Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs.
OBJECTIVE
To estimate the risk of acute hepatotoxicity associated with nimesulide compared with other non-steroidal anti-inflammatory drugs.


METHODS
Retrospective cohort and nested case-control study.


METHODS
Umbria region, Italy.


METHODS
400 000 current, recent, and past users (almost 2 million prescriptions) of non-steroidal anti-inflammatory drugs between 1 January 1997 and 31 December 2001.


METHODS
Admissions to hospital for acute non-viral hepatitis and incidence of all hepatopathies and liver injury among users of nimesulide and other non-steroidal anti-inflammatory drugs.


RESULTS
Current use of non-steroidal anti-inflammatory drugs was associated with a 1.4 (95% confidence interval 1.0 to 2.1) increased risk of hepatopathy compared with past use. In current users of nimesulide the rate ratio for all hepatopathies and more severe liver injury was 1.3 (0.7 to 2.3) and 1.9 (1.1 to 3.8), respectively.


CONCLUSIONS
The risk of liver injury in patients taking nimesulide and other non-steroidal anti-inflammatory drugs is small.
Traversa
Giuseppe
G
Department of Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy. giuseppe.traversa@iss.it
Bianchi
Clara
C
Da Cas
Roberto
R
Abraha
Iosief
I
Menniti-Ippolito
Francesca
F
Venegoni
Mauro
M
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D016022:Case-Control Studies; D056486:Chemical and Drug Induced Liver Injury; D015331:Cohort Studies; D016001:Confidence Intervals; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D013449:Sulfonamides / Q000009:adverse effects*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013449:Sulfonamides; C012655:nimesulide