Systematic Review And Meta-analysis: Bezafibrate In Patients With Primary Biliary Cirrhosis

Background and aim: Ursodeoxycholic acid(UDCA)is the standard treatment for primary biliary cirrhosis(PBC),but not all cases respond well.Evidence has shown that combination therapy of UDCA with bezafibrate significantly improved liver function.A meta-analysis was performed to assess the efficacy and safety of UDCA and bezafibrate combination therapy in the treatment of PBC.Results: Nine trials,with a total of 269 patients,were included in the analysis.The bias risk of these trials was high.Compared with UDCA alone,the combination with bezafibrate improved the Mayo risk score(mean difference [MD],0.60;95% confidence interval [CI],0.25–0.95;P=0.0008)and liver biochemistry: alkaline phosphatase(MD,-238.21 IU/L;95% CI,-280.83--195.60;P,0.00001);gamma-glutamyltransferase(MD,-38.23 IU/L;95% CI,-50.16--25.85;P,0.00001);immunoglobulin M(MD,-128.63 IU/L;95% CI,-151.55 to-105.71;P,0.00001);bilirubin(MD,-0.20 mg/d L;95% CI,-0.33 to-0.07;P=0.002);triglycerides(MD,-26.84 mg/d L;95% CI,-36.51 to-17.17;P,0.0001);total cholesterol(MD,-21.58 mg/d L;95% CI,-30.81 to-12.34;P,0.0001),and serum alanine aminotransferase(MD,-10.24 IU/L;95% CI,-12.65 to-78.5;P,0.00001).However,combination therapy showed no significant differences in the incidence of all-cause mortality or pruritus,and may have resulted in more adverse events(risk ratio [RR],0.22;95% CI,0.07–0.67;P=0.008).Conclusion: Combination therapy improved liver biochemistry and the prognosis of PBC,but did not improve clinical symptoms or incidence of death.Attention should be paid to adverse events when using bezafibrate.