背景:Ocedurenone(KBP-5074),非甾体盐皮质激素受体拮抗剂,有文献记载可降低3b/4期慢性肾脏病(CKD)伴不受控或顽固性高血压患者的血压(BLOCK-CKD研究)。然而,Ocedurenone在西班牙裔患者或4期CKD患者等亚组中的疗效和安全性,糖尿病,或非常高的白蛋白尿尚未报告。
方法:共有162名患者参加了BLOCK-CKD研究。这些分析的主要终点是收缩压(SBP)从基线到第84天的变化。针对人口统计的SBP的预先指定的亚组分析(例如,种族,年龄)和医疗(例如,CKD阶段,糖尿病,白蛋白尿,基线估计肾小球滤过率[eGFR])。安全性分析的重点是血清钾水平相对于基线的变化。
结果:与整个研究队列相比,各亚组的SBP降低是一致的。在西班牙裔患者中观察到安慰剂调整的SBP降低(0.25mg和0.5mg分别为-8.1mmHg和-9.9mmHg,分别,总n=35)和CKD4期患者(0.25mg和0.5mg的-9.3mmHg和-10.4mmHg,分别,总计n=64),糖尿病(0.25mg和0.5mg的-6.9mmHg和-11.6mmHg,分别,总n=51)和非常高的白蛋白尿(0.25mg和0.5mg的-13.1mmHg和-12.3mmHg,分别,总计n=85)。无论基线eGFR如何,所有患者亚组的血清钾变化相似,糖尿病状态,或蛋白尿的程度。没有高钾血症病例需要干预或导致研究中止。
结论:Ocedurenone在所有患者亚组中持续降低SBP。此外,虽然血清钾水平出现小幅升高,它们与Ocedurenone或研究中止无关.
BACKGROUND: Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney disease (CKD) with uncontrolled or resistant hypertension (BLOCK-CKD study). However, the efficacy and safety of Ocedurenone in subgroups such as Hispanic patients or those with stage 4 CKD, diabetes, or very high albuminuria have not been reported.
METHODS: A total of 162 patients were enrolled in the BLOCK-CKD study. The primary endpoint of these analyses was change in systolic blood pressure (SBP) from baseline to day 84. Prespecified subgroup analysis of SBP focused on demographic (e.g., ethnicity, age) and medical (e.g., CKD stage, diabetes, albuminuria, baseline estimated glomerular filtration rate [eGFR]). The safety analysis focused on changes in serum potassium levels from baseline.
RESULTS: SBP reductions were consistent across subgroups compared with the overall study cohort. Placebo-adjusted SBP reductions were observed in Hispanic patients (-8.1 and -9.9 mm Hg for 0.25 and 0.5 mg, respectively, total n = 35) and patients with CKD stage 4 (-9.3 and -10.4 mm Hg for 0.25 and 0.5 mg, respectively, total n = 64), diabetes (-6.9 and -11.6 mm Hg for 0.25 and 0.5 mg, respectively, total n = 51), and very high albuminuria (-13.1 and -12.3 mm Hg for 0.25 and 0.5 mg, respectively, total n = 85). Changes in serum potassium were similar across all patient subgroups regardless of baseline eGFR, diabetes status, or degree of proteinuria. No cases of hyperkalemia required intervention or resulted in study discontinuation.
CONCLUSIONS: Ocedurenone consistently reduced in SBP in all patient subgroups. Moreover, while small elevations in serum potassium occurred, they were not associated with Ocedurenone or study discontinuation.