Obeticholic Acid and Fibrates in Primary Biliary Cholangitis: Comparative Effects in a Multicentric Observational Study
Por:
Reig, A, Alvarez-Navascues, C, Vergara, M, Gomez-Dominguez, E, Gallego-Moya, A, Perez-Medrano, IM, Fabrega, E, Hernandez-Guerra, M, Berenguer, M, Estevez, P, Arencibia, A, Morillas, RM, Horta, D, Albillos, A, Casado, M, De la Cruz, G, Fernandez-Bonilla, E, Molina, E, Hijona, L, Diago, M, Fernandez-Rodriguez, CM, Gonzalez-Santiago, JM, Sala, M, Gomez-Camarero, J, Romero-Gomez, M, Suarez, F, Vargas, V, Ferre-Aracil, C, Andrade, RJ, Chahri, N, Pares, A
Publicada:
1 nov 2021
Resumen:
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.
Filiaciones:
Reig, A:
Univ Barcelona, Hosp Clin, Liver Unit, IDIBAPS, Barcelona, Spain
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Alvarez-Navascues, C:
Hosp Univ Cent Asturias, Unidad Hepatol, Serv Aparato Digest, Oviedo, Spain
Vergara, M:
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Univ Autonoma Barcelona, Inst Invest & Innovacio Parc Tauli I3PT, Parc Tauli Hosp Univ, Unidad Hepatol,Serv Aparato Digest,Inst Carlos II, Bellaterra, Spain
Gomez-Dominguez, E:
Hosp 12 Octubre, Unidad Hepatol, Serv Aparato Digest, Madrid, Spain
Gallego-Moya, A:
Hosp Santa Creu & Sant Pau, Unidad Hepatol, Serv Aparato Digest, Barcelona, Spain
Perez-Medrano, IM:
Complejo Hosp Univ Pontevedra, Unidad Hepatol, Serv Aparato Digest, Pontevedra, Spain
IIS Galicia Sur, Pontevedra, Spain
Fabrega, E:
Hosp Marques Valdecilla, Unidad Hepatol, Serv Aparato Digest, Santander, Spain
Hernandez-Guerra, M:
Hosp Univ Canarias, Unidad Hepatol, Serv Aparato Digest, Santa Cruz De Tenerife, Spain
Berenguer, M:
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Hosp Univ, Unidad Hepatol, Serv Aparato Digest, Valencia, Spain
IIS Fe, Valencia, Spain
Univ Valencia, Valencia, Spain
Estevez, P:
Hosp Alvaro Cunqueiro Pontevedra, Unidad Hepatol, Serv Aparato Digest, Vigo, Spain
Arencibia, A:
Hosp Univ Nuestra Senora Candelaria, Unidad Hepatol, Serv Aparato Digest, Santa Cruz De Tenerife, Spain
Morillas, RM:
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Univ Autonoma Barcelona, Hosp Germans Trias & Pujol, Hepatol Dept, Res Inst,IGPT, Barcelona, Spain
Horta, D:
Hosp Mutua Terrassa, Unidad Hepatol, Serv Aparato Digest, Terrassa, Spain
Albillos, A:
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Univ Alcala De Henares, Hosp Univ Ramon y Cajal, Serv Gastroenterol, IRYCIS, Madrid, Spain
Casado, M:
Hosp Univ Torrecardenas, Unidad Hepatol, Serv Aparato Digest, Almeria, Spain
De la Cruz, G:
Complejo Hosp Univ Toledo, Unidad Hepatol, Serv Aparato Digest, Toledo, Spain
Fernandez-Bonilla, E:
Hosp Univ Miguel Servet, Unidad Hepatol, Serv Aparato Digest, Zaragoza, Spain
Molina, E:
Hosp Clin Santiago de Compostela, Unidad Hepatol, Serv Aparato Digest, Santiago De Compostela, Spain
Hijona, L:
Hosp Osi Arraba Txagorritxu, Unidad Hepatol, Serv Aparato Digest, Vitoria, Spain
Diago, M:
Consorcio Hosp Gen Valencia, Unidad Hepatol, Serv Aparato Digest, Valencia, Spain
Fernandez-Rodriguez, CM:
Univ Rey Juan Carlos, Unidad Hepatol, Serv Aparato Digest, Hosp Univ Fdn, Alcorcon, Alcorcon, Spain
Gonzalez-Santiago, JM:
Complejo Asistencial Univ Salamanca, Unidad Hepatol, Serv Aparato Digest, ISBAL, Salamanca, Spain
Sala, M:
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Hosp Univ Josep Trueta, Unidad Hepatol, Serv Aparato Digest, Girona, Spain
Gomez-Camarero, J:
Hosp Univ Burgos, Unidad Hepatol, Serv Aparato Digest, Burgos, Spain
Romero-Gomez, M:
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Hosp Univ Virgen Rocio, Unidad Hepatol, Serv Aparato Digest, Seville, Spain
Suarez, F:
Hosp Univ A Coruna, Unidad Hepatol, Serv Aparato Digest, La Coruna, Spain
Vargas, V:
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Univ Autonoma Barcelona, Hosp Vall dHebron, Serv Med Interna Hepatol, Barcelona, Spain
Ferre-Aracil, C:
Hosp Univ Puerta Hierro Majadahonda, Unidad Hepatol, Serv Aparato Digest, Majadahonda, Spain
Andrade, RJ:
CIBEREHD Inst Salud Carlos III, Madrid, Spain
Univ Malaga, Ctr Invest Biomed Red Enfermedades Hepat & Digest, Inst Invest Biomed Malaga IBIMA, Hosp Univ Virgen Victoria,Unidad Gest Clin Aparat, Malaga, Spain
Chahri, N:
Hosp Univ Sagrat Cor, Unidad Hepatol, Serv Aparato Digest, Barcelona, Spain
Pares, A:
Univ Barcelona, Hosp Clin, Liver Unit, IDIBAPS, Barcelona, Spain
CIBEREHD Inst Salud Carlos III, Madrid, Spain
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