OBJECTIVE To study whether the effects of intensive glycemic control on major vascular outcomes (a composite of major macrovascular and major microvascular events), all-cause mortality, and severe hypoglycemia events differ among participants with different levels of 10-year risk of atherosclerotic cardiovascular disease (ASCVD) and hemoglobin A1c (HbA1c) at baseline. RESEARCH DESIGN AND METHODS We studied the effects of more intensive glycemic control in 11,071 patients with type 2 diabetes (T2D), without missing values, in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial, using Cox models. RESULTS During 5 years' follow-up, intensive glycemic control reduced major vascular events (hazard ratio [HR] 0.90 [95% CI 0.83-0.98]), with the major driver being a reduction in the development of macroalbuminuria. There was no evidence of differences in the effect, regardless of baseline ASCVD risk or HbA1c level (P for interaction = 0.29 and 0.94, respectively). Similarly, the beneficial effects of intensive glycemic control on all-cause mortality were not significantly different across baseline ASCVD risk (P = 0.15) or HbA1c levels (P = 0.87). The risks of severe hypoglycemic events were higher in the intensive glycemic control group compared with the standard glycemic control group (HR 1.85 [1.41-2.42]), with no significant heterogeneity across subgroups defined by ASCVD risk or HbA1c at baseline (P = 0.09 and 0.18, respectively). CONCLUSIONS The major benefits for patients with T2D in ADVANCE did not substantially differ across levels of baseline ASCVD risk and HbA1c.

中文翻译：

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在ADVANCE试验中，强化血糖控制对不同心血管风险水平和血红蛋白A1c的2型糖尿病患者临床结局的影响。

目的研究强化血糖控制对主要动脉结局（主要大血管和主要微血管事件的综合），全因死亡率和严重低血糖事件的影响在具有不同水平的动脉粥样硬化性心血管疾病十年风险的参与者之间是否存在差异（ASCVD）和血红蛋白A1c（HbA1c）在基线。研究设计和方法我们在糖尿病和血管疾病的作用：前TERAX和Diamicron改良释放控制评估（ADVANCE）试验中，研究了加强血糖控制在11071名2型糖尿病（T2D）患者中的价值，没有遗漏值，使用考克斯模型。结果在5年的随访中，严格的血糖控制减少了主要血管事件（危险比[HR] 0.90 [95％CI 0.83-0.98]），其主要驱动力是减少巨蛋白尿的发展。不论基线ASCVD风险或HbA1c水平如何，均没有证据表明其作用存在差异（相互作用的P分别为0.29和0.94）。同样，强化血糖控制对全因死亡率的有利影响在基线ASCVD风险（P = 0.15）或HbA1c水平（P = 0.87）之间也没有显着差异。与标准血糖对照组相比，高血糖对照组的严重低血糖事件的风险更高（HR 1.85 [1.41-2.42]），在基线时由ASCVD风险或HbA1c定义的亚组之间无显着异质性（P = 0.09和分别为0.18）。结论ADVANCE对T2D患者的主要益处在基线ASCVD风险水平和HbA1c水平上没有显着差异。