FDA approves tirzepatide for reducing cardiovascular risk in adults with type 2 diabetes
The U.S. Food and Drug Administration (FDA) has approved tirzepatide to reduce the risk of cardiovascular events—including death, nonfatal myocardial infarction and nonfatal stroke—in adult patients with type 2 diabetes.
Tirzepatide is a popular dual GIP and GLP-1 hormone receptor agonist sold by Eli Lilly and Company under the brand names Mounjaro and Zepbound. It has traditionally been used to treat blood sugar control under the brand name Mounjaro and used for chronic weight management and sleep apnea under the brand name Zepbound. This latest approval is officially for Mounjaro.
More GLP-1 receptor agonists are being approved to combat cardiovascular events in patients with type 2 diabetes. With this announcement, however, tirzepatide is the first dual GIP and GLP-1 receptor agonist to receive such an approval.
FDA approval follows head-to-head data
This approval was largely based on data from SURPASS-CVOT, a head-to-head cardiovascular outcomes trial comparing tirzepatide with dulaglutide in adults with type 2 diabetes and established atherosclerotic cardiovascular disease. That trial confirmed that tirzepatide was noninferior to dulaglutide, a GLP-1 receptor agonist known for its cardiovascular benefits. In fact, tirzepatide outperforms dulaglutide in terms of major adverse cardiovascular events. While the initial SURPASS-CVOT results were published in The New England Journal of Medicine in 2025, an additional look at those data was published in JAMA Cardiology in March 2026.[1, 2]
“For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro—the No. 1 most prescribed branded type 2 diabetes medicine for adults in the U.S.—now gives them a proven way to lower that risk, adding to the strong foundation it has already built in A1C and weight," Kenneth Custer, PhD, executive vice president and president of Lilly Cardiometabolic Health, said in a statement. “We set a higher bar by testing Mounjaro against a GLP-1 medicine with proven cardiovascular benefit, one that reflects the depth of evidence Lilly continues to build in this field.”
“While a large portion of type 2 diabetes care is focused on glucose control, mitigating cardiovascular risk is essential and can be overlooked,” added SURPASS-CVOT coauthor David A. D'Alessio, MD director of the division of endocrinology and metabolism at Duke University School of Medicine. “This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time.”
It’s no surprise to the cardiology community that tirzepatide can have an impact on cardiovascular health. Over the years, several studies have linked the diabetes drug to various cardiovascular benefits. Click here, here, here, here, here or here for just a handful of examples.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.