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

BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7405.18 (Published 03 July 2003) Cite this as: BMJ 2003;327:18
  1. Giuseppe Traversa, senior epidemiologist (giuseppe.traversa{at}iss.it)1,
  2. Clara Bianchi, statistician1,
  3. Roberto Da Cas, data manager1,
  4. Iosief Abraha, epidemiologist2,
  5. Francesca Menniti-Ippolito, senior epidemiologist1,
  6. Mauro Venegoni, head3
  1. 1Department of Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy
  2. 2Regional Health Authority of the Umbria Region, 06124 Perugia, Italy
  3. 3Department of Internal Medicine, Fatebenefratelli Hospital, 20121 Milan, Italy
  1. Correspondence to: G Traversa
  • Accepted 16 June 2003

Abstract

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

Design Retrospective cohort and nested case-control study.

Setting Umbria region, Italy.

Participants 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.

Main outcome measures 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.

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

Footnotes

  • Contributors All authors contributed to designing the study, interpreting the results, and writing the paper. GT will act as guarantor for the paper.

  • Funding Expenses were covered by NHS funds. The study was partly supported by research funds from the Ministry of Health and the Umbria Regional Health Authority.

  • Competing interests None declared.

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