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常规降压对老年糖尿病患者的疗效和安全性:来自 ADVANCE 试验的结果。

Efficacy and safety of routine blood pressure lowering in older patients with diabetes: results from the ADVANCE trial.

机构信息

The George Institute for International Health, University of Sydney, New South Wales, Australia.

出版信息

J Hypertens. 2010 Jun;28(6):1141-9.

PMID:20486273
Abstract

OBJECTIVE

The efficacy and safety of blood pressure lowering in elderly patients have not been sufficiently investigated in patients with diabetes. Using data from the Action in Diabetes and Vascular disease: preterAx and diamicroN-MR Controlled Evaluation study, we assessed the efficacy and safety of routine blood pressure lowering to prevent major clinical outcomes in elderly patients with type 2 diabetes.

METHODS

Eleven thousand one hundred and forty patients aged at least 55 years with type 2 diabetes (mean 66+/-6 years) were randomly assigned to perindopril-indapamide or placebo. The primary endpoint was a composite of major macrovascular and microvascular disease. The effects of active treatment on outcomes were estimated in subgroups according to age: below 65, 65-74 and at least 75 years.

RESULTS

During a mean 4.3-year follow-up, 1799 (16.1%) patients experienced a major event. Active treatment produced similar relative risk reductions for the primary outcome, major macrovascular disease, death and renal events across age groups (all P heterogeneity >0.3). Over 5 years, active treatment was estimated to prevent one primary outcome in every 21, 71 and 118 patients of at least 75, 65-74 and below 65 years, respectively. Similar patterns of benefits were observed for secondary outcomes. There were no differences in the tolerability between randomized allocations across age groups (all P heterogeneity >0.6)

CONCLUSION

Routine administration of perindopril-indapamide lowers blood pressure safely and reduces the risk of major clinical outcomes in patients of at least 75 years with type 2 diabetes. The greater absolute benefits in older patients in this age group were not offset by an increased risk of side effects.

摘要

目的

在患有糖尿病的患者中,尚未充分研究降压治疗对老年患者的疗效和安全性。利用来自糖尿病和血管疾病的行动:预先和 diamicroN-MR 对照评估研究的数据,我们评估了常规降压治疗预防 2 型糖尿病老年患者主要临床结局的疗效和安全性。

方法

11140 例年龄至少 55 岁的 2 型糖尿病患者(平均 66+/-6 岁)被随机分配至培哚普利吲达帕胺或安慰剂组。主要终点是主要大血管和微血管疾病的复合终点。根据年龄亚组(<65 岁、65-74 岁和≥75 岁)估计活性治疗对结局的影响。

结果

在平均 4.3 年的随访期间,1799 例(16.1%)患者发生了主要事件。在所有年龄组中,活性治疗对主要结局、大血管疾病、死亡和肾脏事件的相对风险降低均相似(所有 P 异质性>0.3)。在 5 年内,估计每 21、71 和 118 例至少 75、65-74 和<65 岁的患者中,活性治疗可预防 1 例主要结局。次要结局也观察到类似的获益模式。在所有年龄组中,随机分组之间的耐受性差异无统计学意义(所有 P 异质性>0.6)。

结论

常规应用培哚普利吲达帕胺可安全降压,并降低 2 型糖尿病至少 75 岁患者主要临床结局的风险。在该年龄组中,老年患者的绝对获益更大,但并未因副作用风险增加而抵消。

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