Yamamoto Koichi, Yarimizu Daisuke, Shimanishi Ayano, Eguchi Shunsuke, Iekushi Kazuma, Takami Yoichi, Nozato Yoichi, Kario Kazuomi, Rakugi Hiromi
Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
Medical Affairs, Novartis Pharma K.K., Tokyo, Japan.
J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14938. doi: 10.1111/jch.14938. Epub 2024 Dec 4.
Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, has demonstrated a superior blood pressure-lowering effect compared with renin-angiotensin system inhibitors in several clinical trials. However, there has been no available evidence on the comparison between sacubitril/valsartan and calcium channel blockers (CCBs), a well-established class of antihypertensive drugs. In this open-label, multicenter study, we aimed to demonstrate the efficacy and safety of sacubitril/valsartan versus amlodipine, one of the most widely used CCBs, after 8 weeks of treatment. A total of 359 Japanese patients with essential hypertension (office systolic blood pressure [SBP] ≥ 150 to < 180 mmHg), aged 18-79, were randomly assigned to receive either once-daily sacubitril/valsartan 200 mg or once-daily amlodipine 5 mg in a 1:1 allocation ratio. The primary endpoint was the noninferiority of sacubitril/valsartan compared with amlodipine in mean change in 24-h SBP from baseline to Week 8, followed by a significance test as a secondary endpoint analysis. The mean change in 24-h SBP in sacubitril/valsartan was noninferior to that in amlodipine (between-treatment difference -0.62 mmHg [95% confidential interval: -3.23 to 1.98; p = 0.003 for noninferiority; independent t-test with noninferiority margin 3.0 mmHg]), with no significant difference observed (p = 0.637). There was no significant difference in the incidence of adverse events (AEs). These results suggested that the blood pressure-lowering effect of sacubitril/valsartan is comparable to that of amlodipine, with no marked differences in tolerability between the two groups. Sacubitril/valsartan, a potent antihypertensive drug comparable to amlodipine, is expected to improve blood pressure control in clinical practice.
沙库巴曲缬沙坦，一种血管紧张素受体脑啡肽酶抑制剂，在多项临床试验中已证明其降压效果优于肾素-血管紧张素系统抑制剂。然而，目前尚无关于沙库巴曲缬沙坦与钙通道阻滞剂（CCB）（一类成熟的抗高血压药物）之间比较的可用证据。在这项开放标签、多中心研究中，我们旨在证明治疗8周后沙库巴曲缬沙坦与氨氯地平（最广泛使用的CCB之一）相比的疗效和安全性。总共359名年龄在18至79岁之间的日本原发性高血压患者（诊室收缩压[SBP]≥150至<180 mmHg），以1:1的分配比例随机分配接受每日一次的沙库巴曲缬沙坦200 mg或每日一次的氨氯地平5 mg。主要终点是沙库巴曲缬沙坦与氨氯地平相比，从基线到第8周24小时SBP平均变化的非劣效性，随后作为次要终点分析进行显著性检验。沙库巴曲缬沙坦组24小时SBP的平均变化不劣于氨氯地平组（组间差异为-0.62 mmHg[95%置信区间：-3.23至1.98；非劣效性检验p = 0.003；非劣效性界值为3.0 mmHg的独立t检验]），未观察到显著差异（p = 0.637）。不良事件（AE）的发生率无显著差异。这些结果表明，沙库巴曲缬沙坦的降压效果与氨氯地平相当，两组之间的耐受性无明显差异。沙库巴曲缬沙坦是一种与氨氯地平相当的强效抗高血压药物，有望在临床实践中改善血压控制。
