FDA approves Mounjaro to reduce heart attack, stroke and cardiovascular death risk in adults with type 2 diabetes

Eli Lilly/Tirzepatide (Mounjaro / Zepbound)

The FDA approved Mounjaro (tirzepatide) to lower the risk of cardiovascular death, heart attack and stroke in adults with type 2 diabetes at high risk of those events. The evidence is SURPASS-CVOT, the first trial to pit two incretin drugs head to head. Mounjaro is now the only drug acting on both GIP and GLP-1 with a proven heart-protection label.

• 13,299 people with type 2 diabetes and established artery disease, at 640 sites in 30 countries; median follow-up about 4 years.
• Comparator was Trulicity (dulaglutide), a GLP-1 drug already proven to cut heart risk, not a placebo.
• Mounjaro had 8% fewer major cardiac events (hazard ratio 0.92, 95.3% CI 0.83–1.01): non-inferior, but not statistically superior to Trulicity.
• Because Trulicity itself lowers risk, the result implies a benefit over no treatment, without a direct placebo number.