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

(1)Instituto Alfa de Gastroenterologia, Hospital das Clínicas da Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.

(2)Hospital da Polícia Militar de Minas Gerais, Belo Horizonte, Brazil.

(3)Departamento de Gastroenterologia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

(4)Disciplina de Gastroenterologia, Universidade Federal de São Paulo, São Paulo, Brazil.

(5)Hospital Universitário Clementino Fraga Filho e Departamento de Clínica Médica da Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.

(6)Centro Universitário Lusíada-UNILUS, Santos, Brazil.

(7)Divisão de Gastroenterologia (Gastrocentro), Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas, Brazil.

(8)Instituto de Gastroenterologia, Endoscopia e Proctologia, Uberlândia, Brazil.

(9)Universidade Federal de Uberlândia, Uberlândia, Brazil.

(10)Hospital de Base do Distrito Federal, Brasília, Brazil.

(11)Hospital Universitário Professor Edgard Santos, Universidade Federal da Bahia, Salvador, Brazil.

(12)Hospital Português, Salvador, Brazil.

(13)Hospital Universitário Cassiano Antônio Moraes, Universidade Federal do Espírito Santo, Vitória, Brazil.

(14)Division of Digestive Health and Liver Diseases, University of Miami Miller School of Medicine, Miami, FL, United States.

(15)Escola Bahiana de Medicina e Saúde Pública, Salvador, Brazil. 

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.