van Staa, T.P.; Travis, S.P.L.; Leufkens, H.G.M.; Logan, R.F.
April 2003
Gut;Apr2003 Supplement 1, Vol. 52, pA14
Academic Journal
The main objective of this study was to evaluate the risk of renal toxicity in patients using aminosalicylates 5-ASA). The medico records of GPs in the UK (from the Genera Practice Research Database) were used to estimate the incidence rates of renal toxicity of adult patients with either a record of inflammatory bowel disease (IBD) or prescription for 5-ASA (eg mesalazine or sulfasalazine) and that of control patients. Each case of renal toxicity was subsequently matched by age, sex, practice, and calendar time to one patient without renal toxicity. 37 984 adult patients with a record of BD or 5-ASA prescription and a similar number of control patients were included n the patients without a history of arthropathy we found that IBD patients using 5-ASA had an increased risk of renal toxicity: the overall incidence was about 1 case per 1000 person-years of treatment (double compared to non-users). The case control analysis revealed the risk of renal disease was related to indicators of IBD severity. It was also increased in current and recent users (ie their last prescription in the 3 to 12 months before the index date of 5-ASA. Compared to non-users, the odds ratio (OR for renal events was 1.80 (95% CI 1.22 to 2.60) in current 5-ASA users. This excess risk markedly reduced in current users after adjustment for concomitant disease and drug use (adjusted OR 1.22 [0.69-2.16]). For recent users, the crude OR was 3.96 (2.20-7.13) and adjusted OR 2.80 (1.33-5.91). Users of mesalazine and sulfasalazine had comparable risks (crude ORs 1.66 [0.94-2.96] and 1.93 [1.18-3.14], and adjusted ORs 1.05 [0.472.31] and 1.34 [0.68-2.62], respectively). There was no relationship between 5-ASA dose and risk of renal disease. Numbers were too small to compare individual 5-ASA compounds. Users of 5-ASA hod an increased risk of renal disease which may be influenced by the underlying disease severity. There were no differences in risk of renal disease between mesalazine and sulfasalazine.


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