Mostrar el registro sencillo del ítem
Serious liver injury induced by Nimesulide: an international collaboration study reporting 57 cases
dc.contributor.author | Bessone, Fernando | |
dc.contributor.author | Hernandez, Nelia | |
dc.contributor.author | Mendizabal, Manuel | |
dc.contributor.author | Ridruejo, Ezequiel | |
dc.contributor.author | Gualano, Gisela | |
dc.contributor.author | Fassio, Eduardo | |
dc.contributor.author | Peralta, Mirta | |
dc.contributor.author | Fainboim, Hugo | |
dc.contributor.author | Anders, Margarita | |
dc.contributor.author | Tanno, Hugo | |
dc.contributor.author | Tanno, Federico | |
dc.contributor.author | Parana, Raymundo | |
dc.contributor.author | Medina-Cáliz, Inmaculada | |
dc.contributor.author | Robles-Díaz, María Mercedes | |
dc.contributor.author | Alvarez-Alvarez, Ismael | |
dc.contributor.author | Niu, Hao | |
dc.contributor.author | Stephens, Camilla | |
dc.contributor.author | Colombato, Luis | |
dc.contributor.author | Arrese, Marco | |
dc.contributor.author | Reggiardo, Maria Virginia | |
dc.contributor.author | Ono, Suzane Kioko | |
dc.contributor.author | Carrilho, Flair | |
dc.contributor.author | Lucena-González, María Isabel | |
dc.contributor.author | Andrade-Bellido, Raúl Jesús | |
dc.date.accessioned | 2022-01-17T12:49:38Z | |
dc.date.available | 2022-01-17T12:49:38Z | |
dc.date.created | 2021-12-20 | |
dc.date.issued | 2021-03-24 | |
dc.identifier.citation | 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 | es_ES |
dc.identifier.uri | https://hdl.handle.net/10630/23626 | |
dc.description.abstract | 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. | es_ES |
dc.description.sponsorship | 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). | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | Springer | es_ES |
dc.rights | info:eu-repo/semantics/openAccess | es_ES |
dc.subject | Hepatitis | es_ES |
dc.subject | Hígado - Enfermedades | es_ES |
dc.subject.other | Nimesulide | es_ES |
dc.subject.other | NSAID | es_ES |
dc.subject.other | Hepatotoxicity | es_ES |
dc.subject.other | Acute Liver Failure | es_ES |
dc.subject.other | Hepatitis | es_ES |
dc.subject.other | Cholestasis | es_ES |
dc.title | Serious liver injury induced by Nimesulide: an international collaboration study reporting 57 cases | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.centro | Facultad de Medicina | es_ES |
dc.identifier.doi | 10.1007/s00204-021-03000-8 | |
dc.type.hasVersion | info:eu-repo/semantics/acceptedVersion | es_ES |