Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis

Aim. To compare the response between the current recommended dosage 13–15 mg/kg/d and 20 mg/kg/d dose of ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) patients who do not respond completely to a standard dose of UDCA. Methods. We included 73 patients with poor response and randomi...

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Main Authors: Xinyu Xiang, Xiaoli Yang, Mengyi Shen, Chen Huang, Yifeng Liu, Xiaoli Fan, Li Yang
Format: Article
Language:English
Published: Wiley 2021-01-01
Series:Canadian Journal of Gastroenterology and Hepatology
Online Access:http://dx.doi.org/10.1155/2021/6691425
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author Xinyu Xiang
Xiaoli Yang
Mengyi Shen
Chen Huang
Yifeng Liu
Xiaoli Fan
Li Yang
author_facet Xinyu Xiang
Xiaoli Yang
Mengyi Shen
Chen Huang
Yifeng Liu
Xiaoli Fan
Li Yang
author_sort Xinyu Xiang
collection DOAJ
description Aim. To compare the response between the current recommended dosage 13–15 mg/kg/d and 20 mg/kg/d dose of ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) patients who do not respond completely to a standard dose of UDCA. Methods. We included 73 patients with poor response and randomized them into two groups to investigate whether increasing the dosage of UDCA was beneficial to nonresponders. Patients assigned to the 13–15 mg/kg/d group continued with standard therapy, and participants in the 18–22 mg/kg/d group switched to the higher dosage (18–22 mg/kg/d), with a follow-up of 12 months for both groups. The primary endpoints were the rate of response at 6 months and drug side effects. Results. According to the Paris 2 criteria, patients receiving 18–22 mg/kg/d UDCA achieved a response rate of 59.4% compared with 36.1% in the standard dosage group (P=0.046) at 6 months, respectively. At 12 months, the high-UDCA-dosage group achieved a response rate of 59.4% compared with 47.2% in the standard dosage group (P=0.295), respectively. Additionally, the risk score predicted by the UK-PBC model was lower in high-dosage UDCA-treated patients than in the standard dosage group (all P<0.05). Side effects include diarrhea, nausea and vomiting, rash, and newly developed high blood pressure, which were mild and tolerated. Conclusions. Patients treated with the high UDCA dosage showed some advantages over those who continued the standard dosage in terms of biochemical remission and disease progression, indicating that standard therapy with UDCA for 6 months and then another 1 year with high UDCA dosage for nonresponders could be a treatment option before second-line therapy is recommended.
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spelling doaj-art-8cf9a60431b44faab004f099345ed5382025-02-03T06:46:51ZengWileyCanadian Journal of Gastroenterology and Hepatology2291-27892291-27972021-01-01202110.1155/2021/66914256691425Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary CholangitisXinyu Xiang0Xiaoli Yang1Mengyi Shen2Chen Huang3Yifeng Liu4Xiaoli Fan5Li Yang6Department of Gastroenterology and Hepatology, Sichuan University-University of Oxford Huaxi Joint Centre for Gastrointestinal Cancer, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Gastroenterology & Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, ChinaDepartment of Gastroenterology and Hepatology, Sichuan University-University of Oxford Huaxi Joint Centre for Gastrointestinal Cancer, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Gastroenterology and Hepatology, Sichuan University-University of Oxford Huaxi Joint Centre for Gastrointestinal Cancer, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Gastroenterology and Hepatology, Sichuan University-University of Oxford Huaxi Joint Centre for Gastrointestinal Cancer, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Gastroenterology and Hepatology, Sichuan University-University of Oxford Huaxi Joint Centre for Gastrointestinal Cancer, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Gastroenterology and Hepatology, Sichuan University-University of Oxford Huaxi Joint Centre for Gastrointestinal Cancer, West China Hospital, Sichuan University, Chengdu, ChinaAim. To compare the response between the current recommended dosage 13–15 mg/kg/d and 20 mg/kg/d dose of ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) patients who do not respond completely to a standard dose of UDCA. Methods. We included 73 patients with poor response and randomized them into two groups to investigate whether increasing the dosage of UDCA was beneficial to nonresponders. Patients assigned to the 13–15 mg/kg/d group continued with standard therapy, and participants in the 18–22 mg/kg/d group switched to the higher dosage (18–22 mg/kg/d), with a follow-up of 12 months for both groups. The primary endpoints were the rate of response at 6 months and drug side effects. Results. According to the Paris 2 criteria, patients receiving 18–22 mg/kg/d UDCA achieved a response rate of 59.4% compared with 36.1% in the standard dosage group (P=0.046) at 6 months, respectively. At 12 months, the high-UDCA-dosage group achieved a response rate of 59.4% compared with 47.2% in the standard dosage group (P=0.295), respectively. Additionally, the risk score predicted by the UK-PBC model was lower in high-dosage UDCA-treated patients than in the standard dosage group (all P<0.05). Side effects include diarrhea, nausea and vomiting, rash, and newly developed high blood pressure, which were mild and tolerated. Conclusions. Patients treated with the high UDCA dosage showed some advantages over those who continued the standard dosage in terms of biochemical remission and disease progression, indicating that standard therapy with UDCA for 6 months and then another 1 year with high UDCA dosage for nonresponders could be a treatment option before second-line therapy is recommended.http://dx.doi.org/10.1155/2021/6691425
spellingShingle Xinyu Xiang
Xiaoli Yang
Mengyi Shen
Chen Huang
Yifeng Liu
Xiaoli Fan
Li Yang
Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis
Canadian Journal of Gastroenterology and Hepatology
title Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis
title_full Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis
title_fullStr Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis
title_full_unstemmed Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis
title_short Ursodeoxycholic Acid at 18–22 mg/kg/d Showed a Promising Capacity for Treating Refractory Primary Biliary Cholangitis
title_sort ursodeoxycholic acid at 18 22 mg kg d showed a promising capacity for treating refractory primary biliary cholangitis
url http://dx.doi.org/10.1155/2021/6691425
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