation. Mortality is higher in older patients with hepatocellular damage and patients with underlying hepatic conditions. The Spanish DILI Registry is a valuable tool in the identification of causative drugs, clinical signatures and prognostic risk factors in DILI and can aid physicians in DILI characterisation and management. Lay summary: Clinical information on drug-induced liver injury (DILI) collected from enrolled patients in the Spanish DILI Registry can guide physicians in the decision-making process. We have found that older patients with hepatocellular type liver injury and patients with additional liver conditions are at a higher risk of mortality. The type of liver injury, patient sex and analytical values of aspartate aminotransferase and total bilirubin can also help predict clinical outcomes.Universitat Autònoma de Barcelona 22021-01-0120212021-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/271904https://dx.doi.org/urn:doi:10.1016/j.jhep.2021.01.029reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengInstituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI19/00883Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI16/01748Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI18/00901Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI18/01804Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI-0285-2016Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI-0274-2016Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI-0310-2018Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PT17/0017/0020Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 JR16/00015Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 B-0002-2019Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 CM17/00243open accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2719042026-06-06T12:50:31Z |
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