Germino F Wilford, Lin Yuhua, Pejović Vojislav, Bowen Lynn
Department of Internal Medicine, Orland Primary Care Specialists, 16660 107 Street, Orland Park, IL 60467, USA.
Ther Adv Cardiovasc Dis. 2012 Oct;6(5):185-99. doi: 10.1177/1753944712459593. Epub 2012 Sep 24.
This retrospective analysis examined the efficacy and tolerability of nebivolol, a ß(1)-selective, vasodilatory β-blocker, in four different age groups of patients with hypertension.
Data were pooled from three 12-week, randomized, placebo-controlled trials (placebo, n = 205; nebivolol [1.25-30/40 mg/day], n = 1811) and stratified into age quartiles (Group 1: 22-46 years; Group 2: 47-53 years; Group 3: 54-62 years; Group 4: 63-84 years). Only patients treated with placebo and the three commonly used nebivolol dosages (5, 10, and 20 mg/day) are presented. Baseline-to-endpoint changes in trough sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR) were analyzed for each age quartile using an analysis of covariance (ANCOVA) model. Tolerability was assessed by means of adverse event (AE) rates.
The analysis comprised 205 placebo-treated patients and 1380 patients treated with nebivolol dosages of 5, 10, or 20 mg/day. Older age was associated with higher SBP values at baseline. In all age groups, each of the three most frequently used nebivolol dosages significantly reduced DBP, compared with placebo (-9.1 to -11.8 mmHg versus -3.4 to -5.9 mmHg; p ≤ 0.008 overall). For SBP, a statistically significant effect versus placebo was observed for all dosages and age groups except for 5 and 10 mg/day in Group 4. Within each group, treatment with nebivolol (all three dosages) and placebo resulted in similar AE rates (nebivolol: 26.1-36.6%; placebo: 36.2-42.6%) and AE-related discontinuation rates (1.8-3.8% versus 0-4.3%). In each age group, there were no significant nebivolol-placebo differences in the rates of patients who experienced clinically significant changes or abnormal endpoint levels of metabolic parameters.
This retrospective analysis suggests that nebivolol monotherapy is efficacious and well tolerated across various age groups, with the efficacy in reducing SBP somewhat diminishing in patients over 62 years of age.
本回顾性分析研究了奈必洛尔（一种β₁选择性、具有血管舒张作用的β受体阻滞剂）在四个不同年龄组高血压患者中的疗效和耐受性。
汇总了三项为期12周的随机、安慰剂对照试验的数据（安慰剂组，n = 205；奈必洛尔组[1.25 - 30/40 mg/天]，n = 1811），并按年龄四分位数分层（第1组：22 - 46岁；第2组：47 - 53岁；第3组：54 - 62岁；第4组：63 - 84岁）。仅呈现接受安慰剂治疗以及三种常用奈必洛尔剂量（5、10和20 mg/天）治疗的患者。使用协方差分析（ANCOVA）模型分析每个年龄四分位数从基线到终点的静息舒张压（DBP）、收缩压（SBP）和心率（HR）的变化。通过不良事件（AE）发生率评估耐受性。
分析纳入了205例接受安慰剂治疗的患者以及1380例接受5、10或20 mg/天奈必洛尔治疗的患者。年龄较大与基线时较高的SBP值相关。在所有年龄组中，与安慰剂相比，三种最常用的奈必洛尔剂量均显著降低了DBP（-9.1至-11.8 mmHg对-3.4至-5.9 mmHg；总体p≤0.008）。对于SBP，除第4组的5和10 mg/天剂量外，所有剂量和年龄组与安慰剂相比均有统计学显著效果。在每组中，奈必洛尔（所有三种剂量）和安慰剂治疗导致的AE发生率相似（奈必洛尔：26.1 - 36.6%；安慰剂：36.2 - 42.6%）以及AE相关停药率相似（1.8 - 3.8%对0 - 4.3%）。在每个年龄组中，经历临床显著变化或代谢参数终点水平异常的患者比例，奈必洛尔与安慰剂之间无显著差异。
本回顾性分析表明，奈必洛尔单药治疗在各年龄组均有效且耐受性良好，62岁以上患者降低SBP的疗效有所降低。
