Intensive Glucose Control Strategy Cuts Nephropathy Risk by 21% in Type 2 Diabetes: Presented at ADA

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Title: Intensive Glucose Control Strategy Cuts Nephropathy Risk by 21% in Type 2 Diabetes: Presented at ADA
URL: http://www.pslgroup.com/dg/22340A.htm
Doctor's Guide
June 9, 2008

By Jill Stein

SAN FRANCISCO -- June 7, 2008 -- Intensive glucose control in patients with type 2 diabetes produced a 10% relative risk reduction in the combined primary outcome of major macrovascular and microvascular complications (P = .01 for both) compared with standard glucose control. This was the finding of the much-anticipated Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial.

The 10% relative reduction in the primary outcome was largely due to a 21% relative reduction in the risk of new or worsening nephropathy, P = .006.

The study was conducted at 215 sites in 20 countries, making it the world's largest study of intensive glucose control in patients with type 2 diabetes. The results were presented on June 6 at the American Diabetes Association (ADA) 68th Scientific Sessions and simultaneously published online in the New England Journal of Medicine (ADVANCE Collaborative Group. 2008;358:2560-2572) .

An earlier phase of the trial that evaluated blood pressure reduction with perindopril and indapamide documented a reduction in the risks of major vascular events and death irrespective of baseline blood pressure.

"The new results show that decreasing haemoglobin A1C to 6.5% is a safe and effective means of decreasing serious complications, especially the risk of kidney disease," said principal investigator Stephen MacMahon, PhD, George Institute, Sydney, Australia. Professor MacMahon reported the data on behalf of the ADVANCE Collaborative Group

Kidney disease accounts for about 20% of all deaths in patients with diabetes.

The trial included 11,140 high-risk, patients with type 2 diabetes. The participants continued their usual method of glucose control while receiving a combination of perindopril and indapamide during a 6-week run-in period. Patients who tolerated and complied with the treatment during the run-in phase were randomised, using a factorial design, to continued therapy with either perindopril and indapamide or matching placebo, and to undergo an intensive blood glucose control strategy, with a target glycated haemoglobin value less than or equal to 6.5%, or standard glucose control.

Primary endpoints were composites of major macrovascular events (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) and major microvascular events (new or worsening nephropathy or retinopathy) assessed jointly and individually.

The study found that the intensive glucose control strategy decreased the average glycated haemoglobin value to 6.5% in a diverse patient population after a median 5 years of follow-up and cut the incidence of the combined primary outcome of major macrovascular or microvascular events. The 20% relative reduction in the primary outcome seen with intensive control strategy was accounted for largely by a 21% relative reduction in the risk of new onset or worsening nephropathy.

Not surprisingly, there was a significantly higher rate of hypoglycaemia in the intensive glucose control group, however, the overall risk of hypoglycaemia remained low.

There was no evidence of an increased risk of death with intensive glucose control strategy.

"The data clearly suggest that the prevention of macrovascular complications of diabetes requires a multifactorial approach that targets all major modifiable risk factors including blood pressure and blood lipids," said Bruce Neal, MD, University of Sydney, Sydney, Australia.

Funding for the study was provided by the National Health and Medical Research Council of Australia and Servier.

[Presentation title: Intensive Blood Glucose Control and Vascular Outcomes in Patients With Type 2 Diabetes.]

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