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PHARAO研究:血管紧张素转换酶抑制剂雷米普利预防血压正常高值患者高血压:德国高血压联盟的一项前瞻性、随机、对照预防试验

The PHARAO study: prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure: a prospective, randomized, controlled prevention trial of the German Hypertension League.

作者信息

Lüders Stephan, Schrader Joachim, Berger Jürgen, Unger Thomas, Zidek Walter, Böhm Michael, Middeke Martin, Motz Wolfgang, Lübcke Cornelia, Gansz Andrea, Brokamp Ludmer, Schmieder Roland E, Trenkwalder Peter, Haller Herrmann, Dominiak Peter

机构信息

Department of Internal Medicine, St-Josefs-Hospital, Cloppenburg, Germany.

出版信息

J Hypertens. 2008 Jul;26(7):1487-96. doi: 10.1097/HJH.0b013e3282ff8864.

Abstract

BACKGROUND

The prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure study addresses the issue of whether progression to manifest hypertension in patients with high-normal blood pressure can be prevented with treatment.

METHODS

A total of 1008 participants with high-normal office blood pressure were randomized to ramipril treatment group (n = 505) and a control group (n = 503). The patients were followed up for 3 years. Primary endpoint was to prevent or delay the progression to manifest hypertension. Secondary endpoints were reduction in the incidence of cerebrovascular and cardiovascular events, as well as the development of hypertension as defined by ambulatory blood pressure monitoring.

FINDINGS

One hundred and fifty-five patients (30.7%) in the ramipril group, and 216 (42.9%) in the control group reached the primary endpoint (relative risk reduction 34.4%, P = 0.0001). Ramipril also proved to be more effective in reducing the incidence of manifest office hypertension in patients with baseline ambulatory blood pressure monitoring high-normal blood pressure. The incidence of cerebrovascular and cardiovascular events showed no statistically significant differences between the two groups. Cough was more frequent in the ramipril group (4.8 vs. 0.4%).

INTERPRETATION

There is now good clinical evidence that patients with high-normal blood pressure (prehypertension) are more likely to progress to manifest hypertension than patients with optimal or normal blood pressure. Additional ambulatory blood pressure monitoring seems to be essential to achieve correct diagnosis. Treatment of patients with high-normal office blood pressure with the angiotensin-converting enzyme inhibitor was well tolerated, and significantly reduced the risk of progression to manifest hypertension.

摘要

背景

血管紧张素转换酶抑制剂雷米普利预防高血压正常高值患者研究探讨了高血压正常高值患者通过治疗能否预防进展为显性高血压这一问题。

方法

共有1008例诊室血压正常高值的参与者被随机分为雷米普利治疗组(n = 505)和对照组(n = 503)。对患者进行3年随访。主要终点是预防或延缓进展为显性高血压。次要终点是降低脑血管和心血管事件的发生率,以及动态血压监测所定义的高血压的发生。

研究结果

雷米普利组155例患者(30.7%)、对照组216例患者(42.9%)达到主要终点(相对风险降低34.4%,P = 0.0001)。对于基线动态血压监测为正常高值的患者,雷米普利在降低显性诊室高血压发生率方面也更有效。两组间脑血管和心血管事件的发生率无统计学显著差异。雷米普利组咳嗽更常见(4.8%对0.4%)。

解读

目前有充分的临床证据表明,高血压正常高值(高血压前期)患者比血压最佳或正常的患者更易进展为显性高血压。似乎有必要进行额外的动态血压监测以实现正确诊断。血管紧张素转换酶抑制剂治疗诊室血压正常高值患者耐受性良好,并显著降低进展为显性高血压的风险。

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