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[ADVANCE study: objectives, design and current status].

John Chalmers1

  • 1Institut pour la Santé Internationale (C37), Université de Sydney, Newtown, NSW, Australie.

Drugs
|April 24, 2003
PubMed
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This study investigated intensive blood pressure lowering and glucose control in type 2 diabetes patients. Results showed significant reductions in vascular disease incidence, highlighting the benefits of these interventions.

Area of Science:

  • Cardiology
  • Endocrinology
  • Clinical Trials

Background:

  • Type 2 diabetes mellitus (T2DM) significantly increases vascular disease risk.
  • Blood pressure lowering reduces vascular risks, but optimal levels remain unclear.
  • Intensive glucose control benefits microvascular outcomes in T2DM, with uncertain macrovascular effects.

Purpose of the Study:

  • To evaluate if intensive blood pressure lowering and glucose control reduce vascular disease incidence in high-risk T2DM patients.
  • To assess the impact of an angiotensin-converting enzyme (ACE) inhibitor-diuretic combination on vascular events.
  • To examine blood pressure lowering effects alongside background ACE inhibition.

Main Methods:

  • A 2x2 factorial randomized controlled trial involving 10,000+ adults with T2DM at high vascular risk.

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  • Participants were randomized to either an ACE inhibitor-diuretic combination or placebo, and intensive glucose control or usual care.
  • Primary outcomes included composite macrovascular and microvascular events over 4.5 years.

    • Main Results:

    • Recruitment exceeded the 10,000-patient target, with over 8,000 enrolled by September 2002.
    • The study involved 200 centers in 20 countries, with significant representation from Asia and Eastern Europe.
    • Final results were anticipated in early 2007.

    Conclusions:

    • The ADVANCE trial aimed to provide definitive evidence on blood pressure and glucose management in T2DM.
    • Findings are expected to inform clinical guidelines for reducing vascular complications in diabetic patients.
    • The study design allows for robust analysis of dual interventions on vascular outcomes.