Long Beach Center for Clinical Research, Long Beach, CA, USA.
Centro Medico Viamonte, Buenos Aires, Argentina.
J Clin Hypertens (Greenwich). 2018 Jan;20(1):150-158. doi: 10.1111/jch.13153. Epub 2018 Jan 16.
A majority of patients with hypertension fail to achieve blood pressure (BP) control despite treatment with commonly prescribed drugs. This randomized, double-blind phase III trial assessed the superiority of sacubitril/valsartan 200 mg (97/103 mg) to continued olmesartan 20 mg in reducing ambulatory systolic BP after 8-week treatment in patients with mild to moderate essential hypertension uncontrolled with olmesartan 20 mg alone. A total of 376 patients were randomized to receive either sacubitril/valsartan (n = 188) or olmesartan (n = 188). Superior reductions in 24-hour mean ambulatory systolic BP were observed in the sacubitril/valsartan group vs the olmesartan group (-4.3 mm Hg vs -1.1 mm Hg, P < .001). Reductions in 24-hour mean ambulatory diastolic BP and pulse pressure and office systolic BP and diastolic BP were significantly greater with sacubitril/valsartan vs olmesartan (P < .014). A greater proportion of patients achieved BP control with sacubitril/valsartan vs olmesartan. The overall incidence of adverse events was comparable between the groups. Compared with continued olmesartan, sacubitril/valsartan was more effective and generally safe in patients with hypertension uncontrolled with olmesartan 20 mg.
尽管大多数高血压患者接受了常用降压药物治疗，但血压（BP）控制仍不理想。这项随机、双盲 III 期试验评估了沙库巴曲缬沙坦 200mg（97/103mg）与奥美沙坦 20mg 相比，在单独使用奥美沙坦 20mg 未能控制的轻中度原发性高血压患者中，治疗 8 周后降低动态收缩压的优越性。共有 376 名患者随机接受沙库巴曲缬沙坦（n=188）或奥美沙坦（n=188）治疗。与奥美沙坦组相比，沙库巴曲缬沙坦组 24 小时平均动态收缩压降低更为显著（-4.3mmHg 比-1.1mmHg，P<.001）。与奥美沙坦相比，沙库巴曲缬沙坦组 24 小时平均动态舒张压和脉压以及诊室收缩压和舒张压降低更显著（P<.014）。与奥美沙坦相比，沙库巴曲缬沙坦组达到血压控制的患者比例更高。两组不良事件总发生率相当。与继续使用奥美沙坦相比，沙库巴曲缬沙坦在奥美沙坦 20mg 控制不佳的高血压患者中更有效且通常安全。
