Findings from a post-hoc analysis of the LEADER cardiovascular (CV) outcomes trial showed that treatment with Victoza (liraglutide) resulted in similar reductions in the risk of major cardiovascular events in people with type 2 diabetes at high CV risk, regardless of whether or not they experienced an episode of severe hypoglycaemia during the trial. Results were presented at the American Diabetes Association 77th Scientific Sessions.
For the overall LEADER population, regardless of treatment group, people who experienced a severe hypoglycaemic episode were at a significantly greater risk of major cardiovascular adverse events (CV death, non-fatal heart attack or non-fatal stroke), CV-death or non-CV death. The risk of a CV event was far greater within 60 days of a severe hypoglycaemic episode occuring. At the same time, people treated with Victoza experienced significantly fewer episodes of severe hypoglycaemia when compared to placebo, both in addition to standard of care.
"It appears that patients who experience severe hypoglycaemia are at an increased risk of cardiovascular events," said Steven P. Marso, medical director for Cardiovascular Services at HCA Midwest Health Heart and Vascular Institute, Kansas City, US and co-chair of the LEADER Steering Committee. "While the lower incidence of severe hypoglycaemia with Victoza could contribute to the observed beneficial effect on major cardiovascular events in LEADER, this new analysis indicates that the results cannot be explained by these differences in hypoglycaemia."