Effectiveness of Bezafibrate and Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis: An Updated Meta-Analysis of Randomized Controlled Trials 930

• Published in: The American journal of gastroenterology Vol. 113; no. Supplement; pp. S519 - S520
• Main Authors: Majeed, Muhammad, Agrawal, Rohit, Shami, Saqib, Gandhi, Seema, Attar, Bashar M., Baig, Muhammad A., Wang, Yuchen, Abu Omar, Yazan, Muhammad, Hassan
• Format: Journal Article
• Language: English
• Published: New York Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01-10-2018
• Subjects: Cholangitis; Gastroenterology; Kinases; Meta-analysis
• ISSN: 0002-9270; 1572-0241
• DOI: 10.14309/00000434-201810001-00930

Introduction: Ursodeoxycholic acid (UDCA) and obeticholic acid are the approved treatments for primary biliary cholangitis. Inadequate response to these medications has led to search for additional therapies such as bezafibrate, which has been the center of several randomized control trials (RCT). We aim to study the efficacy and safety of combination therapy of UDCA and bezafbrate to UDCA alone in our updated meta-analysis of 10 RCTs. Methods: We searched the PubMed, Ovid and Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception till June, 2018 using a variety of key words for all RCT comparing the combination of UDCA and bezafibrate with UDCA monotherapy. Mean difference (MD) and standardized mean difference (SMD) were used to assess the treatment effect of combination therapy with UDCA alone. An inverse variance method was used to pool data into a random-effects model. Risk of bias was accessed using Cochrane collaboration tool. Results: We analyzed ten trials including 369 patients in this meta-analysis. Bezafibrate at 400mg/ day and UDCA at 600-1500mg/day were used in all trials. All RCTs had low risk of bias. Combination therapy with UDCA and bezafibrate was more effective than UDCA monotherapy in improving triglyceride (SMD: -0.80mg/dl; 95% CI: -1.41 to -0.19; p 0.01), immunoglobulin M (SMD -1.48; 95% CI -2.39 to -0.56; p 0.002), alanine aminotransferase (SMD -2.04; 95% CI -3.30 to -0.79; p 0.001), alkaline phosphatase (SMD -2.33; 95% CI -4.03 to -0.63; p 0.007) and cholesterol (SMD -4.61; 95% CI -7.34 to -1.89; p 0.001). However, no difference between 2 groups was found for myalgia (OD's ratio 2.12; 95% CI 0.85 to 5.28; p 0.104), creatine kinase level (SMD 3.966; 95% CI 0.68 to 22.92; p 0.124), gamma glutamyl transferase (SMD -1.29; 95% CI -2.67 to 0.08; p 0.065), aspartate aminotransferase (SMD -0.34; 95% CI -1.76 to 1.08; p 0.639), albumin (SMD 0.35; 95% CI -0.40 to 1.10; p 0.358) and bilirubin (SMD -0.77; 95% CI -2.20 to 0.65; p 0.287). There was no mortality difference in 2 groups as no death was reported in any of the trials. Conclusion: Combination therapy is superior to monotherapy in improving liver biochemistry without any significant increase in side effects in patients with primary biliary cholangitis.