Obeticholic Acid and Fibrates in Primary Biliary Cholangitis: Comparative Effects in a Multicentric Observational Study.
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Reig Anna, Álvarez-Navascués Carmen, Vergara Mercedes, Gómez-Domínguez Elena, Gallego-Moya Adolfo, Pérez-Medrano Indhira M, Fábrega Emilio, Hernández-Guerra Manuel, Berenguer Marina, Estevez Pamela, Arencibia Ana, Morillas Rosa M, Horta Diana, Albillos Agustín, Casado Marta, De la Cruz Gema, Fernandez-Bonilla Eva, Molina Esther, Hijona Lander, Diago Moises, Fernández-Rodriguez Conrado M, González-Santiago Jesús M, Sala Margarita, Gómez-Camarero Judith, Romero-Gomez Manuel, Suárez Francisco, Vargas Victor, Ferre-Aracil Carlos, Andrade Raúl J, Chahri Nadia, Parés Albert
Аннотация
METHODS: Data from patients included in the ColHai registry treated with OCA, fibrates, or both were recorded during a year, as well as adverse events and treatment discontinuation.
RESULTS: Eighty-six patients were treated with OCA, 250 with fibrates (81% bezafibrate; 19% fenofibrate), and 15 with OCA plus fibrates. OCA group had baseline significantly higher alkaline phosphatase (ALP) (P = 0.01) and lower platelets (P = 0.03) than fibrates. Both treatments significantly decreased ALP, gamma-glutamyl transferase (GGT), and transaminases and improved Globe score. Albumin and immunoglobulin type M improved in the fibrates group. ALP decrease was higher under fibrates, whereas alanine aminotransferase decline was higher under OCA. Although baseline transaminases and GGT were higher in patients with OCA plus fibrates, significant ALP, GGT, alanine aminotransferase, and Globe score improvement were observed during triple therapy. Adverse events were reported in 14.7% of patients (21.3% OCA; 17.6% fenofibrate; 10.7% bezafibrate), mainly pruritus (10.1% with OCA). Discontinuation was more frequent in fenofibrate treatment mainly because of intolerance or adverse events.
DISCUSSION: Second-line therapy with OCA or fibrates improves hepatic biochemistry and the GLOBE score in primary biliary cholangitis patients with suboptimal response to ursodeoxycholic acid. Simultaneous treatment with OCA and fibrates improved ALP as well.