RT Journal Article
T1 Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry
A1 Stephens, Camilla
A1 Robles-Díaz, María Mercedes
A1 Medina-Cáliz, Inmaculada
A1 García-Cortés, Miren
A1 Ortega-Alonso, Aida
A1 Sanabria-Cabrera, Judith Adriana
A1 González-Jiménez, Andrés
A1 Álvarez-Álvarez, Ismael
A1 Slim, Mahmoud
A1 Jiménez-Pérez, Miguel
A1 González-Grande, Rocío
A1 Fernández, M. Carmen
A1 Casado, Marta
A1 Soriano, German
A1 Roman, Eva
A1 Hallal, Hacibe
A1 Romero-Gomez, Manuel
A1 Castiella, Agustin
A1 Conde, Isabel
A1 Prieto, Martin
A1 Moreno-Planas, José María
A1 Giraldez, Alvaro
A1 Moreno-Sanfiel, J Miguel
A1 Kaplowitz, Neil
A1 Lucena-González, María Isabel
A1 Andrade-Bellido, Raúl Jesús
K1 Hepatitis
K1 Epidemiología
AB 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%).
PB Elsevier
YR 2021
FD 2021-02-01
LK https://hdl.handle.net/10630/23625
UL https://hdl.handle.net/10630/23625
LA eng
NO 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.
NO 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.
DS RIUMA. Repositorio Institucional de la Universidad de Málaga
RD 21 ene 2026