Abstract
Marso S, Daniels G, Brown-Frandsen K, et al.
N Engl J Med. Epub ahead of print 13 June 2016. DOI: 10.1056/NEJMoa1603827.
Type 2 diabetes mellitus (T2DM) substantially increases risk of cardiovascular disease (CVD). However, whether glucose-lowering agents improve CV health is controversial, especially since rosiglitazone was reported in 2007 to increase rate of CV events despite powerful anti-hyperglycaemic action. New diabetes drugs are now required to undergo extensive testing to demonstrate they are at least safe to use. This study is the CV safety trial for liraglutide, a glucagon-like peptide-1 analogue used to reduce weight and improve glycaemia in T2DM.
In this trial, approximately 10,000 patients randomly received daily liraglutide or a placebo injection and were followed up for a median of 3.8 years. The study was designed to demonstrate non-inferiority, but the key result was a significant reduction in fatal/non-fatal CVD from 15 to 13% in liraglutide-treated patients. This equates to a number-needed to treat of 66 patients for three years to prevent one event. It should be noted that as patients were treated to glycaemic, blood pressure and lipid targets, there were differences in other diabetes and CV medications in the treatment groups, which could have independently influenced the outcome.
Nevertheless, this is an important study, as the results presented suggest liraglutide is one of the few diabetes drugs which actually improves CV outcomes.