Gandhi, SeemaAgrawal, RohitWang, YuchenSaqib, ShamiWang, YantingOmar, Yazan AbuMbachi, ChimeziFlores, EstefaniaMajeed, MuhammadAttar, Bashar M.Udechukwu, VictorDemetria, MelchorBackground 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. Keywords Primary biliary cholangitis, ursodeoxycholic acid, bezafibrate, combination therapy Ann Gastroenterol 2019; 32 (5): 489-497text/htmlapplication/pdfhttp://www.annalsgastro.gr/index.php/annalsgastro/article/view/4608engHellenic Society of GastroenterologyCopyright (c) 2019 Annals of Gastroenterology1792-74631108-7471Annals of Gastroenterology; Volume 32, No 5 (2019); 489Effectiveness of bezafibrate and ursodeoxycholic acid in patients with primary biliary cholangitis: a meta-analysis of randomized controlled trialsinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion2019-08-24Δημοσίευση σε περιοδικόPublication in journalΓαστροεντερολογίαGastroenterologyisi -Gastroenterology & Hepatology covers resources on the anatomy, physiology, biochemistry, and pathology of the digestive system. This category includes specific resources on the prognosis and treatment of digestive diseases; stomach ulcers; metabolic, genetic, infectious and chemically induced diseases of the liver; colitis; diseases of the pancreas and diseases of the rectum.Επιστημονικό άρθροScientific articleΕλληνική Γαστροεντερολογική ΕταιρίαGreek Aggregator OpenArchives.gr | National Documentation Centre (EKT)other