The George Institute for Global Health, University of Sydney, Sydney, Australia.
Diabetes Res Clin Pract. 2012 Oct;98(1):83-90. doi: 10.1016/j.diabres.2012.05.002. Epub 2012 Jun 5.
To asses differences in treatment effects of a fixed combination of perindopril-indapamide on major clinical outcomes in patients with type 2 diabetes across subgroups of cardiovascular risk.
11,140 participants with type 2 diabetes, from the ADVANCE trial, were randomized to perindopril-indapamide or matching placebo. The Framingham equation was used to calculate 5-year CVD risk and to divide participants into two risk groups, moderate-high risk (<25% and no history of macrovascular disease), very high risk (>25% and/or history of macrovascular disease). Endpoints were macrovascular and microvascular events.
The mean age of participants was 66 years (42.5% female). 1000 macrovascular and 916 microvascular events were recorded over follow-up of 4.3 years. Relative treatment effects were similar across risk groups, (all P-values for heterogeneity ≥0.38). Hazard ratios for combined macro- and microvascular events were 0.89 (0.77-1.03) for the moderate-high risk and 0.92 (0.81-1.03) for the very high risk. Absolute treatment effects tended to be greater in the high risk groups although differences were not statistically significant (P>0.05).
Relative effects of blood pressure lowering with perindopril-indapamide on cardiovascular outcomes were similar across risk groups whilst absolute effects trended to be greater in the high risk group.
评估培哚普利吲达帕胺固定复方制剂在不同心血管风险亚组的 2 型糖尿病患者主要临床结局的治疗效果差异。
ADVANCE 试验共纳入 11140 例 2 型糖尿病患者，随机分配至培哚普利吲达帕胺组或匹配安慰剂组。采用弗雷明汉方程计算 5 年心血管疾病风险，并将参与者分为中高危组（<25%，无大血管疾病史）和极高危组（>25%，或有大血管疾病史）。主要终点为大血管和微血管事件。
参与者的平均年龄为 66 岁（42.5%为女性）。随访 4.3 年后，共记录到 1000 例大血管事件和 916 例微血管事件。在各风险组中，相对治疗效果相似（所有异质性 P 值均≥0.38）。中高危组和极高危组复合大血管和微血管事件的风险比分别为 0.89（0.77-1.03）和 0.92（0.81-1.03）。尽管高危组的绝对治疗效果似乎更大，但差异无统计学意义（P>0.05）。
培哚普利吲达帕胺降低血压对心血管结局的相对疗效在各风险组中相似，而绝对疗效在高危组中呈增加趋势。
