Preliminary findings from the largest-ever study of diabetes products do not confirm the increased risk of death linked to intensive treatment and reported by researchers on the ACCORD trial only last week.

Interim results from the ADVANCE Study, involving 11,140 high-risk patients with type 2 diabetes, provide no evidence of an increased risk of death among those patients receiving intensive treatment to lower blood glucose. These findings contrast with those reported last week by the US National Heart Lung and Blood Institute which suggested that intensive glucose-lowering treatment levels had increased the death rate among patients with diabetes recruited to the ACCORD trial.

The NHLBI halted one treatment arm of the 10,251-patient ACCORD trial 18 months early due to safety concerns after a review of available data. Specifically, a halt has been called to a study of adults with type 2 diabetes at especially high risk for heart attack and stroke after it was revealed that 257 patients in the intensive treatment group have died, compared with 203 on standard therapy.

Chairman of the ADVANCE Data Monitoring and Safety Committee, Oxford University’s Rory Collins, said the interim results from his trials “provide no confirmation of the adverse mortality trend reported from the ACCORD study." He also noted that the ADVANCE findings were based on more than twice as much data and similar levels of glucose control as in ACCORD.

ADVANCE principal investigator, Stephen MacMahon from The George Institute for International Health in Sydney, stated that "due to the unexpected report from the ACCORD trial, we felt it was in the public interest for us to ask our DMSC to make a statement".

ADVANCE, supported by the National Health & Medical Research Council of Australia and the Paris-based, Institute de Recherche Internationales Servier, started in July 2001 and patients were treated and followed-up for an average of five years. Final patient visits have been completed, and the study data
base “is close to finalisation. We expect to have definitive results soon," said study director Anushka Patel, from The George Institute.

The American Diabetes Association issued a statement saying that ADVANCE "further magnifies the uncertainty over whether intensive glucose control may harm some people with diabetes."