What is the efficacy of Mounjaro (tirzepatide)?

From the Guidelines

Mounjaro (tirzepatide) is a highly effective medication for type 2 diabetes management, with a dual mechanism of action that activates both GLP-1 and GIP receptors, leading to significant reductions in HbA1c levels and weight loss. According to the most recent evidence from 1, Mounjaro has been classified as a Dual GIP and GLP-1 RA, with very high glucose-lowering efficacy and a high potential for weight loss. The medication is typically started at 2.5mg weekly by subcutaneous injection, with gradual dose increases every 4 weeks up to a maximum of 15mg weekly, as indicated in the dosing considerations for Dual GIP and GLP-1 RA in 1. Some key points to consider when prescribing Mounjaro include:

• Its potential impact on drug absorption, particularly for orally administered medications, as noted in 1
• The need for slower dose titration in patients experiencing gastrointestinal side effects, as recommended in 1
• The importance of monitoring for potential adverse effects, such as pancreatitis, thyroid C-cell tumors, and biliary disease, as mentioned in 1
• The potential benefits of Mounjaro on cardiovascular outcomes, as suggested by the network meta-analysis in 1, which found that GLP1 agonists, including dual GIP and GLP-1 agonists like tirzepatide, may reduce all-cause mortality and MACE compared to usual care. However, it is essential to weigh these benefits against the potential risks and consider individual patient factors, such as kidney function and history of pancreatitis, when making treatment decisions. Overall, Mounjaro is a valuable option for patients with type 2 diabetes who have not responded adequately to other treatments, due to its high efficacy and potential benefits on weight loss and cardiovascular outcomes.

From the FDA Drug Label

The effectiveness of MOUNJARO as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus was established in five trials In these trials, MOUNJARO was studied as monotherapy (SURPASS-1); as an add-on to metformin, sulfonylureas, and/or sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors) (SURPASS-2, -3, and -4); and in combination with basal insulin with or without metformin (SURPASS-5) In these trials, MOUNJARO (5 mg, 10 mg, and 15 mg given subcutaneously once weekly) was compared with placebo, semaglutide 1 mg, insulin degludec, and/or insulin glargine. In adult patients with type 2 diabetes mellitus, treatment with MOUNJARO produced a statistically significant reduction from baseline in HbA1c compared to placebo

• Efficacy of Mounjaro: Mounjaro has been shown to be effective in improving glycemic control in adults with type 2 diabetes mellitus.
• Key findings:
  • Statistically significant reduction in HbA1c compared to placebo
  • Effective as monotherapy or in combination with other medications
  • No significant impact of age, gender, race, ethnicity, region, or baseline characteristics on efficacy 2
  • Similar findings were reported in another study 2

From the Research

Efficacy of Mounjaro

• Mounjaro (tirzepatide) is a dual incretin agonist of the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, approved for use as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM) 3.
• In phase III SURPASS trials, once-weekly subcutaneous tirzepatide was superior to the GLP-1 receptor agonists (RAs) dulaglutide and semaglutide, as well as basal and prandial insulin, for glycaemic control and weight loss in adults with inadequately controlled T2DM 3, 4.
• Tirzepatide was associated with a low risk of clinically significant or severe hypoglycaemia and no increased risk of major adverse cardiovascular events 3, 5.
• The most common adverse events were gastrointestinal events, including nausea, diarrhoea, decreased appetite, and vomiting 3, 4, 6.

Glycaemic Control and Weight Loss

• Tirzepatide reduced HbA1c levels by 1.24 to 2.58% and body weight by 5.4-11.7 kg in clinical trials 3, 5.
• A sizable proportion of patients (23.0 to 62.4%) reached an HbA1c of < 5.7%, and 20.7 to 68.4% lost more than 10% of their baseline body weight 5.
• Tirzepatide was significantly more effective in reducing HbA1c and body weight than the selective GLP-1 RA semaglutide and titrated basal insulin 5, 6.

Safety Profile

• Tirzepatide was generally well tolerated, with a safety profile consistent with that of GLP-1 RAs 3, 6.
• The most frequent adverse events were mild to moderate and transient gastrointestinal events, including nausea, diarrhoea, and vomiting 3, 4, 6.
• No clinically significant or severe hypoglycaemia were reported with tirzepatide 6.