Effects of intensive blood-pressure control in type 2 diabetes mellitus.
Effects of intensive blood-pressure control in type 2 diabetes mellitus.
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DOI：
10.1056/nejmoa1001286
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发表时间：
2010-04-29
期刊：
影响因子：
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通讯作者：
Ismail-Beigi F
中科院分区：
文献类型：
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作者：
ACCORD Study Group;Cushman WC;Evans GW;Byington RP;Goff DC Jr;Grimm RH Jr;Cutler JA;Simons-Morton DG;Basile JN;Corson MA;Probstfield JL;Katz L;Peterson KA;Friedewald WT;Buse JB;Bigger JT;Gerstein HC;Ismail-Beigi F
随机试验没有证据支持将 2 型糖尿病患者的收缩压降低到 135 至 140 mm Hg 以下的策略。我们研究了针对心血管事件高风险的 2 型糖尿病患者，针对正常收缩压（即 <120 mm Hg）的治疗是否可以减少主要心血管事件。共有 4733 名 2 型糖尿病患者被随机分配接受强化治疗（目标收缩压低于 120 毫米汞柱）或标准治疗（目标收缩压低于 140 毫米汞柱）。主要复合结局是非致命性心肌梗塞、非致命性中风或心血管原因死亡。平均随访时间为 4.7 年。 1年后，强化治疗组的平均收缩压为119.3毫米汞柱，标准治疗组的平均收缩压为133.5毫米汞柱。强化治疗组主要结局的年发生率为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[CI]为0.73至1.06；P = 0.20）。两组全因年死亡率分别为 1.28% 和 1.19%（风险比，1.07；95% CI，0.85 至 1.35；P = 0.55）。两组中风（预先设定的次要结局）的年发生率分别为 0.32% 和 0.53%（风险比，0.59；95% CI，0.39 至 0.89；P = 0.01）。强化治疗组 2362 名参与者中有 77 名（3.3%）发生了归因于抗高血压治疗的严重不良事件，标准治疗组 2371 名参与者中有 30 名（1.3%）（P <0.001）。在心血管事件高风险的 2 型糖尿病患者中，与低于 140 mm Hg 的收缩压目标相比，目标收缩压低于 120 mm Hg 并不会降低致命和非致命主要心血管事件的复合结局发生率。 （ClinicalTrials.gov 编号，NCT00000620。）
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.)