Drug updated on 10/18/2024
| Dosage Form | Tablet (oral; 60 mg, 80 mg, 100 mg) |
| Drug Class | Thyroid hormone receptor-beta (THR-beta) agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
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Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Hepatic Fat Reduction: Resmetirom significantly reduced hepatic fat content across doses, with an SMD (Standardized Mean Difference) of -4.61 (95% CI (Confidence Interval) -6.77 to -2.44, P < 0.0001). Reductions from baseline were observed with Resmetirom 80 mg (MD (Mean Difference) -27.76%, 95% CI -32.84 to -22.69, P < .00001) and Resmetirom 100 mg (MD -36.01%, 95% CI -41.54 to -30.48, P < .00001). FibroScan attenuation parameter results showed reductions for Resmetirom 80 mg (MD -21.45 dBm, 95% CI -29.37 to -13.52, P < .00001) and Resmetirom 100 mg (MD -25.51 dBm, 95% CI -33.53 to -17.49, P < .00001).
- NASH (RCTs) Resolution: Resmetirom increased the likelihood of NASH resolution without worsening fibrosis (RR (Relative Risk) 2.51, 95% CI 1.74-3.64, P = 0.00001).
- Liver Fibrosis Improvement: Improvement in liver fibrosis was observed with Resmetirom (RR 2.31, 95% CI 1.20-4.44, P = 0.01).
- Resmetirom was generally well-tolerated, with no significant impact on thyroid function. Nausea and diarrhea were reported more frequently compared to placebo. No significant safety concerns or adverse effects were specified for particular population types or subgroups.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rezdiffra (resmetirom) Prescribing Information. | 2024 | Madrigal Pharmaceuticals Inc., West Conshohocken, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Safety and efficacy of resmetirom in the treatment of patients with non-alcoholic steatohepatitis and liver fibrosis: a systematic review and meta-analysis | 2024 | Annals of Medicine & Surgery |
| Role of Resmetirom, a Liver-Directed, Thyroid Hormone Receptor Beta-Selective Agonist, in Managing Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis | 2024 | Endocrine Practice |
| Pharmacotherapeutic Impact on Nonalcoholic Steatohepatitis Histology: A Systematic Review and Network Meta-analysis | 2022 | Journal of Clinical and Experimental Hepatology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Expert Panel Recommendations: Practical Clinical Applications for Initiating and Monitoring Resmetirom in Patients with MASH/NASH and Moderate to Noncirrhotic Advanced Fibrosis | 2024 | Clinical Gastroenterology and Hepatology |