State University of New York Downstate College of Medicine, Brooklyn, New York, USA.
Urovant Sciences, Irvine, California, USA.
Blood Press Monit. 2022 Apr 1;27(2):128-134. doi: 10.1097/MBP.0000000000000572.
To characterize the blood pressure (BP) profile of the new β3-adrenergic receptor agonist, vibegron, in patients with overactive bladder.
Patients were randomized to once-daily vibegron 75 mg or placebo for 28 days and underwent ambulatory BP monitoring. The primary endpoint was change from baseline (CFB) to day 28 in mean daytime ambulatory systolic BP (SBP). Secondary endpoints were CFB in mean 24-h SBP and in mean daytime and mean 24-h ambulatory diastolic BP (DBP) and heart rate (HR). Safety was assessed through adverse event reporting.
Of 214 patients randomized, 96 receiving vibegron and 101 receiving placebo had evaluable baseline and day 28 measurements. Overall, 39.6 and 30.7% of patients receiving vibegron and placebo, respectively, had preexisting hypertension. The least squares mean difference (LSMD; 90% confidence interval) between vibegron and placebo in CFB in mean daytime SBP was 0.8 (-0.9, 2.5) mmHg. LSMD in CFB in mean daytime DBP and HR was 0.0 mmHg and 0.9 bpm, respectively. No significant differences between treatments were seen in CFB in mean 24-h SBP (LSMD, 0.6 mmHg), DBP (-0.2 mmHg) or HR (1.0 bpm). The most common treatment-emergent adverse event was hypertension, with rates comparable between groups [vibegron: n = 5 (4.7%); placebo: n = 4 (3.7%)]. One patient receiving vibegron took a prohibited medication (phentermine) known to increase BP.
Once-daily vibegron had no statistically significant or clinically relevant effects on BP or HR.
描述新型β3-肾上腺素能受体激动剂维贝格隆在膀胱过度活动症患者中的血压（BP）特征。
患者随机分为每日一次维贝格隆 75mg 或安慰剂治疗 28 天，并接受动态血压监测。主要终点为从基线（CFB）到第 28 天的日间平均动态收缩压（SBP）的变化。次要终点为 24 小时平均 SBP 及日间、24 小时平均舒张压（DBP）和心率（HR）的 CFB。通过不良事件报告评估安全性。
在 214 名随机患者中，96 名接受维贝格隆治疗，101 名接受安慰剂治疗，有可评估的基线和第 28 天的测量值。总体而言，分别有 39.6%和 30.7%的接受维贝格隆和安慰剂治疗的患者存在高血压前期。维贝格隆和安慰剂在 CFB 中日间平均 SBP 的最小二乘均数差（LSMD；90%置信区间）为 0.8（-0.9，2.5）mmHg。CFB 中日间平均 DBP 和 HR 的 LSMD 分别为 0.0mmHg 和 0.9bpm。在 CFB 中 24 小时平均 SBP（LSMD，0.6mmHg）、DBP（-0.2mmHg）或 HR（1.0bpm）方面，治疗组之间无显著差异。最常见的治疗后不良事件是高血压，两组发生率相当[维贝格隆：n=5（4.7%）；安慰剂：n=4（3.7%）]。一名接受维贝格隆治疗的患者服用了已知会升高血压的禁用药物（苯丙醇胺）。
每日一次维贝格隆对血压或心率没有统计学意义或临床相关影响。
