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Drug Linked to Worse Outcome in Sclerosing Cholangitis

Last Updated: August 31, 2009.

The use of high-dose ursodeoxycholic acid for primary sclerosing cholangitis is associated with worse clinical outcomes compared to placebo, according to research published in the September issue of Hepatology.

MONDAY, Aug. 31 (HealthDay News) -- The use of high-dose ursodeoxycholic acid (UDCA) for primary sclerosing cholangitis (PSC) is associated with worse clinical outcomes compared to placebo, according to research published in the September issue of Hepatology.

Keith D. Lindor, M.D., of the Mayo Clinic in Rochester, Minn., and colleagues analyzed data from 150 adults with PSC who were randomized to receive 28 to 30 milligrams of UDCA per kilogram daily or placebo. The primary end point was time to first event such as death, transplantation, development of varices, or progression to cirrhosis.

The study was halted after six years. By the end of the study, the researchers found that more patients in the UDCA group had reached a clinical end point (39 versus 26 percent). After adjustment, the risk of a primary end point was 2.3 times higher for those in the UDCA group.

"At this time, UDCA at a dose of 25 to 30 mg/kg/day for patients with PSC should not be used because of the increased risk of clinically important adverse end points. There is no treatment that can be recommended at this time, and only therapy in the context of prospective trials should be considered," the authors write. "It is hoped that in the near future, a safe and effective therapy for patients with PSC will be developed, but high-dose UDCA cannot be recommended despite findings in a recent pilot study."

The study was supported in part by Axcan Pharma.

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