Primary Sclerosing Cholangitis
High dose ursodeoxycholic acid in primary sclerosing cholangitis does not prevent colorectal neoplasia
Dr L. Lindström, Department of Gastroenterology and Hepatology, Karolinska University Hospital, Huddinge, K63, 141 86 Stockholm, Sweden.
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.
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.
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.
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 (P = 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.
Long-term high dose ursodeoxycholic acid does not prevent colorectal cancer or dysplasia in patients with primary sclerosing cholangitis-associated inflammatory bowel disease.