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A randomized, double-blind, placebo-controlled trial of ursodeoxycholic acid in primary biliary cirrhosis

✍ Scribed by Burton Combes; Robert L. Carithers Jr.; Willis C. Maddrey; Danyu Lin; Dr Mary F. McDonald; Dr Donald E. Wheeler; Dr Edwin H. Eigenbrodt; Santiago J. Muñoz; Raphael Rubin; Guadalupe Garcia-Tsao; Gregory F. Bonner; Alexander B. West; James L. Boyer; Velimir A. Luketic; Mitchell L. Shiffman; A. Scott Mills; Marion G. Peters; Heather M. White; Rowen K. Zetterman; Stephen S. Rossi; Alan F. Hofmann; Rodney S. Markin

Publisher
John Wiley and Sons
Year
1995
Tongue
English
Weight
792 KB
Volume
22
Category
Article
ISSN
0270-9139

No coin nor oath required. For personal study only.

✦ Synopsis

One hundred fifty-one patients with primary biliary cirrhosis (PBC) grouped into four strata based on entry serum bilirubin (<2 mg/dL vs. 2 mg/dL or greater) and liver histology (stages I, 1 1 vs. stages 111, IV-Ludwig criteria) were randomized within each stratum to ursodiol or placebo given in a single dose of 10 to 12 mgkg at bedtime for 2 years. Placebo-(n = 74) and ursodioltreated (n = 77) patients were well matched at baseline for demographic and prognostic factors. Ursodiol induced major improvements in biochemical tests of the liver in strata 1 and 2 (entry bilirubin <2), but had less effect on laboratory tests in patients with entry serum bilirubin of 2 2 (strata 3 and 4). Histology was favorably affected by ursodiol in patients in strata 1 and 2 but not in strata 3 and 4. Ursodiol enrichment in fasting bile obtained at the conclusion of the trial was approximately 40% and comparable in all strata. Thus, differences in ursodiol enrichment of the bile acid pool do not explain better responses of laboratory tests and histology found in patients with less advanced PBC. Patients treated with ursodiol tended to develop a treatment failure less frequently than those who received placebo, particularly in strata 1 and 2 (ursodiol42%, placebo WO,

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