Abstract：
This study aimed to identify factors associated with a strong home blood pressure (BP)-lowering effect of esaxerenone and the incidence of elevated serum potassium levels in hypertensive patients treated with esaxerenone. A pooled analysis of five multicenter, prospective, open-label single-arm studies was conducted, including 479 patients in the full analysis set (FAS) and 492 patients in the safety analysis set. Multivariate linear regression analysis of morning home systolic BP (SBP) and diastolic BP (DBP) changes from baseline to Week 12 in the FAS (primary endpoint) showed that male sex (estimated change 4.37 mmHg), office pulse rate ≥100 beats/min (25.10 mmHg), and calcium channel blocker (CCB) use as a basal antihypertensive agent (4.53 mmHg) were significantly associated with a positive estimated change (weaker BP-lowering effect) in morning home SBP. CCB use (3.70 mmHg) was associated with a positive estimated change in morning home DBP. Urine albumin-to-creatinine ratio 30 to <300 mg/gCr (-4.13 mmHg) was significantly associated with a negative estimated change (stronger BP-lowering effect) in morning home SBP. Based on multivariate logistic regression analysis, elevated baseline serum potassium level (≥4.5 vs < 4.5 mEq/L, odds ratio 13.502) was significantly associated with a high incidence of serum potassium level ≥5.5 mEq/L after esaxerenone treatment. In conclusion, factors associated with a strong BP-lowering effect of esaxerenone were female sex and use of renin-angiotensin system inhibitors as a basal antihypertensive drug. Patients with baseline serum potassium levels ≥4.5 mEq/L had an increased risk of developing elevated serum potassium levels (≥5.5 mEq/L) after esaxerenone treatment.
摘要：
这项研究旨在确定与艾沙司酮具有强烈的家庭血压（BP）降低作用以及接受艾沙司酮治疗的高血压患者血清钾水平升高的发生率相关的因素。对五个多中心的汇总分析，prospective,进行了开放标签单臂研究，包括完整分析集（FAS）中的479名患者和安全性分析集中的492名患者。FAS（主要终点）从基线到第12周的早晨家庭收缩压（SBP）和舒张压（DBP）变化的多元线性回归分析显示，男性（估计变化4.37mmHg），办公室脉搏率≥100次/分钟（25.10mmHg），使用钙通道阻滞剂(CCB)作为基础降压药(4.53mmHg)与上午家庭SBP的阳性估计变化(降低BP的作用较弱)显著相关.CCB使用（3.70mmHg）与早晨家庭DBP的估计变化有关。尿白蛋白与肌酐比值30至<300mg/gCr（-4.13mmHg）与早晨家庭SBP的负估计变化（降低BP的作用更强）显着相关。基于多元逻辑回归分析，基线血清钾水平升高(≥4.5vs<4.5mEq/L，比值比13.502）与伊沙雷酮治疗后血清钾水平≥5.5mEq/L的高发生率显着相关。总之,与艾沙司酮有较强的降BP作用相关的因素是女性和使用肾素-血管紧张素系统抑制剂作为基础降压药.基线血清钾水平≥4.5mEq/L的患者在伊沙雷酮治疗后出现血清钾水平升高（≥5.5mEq/L）的风险增加。
