ADVANCE--Action in Diabetes and Vascular Disease: patient recruitment and characteristics of the study population at baseline.

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.