Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes
N Engl J Med 2016;375:311–22 DOI: 10.1056/NEJMoa1603827
Glycaemic control is associated with reductions in microvascular complications, but the macrovascular benefits are less certain, and concern has been raised about the CV safety of antihyperglycemic therapies, leading regulatory authorities to mandate CV safety assessments of new treatments for diabetes.
LEADER was a randomised trial in 9340 patients with T2D and high CV risk. Data collected over 54 months showed the primary outcome occurred in significantly fewer liraglutide- than placebo-treated patients. Rates of nonfatal MI, nonfatal stroke, and hospitalisation for heart failure were also non-significantly lower with liraglutide than placebo. In addition, benefits were seen for prespecified microvascular outcomes. The authors concluded that – among T2D patients at high risk for CV events while they were taking standard therapy – those in the liraglutide group had lower rates of CV events and death from any cause than did those in the placebo group.