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VIENNA, Austria, 2 September 2007 – The routine administration of a fixed combination of perindopril and indapamide (Preterax) improves survival and reduces coronary and renal events in diabetics, according to the results of the blood-pressure-lowering arm of the landmark, five year ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation) study presented today at the European Society of Cardiology (ESC) meeting1, and published online in The Lancet.

ADVANCE is the first and largest trial ever performed with a fixed combination antihypertensive in type 2 diabetic patients. The multicentre, randomised, placebo controlled study involved a total of 11,140 patients with type 2 diabetes from 20 countries worldwide. Patients included were both normotensive and hypertensive and were already receiving most of the usual treatments provided to patients with diabetes, including other blood- pressure lowering drugs.

ADVANCE showed that Preterax significantly reduces total mortality by 14% and the risk of cardiovascular death by 18%. In absolute terms, one death would be avoided for every 79 patients treated with Preterax for five years. In addition, patients receiving Preterax achieved a significant 14% reduction in total coronary events and a 21% reduction in renal events. That means that one coronary event would be avoided for every 75 patients treated with Preterax for five years and one renal event would be avoided for every 20 patients treated with Preterax for five years.

“The results of ADVANCE should have major implications for guidelines, clinical care and public policies”, says co-principal study organiser Professor Stephen MacMahon from The George Institute for Global Health, Sydney Australia. He adds, “These results represent an important step forward in health care for the millions of people with diabetes worldwide. This treatment reduced the likelihood of dying from the complications of diabetes by almost one-fifth, with virtually no side-effects.”

Preterax was chosen for the ADVANCE trial for its efficacy in treating the alterations in both large arteries and the microcirculation which commonly occur in hypertensives and diabetics. Moreover, Preterax achieves a strong blood pressure lowering efficacy, specific benefits on cardiac perfusion and protection of the heart and kidney.
Globally, there are approximately 250 million people with diabetes, most of who will eventually be killed or disabled by the complications of their condition. The most common cause of death in people with diabetes is heart disease. Kidney disease also affects a large proportion. In 2006, the United Nations issued a statement calling for increased international action to combat the global epidemic of diabetes.

“Diabetes is emerging as one of the greatest 21st century threats to the health of populations worldwide. The health gains seen in the ADVANCE study have been obtained in addition to the benefits provided by patients’ existing treatment. If the benefits seen in ADVANCE were applied to just half the population with diabetes worldwide, more than a million deaths would be avoided over five years. There is now a case for considering routine treatment with Preterax for patients with type 2 diabetes”, comments Professor John Chalmers, ADVANCE co-principal investigator also from the George Institute for Global Health.

The ADVANCE study was initiated and designed by the investigators and co-sponsored by The George Institute for Global Health and the University of Sydney, and Servier. A second arm of the study, that sets out to assess the risks and benefits of intensive glucose lowering using a gliclazide MR-based regimen (Diamicron MR) will report later.

Preterax and Diamicron MR are registered products of Servier.




For further information, please contact:

Moira Gitsham, Tonic Life Communications. Email: moira.gitsham@toniclc.com, telephone: +33 6207 40192
Leah Baldwin, Tonic Life Communications. Email: leah.baldwin@toniclc.com, telephone: +44 7788 191434
Matthew Foster, Tonic Life Communications. Email: matthew.foster@toniclc.com, telephone: +44 7921 622641

Note for editors:

Perindopril / indapamide combinations are registered under the following trade names: Preterax, BiPreterax, Preterax Forte, Biprel, Noliprel, Noliprel Forte, Prelectal, Prelectal forte, Predonium, Noliprel, Coversyl Plus, Coversyl Comp, Coversum Combi, Armix Comb, Prestarium Combi, Prestarium Plus.

1. Data presented at a hotline session of the European Society of Cardiology meeting, 2 September 2007.