Reuters Health Information (2011-05-24): High dose ursodeoxycholic acid tied to neoplasia in UC
High dose ursodeoxycholic acid tied to neoplasia in UC
Last Updated: 2011-05-24 12:50:03 -0400 (Reuters Health)
NEW YORK (Reuters Health) - In patients with ulcerative colitis (UC) and primary sclerosing cholangitis (PSC), high doses of ursodeoxycholic acid (UDCA) are associated with an increased risk of colorectal neoplasia, a new study shows.
"We were surprised at our findings with the high dose of UDCA," Dr. Keith Lindor from the Mayo Clinic in Rochester, Minnesota told Reuters Health by email, "especially since lower doses of UDCA have been proposed to reduce the risk of colorectal neoplasia in patients with PSC and colitis."
"This result was comparable to the unexpected result from the main study, in which high doses of UDCA were associated with more frequent adverse liver outcomes," he added.
In the current follow-up study, reported online May 10th in the American Journal of Gastroenterology, Dr. Lindor and colleagues compared 25 patients treated with UDCA (28-30 mg/kg/day) with 31 who received placebo. All of them were participants in an earlier study of high-dose UDCA in treatment of PSC.
During a mean follow-up of approximately four years, 12 patients developed colorectal neoplasia (dysplasia and cancer), nine of whom were in the UDCA group.
Patients receiving UDCA were at significantly increased risk for colorectal neoplasia (hazard ratio, 4.44), even after accounting for smoking history and UC duration.
There is no alternative to UDCA, but the research team concludes that UDCA doses above 28 mg/kg/day are not "supported for treatment by any evidence at this time."
Am J Gastroenterol 2011.