@article{335cb6205df44b09a33eae0a8044ca87,
title = "Study rationale and design of ADVANCE: Action in diabetes and vascular disease - Preterax and diamicron MR controlled evaluation",
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.",
keywords = "Blood glucose, Blood pressure, Cardiovascular disease, Controlled clinical trial, Diabetes mellitus, Diabetic nephropathy, Diabetic retinopathy",
author = "J. Chalmers and M. Cooper and E. Ferrannini and P. Glasziou and D. Grobbee and P. Hamet and S. Harrap and L. Liu and S. MacMahon and G. Mancia and M. Marre and D. Matthews and C. Mogensen and B. Neal and {Yu Pan}, C. and N. Poulter and A. Rodgers and B. Williams and M. Woodward and R. Collins and P. Sandercock and P. Sleight and R. Holman and G. Fulcher and C. Pollock and D. Celermajer and J. Watson and B. Harrisberg and R. Currie and S. Girgis and K. Jayne and H. Monaghan and A. Patel and A. Richens and B. Gray and A. Milne and A. Adderkin and A. Bak and S. Flett and {De Guise}, D. and E. Jetses and J. Reid and R. Stolk and W. Wang and F. Williams and X. Zou",
note = "Funding Information: Acknowledgements. ADVANCE is an investigator-initiated and -conducted study, funded by a grant from the Institut de Re-cherches Internationales Servier. Members of the Management Committee: J. Chalmers*, Chairman, Australia; M. Cooper, Australia; E. Ferrannini*, Italy; P. Glasziou, Australia; D. Grobbee, Netherlands; P. Hamet, Canada; S. Harrap, Australia; L. Liu, People's Republic of China; S. MacMahon*, Vice-Chairman, Australia; G. Mancia, Italy; M. Marre, France; D. Matth-ews, United Kingdom; C. Mogensen, Denmark; B. Neal*, Australia; C. Yu Pan, People's Republic of China; N. Poulter, United Kingdom; A. Rodgers, New Zealand; B. Williams, United Kingdom; M. Woodward, Australia. Members of the Data and Safety Monitoring Committee (United Kingdom): R. Collins, P. Sanderc oc k, P. Sleight, R. Holman. Members of the Endpoint Adjudication Committee (Australia): G. Fulcher, C. Pollock, D. Celermajer, J. Watson, B. Harrisberg. Staff of the International Coordinating Centre (Australia): R. Currie, S. Girgis*, K. Jayne, H. Monaghan, A. Patel*, A. Richens. Staff of the Data Management Centre (New Zealand): B. Gray, A. Milne. Staff of the Regional Coordinating Centres: A. Adderkin, United Kingdom; A. Bak, Netherlands; S. Flett, Australia; D. de Guise, Canada; E. Jetses, Netherlands; J. Reid, Australia; R. Stolk, Netherlands; W. Wang, China; F. Williams, Australia; X. Zou, China. *Members of the Writing Subcommittee.",
year = "2001",
doi = "10.1007/s001250100612",
language = "English (US)",
volume = "44",
pages = "1118--1120",
journal = "Diabetologia",
issn = "0012-186X",
publisher = "Springer Verlag",
number = "9",
}