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16.06.2008 – 16:51

Servier Laboratories

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

Berlin (ots/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%,
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
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.
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.
(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
(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 /