Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry
Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Agencia Española del Medicamento; Consejería de Salud de Andalucía. Background & Aims: Prospective drug-induced liver injury (DILI) registries are important sources of information on idiosyncratic DILI. We aimed to present a comprehensi...
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| creator | Stephens, Camilla Garcia-Cortes, Miren Ortega-Alonso, Aida Sanabria-Cabrera, Judith Gonzalez-Jimenez, Andrés Álvarez-Álvarez, Ismael Slim, Mahmoud Jimenez-Perez, Miguel Fernández, M.Carmen Soriano, German Roman, Eva Castiella, Agustin Conde, Isabel Moreno-Planas, Jose Maria Giraldez, Alvaro Kaplowitz, Neil Lucena, M. Isabel Andrade, Raúl J Pinazo, Jose García Muñoz, B Alcántara, Ramiro Hernández, Andrés Escaño, M.D.García González-Jiménez, A Cueto, Alejandro Bonilla, Elvira Di Zeo, D Niu, H Villanueva, M Papineau, A González-Grande, Rocío López Ortega, S Santaella, I Ocaña, A Palomino, P Fernández, Maria Carmen Peláez, Gloria Casado, M Millán-Domínguez, R Fombuena, Blanca Gallego, Rocío Del Campo, José Antonio Calle-Sanz, R Rojas, Lourdes Rojas, Ángela Guarner, Carlos Quijada Manuitt, M.A Antonijoan Arbós, Rosa Ma Sánchez Delgado, J Titos Arcos, J.C Egea Caparrós, J.M Arenas, Juan Ignacio Gómez García, Alexandra Esandi, F.J Martínez Odriozola, Pedro Crespo García, Javier Iruzubieta, Paula Cabezas González, Joaquín Rodríguez Seguel, Elisa Cuaresma, María González-Gallego, Javier Sánchez Campos, S Quiles, Rosa González, José Manuel Lorenzo, Sara Prieto, Martín Conde Amiel, I Berenguer, Marina García-Eliz, María Primo, Joaquín Molés, José Ramón Garayoa, Ana Carrascosa, Miguel Gómez Domínguez, Elena Farré, Magí Barriocanal, Ana María Sanz, Yolanda Morillas Cunill, Rosa Ma Sala, Margarita Masnou Ridaura, H Bruguera, Miquel Gines, P Lens, Sabela Hernández Guerra, Manuel Moreno Sanfiel, J.M Fernández, Conrado Montero, José Luís de la Mata, Manuel Fuentes Olmo, J Fernández Bonilla, E.M Martínez-Ródenas, Ponciano Gómez Garrido, M Rendón, Paloma García Samaniego, Javier Madejón, Antonio Calleja, Jose Luis Cabriada, José Luis Pérez-Moreno, José Manuel Lara, Carmen Universitat Autònoma de Barcelona |
| description | Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Agencia Española del Medicamento; Consejería de Salud de Andalucía.
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 |
| format | Article |
| fullrecord | <record><control><sourceid>csuc_XX2</sourceid><recordid>TN_cdi_csuc_recercat_oai_recercat_cat_2072_531479</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>oai_recercat_cat_2072_531479</sourcerecordid><originalsourceid>FETCH-csuc_recercat_oai_recercat_cat_2072_5314793</originalsourceid><addsrcrecordid>eNqdi7EKwkAQRNNYiPoP-wMBkyhiHRUDVmoflsvmbiG5C7unmL83gmBvMcybBzNPsAz9IOTIKz8J0GM3KusEDfDkrIsKFtlTA62EHrrgbRpJeqDXQMLkDUFoITqC24Ce1cGhulRwJcsaZVwmsxY7pdW3F0l2Ot7Lc2r0YWohQ2Iw1gH5Nz7J17u83hbZZrcv_vm8ASkmSq4</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry</title><source>Recercat</source><creator>Stephens, Camilla ; Garcia-Cortes, Miren ; Ortega-Alonso, Aida ; Sanabria-Cabrera, Judith ; Gonzalez-Jimenez, Andrés ; Álvarez-Álvarez, Ismael ; Slim, Mahmoud ; Jimenez-Perez, Miguel ; Fernández, M.Carmen ; Soriano, German ; Roman, Eva ; Castiella, Agustin ; Conde, Isabel ; Moreno-Planas, Jose Maria ; Giraldez, Alvaro ; Kaplowitz, Neil ; Lucena, M. Isabel ; Andrade, Raúl J ; Pinazo, Jose ; García Muñoz, B ; Alcántara, Ramiro ; Hernández, Andrés ; Escaño, M.D.García ; González-Jiménez, A ; Cueto, Alejandro ; Bonilla, Elvira ; Di Zeo, D ; Niu, H ; Villanueva, M ; Papineau, A ; González-Grande, Rocío ; López Ortega, S ; Santaella, I ; Ocaña, A ; Palomino, P ; Fernández, Maria Carmen ; Peláez, Gloria ; Casado, M ; Millán-Domínguez, R ; Fombuena, Blanca ; Gallego, Rocío ; Del Campo, José Antonio ; Calle-Sanz, R ; Rojas, Lourdes ; Rojas, Ángela ; Guarner, Carlos ; Quijada Manuitt, M.A ; Antonijoan Arbós, Rosa Ma ; Sánchez Delgado, J ; Titos Arcos, J.C ; Egea Caparrós, J.M ; Arenas, Juan Ignacio ; Gómez García, Alexandra ; Esandi, F.J ; Martínez Odriozola, Pedro ; Crespo García, Javier ; Iruzubieta, Paula ; Cabezas González, Joaquín ; Rodríguez Seguel, Elisa ; Cuaresma, María ; González-Gallego, Javier ; Sánchez Campos, S ; Quiles, Rosa ; González, José Manuel ; Lorenzo, Sara ; Prieto, Martín ; Conde Amiel, I ; Berenguer, Marina ; García-Eliz, María ; Primo, Joaquín ; Molés, José Ramón ; Garayoa, Ana ; Carrascosa, Miguel ; Gómez Domínguez, Elena ; Farré, Magí ; Barriocanal, Ana María ; Sanz, Yolanda ; Morillas Cunill, Rosa Ma ; Sala, Margarita ; Masnou Ridaura, H ; Bruguera, Miquel ; Gines, P ; Lens, Sabela ; Hernández Guerra, Manuel ; Moreno Sanfiel, J.M ; Fernández, Conrado ; Montero, José Luís ; de la Mata, Manuel ; Fuentes Olmo, J ; Fernández Bonilla, E.M ; Martínez-Ródenas, Ponciano ; Gómez Garrido, M ; Rendón, Paloma ; García Samaniego, Javier ; Madejón, Antonio ; Calleja, Jose Luis ; Cabriada, José Luis ; Pérez-Moreno, José Manuel ; Lara, Carmen ; Universitat Autònoma de Barcelona</creator><creatorcontrib>Stephens, Camilla ; Garcia-Cortes, Miren ; Ortega-Alonso, Aida ; Sanabria-Cabrera, Judith ; Gonzalez-Jimenez, Andrés ; Álvarez-Álvarez, Ismael ; Slim, Mahmoud ; Jimenez-Perez, Miguel ; Fernández, M.Carmen ; Soriano, German ; Roman, Eva ; Castiella, Agustin ; Conde, Isabel ; Moreno-Planas, Jose Maria ; Giraldez, Alvaro ; Kaplowitz, Neil ; Lucena, M. Isabel ; Andrade, Raúl J ; Pinazo, Jose ; García Muñoz, B ; Alcántara, Ramiro ; Hernández, Andrés ; Escaño, M.D.García ; González-Jiménez, A ; Cueto, Alejandro ; Bonilla, Elvira ; Di Zeo, D ; Niu, H ; Villanueva, M ; Papineau, A ; González-Grande, Rocío ; López Ortega, S ; Santaella, I ; Ocaña, A ; Palomino, P ; Fernández, Maria Carmen ; Peláez, Gloria ; Casado, M ; Millán-Domínguez, R ; Fombuena, Blanca ; Gallego, Rocío ; Del Campo, José Antonio ; Calle-Sanz, R ; Rojas, Lourdes ; Rojas, Ángela ; Guarner, Carlos ; Quijada Manuitt, M.A ; Antonijoan Arbós, Rosa Ma ; Sánchez Delgado, J ; Titos Arcos, J.C ; Egea Caparrós, J.M ; Arenas, Juan Ignacio ; Gómez García, Alexandra ; Esandi, F.J ; Martínez Odriozola, Pedro ; Crespo García, Javier ; Iruzubieta, Paula ; Cabezas González, Joaquín ; Rodríguez Seguel, Elisa ; Cuaresma, María ; González-Gallego, Javier ; Sánchez Campos, S ; Quiles, Rosa ; González, José Manuel ; Lorenzo, Sara ; Prieto, Martín ; Conde Amiel, I ; Berenguer, Marina ; García-Eliz, María ; Primo, Joaquín ; Molés, José Ramón ; Garayoa, Ana ; Carrascosa, Miguel ; Gómez Domínguez, Elena ; Farré, Magí ; Barriocanal, Ana María ; Sanz, Yolanda ; Morillas Cunill, Rosa Ma ; Sala, Margarita ; Masnou Ridaura, H ; Bruguera, Miquel ; Gines, P ; Lens, Sabela ; Hernández Guerra, Manuel ; Moreno Sanfiel, J.M ; Fernández, Conrado ; Montero, José Luís ; de la Mata, Manuel ; Fuentes Olmo, J ; Fernández Bonilla, E.M ; Martínez-Ródenas, Ponciano ; Gómez Garrido, M ; Rendón, Paloma ; García Samaniego, Javier ; Madejón, Antonio ; Calleja, Jose Luis ; Cabriada, José Luis ; Pérez-Moreno, José Manuel ; Lara, Carmen ; Universitat Autònoma de Barcelona</creatorcontrib><description>Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Agencia Española del Medicamento; Consejería de Salud de Andalucía.
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.</description><language>eng</language><subject>Causative agents ; DILI ; Drug-induced autoimmune hepatitis ; Epidemiology ; Hepatotoxicity ; Liver-related death ; Outcome ; Risk factors ; Therapy in DILI</subject><creationdate>2021</creationdate><rights>open access Aquest 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</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,776,881,26951</link.rule.ids><linktorsrc>$$Uhttps://recercat.cat/handle/2072/531479$$EView_record_in_Consorci_de_Serveis_Universitaris_de_Catalunya_(CSUC)$$FView_record_in_$$GConsorci_de_Serveis_Universitaris_de_Catalunya_(CSUC)$$Hfree_for_read</linktorsrc></links><search><creatorcontrib>Stephens, Camilla</creatorcontrib><creatorcontrib>Garcia-Cortes, Miren</creatorcontrib><creatorcontrib>Ortega-Alonso, Aida</creatorcontrib><creatorcontrib>Sanabria-Cabrera, Judith</creatorcontrib><creatorcontrib>Gonzalez-Jimenez, Andrés</creatorcontrib><creatorcontrib>Álvarez-Álvarez, Ismael</creatorcontrib><creatorcontrib>Slim, Mahmoud</creatorcontrib><creatorcontrib>Jimenez-Perez, Miguel</creatorcontrib><creatorcontrib>Fernández, M.Carmen</creatorcontrib><creatorcontrib>Soriano, German</creatorcontrib><creatorcontrib>Roman, Eva</creatorcontrib><creatorcontrib>Castiella, Agustin</creatorcontrib><creatorcontrib>Conde, Isabel</creatorcontrib><creatorcontrib>Moreno-Planas, Jose Maria</creatorcontrib><creatorcontrib>Giraldez, Alvaro</creatorcontrib><creatorcontrib>Kaplowitz, Neil</creatorcontrib><creatorcontrib>Lucena, M. Isabel</creatorcontrib><creatorcontrib>Andrade, Raúl J</creatorcontrib><creatorcontrib>Pinazo, Jose</creatorcontrib><creatorcontrib>García Muñoz, B</creatorcontrib><creatorcontrib>Alcántara, Ramiro</creatorcontrib><creatorcontrib>Hernández, Andrés</creatorcontrib><creatorcontrib>Escaño, M.D.García</creatorcontrib><creatorcontrib>González-Jiménez, A</creatorcontrib><creatorcontrib>Cueto, Alejandro</creatorcontrib><creatorcontrib>Bonilla, Elvira</creatorcontrib><creatorcontrib>Di Zeo, D</creatorcontrib><creatorcontrib>Niu, H</creatorcontrib><creatorcontrib>Villanueva, M</creatorcontrib><creatorcontrib>Papineau, A</creatorcontrib><creatorcontrib>González-Grande, Rocío</creatorcontrib><creatorcontrib>López Ortega, S</creatorcontrib><creatorcontrib>Santaella, I</creatorcontrib><creatorcontrib>Ocaña, A</creatorcontrib><creatorcontrib>Palomino, P</creatorcontrib><creatorcontrib>Fernández, Maria Carmen</creatorcontrib><creatorcontrib>Peláez, Gloria</creatorcontrib><creatorcontrib>Casado, M</creatorcontrib><creatorcontrib>Millán-Domínguez, R</creatorcontrib><creatorcontrib>Fombuena, Blanca</creatorcontrib><creatorcontrib>Gallego, Rocío</creatorcontrib><creatorcontrib>Del Campo, José Antonio</creatorcontrib><creatorcontrib>Calle-Sanz, R</creatorcontrib><creatorcontrib>Rojas, Lourdes</creatorcontrib><creatorcontrib>Rojas, Ángela</creatorcontrib><creatorcontrib>Guarner, Carlos</creatorcontrib><creatorcontrib>Quijada Manuitt, M.A</creatorcontrib><creatorcontrib>Antonijoan Arbós, Rosa Ma</creatorcontrib><creatorcontrib>Sánchez Delgado, J</creatorcontrib><creatorcontrib>Titos Arcos, J.C</creatorcontrib><creatorcontrib>Egea Caparrós, J.M</creatorcontrib><creatorcontrib>Arenas, Juan Ignacio</creatorcontrib><creatorcontrib>Gómez García, Alexandra</creatorcontrib><creatorcontrib>Esandi, F.J</creatorcontrib><creatorcontrib>Martínez Odriozola, Pedro</creatorcontrib><creatorcontrib>Crespo García, Javier</creatorcontrib><creatorcontrib>Iruzubieta, Paula</creatorcontrib><creatorcontrib>Cabezas González, Joaquín</creatorcontrib><creatorcontrib>Rodríguez Seguel, Elisa</creatorcontrib><creatorcontrib>Cuaresma, María</creatorcontrib><creatorcontrib>González-Gallego, Javier</creatorcontrib><creatorcontrib>Sánchez Campos, S</creatorcontrib><creatorcontrib>Quiles, Rosa</creatorcontrib><creatorcontrib>González, José Manuel</creatorcontrib><creatorcontrib>Lorenzo, Sara</creatorcontrib><creatorcontrib>Prieto, Martín</creatorcontrib><creatorcontrib>Conde Amiel, I</creatorcontrib><creatorcontrib>Berenguer, Marina</creatorcontrib><creatorcontrib>García-Eliz, María</creatorcontrib><creatorcontrib>Primo, Joaquín</creatorcontrib><creatorcontrib>Molés, José Ramón</creatorcontrib><creatorcontrib>Garayoa, Ana</creatorcontrib><creatorcontrib>Carrascosa, Miguel</creatorcontrib><creatorcontrib>Gómez Domínguez, Elena</creatorcontrib><creatorcontrib>Farré, Magí</creatorcontrib><creatorcontrib>Barriocanal, Ana María</creatorcontrib><creatorcontrib>Sanz, Yolanda</creatorcontrib><creatorcontrib>Morillas Cunill, Rosa Ma</creatorcontrib><creatorcontrib>Sala, Margarita</creatorcontrib><creatorcontrib>Masnou Ridaura, H</creatorcontrib><creatorcontrib>Bruguera, Miquel</creatorcontrib><creatorcontrib>Gines, P</creatorcontrib><creatorcontrib>Lens, Sabela</creatorcontrib><creatorcontrib>Hernández Guerra, Manuel</creatorcontrib><creatorcontrib>Moreno Sanfiel, J.M</creatorcontrib><creatorcontrib>Fernández, Conrado</creatorcontrib><creatorcontrib>Montero, José Luís</creatorcontrib><creatorcontrib>de la Mata, Manuel</creatorcontrib><creatorcontrib>Fuentes Olmo, J</creatorcontrib><creatorcontrib>Fernández Bonilla, E.M</creatorcontrib><creatorcontrib>Martínez-Ródenas, Ponciano</creatorcontrib><creatorcontrib>Gómez Garrido, M</creatorcontrib><creatorcontrib>Rendón, Paloma</creatorcontrib><creatorcontrib>García Samaniego, Javier</creatorcontrib><creatorcontrib>Madejón, Antonio</creatorcontrib><creatorcontrib>Calleja, Jose Luis</creatorcontrib><creatorcontrib>Cabriada, José Luis</creatorcontrib><creatorcontrib>Pérez-Moreno, José Manuel</creatorcontrib><creatorcontrib>Lara, Carmen</creatorcontrib><creatorcontrib>Universitat Autònoma de Barcelona</creatorcontrib><title>Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry</title><description>Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Agencia Española del Medicamento; Consejería de Salud de Andalucía.
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.</description><subject>Causative agents</subject><subject>DILI</subject><subject>Drug-induced autoimmune hepatitis</subject><subject>Epidemiology</subject><subject>Hepatotoxicity</subject><subject>Liver-related death</subject><subject>Outcome</subject><subject>Risk factors</subject><subject>Therapy in DILI</subject><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>XX2</sourceid><recordid>eNqdi7EKwkAQRNNYiPoP-wMBkyhiHRUDVmoflsvmbiG5C7unmL83gmBvMcybBzNPsAz9IOTIKz8J0GM3KusEDfDkrIsKFtlTA62EHrrgbRpJeqDXQMLkDUFoITqC24Ce1cGhulRwJcsaZVwmsxY7pdW3F0l2Ot7Lc2r0YWohQ2Iw1gH5Nz7J17u83hbZZrcv_vm8ASkmSq4</recordid><startdate>2021</startdate><enddate>2021</enddate><creator>Stephens, Camilla</creator><creator>Garcia-Cortes, Miren</creator><creator>Ortega-Alonso, Aida</creator><creator>Sanabria-Cabrera, Judith</creator><creator>Gonzalez-Jimenez, Andrés</creator><creator>Álvarez-Álvarez, Ismael</creator><creator>Slim, Mahmoud</creator><creator>Jimenez-Perez, Miguel</creator><creator>Fernández, M.Carmen</creator><creator>Soriano, German</creator><creator>Roman, Eva</creator><creator>Castiella, Agustin</creator><creator>Conde, Isabel</creator><creator>Moreno-Planas, Jose Maria</creator><creator>Giraldez, Alvaro</creator><creator>Kaplowitz, Neil</creator><creator>Lucena, M. Isabel</creator><creator>Andrade, Raúl J</creator><creator>Pinazo, Jose</creator><creator>García Muñoz, B</creator><creator>Alcántara, Ramiro</creator><creator>Hernández, Andrés</creator><creator>Escaño, M.D.García</creator><creator>González-Jiménez, A</creator><creator>Cueto, Alejandro</creator><creator>Bonilla, Elvira</creator><creator>Di Zeo, D</creator><creator>Niu, H</creator><creator>Villanueva, M</creator><creator>Papineau, A</creator><creator>González-Grande, Rocío</creator><creator>López Ortega, S</creator><creator>Santaella, I</creator><creator>Ocaña, A</creator><creator>Palomino, P</creator><creator>Fernández, Maria Carmen</creator><creator>Peláez, Gloria</creator><creator>Casado, M</creator><creator>Millán-Domínguez, R</creator><creator>Fombuena, Blanca</creator><creator>Gallego, Rocío</creator><creator>Del Campo, José Antonio</creator><creator>Calle-Sanz, R</creator><creator>Rojas, Lourdes</creator><creator>Rojas, Ángela</creator><creator>Guarner, Carlos</creator><creator>Quijada Manuitt, M.A</creator><creator>Antonijoan Arbós, Rosa Ma</creator><creator>Sánchez Delgado, J</creator><creator>Titos Arcos, J.C</creator><creator>Egea Caparrós, J.M</creator><creator>Arenas, Juan Ignacio</creator><creator>Gómez García, Alexandra</creator><creator>Esandi, F.J</creator><creator>Martínez Odriozola, Pedro</creator><creator>Crespo García, Javier</creator><creator>Iruzubieta, Paula</creator><creator>Cabezas González, Joaquín</creator><creator>Rodríguez Seguel, Elisa</creator><creator>Cuaresma, María</creator><creator>González-Gallego, Javier</creator><creator>Sánchez Campos, S</creator><creator>Quiles, Rosa</creator><creator>González, José Manuel</creator><creator>Lorenzo, Sara</creator><creator>Prieto, Martín</creator><creator>Conde Amiel, I</creator><creator>Berenguer, Marina</creator><creator>García-Eliz, María</creator><creator>Primo, Joaquín</creator><creator>Molés, José Ramón</creator><creator>Garayoa, Ana</creator><creator>Carrascosa, Miguel</creator><creator>Gómez Domínguez, Elena</creator><creator>Farré, Magí</creator><creator>Barriocanal, Ana María</creator><creator>Sanz, Yolanda</creator><creator>Morillas Cunill, Rosa Ma</creator><creator>Sala, Margarita</creator><creator>Masnou Ridaura, H</creator><creator>Bruguera, Miquel</creator><creator>Gines, P</creator><creator>Lens, Sabela</creator><creator>Hernández Guerra, Manuel</creator><creator>Moreno Sanfiel, J.M</creator><creator>Fernández, Conrado</creator><creator>Montero, José Luís</creator><creator>de la Mata, Manuel</creator><creator>Fuentes Olmo, J</creator><creator>Fernández Bonilla, E.M</creator><creator>Martínez-Ródenas, Ponciano</creator><creator>Gómez Garrido, M</creator><creator>Rendón, Paloma</creator><creator>García Samaniego, Javier</creator><creator>Madejón, Antonio</creator><creator>Calleja, Jose Luis</creator><creator>Cabriada, José Luis</creator><creator>Pérez-Moreno, José Manuel</creator><creator>Lara, Carmen</creator><creator>Universitat Autònoma de Barcelona</creator><scope>XX2</scope></search><sort><creationdate>2021</creationdate><title>Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry</title><author>Stephens, Camilla ; Garcia-Cortes, Miren ; Ortega-Alonso, Aida ; Sanabria-Cabrera, Judith ; Gonzalez-Jimenez, Andrés ; Álvarez-Álvarez, Ismael ; Slim, Mahmoud ; Jimenez-Perez, Miguel ; Fernández, M.Carmen ; Soriano, German ; Roman, Eva ; Castiella, Agustin ; Conde, Isabel ; Moreno-Planas, Jose Maria ; Giraldez, Alvaro ; Kaplowitz, Neil ; Lucena, M. Isabel ; Andrade, Raúl J ; Pinazo, Jose ; García Muñoz, B ; Alcántara, Ramiro ; Hernández, Andrés ; Escaño, M.D.García ; González-Jiménez, A ; Cueto, Alejandro ; Bonilla, Elvira ; Di Zeo, D ; Niu, H ; Villanueva, M ; Papineau, A ; González-Grande, Rocío ; López Ortega, S ; Santaella, I ; Ocaña, A ; Palomino, P ; Fernández, Maria Carmen ; Peláez, Gloria ; Casado, M ; Millán-Domínguez, R ; Fombuena, Blanca ; Gallego, Rocío ; Del Campo, José Antonio ; Calle-Sanz, R ; Rojas, Lourdes ; Rojas, Ángela ; Guarner, Carlos ; Quijada Manuitt, M.A ; Antonijoan Arbós, Rosa Ma ; Sánchez Delgado, J ; Titos Arcos, J.C ; Egea Caparrós, J.M ; Arenas, Juan Ignacio ; Gómez García, Alexandra ; Esandi, F.J ; Martínez Odriozola, Pedro ; Crespo García, Javier ; Iruzubieta, Paula ; Cabezas González, Joaquín ; Rodríguez Seguel, Elisa ; Cuaresma, María ; González-Gallego, Javier ; Sánchez Campos, S ; Quiles, Rosa ; González, José Manuel ; Lorenzo, Sara ; Prieto, Martín ; Conde Amiel, I ; Berenguer, Marina ; García-Eliz, María ; Primo, Joaquín ; Molés, José Ramón ; Garayoa, Ana ; Carrascosa, Miguel ; Gómez Domínguez, Elena ; Farré, Magí ; Barriocanal, Ana María ; Sanz, Yolanda ; Morillas Cunill, Rosa Ma ; Sala, Margarita ; Masnou Ridaura, H ; Bruguera, Miquel ; Gines, P ; Lens, Sabela ; Hernández Guerra, Manuel ; Moreno Sanfiel, J.M ; Fernández, Conrado ; Montero, José Luís ; de la Mata, Manuel ; Fuentes Olmo, J ; Fernández Bonilla, E.M ; Martínez-Ródenas, Ponciano ; Gómez Garrido, M ; Rendón, Paloma ; García Samaniego, Javier ; Madejón, Antonio ; Calleja, Jose Luis ; Cabriada, José Luis ; Pérez-Moreno, José Manuel ; Lara, Carmen ; Universitat Autònoma de Barcelona</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-csuc_recercat_oai_recercat_cat_2072_5314793</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Causative agents</topic><topic>DILI</topic><topic>Drug-induced autoimmune hepatitis</topic><topic>Epidemiology</topic><topic>Hepatotoxicity</topic><topic>Liver-related death</topic><topic>Outcome</topic><topic>Risk factors</topic><topic>Therapy in DILI</topic><toplevel>online_resources</toplevel><creatorcontrib>Stephens, Camilla</creatorcontrib><creatorcontrib>Garcia-Cortes, Miren</creatorcontrib><creatorcontrib>Ortega-Alonso, Aida</creatorcontrib><creatorcontrib>Sanabria-Cabrera, Judith</creatorcontrib><creatorcontrib>Gonzalez-Jimenez, Andrés</creatorcontrib><creatorcontrib>Álvarez-Álvarez, Ismael</creatorcontrib><creatorcontrib>Slim, Mahmoud</creatorcontrib><creatorcontrib>Jimenez-Perez, Miguel</creatorcontrib><creatorcontrib>Fernández, M.Carmen</creatorcontrib><creatorcontrib>Soriano, German</creatorcontrib><creatorcontrib>Roman, Eva</creatorcontrib><creatorcontrib>Castiella, Agustin</creatorcontrib><creatorcontrib>Conde, Isabel</creatorcontrib><creatorcontrib>Moreno-Planas, Jose Maria</creatorcontrib><creatorcontrib>Giraldez, Alvaro</creatorcontrib><creatorcontrib>Kaplowitz, Neil</creatorcontrib><creatorcontrib>Lucena, M. Isabel</creatorcontrib><creatorcontrib>Andrade, Raúl J</creatorcontrib><creatorcontrib>Pinazo, Jose</creatorcontrib><creatorcontrib>García Muñoz, B</creatorcontrib><creatorcontrib>Alcántara, Ramiro</creatorcontrib><creatorcontrib>Hernández, Andrés</creatorcontrib><creatorcontrib>Escaño, M.D.García</creatorcontrib><creatorcontrib>González-Jiménez, A</creatorcontrib><creatorcontrib>Cueto, Alejandro</creatorcontrib><creatorcontrib>Bonilla, Elvira</creatorcontrib><creatorcontrib>Di Zeo, D</creatorcontrib><creatorcontrib>Niu, H</creatorcontrib><creatorcontrib>Villanueva, M</creatorcontrib><creatorcontrib>Papineau, A</creatorcontrib><creatorcontrib>González-Grande, Rocío</creatorcontrib><creatorcontrib>López Ortega, S</creatorcontrib><creatorcontrib>Santaella, I</creatorcontrib><creatorcontrib>Ocaña, A</creatorcontrib><creatorcontrib>Palomino, P</creatorcontrib><creatorcontrib>Fernández, Maria Carmen</creatorcontrib><creatorcontrib>Peláez, Gloria</creatorcontrib><creatorcontrib>Casado, M</creatorcontrib><creatorcontrib>Millán-Domínguez, R</creatorcontrib><creatorcontrib>Fombuena, Blanca</creatorcontrib><creatorcontrib>Gallego, Rocío</creatorcontrib><creatorcontrib>Del Campo, José Antonio</creatorcontrib><creatorcontrib>Calle-Sanz, R</creatorcontrib><creatorcontrib>Rojas, Lourdes</creatorcontrib><creatorcontrib>Rojas, Ángela</creatorcontrib><creatorcontrib>Guarner, Carlos</creatorcontrib><creatorcontrib>Quijada Manuitt, M.A</creatorcontrib><creatorcontrib>Antonijoan Arbós, Rosa Ma</creatorcontrib><creatorcontrib>Sánchez Delgado, J</creatorcontrib><creatorcontrib>Titos Arcos, J.C</creatorcontrib><creatorcontrib>Egea Caparrós, J.M</creatorcontrib><creatorcontrib>Arenas, Juan Ignacio</creatorcontrib><creatorcontrib>Gómez García, Alexandra</creatorcontrib><creatorcontrib>Esandi, F.J</creatorcontrib><creatorcontrib>Martínez Odriozola, Pedro</creatorcontrib><creatorcontrib>Crespo García, Javier</creatorcontrib><creatorcontrib>Iruzubieta, Paula</creatorcontrib><creatorcontrib>Cabezas González, Joaquín</creatorcontrib><creatorcontrib>Rodríguez Seguel, Elisa</creatorcontrib><creatorcontrib>Cuaresma, María</creatorcontrib><creatorcontrib>González-Gallego, Javier</creatorcontrib><creatorcontrib>Sánchez Campos, S</creatorcontrib><creatorcontrib>Quiles, Rosa</creatorcontrib><creatorcontrib>González, José Manuel</creatorcontrib><creatorcontrib>Lorenzo, Sara</creatorcontrib><creatorcontrib>Prieto, Martín</creatorcontrib><creatorcontrib>Conde Amiel, I</creatorcontrib><creatorcontrib>Berenguer, Marina</creatorcontrib><creatorcontrib>García-Eliz, María</creatorcontrib><creatorcontrib>Primo, Joaquín</creatorcontrib><creatorcontrib>Molés, José Ramón</creatorcontrib><creatorcontrib>Garayoa, Ana</creatorcontrib><creatorcontrib>Carrascosa, Miguel</creatorcontrib><creatorcontrib>Gómez Domínguez, Elena</creatorcontrib><creatorcontrib>Farré, Magí</creatorcontrib><creatorcontrib>Barriocanal, Ana María</creatorcontrib><creatorcontrib>Sanz, Yolanda</creatorcontrib><creatorcontrib>Morillas Cunill, Rosa Ma</creatorcontrib><creatorcontrib>Sala, Margarita</creatorcontrib><creatorcontrib>Masnou Ridaura, H</creatorcontrib><creatorcontrib>Bruguera, Miquel</creatorcontrib><creatorcontrib>Gines, P</creatorcontrib><creatorcontrib>Lens, Sabela</creatorcontrib><creatorcontrib>Hernández Guerra, Manuel</creatorcontrib><creatorcontrib>Moreno Sanfiel, J.M</creatorcontrib><creatorcontrib>Fernández, Conrado</creatorcontrib><creatorcontrib>Montero, José Luís</creatorcontrib><creatorcontrib>de la Mata, Manuel</creatorcontrib><creatorcontrib>Fuentes Olmo, J</creatorcontrib><creatorcontrib>Fernández Bonilla, E.M</creatorcontrib><creatorcontrib>Martínez-Ródenas, Ponciano</creatorcontrib><creatorcontrib>Gómez Garrido, M</creatorcontrib><creatorcontrib>Rendón, Paloma</creatorcontrib><creatorcontrib>García Samaniego, Javier</creatorcontrib><creatorcontrib>Madejón, Antonio</creatorcontrib><creatorcontrib>Calleja, Jose Luis</creatorcontrib><creatorcontrib>Cabriada, José Luis</creatorcontrib><creatorcontrib>Pérez-Moreno, José Manuel</creatorcontrib><creatorcontrib>Lara, Carmen</creatorcontrib><creatorcontrib>Universitat Autònoma de Barcelona</creatorcontrib><collection>Recercat</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Stephens, Camilla</au><au>Garcia-Cortes, Miren</au><au>Ortega-Alonso, Aida</au><au>Sanabria-Cabrera, Judith</au><au>Gonzalez-Jimenez, Andrés</au><au>Álvarez-Álvarez, Ismael</au><au>Slim, Mahmoud</au><au>Jimenez-Perez, Miguel</au><au>Fernández, M.Carmen</au><au>Soriano, German</au><au>Roman, Eva</au><au>Castiella, Agustin</au><au>Conde, Isabel</au><au>Moreno-Planas, Jose Maria</au><au>Giraldez, Alvaro</au><au>Kaplowitz, Neil</au><au>Lucena, M. Isabel</au><au>Andrade, Raúl J</au><au>Pinazo, Jose</au><au>García Muñoz, B</au><au>Alcántara, Ramiro</au><au>Hernández, Andrés</au><au>Escaño, M.D.García</au><au>González-Jiménez, A</au><au>Cueto, Alejandro</au><au>Bonilla, Elvira</au><au>Di Zeo, D</au><au>Niu, H</au><au>Villanueva, M</au><au>Papineau, A</au><au>González-Grande, Rocío</au><au>López Ortega, S</au><au>Santaella, I</au><au>Ocaña, A</au><au>Palomino, P</au><au>Fernández, Maria Carmen</au><au>Peláez, Gloria</au><au>Casado, M</au><au>Millán-Domínguez, R</au><au>Fombuena, Blanca</au><au>Gallego, Rocío</au><au>Del Campo, José Antonio</au><au>Calle-Sanz, R</au><au>Rojas, Lourdes</au><au>Rojas, Ángela</au><au>Guarner, Carlos</au><au>Quijada Manuitt, M.A</au><au>Antonijoan Arbós, Rosa Ma</au><au>Sánchez Delgado, J</au><au>Titos Arcos, J.C</au><au>Egea Caparrós, J.M</au><au>Arenas, Juan Ignacio</au><au>Gómez García, Alexandra</au><au>Esandi, F.J</au><au>Martínez Odriozola, Pedro</au><au>Crespo García, Javier</au><au>Iruzubieta, Paula</au><au>Cabezas González, Joaquín</au><au>Rodríguez Seguel, Elisa</au><au>Cuaresma, María</au><au>González-Gallego, Javier</au><au>Sánchez Campos, S</au><au>Quiles, Rosa</au><au>González, José Manuel</au><au>Lorenzo, Sara</au><au>Prieto, Martín</au><au>Conde Amiel, I</au><au>Berenguer, Marina</au><au>García-Eliz, María</au><au>Primo, Joaquín</au><au>Molés, José Ramón</au><au>Garayoa, Ana</au><au>Carrascosa, Miguel</au><au>Gómez Domínguez, Elena</au><au>Farré, Magí</au><au>Barriocanal, Ana María</au><au>Sanz, Yolanda</au><au>Morillas Cunill, Rosa Ma</au><au>Sala, Margarita</au><au>Masnou Ridaura, H</au><au>Bruguera, Miquel</au><au>Gines, P</au><au>Lens, Sabela</au><au>Hernández Guerra, Manuel</au><au>Moreno Sanfiel, J.M</au><au>Fernández, Conrado</au><au>Montero, José Luís</au><au>de la Mata, Manuel</au><au>Fuentes Olmo, J</au><au>Fernández Bonilla, E.M</au><au>Martínez-Ródenas, Ponciano</au><au>Gómez Garrido, M</au><au>Rendón, Paloma</au><au>García Samaniego, Javier</au><au>Madejón, Antonio</au><au>Calleja, Jose Luis</au><au>Cabriada, José Luis</au><au>Pérez-Moreno, José Manuel</au><au>Lara, Carmen</au><au>Universitat Autònoma de Barcelona</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry</atitle><date>2021</date><risdate>2021</risdate><abstract>Altres ajuts: Fondo Europeo de Desarrollo Regional (FEDER); Agencia Española del Medicamento; Consejería de Salud de Andalucía.
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.</abstract><oa>free_for_read</oa></addata></record> |
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| source | Recercat |
| subjects | Causative agents DILI Drug-induced autoimmune hepatitis Epidemiology Hepatotoxicity Liver-related death Outcome Risk factors Therapy in DILI |
| title | Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry |
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