Effectiveness of bezafibrate and ursodeoxycholic acid in patients with primary biliary cholangitis: a meta-analysis of randomized controlled trials.

BACKGROUND

Ursodeoxycholic acid (UDCA) and obeticholic acid are currently approved treatments for primary biliary cholangitis (PBC). Since some patients do not respond adequately to UDCA, other therapies, such as bezafibrate, have been developed. In this meta-analysis we evaluated the efficacy and safety of using both UDCA and bezafibrate in patients with an inadequate response to UDCA.

METHODS

We evaluated all randomized controlled trials comparing the combination of UDCA and bezafibrate with UDCA monotherapy. Standardized mean difference (SMD) was used to assess the treatment effect of combination therapy compared with UDCA alone.

RESULTS

Ten trials with a total of 369 patients were analyzed. UDCA and bezafibrate combination therapy was more effective than UDCA monotherapy in improving alanine aminotransferase (SMD -2.04, 95% confidence interval [CI] -3.30 to -0.79), alkaline phosphatase at both less than 12 months (SMD -3.63, 95%CI -6.43 to -0.84) and more than 12 months (SMD -2.33, 95%CI -4.03 to -0.63), gamma-glutamyltransferase (SMD -1.29, 95%CI -2.67 to 0.08), triglyceride (SMD -0.80, 95%CI -1.41 to -0.19), immunoglobulin M (SMD -1.48, 95%CI -2.39 to -0.56), and cholesterol (SMD -4.61, 95%CI -7.34 to -1.89). There was no difference between the 2 groups in bilirubin, aspartate aminotransferase or albumin. None of the adverse effects differed statistically between the 2 groups.

CONCLUSION

UDCA and bezafibrate combined treatment is superior to UDCA alone in UDCA non-responders with regard to decreasing liver biochemistry markers, without any significant increase in side effects in patients with PBC.