N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
There is no evidence from randomized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus. We investigated whether therapy targeting normal systolic pressure (i.e., <120 mm Hg) reduces major cardiovascular events in participants with type 2 diabetes at high risk for cardiovascular events.
A total of 4733 participants with type 2 diabetes were randomly assigned to intensive therapy, targeting a systolic pressure of less than 120 mm Hg, or standard therapy, targeting a systolic pressure of less than 140 mm Hg. The primary composite outcome was nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years.
After 1 year, the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the standard-therapy group. The annual rate of the primary outcome was 1.87% in the intensive-therapy group and 2.09% in the standard-therapy group (hazard ratio with intensive therapy, 0.88; 95% confidence interval [CI], 0.73 to 1.06; P=0.20). The annual rates of death from any cause were 1.28% and 1.19% in the two groups, respectively (hazard ratio, 1.07; 95% CI, 0.85 to 1.35; P=0.55). The annual rates of stroke, a prespecified secondary outcome, were 0.32% and 0.53% in the two groups, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P=0.01). Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group (3.3%) and 30 of the 2371 participants in the standard-therapy group (1.3%) (P<0.001).
In patients with type 2 diabetes at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events. (ClinicalTrials.gov number, NCT00000620.)
没有随机试验的证据支持将收缩压降至 135 至 140mmHg 以下的策略用于 2 型糖尿病患者。我们研究了将目标收缩压设定为正常范围（即<120mmHg）的治疗方法是否可以降低心血管事件高危的 2 型糖尿病患者的主要心血管事件发生率。
共有 4733 名 2 型糖尿病患者被随机分配到强化治疗组，目标收缩压<120mmHg；或标准治疗组，目标收缩压<140mmHg。主要复合结局是非致死性心肌梗死、非致死性卒中和心血管原因导致的死亡。平均随访时间为 4.7 年。
治疗 1 年后，强化治疗组的平均收缩压为 119.3mmHg，标准治疗组为 133.5mmHg。强化治疗组的主要结局年发生率为 1.87%，标准治疗组为 2.09%（强化治疗的风险比为 0.88；95%置信区间为 0.73 至 1.06；P=0.20）。两组的任何原因死亡率分别为 1.28%和 1.19%（风险比为 1.07；95%置信区间为 0.85 至 1.35；P=0.55）。两组的卒中发生率（预先设定的次要结局）分别为 0.32%和 0.53%（风险比为 0.59；95%置信区间为 0.39 至 0.89；P=0.01）。强化治疗组 2362 名患者中有 77 例（3.3%）和标准治疗组 2371 名患者中有 30 例（1.3%）发生与降压治疗相关的严重不良事件（P<0.001）。
与收缩压目标<140mmHg 相比，将心血管事件高危的 2 型糖尿病患者的收缩压目标设定为<120mmHg 并不能降低致死性和非致死性主要心血管事件的复合发生率。（ClinicalTrials.gov 编号，NCT00000620。）
