Liraglutide gets new cardiovascular indication

The FDA approved a new indication for liraglutide to reduce the risk of myocardial infarction, stroke, and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.


The FDA recently approved a new indication for liraglutide (Victoza) to reduce the risk of myocardial infarction, stroke, and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, the manufacturer announced on Aug. 25.

The approval follows results from the industry-funded Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial, published last year by the New England Journal of Medicine and summarized in the July 2016 ACP Diabetes Monthly.

Researchers found that the type 2 diabetes drug significantly reduced the risk of adverse cardiovascular events compared to placebo in 9,340 patients over a median of 3.8 years of follow-up. The rate of a composite endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke was 13% lower in participants who received a daily liraglutide injection (1.8 mg) than in those who received placebo.