학술논문
Predictive factors for decompensating events in patients with cirrhosis with primary biliary cholangitis under different lines of therapy.
Document Type
Academic Journal
Author
Ampuero J; Hospital Universitario Virgen del Rocío, Sevilla, Spain.; Instituto de Biomedicina de Sevilla, Spain.; Universidad de Sevilla, Spain.; CIBERehd, Spain.; Lucena A; Hospital Universitario Virgen del Rocío, Sevilla, Spain.; Berenguer M; CIBERehd, Spain.; Hepatology and Liver Transplantation Unit, IISLaFe, La Fe University Hospital, Valencia, Spain.; University of Valencia, Dept of Medicine, Valencia, Spain.; Hernández-Guerra M; Hospital Universitario de Canarias, Spain.; Molina E; Hospital Clinico Universitario de Santiago, Spain.; Gómez-Camarero J; Complejo Asistencial Universitario de Burgos, Spain.; Valdivia C; CIBERehd, Spain.; Hospital Universitario Reina Sofía, Córdoba, Spain.; Gómez E; Hospital Universitario 12 de Octubre, Madrid, Spain.; Casado M; Unidad de Aparato Digestivo, Hospital Universitario Torrecardenas, Almería, Spain.; Álvarez-Navascuez C; Hospital Universitario Central de Asturias, Oviedo, Spain.; Jorquera F; CIBERehd, Spain.; Servicio de Aparato Digestivo, Complejo Asistencial Universitario de León, León, Castilla y León, Spain.; García-Buey L; Gastroenterology Department, Hospital Universitario La Princesa, IIS-IP, Universidad Autónoma de Madrid, Spain.; Díaz-González Á; Servicio de Gastroenterología y Hepatología. Grupo de Investigación Clínica y Traslacional en Enfermedades Digestivas, Instituto de Investigación Valdecilla (IDIVAL), Hospital Universitario Marqués de Valdecilla, Santander, Spain.; Morillas R; CIBERehd, Spain.; Liver Section, Hospital Universitari Germans Trias i Pujol, IGTP, Badalona, Spain.; Universitat Autònoma de Barcelona, Spain.; García-Retortillo M; Hospital del Mar, Barcelona, Spain.; Sousa JM; Hospital Universitario Virgen del Rocío, Sevilla, Spain.; Pérez-Medrano I; Complexo Hospitalario Universitario de Pontevedra. Instituto de Investigación Sanitaria Galicia Sur (IISGS).; Simón MÁ; CIBERehd, Spain.; Servicio de Aparato Digestivo, Hospital Clínico Universitario, Zaragoza, Spain.; Instituto de Investigacion Sanitaria de Aragon (IIS Aragón), Universidad de Zaragoza, Spain.; Martínez J; CIBERehd, Spain.; Hospital Universitario Ramón y Cajal, Madrid, Spain.; Arenas J; Hospital Universitario Donostia, San Sebastián, Spain.; Londoño MC; CIBERehd, Spain.; Liver Unit, Hospital Clínic Barcelona, Fundació de Recerca Clínic Barcelona-Institut d'Investigacions Biomèdiques August Pi i Sunyer, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), University of Barcelona, Barcelona, Spain.; Olveira A; Hospital Universitario La Paz, Madrid, Spain.; Fernández-Rodríguez C; Hospital Universitario Fundación Alcorcon, Universidad Rey Juan Carlos, Madrid, Spain.
Source
Publisher: Wolters Kluwer Health, Inc Country of Publication: United States NLM ID: 8302946 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-3350 (Electronic) Linking ISSN: 02709139 NLM ISO Abbreviation: Hepatology Subsets: MEDLINE
Subject
Language
English
Abstract
Background and Aims: The landscape in primary biliary cholangitis (PBC) has changed with the advent of second-line treatments. However, the use of obeticholic acid (OCA) and fibrates in PBC-related cirrhosis is challenging. We assessed the impact of receiving a second-line therapy as a risk factor for decompensated cirrhosis in a real-world population with cirrhosis and PBC, and identify the predictive factors for decompensated cirrhosis in these patients.
Approach and Results: Multicenter study enrolling 388 patients with PBC-cirrhosis from the Spanish ColHai registry. Biopsy (20%), ultrasound (59%), or transient elastography (21%) defined cirrhosis, and the presence of varices and splenomegaly defined clinically significant portal hypertension (CSPH). Paris-II and PBC OCA international study of efficacy criteria determined the response to ursodeoxycholic acid (UDCA), fibrates (n=93), and OCA (n=104). The incidence of decompensated cirrhosis decreased for UDCA versus OCA or fibrates in the real-world population, but they were similar considering the propensity score-matched cohort (UDCA 3.77 vs. second-line therapy 4.5 100 persons-year, respectively), as patients on second-line therapy exhibited advanced liver disease. Consequently, GGT, albumin, platelets, clinically significant portal hypertension, and UDCA response were associated with a decompensating event. OCA response (achieved in 52% of patients) was associated with bilirubin (OR 0.21 [95% CI: 0.06-0.73]) and AST (OR 0.97 [95% CI: 0.95-0.99]), while fibrate response (achieved in 55% of patients) with AST [OR 0.96 (95% CI: 0.95-0.98]). In patients treated with OCA, drug response (sHR 0.23 [95% CI: 0.08-0.64]), diabetes (sHR 5.62 [95% CI: 2.02-15.68]), albumin (sHR 0.34 [95% CI: 0.13-0.89]), and platelets (sHR 0.99 [95% CI: 0.98-1.00]) were related to decompensation. In patients treated with fibrate, drug response (sHR 0.36 (95% CI: 0.14-0.95]), albumin (sHR 0.36 (95% CI: 0.16-0.81]), and clinically significant portal hypertension (sHR 3.70 (95% CI: 1.17-11.70]) were associated with decompensated cirrhosis.
Conclusions: Advanced PBC, rather than OCA and fibrates, was found to be associated with decompensating events. Therefore, biochemical and clinical variables should be considered when making decisions about the management of these drugs. Moreover, a positive response to OCA and fibrates reduced the risk of decompensation.
(Copyright © 2024 American Association for the Study of Liver Diseases.)
Approach and Results: Multicenter study enrolling 388 patients with PBC-cirrhosis from the Spanish ColHai registry. Biopsy (20%), ultrasound (59%), or transient elastography (21%) defined cirrhosis, and the presence of varices and splenomegaly defined clinically significant portal hypertension (CSPH). Paris-II and PBC OCA international study of efficacy criteria determined the response to ursodeoxycholic acid (UDCA), fibrates (n=93), and OCA (n=104). The incidence of decompensated cirrhosis decreased for UDCA versus OCA or fibrates in the real-world population, but they were similar considering the propensity score-matched cohort (UDCA 3.77 vs. second-line therapy 4.5 100 persons-year, respectively), as patients on second-line therapy exhibited advanced liver disease. Consequently, GGT, albumin, platelets, clinically significant portal hypertension, and UDCA response were associated with a decompensating event. OCA response (achieved in 52% of patients) was associated with bilirubin (OR 0.21 [95% CI: 0.06-0.73]) and AST (OR 0.97 [95% CI: 0.95-0.99]), while fibrate response (achieved in 55% of patients) with AST [OR 0.96 (95% CI: 0.95-0.98]). In patients treated with OCA, drug response (sHR 0.23 [95% CI: 0.08-0.64]), diabetes (sHR 5.62 [95% CI: 2.02-15.68]), albumin (sHR 0.34 [95% CI: 0.13-0.89]), and platelets (sHR 0.99 [95% CI: 0.98-1.00]) were related to decompensation. In patients treated with fibrate, drug response (sHR 0.36 (95% CI: 0.14-0.95]), albumin (sHR 0.36 (95% CI: 0.16-0.81]), and clinically significant portal hypertension (sHR 3.70 (95% CI: 1.17-11.70]) were associated with decompensated cirrhosis.
Conclusions: Advanced PBC, rather than OCA and fibrates, was found to be associated with decompensating events. Therefore, biochemical and clinical variables should be considered when making decisions about the management of these drugs. Moreover, a positive response to OCA and fibrates reduced the risk of decompensation.
(Copyright © 2024 American Association for the Study of Liver Diseases.)