Summary

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• This summary is based on the review of five systematic review(s)/meta-analysis(es). ^[1-5]
• Effectiveness in NASH (non-alcoholic steatohepatitis) Treatment: Obeticholic acid (OCA) significantly improved fibrosis by ≥1 stage without worsening NASH, with dose-dependent effectiveness noted. At 10 mg, the odds ratio (OR) was 1.61 (95% CI (confidence interval): 1.03-2.51, p = 0.03), and at 25 mg, the OR was 2.23 (95% CI: 1.55-3.18, p < 0.001), showing increased efficacy at higher doses.
• Effectiveness in PBC (Primary Biliary Cholangitis) Treatment: In primary biliary cholangitis (PBC), lower doses of OCA demonstrated greater effectiveness, with an OR of 7.66 (95% CI: 3.12-18.81, p < 0.001) at 5 mg and an OR of 5.18 (95% CI: 2-13.41, p = 0.001) at 10 mg. OCA treatment showed a 65% overall treatment response rate (95% CI: 56%-74%) in PBC patients, alongside significant reductions in total cholesterol and HDL levels.
• Combination Therapy with UDCA in PBC: Combining OCA with ursodeoxycholic acid (UDCA) was more effective than UDCA monotherapy, yielding superior clinical outcomes in patients with PBC who had an inadequate response to UDCA alone.
• Pruritis and Gastrointestinal Effects: OCA increased the risk of pruritis by 75% (RR: 1.75, 95% CI: 1.43-2.15, p < 0.01), with higher risk at 25 mg doses (RR: 3.07, 95% CI: 1.74-5.41). It also increased constipation (RR: 1.88, 95% CI: 1.45-2.43, p < 0.01) and reduced the incidence of diarrhea (RR: 0.62, 95% CI: 0.50-0.77, p < 0.01).
• Hyperlipidemia and Cardiovascular Events: OCA raised the risk of hyperlipidemia (RR: 2.69, 95% CI: 1.85-3.92, p < 0.01), though it did not significantly increase cardiovascular events. Higher doses (25 mg) resulted in more adverse events and discontinuations compared to the 10 mg dose.
• There is no population type or subgroup information available in the reviewed studies.