Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes
Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes
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DOI：
10.1056/nejmoa0808431
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发表时间：
2009-01-08
影响因子：
158.5
通讯作者：
Huang, Grant D.
中科院分区：
文献类型：
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作者：
Duckworth, William;Abraira, Carlos;Huang, Grant D.
背景强化血糖控制对长期2型糖尿病患者心血管事件的影响尚不清楚。方法：我们随机分配1791名对2型糖尿病治疗反应不理想的退伍军人（平均年龄60.4岁）接受强化或标准血糖控制。其他心血管危险因素统一处理。自诊断出糖尿病以来的平均年数为11.5年，40%的患者已经有过心血管疾病。强化治疗组的目标是与标准治疗组相比，糖化血红蛋白水平绝对降低1.5个百分点。主要终点是从随机分配到首次发生主要心血管事件、心肌梗死、中风、心血管原因死亡、充血性心力衰竭、血管疾病手术、不能手术的冠状动脉疾病和缺血性坏疽截肢的时间。结果中位随访5.6年。标准治疗组的中位糖化血红蛋白水平为8.4%，强化治疗组为6.9%。标准治疗组264例患者出现主要结局，强化治疗组235例患者出现主要结局（强化治疗组的风险比为0.88；95%可信区间[CI]， 0.74 ~ 1.05; P = 0.14）。两组在主要结局的任何组成部分或任何原因的死亡率方面均无显著差异（风险比为1.07；95% CI为0.81 ~ 1.42;P = 0.62）。两组微血管并发症无明显差异。不良事件发生率，以低血糖为主，标准治疗组为17.6%，强化治疗组为24.1%。结论：控制不良的2型糖尿病患者强化血糖控制对主要心血管事件、死亡或微血管并发症发生率无显著影响。(临床试验。网址：NCT00032487)。
Background The effects of intensive glucose control on cardiovascular events in patients with long-standing type 2 diabetes mellitus remain uncertain.Methods We randomly assigned 1791 military veterans ( mean age, 60.4 years) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or standard glucose control. Other cardiovascular risk factors were treated uniformly. The mean number of years since the diagnosis of diabetes was 11.5, and 40% of the patients had already had a cardiovascular event. The goal in the intensive- therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level, as compared with the standard- therapy group. The primary outcome was the time from randomization to the first occurrence of a major cardiovascular event, a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene.Results The median follow- up was 5.6 years. Median glycated hemoglobin levels were 8.4% in the standard- therapy group and 6.9% in the intensive- therapy group. The primary outcome occurred in 264 patients in the standard- therapy group and 235 patients in the intensive- therapy group (hazard ratio in the intensive- therapy group, 0.88; 95% confidence interval [CI], 0.74 to 1.05; P = 0.14). There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause ( hazard ratio, 1.07; 95% CI, 0.81 to 1.42; P = 0.62). No differences between the two groups were observed for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard- therapy group and 24.1% in the intensive- therapy group.Conclusions Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications. (ClinicalTrials. gov number, NCT00032487.).