Liraglutide (Victoza, Novo Nordisk) has secured FDA approval for a new indication 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 FDA's decision is based on the results of the landmark LEADER trial, which demonstrated that liraglutide significantly reduced the risk of a three-component endpoint consisting of CV death, nonfatal heart attack, or nonfatal stroke by 13% versus placebo (P = 0.01), with an absolute risk reduction (ARR) of 1.9%.
CV disease is the leading cause of morbidity and mortality in patients with diabetes. Studies have shown that adults with type-2 diabetes are up to four times more likely to develop CV disease. Liraglutide demonstrated a life-saving benefit that included a 22% reduction in CV death and a 15% reduction in all-cause death (ARR, 1.3% and 1.4%, respectively).
LEADER was a multicenter, international, randomized, double-blind, placebo-controlled trial investigating the long-term (3.5–5 years) effects of liraglutide compared to placebo, both in addition to standard of care, in people with type-2 diabetes at high risk of major adverse CV events. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments, and CV medications.
The LEADER trial was initiated in September 2010 and randomized 9,340 people with type-2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite CV outcome comprised of CV death, nonfatal myocardial infarction, or nonfatal stroke.
Liraglutide is the only type-2 diabetes treatment with an approved U.S. indication for reducing the risk of three major adverse CV events.
The 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 of Cardiovascular Services at HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in LEADER.
Liraglutide is a human glucagon-like peptide-1 analog that was approved by the FDA in January 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.
Source: Novo Nordisk, Inc.; August 25, 2017.