Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)
Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)
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DOI：
10.1161/hypertensionaha.119.13569
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发表时间：
2020-01-01
期刊：
影响因子：
8.3
通讯作者：
Yamakawa, Satoru
中科院分区：
文献类型：
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作者：
Ito, Sadayoshi;Itoh, Hiroshi;Yamakawa, Satoru
盐皮质激素受体（MR）与高血压的病理学有关。推荐使用MR阻滞剂治疗盐敏感性或顽固性高血压。然而，目前可用的MR阻滞剂的使用受到不良事件的限制。这项III期多中心、随机、双盲研究比较了依沙酮（一种新型选择性非甾体类MR阻滞剂）2.5和5 mg/天与依普利酮50 mg/天在日本原发性高血压患者中的疗效和安全性。经过4周的洗脱期后，1001名合格的高血压成年患者被随机平均分配至依沙普利酮2.5或5 mg/天或依普利酮50 mg/天治疗组，每天口服一次，持续12周。主要终点是治疗结束时坐位收缩压或舒张压（BP）较基线的变化。依沙普利酮2.5 mg/天在降低坐位血压和24小时血压方面不劣于依普利酮。依沙昔酮5 mg/天组的血压下降幅度明显大于依沙昔酮2.5 mg/天组。在所有治疗组中，昼夜血压的变化显示出持续的24小时降压作用。达到目标坐位血压的患者比例（
Mineralocorticoid receptors (MRs) are implicated in the pathology of hypertension. MR blockers are recommended for the treatment of salt-sensitive or resistant hypertension. However, use of currently available MR blockers is limited by adverse events. This phase 3 multicenter, randomized, double-blind study compared the efficacy and safety of esaxerenone, a new selective nonsteroidal MR blocker, at 2.5 and 5 mg/day and eplerenone 50 mg/day in Japanese patients with essential hypertension. After a 4-week washout period, 1001 eligible adults with hypertension were randomized evenly to esaxerenone 2.5 or 5 mg/day or eplerenone 50 mg/day treatments, taken orally once daily for 12 weeks. Primary end points were changes in sitting systolic or diastolic blood pressure (BP) from baseline at the end of treatment. Esaxerenone 2.5 mg/day was noninferior to eplerenone for reductions in sitting and 24-hour BP. Reductions in BP with esaxerenone 5 mg/day were significantly greater than those with esaxerenone 2.5 mg/day. Changes in diurnal BP showed persistent 24-hour antihypertensive effects in all treatment groups. The proportions of patients achieving target sitting BP (