Gastroenterology
Volume 124, Issue 4 , Pages 889-893, April 2003

Ursodeoxycholic acid as a chemopreventive agent in patients with ulcerative colitis and primary sclerosing cholangitis☆☆

Presented in part at the 102nd Annual Meeting of the American Gastroenterological Association, May 20-23, 2001, Atlanta, Georgia (Gastroenterology 2001;120:A447).

Division of Gastroenterology and Hepatology and Division of Biostatistics, Mayo Clinic and Foundation, Rochester, Minnesota

Received 2 October 2002; accepted 20 December 2002.

Abstract 

Background & Aims: Ursodeoxycholic acid (UDCA) has shown effectiveness as a colon cancer chemopreventive agent in preclinical studies. In addition, a recent report suggests that it also may decrease the risk for developing colorectal dysplasia in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC). We sought to evaluate the effect of UDCA on colorectal neoplasia in a group of patients with UC and PSC enrolled in a randomized, placebo-controlled trial. Methods: From a prior, randomized, placebo-controlled trial of UDCA therapy in PSC at our center, we followed-up patients with concomitant UC to assess the effect of UDCA on the development of colorectal dysplasia and cancer as compared with placebo. Results: Fifty-two subjects were followed-up for a total of 355 person-years. Those originally assigned to receive UDCA had a relative risk of 0.26 for developing colorectal dysplasia or cancer (95% confidence interval, 0.06-0.92; P = 0.034). Many of the patients originally assigned to the placebo group eventually received open-label UDCA. Assigning these patients to the UDCA group from the time they began active therapy did not change the magnitude of the protective effect (relative risk, 0.26; 95% confidence interval, 0.07-0.99; P = 0.049). Conclusions: UDCA significantly decreases the risk for developing colorectal dysplasia or cancer in patients with UC and PSC.

Abbreviations:  DCA , deoxycholic acid, PSC , primary sclerosing cholangitis

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 Address requests for reprints to: Darrell S. Pardi, M.D., 200 First Street SW, Rochester, Minnesota 55905. e-mail: pardi.darrell@mayo.edu; fax: (507) 284-5486.

☆☆ Dr. Keith Lindor receives research funding from Axcan.

 0016-5085/03/$30.00

PII: S0016-5085(03)00070-2

Gastroenterology
Volume 124, Issue 4 , Pages 889-893, April 2003