Abstract:
This phase III study assessed the efficacy and safety of sacubitril/valsartan compared with those of olmesartan in Japanese patients with essential hypertension. Patients (n = 1161, aged ≥20 years) with mild to moderate hypertension (mean sitting systolic blood pressure [msSBP] ≥150 to <180 mmHg) were randomized to receive sacubitril/valsartan 200 mg (n = 387), sacubitril/valsartan 400 mg (n = 385), or olmesartan 20 mg (n = 389) once daily for 8 weeks. The primary assessment was a reduction in msSBP from baseline with sacubitril/valsartan 200 mg vs. olmesartan 20 mg at Week 8. Secondary assessments included msSBP reduction with sacubitril/valsartan 400 mg vs. olmesartan at Week 8 and reductions in mean sitting diastolic blood pressure (msDBP), mean sitting pulse pressure (msPP), and overall blood pressure (BP) control rate for all treatment groups at Week 8. Sacubitril/valsartan 200 mg provided a significantly greater reduction in msSBP from baseline than olmesartan at Week 8 (between-treatment difference: -5.01 mmHg [95% confidence interval: -6.95 to -3.06 mmHg, P < 0.001 for noninferiority and superiority]). Greater reductions in msSBP with sacubitril/valsartan 400 mg vs. olmesartan, as well as in msDBP and msPP with both doses of sacubitril/valsartan vs. olmesartan (P < 0.05 for all), were also observed. Patients treated with sacubitril/valsartan achieved an overall higher BP control rate. The safety and tolerability profiles of sacubitril/valsartan were generally comparable to those of olmesartan. The adverse event rate with sacubitril/valsartan was not dose-dependent. Treatment with sacubitril/valsartan was effective and provided superior BP reduction, with a higher proportion of patients achieving target BP goals than treatment with olmesartan in Japanese patients with mild to moderate essential hypertension.
摘要:
这项III期研究评估了沙库巴曲/缬沙坦与奥美沙坦在日本原发性高血压患者中的疗效和安全性。轻度至中度高血压(平均坐位收缩压[msSBP]≥150至<180mmHg)的患者(n=1161,年龄≥20岁)随机接受沙库巴曲/缬沙坦200mg(n=387),沙库必曲/缬沙坦400毫克(n=385),或奥美沙坦20毫克(n=389),每日一次,持续8周。主要评估是沙库比曲/缬沙坦200mg与msSBP从基线降低奥美沙坦20毫克在第8周。次要评估包括沙库巴曲/缬沙坦400mg与msSBP降低第8周时奥美沙坦和平均坐位舒张压(msDBP)降低,平均坐位脉压(msPP),在第8周,所有治疗组的总体血压(BP)控制率。在第8周时,Sacubitril/缬沙坦200mg与奥美沙坦相比,msSBP从基线的下降幅度明显大于奥美沙坦(治疗间差异:-5.01mmHg[95%置信区间:-6.95至-3.06mmHg,非劣效性和优越性P<0.001)。沙库巴曲/缬沙坦400mg与msSBP的减少更大奥美沙坦,以及在msDBP和msPP中两种剂量的沙库必曲/缬沙坦与奥美沙坦(均P<0.05),也被观察到了。用沙库巴曲/缬沙坦治疗的患者总体血压控制率较高。沙库巴曲/缬沙坦的安全性和耐受性通常与奥美沙坦相当。沙库巴曲/缬沙坦的不良事件发生率不是剂量依赖性的。沙库必曲/缬沙坦治疗是有效的,并提供优越的血压降低,在日本轻中度原发性高血压患者中,达到目标BP目标的患者比例高于奥美沙坦治疗。