The Relationship Between Hypoglycemia and Cardiovascular Outcomes in LEADER

June 14, 2018. In the cardiovascular (CV) outcomes trial, Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER), liraglutide significantly lowered both the risk of CV events and hypoglycemia compared with placebo. Patients (N=9,340) had type 2 diabetes, were at high risk for CV disease, and were followed for 3.5 to 5.0 years. This post hoc study analyzed the relationship between severe hypoglycemia and time to first major adverse cardiovascular event (MACE), CV death, non-CV death, or all-cause death. A total of 114 and 153 liraglutide and placebo patients, respectively, experienced severe hypoglycemia (rate ratio 0.69; 95% confidence interval: 0.51-0.93). At baseline, these patients had higher incidence of kidney disease and heart failure, longer diabetes duration, and used insulin more frequently than patients without subsequent hypoglycemia. A combined analysis of liraglutide and placebo showed that MACE, CV death, and all-cause death were more likely to occur in patients with severe hypoglycemia. Risk was highest shortly after the hypoglycemic event. There was no significant difference in the impact of liraglutide on the risk of MACE between patients with and without severe hypoglycemia. Although causality was not established, this study demonstrates that patients with severe hypoglycemia are at increased risk for CV events and death. Read the abstract here.