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1. Rechallenge in idiosyncratic drug-induced liver injury: An analysis of cases in two large prospective registries according to existing definitions

Author

J.M. Pinazo-Bandera, H. Niu, I. Alvarez-Alvarez, I. Medina-Cáliz, E. Del Campo-Herrera, A. Ortega-Alonso, M. Robles-Díaz, N. Hernández, R. Paraná, V. Nunes, M. Girala, F. Bessone, M.I. Lucena, R.J. Andrade, and M. García Cortés

Subjects
Drug-induced liver injury, hepatotoxicity, positive rechallenge, acute liver failure, Therapeutics. Pharmacology, RM1-950
Abstract

Introduction: Data on positive rechallenge in idiosyncratic drug-induced liver injury (DILI) are scarce. We aim to analyse the clinical presentation, outcome and drugs associated with positive rechallenge in two DILI registries. Methods: Cases from the Spanish and Latin American DILI registries were included. Demographics, clinical characteristics and outcome of cases with positive rechallenge according to CIOMS/RUCAM and current definitions were analysed. Results: Of 1418 patients with idiosyncratic DILI, 58 cases had positive rechallenge (4.1%). Patients with positive rechallenge had shorter duration of therapy (p=0.001) and latency (p=0.003). In patients with rechallenge, aspartate transaminase levels were increased (p=0.026) and showed a prolonged time to recovery (p=0.020), albeit no differences were seen in terms of fatal outcomes. The main drug implicated in rechallenge was amoxicillin-clavulanate (17%). The majority of re-exposure events were unintentional (71%). Using both existing definitions of positive rechallenge, there were four cases which exclusively fulfilled the current criteria and five which only meet the historical definition. All cases of positive rechallenge, irrespective of the pattern of damage, fulfilled the criteria of either alanine transaminase (ALT) ≥3 times the upper limit of normal (ULN) and/or alkaline phosphatase (ALP) ≥2 times ULN. Conclusions: Episodes of rechallenge were characterised by shorter duration of therapy and latency, and longer time to resolution, but did not show an increased incidence of fatal outcome. Based on our findings, ALT ≥3 times ULN and/or ALP ≥2 times ULN, regardless of the pattern of damage, is proposed as a new definition of rechallenge in DILI.

Published
2024
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2. Clinical Characteristics and Outcome of Drug‐Induced Liver Injury in the Older Patients: From the Young‐Old to the Oldest‐Old

Author

Rianne A. Weersink, Ismael Alvarez‐Alvarez, Inmaculada Medina‐Cáliz, Judith Sanabria‐Cabrera, Mercedes Robles‐Díaz, Aida Ortega‐Alonso, Miren García‐Cortés, Elvira Bonilla, Hao Niu, German Soriano, Miguel Jimenez‐Perez, Hacibe Hallal, Sonia Blanco, Neil Kaplowitz, M. Isabel Lucena, Raúl J. Andrade, R.J. Andrade, M.I. Lucena, C. Stephens, M. García Cortés, M. Robles Díaz, A. Ortega Alonso, J. Pinazo, B. García Muñoz, R. Alcántara, A. Hernández, M.D. García‐Escaño, I. Medina‐Cáliz, J. Sanabria‐Cabrera, I. Alvarez‐Alvarez, E. Bonilla, H. Niu, D. Di‐Zeo, E. Del Campo, M. Jiménez Pérez, R. González Grande, S. López Ortega, I. Santaella, A. Ocaña, P. Palomino, M.C. Fernández, A. Porcel, M. Casado, M. González Sánchez, M. Romero‐Gómez, R. Millán‐Domínguez, B. Fombuena, R. Gallego, J. Ampuero, J.A. del Campo, R. Calle‐Sanz, L. Rojas, A. Rojas, A. Gil Gómez, E. Vilar, G. Soriano, C. Guarner, E.M. Román, M.A. Quijada Manuitt, R.M. Antonijoan Arbos, M. Farré, E. Montané, A.L. Arellano, A.M. Barriocanal, Y. Sanz, R.M. Morillas, M. Sala, H. Masnou Ridaura, J. Sánchez Delgado, M. Vergara Gómez, H. Hallal, E. García Oltra, J.C. Titos Arcos, A. Pérez Martínez, C. Sánchez Cobarro, J.M. Egea Caparrós, A. Castiella, J. Arenas, M.I. Gomez Osua, A. Gómez García, F.J. Esandi, S. Blanco, P. Martínez Odriozola, J. Crespo, P. Iruzubieta, J. Cabezas, A. Giráldez Gallego, E. del P. Rodríguez Seguel, M. Cuaresma, M. Prieto, I. Conde Amiel, M. Berenguer, M. García‐Eliz, J.M. Moreno, P. Martínez‐Rodenas, M. Garrido, C. Oliva, E. Gómez Domínguez, L. Cabrera, L. Cuevas, M. Bruguera, P. Gines, S. Lens, J.C. García, Z. Mariño, M. Hernández Guerra, M. Moreno San Fiel, C. Boada Fernández del Campo, J. Fuentes Olmo, E.M. Fernández Bonilla, F. Jorquera, and J. González Gallego

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Hígado - Enfermedades, Comorbidity, elderly, Severity of Illness Index, 030226 pharmacology & pharmacy, Culprit, oldest-old, Young Adult, 03 medical and health sciences, Liver disease, Sex Factors, 0302 clinical medicine, Levofloxacin, Internal medicine, medicine, Humans, Pharmacology (medical), Ticlopidine, Child, Aged, Aged, 80 and over, Pharmacology, Polypharmacy, business.industry, Age Factors, Odds ratio, Middle Aged, Jaundice, medicine.disease, mortality, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Spain, 030220 oncology & carcinogenesis, comorbitity, Female, Chemical and Drug Induced Liver Injury, medicine.symptom, business, drug-induced liver injury, Cholestatic, medicine.drug
Abstract

Old patients with hepatotoxicity have been scarcely studied in idiosyncratic drug-induced liver injury (DILI) cohorts. We sought for the distinctive characteristics of DILI in older patients across age groups. A total of 882 DILI patients included in the Spanish DILI Registry (33% ≥65 years) were categorized according to age: “young” (

Published
2020
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