Major International Diabetes Study Does not Confirm Increased Risk of Death Reported by US Trial

Paris (ots/PRNewswire) -

- Preliminary Findings from the Largest-Ever Study of Treatments
for Diabetes Provide no Evidence That Intensive Treatment to Lower
Blood Glucose (Sugar) Increases Risk of Death

Interim results from the ADVANCE Study, involving 11,140
high-risk patients with type 2 diabetes, provide no evidence of an
increased risk of death among those patients receiving intensive
treatment to lower blood glucose (sugar).

These findings contrast with those reported last week by the US
National Heart Lung and Blood Institute suggesting that intensive
glucose lowering treatment levels had increased the death rate among
patients with diabetes recruited to the ACCORD trial.

ADVANCE was designed to answer two questions in patients with
type 2 diabetes: first, does intensive treatment to lower blood
pressure improve outcome; and second, does intensive treatment to
reduce blood glucose improve outcome.

In September 2007, the ADVANCE Collaborative Group published
evidence in The Lancet showing that the blood pressure lowering
treatment had reduced the death rate among participants. In January
2008, the part of the study designed to assess the effects of the
intensive treatment to reduce blood glucose was completed. As in
ACCORD, this intensive treatment program was designed to lower blood
glucose to levels below those usually recommended by clinical
guidelines.

Chairman of the ADVANCE Data Monitoring and Safety Committee,
Professor Rory Collins from the University of Oxford, said "The
interim results from ADVANCE provide no confirmation of the adverse
mortality trend reported from the ACCORD study." He also noted that
the ADVANCE interim results were based on more than twice as much
data and similar levels of glucose control as in ACCORD. The members
of the Data Monitoring and Safety Committee are the only members of
ADVANCE study team with access to the study results.

ADVANCE principal investigator, Professor Stephen MacMahon from
The George Institute for International Health in Sydney, stated that
"Due to the unexpected report from the ACCORD trial, we felt it was
in the public interest for us to ask our Data Monitoring and Safety
Committee to make a statement as to whether the available data from
ADVANCE provide any support for the suggestion that intensive blood
glucose lowering may increase mortality."

In ADVANCE, the intensive blood glucose lowering program aimed to
reduce levels of haemoglobin A1c (a marker of long term blood glucose
control) to below 6.5%. This treatment regimen included a
sulfonylurea drug, gliclazide modified release, for all patients and
a range of other drugs for those not reaching target blood glucose
levels.

ADVANCE commenced in July 2001 and patients were treated and
followed-up for an average of five years. The Data Monitoring and
Safety Committee, comprising a panel of independent experts in the
field, met every six months to review the study data for any safety
issues or other concerns.

ADVANCE Management Committee Chairman, Professor John Chalmers,
commented "Doctors and patients should feel reassured that the
mortality trend reported by the ACCORD study has not been found in
the interim results from ADVANCE. However, we need to await more
definitive analyses and reports from both studies before drawing
final conclusions."

"Final patient visits have been completed, and the ADVANCE study
data base is close to finalisation. We expect to have definitive
results soon," said Study Director, Dr Anushka Patel, from The George
Institute. "At this stage, the Data Monitoring and Safety Committee
have reviewed results that are more than 99% complete, so we are
confident that the interim findings communicated here are a reliable
guide to the final results."

ADVANCE was conducted by an independent collaborative group of
medical researchers, with support from the National Health & Medical
Research Council of Australia and the Paris-based, Institute de
Recherche Internationales Servier.

Notes to Editor:

- 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
Australia'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.

- The Institute de Recherche Internationales Servier is the
international research funding arm of the French pharmaceutical
company, Servier. Servier manufacture modified release gliclazide
(Diamicron MR(TM)) and the fixed combination of perindopril and
indapamide (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).

- ADVANCE was designed, conducted, monitored, analysed and
reported by a collaborative medical research group independently of
all study sponsors.

- Blood pressure treatment comprised a blood pressure lowering
treatment regimen including the ACE inhibitor, perindopril, and the
diuretic, indapamide. This treatment was shown to reduce mortality in
patients with diabetes and the results were reported last year in The
Lancet.

- Lancet reference: ADVANCE Collaborative Group; Patel A,
MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S,
Poulter N, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Heller
S, Liu L, Mancia G, Mogensen C, Pan C, Rodgers A, Williams B. 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

http://www.advance-trial.com

http://www.thegeorgeinstitute.org.au

ots Originaltext: Servier Laboratories
Im Internet recherchierbar: http://www.presseportal.de

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