High dose ursodeoxycholic acid in primary sclerosing cholangitis does not prevent colorectal neoplasia

Authors


Correspondence to:

Dr L. Lindström, Department of Gastroenterology and Hepatology, Karolinska University Hospital, Huddinge, K63, 141 86 Stockholm, Sweden.

E-mail: lina.lindstrom@karolinska.se

Summary

Background

Patients with primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD) have a high risk of developing colorectal cancer and dysplasia. Ursodeoxycholic acid (UDCA) has been suggested to have chemopreventive effects on the development of colorectal cancer and dysplasia but long-term data and larger trials are lacking.

Aim

To evaluate the effect of high dose (17–23 mg/kg/day) UDCA on colorectal neoplasia in a cohort of patients with PSC and IBD.

Methods

From our previous 5-year randomised controlled trial of UDCA vs. placebo in PSC, we performed a follow-up of 98 patients with concomitant IBD from entry of the trial 1996–1997 until 2009 for development of colorectal cancer or dysplasia.

Results

The total follow-up time was 760 person-years. Dysplasia/cancer-free survival was compared between placebo- (n = 50) and UDCA-treated (n = 48) patients. There was a similar frequency of dysplasia or cancer after 5 years between patients originally assigned to UDCA or placebo (13% vs. 16%) and no difference in dysplasia/cancer-free survival (= 0.46, log rank test). At the end of 2009 no difference in cancer-free survival was detected, 30% of the placebo patients compared with 27% of UDCA patients had developed colorectal cancer or dysplasia.

Conclusions

Long-term high dose ursodeoxycholic acid does not prevent colorectal cancer or dysplasia in patients with primary sclerosing cholangitis-associated inflammatory bowel disease.

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