Prognostic factors and long-term effects of ursodeoxycholic acid on liver biochemical parameters in patients with primary biliary cirrhosis

Background/Aims: Serum bilirubin is a prognostic factor in untreated primar y biliary cirrhosis (PBC), but this has been less extensively documented fo r patients treated with UDCA, The aims of this study were to define the eff ects of UDCA on serum liver tests and to assess prognostic factors in patie nts on prolonged UDCA treatment, Methods: Analysis of laboratory parameters obtained before and during treat ment with UDCA of 203 PBC patients who were followed for a mean of 48 month s. Univariate and multivariate analyses were performed to assess the progno stic value of pre-entry and followup variables with respect to treatment fa ilure, and survival, Results: Actuarial 5-year incidences of treatment failure and transplantion -free survival were 27 and 79%, respectively, According to the univariate a nalysis the following variables were significantly associated with prognosi s: pre-entry presence of cirrhosis and pretreatment levels of serum bilirub in and albumin, bilirubin levels during follow-up, the occurrence of bioche mical remission and normalisation of serum bilirubin. Multivariate analysis revealed that bilirubin during follow-up was the best predictor, Alkaline phophatase, aspartate aminotransferase and IgM decreased significantly duri ng the first 6 months of treatment and subsequently remained at this lower level, Serum bilirubin showed the same initial pattern, but a significant i ncrease 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 con trast to alkaline phosphatase and the transaminases, appears to increase,af ter 4 years of treatment.