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首页> 外文期刊>Current medical research and opinion >Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension.
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Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension.

机译：阿利吉仑和氨氯地平联合治疗高血压患者的长期安全性，耐受性和疗效。

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OBJECTIVE: Most patients with hypertension require antihypertensive combination therapy to achieve BP control. This study investigated the safety and efficacy of the direct renin inhibitor aliskiren combined with the calcium channel blocker amlodipine. METHODS: Overall, 556 patients with hypertension (msDBP > or =95-<110 mmHg) received open-label aliskiren/amlodipine 150/5 mg for 2 weeks, followed by forced titration to aliskiren/amlodipine 300/10 mg for 52 weeks. Add-on hydrochlorothiazide (HCT) was permitted from week 10 to achieve BP control (<140/90 mmHg). The primary objective of the study was to evaluate the long-term safety and tolerability of aliskiren/amlodipine combination therapy; the BP-lowering efficacy of the combination was also assessed (week 54 endpoint; last observation carried forward). TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00402103. RESULTS: In total, 452 patients completed 54 weeks' treatment with aliskiren/amlodipine 300/10 mg, with or without add-on HCT. The most frequently reported adverse events (AEs) were peripheral edema, upper respiratory tract infection, headache and bronchitis. Peripheral edema (the most common AE), occurred in 22.7% of treated patients, and was generally mild or moderate in intensity and transient in nature. Few patients exhibited laboratory abnormalities. Aliskiren/amlodipine combination therapy provided a mean BP reduction from baseline to week 54 of 24.2/15.5 mmHg; 74.3% of patients achieved BP control. In the subgroup of patients with stage 2 hypertension (baseline msSBP > or =160 mmHg and/or msDBP > or =100 mmHg), the mean BP reduction at week 54 was 29.1/17.1 mmHg, and 67.0% of patients achieved BP control. CONCLUSION: In this open-label study, aliskiren/amlodipine 300/10 mg combination therapy, with or without add-on HCT, effectively reduced BP, particularly in patients with stage 2 hypertension. The most common AE was peripheral edema, consistent with the known AE profile of high-dose (10 mg) amlodipine. Further studies comparing the aliskiren/amlodipine combination with the component monotherapies and other antihypertensive combinations are warranted.
机译：目的：大多数高血压患者需要抗高血压联合治疗以控制血压。这项研究调查了直接肾素抑制剂阿利吉仑与钙通道阻滞剂氨氯地平联合的安全性和有效性。方法：总共556例高血压患者（msDBP>或= 95- <110 mmHg）接受开放标签的阿利吉仑/氨氯地平150/5 mg疗程2周，然后强制滴定至阿利吉仑/氨氯地平300/10 mg，持续52周。从第10周开始允许加用氢氯噻嗪（HCT）以控制血压（<140/90 mmHg）。该研究的主要目的是评估阿利吉仑/氨氯地平联合治疗的长期安全性和耐受性。还评估了该组合降低BP的功效（第54周终点;结转了最后观察）。试验注册：ClinicalTrials.gov标识符NCT00402103。结果：总共452例患者接受了阿利吉仑/氨氯地平300/10 mg，有或没有HCT的治疗，完成了54周的治疗。最常见的不良事件是周围水肿，上呼吸道感染，头痛和支气管炎。周围水肿（最常见的AE）发生在接受治疗的患者中，占22.7％，强度一般为轻度或中度，本质上是短暂的。很少有患者表现出实​​验室异常。 Aliskiren /氨氯地平联合治疗从基线到第54周的平均BP降低为24.2 / 15.5 mmHg; 74.3％的患者达到了血压控制。在患有2期高血压的患者亚组中（基线msSBP>或= 160 mmHg和/或msDBP>或= 100 mmHg），第54周的平均BP降低为29.1 / 17.1 mmHg，并且67.0％的患者实现了BP控制。结论：在这项开放性研究中，阿利吉仑/氨氯地平300/10 mg联合治疗（有或没有加用HCT）可有效降低BP，特别是在2期高血压患者中。最常见的AE是周围性水肿，与大剂量氨氯地平（10 mg）的已知AE情况一致。需要进一步比较阿利吉仑/氨氯地平联合单药疗法和其他降压药联合疗法。

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