Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen) |
Drug Class | Glucose-dependent insulinotropic polypeptides (GIP) and glucagon-like peptide 1 (GLP-1) receptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Summary
- Mounjaro (tirzepatide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- HbA1c Reduction: Tirzepatide 15 mg showed the most significant HbA1c reduction compared to subcutaneous semaglutide 1.0 mg and oral semaglutide 14 mg. It also demonstrated superior HbA1c reduction compared to basal insulin, GLP-1RAs, and placebo, with higher doses (10 mg and 15 mg) being more effective.
- Body Weight Reduction: Tirzepatide 15 mg was most effective in reducing body weight compared to semaglutide and other comparators. Higher doses (10 mg and 15 mg) showed more significant weight reduction compared to lower doses and other agents.
- Fasting Plasma Glucose: Tirzepatide effectively lowered fasting plasma glucose levels compared to basal insulin and GLP-1RAs.
- HbA1c Target Achievement: A higher proportion of patients achieved HbA1c targets with tirzepatide compared to other glucose-lowering agents.
- Gastrointestinal Adverse Events: Higher incidence of nausea, vomiting, diarrhea, decreased appetite, dyspepsia, and constipation was observed with tirzepatide, with more frequent and severe events at higher doses (10 mg and 15 mg) compared to placebo and other glucose-lowering agents.
- Hypoglycemia and Cardiovascular Safety: Tirzepatide did not significantly increase the incidence of hypoglycemia compared to placebo, basal insulin, or GLP-1RAs, and there was no significant increase in serious cardiovascular events or mortality.
- Discontinuation and Injection-Site Reactions: Higher doses (10 mg and 15 mg) of tirzepatide were associated with higher discontinuation rates due to adverse events and more frequent injection-site reactions. Additionally, an increased risk of gallbladder or biliary diseases was noted, though not for pancreatitis.
- Tirzepatide demonstrated significant effectiveness in reducing HbA1c levels and inducing weight loss among Japanese patients with type 2 diabetes, with consistent efficacy observed across the general type 2 diabetes population when compared to various glucose-lowering agents; however, higher doses required specific attention due to increased rates of gastrointestinal adverse events and discontinuation.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Mounjaro (tirzepatide) Prescribing Information. | 2023 | Lilly USA LLC, Indianapolis, IN |