Nelia Hernández1, Fernando Bessone2, Adriana Sánchez1, María di Pace1, Javier Brahm3, Rodrigo Zapata4, Ruby A Chirino5, Milagros Dávalos6, Nahum Méndez-Sánchez7, Marco Arrese8, María Schinoni9, M Isabel Lucena10, Raúl J Andrade10. 1. Hospital de Clínicas, Clínica de Gastroenterología, Facultad de Medicina, Universidad de la República, Montevideo, Uruguay. 2. Facultad de Ciencias Médicas, Servicio de Gastroenterología y Hepatología, Hospital Provincial del Centenario. Universidad Nacional de Rosario, Argentina. 3. Sección de Gastroenterología, Departamento de Medicina Interna, Hospital Clínico Universidad de Chile y Departamento de Gastroenterología, Clínica Las Condes, Santiago, Chile. 4. Departamento de Gastroenterología, Hospital Salvador. Universidad de Chile y Clínica Alemana de Santiago. Universidad del Desarrollo, Santiago, Chile. 5. Hospital Ángeles de Pedregal, México, D.F. 6. Servicio de Hígado. Departamento del Aparato Digestivo. Hospital Nacional Edgardo Rebagliati. Lima, Perú 7. Departamento de Investigación Biomédica. Unidad de Hepatología, Fundación Clínica Médica Sur. Ciudad de México, México. 8. Departamento de Gastroenterología, Facultad de Medicina Pontificia. Universidad Católica de Chile, Santiago. Chile. 9. Hospital Universitario Edgar Santos. Universidad Federal de Bahía. Salvador de Bahía. Brazil. 10. Unidad de Hepatología y Servicio de Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga-IBIMA, Málaga. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), España.
Abstract
INTRODUCTION: Drug-induced liver injury (DILI) remains a major problem for drug development and represents a challenging diagnosis for clinicians. The absence of specific biomarkers for diagnosing DILI precludes the availability of reliable data on the epidemiology of the disease. In this study we aimed to describe the features of idiosyncratic hepatotoxicity reports in Latin American countries. MATERIAL AND METHODS: A literature search was performed using the online version of MEDLINE, EMBASE, Scopus, Google Scholar and specific data bases from Latin America (LA) (Scielo, Lilacs) to identify any case report or case series of published DILI from 1996 to 2012. From 1996 to 2012, a total of 176 patients with DILI were published in LA, involving 53 suspicious drugs. The median age in the adult population of these patients was 55 years (17-82) with prevalence of women (67%). Among main therapeutic classes, the rank order was led by non-steroidal anti-inflammatory (61 cases) and systemic antibacterial drugs (37 cases). Nimesulide was the individual drug responsible for the highest number of cases (53), followed by cyproterone acetate (18), nitrofurantoin (17), antituberculous drugs (13) and flutamide (12). Thirty two percent of published cases evolved to acute liver failure (ALF), and half of the subjects required liver transplantation or eventually died. CONCLUSIONS: This study represents the first structured attempt to assess the spectrum of DILI profile in LA. The establishment of a Latin American registry to collect prospective DILI cases using a standardized protocol will advance our knowledge about idiosyncratic DILI in this region.
INTRODUCTION:Drug-induced liver injury (DILI) remains a major problem for drug development and represents a challenging diagnosis for clinicians. The absence of specific biomarkers for diagnosing DILI precludes the availability of reliable data on the epidemiology of the disease. In this study we aimed to describe the features of idiosyncratic hepatotoxicity reports in Latin American countries. MATERIAL AND METHODS: A literature search was performed using the online version of MEDLINE, EMBASE, Scopus, Google Scholar and specific data bases from Latin America (LA) (Scielo, Lilacs) to identify any case report or case series of published DILI from 1996 to 2012. From 1996 to 2012, a total of 176 patients with DILI were published in LA, involving 53 suspicious drugs. The median age in the adult population of these patients was 55 years (17-82) with prevalence of women (67%). Among main therapeutic classes, the rank order was led by non-steroidal anti-inflammatory (61 cases) and systemic antibacterial drugs (37 cases). Nimesulide was the individual drug responsible for the highest number of cases (53), followed by cyproterone acetate (18), nitrofurantoin (17), antituberculous drugs (13) and flutamide (12). Thirty two percent of published cases evolved to acute liver failure (ALF), and half of the subjects required liver transplantation or eventually died. CONCLUSIONS: This study represents the first structured attempt to assess the spectrum of DILI profile in LA. The establishment of a Latin American registry to collect prospective DILI cases using a standardized protocol will advance our knowledge about idiosyncratic DILI in this region.