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Randomized Controlled Trial
. 2011 Sep;106(9):1638-45.
doi: 10.1038/ajg.2011.156. Epub 2011 May 10.

High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis

John E Eaton  1 , Marina G Silveira, Darrell S Pardi, Emmanouil Sinakos, Kris V Kowdley, Velimir A C Luketic, M Edwyn Harrison, Timothy McCashland, Alex S Befeler, Denise Harnois, Roberta Jorgensen, Jan Petz, Keith D Lindor
Affiliations
Randomized Controlled Trial

High-dose ursodeoxycholic acid is associated with the development of colorectal neoplasia in patients with ulcerative colitis and primary sclerosing cholangitis

John E Eaton et al. Am J Gastroenterol. 2011 Sep.

Abstract

Objectives: Some studies have suggested that ursodeoxycholic acid (UDCA) may have a chemopreventive effect on the development of colorectal neoplasia in patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC). We examined the effects of high-dose (28-30 mg/kg/day) UDCA on the development of colorectal neoplasia in patients with UC and PSC.

Methods: Patients with UC and PSC enrolled in a prior, multicenter randomized placebo-controlled trial of high-dose UDCA were evaluated for the development of colorectal neoplasia. Patients with UC and PSC who received UDCA were compared with those who received placebo. We reviewed the pathology and colonoscopy reports for the development of low-grade or high-grade dysplasia or colorectal cancer.

Results: Fifty-six subjects were followed for a total of 235 patient years. Baseline characteristics (including duration of PSC and UC, medications, patient age, family history of colorectal cancer, and smoking status) were similar for both the groups. Patients who received high-dose UDCA had a significantly higher risk of developing colorectal neoplasia (dysplasia and cancer) during the study compared with those who received placebo (hazard ratio: 4.44, 95% confidence interval: 1.30-20.10, P=0.02).

Conclusions: Long-term use of high-dose UDCA is associated with an increased risk of colorectal neoplasia in patients with UC and PSC.

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Figures

Figure 1
Figure 1
Kaplan–Meier estimates of proportion of patients free of colorectal neoplasia according to randomization group. UDCA, ursodeoxycholic acid.
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