NEW ORLEANS — New data from the LEADER trial demonstrate that liraglutide (Victoza®, Novo Nordisk) lowers the rate of a composite end point of first occurrence of death from cardiovascular (CV) causes, nonfatal myocardial infarction (MI), or nonfatal stroke in patients with type 2 diabetes when compared with placebo.
“As the study was designed to only demonstrate that the drug was safe, we were a little surprised at the higher bar of showing that the drug was effective at reducing the risk of heart attack, stroke, and death as well as evidence of kidney disease,” John B. Buse, MD, PhD, of the University of North Carolina School of Medicine, Chapel Hill, told Endocrinology Advisor.
Dr Buse and fellow researchers from the LEADER trial presented their findings at the American Diabetes Association (ADA) 76th Scientific Sessions.
Dr Buse explained that the primary aim of the double blind trial was to evaluate the CV safety of liraglutide, as part of the mandate of the Food and Drug Administration (FDA). In all, 9340 patients with type 2 diabetes and high CV risk were randomly assigned to either liraglutide (n=4668) or placebo (n=4672).
First occurrence of death from CV causes, nonfatal MI, or nonfatal stroke served as the primary composite outcome in the time-to-event analysis. Researchers hypothesized that liraglutide would be noninferior to placebo in the primary outcome, with a margin of 1.30 for the upper boundary of the 95% confidence interval (CI) of the hazard ratio (HR), according to study methodology.
Liraglutide Superior in Primary Outcome, Mortality
During follow-up (median, 3.8 years), fewer patients experienced the primary outcome in the liraglutide arm than in the placebo arm (13% vs 14.9%; HR=0.87; 95% CI, 0.78-0.97; noninferiority, P<.001; superiority, P=.01).1 The CV mortality rate was lower in the liraglutide group (4.7% vs 6%; HR=0.78; 95% CI, 0.66-0.93; P=.007), as was the all-cause mortality rate (8.2% vs 9.6%; HR=0.85; 95% CI, 0.74-0.97; P=.02).1
Numerical, but not statistically significant, differences in favor of liraglutide were reported in rates of nonfatal MI, nonfatal stroke, heart failure hospitalization, and incidence of pancreatitis.
During a press conference, Bernard Zinman, MD, study investigator with Mount Sinai Hospital, Toronto, also discussed the microvascular outcomes observed in the trial.
“There is a significant reduction of 22% in the development of the renal outcomes with liraglutide compared to placebo,” Dr Zinman said. “With respect to eye events, there is no significant difference [between groups].”
Furthermore, gastrointestinal events were the most frequent adverse events leading to the discontinuation of the study drug.
“The conversation in diabetes care is changing from ‘Let’s work to get your blood sugar controlled’ to ‘We can work to prevent heart attacks, strokes, and death,’” Dr Buse said. “That is a very different message that I hope will inspire doctors, patients, and payers to change their focus in diabetes care.”
This article originally appeared on Endocrinology Advisor