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. 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.