The US Food and Drug Administration has expanded the approved use of Mounjaro, or tirzepatide, to include reducing the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk.
What changed
The updated prescribing information now includes reduction of cardiovascular death, non-fatal heart attack and non-fatal stroke. Mounjaro was already approved to improve blood-sugar control alongside diet and exercise in adults and eligible paediatric patients with type 2 diabetes.
Eli Lilly announced the new indication on August 28. The company’s current US prescribing information reflects the cardiovascular indication and remains the controlling source for clinicians.
Evidence behind the decision
Lilly previously reported results from a cardiovascular-outcomes trial comparing Mounjaro with Trulicity. The primary composite outcome was 8% lower with Mounjaro, and the study met its pre-specified requirement to show that Mounjaro was not worse than the comparator. The confidence interval means the result should not be interpreted as proof of an 8% reduction for every patient.
The trial also reported lower all-cause mortality, but treatment decisions must consider the complete study, label warnings, contraindications and an individual patient’s health.
What patients should know
The approval does not make tirzepatide suitable for everyone. It is a prescription medicine and can cause gastrointestinal side effects and other serious adverse reactions described in the label. Patients should not start, stop or change treatment based on a news report.
People already using Mounjaro should discuss the updated indication with their healthcare professional, particularly if they have cardiovascular disease, take other glucose-lowering medicines or experience side effects.
