强化血糖控制对心血管结局的长期影响。
Long-term effects of intensive glucose lowering on cardiovascular outcomes.
出版信息
N Engl J Med. 2011 Mar 3;364(9):818-28. doi: 10.1056/NEJMoa1006524.
BACKGROUND
Intensive glucose lowering has previously been shown to increase mortality among persons with advanced type 2 diabetes and a high risk of cardiovascular disease. This report describes the 5-year outcomes of a mean of 3.7 years of intensive glucose lowering on mortality and key cardiovascular events.
METHODS
We randomly assigned participants with type 2 diabetes and cardiovascular disease or additional cardiovascular risk factors to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level of 7 to 7.9%). After termination of the intensive therapy, due to higher mortality in the intensive-therapy group, the target glycated hemoglobin level was 7 to 7.9% for all participants, who were followed until the planned end of the trial.
RESULTS
Before the intensive therapy was terminated, the intensive-therapy group did not differ significantly from the standard-therapy group in the rate of the primary outcome (a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes) (P=0.13) but had more deaths from any cause (primarily cardiovascular) (hazard ratio, 1.21; 95% confidence interval [CI], 1.02 to 1.44) and fewer nonfatal myocardial infarctions (hazard ratio, 0.79; 95% CI, 0.66 to 0.95). These trends persisted during the entire follow-up period (hazard ratio for death, 1.19; 95% CI, 1.03 to 1.38; and hazard ratio for nonfatal myocardial infarction, 0.82; 95% CI, 0.70 to 0.96). After the intensive intervention was terminated, the median glycated hemoglobin level in the intensive-therapy group rose from 6.4% to 7.2%, and the use of glucose-lowering medications and rates of severe hypoglycemia and other adverse events were similar in the two groups.
CONCLUSIONS
As compared with standard therapy, the use of intensive therapy for 3.7 years to target a glycated hemoglobin level below 6% reduced 5-year nonfatal myocardial infarctions but increased 5-year mortality. Such a strategy cannot be recommended for high-risk patients with advanced type 2 diabetes. (Funded by the National Heart, Lung and Blood Institute; ClinicalTrials.gov number, NCT00000620.).
背景
先前的研究表明，强化血糖控制会增加伴有高心血管疾病风险的晚期 2 型糖尿病患者的死亡率。本报告描述了强化血糖控制 3.7 年后 5 年的死亡率和主要心血管事件结果。
方法
我们将 2 型糖尿病伴有心血管疾病或其他心血管危险因素的患者随机分为强化治疗组（糖化血红蛋白目标值＜6.0%）和标准治疗组（目标值 77.9%）。由于强化治疗组死亡率较高，强化治疗终止后，所有患者的糖化血红蛋白目标值均为 77.9%，直至试验计划结束。
结果
在强化治疗终止前，强化治疗组主要复合终点（非致死性心肌梗死、非致死性卒中和心血管原因导致的死亡）发生率与标准治疗组无显著差异（P=0.13），但全因死亡率更高（主要是心血管原因）（风险比 1.21；95%置信区间 [CI]，1.02 至 1.44），而非致死性心肌梗死更少（风险比 0.79；95% CI，0.66 至 0.95）。这些趋势在整个随访期间持续存在（死亡风险比 1.19；95% CI，1.03 至 1.38；非致死性心肌梗死风险比 0.82；95% CI，0.70 至 0.96）。强化干预终止后，强化治疗组的糖化血红蛋白中位数从 6.4%升至 7.2%，两组的降糖药物使用、严重低血糖发生率和其他不良事件发生率相似。
结论
与标准治疗相比，强化治疗 3.7 年使糖化血红蛋白水平低于 6%可降低 5 年非致死性心肌梗死发生率，但增加 5 年死亡率。这种策略不能推荐给伴有晚期 2 型糖尿病的高危患者。（由美国国立心肺血液研究所资助；ClinicalTrials.gov 注册号：NCT00000620。）
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