Tirzepatide, a dual GIP and GLP-1 receptor agonist with known benefits for glycaemic control and weight management, has demonstrated cardiovascular noninferiority compared to dulaglutide in patients with type 2 diabetes and established cardiovascular disease, according to the SURPASS-CVOT trial.¹
SURPASS-CVOT (NCT04255433) was a double-blind, active-comparator, noninferiority trial that randomised patients with type 2 diabetes and atherosclerotic cardiovascular disease in a 1:1 ratio. The study compared weekly subcutaneous injections of tirzepatide (up to 15 mg) with dulaglutide (1.5 mg), a GLP-1 receptor agonist with proven cardiovascular benefits.
The trial enrolled 13,165 patients (6,586 in the tirzepatide group and 6,579 in the dulaglutide group). The mean age of participants was 64.1 years, the mean body-mass index was 32.6, and the mean glycated haemoglobin level was 8.4%.
The primary endpoint was a composite of death from cardiovascular causes, myocardial infarction, or stroke (MACE). Noninferiority was established if the upper limit of the 95.3% confidence interval for the hazard ratio was below 1.05.
A primary MACE event occurred in 801 patients (12.2%) in the tirzepatide group compared to 862 patients (13.1%) in the dulaglutide group.
The results confirmed noninferiority for tirzepatide versus dulaglutide (hazard ratio, 0.92; 95.3% confidence interval, 0.83 to 1.01; P=0.003 for noninferiority). The trial did not meet the prespecified criteria for superiority (P=0.09).
The incidence of adverse events was generally similar between the two groups, although a higher rate of gastrointestinal adverse events was observed in the tirzepatide group.
Among patients with type 2 diabetes and established atherosclerotic cardiovascular disease, treatment with tirzepatide was noninferior to dulaglutide with respect to the primary composite cardiovascular endpoint. These findings establish the cardiovascular safety of tirzepatide in this high-risk patient population when compared against an active agent with known cardiovascular benefits.
This study was funded by Eli Lilly.
References
1. Nicholls SJ, Pavo I, Bhatt DL, et al. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. N Engl J Med 2025;393:2409-2420. https://doi.org/10.1056/NEJMoa2505928
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