Yuan Gao1, Li Li2, Bei Li2, Yutao Zhan2. 1. Department of Rheumatism Medicine, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China. 2. Department of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.
Abstract
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, I 2 = 0%) and high-density lipoprotein levels (P < 0.05) with no heterogeneity (P=0.82, I 2 = 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.
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 PBCpatients. 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 PBCpatients. 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 PBCpatients (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, I 2 = 0%) and high-density lipoprotein levels (P < 0.05) with no heterogeneity (P=0.82, I 2 = 0%). Conclusions: This meta-analysis demonstrated that OCA was a promising additional treatment for PBCpatients and might reduce serum cholesterol levels. The longer follow-up studies are needed to give more evidence.
Authors: Keith D Lindor; M Eric Gershwin; Raoul Poupon; Marshall Kaplan; Nora V Bergasa; E Jenny Heathcote Journal: Hepatology Date: 2009-07 Impact factor: 17.425
Authors: Craig Lammert; Brian D Juran; Erik Schlicht; Landon L Chan; Elizabeth J Atkinson; Mariza de Andrade; Konstantinos N Lazaridis Journal: J Gastroenterol Date: 2013-12-08 Impact factor: 7.527