Response Rate and Impact on Lipid Profiles of Obeticholic Acid Treatment for Patients with Primary Biliary Cholangitis: A Meta-Analysis

Background. Up to 40% of patients with primary biliary cholangitis (PBC) have an inadequate response to ursodeoxycholic acid (UDCA). Obeticholic acid (OCA) is considered the addition of treatment, but the response rate based on commonly referenced biochemical response criteria and lipids’ impact was...

Full description

Saved in:
Bibliographic Details
Main Authors: Yuan Gao, Li Li, Bei Li, Yutao Zhan
Format: Article
Language:English
Published: Wiley 2021-01-01
Series:Canadian Journal of Gastroenterology and Hepatology
Online Access:http://dx.doi.org/10.1155/2021/8829510
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1832550113927495680
author Yuan Gao
Li Li
Bei Li
Yutao Zhan
author_facet Yuan Gao
Li Li
Bei Li
Yutao Zhan
author_sort Yuan Gao
collection DOAJ
description Background. Up to 40% of patients with primary biliary cholangitis (PBC) have an inadequate response to ursodeoxycholic acid (UDCA). Obeticholic acid (OCA) is considered the addition of treatment, but the response rate based on commonly referenced biochemical response criteria and lipids’ impact was unclear. Previous studies reported inconsistency results partially due to small sample size. Therefore, we performed a meta-analysis and aimed to explore OCA treatment’s response rate and effect on lipids’ profiles in PBC patients. Methods. We performed PubMed, Embase, and Cochrane controlled trials register (updated to JUN 2019) databases and manual bibliographical searches for randomized controlled trials reporting on OCA treatment in PBC patients. Two researchers independently extracted data and assessed the risk of bias of studies. We calculated risk ratio (RR) for the overall complete response rate, and the standardized mean difference (SMD) for the serum lipids changes after OCA treatment, all with 95% confidence intervals (CIs) using fixed-effects models. We registered this meta-analysis with PROSPERO (registration number: CRD42020148550). Results. Three trials, with 265 patients, were selected for the analysis. OCA was superior to placebo in PBC patients (RR, 1.48; 95% CI, 1.15–1.90). OCA’s pooled treatment response rate was 65% (95% CI, 56%–74%), corresponding to Paris I criteria. Besides, OCA significantly decreased total cholesterol (P=0.02) with no heterogeneity (P=0.87, I2 = 0%) and high-density lipoprotein levels (P<0.05) with no heterogeneity (P=0.82, I2 = 0%). Conclusions. This meta-analysis demonstrated that OCA was a promising additional treatment for PBC patients and might reduce serum cholesterol levels. The longer follow-up studies are needed to give more evidence.
format Article
id doaj-art-061c304b21f8414396037f9e4829a82d
institution Kabale University
issn 2291-2789
2291-2797
language English
publishDate 2021-01-01
publisher Wiley
record_format Article
series Canadian Journal of Gastroenterology and Hepatology
spelling doaj-art-061c304b21f8414396037f9e4829a82d2025-02-03T06:07:40ZengWileyCanadian Journal of Gastroenterology and Hepatology2291-27892291-27972021-01-01202110.1155/2021/88295108829510Response Rate and Impact on Lipid Profiles of Obeticholic Acid Treatment for Patients with Primary Biliary Cholangitis: A Meta-AnalysisYuan Gao0Li Li1Bei Li2Yutao Zhan3Department of Rheumatism Medicine, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, ChinaDepartment of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, ChinaDepartment of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, ChinaDepartment of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, ChinaBackground. Up to 40% of patients with primary biliary cholangitis (PBC) have an inadequate response to ursodeoxycholic acid (UDCA). Obeticholic acid (OCA) is considered the addition of treatment, but the response rate based on commonly referenced biochemical response criteria and lipids’ impact was unclear. Previous studies reported inconsistency results partially due to small sample size. Therefore, we performed a meta-analysis and aimed to explore OCA treatment’s response rate and effect on lipids’ profiles in PBC patients. Methods. We performed PubMed, Embase, and Cochrane controlled trials register (updated to JUN 2019) databases and manual bibliographical searches for randomized controlled trials reporting on OCA treatment in PBC patients. Two researchers independently extracted data and assessed the risk of bias of studies. We calculated risk ratio (RR) for the overall complete response rate, and the standardized mean difference (SMD) for the serum lipids changes after OCA treatment, all with 95% confidence intervals (CIs) using fixed-effects models. We registered this meta-analysis with PROSPERO (registration number: CRD42020148550). Results. Three trials, with 265 patients, were selected for the analysis. OCA was superior to placebo in PBC patients (RR, 1.48; 95% CI, 1.15–1.90). OCA’s pooled treatment response rate was 65% (95% CI, 56%–74%), corresponding to Paris I criteria. Besides, OCA significantly decreased total cholesterol (P=0.02) with no heterogeneity (P=0.87, I2 = 0%) and high-density lipoprotein levels (P<0.05) with no heterogeneity (P=0.82, I2 = 0%). Conclusions. This meta-analysis demonstrated that OCA was a promising additional treatment for PBC patients and might reduce serum cholesterol levels. The longer follow-up studies are needed to give more evidence.http://dx.doi.org/10.1155/2021/8829510
spellingShingle Yuan Gao
Li Li
Bei Li
Yutao Zhan
Response Rate and Impact on Lipid Profiles of Obeticholic Acid Treatment for Patients with Primary Biliary Cholangitis: A Meta-Analysis
Canadian Journal of Gastroenterology and Hepatology
title Response Rate and Impact on Lipid Profiles of Obeticholic Acid Treatment for Patients with Primary Biliary Cholangitis: A Meta-Analysis
title_full Response Rate and Impact on Lipid Profiles of Obeticholic Acid Treatment for Patients with Primary Biliary Cholangitis: A Meta-Analysis
title_fullStr Response Rate and Impact on Lipid Profiles of Obeticholic Acid Treatment for Patients with Primary Biliary Cholangitis: A Meta-Analysis
title_full_unstemmed Response Rate and Impact on Lipid Profiles of Obeticholic Acid Treatment for Patients with Primary Biliary Cholangitis: A Meta-Analysis
title_short Response Rate and Impact on Lipid Profiles of Obeticholic Acid Treatment for Patients with Primary Biliary Cholangitis: A Meta-Analysis
title_sort response rate and impact on lipid profiles of obeticholic acid treatment for patients with primary biliary cholangitis a meta analysis
url http://dx.doi.org/10.1155/2021/8829510
work_keys_str_mv AT yuangao responserateandimpactonlipidprofilesofobeticholicacidtreatmentforpatientswithprimarybiliarycholangitisametaanalysis
AT lili responserateandimpactonlipidprofilesofobeticholicacidtreatmentforpatientswithprimarybiliarycholangitisametaanalysis
AT beili responserateandimpactonlipidprofilesofobeticholicacidtreatmentforpatientswithprimarybiliarycholangitisametaanalysis
AT yutaozhan responserateandimpactonlipidprofilesofobeticholicacidtreatmentforpatientswithprimarybiliarycholangitisametaanalysis