New Advance Findings Show How to Combine Intensive Blood Glucose and Blood Pressure Lowering for Further Benefits in Type 2 Diabetes

ADVANCE treatment strategy has potential to save lives and protect millions of diabetics worldwide from serious complications

ROME, Italy, 8 September 2008 – According to new data presented today at the European Association for the Study of Diabetes (EASD) congress, combining intensive blood sugar control based on gliclazide modified release (Diamicron MR®) with intensive blood pressure lowering based on a fixed combination of perindopril and indapamide (Preterax®) can reduce the risk of death from heart disease by nearly one quarter (24%) and the risk of kidney complications by one third (33%) in patients with type 2 diabetes. 

These latest results from ADVANCE (Action in Diabetes and Vascular Disease), the largest ever trial performed in patients with type 2 diabetes, provide further evidence for a new therapeutic strategy with the potential to save lives and protect millions of diabetics worldwide from serious complications.

The new ADVANCE results show that the benefits of tight blood glucose control and blood pressure lowering are both independent and fully additive. This new evidence represents an important step forward for the management of millions of people with diabetes worldwide, as the treatment strategy used in ADVANCE reduced both the likelihood of developing and dying from the complications of diabetes.

Intensive and progressive blood glucose control for long term benefits

These latest combined findings follow the recent publication of the results from the glucose lowering arm of the study in the New England Journal of Medicine.1 These results showed that an intensive strategy including first systematically prescribing the sulfonylurea gliclazide modified release, up to the maximal dose of 4 tablets per day, and then progressively other conventional drugs, lowers blood glucose levels safely to hemoglobin A1c levels of 6.5% and protects patients against the serious complications of diabetes.

In particular, this intensive strategy reduced the risk of kidney disease by one-fifth, and reduced the risk of proteinuria, a potent predictor of increased cardiovascular risk, by nearly one third (30%). These results go beyond existing evidence, and could potentially benefit millions of patients worldwide, since renal disease is one of the most serious and disabling consequences of diabetes, leading to death in one in five people with diabetes.

The intensive strategy based on modified release gliclazide provided all these benefits with a low risk of hypoglycemia (4 times less compared to previous studies) and no weight gain in contrast with other therapeutic strategies based on early and higher use of insulin as well as glitazones, as shown in ACCORD. 2

Today, it is clear that the prevention of the serious complications of diabetes requires multi-factorial intervention, since the new ADVANCE results show that the benefits of intensive blood glucose and blood pressure lowering are independent and fully additive in reducing cardiovascular death (-24%) and renal complications (-33%). In this context, an intensive and progressive glucose control strategy as chosen in ADVANCE can play an important role, in particular in protecting the kidneys.

ADVANCE

ADVANCE was initiated and designed by the researchers at Australia’s George Institute for International Health and co-sponsored by the Australian government’s National Health and Medical Research Council, and Servier. The multicenter, randomized, placebo controlled study involved a total of 11,140 patients with type 2 diabetes from 20 countries worldwide with a five year follow-up. The choice of Diamicron MR was based on its well known efficacy and safety profile, as proven by millions of diabetic patients treated every day.

ENDS

For further information, please contact:

Sarah Ballard or Claire Mosley

Tonic Life Communications

Tel: +44 207 798 9900/ Mobile: +44 7989 689 283

E-mail: sarah.ballard@toniclc.com  /  claire.mosley@toniclc.com

www.advance-trial.com

Notes to editor:

ADVANCE was designed, conducted, monitored, analysed and reported by a collaborative medical research group supported by the Australian Government’s National Health and Medical Research Council after full peer review. The study was carried out independently of the industry sponsor and the Management Committee, whose membership did not include any industry representatives, had final responsibility for the reporting of results.

The George Institute for International Health is an internationally-recognised health research organisation, undertaking high impact research across a broad health landscape.  It is a leader in the clinical trials, health policy and capacity-building areas.

The National Health & Medical Research Council of Australia is the Australian Government’s peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research.

Servier is France’s leading independent pharmaceutical company and the second largest French drug company worldwide. Servier has been committed to optimisation of the treatment of type 2 diabetes for over 30 years, through the discovery of original antidiabetic agents and numerous activities promoting research and education.  The research funding arm of French pharmaceutical company Servier is the Institut de Recherche International Servier.

Diamicron MR is an effective and safe once daily oral antidiabetic agent containing a modified-release version of the active ingredient gliclazide. In addition to its blood glucose lowering effects, the drug has well-documented vascular protective properties. Diamicron MR is registered by Servier in some countries also as Diamicron 30 mg, Diaglucide MR 30mg, Gluctam MR 30 mg, Diaprel MR, Diabeton MR, Diamicron Uno 30 mg, Diabeton MB, Uni Diamicron, Diamicron LM 30 mg, Unidiamicron, Dianormax MR, Diamicron MR Tablets 30 mg, Diamicron 30 mg MR, Dramion 30mg.   
 

The fixed combination of perindopril and indapamide is marketed in 97 countries worldwide under the brand names Preterax™ ,Predonium™, Biprel, Prelectal, Noriplex or Noliprel.

References:

1.             The ADVANCE collaborative Group. Intensive blood glucose control and vascular outcomes in patients with Type 2 Diabetes. N Engl J Med 2008;358:2560-72.

2.             The ACCORD study Group. Effects of Intensive Glucose Lowering in type 2 Diabetes. N Engl J Med 2008;358:2545-59.

www.advance-trial.com

Posted: September 2008

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