Patients with type 2 diabetes who experience an episode of severe hypoglycemia are at increased risk for all-cause mortality, according to findings from a double-blind clinical trial published in Diabetologia.
Patient data was examined from the Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE, ClinicalTrials.Gov Identifier: NCT01959529).
Major adverse cardiac events (MACE) and mortality outcomes in patients who had developed a severe hypoglycemic episode during the DEVOTE trial were then analyzed.
There was a higher risk for MACE in participants who had a severe hypoglycemic episode during the trial period compared with participants without such an experience, although this trend was not considered statistically significant (hazard ratio [HR] 1.38, 95% CI 0.96, 1.96; P =.080).
Participants who developed severe hypoglycemia had a significant risk for all-cause mortality vs participants with no severe hypoglycemic episodes (HR 2.51, 95% CI 1.79, 3.50; P <.001). Following adjustment for age, body mass index, duration of diabetes, insulin regimen, gender, and cardiovascular risk group, the association between all-cause mortality and severe hypoglycemia remained.
According to the investigators, the DEVOTE trial failed to identify the exact impact of non-severe hypoglycemic events on mortality outcomes in patients with type 2 diabetes. Also, only a small percentage of DEVOTE trial participants experienced a severe event, further limiting the power of the findings.
Although the results of this trial support the correlation between all-cause mortality and severe hypoglycemia, the investigators suggest that the current analysis does “not establish whether hypoglycemia serves as a risk marker for these events or directly contributes to their occurrence.”
Pieber TR, Marso SP, McGuire DK, et al. DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality [published online September 15, 2017]. Diabetologia. doi:10.1007/s00125-017-4422-0