The type 2 diabetes treatment Victoza (liraglutide) has been approved by the Food and Drug Administration for a new indication – to reduce the risk of several adverse cardiovascular events, according to a press release from Novo Nordisk.
FDA approval was based on results from the LEADER (NCT01179048) trial, where people with type 2 diabetes who received liraglutide were 13% less likely to experience cardiovascular death, nonfatal heart attack, or nonfatal stroke then type 2 diabetes patients who received a placebo, with an absolute risk reduction of 1.9%. Notably, risk of cardiovascular death was reduced by 22% in the liraglutide group, compared with the control group, and all-cause death was reduced by 15%.
Victoza, an injectable human glucagon-like peptide-1 (GLP-1) analog, received FDA approval on Jan. 25, 2010 as a supplement to proper diet and exercise to improve glycemic control in adults with type 2 diabetes. The most common adverse events associated with Victoza are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.
“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. More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue,” Steve Marso, MD, medical director at the Cardiovascular Services HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in LEADER said in the press release.
Find the full press release on the Novo Nordisk website .