Androscoggin Cardiology Associates, Auburn, Maine 04210-5967, USA.
Clin Ther. 2011 Sep;33(9):1150-61. doi: 10.1016/j.clinthera.2011.07.020. Epub 2011 Aug 24.
Nebivolol is a β(1)-selective β-blocker with NO-mediated vasodilatory properties, approved in the United States for the treatment of stage I-II hypertension.
The purpose of this pooled analysis was to summarize efficacy and provide a brief overview of the tolerability associated with the use of nebivolol.
PubMed was searched for randomized, double-blind, placebo-controlled, parallel-group trials of monotherapy with nebivolol for stage I-II hypertension of at least 12 weeks' duration. This article reports pooled changes in sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR) at trough; proportions of responders (patients whose end-point sitting DBP at trough was <90 mm Hg or whose sitting DBP at trough had decreased from baseline by ≤10 mm Hg); and the most frequent adverse events (AEs). These data were also summarized in the subpopulation of black patients.
The literature search yielded 3 similarly designed studies. In all 3 trials, a single-blind placebo run-in phase (4-6 weeks) was followed by randomization (baseline) and a 12-week double-blind treatment phase in which patients received nebivolol 1.25 to 30 or 40 mg/d or placebo. The primary efficacy measure in all 3 trials was the mean change from baseline in sitting DBP at 12 weeks, based on the intent-to-treat population. In the pooled sample, 930 (46.1%) patients were women, and the mean age was 53.6 years. Compared with placebo (n = 205), the reductions in DBP (up to 11.1 mm Hg), SBP (up to 12.4 mm Hg), and HR (up to 9.2 beats/min) were significantly greater with nebivolol (n = 1811) at the recommended dosages of 5-30/40 mg/d (all, P < 0.001). The most commonly reported AEs were headache (nebivolol, all dosages, 7.1%; placebo, 5.9%), fatigue (3.6% vs 1.5%, respectively), and nasopharyngitis (3.1% vs 4.4%). The efficacy and tolerability of nebivolol in black patients were similar to those observed in the total study population.
Based on the pooled results from the 3 monotherapy trials reported here, nebivolol administered for 12 weeks was efficacious and generally well tolerated in patients with stage I-II hypertension.
比索洛尔是一种具有 NO 介导的血管扩张特性的β（1）选择性β受体阻滞剂，已获美国批准用于治疗 I 期- II 期高血压。
本汇总分析旨在总结疗效，并简要概述与使用比索洛尔相关的耐受性。
检索了 PubMed 上为期至少 12 周的 I 期- II 期高血压单药治疗的随机、双盲、安慰剂对照、平行组试验的比索洛尔的随机、双盲、安慰剂对照、平行组试验。本文报告了在最低点时的坐姿舒张压（DBP）、收缩压（SBP）和心率（HR）的汇总变化；应答者的比例（终点时坐姿 DBP ＜90mmHg 的患者或坐姿 DBP 在最低点时较基线下降 ≥10mmHg 的患者）；以及最常见的不良反应（AE）。这些数据也在黑人患者亚群中进行了总结。
文献检索得到了 3 项设计相似的研究。在所有 3 项试验中，均先进行了为期 4-6 周的单盲安慰剂导入期，然后进行随机分组（基线）和为期 12 周的双盲治疗期，在此期间，患者接受比索洛尔 1.25 至 30 或 40mg/d 或安慰剂治疗。所有 3 项试验中的主要疗效指标均为 12 周时基于意向治疗人群的坐姿 DBP 自基线的平均变化。在汇总样本中，930 名（46.1%）患者为女性，平均年龄为 53.6 岁。与安慰剂（n=205）相比，比索洛尔（n=1811）在推荐剂量为 5-30/40mg/d 时，DBP（最多下降 11.1mmHg）、SBP（最多下降 12.4mmHg）和 HR（最多下降 9.2 次/分钟）的下降幅度明显更大（均，P＜0.001）。报告最多的不良反应是头痛（比索洛尔，所有剂量，7.1%；安慰剂，5.9%）、疲劳（分别为 3.6%和 1.5%）和鼻咽炎（3.1%和 4.4%）。比索洛尔在黑人患者中的疗效和耐受性与总研究人群相似。
根据本文报道的 3 项单药治疗试验的汇总结果，比索洛尔治疗 12 周对 I 期- II 期高血压患者有效且一般耐受良好。
