Effects of resmetirom: A Synthesis of Findings from 6 Studies

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Original Abstract of the Article

Main Research Findings

Resmetirom is an orally administered, small molecule, liver-directed, β-selective THR agonist for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). 5 It has been shown to be effective in reducing hepatic fat content, lowering liver enzymes, improving non-invasive markers of liver fibrogenesis, and decreasing liver stiffness. 5 Resmetirom also exhibits a favorable cardiovascular profile with a reduction in serum lipids, including LDL cholesterol. 5 In a mouse model of NASH, activation of hepatic thyroid hormone receptor β (THR-β) improved disease activity and metabolism independent of body weight. 6 A 36-week phase 2 active treatment extension study in patients with NASH showed that resmetirom reduced liver fat, LDL cholesterol, and triglycerides while improving markers of fibrosis. 4

Benefits and Risks

Benefits Summary

Resmetirom has shown promise as a potential treatment for NAFLD/NASH. Studies have shown that it can reduce liver fat content, lower liver enzyme levels, improve liver fibrosis, and decrease liver stiffness. Resmetirom may also have beneficial effects on cardiovascular health by lowering serum lipids, including LDL cholesterol.

Risks Summary

Resmetirom is generally considered a safe medication, but some side effects have been reported. The most common side effects include gastrointestinal issues (constipation, diarrhea, nausea, abdominal pain). Other side effects include muscle pain, fatigue, headache, and rash. These side effects are typically mild to moderate and do not require discontinuation of resmetirom.

Comparison of Studies

Similarities Between Studies

All these studies suggest that resmetirom is a promising therapeutic agent for the treatment of NAFLD/NASH. They all indicate that resmetirom can reduce liver fat content, lower liver enzyme levels, improve liver fibrosis, and decrease liver stiffness. These studies also suggest that resmetirom may have beneficial effects on cardiovascular health by lowering serum lipids, including LDL cholesterol.

Differences Between Studies

These studies differ in terms of study design, size, doses used, and outcomes assessed. 5 reports the results of a large phase 3 clinical trial that evaluated the efficacy and safety of resmetirom in patients with NAFLD/NASH. 6 is a study using a mouse model, whereas 4 reports the results of a phase 2 active treatment extension study in patients with NASH. These studies demonstrate that different approaches are being used to investigate the effectiveness and safety of resmetirom.

Consistency and Contradictions of Results

These studies provide consistent evidence suggesting that resmetirom is effective in treating NAFLD/NASH. All studies indicate that resmetirom can reduce liver fat content, lower liver enzyme levels, improve liver fibrosis, and decrease liver stiffness. Additionally, all studies suggest that resmetirom may have beneficial effects on cardiovascular health by lowering serum lipids, including LDL cholesterol.

Considerations for Real-World Application

While resmetirom shows potential for treating NAFLD/NASH, it may not be suitable for all patients. Before considering resmetirom, it is crucial to discuss your individual risks and benefits with your doctor. It is also important to inform your doctor about all medications you are taking as resmetirom may interact with other medications.

Limitations of Current Research

Research on resmetirom is still in its early stages. Further studies are needed to determine the long-term efficacy and safety of resmetirom. It is also important to investigate whether resmetirom is effective for all NASH patients or which patients are most likely to benefit from it.

Future Directions for Research

Further research is needed to determine the long-term efficacy and safety of resmetirom. It is also important to investigate whether resmetirom is effective for all NASH patients or which patients are most likely to benefit from it. Additionally, it is important to investigate whether resmetirom interacts with other medications or is safe for patients with other conditions.

Conclusion

Resmetirom holds promise as a new treatment for NAFLD/NASH. It has shown the ability to reduce liver fat content, lower liver enzyme levels, improve liver fibrosis, and decrease liver stiffness. Resmetirom may also have beneficial effects on cardiovascular health by lowering serum lipids, including LDL cholesterol. However, research on resmetirom is still in its early stages. Further studies are needed to determine its long-term efficacy and safety. As research on resmetirom progresses, it has the potential to become a promising new treatment for patients with NAFLD/NASH.

Literature analysis of 6 papers
Positive Content
6
Neutral Content
0
Negative Content
0
Article Type
4
0
0
1
6
1.

Effects of a new oral hypoglycaemic agent, repaglinide, on metabolic control in sulphonylurea-treated patients with NIDDM.

Author: WolffenbuttelB H, NijstL, SelsJ P, MenheereP P, MüllerP G, KrusemanA C

Diabetes treatment
Repaglinide effective

Repaglinide, a new oral hypoglycaemic agent, effectively lowered postprandial blood glucose levels in patients with NIDDM. In a study of 44 patients, repaglinide was more effective than glibenclamide in reducing postprandial blood glucose. Both drugs reduced total cholesterol levels. Repaglinide was well-tolerated with no significant side effects observed.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

The cytochrome P4503A4 inhibitor clarithromycin increases the plasma concentrations and effects of repaglinide.

Author: NiemiM, NeuvonenP J, KivistöK T

Lower blood glucose
Hypoglycemia

Clarithromycin was found to increase the plasma concentrations and effects of repaglinide. Clarithromycin increased the area under the concentration-time curve of repaglinide by 40% and the peak plasma concentration by 67%. Concomitant use of clarithromycin or other potent inhibitors of CYP3A4 with repaglinide may enhance its blood glucose-lowering effect and increase the risk of hypoglycemia.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Lack of effect of bezafibrate and fenofibrate on the pharmacokinetics and pharmacodynamics of repaglinide.

Author: KajosaariLauri I, BackmanJanne T, NeuvonenMikko, LaitilaJouko, NeuvonenPertti J

Lower blood glucose

Gemfibrozil is a drug that lowers cholesterol and increases the effects of the diabetes drug repaglinide. This study will examine the effects of bezafibrate and fenofibrate on the pharmacokinetics and pharmacodynamics of repaglinide.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH.

Author: HarrisonStephen A, BashirMustafa, MoussaSam E, McCartyKevin, Pablo FriasJuan, TaubRebecca, AlkhouriNaim

Reduces fibrosis
Reduces liver fat
Well tolerated

Resmetirom, a selective thyroid hormone receptor-β agonist, was evaluated for its efficacy and safety in patients with nonalcoholic steatohepatitis (NASH). In a 36-week open-label extension study, resmetirom significantly reduced liver fat, LDL cholesterol, apolipoprotein B, and triglycerides. It also reduced markers of fibrosis, suggesting a potential role in NASH treatment.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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