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Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has approved Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk. The decision was based on the SURPASS-CVOT trial, which showed tirzepatide was noninferior — but not superior — to dulaglutide in preventing cardiovascular death, nonfatal heart attack, or nonfatal stroke. The trial spanned 13,299 patients across 30 countries.
The FDA has expanded the label for Mounjaro (tirzepatide, Eli Lilly) to include reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who are at high cardiovascular risk. This adds a new cardiovascular indication to a drug already approved for glycemic control in adults and children aged 10 and older with type 2 diabetes.
The approval was grounded in data from SURPASS-CVOT, a randomized, double-blind, phase 3 cardiovascular outcomes trial. Tirzepatide demonstrated noninferiority to dulaglutide — an already-established GLP-1 receptor agonist — for time to first MACE, though superiority was not established. The drug's safety profile remained consistent with prior data, with gastrointestinal side effects being the most common, typically mild to moderate and occurring mainly during dose escalation.
By the Numbers:
Why it matters: This label expansion positions Mounjaro alongside other GLP-1-based therapies with cardiovascular benefits, giving clinicians another evidence-backed option for patients with type 2 diabetes and high cardiovascular risk — including those with cerebrovascular disease.
