Primary biliary cirrhosis: incidence and predictive factors of cirrhosis development in ursodiol-treated patients.
OBJECTIVE
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.
Corpechot
Christophe
C
Service d'Hépatologie, Hôpital Saint-Antoine, Paris, France.
Carrat
Fabrice
F
Poupon
Raoul
R
Poupon
Renee-Eugenie
RE
D001663:Bilirubin / Q000097:blood; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D015994:Incidence; D008099:Liver / Q000473:pathology; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy / Q000453:epidemiology / Q000473:pathology; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D015999:Multivariate Analysis; D009336:Necrosis; D011237:Predictive Value of Tests; D011379:Prognosis; D012307:Risk Factors; D012709:Serum Albumin; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
D002756:Cholagogues and Choleretics; D012709:Serum Albumin; D014580:Ursodeoxycholic Acid; D001663:Bilirubin