AUTHOR=Cançado Guilherme Grossi Lopes , Couto Cláudia Alves , Guedes Laura Vilar , Braga Michelle Harriz , Terrabuio Débora Raquel Benedita , Cançado Eduardo Luiz Rachid , Ferraz Maria Lucia Gomes , Villela-Nogueira Cristiane Alves , Nardelli Mateus Jorge , Faria Luciana Costa , Oliveira Elze Maria Gomes de , Rotman Vivian , Mazo Daniel Ferraz de Campos , Borges Valéria Ferreira de Almeida e , Mendes Liliana Sampaio Costa , Codes Liana , Pessoa Mario Guimarães , Signorelli Izabelle Venturini , Levy Cynthia , Bittencourt Paulo Lisboa 

TITLE=Fibrates for the Treatment of Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid: An Exploratory Study

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 12 - 2021

YEAR=2022

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.818089

DOI=10.3389/fphar.2021.818089

ISSN=1663-9812

ABSTRACT=Aims: Up to 40% of patients with primary biliary cholangitis (PBC) will have a suboptimal biochemical response to ursodeoxycholic acid (UDCA), which can be improved by the addition of fibrates. This exploratory study aims to evaluate the long-term real life biochemical response of different fibrates in subjects with UDCA-unresponsive PBC, including ciprofibrate. Methods: The Brazilian Cholestasis Study Group multicentre database was reviewed to assess response rates to UDCA plus fibrates in patients with UDCA-unresponsive PBC, 1- and 2- years after treatment initiation by different validated criteria. Results: 27 patients (100% females, mean age 48.9 ± 9.2 years) with PBC were included. Overall response rates to fibrates by each validated criteria varied from 39-60% and 39-76% at 12 and 24 months after treatment combination, respectively. Combination therapy resulted in a significant decrease in ALT and ALP only after 2 years, while GGT significantly improved in the first year of treatment. Treatment response rates at 1 and 2 years appear to be comparable between ciprofibrate and bezafibrate using all available criteria.
Conclusions: Our findings endorse the efficacy of fibrate add-on treatment in PBC patients with suboptimal response to UDCA. Ciprofibrate appears to be as effective as bezafibrate and should be assessed in large clinical trials as a possibly new, cheaper and promising option for treatment of UDCA-unresponsive PBC patients.