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  3. Longitudinal outcomes of obeticholic acid therapy in ursodiol-nonresponsive primary biliary cholangitis: Stratifying the impact of add-on fibrates in real-world practice

Longitudinal outcomes of obeticholic acid therapy in ursodiol-nonresponsive primary biliary cholangitis: Stratifying the impact of add-on fibrates in real-world practice

Data de publicação: Data Ahead of Print:

Autores da FMUP

  • Manuel Guilherme Gonçalves Macedo

    Autor

Participantes de fora da FMUP

  • Gomez, E.
  • Montero, J. L.
  • Molina, E.
  • Garcia-Buey, L.
  • Casado, M.
  • Fuentes, J.
  • Simon, M. A.
  • Diaz-Gonzalez, A.
  • Jorquera, F.
  • Morillas, R. M.
  • Presa, J.
  • Berenguer, M.
  • Conde, M. I.
  • Olveira, A.
  • Garrido, I.
  • Hernandez-Guerra, M.
  • Olivas, I.
  • Rodriguez-Taje, S.
  • Londono, M.
  • Sousa, J. M.
  • Ampuero, J.
  • Romero-Gonzalez, E.
  • Gonzalez-Padilla, Sh.
  • Escudero-Garcia, D.
  • Carvalho, A.
  • Santos, A.
  • Gutierrez, M. L.
  • Perez-Fernandez, E.
  • Aburruza, L.
  • Uriz, J.
  • Gomes, D.
  • Santos, L.
  • Martinez-Gonzalez, J.
  • Albillos, A.
  • Fernandez-Rodriguez, C. M.

Unidades de investigação

Abstract

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.

Dados da publicação

ISSN/ISSNe:
0269-2813, 1365-2036

ALIMENTARY PHARMACOLOGY & THERAPEUTICS  Wiley-Blackwell Publishing Ltd

Tipo:
Article
Páginas:
1604-1615
Link para outro recurso:
www.scopus.com

Citações Recebidas na Web of Science: 2

Citações Recebidas na Scopus: 2

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Keywords

  • PLACEBO-CONTROLLED TRIAL; URSODEOXYCHOLIC ACID; BIOCHEMICAL RESPONSE; CIRRHOSIS; BEZAFIBRATE; SURVIVAL

Campos de estudo

Proyectos asociados

The contribution of endoscopic ultrasound and biomarkers in the management of pancreatic adenocarcinoma and its precursor lesions.

Investigador Principal: Manuel Guilherme Gonçalves Macedo

Estudo Clínico Académico . 2023

Noninvasive serum biomarkers of portal hypertension in liver cirrhosis

Investigador Principal: Manuel Guilherme Gonçalves Macedo

Estudo Clínico Académico . 2023

Otimização do rendimento da colangiopancreatografia retrógrada endoscópica na avaliação das estenoses pancreato-biliares indeterminadas

Investigador Principal: Manuel Guilherme Gonçalves Macedo

Estudo Clínico Académico . 2023

Endoscopic Treatment Of Upper Gastrointestinal Postsurgical Leaks

Investigador Principal: Manuel Guilherme Gonçalves Macedo

Estudo Clínico Académico . 2023

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