Examinando por Autor "Montero, J.L."

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Longitudinal outcomes of obeticholic acid therapy in ursodiol-nonresponsive primary biliary cholangitis: Stratifying the impact of add-on fibrates in real-world practice
(Wiley, 2024-05-01) Gómez, E.; Montero, J.L.; Molina, E.; García-Buey, L.; Casado, M.; Fuentes, J.; Simón, M.A.; Díaz-González, A.; Jorquera, F.; Morillas, R.M.; Presa, J.; Berenguer, M.; Conde, M.I.; Olveira, A.; Macedo, G.; Garrido, I.; Hernández-Guerra, M.; Olivas, I.; Rodríguez-Tajes, S.; Londoño, M.; Sousa, J.M.; Ampuero, J.; Romero-González, E.; González-Padilla, Sh.; Escudero-García, D.; Carvalho, A.; Santos, A.; Gutiérrez, M.L.; Pérez-Fernández, E.; Alburruza, L.; Uriz, J.; Gomes, D.; Santos, L.; Martínez-González, J.; Albillos, A.; Fernández-Rodríguez, C.M.
Background Suboptimal response to ursodeoxycholic acid occurs in 40% of primary biliary cholangitis (PBC) patients, affecting survival. Achieving a deep response (normalisation of alkaline phosphatase [ALP] and bilirubin ≤0.6 upper limit of normal) improves survival. Yet, the long-term effectiveness of second-line treatments remains uncertain. Aims To evaluate the long-term effectiveness of obeticholic acid (OCA) ± fibrates. Focusing on biochemical response (ALP ≤1.67 times the upper limit of normal, with a decrease of at least 15% from baseline and normal bilirubin levels), normalisation of ALP, deep response and biochemical remission (deep response plus aminotransferase normalisation). Methods We conducted a longitudinal, observational, multicentre study involving ursodeoxyccholic acid non-responsive PBC patients (Paris-II criteria) from Spain and Portugal who received OCA ± fibrates. Results Of 255 patients, median follow-up was 35.1 months (IQR: 20.2–53). The biochemical response in the whole cohort was 47.2%, 61.4% and 68.6% at 12, 24 and 36 months. GLOBE-PBC and 5-year UK-PBC scores improved (p < 0.001). Triple therapy (ursodeoxycholic acid plus OCA plus fibrates) had significantly higher response rates than dual therapy (p = 0.001), including ALP normalisation, deep response and biochemical remission (p < 0.001). In multivariate analysis, triple therapy remained independently associated with biochemical response (p = 0.024), alkaline phosphatase normalisation, deep response and biochemical remission (p < 0.001). Adverse effects occurred in 41.2% of cases, leading to 18.8% discontinuing OCA. Out of 55 patients with cirrhosis, 12 developed decompensation. All with baseline portal hypertension. Conclusion Triple therapy was superior in achieving therapeutic goals in UDCA-nonresponsive PBC. Decompensation was linked to pre-existing portal hypertension