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Serious liver injury induced by Nimesulide: an international collaborative study.
- Source :
-
Archives of toxicology [Arch Toxicol] 2021 Apr; Vol. 95 (4), pp. 1475-1487. Date of Electronic Publication: 2021 Mar 24. - Publication Year :
- 2021
-
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.
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal administration & dosage
Bilirubin metabolism
Chemical and Drug Induced Liver Injury epidemiology
Chemical and Drug Induced Liver Injury physiopathology
Child
Cholestasis chemically induced
Cholestasis epidemiology
Cohort Studies
Female
Humans
Jaundice chemically induced
Jaundice epidemiology
Latin America epidemiology
Liver Failure, Acute epidemiology
Male
Middle Aged
Registries
Risk Factors
Spain epidemiology
Sulfonamides administration & dosage
Time Factors
Young Adult
Anti-Inflammatory Agents, Non-Steroidal adverse effects
Chemical and Drug Induced Liver Injury etiology
Liver Failure, Acute chemically induced
Sulfonamides adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1432-0738
- Volume :
- 95
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Archives of toxicology
- Publication Type :
- Academic Journal
- Accession number :
- 33759010
- Full Text :
- https://doi.org/10.1007/s00204-021-03000-8