TY - JOUR
T1 - ADVANCE – Action in diabetes and vascular disease
T2 - Patient recruitment and characteristics of the study population at baseline
AU - ADVANCE Collaborative Group
AU - Chalmers, John
PY - 2005/7
Y1 - 2005/7
N2 - Aims: The primary aim of ADVANCE is to determine the effects on macrovascular and microvascular disease of blood pressure lowering (with an ACE inhibitor-diuretic combination), irrespective of initial blood pressure level; and of intensive glucose lowering, in high-risk individuals with Type 2 diabetes. Methods: The study is a 2 x 2 factorial randomized controlled trial. Following 6 weeks on active perindopril-indapamide combination, eligible participants were randomized to perindopril/indapamide (initially 2.0/0.625 mg daily, increasing to 4.0/1.25 mg daily after 3 months) or matching placebo; and to an intensive gliclazide MR-based glucose control regimen aiming for a haemoglobin A1c (HbA1c) value of 6.5% or lower, or local standard therapy. The study is being conducted in 215 centres in 20 countries within Australasia, Asia, Europe and North America. Results: Recruitment commenced in June 2001 and was completed in March 2003, with the inclusion of 11 140 randomized participants. Fifty-seven per cent of participants are male and the mean age at baseline was 66 years. On average, the diagnosis of diabetes was made 8 years before study entry. At baseline 32 and 10% of patients had a history of macrovascular and microvascular disease, respectively. The mean blood pressure at baseline was 145/81 mmHg; the mean HbA1c concentration was 7.5%. While blood pressure and HbA1c values were broadly similar, certain characteristics of randomized participants varied between countries. Conclusions: With successful worldwide recruitment completed, ADVANCE should provide reliable and broadly generalizable results on the effects of routine blood pressure lowering and intensive glucose control in high-risk individuals with Type 2 diabetes.
AB - Aims: The primary aim of ADVANCE is to determine the effects on macrovascular and microvascular disease of blood pressure lowering (with an ACE inhibitor-diuretic combination), irrespective of initial blood pressure level; and of intensive glucose lowering, in high-risk individuals with Type 2 diabetes. Methods: The study is a 2 x 2 factorial randomized controlled trial. Following 6 weeks on active perindopril-indapamide combination, eligible participants were randomized to perindopril/indapamide (initially 2.0/0.625 mg daily, increasing to 4.0/1.25 mg daily after 3 months) or matching placebo; and to an intensive gliclazide MR-based glucose control regimen aiming for a haemoglobin A1c (HbA1c) value of 6.5% or lower, or local standard therapy. The study is being conducted in 215 centres in 20 countries within Australasia, Asia, Europe and North America. Results: Recruitment commenced in June 2001 and was completed in March 2003, with the inclusion of 11 140 randomized participants. Fifty-seven per cent of participants are male and the mean age at baseline was 66 years. On average, the diagnosis of diabetes was made 8 years before study entry. At baseline 32 and 10% of patients had a history of macrovascular and microvascular disease, respectively. The mean blood pressure at baseline was 145/81 mmHg; the mean HbA1c concentration was 7.5%. While blood pressure and HbA1c values were broadly similar, certain characteristics of randomized participants varied between countries. Conclusions: With successful worldwide recruitment completed, ADVANCE should provide reliable and broadly generalizable results on the effects of routine blood pressure lowering and intensive glucose control in high-risk individuals with Type 2 diabetes.
KW - Blood pressure
KW - Glucose control
KW - Macrovascular disease
KW - Microvascular disease
KW - Type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=21744456865&partnerID=8YFLogxK
U2 - 10.1111/j.1464-5491.2005.01596.x
DO - 10.1111/j.1464-5491.2005.01596.x
M3 - Article
C2 - 15975103
AN - SCOPUS:21744456865
SN - 0742-3071
VL - 22
SP - 882
EP - 888
JO - Diabetic Medicine
JF - Diabetic Medicine
IS - 7
ER -