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首个由自我测量家庭血压指导的降压治疗临床试验中的心血管结局。

Cardiovascular outcomes in the first trial of antihypertensive therapy guided by self-measured home blood pressure.

机构信息

1] Department of Cardiovascular Diseases, Division of Hypertension and Cardiovascular Rehabilitation, Studies Coordinating Centre, University of Leuven, Leuven, Belgium [2] Department of Planning for Drug Development and Clinical Evaluation, Tohoku University Graduate School of Pharmaceutical Sciences, Sendai, Japan.

出版信息

Hypertens Res. 2012 Nov;35(11):1102-10. doi: 10.1038/hr.2012.125. Epub 2012 Aug 16.

Abstract

Hypertension guidelines recommend blood pressure self-measurement at home (HBP), but no previous trial has assessed cardiovascular outcomes in hypertensive patients treated according to HBP. The multicenter Hypertension Objective Treatment Based on Measurement by Electrical Devices of Blood Pressure (HOMED-BP; 2001-2010) trial involved 3518 patients (50% women; mean age 59.6 years) with an untreated systolic/diastolic HBP of 135-179/85-119 mm Hg. In a 2 × 3 design, patients were randomized to usual control (125-134/80-84 mm Hg (UC)) vs. tight control (<125/<80 mm Hg (TC)) of HBP and to initiation of drug treatment with angiotensin converting enzyme inhibitors, angiotensin receptor blockers or calcium channel blockers. During follow-up, a computer algorithm automatically generated treatment recommendations based on HBP. At the last follow-up (median 5.3 years), TC patients used more antihypertensive drugs than UC patients (1.82 vs. 1.74 defined daily doses, P=0.045) and had a greater HBP reduction (21.3/13.1 mm Hg vs. 22.7/13.9 mm Hg, P=0.018/0.020), but they less frequently achieved the lower HBP targets (37.4 vs. 63.5%, P<0.0001). The primary end point, cardiovascular death plus stroke and myocardial infarction, occurred in 25 UC and 26 TC patients (hazard ratio, 1.02; 95% confidence interval, 0.59-1.77; P=0.94). Rates were similar (P≥0.13) in the three drug groups. In all patients combined, the risk of the primary end point independently increased by 41% (6-89%; P=0.019) and 47% (15-87%; P=0.0020) for a 1-s.d. increase in baseline (12.5 mm Hg) and follow-up (13.2 mm Hg) systolic HBP. The 5-year risk was minimal (≤1%) if on-treatment systolic HBP was 131.6 mm Hg or less. HOMED-BP proved the feasibility of adjusting antihypertensive drug treatment based on HBP and suggests that a systolic HBP level of 130 mm Hg should be an achievable and safe target.

摘要

高血压指南建议在家中进行血压自我测量(HBP),但以前没有试验评估过根据 HBP 治疗的高血压患者的心血管结局。多中心高血压客观治疗基于电气设备测量血压(HOMED-BP;2001-2010 年)试验涉及 3518 名患者(50%为女性;平均年龄 59.6 岁),未经治疗的收缩压/舒张压 HBP 为 135-179/85-119mmHg。在 2×3 设计中,患者被随机分为常规对照组(125-134/80-84mmHg(UC))与严格对照组(<125/<80mmHg(TC))的 HBP 治疗和血管紧张素转换酶抑制剂、血管紧张素受体阻滞剂或钙通道阻滞剂的起始药物治疗。在随访期间,计算机算法会根据 HBP 自动生成治疗建议。在最后一次随访(中位数 5.3 年)时,TC 患者比 UC 患者使用更多的降压药物(1.82 与 1.74 定义日剂量,P=0.045),并且 HBP 降低更多(21.3/13.1mmHg 与 22.7/13.9mmHg,P=0.018/0.020),但他们实现较低的 HBP 目标的频率较低(37.4%与 63.5%,P<0.0001)。主要终点,心血管死亡加中风和心肌梗死,发生在 25 例 UC 和 26 例 TC 患者中(风险比,1.02;95%置信区间,0.59-1.77;P=0.94)。在所有药物组中,发生率相似(P≥0.13)。在所有患者中,主要终点的风险独立增加了 41%(6-89%;P=0.019)和 47%(15-87%;P=0.0020),基线(12.5mmHg)和随访(13.2mmHg)收缩压 HBP 增加一个标准差。如果治疗中的收缩压 HBP 为 131.6mmHg 或更低,则 5 年的风险最小(≤1%)。HOMED-BP 证明了根据 HBP 调整降压药物治疗的可行性,并表明收缩压 HBP 水平为 130mmHg 应该是可实现和安全的目标。

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