RT Journal Article
T1 Obeticholic Acid and Fibrates in Primary Biliary Cholangitis: Comparative Effects in a Multicentric Observational Study
A1 Reig, Anna
A1 Alvarez-Navascues, Carmen
A1 Vergara, Mercedes
A1 Gomez-Dominguez, Elena
A1 Gallego-Moya, Adolfo
A1 Perez-Medrano, Indhira M.
A1 Fabrega, Emilio
A1 Hernandez-Guerra, Manuel
A1 Berenguer, Marina
A1 Estevez, Pamela
A1 Arencibia, Ana
A1 Morillas, Rosa M.
A1 Horta, Diana
A1 Albillos, Agustin
A1 Casado, Marta
A1 De la Cruz, Gema
A1 Fernandez-Bonilla, Eva
A1 Molina, Esther
A1 Hijona, Lander
A1 Diago, Moises
A1 Fernandez-Rodriguez, Conrado M.
A1 Gonzalez-Santiago, Jesus M.
A1 Sala, Margarita
A1 Gomez-Camarero, Judith
A1 Romero-Gomez, Manuel
A1 Suarez, Francisco
A1 Vargas, Victor
A1 Ferre-Aracil, Carlos
A1 Andrade, Raul J.
A1 Chahri, Nadia
A1 Pares, Albert
K1 Placebo-controlled trial
K1 Ursodeoxycholic acid
K1 Biochemical response
K1 Cirrhosis
K1 Bezafibrate
K1 Prognosis
AB INTRODUCTION: Obeticholic acid (OCA) and fibrates therapy results in biochemical improvement in placebo-controlled trials in patients with primary biliary cholangitis and insufficient response to ursodeoxycholic acid. There is scarce information outside of clinical trials. Therefore, we have assessed the effectiveness and adverse events of these treatments. 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.
PB Lippincott williams & wilkins
SN 0002-9270
YR 2021
FD 2021-11-01
LK https://hdl.handle.net/10668/24993
UL https://hdl.handle.net/10668/24993
LA en
DS RISalud
RD Apr 4, 2025