COMUNICADO: Preterax(R) Prevents and Reverses Renal Disease in Type 2 Diabetics

Actualizado 16/06/2008 18:47:09 CET

BERLIN, June 16 /PRNewswire/ -- New results of the ADVANCE (Action in Diabetes and Vascular disease: PreterAx and DiamicroN-MR Controlled Evaluation) trial have been presented today at the European Society of Hypertension (ESH) and show that the antihypertensive Preterax - a fixed combination of the ACE-inhibitor perindopril and the diuretic indapamide - reduces the likelihood of new or worsening nephropathy (kidney damage) in patients with type 2 diabetes mellitus by up to 31% and in patients with existing kidney damage leads to nephropathy regression in about one-in-six.(1)

In this new ADVANCE analysis, Preterax reduces the risk of developing new onset microalbuminuria by 21% (P<0.0001) and macroalbuminuria by 31% (P=0.002) and regresses renal disease by improving existing microalbuminuria or macroalbuminuria at baseline by 16% compared with placebo (P=0.002). Furthermore, restoration of normoalbuminuria is improved by 15% (P=0.006) in patients treated with Preterax. Preterax's renoprotective benefits were independent of concomitant treatments with other antihypertensives, initial blood pressure or duration of diabetes or glycaemic control.(1)

ADVANCE is the largest study performed in patients with type 2 diabetes.(2) It looked firstly at whether routine blood pressure lowering using Preterax, and secondly whether an intensive glucose control strategy using Diamicron MR (gliclazide MR) prevented vascular complications. The blood pressure arm of the study reported that Preterax reduced death from all-causes (-14%, p=0.025) and cardiovascular death (-18%, p=0.027) as well as the risks of coronary and renal events.(2) New data regarding the glucose arm were recently released at the American Diabetes Association, showing that intensive blood glucose control using modified release Diamicron MR, and other glucose lowering drugs as required, protects against serious vascular complications of the disease (-10%, p=0.01) and renal events (-21%, p=0.006).

Type 2 diabetes is the leading cause of end-stage kidney disease, accounting for up to one half of all new cases in the industrialised world. The new data suggest that routine administration of a fixed combination of perindopril and indapamide result in marked renoprotection and help preserve diabetic patients' kidney function, autonomy and quality of life, while potentially reducing the need for dialysis and kidney transplants. These results confirm that Preterax is now the only antihypertensive combination to have demonstrated life saving benefits with overall cardiovascular and renal protection.

Notes to Editors

About diabetic nephropathy

Type 2 diabetes is a major cause of kidney disease, and end-stage kidney disease accounts for between 30% and 50% of new cases.(3) Raised levels of albumin in urine (microalbuminuria), is one of the earliest signs that indicates that a patient has developed kidney damage; higher levels (macroalbuminuria) suggest more serious nephropathy.(4) Approximately 25% of patients with type 2 diabetes show either microalbuminuria or macroalbuminuria 10 years after diagnosis. Approximately 3% of these convert to overt nephropathy each year.(5)

Blood pressure strongly influences the risk of developing microalbuminuria and its progression to nephropathy.(6) In patients with hypertension, nephropathy strongly predicts the risk of future cardiovascular events and death.(2) Patients with end stage kidney disease need dialysis or a kidney transplant.

About ADVANCE

ADVANCE involved 11,140 type 2 diabetic patients from more than 20 countries followed up, on average, for 4.3 years. It is a multicentre, randomised, placebo-controlled study that enrolled both patients with normal blood pressure (normotensive) and hypertensives from 20 countries. Patients already received usual treatments for type 2 diabetes, including other antihypertensives.

In ADVANCE, the average blood pressure fell below 135/75 mmHg in patients treated with Preterax, possibly the best BP control yet achieved in a major trial in type 2 diabetes. Previous results from ADVANCE showed that Preterax reduces total mortality by 14% and cardiovascular death by 18% in type 2 diabetes patients. Therefore, Preterax would avoid one death for every 79 patients treated for five years. In addition, Preterax reduced total coronary events by 14%. Preterax would avoid one coronary event for every 75 patients treated for five years. Global benefits of Preterax in the renal function were already demonstrated in the main analysis of ADVANCE, with a reduction of the risk of all renal events by 21% compared with placebo (P<0.0001) which translate into one renal event avoided for every 20 patients treated for five years with Preterax.(2)

The investigators who initiated and designed ADVANCE chose Preterax because of its efficacy in treating alterations in large arteries and the microcirculation that are common in hypertensives and diabetics. Preterax effectively reduces blood pressure, improves cardiac perfusion and protects the heart and kidney.

Results from a second arm of the study, assessing intensive glucose lowering using a gliclazide MR-based regimen (Diamicron MR) were recently published in the New England Journal of Medicine.(7)

About Preterax

Preterax contains the ACE inhibitor perindopril and the thiazide-like sulphonamide diuretic indapamide. Preterax and Diamicron MR are registered products of Servier. 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, and Prestarium Plus.

References

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(1) Chalmers J. Renoprotection with perindopril-indapamide below current recommended blood pressure targets in patients with type 2 diabetes mellitus: results of the ADVANCE trial. European Society of Hypertension Hotline Session, June 16, 2008; Berlin.

(2) Patel A, MacMahon S, Chalmers J, et al. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet 2007;370:829-40

(3) System URD. US Renal Data System. USRDS 2007 annual data report

(4) Mancia G, De Backer G, Dominiczak A et al. Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2007;25:1105-87

(5) Adler AI, Stevens RJ, Manley SE et al. Development and progression of nephropathy in type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS 64). Kidney Int 2003; 63: 225-32

(6) Ritz E, Orth SR. Nephropathy in patients with type 2 diabetes mellitus. N Engl J Med 1999;341:1127-33

(7) 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

For further information, please contact: Leah Baldwin, Tonic Life Communications, +44-207-798-9923 / leah.baldwin@toniclc.com

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