Patients with type 2 diabetes at high risk of cardiovascular events had lower rates of nonfatal myocardial infarction (MI), nonfatal stroke and death from any cause when taking liraglutide, compared to those taking placebo, according to results of the LEADER Trial presented June 13 at the American Diabetes Association’s 76th Scientific Sessions in New Orleans and simultaneously published in the New England Journal of Medicine.

The trial, led by Steven P. Marso, MD, FACC, looked at 9,340 patients with type 2 diabetes who were randomly assigned to receive liraglutide or placebo. The median follow-up time was 3.8 years. Results showed that the primary outcome – the first occurrence of death from cardiovascular-related causes, nonfatal MI or nonfatal stroke – occurred in far fewer patients in the liraglutide group (13 percent) than in the placebo group (14.9 percent).

Further, fewer patients (4.7 percent) died from cardiovascular causes in the liraglutide group, compared to the placebo group (6.0 percent). Additionally, the rate of death from any cause was lower in those assigned to liraglutide (8.2 percent) compared to placebo (9.6 percent). However, the rates of MI, nonfatal stroke and hospitalization for heart failure were not significantly lower with liraglutide.

Moving forward, the researchers note that some limitations of the trial include a follow-up period of only 3.5 to five years and explain that additional data beyond that time period are needed. They caution that the trial recruited participants at high risk for cardiovascular disease, so observed benefits and risks may not apply to lower-risk patients. 

Keywords: Diabetes Mellitus, Type 2, Heart Failure, Hospitalization, Myocardial Infarction, Risk Assessment, Stroke, Metabolic Syndrome

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