Victoza Approved to Reduce Risk of MACE

Approval was based on data from the randomized, double-blind, placebo-controlled LEADER trial
Approval was based on data from the randomized, double-blind, placebo-controlled LEADER trial

Victoza (liraglutide; Novo Nordisk) has been approved to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke, and CV death in adults with type 2 diabetes and established CV disease.

The Food and Drug Administration (FDA) approval was based on data from the randomized, double-blind, placebo-controlled LEADER trial (n=9,340) that evaluated long-term effects of Victoza vs. placebo in patients with type 2 diabetes with high risk of major cardiovascular events (MACE). The primary endpoint was the first occurrence of a composite CV outcome comprised of CV death, non-fatal heart attack or non-fatal stroke.

The study showed Victoza significantly lowered the risk of the 3-component endpoint by 13% vs. placebo (P=0.01) with an absolute risk reduction (ARR) of 1.9%. Specifically, treatment with Victoza demonstrated a 22% (ARR 1.3%) reduction in CV death and a 15% (ARR 1.4%) reduction in all-cause death.

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"Today's news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events," said Steve Marso, MD, Medical Director, Cardiovascular Services HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in LEADER. "More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue."

Victoza, a glucagon-like peptide-1 (GLP-1) receptor agonist, is already approved as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes. It is available as a 6mg/mL strength subcutaneous injection in multi-dose pre-filled pens. 

For more information call (800) 727-6500 or visit Victoza.com.