RT Journal Article
T1 Serious liver injury induced by Nimesulide: an international collaboration study reporting 57 cases
A1 Bessone, Fernando
A1 Hernandez, Nelia
A1 Mendizabal, Manuel
A1 Ridruejo, Ezequiel
A1 Gualano, Gisela
A1 Fassio, Eduardo
A1 Peralta, Mirta
A1 Fainboim, Hugo
A1 Anders, Margarita
A1 Tanno, Hugo
A1 Tanno, Federico
A1 Parana, Raymundo
A1 Medina-Cáliz, Inmaculada
A1 Robles-Díaz, María Mercedes
A1 Álvarez-Álvarez, Ismael
A1 Niu, Hao
A1 Stephens, Camilla
A1 Colombato, Luis
A1 Arrese, Marco
A1 Reggiardo, Maria Virginia
A1 Ono, Suzane Kioko
A1 Carrilho, Flair
A1 Lucena-González, María Isabel
A1 Andrade-Bellido, Raúl Jesús
K1 Hepatitis
K1 Hígado - Enfermedades
AB Nimesulide is a non-steroidal anti-inflammatory drug still marketed in many countries. We aim to analyze the clinical phenotype, outcome, and histological features of nimesulide-induced liver injury (nimesulide-DILI). We analyzed 57 cases recruited from the Spanish and LATIN DILI registries. Causality was assessed by the RUCAM scale. Mean age of the whole case series was 59 years (86% women) with a median time to onset of 40 days. A total of 46 patients (81%) were jaundiced. Nimesulide-DILI pattern was hepatocellular in 38 (67%), mixed in 12 (21%), and cholestatic in 7 (12%) cases. Transaminases were elevated with a mean of nearly 20-fold the upper limit of normality (ULN), while alkaline phosphatase showed a 2-fold mean elevation above ULN. Total bilirubin showed a mean elevation of 13-fold the ULN. Liver histology was obtained in 14 cases (25%), most of them with a hepatocellular pattern. Median time to recovery was 60 days. Overall, 12 patients (21%) developed acute liver failure (ALF), five (8.8%) died, three underwent liver transplantation (5.3%), and the remaining four resolved. Latency was ≤15 days in 12 patients (21%) and one patient developed ALF within seven days from treatment initiation. Increased total bilirubin and aspartate transaminase levels were independently associated with the development of ALF. In summary, nimesulide-DILI affects mainly women and presents typically with a hepatocellular pattern. It is associated with ALF and death in a high proportion of patients. Shorter (≤15 days) duration of therapy does not prevent serious nimesulide hepatotoxicity, making its risk/benefit ratio clearly unfavorable.
PB Springer
YR 2021
FD 2021-03-24
LK https://hdl.handle.net/10630/23626
UL https://hdl.handle.net/10630/23626
LA eng
NO Bessone, F., Hernandez, N., Mendizabal, M. et al. Serious liver injury induced by Nimesulide: an international collaborative study. Arch Toxicol 95, 1475–1487 (2021). https://doi.org/10.1007/s00204-021-03000-8
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: PI18-00901; PI 18/01804; PT20/00127) and Agencia Española del Medicamento. Plataforma ISCiii de Investigación Clínica and CIBERehd are funded by ISCIII. MRD holds a Joan Rodes (JR16/00015)/Acción B clinicos investigadores (B-0002-2019) research contract from ISCIII and Consejería de Salud de Andalucía, IAA holds a Sara Borrell research contract from the National Health System, ISCIII (CD 20/00083).
DS RIUMA. Repositorio Institucional de la Universidad de Málaga
RD 21 ene 2026