Elliott William J, Whitmore Jennifer, Feldstein Jeffrey D, Bakris George L
Division of Pharmacology, Pacific Northwest University of Health Sciences, Yakima, WA, USA.
XOMA Corp., Berkeley, CA, USA.
J Am Soc Hypertens. 2015 Apr;9(4):266-74. doi: 10.1016/j.jash.2015.01.012. Epub 2015 Jan 29.
To study the efficacy and safety of a new combination of perindopril arginine and amlodipine besylate, 837 subjects were enrolled in a three-arm, prospective, 59-center, randomized clinical trial. For 42 days, subjects (average seated blood pressure [BP], 158 ± 12/101 ± 5 mm Hg; age, 52 ± 10 years; 52% male; 34% black; 20% diabetic) received amlodipine/perindopril arginine (10/14 mg/d), perindopril erbumine (16 mg/d), or amlodipine (10 mg/d). Goal BP was <140/90 or <130/80 mm Hg in diabetics, per JNC 7 guidelines. The combination showed the largest change in seated BP (-23.7/-15.7 vs. -13.7/-9.5 vs. -19.3/-13.2 mm Hg, respectively; P < .0001), the highest proportion at goal BP (51% vs. 26% vs. 37%; P < .0001), and a lower incidence of pedal edema and adverse events compared with amlodipine. No deaths or significant differences across groups in early discontinuation, serum potassium, or rates of total or serious adverse events or glomerular filtration, were observed.
为研究培哚普利精氨酸与苯磺酸氨氯地平新组合的疗效和安全性，837名受试者参加了一项三臂、前瞻性、59中心的随机临床试验。在42天的时间里，受试者（平均坐位血压[BP]为158±12/101±5mmHg；年龄52±10岁；52%为男性；34%为黑人；20%患有糖尿病）接受氨氯地平/培哚普利精氨酸（10/14mg/天）、培哚普利叔丁胺盐（16mg/天）或氨氯地平（10mg/天）治疗。根据美国国立综合癌症网络（JNC）7指南，糖尿病患者的目标血压为<140/90或<130/80mmHg。该组合显示坐位血压变化最大（分别为-23.7/-15.7mmHg、-13.7/-9.5mmHg和-19.3/-13.2mmHg；P<.0001），达到目标血压的比例最高（51%、26%和37%；P<.0001），与氨氯地平相比，足部水肿和不良事件的发生率更低。未观察到死亡情况，且在早期停药、血清钾、总不良事件或严重不良事件发生率或肾小球滤过率方面，各组之间无显著差异。
