Primary biliary cirrhosis: incidence and predictive factors of cirrhosis development in ursodiol-treated patients

Gastroenterology. 2002 Mar;122(3):652-8. doi: 10.1053/gast.2002.31880.


Background & aims: Ursodeoxycholic acid (UDCA) slows the progression of primary biliary cirrhosis (PBC). However, some UDCA-treated patients escape and progress toward cirrhosis and end-stage disease. This study aimed to assess the incidence of cirrhosis in UDCA-treated patients with PBC and to determine the predictive factors of cirrhosis development under this treatment.

Methods: A Markov model was used to describe the progression toward cirrhosis in 183 UDCA-treated patients with PBC. A total of 254 pairs of liver biopsy specimens collected during 655 patient-years were studied.

Results: The incidence of cirrhosis after 5 years of UDCA treatment was 4%, 12%, and 59% among patients followed-up from stages I, II, and III, respectively. At 10 years, the incidence was 17%, 27%, and 76%, respectively. The median time for developing cirrhosis from stages I, II, and III was 25 years, 20 years, and 4 years, respectively. The independent predictive factors of cirrhosis development were serum bilirubin greater than 17 mumol/L, serum albumin less than 38 g/L, and moderate to severe lymphocytic piecemeal necrosis.

Conclusions: This study provides new data about the time course of PBC under UDCA and constitutes a rationale for the design and evaluation of clinical trials aimed to assess the efficacy of drugs associated with UDCA.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bilirubin / blood
  • Cholagogues and Choleretics / therapeutic use*
  • Disease Progression
  • Female
  • Humans
  • Incidence
  • Liver / pathology
  • Liver Cirrhosis, Biliary* / drug therapy
  • Liver Cirrhosis, Biliary* / epidemiology
  • Liver Cirrhosis, Biliary* / pathology
  • Male
  • Markov Chains
  • Middle Aged
  • Multivariate Analysis
  • Necrosis
  • Predictive Value of Tests
  • Prognosis
  • Risk Factors
  • Serum Albumin
  • Ursodeoxycholic Acid / therapeutic use*


  • Cholagogues and Choleretics
  • Serum Albumin
  • Ursodeoxycholic Acid
  • Bilirubin