The US Food and Drug Administration approved an expanded indication for tirzepatide (Mounjaro) to reduce the risk of major cardiovascular events in adults with type 2 diabetes at high risk for these events, according to a press release from Eli Lilly and Company. The expanded indication includes reducing the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Tirzepatide is also approved as an adjunct to diet and exercise to improve glycemic control in patients aged 10 years and older with type 2 diabetes.
The approval was based on results from SURPASS-CVOT, a phase 3, randomized, double-blind, parallel-group trial that compared tirzepatide with dulaglutide, a glucagon-like peptide-1 receptor agonist with established cardiovascular benefit. The trial included 13,299 participants with type 2 diabetes and established atherosclerotic cardiovascular disease across 640 sites in 30 countries.
Participants were randomly assigned 1:1 to receive tirzepatide 15 mg or the maximum tolerated dose or dulaglutide 1.5 mg subcutaneously once weekly. The primary objective was to determine whether tirzepatide was noninferior to dulaglutide for major adverse cardiovascular events, defined as a composite of cardiovascular death, myocardial infarction, or stroke.
Over a median follow-up of approximately 4 years, tirzepatide was noninferior to dulaglutide for the primary cardiovascular outcome. The rate of cardiovascular death, myocardial infarction, or stroke was 8% lower with tirzepatide than with dulaglutide. Tirzepatide did not demonstrate superiority over dulaglutide.
“Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event,” said study coauthor David A. D’Alessio, MD, 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.”
Safety and tolerability findings with tirzepatide were generally consistent with its established safety profile. Gastrointestinal adverse events were the most commonly reported events in SURPASS-CVOT and were generally mild to moderate in severity, occurring primarily during dose escalation.
Tirzepatide is administered subcutaneously once weekly. Warnings include thyroid tumors, including thyroid cancer. Serious adverse effects may include pancreatitis, hypoglycemia, serious allergic reactions, dehydration leading to kidney problems, severe stomach problems, vision changes, gallbladder problems, and food or liquid entering the lungs during procedures involving anesthesia or deep sedation.
Source: Eli Lilly and Company