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. 2022 Jan 20:12:818089.
doi: 10.3389/fphar.2021.818089. eCollection 2021.

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

Guilherme Grossi Lopes Cançado  1   2 , Cláudia Alves Couto  1 , Laura Vilar Guedes  3 , Michelle Harriz Braga  3 , Débora Raquel Benedita Terrabuio  3 , Eduardo Luiz Rachid Cançado  3 , Maria Lucia Gomes Ferraz  4 , Cristiane Alves Villela-Nogueira  5 , Mateus Jorge Nardelli  1 , Luciana Costa Faria  1 , Elze Maria Gomes de Oliveira  6 , Vivian Rotman  5 , Daniel Ferraz de Campos Mazo  7 , Valéria Ferreira de Almeida E Borges  8   9 , Liliana Sampaio Costa Mendes  10 , Liana Codes  11   12 , Mario Guimarães Pessoa  3 , Izabelle Venturini Signorelli  13 , Cynthia Levy  14 , Paulo Lisboa Bittencourt  12   15
Affiliations

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

Guilherme Grossi Lopes Cançado et al. Front Pharmacol. .

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.

Keywords: bezafibrate; ciprofibrate; fibrate; primary biliary cholangitis; treatment failure; ursodeoxycholic acid.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
(A) Paired biochemical global response rate stratified by different criteria 1 and 2 years after associating fibrates to UDCA. Deltas show the percentage response gain between 1 and 2 years of treatment. (B) Comparison between bezafibrate and ciprofibrate response to treatment according to different criteria 1 and 2 years after associating fibrates to UDCA.
See this image and copyright information in PMC

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