A team from Paris, France, assessed the effect of ursodeoxycholic acid (UDCA) therapy on liver fibrosis progression in primary biliary cirrhosis (PBC).
A Markov model was used to analyze the progression rates between early and late histologic stages in 103 patients with PBC enrolled in a randomized, double-blind, placebo-controlled trial of UDCA.
Early stage was defined by the presence of portal and periportal lesions without extensive fibrosis, whereas late stage was defined by the presence of numerous septa, bridging fibrosis, or cirrhosis.
A total of 162 pairs of liver biopsy specimens were studied.
5-fold lower progression rate to extensive fibrosis using UDCA
The team found that UDCA therapy was associated with a 5-fold lower progression rate from early stage disease to extensive fibrosis or cirrhosis (7% per year under UDCA vs. 34% per year under placebo). However UDCA therapy was not associated with a significant difference in regression rates (3% per year under both UDCA and placebo).
At 4 years, the probability of UDCA-treated patients remaining in early stage disease was found to be 76%, as compared with 29% in placebo-treated patients.
On behalf of the group Dr Christophe Corpechot said in conclusion, "UDCA therapy significantly delays the progression of liver fibrosis in PBC.
"Markov modeling should prove useful in assessing the efficacy of future medical treatments in clinical trials involving histologic endpoints."