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ADVANCE
Action in Diabetes and Vascular disease; Preterax and Diamicron-MR Controlled Evaluation
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Author(s) |
(a) Chalmers J
(b) ADVANCE Collaborative Group
(c) Chalmers J, Perkovic V, Joshi R, Patel A
(d) Du X, Ninomiya T, de Galan B, Abadir E, Chalmers J, Pillai A, Woodward M, Cooper M, Harrap S, Hamet P, Poulter N, Lip GYH, Patel A
(e) Zoungas S, de Galan BE, Ninomiya T, Grobbee D, Hamet P, Heller S, MacMahon S, Marre M, Neal B, Patel A, Woodward M, Chalmers J |
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Title(s) |
(a) Etude ADVANCE: objectifs, protocole et état actuel
(b) ADVANCE – Action in Diabetes and Vascular Disease: patient recruitment and characteristics of the study population at baseline
(c) ADVANCE: breaking new ground in type 2 diabetes
(d) Risks of cardiovascular events and effects of routine blood pressure lowering among patients with type 2 diabetes and atrial fibrillation: results of the ADVANCE study
(e) Combined effects of routine blood pressure lowering and intensive glucose control on macrovascular and microvascular outcomes in patients with type 2 diabetes. New results from the ADVANCE trial |
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Reference(s) |
(a) Drugs 2003;63 Special Issue 1:39–44
(b) Diabet Med 2005;22:882–8
(c) J Hypertens 2006;24 Suppl 5:S22–8
(d) Eur Heart J 2009;30:1128–35
(e) Diabetes Care 2009;32:2068–74 |
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Disease |
Type 2 diabetes mellitus |
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Purpose |
To assess whether antihypertensive treatment with an ACE inhibitor and a diuretic plus intensive glycaemic control can reduce mortality and cardiovascular disease outcomes in high-risk patients with type 2 diabetes with and without atrial fibrillation |
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Study design |
Randomised, 2 x 2 factorial
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Follow-up |
Mean 4.3 years
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Patients |
11,140 patients, aged ≥ 55 years, with type 2 diabetes diagnosed at age ≥ 30 years and a substantially elevated risk of vascular disease
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Treatment regimen |
Perindopril, 2 mg/day, plus indapamide, 0.625 mg/day, for 3 months, then perindopril, 4 mg/day, plus indapamide, 1.25 mg/day, or placebo, in addition to either glycaemic control with gliclazide, to target HbA1c ≤ 6.5%, or standard guideline-based therapy
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Results |
Patients with atrial fibrillation at baseline were found at significantly higher risks of cardiovascular events and all-cause mortality compared to those without atrial fibrillation. After adjusting for a range of covariate, atrial fibrillation was associated with a 61% greater risk of all-cause mortality (p < 0.0001) and comparable higher risk of cardiovascular death, stroke and heart failure (all p < 0.001). Treatment with perindopril plus indapamide reduced BP more than placebo in patients with and without atrial fibrillation. Active treatment produced similar relative risk reductions in all-cause mortality, cardiovascular death and major coronary events in patients with and without atrial fibrillation (all p < 0.3). No interaction was found between perindopril plus indapamide treatment and intensive glycaemic control for any clinical endpoint (p > 0.1). Compared to patients receiving standard glycaemic control, combination treatment with perindopril plus indapamide and intensive glycaemic control was associated with an 18% reduction in the risk of all-cause mortality (95% CI 1–32; p = 0.04) |
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Comments |
This study has been the basis for a number of publications. A selection of references:
Cognitive function
– de Galan BE et al, Diabetologia 2009;52:2328–36
Renal outcomes
– de Galan BE et al, J Am Soc Nephrol 2009;20:883–92
– Ninomiya T et al, J Am Soc Nephrol 2009;20:1813–21
Retinal measurement (AdRem substudy)
– Stolk RP et al. Contemp Clin Trials 2007;28:6–17
– Stolk RP et al. Diabetes Care 2008;31:708–13
– Beulens JWJ et al, Diabetologia 2009;52:2027–36 |
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