Department of Cardiology, Zhong Shan Hospital, Fudan University, Shanghai, China.
Hypertens Res. 2012 Jan;35(1):28-33. doi: 10.1038/hr.2011.150. Epub 2011 Sep 8.
This 8-week, randomized, double-blind, parallel-group study compared the efficacy and safety of aliskiren with ramipril in Asian patients with mild to moderate hypertension. Following a 2- to 3-week placebo run-in period, patients with mean sitting diastolic blood pressure (msDBP) ≥95 and <110 mm Hg were randomized to receive once daily dose of either aliskiren 75, 150, 300 mg or ramipril 5 mg for 8 weeks. Efficacy variables were the changes in msDBP and mean sitting systolic BP (msSBP) and BP control rates (<140/90 mm Hg). Safety was assessed by recording adverse events (AEs) and serious AEs (SAEs). Of 1316 randomized patients, 1160 (88.1%) completed the study. At the study endpoint, patients on aliskiren had greater mean BP reductions (14.39/11.63 mm Hg for 300 mg; 12.16/10.04 mm Hg for 150 mg; 12.24/10.66 mm Hg for 75 mg) than those on 5 mg ramipril (11.46/9.19 mm Hg). All aliskiren doses were statistically non-inferior (P<0.0001) to ramipril in reducing msDBP. The reduction in BP for aliskiren 300 mg was statistically superior vs. ramipril (P<0.002). Blood pressure control rates were higher for aliskiren (300 mg, 52.29%; 150 mg, 48.11%; 75 mg, 45.68%) than for ramipril (5 mg, 43.7%); the difference for aliskiren 300 mg vs. ramipril 5 mg was statistically significant (P<0.05). Aliskiren was well tolerated with a fourfold lower incidence of cough (0.6-1.2%) compared with ramipril (5.2%). SAEs were rare in this study (0.5%). Aliskiren produced greater BP reductions with a lower incidence of cough than ramipril in Asian patients with mild to moderate hypertension.
这项为期 8 周、随机、双盲、平行组研究比较了阿利吉仑与雷米普利在亚洲轻中度高血压患者中的疗效和安全性。在 2-3 周的安慰剂导入期后，平均坐位舒张压（msDBP）≥95mmHg 且<110mmHg 的患者被随机分为每日一次接受阿利吉仑 75、150、300mg 或雷米普利 5mg 治疗 8 周。疗效变量为 msDBP 和平均坐位收缩压（msSBP）的变化以及血压控制率（<140/90mmHg）。安全性通过记录不良事件（AE）和严重不良事件（SAE）来评估。在 1316 名随机患者中，1160 名（88.1%）完成了研究。在研究终点，阿利吉仑治疗组的平均血压降低幅度更大（300mg 组为 14.39/11.63mmHg；150mg 组为 12.16/10.04mmHg；75mg 组为 12.24/10.66mmHg），高于雷米普利 5mg 组（11.46/9.19mmHg）。所有阿利吉仑剂量在降低 msDBP 方面均非劣效于雷米普利（P<0.0001）。阿利吉仑 300mg 降低血压的效果优于雷米普利（P<0.002）。阿利吉仑的血压控制率更高（300mg 组为 52.29%；150mg 组为 48.11%；75mg 组为 45.68%），高于雷米普利 5mg 组（43.7%），阿利吉仑 300mg 组与雷米普利 5mg 组之间的差异有统计学意义（P<0.05）。与雷米普利（5.2%）相比，阿利吉仑的咳嗽发生率低四倍（0.6-1.2%），耐受性良好。在这项研究中，SAE 很少见（0.5%）。与雷米普利相比，阿利吉仑在亚洲轻中度高血压患者中可更大幅度地降低血压，且咳嗽发生率更低。
