Major ADVANCE for Type 2 DiabeticsBlood pressure lowering drug (Pr)Coversyl(R) Plus reduces mortality in type 2 diabetics
VIENNA, Austria, Sept. 4 /CNW/ - The routine administration of a fixed combination of perindopril and indapamide (Coversyl Plus) 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(1) (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation) study presented Sunday at the European Society of Cardiology (ESC) meeting and published online in The Lancet. In Canada, (Pr)Preterax(R) is marketed under the brand name Coversyl Plus.
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. There were 11 trial sites in Canada with hundreds of enrolled patients. 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 Coversyl Plus significantly reduces total mortality by 14 per cent (p=0.03) and the risk of cardiovascular death by 18 per cent (p=0.03) compared to placebo. In addition, diabetes patients receiving Coversyl Plus achieved a significant 14 per cent (p=0.03) reduction in total coronary events, including heart attacks, and a 21 per cent (p=0.01) reduction in new or worsening kidney disease.
"The results of ADVANCE will have a significant and immediate impact on the management of type 2 diabetes patients in Canada and across the world," says Canadian lead investigator Dr. Pavel Hamet, Professor of Medicine, Canada Research Chair, Predictive Genomics, Chief, Gene Medicine Services at Center Hospitalier de L'Université de Montréal. "This treatment reduced the likelihood of dying from the complications of diabetes by almost one-fifth, with virtually no side-effects. These findings translate into one life saved in every diabetes-treating physician's office in Canada each year."
Coversyl Plus was chosen for the ADVANCE trial for its efficacy in blood pressure lowering. In 2002, Coversyl Plus was approved in Canada for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate.
"I was diagnosed with high blood pressure when I was 14 and later found out I also had type 2 diabetes," says ADVANCE study patient Janine Lemay. "Four members of my family died from heart attacks and I believed that this was how I was going to die as well. The results of the ADVANCE trial are very important to me because Coversyl Plus is the only treatment that has managed my high blood pressure. I now feel great and am able to enjoy my life again."
Globally, there are approximately 250 million people with diabetes, most of who will eventually die or be disabled by the complications of their condition. In Canada, type 2 diabetes is one of the fastest growing diseases with more than 60,000 new cases yearly.(2) Approximately 41,500 Canadians die
from type 2 diabetes complications annually.(3) Economically, diabetes and its complications cost the Canadian healthcare system an estimated $13.2 billion every year in direct and indirect costs, including physician care, medication, long-term disability and early death.(3) 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 and 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 5 years... there is now a case for considering routine treatment with Coversyl Plus for patients with type 2 diabetes," comments Professor John Chalmers, ADVANCE co-principal Investigator from the George Institute for International Health, Sydney, Australia.
The ADVANCE study was initiated and designed by the investigators and co-sponsored by The George Institute for International 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 ((Pr)Diamicron(R) MR) will report later.
About Coversyl Plus
Coversyl Plus is a fixed-dose combination product of perindopril erbumine, an angiotensin converting enzyme (ACE) inhibitor, and indapamide, a chlorosulphamoyl diuretic. It has been approved in Canada in 2002 for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. Coversyl Plus is not indicated for initial therapy. Full prescribing information for Coversyl Plus is available upon request from Servier Canada Inc.
About Servier Canada Inc.
Servier Canada Inc. (www.servier.ca) is a pharmaceutical company, based in Laval (Quebec) that focuses on the development of therapies to treat cardiovascular, metabolic and central nervous system diseases. It is the Canadian subsidiary of the Servier Research Group, the leading French-based independent (private) pharmaceutical company, which is present in 140 countries around the world.
The Servier Research Group distinguishes itself by investing 25 per cent of its income in research and development which is approximately double the industry average. This enables the advancement of scientific knowledge and the discovery of therapeutic innovations leading to improved patient care and
Coversyl Plus and Diamicron MR are registered products of Servier.
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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, Noriplel, 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
Accessed August 2007
Accessed August 2007
/For further information: Fiona Robinson, Hill and Knowlton Canada, (416)
Posted: September 2007