Systematic review and meta-analysis: bezafibrate in patients with primary biliary cirrhosis
Received 8 July 2015
Accepted for publication 18 August 2015
Published 30 September 2015 Volume 2015:9 Pages 5407—5419
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Editor who approved publication: Prof. Dr. Wei Duan
Qin Yin,1,2,* Jingjing Li,3,* Yujing Xia,3 Rong Zhang,3,4 Jianrong Wang,3,4 Wenxia Lu,3,4 Yuqing Zhou,1,2 Yuanyuan Zheng,3 Huerxidan Abudumijiti,3 Rongxia Chen,3 Kan Chen,3 Sainan Li,3 Tong Liu,3 Fan Wang,3 Jie Lu,3 Yingqun Zhou,3 Chuanyong Guo3
1Department of Gastroenterology, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, 2The First Affiliated Hospital of Soochow University, Suzhou, 3Department of Gastroenterology, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, 4The First Clinical Medical College of Nanjing Medical University, Nanjing, People’s Republic of China
*These authors contributed equally to this work and should be considered co-first authors
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 to -195.60; P<0.00001); gamma-glutamyltransferase (MD, -38.23 IU/L; 95% CI, -50.16 to -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/dL; 95% CI, -0.33 to -0.07; P=0.002); triglycerides (MD, -26.84 mg/dL; 95% CI, -36.51 to -17.17; P<0.0001); total cholesterol (MD, -21.58 mg/dL; 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.
Keywords: bezafibrate, meta-analysis, primary biliary cirrhosis, ursodeoxycholic acid
Erratum for this paper has been published.
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