The ACCORD and ADVANCE trials – could hypoglycemia have contributed to the differences seen in cardiac mortality?
Professor Simon Heller and Dr Rory McCrimmon of the Editorial Board
Diabetic Hypoglycemia September 2008, Volume 1, Issue 2: page 1
In February 2008, the diabetes world was startled by the premature termination of the glucose control component of the ACCORD trial at the request of the independent data monitoring and safety committee. The trial, which had been running for 3 years, had been designed to examine whether aggressive treatment of blood glucose, lipids and blood pressure (BP) could lower the risk of cardiovascular disease (CVD) in 10,000 individuals with established type 2 diabetes. In particular, the trial investigators hoped to establish whether lowering blood glucose to near normal levels would significantly reduce macrovascular disease, an unresolved issue in the management of type 2 diabetes.
The glucose control arm of the trial was terminated early due to an unexpected increase in the number of sudden cardiac deaths in those participants receiving intensive glucose lowering treatment. This announcement was followed by a press release from investigators involved in the ADVANCE Trial that tested a similar hypothesis in over 11,000 individuals with type 2 diabetes recruited worldwide, and which completed in late 2007 after 5 years. The ADVANCE trial investigators found no evidence of increased overall or cardiac mortality in their intensively treated population.