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Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry
dc.contributor.author | Stephens, Camilla | |
dc.contributor.author | Robles-Díaz, María Mercedes | |
dc.contributor.author | Medina-Cáliz, Inmaculada | |
dc.contributor.author | García-Cortés, Miren | |
dc.contributor.author | Ortega-Alonso, Aida | |
dc.contributor.author | Sanabria-Cabrera, Judith Adriana | |
dc.contributor.author | González-Jiménez, Andrés | |
dc.contributor.author | Alvarez-Alvarez, Ismael | |
dc.contributor.author | Slim, Mahmoud | |
dc.contributor.author | Jiménez-Pérez, Miguel | |
dc.contributor.author | González-Grande, Rocío | |
dc.contributor.author | Fernández, M. Carmen | |
dc.contributor.author | Casado, Marta | |
dc.contributor.author | Soriano, German | |
dc.contributor.author | Roman, Eva | |
dc.contributor.author | Hallal, Hacibe | |
dc.contributor.author | Romero-Gomez, Manuel | |
dc.contributor.author | Castiella, Agustin | |
dc.contributor.author | Conde, Isabel | |
dc.contributor.author | Prieto, Martin | |
dc.contributor.author | Moreno-Planas, José María | |
dc.contributor.author | Giraldez, Alvaro | |
dc.contributor.author | Moreno-Sanfiel, J Miguel | |
dc.contributor.author | Kaplowitz, Neil | |
dc.contributor.author | Lucena-González, María Isabel | |
dc.contributor.author | Andrade-Bellido, Raúl Jesús | |
dc.date.accessioned | 2022-01-17T12:07:00Z | |
dc.date.available | 2022-01-17T12:07:00Z | |
dc.date.created | 2021-12-20 | |
dc.date.issued | 2021-02-01 | |
dc.identifier.citation | Stephens C, Robles-Diaz M, Medina-Caliz I, Garcia-Cortes M, Ortega-Alonso A, Sanabria-Cabrera J, Gonzalez-Jimenez A, Alvarez-Alvarez I, Slim M, Jimenez-Perez M, Gonzalez-Grande R, Fernández MC, Casado M, Soriano G, Román E, Hallal H, Romero-Gomez M, Castiella A, Conde I, Prieto M, Moreno-Planas JM, Giraldez A, Moreno-Sanfiel JM, Kaplowitz N, Lucena MI, Andrade RJ; Participating clinical centres. Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry. J Hepatol. 2021 Jul;75(1):86-97. doi: 10.1016/j.jhep.2021.01.029. | es_ES |
dc.identifier.uri | https://hdl.handle.net/10630/23625 | |
dc.description.abstract | 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%). | es_ES |
dc.description.sponsorship | The present study has been supported by grants of Instituto de Salud Carlos III cofounded by Fondo Europeo de Desarrollo Regional – FEDER (contract numbers: PI19/00883, PI16/01748, PI18/00901, PI18/01804, PI-0285-2016, PI-0274-2016, PI-0310- 2018, PT17/0017/0020) and Agencia Española del Medicamento. CIBERehd and Plataforma ISCIII Ensayos Clinicos are funded by Instituto de Salud Carlos III. MRD holds a Joan Rodes (JR16/ 00015)/Acción B clinicos investigadores (B-0002-2019) and JSC a Rio Hortega (CM17/00243) research contract from ISCIII and Consejería de Salud de Andalucía. The funding sources had no involvement in the study design; in the collection, analysis, and interpretation of data; in the writing of the report or in the de- cision to submit the manuscript for publication. | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | Elsevier | es_ES |
dc.rights | info:eu-repo/semantics/openAccess | es_ES |
dc.subject | Hepatitis | es_ES |
dc.subject | Epidemiología | es_ES |
dc.subject.other | DILI | es_ES |
dc.subject.other | Hepatotoxicity | es_ES |
dc.subject.other | causative agents | es_ES |
dc.subject.other | drug-induced autoimmune hepatitis | es_ES |
dc.subject.other | epidemiology | es_ES |
dc.subject.other | outcome | es_ES |
dc.subject.other | risk factors | es_ES |
dc.subject.other | therapy in DILI | es_ES |
dc.title | Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.centro | Facultad de Medicina | es_ES |
dc.identifier.doi | 10.1016/j.jhep.2021.01.029 | |
dc.type.hasVersion | info:eu-repo/semantics/publishedVersion | es_ES |