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Study finds adverse effects in treatment for primary sclerosing cholangitis
Date:8/19/2009

Primary sclerosing cholangitis (PSC) is an uncommon chronic liver disease characterized by progressive inflammation and destruction of the bile ducts. The disease progresses slowly, usually leading to biliary cirrhosis, portal hypertension and liver failure over a 10-15 year period. PSC is a common cause of adult cholestatic liver diseases and a primary source behind many of the liver transplantations in U.S. adults. At least 70% of PSC cases are associated with chronic inflammatory bowel disease (IBD), usually ulcerative colitis. Currently, there is no cure for PSC and prospective treatments remain ineffective.

A recently ceased study, led by Keith Lindor, M.D., from the Fiterman Center for Digestive Diseases at the Mayo Clinic, determined that PSC patients treated with high-dose Ursodeoxycholic Acid (UDCA) had poorer clinical results compared to those not receiving the therapy. More patients developed esophageal or gastric varices (enlarged veins), died, or became eligible for liver transplantation in the group receiving UDCA compared to the placebo group despite improvement in liver tests. Findings from this study are published in Hepatology, a journal of the American Association for the Study of Liver Diseases.

One hundred fifty adult PSC patients entered the study at seven U.S. sites over a three-year period. Half of the participants in the double-blind controlled trial were given high-dose UDCA (28-30 mg/kg/day), while the others received a placebo. Liver biopsy and imaging of the bile ducts were performed to monitor patients' response to the therapy. The primary outcome measure was development of cirrhosis, varices, cholangiocarcinoma-a bile duct cancer, meeting minimal listing criteria for transplant, liver transplantation or death.

"Our results showed patients on UDCA had a 2.1 times greater chance for death, transplantation or meeting minimal listing criteria than for those in the placebo group," explained
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Contact: Dawn Peters
medicalnews@wiley.com
Wiley-Blackwell
Source:Eurekalert

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