ADVANCE Diabetes Trial Results Confirm No Evidence of Safety Risk



    Findings from largest-ever clinical trial of diabetes treatments show no
    evidence that intensive treatment to lower blood glucose is associated
    with increased mortality

    MONTREAL, Feb. 28 /CNW Telbec/ - Data from the ADVANCE Study, involving
11,140 high-risk patients with type 2 diabetes, provides no evidence of an
increased risk of death among those patients receiving aggressive treatment to
lower blood glucose.
    This contrasts findings from the 10,251 patient ACCORD trial which halted
the intensive glucose control arm of the study 18 months early because a data
review revealed that patients who received intensive treatment to lower blood
glucose are at higher risk for death. While the trial will continue, patients
will be transitioned from the intensive treatment arm (targeting A1c levels of
(less than)6.0 %) to the less intensive, standard treatment arm (targeting A1c
levels of 7.0 to 7.9%).
    "Unlike what we saw in ACCORD, a rigorous review of ADVANCE data by the
Data and Safety Monitoring Committee shows that the treatment strategy of
intensively lowering blood sugar does not pose greater risk to our patients
with type 2 diabetes", says Canadian lead investigator and member of ADVANCE
Management Committee Dr. Pavel Hamet, professor of Medicine, Canada Research
Chair of Predictive Genomics at Université de Montréal and Chief, Gene
Medicine Services at Centre Hospitalier de l'Université de Montréal. "ADVANCE
is a landmark study and will continue as planned to completion. The results
will provide crucial information to help us better reduce the significant
health risks associated with type 2 diabetes."
    Type 2 diabetes increases the risk of many complications, especially
cardiovascular disease, which is the leading cause of death in people with
diabetes. Both the ADVANCE and ACCORD studies examined the effects of
intensive blood glucose and blood pressure control on the risk of
cardiovascular events such as heart attack, stroke, or death from
cardiovascular disease in patients with type 2 diabetes. A successful
reduction in overall and cardiovascular mortality in the intensive blood
pressure arm has been reported from the ADVANCE trial and published in The
Lancet in September 2007.(1)
    In ADVANCE and ACCORD, the intensive treatment arm targeted blood glucose
levels below those recommended in current treatment guidelines because
previous studies suggest that reducing blood sugar to levels to those found in
non-diabetic adults may reduce the rate of cardiovascular disease in patients
with diabetes.
    In the ADVANCE trial, which involves 20 countries worldwide including
Canada, the intensive blood glucose lowering program aimed to reduce levels of
hemoglobin A1c (a marker of long term blood glucose control) to (less than or
equal to)6.5%. Treatment included a sulfonylurea drug, gliclazide modified
release, for all patients, and a number of other agents for those patients
unable to reach target blood glucose levels. The ADVANCE trial was started in
2001 and patients were followed for an average of five years.
    Because the A1c targets in ACCORD and ADVANCE are similar, and the
intensive blood glucose control arm of ACCORD was stopped early, the ADVANCE
mortality data was reviewed by the Data and Safety Monitoring Committee to
determine if there was a similar excess risk of mortality. This committee
advised that data did not provide any confirmation of the adverse mortality
trend reported from ACCORD.
    "Final patient visits have been completed and the ADVANCE study data base
is close to finalization. We expect to have definitive results soon," said
Study Director, Dr. Anushka Patel, from The George Institute in Sydney,
Australia. "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 are a reliable guide to the final results."
    Final data from the ADVANCE trial is expected to be promising in terms of
risk minimization but multiple analyses are required before conclusions can be
drawn regarding the effects of intensive glucose control on patient outcomes.
Additional data will be available specifically from ADVANCE, and Dr. Hamet's
team, in collaboration with Prognomix in Montréal, is performing genomic
studies of the risk of complications of diabetes in this unique worldwide
patient cohort.
    The ADVANCE trial was conducted by an independent collaborative group of
medical researchers with support from the National Health & Medical Research
Council of Australia and the Institut de Recherche Internationales Servier.
The results of the blood pressure control arm of ADVANCE were presented at the
annual meeting of the European Society of Cardiology in Vienna, Austria in
September 2007. Final results of the glucose control arm of the ADVANCE trial
will be released earlier than expected, by the middle of 2008.

    The Université de Montréal with its two affiliate schools, HEC Montréal
and l'Ecole Polytechnique, constitutes the leading centre for higher learning
and research in Québec, the second in Canada, and one of the largest in North
America. Its faculty of medicine is the largest in Canada in terms of student
enrolment, and one of the major centres for health research in the country.

    The Centre hospitalier de l'Université de Montréal (CHUM) provides
specialized and ultra-specialized services to its regional and supraregional
clienteles. Within its more immediate coverage area, CHUM also offers general
and specialized hospital care and services. The CHUM has a five-part mandate,
comprising research, teaching, the assessment of technologies and healthcare
intervention methods, and the promotion of an integrated-networks approach to
health care. Hôtel-Dieu, Hôpital Notre-Dame, and Hôpital Saint-Luc form the
CHUM, with 10,000 employees, 900 physicians, 270 researchers, 5,000 students
and trainees and 800 volunteers providing services to more than 500,000
patients each year.

    The George Institute for International Health is an
internationally-recognized health research organization, undertaking high
impact research across a broad health landscape. It is a leader in the
clinical trials, health policy and capacity-building areas.

    Prognomix is a Montreal biotech company focused on the discovery of
genetic signatures associated with the complications of Type II Diabetes. The
company is concentrating on developing a molecular diagnostic test pertinent
for detection of risks to develop renal, ocular, cardiac, cerebral, vascular
and other complications of diabetic disease.

    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 Institut de Recherche Internationales Servier is the international
research funding arm of the French pharmaceutical company, Servier. Servier
manufactures 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).

    Reference:

    
    (1) 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;370:829-40.
    




For further information:

For further information: Muriel Haraoui (English media relations), HKDP
Communications and Public Affairs, (514) 395-0375 X 235, mharaoui@hkdp.qc.ca;
Genevieve Déry (French media relations), HKDP Communications and Public
Affairs, (514) 395-0375 X 232, gdery@hkdp.qc.ca; Sophie Langlois, Université
de Montréal, (514) 343-7704, sophie.langlois@umontreal.ca; Nathalie Forgue,
Centre hospitalier de l'Université de Montréal, (514) 890-8000 X 14342

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Centre hospitalier de l'Université de Montréal (CHUM)

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