Efficacy and safety of obeticholic acid in liver disease—A systematic review and meta-analysis - 14/05/21
, Harsh Vardhan Tevethia a, 1, Juan Pablo Arab b, Roberto Candia b, Madhumita Premkumar c, Pramod Kumar a, Mithun Sharma a, D. Nageshwar Reddy a, Nagaraja Rao Padaki aBenvenuto su EM|consulte, il riferimento dei professionisti della salute.
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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.
Il testo completo di questo articolo è disponibile in PDF.Abbreviations : ALP, OCA, FGF-19, FXR, NASH, OR, PBC, PSC, ULN
Keywords : Obeticholic acid, NASH, Cholestatic liver disease, PBC, PSC, Meta-analysis
Mappa
| ☆ | The abstract was presented as a poster at TLMdX 2020. |
Vol 45 - N° 3
Articolo 101675- Maggio 2021 Ritorno al numero
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