Study rationale and design of ADVANCE: Action in diabetes and vascular disease - Preterax and diamicron MR controlled evaluation

J. Chalmers, M. Cooper, E. Ferrannini, P. Glasziou, D. Grobbee, P. Hamet, S. Harrap, L. Liu, S. MacMahon, G. Mancia, M. Marre, D. Matthews, C. Mogensen, B. Neal, C. Yu Pan, N. Poulter, A. Rodgers, B. Williams, M. Woodward, R. CollinsP. Sandercock, P. Sleight, R. Holman, G. Fulcher, C. Pollock, D. Celermajer, J. Watson, B. Harrisberg, R. Currie, S. Girgis, K. Jayne, H. Monaghan, A. Patel, A. Richens, B. Gray, A. Milne, A. Adderkin, A. Bak, S. Flett, D. De Guise, E. Jetses, J. Reid, R. Stolk, W. Wang, F. Williams, X. Zou

Research output: Contribution to journalArticle

Abstract

Aims/hypothesis. Patients with Type II (non-insulin-dependent) diabetes mellitus are at increased risk of macrovascular and microvascular disease, both of which are reduced by controlling raised blood pressure in hypertensive patients. Intensive glycaemic control has also been shown to reduce microvascular disease but the effects on macrovascular disease remain uncertain. This study will examine the hypotheses that lowering blood pressure with an ACE inhibitor-diuretic combination and intensively controlling gylcaemia with a sulphonylurea-based regimen in high-risk patients with Type II diabetes (both hypertensive and non-hypertensive) reduces the incidence of macrovascular and microvascular disease. Methods. The study is a 2 × 2 factorial randomised controlled trial that will include 10000 adults with Type II diabetes at high risk of vascular disease. Following 6 weeks on open label perindopril-indapamide combination, eligible patients are randomised to continued perindopril-indapamide or matching placebo, and to an intensive gliclazide MR-based glucose control regimen or usual guidelines-based therapy. Primary outcomes are, first, the composite of non-fatal stroke, non-fatal myocardial infarction or cardiovascular death and, second, the composite of new or worsening nephropathy or diabetic eye disease. The scheduled average duration of treatment and follow-up is 4.5 years. The study will be conducted in approximately 200 centres in Australasia, Asia, Europe and North America. Conclusion/interpretation. ADVANCE is designed to provide reliable evidence on the balance of benefits and risks conferred by blood pressure lowering therapy and intensive glucose control therapy in high-risk diabetic patients, regardless of initial blood pressure or glucose concentrations.

Original languageEnglish
Pages (from-to)1118-1120
Number of pages3
JournalDiabetologia
Volume44
Issue number9
DOIs
Publication statusPublished - 2001

Keywords

  • Blood glucose
  • Blood pressure
  • Cardiovascular disease
  • Controlled clinical trial
  • Diabetes mellitus
  • Diabetic nephropathy
  • Diabetic retinopathy

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

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    Chalmers, J., Cooper, M., Ferrannini, E., Glasziou, P., Grobbee, D., Hamet, P., Harrap, S., Liu, L., MacMahon, S., Mancia, G., Marre, M., Matthews, D., Mogensen, C., Neal, B., Yu Pan, C., Poulter, N., Rodgers, A., Williams, B., Woodward, M., ... Zou, X. (2001). Study rationale and design of ADVANCE: Action in diabetes and vascular disease - Preterax and diamicron MR controlled evaluation. Diabetologia, 44(9), 1118-1120. https://doi.org/10.1007/s001250100612