基于奥美沙坦酯的治疗方案对 1 或 2 期高血压患者收缩压的影响：一项随机、双盲、安慰剂对照研究。

Effect of an olmesartan medoxomil-based treatment algorithm on systolic blood pressure in patients with stage 1 or 2 hypertension: a randomized, double-blind, placebo-controlled study.

机构信息

The Christ Hospital Heart and Vascular Center/The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio 45219, USA.

出版信息

Am J Cardiovasc Drugs. 2010;10(4):239-46. doi: 10.2165/11538630-000000000-00000.

DOI:10.2165/11538630-000000000-00000

PMID:20653330

Abstract

BACKGROUND AND OBJECTIVE

Elevated systolic BP (SBP) is a major contributor to cardiovascular disease. SBP control reduces the occurrence of stroke, heart failure, and cardiovascular and total mortality. The aim of this study was to analyze the magnitude of SBP reductions and the achievement of individual SBP targets in the original BENIFORCE study.

METHODS

An olmesartan medoxomil-based treatment algorithm was evaluated in a double-blind, placebo-controlled titration study in 276 patients with stage 1 (47.1%) or 2 (52.9%) hypertension. After placebo run-in, patients were randomized to placebo (12 weeks) or olmesartan medoxomil 20 mg/day (weeks 1-3). Olmesartan medoxomil was uptitrated to 40 mg/day (weeks 4-6), then olmesartan medoxomil/hydrochlorothiazide (HCTZ) 40/12.5 mg per day (weeks 7-9), and olmesartan medoxomil/HCTZ 40/25 mg per day (weeks 10-12) if BP remained ≥120/80 mmHg at any time interval.

SETTING

The BENIFORCE study was a multicenter (29 sites) study conducted between January and October 2007 in the US.

RESULTS

In patients receiving olmesartan medoxomil-based therapy, 81.0%, 67.2%, and 46.6% of patients with stage 1 hypertension and 70.4%, 49.4%, and 23.5% of patients with stage 2 hypertension achieved SBP targets of <140, <130, and <120 mmHg, respectively (all p < 0.01 vs placebo). The proportions of patients achieving SBP targets increased with escalating doses of olmesartan medoxomil and HCTZ, administered alone or in combination, and was highest for combination therapy. Similarly, escalating doses of olmesartan medoxomil or olmesartan medoxomil/HCTZ increased the proportion of patients achieving SBP reductions of >15 but ≤30, >30 but ≤45, and >45 mmHg compared with placebo.

CONCLUSION

An olmesartan medoxomil-based treatment algorithm effectively reduced SBP and achieved SBP targets in patients with stage 1 or 2 hypertension. This regimen resulted in >80% of patients achieving SBP reductions of ≥15 mmHg while 44% achieved SBP reductions of >30 mmHg.

摘要

背景与目的

收缩压（SBP）升高是心血管疾病的主要病因。SBP 控制可降低中风、心力衰竭以及心血管和全因死亡率的发生风险。本研究旨在分析 BENIFORCE 研究中 SBP 降低幅度以及达到个体 SBP 目标的情况。

方法

在一项 276 例 1 期（47.1%）或 2 期（52.9%）高血压患者的双盲、安慰剂对照滴定研究中，评估了基于奥美沙坦酯的治疗方案。在安慰剂导入期后，患者被随机分配至安慰剂组（12 周）或奥美沙坦酯 20 mg/天组（第 1-3 周）。奥美沙坦酯滴定至 40 mg/天（第 4-6 周），然后奥美沙坦酯/氢氯噻嗪（HCTZ）20/12.5 mg/天（第 7-9 周），如果任何时间间隔的血压仍≥120/80mmHg，则奥美沙坦酯/HCTZ 40/25 mg/天（第 10-12 周）。

地点

BENIFORCE 研究是 2007 年 1 月至 10 月在美国 29 个中心进行的一项多中心研究。

结果

接受奥美沙坦酯治疗的患者中，1 期高血压患者中分别有 81.0%、67.2%和 46.6%，2 期高血压患者中分别有 70.4%、49.4%和 23.5%达到 SBP 目标值<140mmHg、<130mmHg 和<120mmHg（均 p<0.01 与安慰剂相比）。随着奥美沙坦酯和 HCTZ 单药或联合递增剂量，达到 SBP 目标的患者比例增加，联合治疗的效果最高。同样，与安慰剂相比，奥美沙坦酯或奥美沙坦酯/HCTZ 递增剂量可使 SBP 降幅>15mmHg 但≤30mmHg、>30mmHg 但≤45mmHg 和>45mmHg 的患者比例增加。