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Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis
- Source :
- Dipòsit Digital de la UB, Universidad de Barcelona, Liver International, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona
- Publication Year :
- 2020
- Publisher :
- Blackwell Publishing Ltd, 2020.
-
Abstract
- Background & Aims: Total bilirubin is a predictor of survival in primary biliary cholangitis, with the main elevated component being direct bilirubin. The purpose of this post hoc analysis was to assess the efficacy and safety of obeticholic acid across quartiles of varying baseline levels of direct bilirubin in the phase 3, randomized, placebo-controlled Primary Biliary Cholangitis Obeticholic Acid International Study of Efficacy. Methods: This analysis assessed patients on the basis of their baseline direct bilirubin level (divided by quartile). Biochemistry and safety outcomes were evaluated within each quartile over time. Results: In the quartile with the highest baseline direct bilirubin (>5.47µmol/L), there was a significant reduction in both direct and total bilirubin at Month 12 compared with placebo. Least squares mean (standard error) change from baseline in direct bilirubin at Month 12 was 4.17 (1.42) µmol/L for placebo, −3.48 (1.63) µmol/L for obeticholic acid 5-10mg and −3.66 (1.51) µmol/L for obeticholic acid 10mg (P&nbsp
- Subjects :
- medicine.medical_specialty
Cirrhosis
Cirrosi hepàtica
Cholangitis
Bilirubin
Malalties del tracte biliar
Chenodeoxycholic Acid
Placebo
Gastroenterology
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Liver Function Tests
Cholestasis
MED/12 - GASTROENTEROLOGIA
Internal medicine
Post-hoc analysis
medicine
Humans
Gut‐liver Axis, Immunology, Immune Mediated and Cholestatic Diseases
In patient
Hepatology
Liver Cirrhosis, Biliary
business.industry
Bilious diseases and biliousness
cirrhosis
Biliary
Obeticholic acid
cholestasi
medicine.disease
chemistry
Quartile
Hepatic cirrhosis
030220 oncology & carcinogenesis
Original Article
030211 gastroenterology & hepatology
bilirubin
cholestasis
business
biliary
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Dipòsit Digital de la UB, Universidad de Barcelona, Liver International, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona
- Accession number :
- edsair.doi.dedup.....097e55503ea1d8e57295d723299bf91a