Drug-Induced Liver Injury in Latin America: 10-year experience of the Latin American DILI (LATINDILI) Network Drug-induced liver injury in Latin America.

Latin America acute liver failure drug-induced liver injury hepatotoxicity prospective

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
ISSN: 1542-7714
Titre abrégé: Clin Gastroenterol Hepatol
Pays: United States
ID NLM: 101160775

Informations de publication

Date de publication:
09 Jul 2024
Historique:
received: 10 04 2024
revised: 28 05 2024
accepted: 20 06 2024
medline: 12 7 2024
pubmed: 12 7 2024
entrez: 11 7 2024
Statut: aheadofprint

Résumé

Latin America is a region of great interest for studying the clinical presentation of idiosyncratic drug-induced liver injury (DILI). A comprehensive analysis of patients enrolled into the LATINDILI Network over a decade is presented. Demographics, clinical presentation, histological findings and outcome of prospectively recruited DILI cases in the LATINDILI Network were analyzed. Suspected culprit drugs were classified according to the Anatomical Therapeutic Chemical classification. Causality was assessed using the Roussel Uclaf Causality Assessment Method (RUCAM) scale. Overall, 468 idiosyncratic DILI cases were analyzed (62% women, mean age 49 years). Hepatocellular injury predominated (62%), jaundice was present in 60% of patients and 42% were hospitalized. 4.1% of the cases had a fatal outcome, and 24 (12%) patients developed chronic DILI. The most common drug classes were systemic anti-infectives (31%), musculoskeletal agents (12%), antineoplastic and immunomodulating agents (11%), and herbal and dietary supplements (HDS, 9%). Notably, none of the patients with DILI due to antibacterials or immunosuppressants had a fatal outcome. In fact, Hy's law showed to have drug-specific predictive value, with anti-tuberculosis drugs, nimesulide and HDS associated with the worst outcome, whereas DILI caused by amoxicillin-clavulanate, nitrofurantoin and diclofenac that fulfilled Hy's law did not have a fatal outcome. Features of DILI in Latin America are comparable to other prospective registries. However, the pattern of drugs responsible for DILI differs. An increasing incidence of HDS, with high mortality rate, and likewise nimesulide and nitrofurantoin was noted. Thus, public health policies should raise awareness of the potential adverse effects of these compounds.

Sections du résumé

BACKGROUND AND AIMS OBJECTIVE
Latin America is a region of great interest for studying the clinical presentation of idiosyncratic drug-induced liver injury (DILI). A comprehensive analysis of patients enrolled into the LATINDILI Network over a decade is presented.
METHODS METHODS
Demographics, clinical presentation, histological findings and outcome of prospectively recruited DILI cases in the LATINDILI Network were analyzed. Suspected culprit drugs were classified according to the Anatomical Therapeutic Chemical classification. Causality was assessed using the Roussel Uclaf Causality Assessment Method (RUCAM) scale.
RESULTS RESULTS
Overall, 468 idiosyncratic DILI cases were analyzed (62% women, mean age 49 years). Hepatocellular injury predominated (62%), jaundice was present in 60% of patients and 42% were hospitalized. 4.1% of the cases had a fatal outcome, and 24 (12%) patients developed chronic DILI. The most common drug classes were systemic anti-infectives (31%), musculoskeletal agents (12%), antineoplastic and immunomodulating agents (11%), and herbal and dietary supplements (HDS, 9%). Notably, none of the patients with DILI due to antibacterials or immunosuppressants had a fatal outcome. In fact, Hy's law showed to have drug-specific predictive value, with anti-tuberculosis drugs, nimesulide and HDS associated with the worst outcome, whereas DILI caused by amoxicillin-clavulanate, nitrofurantoin and diclofenac that fulfilled Hy's law did not have a fatal outcome.
CONCLUSION CONCLUSIONS
Features of DILI in Latin America are comparable to other prospective registries. However, the pattern of drugs responsible for DILI differs. An increasing incidence of HDS, with high mortality rate, and likewise nimesulide and nitrofurantoin was noted. Thus, public health policies should raise awareness of the potential adverse effects of these compounds.

Identifiants

pubmed: 38992407
pii: S1542-3565(24)00605-0
doi: 10.1016/j.cgh.2024.06.030
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Auteurs

Fernando Bessone (F)

Hospital Provincial del Centenario, Facultad de Medicina, Universidad Nacional de Rosario, Rosario, Argentina. Electronic address: bessonefernando@gmail.com.

Nelia Hernandez (N)

Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay.

Inmaculada Medina-Caliz (I)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain.

Miren García-Cortés (M)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

María I Schinoni (MI)

Hospital Universitário Prof. Edgard Santos-UFBA, Salvador de Bahia, Brazil.

Manuel Mendizabal (M)

Hospital Universitario Austral, Buenos Aires, Argentina.

Daniela Chiodi (D)

Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay.

Vinicius Nunes (V)

Hospital Universitário Prof. Edgard Santos-UFBA, Salvador de Bahia, Brazil.

Ezequiel Ridruejo (E)

Centro de Educación Médica e Investigaciones Clínicas, Buenos Aires, Argentina.

Ximena Pazos (X)

Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay.

Genario Santos (G)

Hospital Universitário Prof. Edgard Santos-UFBA, Salvador de Bahia, Brazil.

Eduardo Fassio (E)

Hospital Alejandro Posadas, Buenos Aires, Argentina.

Raymundo Parana (R)

Hospital Universitário Prof. Edgard Santos-UFBA, Salvador de Bahia, Brazil; Facultad de Medicina, Universidad Nacional de Bahia, Salvador de Bahia, Brazil.

Virginia Reggiardo (V)

Hospital Provincial del Centenario, Facultad de Medicina, Universidad Nacional de Rosario, Rosario, Argentina.

Hugo Tanno (H)

Hospital Provincial del Centenario, Facultad de Medicina, Universidad Nacional de Rosario, Rosario, Argentina.

Adriana Sanchez (A)

Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay.

Federico Tanno (F)

Hospital Provincial del Centenario, Facultad de Medicina, Universidad Nacional de Rosario, Rosario, Argentina.

Pedro Montes (P)

Hospital Nacional Daniel Alcides Carrion, Callao, Peru.

Martin Tagle (M)

Clínica Anglo Americana, Lima, Peru.

Marco Arrese (M)

Pontificia Universidad Catolica de Chile, Santiago de Chile, Chile.

Javier Brahm (J)

Pontificia Universidad Catolica de Chile, Santiago de Chile, Chile.

Marcos Girala (M)

Hospital de Clínicas, Asunción, Paraguay.

M Isabel Lizarzabal (MI)

Hospital Universitario de Maracaibo, Maracaibo, Venezuela.

Enrique Carrera (E)

Hospital de Especialidades Eugenio Espejo, Quito, Ecuador.

Alina Zerega (A)

Hospital Allende, Ciudad de Córdoba, Córdoba, Argentina.

Carla Bianchi (C)

Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay.

Laura Reyes (L)

Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay.

Daina Arnedillo (D)

Hospital Provincial del Centenario, Facultad de Medicina, Universidad Nacional de Rosario, Rosario, Argentina.

Antonella Cordone (A)

Hospital Provincial del Centenario, Facultad de Medicina, Universidad Nacional de Rosario, Rosario, Argentina.

Gisela Gualano (G)

Hospital Alejandro Posadas, Buenos Aires, Argentina.

Fernanda Jaureguizahar (F)

Hospital Provincial del Centenario, Facultad de Medicina, Universidad Nacional de Rosario, Rosario, Argentina.

Gabriel Rifrani (G)

Hospital Provincial del Centenario, Facultad de Medicina, Universidad Nacional de Rosario, Rosario, Argentina.

Mercedes Robles-Díaz (M)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

Aida Ortega-Alonso (A)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

José M Pinazo-Bandera (JM)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

Camilla Stephens (C)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.

Judith Sanabria-Cabrera (J)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Plataforma de Investigación Clínica y Ensayos Clínicos IBIMA, Plataforma ISCIII de Investigación Clínica, SCReN, Madrid, Spain.

Elvira Bonilla-Toyos (E)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Plataforma de Investigación Clínica y Ensayos Clínicos IBIMA, Plataforma ISCIII de Investigación Clínica, SCReN, Madrid, Spain.

Hao Niu (H)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Plataforma de Investigación Clínica y Ensayos Clínicos IBIMA, Plataforma ISCIII de Investigación Clínica, SCReN, Madrid, Spain.

Ismael Alvarez-Alvarez (I)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Plataforma de Investigación Clínica y Ensayos Clínicos IBIMA, Plataforma ISCIII de Investigación Clínica, SCReN, Madrid, Spain.

M Isabel Lucena (MI)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Plataforma de Investigación Clínica y Ensayos Clínicos IBIMA, Plataforma ISCIII de Investigación Clínica, SCReN, Madrid, Spain.

Raul J Andrade (RJ)

Servicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: andrade@uma.es.

Classifications MeSH