Punzi Henry, Lewin Andrew, Lukić Tatjana, Goodin Thomas
Trinity Hypertension & Metabolic Research Institute, 1932 Walnut Plaza, Carrollton, TX 75006, USA.
Ther Adv Cardiovasc Dis. 2010 Dec;4(6):349-57. doi: 10.1177/1753944710387629.
Hispanics have lower rates of hypertension control compared with black and white patients. Nebivolol is a vasodilatory β1-selective blocker, with neutral metabolic effects. This phase IV trial evaluated the efficacy and safety of nebivolol in Hispanics with stage I-II hypertension.
Self-identified Hispanics with stage I-II hypertension were randomized to receive a double-blind treatment: placebo (n = 136) or nebivolol (n = 141, starting dose 5 mg/day) for 8 weeks. Nebivolol dosage could be uptitrated at 2-week intervals to 10, 20, or 40 mg/day, as needed to achieve diastolic blood pressure (DBP) control (JNC7 criteria). Efficacy outcome measures were the mean changes from baseline to the end of week 8 in trough-seated DBP (primary) and systolic blood pressure (SBP) (secondary). Safety and tolerability were also assessed.
Baseline SBP/DBP (mmHg) was similar in both treatment groups (nebivolol: 156/100; placebo: 157/101). A total of 135 (96%) and 121 (89%) nebivolol- and placebo-treated participants completed the double-blind phase, respectively. Compared with the placebo, nebivolol treatment was associated with significant mean reductions in both trough-seated DBP and SBP (DBP: -11.1 mmHg vs. -7.3 mmHg, p < 0.0001; SBP: -14.1 mmHg vs. -9.3 mmHg; p = 0.001). Treatment-emergent adverse event (TEAE) rates were 17% (nebivolol) and 22% (placebo); the most frequent TEAEs were headache (4% vs. 6%, respectively), upper respiratory tract infection (2% vs. 2%), and dizziness (1% vs. 3%).
In Hispanics with stage I-II hypertension, 8-week nebivolol monotherapy resulted in significant reductions in blood pressure. The safety and tolerability profile of nebivolol was similar to that of placebo.
与黑人和白人患者相比，西班牙裔高血压患者的血压控制率较低。奈必洛尔是一种具有血管舒张作用的β1选择性阻滞剂，对代谢无不良影响。这项IV期试验评估了奈必洛尔治疗I-II期高血压西班牙裔患者的疗效和安全性。
自我认定为患有I-II期高血压的西班牙裔患者被随机分配接受双盲治疗：安慰剂组（n = 136）或奈必洛尔组（n = 141，起始剂量5毫克/天），为期8周。根据达到舒张压（DBP）控制（JNC7标准）的需要，奈必洛尔剂量可每2周递增至10、20或40毫克/天。疗效指标为从基线到第8周结束时卧位舒张压（主要指标）和收缩压（次要指标）的平均变化。同时评估安全性和耐受性。
两个治疗组的基线收缩压/舒张压（mmHg）相似（奈必洛尔组：156/100；安慰剂组：157/101）。分别有135名（96%）和121名（89%）接受奈必洛尔和安慰剂治疗的参与者完成了双盲阶段。与安慰剂相比，奈必洛尔治疗使卧位舒张压和收缩压均显著降低（舒张压：-11.1 mmHg对-7.3 mmHg，p < 0.0001；收缩压：-14.1 mmHg对-9.3 mmHg；p = 0.001）。治疗中出现的不良事件（TEAE）发生率分别为17%（奈必洛尔组）和22%（安慰剂组）；最常见的TEAE是头痛（分别为4%对6%）、上呼吸道感染（2%对2%）和头晕（1%对3%）。
在患有I-II期高血压的西班牙裔患者中，8周的奈必洛尔单药治疗可显著降低血压。奈必洛尔的安全性和耐受性与安慰剂相似。
