Largest Ever Study of Diabetes Shows Intensive Glucose Control Reduces Serious Complications (6/11/2008)

ADVANCE Results go Beyond Existing Evidence

New results from the world's largest ever study of diabetes treatments show that intensive blood glucose (sugar) control using modified release gliclazide and other drugs as required, protects patients against serious complications of the disease. In particular, intensive treatment reduces the risk of kidney disease by one-fifth. Presented at the American Diabetes Association and published in the New England Journal of Medicine, the results of ADVANCE (Action in Diabetes and Vascular Disease) show that this intensive treatment strategy has the potential to benefit millions of diabetic patients worldwide.

Professor Bryan Williams, Professor of Medicine, School of Medicine, University of Leicester and Consultant Physician, University Hospitals of Leicester, Leicester Hypertension Clinic was on the International management committee that designed and led this major study. He was also one of the authors of the report that appeared in the New England Journal of Medicine - one of the premier medical journals.

He said: "This was one of the largest ever studies to evaluate whether intensified glucose control in people with diabetes is effective at reducing their risk of cardiovascular disease. Its importance was heightened further by a parallel NIH-funded study in the U.S. which suggested no benefit from intensified glucose control and an increased risk of death. Our study suggested that there was no benefit from intensified glucose control in preventing major cardiovascular events in people with diabetes.

"These studies suggest that for people with type 2 diabetes, once blood glucose is reasonably well controlled, efforts should be directed at intensifying blood pressure and lipid control to reduce cardiovascular risk and improve survival" "These results are hugely important for the NHS because vast sums of money are spent on intensifying glucose control for people with type 2 diabetes, the data suggest that this money would be better spent on improving blood pressure and blood lipids in these patients."

Diabetes mellitus is one of the greatest threats to the health of populations worldwide. India has the highest number of people with diabetes in the world (40.9 million), with around 250 million people globally living with the condition. This number is estimated to rise to 380 million in 2025, when the largest increases in diabetes prevalence will take place in developing countries.

Chief investigator of the study, Professor Stephen MacMahon, Principal Director of The George Institute, Australia said "We are facing a global epidemic of diabetes. The ADVANCE results go beyond existing evidence as we have now shown that reducing the haemogloboin A1c level (a marker of blood glucose control) to 6.5% is a safe and effective way to reduce serious complications, particularly the risk of kidney disease, one of the most serious and disabling consequences of diabetes, leading to death in one in five people with diabetes."

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

"Moreover, in contrast to the recently halted ACCORD study, there was no evidence whatsoever of any increased risk of death among those receiving intensive treatment in ADVANCE."

"The ADVANCE study has provided vital information to India about the effects of managing blood glucose levels in diabetes. This is important as India is estimated to have over 40 million persons with diabetes - the highest population of diabetes in the world," said Professor Nikhil Tandon, National Co-ordinator for ADVANCE, at the All India Institute of Medical Sciences.

ADVANCE was initiated and designed by physicians at Australia's George Institute for International Health and involved a group of independent medical researchers from 20 countries worldwide. The study involved 11,140 patients with type 2 diabetes who were treated and followed up for five years. The study aimed to reduce levels of haemogloboin 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 haemoglobin target.

The major findings of ADVANCE show that intensive blood glucose lowering treatment:

• 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.

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

The George Institute, India which was launched in 2007, is working to reduce the burden of disease caused by conditions such as diabetes. This new information in the management of diabetes is directly aligned with the Institute's goal to identify practical new ways of addressing this serious health problem.

Note: This story has been adapted from a news release issued by the University of Leicester

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