Clinical-Alimentary TractUrsodeoxycholic acid as a chemopreventive agent in patients with ulcerative colitis and primary sclerosing cholangitis☆,☆☆,★
Section snippets
Materials and methods
The study protocol was reviewed and approved by the Mayo Clinic Institutional Review Board. All patients with UC from the initial PSC-UDCA trial potentially were eligible for the current study. The diagnosis of PSC was based on typical cholangiographic and liver biopsy criteria,22 and the diagnosis of UC was based on typical clinical, endoscopic, and histologic criteria. Patients with dysplasia, colon cancer, or colectomy before or within 6 months of entering the initial study were excluded. In
Results
Of the 85 patients with UC from the original study, 33 (39%) were excluded, leaving 52 patients in this follow-up study. Twenty-four patients were excluded because they were inappropriate for the present study: 17 (20%) had proctocolectomy before study entry, 5 (6%) had cancer or dysplasia diagnosed before or within 6 months of study entry, 1 diagnosis was changed to Crohn's disease, and 1 died shortly after entering the original study. Thus, only 9 patients (10% of the original cohort) who
Discussion
Our comparison of colorectal neoplasia development in PSC-UC patients entered into a randomized, placebo-controlled trial suggests a significant chemoprotective effect for UDCA in these patients, with a 74% reduction in the risk for dysplasia or cancer in those assigned to the UDCA group.
The rationale for using UDCA as a chemopreventive agent is based on in vitro and animal models and uncontrolled clinical studies. UDCA inhibits proliferation of colon cancer cell lines in vitro,15 and in rats
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Address requests for reprints to: Darrell S. Pardi, M.D., 200 First Street SW, Rochester, Minnesota 55905. e-mail: [email protected]; fax: (507) 284-5486.
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Dr. Keith Lindor receives research funding from Axcan.
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0016-5085/03/$30.00