+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Ursodiol for primary sclerosing cholangitis. Mayo Primary Sclerosing Cholangitis-Ursodeoxycholic Acid Study Group



Ursodiol for primary sclerosing cholangitis. Mayo Primary Sclerosing Cholangitis-Ursodeoxycholic Acid Study Group



New England Journal of Medicine 336(10): 691-695



There is no satisfactory medical therapy for patients with primary sclerosing cholangitis. Ursodiol (ursodeoxycholic acid) benefits patients with primary biliary cirrhosis, another cholestatic liver disease. From May 1989 to July 1995, we enrolled 105 patients with well-documented primary sclerosing cholangitis in a randomized, double-blind study comparing ursodiol (13 to 15 mg per kilogram of body weight per day in divided doses) with placebo. The primary outcome was the time to treatment failure, defined as death; liver transplantation; histologic progression by two stages (of four) or progression to cirrhosis; the development of varices, ascites, or encephalopathy; sustained quadrupling of the serum bilirubin concentration; marked worsening of fatigue or pruritus; inability to tolerate the drug; or voluntary withdrawal from the study. We analyzed data on the 51 patients in each group with at least 3 months of follow-up; the median follow-up was 2.2 years. There was no significant difference between the groups in time to treatment failure (relative risk of treatment failure in the ursodiol group, 1.01; 95 percent confidence interval, 0.6 to 1.7). During the first two years of follow-up, treatment was unsuccessful in 17 of 32 patients (53 percent) in the placebo group and 16 of 31 (52 percent) in the ursodiol group. There were also no differences in time to treatment failure for patients with early-stage disease or in time to liver transplantation. Ursodiol, but not placebo, was associated with improvement in serum alkaline phosphatase, aspartate aminotransferase, bilirubin, and albumin levels at one and two years. In a group of patients with well-defined primary sclerosing cholangitis, ursodiol provided no clinical benefit.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 047890732

Download citation: RISBibTeXText

PMID: 9041099

DOI: 10.1056/nejm199703063361003


Related references

Effects of ursodiol on bile acid metabolism in primary biliary cirrhosis pbc and primary sclerosing cholangitis psc. Williams, C N (Ed ) Falk Symposium, 56 Trends in Inflammatory Bowel Disease Therapy; Symposium, Halifax, Nova Scotia, Canada, June 6-9, 1990 Xviii+462p Kluwer Academic Publishers: Dordrecht, Netherlands; (Dist in The Usa And Canada By Kluwer Academic Publishers: Hingham, Massachusetts, Usa) Illus 423, 1991

High prevalence of small duct primary sclerosing cholangitis among patients with overlapping autoimmune hepatitis and primary sclerosing cholangitis. European Journal of Internal Medicine 20(2): 190-196, 2009

Natural history of primary sclerosing cholangitis A longterm follow-up study of 394 European primary sclerosing cholangitis patients. Journal of Hepatology 32(Suppl. 2): 32, 2000

Increased risk of primary sclerosing cholangitis and ulcerative colitis in first-degree relatives of patients with primary sclerosing cholangitis. Clinical Gastroenterology and Hepatology 6(8): 939-943, 2008

Effect of ursodiol udca on bile acid metabolism in primary sclerosing cholangitis psc. Gastroenterology 96(5 Part 2): A575, 1989

Ursodeoxycholic acid in primary sclerosing cholangitis. Alimentary Pharmacology and Therapeutics 35(5): 622-623, 2012

Ursodeoxycholic acid for primary sclerosing cholangitis. Journal of Hepatology 11(1): 120-123, 1990

Treatment of primary biliary cirrhosis and primary sclerosing cholangitis: use of ursodeoxycholic acid. Current Gastroenterology Reports 1(1): 38-41, 2000

Ursodeoxycholic acid in the treatment of primary biliary cirrhosis and primary sclerosing cholangitis in pregnancy. Hepatology 36(4 Part 2): 491A, 2002

The effect of ursodeoxycholic acid urso in primary sclerosing cholangitis a comparison to primary biliary cirrhosis. Gastroenterology 94(5 Part 2): A595, 1988

Treatment of primary sclerosing cholangitis with ursodeoxycholic acid. Zeitschrift für Gastroenterologie. Verhandlungsband 24: 136, 1989

Ursodeoxycholic acid for the treatment of primary sclerosing cholangitis: the more the better?. Zeitschrift für Gastroenterologie 48(5): 569-570, 2010

Ursodeoxycholic acid in the treatment of primary sclerosing cholangitis. Annals of Medicine 26(5): 345-349, 1994

Ursodeoxycholic acid in the treatment of primary sclerosing cholangitis. Italian Journal of Gastroenterology 28(3): 178-180, 1996

Urinary excretion of ursodeoxycholic acid during treatment of patients with primary biliary cirrhosis and primary sclerosing cholangitis. Journal of Hepatology 7, 1988