Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs

doi:10.1136/bmj.327.7405.18

BMJ 2003;327:18-22 (5 July), doi:10.1136/bmj.327.7405.18

Paper

Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs

Giuseppe Traversa, senior epidemiologist¹, Clara Bianchi, statistician¹, Roberto Da Cas, data manager¹, Iosief Abraha, epidemiologist², Francesca Menniti-Ippolito, senior epidemiologist¹, Mauro Venegoni, head³

¹ Department of Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy, ² Regional Health Authority of the Umbria Region, 06124 Perugia, Italy, ³ Department of Internal Medicine, Fatebenefratelli Hospital, 20121 Milan, Italy

Correspondence to: G Traversa giuseppe.traversa{at}iss.it

Objective To estimate the risk of acute hepatotoxicity associated with nimesulide compared with other non-steroidal anti-inflammatorydrugs.

Design Retrospective cohort and nested case-control study.

Setting Umbria region, Italy.

Participants 400 000 current, recent, and past users (almost2 million prescriptions) of non-steroidal anti-inflammatorydrugs between 1 January 1997 and 31 December 2001.

Main outcome measures Admissions to hospital for acute non-viral hepatitis and incidence of all hepatopathies and liver injuryamong users of nimesulide and other non-steroidal anti-inflammatorydrugs.

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

Conclusion The risk of liver injury in patients taking nimesulide and other non-steroidal anti-inflammatory drugs is small.

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