Juhasz Attila, Wu Jingtao, Hisada Michie, Tsukada Tomoka, Jeong Myung Ho
Takeda Development Center Europe, Ltd., 61 Aldwych, London, WC2B 4AE UK.
Present at GE Healthcare, Little Chalfont, UK.
Clin Hypertens. 2018 Feb 7;24:2. doi: 10.1186/s40885-018-0086-4. eCollection 2018.
This was a phase 3, randomized, double-blind, placebo-controlled study.
Adult Korean patients with essential hypertension and a baseline mean sitting clinic systolic blood pressure (scSBP) ≥150 and ≤180 mmHg were randomized to 6-week treatment with placebo ( = 65), azilsartan medoxomil (AZL-M) 40 mg ( = 132), or AZL-M 80 mg ( = 131). The primary endpoint was the change from baseline to week 6 in trough scSBP.
The least-squares mean (standard error) change from baseline in trough scSBP in the placebo, AZL-M 40-mg, and 80-mg groups at week 6 were - 8.8 (2.00), - 22.1 (1.41), and - 23.7 (1.40) mmHg, respectively ( < 0.001 for AZL-M 40 and 80 mg vs placebo). No clinically meaningful heterogeneity in efficacy was observed between subgroups (age, sex, diabetes status) and the overall population. Treatments were well tolerated and adverse events were similar between groups.
Results of this study confirm a positive benefit-risk profile of AZL-M for essential hypertension in Korean adults.
Clinicaltrial.gov; identifier number: NCT02203916. Registered July 28, 2014 (retrospectively registered).
这是一项3期随机双盲安慰剂对照研究。
韩国成年原发性高血压患者，基线平均诊室坐位收缩压（scSBP）≥150且≤180 mmHg，被随机分为三组，分别接受为期6周的安慰剂治疗（n = 65）、阿齐沙坦美洛昔酯（AZL-M）40 mg治疗（n = 132）或AZL-M 80 mg治疗（n = 131）。主要终点是从基线到第6周谷值scSBP的变化。
在第6周时，安慰剂组、AZL-M 40 mg组和80 mg组谷值scSBP相对于基线的最小二乘均值（标准误）变化分别为-8.8（2.00）、-22.1（1.41）和-23.7（1.40）mmHg（AZL-M 40 mg和80 mg组与安慰剂组相比，P < 0.001）。在亚组（年龄、性别、糖尿病状态）和总体人群之间未观察到疗效上有临床意义的异质性。治疗耐受性良好，各组不良事件相似。
本研究结果证实了阿齐沙坦美洛昔酯对韩国成年原发性高血压患者具有良好的效益风险比。
Clinicaltrial.gov；标识符编号：NCT02203916。2014年7月28日注册（追溯注册）。
