Continuous treatment with ursodeoxycholic acid over five years generates benefits in mortality rate and transplantation rate in primary biliary cholangitis: systematic review of the literature and meta-analysis

Abstract

Objectives: Primary biliary cholangitis (PBC) is an inflammatory and chronic autoimmune cholestatic liver disease that, when left untreated, progresses to cirrhosis and eventually liver failure in a period of 10 to 20 years. This study aimed to evaluate the long-term impact of treatment with ursodeoxycholic acid (UDCA) in patients with PBC. Methods: A systematic literature review was conducted until May 2017. The endpoints included transplant-free survival (TFS) or death, overall survival (OS), mortality rate, transplantation rates and the combined rate of deaths and transplants. Data analysis was performed using a random effects model with the DerSimonian and Laird method. Results: Twelve studies were included in the meta-analysis. Treatment with UDCA showed an increase in TFS time in the long-term follow up from the fifth year of treatment, with statistically significant results for the years 5 and 10 (p < 0.01). Meta-analysis results for mortality rates, transplantation and combined mortality and transplantation rates were not significant for the three outcomes presented. The inclusion of the theoretical comparator arm studies significantly altered the results of the main analysis, making the results statistically significant from the third year of follow-up. Conclusions: UDCA is effective in increasing TFS or death, with statistically significant results at 5 and 10 years, when patients are treated chronically.