October 8th, 2010
Analysis of ADVANCE Explores Role of Hypoglycemia
Larry Husten, PHD
A new analysis of the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation) trial sheds light on the role of hypoglycemia in recent trials of glucose control. In a paper in the New England Journal of Medicine, the ADVANCE investigators report that 2.1% of 11,140 patients with type 2 diabetes developed severe hypoglycemia in the course of the trial. Patients with severe hypoglycemia had a significantly elevated risk of major macrovascular events, major microvascular events, and death from a cardiovascular cause or from any cause.
However, the investigators did not find either a temporal or a dose-response relationship between hypoglycemia and outcome. The authors conclude that “although our findings cannot exclude the possibility that severe hypoglycemia has a direct causal link with these outcomes, they suggest that it is as likely to be a marker of vulnerability to a wide range of adverse clinical outcomes.”