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=12
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=Aim: 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, including ciprofibrate, in subjects with UDCA-unresponsive PBC.
Methods: The Brazilian Cholestasis Study Group multicenter database was reviewed to assess the response rates to UDCA plus fibrates in patients with UDCA-unresponsive PBC 1 and 2 years after treatment initiation by different validated criteria.
Results: In total, 27 patients (100% women, mean age 48.9 ± 9.2 years) with PBC were included. Overall response rates to fibrates by each validated criterion varied from 39 to 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.
Conclusion: Our findings endorse the efficacy of fibrate add-on treatment in PBC patients with suboptimal response to UDCA. Ciprofibrate appears to be at least 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.