Does Mounjaro Reduce the Risk of Heart Attack + Stroke with Type 2 Diabetes? The FDA Says Yes

If you live with type 2 diabetes (T2D), this is big news about heart health. Heart disease is the number one cause of death in people with diabetes, and Mounjaro just received FDA approval that could have a major impact on that.

On August 28, the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide), Eli Lilly’s dual GLP-1/GIP receptor agonist, to reduce the risk of major cardiovascular events—including death, non-fatal heart attack and non-fatal stroke—in adults with T2D. People who live with diabetes are twice as likely to have heart disease or stroke than people living without diabetes. 

Mounjaro is already FDA-approved to improve blood sugar in adults and children 10 years of age and older with T2D. This approval moves Mounjaro from a medication reserved for A1C and weight management to reducing cardiovascular risk too.

Why this FDA approval matters

This is a great thing. As many as 1 in 3 adults in the US with T2D have undetected cardiovascular disease. That’s a lot of people who may be living with undetected cardiovascular disease simply because they haven’t had a heart attack or stroke yet. 

What is the new FDA approval based on? 

The new approval is based on results from SURPASS-CVOT, a landmark cardiovascular outcomes trial.

• The trial followed more than 13,000 people across 30 countries for more than four and a half years. 
• Instead of comparing tirzepatide to a placebo, researchers compared tirzepatide directly to dulaglutide, a GLP-1 receptor agonist that already has established cardiovascular benefit. 
• Mounjaro met the trial’s criteria for non-inferiority, meaning it performed at least as well as dulaglutide at preventing major cardiovascular events. 
• Researchers saw an 8% lower rate of cardiovascular death, heart attack or stroke with tirzepatide compared with dulaglutide.

“For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro, the number one 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,” said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. “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.” 

Why does T2D care go beyond glucose management?

Research has proven over time that diabetes is about so much more than glucose. Blood pressure, cholesterol, kidney health, weight, activity level, mental health, diet, heart health, access to medications and quality of life all matter too. 

“Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event,” said David A. D’Alessio, M.D., study co-author and director of the Division of Endocrinology and Metabolism at Duke University School of Medicine. “While a large portion of type 2 diabetes care is focused on glucose control, mitigating cardiovascular risk is essential and can be overlooked. This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time.”  

Preventive heart maintenance is important for people who haven’t yet had a heart attack or stroke but still carry significant cardiovascular risk, as do all people living with diabetes. 

Mounjaro is now the first and only dual GLP-1/GIP receptor agonist with an FDA-approved indication to reduce the risk of cardiovascular death, heart attack or stroke in adults with T2D at high cardiovascular risk. 

Want to learn more about GLP-1s and diabetes? GLP-1s aren’t one-size-fits-all, and there’s a lot to learn as you go. Explore our GLP-1 Hub for more on how these medications work, what they treat and how to navigate them with your care team.