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The Largest Ever Study of Diabetes Shows Intensive Glucose Control Reduces Serious Complications

Saturday, June 7, 2008 General News
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SAN FRANCISCO, California, June 6

- "ADVANCE Results go Beyond Existing Evidence"

New results from the world's largest ever study of diabetes treatmentsshow that intensive blood glucose (sugar) control using modified releasegliclazide and other drugs as required, protects patients against seriouscomplications of the disease. In particular, intensive treatment reduces therisk of kidney disease by one-fifth. Presented today at the American DiabetesAssociation and published in the New England Journal of Medicine, the resultsof ADVANCE (Action in Diabetes and Vascular Disease) show that this intensivetreatment strategy has the potential to benefit millions of diabetic patientsworldwide.
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Diabetes mellitus is one of the greatest threats to the health ofpopulations worldwide. Globally, there are approximately 250 million peoplewith diabetes and that number is estimated to rise to 380 million in 2025.
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Chief investigator of the study, Professor Stephen MacMahon, PrincipalDirector of The George Institute, Australia said "We are facing a globalepidemic of diabetes. The ADVANCE results go beyond existing evidence as wehave now shown that reducing the haemoglobin A1c level (a marker of bloodglucose control) to 6.5% is a safe and effective way to reduce seriouscomplications, particularly the risk of kidney disease, one of the mostserious and disabling consequences of diabetes, leading to death in one infive people with diabetes."

"Hypoglycemia (low blood sugar) was uncommon in the ADVANCE study,although as expected it was more frequent among those receiving intensivetreatment," pointed out Study Director, Associate Professor Anushka Patelfrom The George Institute. "These findings reinforce that blood glucoselowering in diabetes is safe and has an important role to play in theprevention of serious complications."

"Moreover, in contrast to the recently halted ACCORD study, there was noevidence whatsoever of any increased risk of death among those receivingintensive treatment in ADVANCE."

ADVANCE was initiated and designed by physicians at Australia's GeorgeInstitute for International Health and involved a group of independentmedical researchers from 20 countries worldwide. The study involved 11,140patients with type 2 diabetes who were treated and followed up for fiveyears. The study aimed to reduce levels of haemoglobin A1c to 6.5% or below.Intensive treatment included the sulfonylurea, modified-release gliclazide,for all patients and other drugs as required to achieve the haemoglobintarget.

The major findings of ADVANCE show that intensive blood glucose loweringtreatment:

"Today, it is clear that the prevention of major vascular complicationsof diabetes requires a multi-factorial approach addressing all modifiablerisk factors," concluded Professor John Chalmers, chairman of the studymanagement group, "among which an intensive glucose control plays animportant role, in particular in protecting the kidneys."

http://www.advance-trial.com- Safely controlled blood glucose to a mean HbA1c level of 6.5% - Significantly reduced the overall risk of serious diabetes complications (by 10%), with a one-fifth reduction in kidney disease (21%) and 30% reduction in the development of proteinuria, a well established marker of increased cardiovascular risk. - Achieved a positive trend towards reduction in the risk of cardiovascular death (12%), although not statistically significant.

SOURCE ADVANCE
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