Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease
Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease
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DOI：
10.1056/nejmoa1600175
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发表时间：
2016-05-26
影响因子：
158.5
通讯作者：
Yusuf, Salim
中科院分区：
文献类型：
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作者：
Lonn, Eva M.;Bosch, Jackie;Yusuf, Salim
背景：降压治疗可降低高危人群和收缩压为160 mm Hg或更高的人群发生心血管事件的风险，但其在中度风险和低血压人群中的作用尚不清楚。方法在一项2 × 2因子试验的比较中，我们随机分配了12,705名没有心血管疾病的中等风险参与者，接受坎地沙坦（16 mg /天）加氢氯噻嗪（12.5 mg /天）或安慰剂治疗。第一个主要结局是心血管死亡、非致死性心肌梗死或非致死性中风的复合结局；第二个主要结局还包括复苏的心脏骤停、心力衰竭和血运重建。中位随访时间为5.6年。结果受试者基线时平均血压为138.1/81.9 mm Hg；积极治疗组的血压下降幅度比安慰剂组大6.0/3.0 mm Hg。积极治疗组有260人（4.1%）出现第一个主要结局，安慰剂组有279人（4.4%）出现第一个主要结局（风险比0.93；95%可信区间[CI]， 0.79 ~ 1.10; P = 0.40）；第二个主要结局分别发生在312名参与者（4.9%）和328名参与者（5.2%）中（风险比，0.95;95% CI, 0.81 ~ 1.11; P = 0.51）。在三个预先设定的基于假设的亚组中，积极治疗组收缩压（>143.5 mm Hg）上三分之一亚组的参与者的第一和第二主要结局的发生率显著低于安慰剂组；在中下三分之一中，效果为中性（两种结果的趋势分别为P = 0.02和P = 0.009）。结论：在没有心血管疾病的中等风险人群中，坎地沙坦（16 mg /天）加氢氯噻嗪（12.5 mg /天）治疗与主要心血管事件发生率低于安慰剂无关。(由加拿大卫生研究院和阿斯利康公司资助；临床试验。网址：NCT00468923。)
BACKGROUNDAntihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear.METHODSIn one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years.RESULTSThe mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P = 0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P = 0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P = 0.02 and P = 0.009, respectively, for trend in the two outcomes).CONCLUSIONSTherapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular events than placebo among persons at intermediate risk who did not have cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; ClinicalTrials. gov number, NCT00468923.)