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ADVANCE diabetes trial results confirm no evidence of safety risk

Montreal, February 28, 2008 - Data from the ADVANCE Study, involving 11,140 high-risk patients with type 2 diabetes, provides no evidence of an increased risk of death among those patients receiving aggressive treatment to lower blood glucose.

This contrasts findings from the 10,251 patient ACCORD trial which halted the intensive glucose control arm of the study 18 months early because a data review revealed that patients who received intensive treatment to lower blood glucose are at higher risk for death. While the trial will continue, patients will be transitioned from the intensive treatment arm (targeting A1c levels of <6.0 %) to the less intensive, standard treatment arm (targeting A1c levels of 7.0 to 7.9%).

Unlike what we saw in ACCORD, a rigorous review of ADVANCE data by the Data and Safety Monitoring Committee shows that the treatment strategy of intensively lowering blood sugar does not pose greater risk to our patients with type 2 diabetes, says Canadian lead investigator and member of ADVANCE Management Committee Dr. Pavel Hamet, professor of Medicine, Canada Research Chair of Predictive Genomics at Universit de Montral and Chief, Gene Medicine Services at Centre Hospitalier de lUniversit de Montral. ADVANCE is a landmark study and will continue as planned to completion. The results will provide crucial information to help us better reduce the significant health risks associated with type 2 diabetes.

Type 2 diabetes increases the risk of many complications, especially cardiovascular disease, which is the leading cause of death in people with diabetes. Both the ADVANCE and ACCORD studies examined the effects of intensive blood glucose and blood pressure control on the risk of cardiovascular events such as heart attack, stroke, or death from cardiovascular disease in patients with type 2 diabetes. A successful reduction in overall and cardiovascular mortality in the intensive blood pressure arm has been reported from the ADVANCE trial and published in The Lancet in September 2007.

In ADVANCE and ACCORD, the intensive treatment arm targeted blood glucose levels below those recommended in current treatment guidelines because previous studies suggest that reducing blood sugar to levels to those found in non-diabetic adults may reduce the rate of cardiovascular disease in patients with diabetes.

In the ADVANCE trial, which involves 20 countries worldwide including Canada, the intensive blood glucose lowering program aimed to reduce levels of hemoglobin A1c (a marker of long term blood glucose control) to ≤6.5%. Treatment included a sulfonylurea drug, gliclazide modified release, for all patients, and a number of other agents for those patients unable to reach target blood glucose levels. The ADVANCE trial was started in 2001 and patients were followed for an average of five years.

Because the A1c targets in ACCORD and ADVANCE are similar, and the intensive blood glucose control arm of ACCORD was stopped early, the ADVANCE mortality data was reviewed by the Data and Safety Monitoring Committee to determine if there was a similar excess risk of mortality. This committee advised that data did not provide any confirmation of the adverse mortality trend reported from ACCORD.

Final patient visits have been completed and the ADVANCE study data base is close to finalization. We expect to have definitive results soon, said Study Director, Dr. Anushka Patel, from The George Institute in Sydney, Australia. At this stage, the Data Monitoring and Safety Committee have reviewed results that are more than 99% complete, so we are confident that the interim findings are a reliable guide to the final results.

Final data from the ADVANCE trial is expected to be promising in terms of risk minimization but multiple analyses are required before conclusions can be drawn regarding the effects of intensive glucose control on patient outcomes. Additional data will be available specifically from ADVANCE, and Dr. Hamets team, in collaboration with Prognomix in Montral, is performing genomic studies of the risk of complications of diabetes in this unique worldwide patient cohort.

The ADVANCE trial was conducted by an independent collaborative group of medical researchers with support from the National Health & Medical Research Council of Australia and the Institut de Recherche Internationales Servier. The results of the blood pressure control arm of ADVANCE were presented at the annual meeting of the European Society of Cardiology in Vienna, Austria in September 2007. Final results of the glucose control arm of the ADVANCE trial will be released earlier than expected, by the middle of 2008.


Contact: Nathalie Forgue
University of Montreal

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