Wu Jiahui, Du Xin, Lv Qiang, Li Zhanquan, Zheng Zeqi, Xia Yong, Tang Chengchun, Yao Zhuhua, Zhang Jun, Long Mingzhi, Hisada Michie, Wu Jingtao, Zhou Wei, Ma Changsheng
Department of Cardiology, Beijing Anzhen Hospital, Beijing.
Department of Cardiology, People's Hospital of Liaoning Province, Liaoning.
Medicine (Baltimore). 2020 Aug 7;99(32):e21465. doi: 10.1097/MD.0000000000021465.
Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has a well-characterized efficacy and safety profile in patients with hypertension. AZL-M is approved for use in over 40 countries globally; however, it is not yet approved in China. Therefore, a phase 3 registration study to assess the efficacy (antihypertensive effect), safety, and tolerability of AZL-M compared with valsartan in Chinese patients with essential hypertension was undertaken.
This multicenter, double-blind, randomized, 8-week phase 3 study compared AZL-M with valsartan in Chinese patients aged ≥18 years with essential hypertension. Endpoints included change from baseline to week 8 in trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters.
Overall, 612 patients (mean age, 57.1 years; 57.5% male) were randomized to AZL-M 80 mg (n = 209), AZL-M 40 mg (n = 199), or valsartan 160 mg (n = 204). Baseline mean scSBP was similar in all groups (157.9-158.5 mm Hg). The mean reduction in trough scSBP from baseline to week 8 was significantly greater with AZL-M 80 mg than with valsartan (-24.2 vs -20.6 mm Hg; P = .010), and noninferior with AZL-M 40 mg versus valsartan (-22.5 vs -20.6 mm Hg; P = .184). Mean reduction in 24-hour mean systolic blood pressure (n = 257) was significantly greater with both AZL-M 80 mg (-17.0 mm Hg; P < .001) and AZL-M 40 mg (-14.7 mm Hg; P = .014) than with valsartan (-9.4 mm Hg). Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate. Dizziness was the most frequent treatment-related treatment-emergent adverse events (AZL-M 80 mg, 1.9%; AZL-M 40 mg, 1.5%; valsartan, 1.0%). The safety and tolerability of AZL-M were comparable with valsartan.
AZL-M was noninferior to valsartan at the 40-mg dose and superior to valsartan at the 80-mg dose in reducing trough scSBP, and showed acceptable safety-consistent with the AZL-M safety profile in other populations-in Chinese adults with hypertension.
NCT02480764.
阿齐沙坦美索米酯（AZL-M）是一种血管紧张素II受体阻滞剂，在高血压患者中具有明确的疗效和安全性。AZL-M在全球40多个国家获批使用；然而，在中国尚未获批。因此，开展了一项3期注册研究，以评估AZL-M与缬沙坦相比，在中国原发性高血压患者中的疗效（降压效果）、安全性和耐受性。
这项多中心、双盲、随机、为期8周的3期研究，将年龄≥18岁的中国原发性高血压患者中的AZL-M与缬沙坦进行了比较。终点包括从基线到第8周的谷值门诊坐位收缩压（scSBP）和动态血压监测参数的变化。
总体而言，612例患者（平均年龄57.1岁；57.5%为男性）被随机分为AZL-M 80mg组（n = 209）、AZL-M 40mg组（n = 199）或缬沙坦160mg组（n = 204）。所有组的基线平均scSBP相似（157.9 - 158.5mmHg）。从基线到第8周，AZL-M 80mg组的谷值scSBP平均降低幅度显著大于缬沙坦组（-24.2 vs -20.6mmHg；P = 0.010），AZL-M 40mg组与缬沙坦组相比不劣（-22.5 vs -20.6mmHg；P = 0.184）。AZL-M 80mg组（-17.0mmHg；P < 0.001）和AZL-M 40mg组（-14.7mmHg；P = 0.014）的24小时平均收缩压平均降低幅度均显著大于缬沙坦组（-9.4mmHg）。各治疗组中治疗出现的不良事件发生率相似（52.8% - 56.5%），且一般为轻度或中度。头晕是最常见的与治疗相关的治疗出现的不良事件（AZL-M 80mg组为1.9%；AZL-M 40mg组为1.5%；缬沙坦组为1.0%）。AZL-M的安全性和耐受性与缬沙坦相当。
在降低谷值scSBP方面，AZL-M 40mg剂量不劣于缬沙坦，80mg剂量优于缬沙坦，并且在患有高血压的中国成年人中显示出可接受的安全性——与AZL-M在其他人群中的安全性特征一致。
NCT02480764。
