5-aminosalicylate use and colorectal cancer risk in inflammatory bowel disease: a large epidemiological study

Tjeerd P van Staa ¹, Timothy R Card ², Herbert G M Leufkens ¹ and Richard F A Logan ^2*

¹ University of Utrecht, Netherlands
² University of Nottingham, United Kingdom

^* To whom correspondence should be addressed. E-mail: richard.logan{at}nottingham.ac.uk.

Accepted 17 June 2005

Abstract

The objective of this study was to evaluate the risk of colorectal cancer (CRC) in patients taking aminosalicylates (5-ASA) for IBD. The General Practice Research Database (GPRD) which contains the primary care records of 5 million people in the UK was used to identify users of either mesalazine, balsalazide, olsalazine, or sulfasalazine with a history of IBD. In a nested case-control analysis, each incident CRC case with any use of a 5-ASA in the 6 months before the CRC diagnosis was matched by age, sex, and calendar time to six control patients who were also currently using a 5- ASA. Patients were then classified according to regularity of use. The analysis was controlled for body mass index, IBD duration, history of colorectal polyps, use of NSAIDs, paracetamol, aspirin, immunosuppressants, oral and rectal glucocorticoids, and prior GI hospitalization, recorded colonoscopy, or number of GP visits for IBD symptoms in the 6 to 24 months before diagnosis. The study population included 18,969 patients, of whom 100 patients had developed CRC during 5-ASA exposure. Most of these cases had a history of ulcerative colitis (76 patients). In the case-control analysis, regular users defined as having 6 or more 5-ASA prescriptions in the previous 12 months were found to have a decreased risk of CRC compared to irregular users (crude OR 0.67 [0.44-1.03]; adjusted OR 0.60 [0.38-0.96]). Regular users of sulfasalazine with 6 to 12 prescriptions before had an adjusted OR of 0.95 [0.22-4.11]; with 13 to 30 prior prescriptions this was 0.41 [0.14-1.20] and with > 30 prior prescriptions this was 0.77 [0.37-1.60]. For mesalazine users, these figures were 1.13 [0.49-2.59], 0.30 [0.11-0.83], and 0.31 [0.11-0.84], respectively. In conclusion, these results show that regular 5-ASA use is associated with some reduction in risk of CRC developing in ulcerative colitis.

Keywords: 5-ASA drugs, Crohn's disease, colorectal cancer, inflammatory bowel disease, ulcerative colitis

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