非糖尿病高血压患者收缩压常规控制与强化控制比较（心脏收缩压研究）：一项开放标签随机试验

Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial.

作者信息

Verdecchia Paolo, Staessen Jan A, Angeli Fabio, de Simone Giovanni, Achilli Augusto, Ganau Antonello, Mureddu Gianfrancesco, Pede Sergio, Maggioni Aldo P, Lucci Donata, Reboldi Gianpaolo

机构信息

Division of Cardiology, Hospital S Maria della Misericordia, Perugia, Italy.

出版信息

Lancet. 2009 Aug 15;374(9689):525-33. doi: 10.1016/S0140-6736(09)61340-4.

DOI:10.1016/S0140-6736(09)61340-4

PMID:19683638

Abstract

BACKGROUND

The level to which systolic blood pressure should be controlled in hypertensive patients without diabetes remains unknown. We tested the hypothesis that tight control compared with usual control of systolic blood pressure would be beneficial in such patients.

METHODS

In this randomised open-label trial undertaken in 44 centres in Italy, 1111 non-diabetic patients with systolic blood pressure 150 mm Hg or greater were randomly assigned to a target systolic blood pressure of less than 140 mm Hg (usual control; n=553) or less than 130 mm Hg (tight control; n=558). After stratification by centre, we used a computerised random function to allocate patients to either group. Observers who were unaware of randomisation read electrocardiograms and adjudicated events. Open-label agents were used to reach the randomised targets. The primary endpoint was the rate of electrocardiographic left ventricular hypertrophy 2 years after randomisation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00421863.

RESULTS

Over a median follow-up of 2.0 years (IQR 1.93-2.03), systolic and diastolic blood pressure were reduced by a mean of 23.5/8.9 mm Hg (SD 10.6/7.0) in the usual-control group and by 27.3/10.4 mm Hg (11.0/7.5) in the tight-control group (between-group difference 3.8 mm Hg systolic [95% CI 2.4-5.2], p<0.0001; and 1.5 mm Hg diastolic [0.6-2.4]; p=0.041). The primary endpoint occurred in 82 of 483 patients (17.0%) in the usual-control group and in 55 of 484 patients (11.4%) of the tight-control group (odds ratio 0.63; 95% CI 0.43-0.91; p=0.013). A composite cardiovascular endpoint occurred in 52 (9.4%) patients in the usual-control group and in 27 (4.8%) in the tight-control group (hazard ratio 0.50, 95% CI 0.31-0.79; p=0.003). Side-effects were rare and did not differ significantly between the two groups.

INTERPRETATION

Our findings lend support to a lower blood pressure goal than is recommended at present in non-diabetic patients with hypertension.

FUNDING

Boehringer-Ingelheim, Sanofi-Aventis, Pfizer.

摘要

背景

高血压非糖尿病患者的收缩压应控制在何种水平尚不清楚。我们检验了这样一个假设：与常规控制收缩压相比，严格控制收缩压对这类患者有益。

方法

在意大利44个中心进行的这项随机开放标签试验中，1111名收缩压为150毫米汞柱或更高的非糖尿病患者被随机分配至收缩压目标小于140毫米汞柱（常规控制组；n = 553）或小于130毫米汞柱（严格控制组；n = 558）。按中心分层后，我们使用计算机随机函数将患者分配至两组。不知随机分组情况的观察者读取心电图并判定事件。使用开放标签药物以达到随机化目标。主要终点是随机分组2年后心电图左心室肥厚发生率。分析采用意向性治疗。本研究已在ClinicalTrials.gov注册，编号为NCT00421863。

结果

在中位随访2.0年（四分位间距1.93 - 2.03年）期间，常规控制组的收缩压和舒张压平均降低23.5/8.9毫米汞柱（标准差10.6/7.0），严格控制组降低27.3/10.4毫米汞柱（11.0/7.5）（组间差异收缩压3.8毫米汞柱[95%置信区间2.4 - 5.2]，p<0.0001；舒张压1.5毫米汞柱[0.6 - 2.4]；p = 0.041）。主要终点在常规控制组483例患者中的82例（17.0%）出现，在严格控制组484例患者中的55例（11.4%）出现（比值比0.63；95%置信区间0.43 - 0.91；p = 0.013）。复合心血管终点在常规控制组52例（9.4%）患者中出现，在严格控制组27例（4.8%）患者中出现（风险比0.50，95%置信区间0.31 - 0.79；p = 0.003）。副作用罕见，两组间无显著差异。