Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry

Carlos Guarner, Rosa Ma Antonijoan Arbós, Magi Farre, Eva Montané Esteva, Camilla Stephens, Mercedes Robles-Díaz, Inmaculada Medina-Cáliz, Miren Garcia-Cortes, Aida Ortega-Alonso, Judith Sanabria-Cabrera, Andrés Gonzalez-Jimenez, Ismael Álvarez-Álvarez, Mahmoud Slim, Miguel Jimenez-Perez, Rocio Gonzalez-Grande, M.Carmen Fernández, Marta Casado, German Soriano, Eva Roman, Hacibe HallalManuel Romero-Gómez, Agustin Castiella, Isabel Conde, Martin Prieto, Jose Maria Moreno-Planas, Alvaro Giraldez, J.Miguel Moreno-Sanfiel, Neil Kaplowitz, M. Isabel Lucena, Raúl J. Andrade, Camilla Stephens, M.G. Cortés, Mercedes Robles-Díaz, Aida Ortega-Alonso, Jose Pinazo, B. García Muñoz, Ramiro Alcántara, Andrés Hernández, M.D.García Escaño, E. del Campo, Inmaculada Medina-Cáliz, Judith Sanabria-Cabrera, A. González-Jiménez, Rocío Sanjuán-Jiménez, Alejandro Cueto, Ismael Álvarez-Álvarez, Elvira Bonilla, D. Di Zeo, H. Niu, M. Villanueva, A. Papineau, M.J. Pérez, Rocío González-Grande, S. López Ortega, I. Santaella, A. Ocaña, P. Palomino, Maria Carmen Fernández, Gloria Peláez, A. Porcel, M. Casado, Mara González Sánchez, R. Millán-Domínguez, Blanca Fombuena, Rocío Gallego, Javier Ampuero, José Antonio Del Campo, R. Calle-Sanz, Lourdes Rojas, Ángela Rojas, Alexandra Gil Gómez, Eduardo Vilar, M.A. Quijada Manuitt, J. Sánchez Delgado, Mariano Vergara Gómez, H. Hallal, Ester García Oltra, J.C. Titos Arcos, Alfonso Pérez Martínez, C. Sánchez Cobarro, J.M. Egea Caparrós, Agustin Castiella, Eva María Zapata, Juan Ignacio Arenas, Alexandra Gómez García, F.J. Esandi, Sonia Blanco, Pedro Martínez Odriozola, Javier Crespo García, Paula Iruzubieta, Joaquín Cabezas González, Álvaro Giráldez Gallego, Elisa Rodríguez Seguel, María Cuaresma, Javier González-Gallego, Francisco Jorquera Plaza, S. Sánchez Campos, Pedro Otazua, A. de Juan Gómez, Javier Salmerón, Ana Gila, Rosa Quiles, José Manuel González, Sara Lorenzo, Martín Prieto, I. Conde Amiel, Marina Berenguer, María García-Eliz, Joaquín Primo, José Ramón Molés, Ana Garayoa, Miguel Carrascosa, Elena Gómez Domínguez, L. Cuevas, Ana María Barriocanal, Ana Lucía Arellano, Yolanda Sanz, Rosa Ma Morillas Cunill, Margarita Sala, H. Masnou Ridaura, Miquel Bruguera, P. Gines, Sabela Lens, Zoe Mariño, Manuel Hernández Guerra, J.M. Moreno Sanfiel, C.Boada Fernández del Campo, Martián Tejedor, Ruth González Ferrer, Conrado Fernández, Marta Fernández Gil, José Luís Montero, Manuel de la Mata, J. Fuentes Olmo, E.M. Fernández Bonilla, Julián M. Moreno, Ponciano Martínez-Ródenas, M. Gómez Garrido, C. Oliva, Paloma Rendón, Javier García Samaniego, Antonio Madejón, Jose Luis Calleja, J.L. Martínez Porras, José Luis Cabriada, José Manuel Pérez-Moreno, Carmen Lara

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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.
Idioma originalAnglès
Pàgines (de-a)0086-97
Nombre de pàgines12
RevistaJournal of Hepatology
Volum75
Número1
DOIs
Estat de la publicacióPublicada - 2021

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