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      Effectiveness of bezafibrate and ursodeoxycholic acid in patients with primary biliary cholangitis: a meta-analysis of randomized controlled trials

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          Abstract

          Background:

          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.

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          Most cited references17

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          Primary biliary cirrhosis.

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            Excellent long-term survival in patients with primary biliary cirrhosis and biochemical response to ursodeoxycholic Acid.

            Because the efficacy of UDCA on long-term outcome of primary biliary cirrhosis (PBC) has not been completely elucidated, we have assessed the course and survival of patients with PBC treated with UDCA and compared with the survival predicted by the Mayo model and the estimated survival of a standardized population. (One hundred ninety-two patients [181 women] with PBC treated with UDCA [15 mg/kg per day] for 1.5-14 years.) Response to treatment was defined by an alkaline phosphatase decrease greater than 40% of baseline values or normal levels after 1 year of treatment. The predicted survival was obtained by the Mayo model and the estimated survival was taken from the standardized matched Spanish population. Seventeen patients died or fulfilled criteria for liver transplantation (8.9%). The observed survival was higher than that predicted by the Mayo model and lower than that of the control population (P < .001). One hundred seventeen patients (61%) responded to treatment. The survival of responders was significantly higher than that predicted by the Mayo model and similar to that estimated for the control population (P = .15). By contrast, the survival of patients without biochemical response was lower than that estimated for the Spanish population (P < .001) although higher than that predicted by the Mayo model. Biochemical response to UDCA after 1 year is associated with a similar survival to the matched control population, clearly supporting the favorable effects of this treatment in PBC. The suboptimal survival of nonresponders identifies the group for further treatments.
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              A Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis

              Patients with primary biliary cholangitis who have an inadequate response to therapy with ursodeoxycholic acid are at high risk for disease progression. Fibrates, which are agonists of peroxisome proliferator-activated receptors, in combination with ursodeoxycholic acid, have shown potential benefit in patients with this condition.
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                Author and article information

                Journal
                Ann Gastroenterol
                Ann Gastroenterol
                Annals of Gastroenterology
                Hellenic Society of Gastroenterology (Greece )
                1108-7471
                1792-7463
                Sep-Oct 2019
                22 July 2019
                : 32
                : 5
                : 489-497
                Affiliations
                [a ]Department of Medicine (Rohit Agrawal, Muhammad Majeed, Yazan Abu Omar, Chimezie Mbachi, Yanting Wang, Estefania Flores, Shami Shaqib, Yuchen Wang, Melchor Demetria)
                [b ]Department of Hospital Medicine (Victor Udechukwu)
                [c ]Department of Division of Gastroenterology and Hepatology, Department of Medicine (Bashar M. Attar, Melchor Demetria, Seema Gandhi), Cook County Health and Hospital System, County, Chicago, IL, USA
                Author notes
                Correspondence to: Rohit Agrawal, MD, Department of Medicine, Cook County Health and Hospital System, IL, USA, e-mail: rohit.agrawal@ 123456cookcountyhhs.org
                Article
                AnnGastroenterol-32-489
                10.20524/aog.2019.0403
                6686091
                31474796
                3b4866f3-cae6-4809-a45c-0ee247a07ed1
                Copyright: © Hellenic Society of Gastroenterology

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 09 April 2019
                : 20 June 2019
                Categories
                Original Article

                primary biliary cholangitis,ursodeoxycholic acid,bezafibrate,combination therapy

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