Drug design, development and therapy · 2015
Combination therapy of fenofibrate and ursodeoxycholic acid in patients with primary biliary cirrhosis who respond incompletely to UDCA monotherapy: a meta-analysis.
Сравнительное исследованиеСтатьяМетаанализПоддержка исследования: вне правительства СШАСистематический обзорНазвание и аннотация: Перевод пока не подготовлен
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Zhang Yan, Li Sainan, He Lei, Wang Fan, Chen Kan, Li Jingjing, Liu Tong, Zheng Yuanyuan, Wang Jianrong, Lu Wenxia, Zhou Yuqing, Yin Qin, Xia Yujing, Zhou Yingqun, Lu Jie, Guo Chuanyong
Аннотация
BACKGROUND: Although the effectiveness of treatment with ursodeoxycholic acid (UDCA) and fenofibrate for primary biliary cirrhosis (PBC) has been suggested by small trials, a systematic review to summarize the evidence has not yet been carried out.
METHODS: A meta-analysis of all long-term randomized controlled trials comparing the combination of UDCA and fenofibrate with UDCA monotherapy was performed via electronic searches.
RESULTS: Six trials, which included 84 patients, were assessed. Combination therapy with UDCA and fenofibrate was more effective than UDCA monotherapy in improving alkaline phosphatase (mean difference [MD]: -90.44 IU/L; 95% confidence interval [CI]: -119.95 to -60.92; P<0.00001), gamma-glutamyl transferase (MD: -61.58 IU/L; 95% CI: -122.80 to -0.35; P=0.05), immunoglobulin M (MD: -38.45 mg/dL; 95% CI: -64.38 to -12.51; P=0.004), and triglycerides (MD: -0.41 mg/dL; 95% CI: -0.82 to -0.01; P=0.05). However, their effects on pruritus (odds ratio [OR]: 0.39; 95% CI: 0.09-1.78; P=0.23), total bilirubin (MD: -0.05 mg/dL; 95% CI: -0.21 to 0.12; P=0.58), and alanine aminotransferase (MD: -3.31 IU/L; 95% CI: -14.60 to 7.97; P=0.56) did not differ significantly. This meta-analysis revealed no significant differences in the incidence of adverse events (OR: 0.21; 95% CI: 0.03-1.25; P=0.09) between patients treated with combination therapy and those treated with monotherapy.
CONCLUSION: In this meta-analysis, combination therapy with UDCA and fenofibrate was more effective in reducing alkaline phosphatase than UDCA monotherapy, but it did not improve clinical symptoms. There did not appear to be an increase in adverse events with combination therapy.
METHODS: A meta-analysis of all long-term randomized controlled trials comparing the combination of UDCA and fenofibrate with UDCA monotherapy was performed via electronic searches.
RESULTS: Six trials, which included 84 patients, were assessed. Combination therapy with UDCA and fenofibrate was more effective than UDCA monotherapy in improving alkaline phosphatase (mean difference [MD]: -90.44 IU/L; 95% confidence interval [CI]: -119.95 to -60.92; P<0.00001), gamma-glutamyl transferase (MD: -61.58 IU/L; 95% CI: -122.80 to -0.35; P=0.05), immunoglobulin M (MD: -38.45 mg/dL; 95% CI: -64.38 to -12.51; P=0.004), and triglycerides (MD: -0.41 mg/dL; 95% CI: -0.82 to -0.01; P=0.05). However, their effects on pruritus (odds ratio [OR]: 0.39; 95% CI: 0.09-1.78; P=0.23), total bilirubin (MD: -0.05 mg/dL; 95% CI: -0.21 to 0.12; P=0.58), and alanine aminotransferase (MD: -3.31 IU/L; 95% CI: -14.60 to 7.97; P=0.56) did not differ significantly. This meta-analysis revealed no significant differences in the incidence of adverse events (OR: 0.21; 95% CI: 0.03-1.25; P=0.09) between patients treated with combination therapy and those treated with monotherapy.
CONCLUSION: In this meta-analysis, combination therapy with UDCA and fenofibrate was more effective in reducing alkaline phosphatase than UDCA monotherapy, but it did not improve clinical symptoms. There did not appear to be an increase in adverse events with combination therapy.