当前位置: X-MOL 学术Hypertens. Res. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Long-term phase 3 study of esaxerenone as mono or combination therapy with other antihypertensive drugs in patients with essential hypertension
Hypertension Research ( IF 4.3 ) Pub Date : 2019-09-25 , DOI: 10.1038/s41440-019-0314-7
Hiromi Rakugi 1 , Sadayoshi Ito 2 , Hiroshi Itoh 3 , Yasuyuki Okuda 4 , Satoru Yamakawa 4
Affiliation  

This study investigated the long-term antihypertensive effects of esaxerenone, a novel nonsteroidal mineralocorticoid receptor blocker, alone or in combination with a calcium channel blocker (CCB) or a renin–angiotensin system (RAS) inhibitor, in Japanese patients with essential hypertension. Patients were treated with esaxerenone starting at 2.5 mg/day increasing to 5 mg/day if required to achieve blood pressure (BP) targets as a monotherapy or with a CCB or RAS inhibitor. After the first 12 weeks of treatment, an additional antihypertensive agent could be added if required to achieve the target BP; the total treatment period was 28 or 52 weeks. The primary endpoint was a change from baseline in sitting BP. Of the 368 enrolled patients, 245 received monotherapy, and 59 and 64, respectively, took a CCB or RAS inhibitor concurrently. Mean changes from baseline in sitting systolic/diastolic BP (95% confidence intervals) at weeks 12, 28 and 52 were −16.1 (−17.3, −14.9)/−7.7 (−8.4, −6.9), −18.9 (−20.2, −17.7)/−9.9 (−10.7, −9.2), and −23.1 (−25.0, −21.1)/−12.5 (−13.6, −11.3) mmHg, respectively (all P < 0.0001 vs baseline). Similar BP reductions at these weeks were observed between all patient subgroups stratified by age, and the observed decreases in 24-h ambulatory BP were consistent with the efficacy observed in sitting BP. Esaxerenone was also well-tolerated with a rate of hyperkalemia at 5.4% (serum potassium ≥5.5 mEq/L), indicating a good safety profile for treatment over the long-term or in combination with a CCB or RAS inhibitor. In conclusion, esaxerenone may be a promising treatment option for patients with hypertension.

中文翻译:

艾沙瑞农单药或与其他抗高血压药物联合治疗原发性高血压患者的长期 3 期研究

本研究调查了艾沙瑞酮(一种新型非甾体盐皮质激素受体阻滞剂)单独或与钙通道阻滞剂(CCB)或肾素-血管紧张素系统(RAS)抑制剂联合使用对日本原发性高血压患者的长期抗高血压作用。患者接受esaxerenone治疗,剂量从2.5 mg/天开始,如果需要作为单一疗法或CCB或RAS抑制剂达到血压(BP)目标,则增加至5 mg/天。治疗前12周后,如果需要达到目标血压,可以添加额外的抗高血压药物;总治疗期为28或52周。主要终点是坐位血压相对于基线的变化。在 368 名入组患者中,245 名接受单一疗法,分别有 59 名和 64 名同时服用 CCB 或 RAS 抑制剂。第12、28和52周时坐位收缩压/舒张压相对于基线的平均变化(95%置信区间)为−16.1(−17.3,−14.9)/−7.7(−8.4,−6.9),−18.9(−20.2,−20.2)分别为-17.7)/-9.9 (-10.7, -9.2) 和-23.1 (-25.0, -21.1)/-12.5 (-13.6, -11.3) mmHg(所有 P < 0.0001 与基线相比)。在按年龄分层的所有患者亚组中,这些周内观察到类似的血压降低,并且观察到的 24 小时动态血压降低与坐位血压观察到的疗效一致。Esaxerenone 的耐受性也良好,高钾血症发生率为 5.4%(血清钾≥5.5 mEq/L),表明长期治疗或与 CCB 或 RAS 抑制剂联合治疗具有良好的安全性。总之,艾沙瑞酮可能是高血压患者一种有前途的治疗选择。
更新日期:2019-09-25
down
wechat
bug