Efficacy and safety of obeticholic acid in liver disease—A systematic review and meta-analysis - 14/05/21
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Highlights |
• | Liver fibrosis is associated with the risk of liver-related adverse outcomes and an increase in all-cause mortality in non-alcoholic steatohepatitis (NASH). |
• | There is no approved pharmacotherapy for NASH. |
• | In this meta-analysis, we found that 10 mg obeticholic acid (OCA) is sufficient to improve fibrosis in NASH with a lower risk of drug discontinuation than 25 mg OCA. |
• | For primary biliary cholangitis (PBC), 5 mg OCA is an adequate add-on therapy (with ursodeoxycholic acid) to achieve biochemical remission. |
• | There was a significant decrease in alkaline phosphatase levels in primary sclerosing cholangitis (PSC) patients. |
Abstract |
Background and aims |
Currently, there is no pharmacotherapy for non-alcoholic steatohepatitis (NASH), a common liver disorder. In contrast, primary biliary cholangitis (PBC) is a chronic cholestatic liver disease for which ursodeoxycholic acid (UDCA) is the drug of choice. However, 50% of PBC patients may not respond to UDCA. Obeticholic acid (OCA) is emerging as a vital pharmacotherapy for these chronic disorders. We aimed to analyse the safety and efficacy of OCA.
Methods |
We performed an extensive search of electronic databases from 01/01/2000 to 31/03/2020. We included randomized controlled trials of OCA in patients with NASH, PBC, and primary sclerosing cholangitis (PSC). We assessed the histological improvement in NASH, reduction in alkaline phosphatase (≤1.67 ULN) in PBC, and the adverse effects of OCA.
Results |
Seven RCTs (n = 2834) were included. Of the total RCTs, there were three on both NASH and PBC and one on PSC. OCA improved NASH fibrosis [OR: 1.95 (1.47–2.59; p < 0.001)]. With the 10 mg OCA dose, the odds of improvement was 1.61 (1.03–2.51; p = 0.03), while with the 25 mg dose, it was 2.23 (1.55−3.18; p < 0.001). However, 25 mg OCA led to significant adverse events and discontinuation of the drug [2.8 (1.42–3.02); p < 0.001)] compared with 10 mg OCA [0.95 (0.6–1.5); p = 0.84] in NASH patients. In PBC patients, the response to 5 mg OCA was better than with the higher doses [5 mg: 7.66 (3.12–18.81; p < 0.001), 10 mg: 5.18 (2–13.41; p = 0.001), 25 mg: 2.36 (0.94–5.93; p = 0.06), 50 mg: 4.08 (1.05–15.78; p = 0.04)]. The risk of pruritus was lowest with 5 mg OCA.
Conclusions |
Lower doses of OCA are effective and safe in NASH and cholestatic liver disease. While 10 mg OCA is effective for NASH fibrosis regression, only 5 mg OCA is required for PBC.
Le texte complet de cet article est disponible en PDF.Abbreviations : ALP, OCA, FGF-19, FXR, NASH, OR, PBC, PSC, ULN
Keywords : Obeticholic acid, NASH, Cholestatic liver disease, PBC, PSC, Meta-analysis
Plan
☆ | The abstract was presented as a poster at TLMdX 2020. |
Vol 45 - N° 3
Article 101675- mai 2021 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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