Findings of the Liraglutide Effect and Action in Evaluation of Cardiovascular Outcome Results (LEADER) cardiovascular outcomes trial showed that patients with type 2 diabetes who experienced an extreme hypoglycemic event had an elevated risk for a cardiovascular event or a cardiovascular-related death, according to a study published in Diabetes Care.

In the LEADER study, patients were randomly assigned into an experiment arm that received liraglutide (n=4668) or into a control arm that received a placebo medication (n=4672) and monitored for the next 3.5 to 5 years for hypoglycemic and major adverse cardiovascular events

Hypoglycemic events were self-reported and severe hypoglycemia required another person’s aid in a resuscitative action. The liraglutide arm had a major adverse cardiovascular event occur in 13% of the patients, and the placebo arm had an occurrence in 15% of patients. The liraglutide arm showed significantly fewer hypoglycemic events than the placebo arm. Overall, patients who had a severe hypoglycemic event had a significant increase in the chance of a major adverse cardiovascular event, cardiovascular death, and all-cause death. The data also show that these cardiovascular events occur a short time after the severe hypoglycemic event.

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These results point to a clinical need to monitor patients closely after a severe hypoglycemic event for symptoms of a cardiovascular event. The researchers noted, “the cardioprotective effects of liraglutide appearing largely independent of reductions in hypoglycemia, minimize[ed] the risk of hypoglycemia.”

This study was supported by Novo Nordisk A/S. Please refer to reference for a complete list of authors’ disclosures.


Zinman B, Marso SP, Christiansen E, Calanna S, Rasmussen S, Buse JB; for the LEADER Publication Committee on behalf of the LEADER Trial Investigators. Hypoglycemia, cardiovascular outcomes, and death: The LEADER experience [published online June 14, 2018]. Diabetes Care. doi: 10.2337/dc17-2677