Prognostic factors and long-term effects of ursodeoxycholic acid on liver biochemical parameters in patients with primary biliary cirrhosis. Dutch Multi-Centre PBC Study Group.
OBJECTIVE
Serum bilirubin is a prognostic factor in untreated primary biliary cirrhosis (PBC), but this has been less extensively documented for patients treated with UDCA. The aims of this study were to define the effects of UDCA on serum liver tests and to assess prognostic factors in patients on prolonged UDCA treatment.


METHODS
Analysis of laboratory parameters obtained before and during treatment with UDCA of 203 PBC patients who were followed for a mean of 48 months. Univariate and multivariate analyses were performed to assess the prognostic value of pre-entry and follow-up variables with respect to treatment failure and survival.


RESULTS
Actuarial 5-year incidences of treatment failure and transplantion-free survival were 27 and 79%, respectively. According to the univariate analysis the following variables were significantly associated with prognosis: pre-entry presence of cirrhosis and pre-treatment levels of serum bilirubin and albumin, bilirubin levels during follow-up, the occurrence of biochemical remission and normalisation of serum bilirubin. Multivariate analysis revealed that bilirubin during follow-up was the best predictor. Alkaline phosphatase, aspartate aminotransferase and IgM decreased significantly during the first 6 months of treatment and subsequently remained at this lower level. Serum bilirubin showed the same initial pattern, but a significant increase was observed after 4 years of treatment.


CONCLUSIONS
Serum bilirubin in both UDCA-treated and untreated patients is the most powerful predictor of prognosis for PBC. The partial therapeutic efficacy of UDCA is illustrated by the finding that serum bilirubin, in contrast to alkaline phosphatase and the transaminases, appears to increase after 4 years of treatment.
van Hoogstraten
H J
HJ
Department of Hepatogastroenterology, Erasmus University Hospital Rotterdam, The Netherlands.
Hansen
B E
BE
van Buuren
H R
HR
ten Kate
F J
FJ
van Berge-Henegouwen
G P
GP
Schalm
S W
SW
D001663:Bilirubin / Q000097:blood*; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008105:Liver Cirrhosis, Biliary / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011379:Prognosis; D011446:Prospective Studies; D012074:Remission Induction; D016896:Treatment Outcome; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid; D001663:Bilirubin