Prognostic factors for transplant-free survival and external validation of prognostic models in Chinese patients with primary biliary cholangitis receiving ursodeoxycholic acid therapy

2017 ◽  
Vol 66 (1) ◽  
pp. S544
Author(s):  
K.S. Cheung ◽  
W.K. Seto ◽  
J. Fung ◽  
C.L. Lai ◽  
M.F. Yuen
2019 ◽  
Vol 71 (2) ◽  
pp. 357-365 ◽  
Author(s):  
Maren H. Harms ◽  
Henk R. van Buuren ◽  
Christophe Corpechot ◽  
Douglas Thorburn ◽  
Harry L.A. Janssen ◽  
...  

Gut ◽  
2019 ◽  
Vol 69 (8) ◽  
pp. 1502-1509 ◽  
Author(s):  
Maren H Harms ◽  
Rozanne C de Veer ◽  
Willem J Lammers ◽  
Christophe Corpechot ◽  
Douglas Thorburn ◽  
...  

ObjectiveThe clinical benefit of ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) has never been reported in absolute measures. The aim of this study was to assess the number needed to treat (NNT) with UDCA to prevent liver transplantation (LT) or death among patients with PBC.MethodsThe NNT was calculated based on the untreated LT-free survival and HR of UDCA with respect to LT or death as derived from inverse probability of treatment weighting-adjusted Cox proportional hazard analyses within the Global PBC Study Group database.ResultsWe included 3902 patients with a median follow-up of 7.8 (4.1–12.1) years. The overall HR of UDCA was 0.46 (95% CI 0.40 to 0.52) and the 5-year LT-free survival without UDCA was 81% (95% CI 79 to 82). The NNT to prevent one LT or death within 5 years (NNT5y) was 11 (95% CI 9 to 13). Although the HR of UDCA was similar for patients with and without cirrhosis (0.33 vs 0.31), the NNT5y was 4 (95% CI 3 to 5) and 20 (95% CI 14 to 34), respectively. Among patients with low alkaline phosphatase (ALP) (≤2× the upper limit of normal (ULN)), intermediate ALP (2–4× ULN) and high ALP (>4× ULN), the NNT5y to prevent one LT or death was 26 (95% CI 15 to 70), 11 (95% CI 8 to 17) and 5 (95% CI 4 to 8), respectively.ConclusionThe absolute clinical efficacy of UDCA with respect to LT or death varied with baseline prognostic characteristics, but was high throughout. These findings strongly emphasise the incentive to promptly initiate UDCA treatment in all patients with PBC and may improve patient compliance.


2019 ◽  
Vol 156 (6) ◽  
pp. S-1321
Author(s):  
Mohammad Alomari ◽  
Fahrettin Covut ◽  
Pravallika Chadalavada ◽  
Deepthi Gunasekaran ◽  
VINAY S. PADBIDRI ◽  
...  

2019 ◽  
Vol 17 (10) ◽  
pp. 2076-2084.e2 ◽  
Author(s):  
Angela C. Cheung ◽  
Willem J. Lammers ◽  
Carla F. Murillo Perez ◽  
Henk R. van Buuren ◽  
Aliya Gulamhusein ◽  
...  

2021 ◽  
Vol 11 (2-S) ◽  
pp. 113-117
Author(s):  
Manali Sudhir Dhage ◽  
Nila Ganamurali ◽  
Dhivya Dhanasekaran ◽  
Sarvesh Sabarathinam

Background: Primary Biliary Cholangitis (PBC) is a persistent liver disease. Ursodeoxycholic acid is used as a first-line treatment for the past two decades. However, concurrent use of Ursodeoxycholic acid reported with a severe adverse drug reaction. Obeticholic acid has been started utilizing as monotherapy and also with Ursodeoxycholic acid in a patient who is intolerant to Ursodeoxycholic acid therapy. We primarily aimed to compare the pharmacokinetic & toxicity profiles of Ursodeoxycholic acid and Obeticholic acid using in silico methods. Method: The pharmacokinetic profile of UDCA & OCA was observed from PKCSM server online database, OSIRIS® property Explorer, T.E.S.T. (Toxicity estimation software tool) & Molinspiration® is used to estimate the drug toxicity profiles. Result: This computer-aided response provides a great understanding and creates a gap between the theoretical and clinical evidence for UDCA & OCA's preference in PBC management. Conclusion: Co-administration of Obeticholic acid with Ursodeoxycholic acid will be an effective treatment for PBC in patients with UDCA intolerants. However, both medications are well-recognized substrates of the CYP3A4 enzyme and may lead to unintended drug interactions and side effects. Keywords: Primary Biliary Cholangitis, Obeticholic acid, Ursodeoxycholic acid, CYP3A4, Drug Interactions, Pharmacokinetics.


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