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Vol 3, No 1 (2002): Practical Diabetology
Original articles (translated)
Published online: 2001-12-06
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Study rationale and design of ADVANCE: action in diabetes and vascular disease-preterax and diamicron MR controlled evaluation

Grupa nadzorująca badanie ADVANCE
Diabetologia Praktyczna 2002;3(1):25-30.

open access

Vol 3, No 1 (2002): Practical Diabetology
Original articles (translated)
Published online: 2001-12-06

Abstract

INTRODUCTION. 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 glycaemia 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.
MATERIAL AND METHODS. The study is a 2 x 2 factorial randomized controlled trial that will include 10 000 adults with Type II diabetes at high risk of vascular disease. Following 6 weeks on open label perindopril-indapamide combination, eligible patients are randomized to continued perindopril-indapamide or matching placebo, and to an intensive gliclazide MR-based glucose control regiment 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. ADVANCE is designed to provide reliable evidence on the balance of benefits and risk conferred by blood pressure lowering therapy and intensive glucose control therapy in high-risk diabetic patients, regardless of initial blood pressure or glucose concentrations.

Abstract

INTRODUCTION. 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 glycaemia 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.
MATERIAL AND METHODS. The study is a 2 x 2 factorial randomized controlled trial that will include 10 000 adults with Type II diabetes at high risk of vascular disease. Following 6 weeks on open label perindopril-indapamide combination, eligible patients are randomized to continued perindopril-indapamide or matching placebo, and to an intensive gliclazide MR-based glucose control regiment 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. ADVANCE is designed to provide reliable evidence on the balance of benefits and risk conferred by blood pressure lowering therapy and intensive glucose control therapy in high-risk diabetic patients, regardless of initial blood pressure or glucose concentrations.
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Keywords

diabetes mellitus; blood pressure; blood glucose; cardiovascular disease; diabetic nephropathy; diabetic retinopathy; controlled clinical trial

About this article
Title

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

Journal

Clinical Diabetology

Issue

Vol 3, No 1 (2002): Practical Diabetology

Pages

25-30

Published online

2001-12-06

Bibliographic record

Diabetologia Praktyczna 2002;3(1):25-30.

Keywords

diabetes mellitus
blood pressure
blood glucose
cardiovascular disease
diabetic nephropathy
diabetic retinopathy
controlled clinical trial

Authors

Grupa nadzorująca badanie ADVANCE

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