Morgado Manuel P, Rolo Sandra A, Castelo-Branco Miguel
Health Sciences Research Centre, University of Beira Interior, Av. Infante D. Henrique, 6200-506 Covilhã, Portugal.
Open Cardiovasc Med J. 2011;5:6-14. doi: 10.2174/1874192401105010006. Epub 2011 Feb 15.
Single-pill combinations of aliskiren/hydrochlorothiazide have recently been approved by the European Medicines Agency for the treatment of hypertension.
This study aimed to assess the antihypertensive efficacy of aliskiren/hydrochlorothiazide combination in reducing systolic and diastolic blood pressure in hypertensive patients.
A search in International Pharmaceutical Abstracts, MEDLINE, The Cochrane Library and ISI Web of Knowledge was performed from 2000 to November 2009, to identify randomized, double-blind, clinical trials using aliskiren/hydrochlorothiazide for the treatment of hypertension. Studies were included if they evaluated the antihypertensive efficacy of aliskiren/hydrochlorothiazide in patients with mild or moderate essential hypertension and age ≥ 18 years. The meta-analytical approach calculated the weighted average reductions of systolic and diastolic blood pressure for each daily dosage combination.
We included 5 clinical trials testing several combinations of aliskiren/hydrochlorothiazide and containing data on 5448 patients. In all studies blood pressure was assessed at inclusion (baseline) and after 8 weeks of therapy. Blood pressure reductions and control rates were significantly (p < 0.05) higher with the aliskiren/hydrochlorothiazide combinations than with placebo and the same doses of aliskiren or hydrochlorothiazide alone. The weighted mean reductions (mm Hg) from baseline of systolic and diastolic blood pressure for each aliskiren/hydrochlorothiazide combination were: -15.8/-10.3 (150/25 mg); -15.9/-11.8 (300/12.5 mg); -16.9/-11.6 (300/25 mg). Blood pressure control rates (%) for the above combinations were, at least, respectively: 43.8, 50.1 and 51.9.
Aliskiren/hydrochlorothiazide provided clinically significant additional blood pressure reductions and improved blood pressure control rates over aliskiren or hydrochlorothiazide monotherapy.
阿利吉仑/氢氯噻嗪单片复方制剂最近已获欧洲药品管理局批准用于治疗高血压。
本研究旨在评估阿利吉仑/氢氯噻嗪复方制剂降低高血压患者收缩压和舒张压的降压疗效。
于2000年至2009年11月在《国际药学文摘》、MEDLINE、Cochrane图书馆和ISI科学网进行检索,以识别使用阿利吉仑/氢氯噻嗪治疗高血压的随机、双盲临床试验。纳入的研究需评估阿利吉仑/氢氯噻嗪对年龄≥18岁的轻度或中度原发性高血压患者的降压疗效。荟萃分析方法计算了每种每日剂量组合的收缩压和舒张压加权平均降低值。
我们纳入了5项临床试验,测试了阿利吉仑/氢氯噻嗪的几种组合,包含5448例患者的数据。在所有研究中,均在纳入时(基线)和治疗8周后评估血压。与安慰剂以及相同剂量的阿利吉仑或氢氯噻嗪单药治疗相比,阿利吉仑/氢氯噻嗪复方制剂的血压降低值和控制率显著更高(p<0.05)。每种阿利吉仑/氢氯噻嗪组合的收缩压和舒张压自基线的加权平均降低值(mmHg)分别为:-15.8/-10.3(150/25mg);-15.9/-11.8(300/12.5mg);-16.9/-11.6(300/25mg)。上述组合的血压控制率(%)分别至少为:43.8、50.1和51.9。
与阿利吉仑或氢氯噻嗪单药治疗相比,阿利吉仑/氢氯噻嗪在临床上能显著进一步降低血压,并提高血压控制率。