Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Int J Clin Pract. 2011 May;65(5):613-23. doi: 10.1111/j.1742-1241.2011.02673.x.
Recent guidelines for the management of hypertension recommend an individualised stepped-care treatment approach in mild-to-moderate hypertensive patients, to achieve blood pressure (BP) goals. This study evaluated the probability of patients achieving BP targets with an aliskiren-based stepped-care treatment regimen.
This was a 24-week, open-label, non-comparator study design that included six sequential 4-week treatment periods in patients with mild-to-moderate hypertension. Over the potential 24 weeks of active treatment, incremental therapy included the following add-on therapies at 4-week intervals: aliskiren 150-300 mg once daily, hydrochlorothiazide (HCTZ) 12.5-25 mg once daily, and finally amlodipine 5-10 mg once daily, as needed to achieve target BP. Subjects achieving BP targets following any given 4 weeks of therapy were considered study completers, while subjects not achieving their clinical BP target entered into the next step of incremental therapy. The primary efficacy end-point was the estimated cumulative probability of patients achieving BP target.
Of 256 patients treated, 232 (90.6%) completed the study. Baseline mean sitting BP was 155.7/91.7 mmHg. At study end-point, the estimated cumulative probability of reaching BP target was 86.12%. The stepped-care treatment regimen was well tolerated at the maximal recommended doses of all the individual complimentary therapies.
An aliskiren-based stepped-care treatment regimen that subsequently included both HCTZ and amlodipine is effective in achieving BP goals in approximately 90% of patients with mild-to-moderate hypertension.
最近的高血压管理指南建议对轻度至中度高血压患者采用个体化阶梯式治疗方法,以达到血压(BP)目标。本研究评估了基于阿利克仑的阶梯式治疗方案使患者达到 BP 目标的可能性。
这是一项 24 周、开放标签、非对照的研究设计,包括 6 个连续的 4 周治疗期,共纳入轻度至中度高血压患者。在潜在的 24 周的积极治疗中,增量治疗包括以下附加治疗:阿利克仑 150-300mg 每日一次、氢氯噻嗪(HCTZ)12.5-25mg 每日一次,最后按需添加氨氯地平 5-10mg 每日一次,以达到目标 BP。在任何给定的 4 周治疗后达到 BP 目标的患者被认为是研究完成者,而未达到临床 BP 目标的患者进入下一个增量治疗步骤。主要疗效终点是患者达到 BP 目标的估计累积概率。
在 256 例接受治疗的患者中,有 232 例(90.6%)完成了研究。基线时坐位平均 BP 为 155.7/91.7mmHg。研究结束时,达到 BP 目标的估计累积概率为 86.12%。在最大推荐剂量下,所有单独的辅助治疗方案均能耐受阶梯式治疗方案。
基于阿利克仑的阶梯式治疗方案随后包括 HCTZ 和氨氯地平,在约 90%的轻度至中度高血压患者中能有效达到 BP 目标。