DEVOTE: Temporal Relationships Between Severe Hypoglycemia, Cardiovascular Outcomes, and Mortality

September 15, 2017. This secondary analysis of the double-blind Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events(DEVOTE) evaluated the association between severe hypoglycemia (SH) and cardiovascular (CV) outcomes/mortality in patients randomly assigned to once-daily treatment with either insulin degludec or insulin glargine U100. Investigators found a non-significant difference in the risk of major adverse cardiovascular events between patients who did and did not experience SH during the DEVOTE trial (HR 1.38, 95% CI 0.96, 1.96; P=0.08). However, patients who experienced SH did have a significantly higher rate of all-cause mortality vs patients with no SH (HR 2.51, 95% CI 1.79, 3.50; P<0.001). Additionally, all-cause mortality risk was elevated at 15, 30, 60, 90, 180 and 365 days following SH events. This relationship between SH and all-cause mortality persisted after adjustment for patient age, sex, A1C, body mass index, diabetes duration, insulin regimen, hepatic impairment, renal status, and CV risk group. Investigators concluded that there is a relationship between SH and all-cause mortality, including an elevated risk of death in the short term following an SH event. Follow this link to read the full article.