Additional fibrate treatment in UDCA‐refractory PBC patients

Background & Aims There is no proven treatment for ursodeoxycholic acid (UDCA)‐refractory primary biliary cholangitis (PBC) other than obeticholic acid. Although fibrates have been reported to improve biochemical parameters, the long‐term effects remain unclear. This study evaluated the effect o...

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Bibliographic Details
Published in:Liver international 2019-09, Vol.39 (9), p.1776-1785
Main Authors: Chung, Sung Won, Lee, Jeong‐Hoon, Kim, Minseok Albert, Leem, Galam, Kim, Sun Woong, Chang, Young, Lee, Hyo Young, Yoon, Jun Sik, Park, Jun Yong, Lee, Yun Bin, Cho, Eun Ju, Yu, Su Jong, Kim, Yoon Jun, Yoon, Jung‐Hwan
Format: Article
Language:English
Subjects:
Alkaline phosphatase
ALP normalization
Bezafibrate
Cholangitis
Cirrhosis
Confidence intervals
Deterioration
Fenofibrate
Liver cirrhosis
Long-term effects
Patients
primary biliary cholangitis
Statistical analysis
Ursodeoxycholic acid
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Summary:Background & Aims There is no proven treatment for ursodeoxycholic acid (UDCA)‐refractory primary biliary cholangitis (PBC) other than obeticholic acid. Although fibrates have been reported to improve biochemical parameters, the long‐term effects remain unclear. This study evaluated the effect of fibrate on clinical outcomes of UDCA‐refractory PBC. Methods Patients whose alkaline phosphatase (ALP) was not normalized with at least 13 mg/kg of UDCA treatment for >1 year were included from two tertiary referral centres. The primary outcome was ALP normalization. Secondary outcomes included the development of cirrhosis and hepatic deterioration. Immortal time bias was adjusted using the Mantel‐Byar method. Results A total of 100 UDCA‐refractory PBC patients were included: 71 patients received UDCA alone (the UDCA group) and 29 patients received UDCA plus additional fibrate treatment of 160 mg/d fenofibrate or 400 mg/d bezafibrate (the fibrate/UDCA group). During the follow‐up period, the probability of ALP normalization was significantly higher in the fibrate/UDCA group (hazard ratio [HR] = 5.00, 95% confidence interval = 2.87‐8.27, P 
ISSN:1478-3223
1478-3231
DOI:10.1111/liv.14165