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Etude ADVANCE
Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial
Dr Anushka Patel FRACP , ADVANCE Collaborative Group
The Lancet 2007; 370:829-840

Les patients atteints d'un diabète de type 2 ont un risque vasculaire accru qui, chez les patients hypertendus, peut être réduit par l'abaissement des chiffres de pression artérielle.
L'étude ADVANCE montre que l'administration en routine d'une combinaison fixe de perindopril-indapamide (Prétérax ®) à des patients atteints de diabète de type 2 est bien tolérée et réduit les risque d'événements cardio-vasculaires majeurs, y compris de décès. Bien que les intervalles de confiance soient larges, ces résultats suggèrent que sur 5 ans, 1 décès toute cause pouvait être évité si 79 patients étaient traités avec ce traitement actif.

Esculape
L'étude Adavance a suivi pendant 4,3 ans "11 140 patients with type 2 diabetes were randomised to treatment with a fixed combination of perindopril and indapamide or matching placebo, in addition to current therapy. "
Cela me semble "unfair" que la moitié des patients DNID soient sous placébothérapie alors que des recommandations pour ces parents diabétiques existent (IEC)

D'autre part, dans cette étude contre placebo, on a du mal à savoir le bénéfice réel de cette association (perindopril and indapamide) versus IEC seul... voire IEC et la place respective du contrôle glycémique et du contrôle de la pression artérielle

Revoir l'étude HOPE ([Effets d'un Inhibiteur de l'enzyme de conversion, le ramipril, sur les incidents cardiovasculaires chez des patients à haut risque ) [Lire]


Background
Blood pressure is an important determinant of the risks of macrovascular and microvascular complications of type 2 diabetes, and guidelines recommend intensive lowering of blood pressure for diabetic patients with hypertension. We assessed the effects of the routine administration of an angiotensin converting enzyme (ACE) inhibitor-diuretic combination on serious vascular events in patients with diabetes, irrespective of initial blood pressure levels or the use of other blood pressure lowering drugs.

Methods
The trial was done by 215 collaborating centres in 20 countries. After a 6-week active run-in period, 11 140 patients with type 2 diabetes were randomised to treatment with a fixed combination of perindopril and indapamide or matching placebo, in addition to current therapy. The primary endpoints were composites of major macrovascular and microvascular events, defined as death from cardiovascular disease, non-fatal stroke or non-fatal myocardial infarction, and new or worsening renal or diabetic eye disease, and analysis was by intention-to-treat. The macrovascular and microvascular composites were analysed jointly and separately. This trial is registered with ClinicalTrials.gov, number NCT00145925.

Findings

After a mean of 4.3 years of follow-up, 73% of those assigned active treatment and 74% of those assigned control remained on randomised treatment.
  • Compared with patients assigned placebo, those assigned active therapy had a mean reduction in systolic blood pressure of 5·6 mm Hg and diastolic blood pressure of 2·2 mm Hg.
  • The relative risk of a major macrovascular or microvascular event was reduced by 9% (861 [15·5%] active vs 938 [16·8%] placebo; hazard ratio 0·91, 95% CI 0·83–1·00, p=0·04).
  • The separate reductions in macrovascular and microvascular events were similar but were not independently significant (macrovascular 0·92; 0·81–1·04, p=0·16; microvascular 0·91; 0·80–1·04, p=0·16).
  • The relative risk of death from cardiovascular disease was reduced by 18% (211 [3·8%] active vs 257 [4·6%] placebo; 0·82, 0·68–0·98, p=0·03) and death from any cause was reduced by 14% (408 [7·3%] active vs 471 [8·5%] placebo; 0·86, 0·75–0·98, p=0·03).
  • There was no evidence that the effects of the study treatment differed by initial blood pressure level or concomitant use of other treatments at baseline.
Interpretation

Routine administration of a fixed combination of perindopril and indapamide to patients with type 2 diabetes was well tolerated and reduced the risks of major vascular events, including death. Although the confidence limits were wide, the results suggest that over 5 years, one death due to any cause would be averted among every 79 patients assigned active therapy.

Esculape :Dans cette étude contre placebo, on a du mal à savoir le bénéfice réel de cette association (perindopril and indapamide) versus IEC seul... voire IEC et la place respective du contrôle glycémique et du contrôle de la pression artérielle
Revoir l'étude HOPE ([Effets d'un Inhibiteur de l'enzyme de conversion, le ramipril, sur les incidents cardiovasculaires chez des patients à haut risque ) [Lire]
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