The U.S. Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide) to help reduce the risk of major heart-related events in people with type 2 diabetes who are at high risk of cardiovascular disease.
The approval follows results from the large SURPASS-CVOT trial, which compared Mounjaro with Trulicity (dulaglutide). More than 13,000 people from 30 countries took part and were followed for about four years.
Major cardiovascular events—including non-fatal heart attacks, non-fatal strokes and cardiovascular deaths—occurred in 12.2% of people taking Mounjaro, compared with 13.1% of those taking Trulicity. Overall, Mounjaro was linked to an 8% lower relative risk of these events.
Doctors say Mounjaro may benefit heart health through several effects, including better blood sugar control, weight loss, lower blood pressure, improved cholesterol levels and reduced inflammation.
The new approval gives doctors another treatment option for people with type 2 diabetes who face a high risk of heart disease. It also formally recognizes cardiovascular risk reduction as an additional benefit of Mounjaro, alongside its effects on blood sugar and weight.
However, experts caution that the study mainly involved people with type 2 diabetes and established cardiovascular disease. The findings may not apply in the same way to people with diabetes who have a lower heart-disease risk.
Researchers also say more studies are needed to determine whether Mounjaro’s heart benefits come directly from the drug or are largely related to improvements in weight, blood sugar and other cardiovascular risk factors.
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