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dc.contributor.author
Bessone, Fernando
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Hernandez, Nelia
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Mendizabal, Manuel
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Ridruejo, Ezequiel
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Gualano, Gisela
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Fassio, Eduardo
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Peralta, Mirta
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Fainboim, Hugo
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Anders, Margarita
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Tanno, Hugo Enrique
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Tanno, Federico Carlos
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Parana, Raymundo
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Medina Caliz, Inmaculada
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Robles Diaz, Mercedes
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Alvarez Alvarez, Ismael
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Niu, Hao
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Stephens, Camilla
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Colombato, Luis
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Arrese, Marco
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Reggiardo, María Virginia
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Ono, Suzane Kioko
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Carrilho, Flair
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Lucena, M. Isabel
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Andrade, Raul J.
dc.date.available
2023-01-11T13:05:37Z
dc.date.issued
2021-04
dc.identifier.citation
Bessone, Fernando; Hernandez, Nelia; Mendizabal, Manuel; Ridruejo, Ezequiel; Gualano, Gisela; et al.; Serious liver injury induced by Nimesulide: an international collaborative study; Springer; Archives of Toxicology; 95; 4; 4-2021; 1475-1487
dc.identifier.issn
0340-5761
dc.identifier.uri
http://hdl.handle.net/11336/184295
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 American 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 twofold 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 7 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.
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application/pdf
dc.language.iso
eng
dc.publisher
Springer
dc.rights
info:eu-repo/semantics/restrictedAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
ACUTE LIVER FAILURE
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CHOLESTASIS
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HEPATITIS
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HEPATOTOXICITY
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NIMESULIDE
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NSAID
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Gastroenterología y Hepatología
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Medicina Clínica
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CIENCIAS MÉDICAS Y DE LA SALUD
dc.title
Serious liver injury induced by Nimesulide: an international collaborative study
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2022-09-07T13:28:28Z
dc.journal.volume
95
dc.journal.number
4
dc.journal.pagination
1475-1487
dc.journal.pais
Alemania
dc.description.fil
Fil: Bessone, Fernando. Universidad Nacional de Rosario; Argentina
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Fil: Hernandez, Nelia. Hospital de Clinicas Dr. Manuel Quintela; Uruguay
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Fil: Mendizabal, Manuel. Universidad Austral. Hospital Universitario Austral; Argentina
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Fil: Ridruejo, Ezequiel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina
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Fil: Gualano, Gisela. Hospital Nacional Profesor Alejandro Posadas; Argentina
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Fil: Fassio, Eduardo. Hospital Nacional Profesor Alejandro Posadas; Argentina
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Fil: Peralta, Mirta. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas "Dr. Francisco Javier Muñiz"; Argentina
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Fil: Fainboim, Hugo. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas "Dr. Francisco Javier Muñiz"; Argentina
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Fil: Anders, Margarita. Hospital Alemán; Argentina
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Fil: Tanno, Hugo Enrique. Universidad Nacional de Rosario; Argentina
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Fil: Tanno, Federico Carlos. Universidad Nacional de Rosario; Argentina
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Fil: Parana, Raymundo. Universidade Federal da Bahia; Brasil
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Fil: Medina Caliz, Inmaculada. Hospital Universitari Virgen de la Victoria; España
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Fil: Robles Diaz, Mercedes. Hospital Universitari Virgen de la Victoria; España
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Fil: Alvarez Alvarez, Ismael. Hospital Universitari Virgen de la Victoria; España
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Fil: Niu, Hao. Hospital Universitari Virgen de la Victoria; España
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Fil: Stephens, Camilla. Hospital Universitari Virgen de la Victoria; España
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Fil: Colombato, Luis. Hospital Británico de Buenos Aires; Argentina
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Fil: Arrese, Marco. Universidad Católica de Chile; Chile. Pontificia Universidad Católica de Chile; Chile
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Fil: Reggiardo, María Virginia. Universidad Nacional de Rosario; Argentina
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Fil: Ono, Suzane Kioko. Universidade de Sao Paulo; Brasil
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Fil: Carrilho, Flair. Universidade de Sao Paulo; Brasil
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Fil: Lucena, M. Isabel. Hospital Universitari Virgen de la Victoria; España
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Fil: Andrade, Raul J.. Hospital Universitari Virgen de la Victoria; España
dc.journal.title
Archives of Toxicology
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1007/s00204-021-03000-8
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