HanYang University Medical Center, Seoul.
Eulji University Hospital, Daejeon.
J Hypertens. 2020 Mar;38(3):527-535. doi: 10.1097/HJH.0000000000002296.
The efficacy and safety of nebivolol in patients with hypertension is well established, but its effect in Asian patients with essential hypertension in the real world has not been studied.
Adult South Korean patients with essential hypertension, with or without comorbidities, were enrolled to participate in this prospective, single-arm, open, observational study; 3011 patients received nebivolol either as monotherapy or add-on therapy. Changes in SBP, DBP and heart rate (HR) at 12 and 24 weeks were evaluated. Subgroup analysis for BP changes in newly diagnosed (de novo) patients and those receiving other antihypertensives at study entry were also conducted.
Nebivolol significantly decreased mean SBP and DBP at 12 and 24 weeks compared with baseline (P < 0.0001). A significant reduction in HR was also observed at 12 and 24 weeks (P < 0.0001). The reductions of SBP and DBP were notably greater when nebivolol was used as monotherapy in de novo patients (P < 0.0001) and as add-on therapy to existing antihypertensives (angiotensin II receptor blockers, angiotensin-converting enzyme inhibitors and calcium channel blockers; P < 0.0001). Majority of the reported adverse events were mild; the most common adverse events were dizziness (1.3%), headache (1.0%) and dyspnea (0.9%).
Despite the limitations associated with observational studies, this real-world study in Asian patients with essential hypertension with and without comorbidities, demonstrated the efficacy and safety of once daily nebivolol, either as monotherapy or add-on therapy.
NCT03847350.SDC Callout: Video Abstract, http://links.lww.com/HJH/B172.
比索洛尔在高血压患者中的疗效和安全性已得到充分证实，但在亚洲原发性高血压患者中的实际效果尚未得到研究。
本前瞻性、单臂、开放、观察性研究纳入了成年韩国原发性高血压患者（伴或不伴合并症），这些患者接受比索洛尔单药或联合治疗。评估治疗 12 周和 24 周时收缩压（SBP）、舒张压（DBP）和心率（HR）的变化。还进行了亚组分析，评估新诊断（de novo）患者和研究入组时接受其他降压药物治疗的患者的血压变化。
与基线相比，比索洛尔在治疗 12 周和 24 周时显著降低了平均 SBP 和 DBP（P<0.0001）。治疗 12 周和 24 周时 HR 也显著降低（P<0.0001）。在 de novo 患者中单药使用比索洛尔（P<0.0001）和在原有降压药物（血管紧张素 II 受体阻滞剂、血管紧张素转换酶抑制剂和钙通道阻滞剂）上加用比索洛尔时，SBP 和 DBP 的降低更为显著（P<0.0001）。大多数报告的不良事件为轻度；最常见的不良事件为头晕（1.3%）、头痛（1.0%）和呼吸困难（0.9%）。
尽管存在观察性研究的局限性，但本研究在亚洲原发性高血压合并或不合并合并症的患者中显示，每日一次比索洛尔单药或联合治疗的疗效和安全性。
NCT03847350.SDC 呼吁：视频摘要，http://links.lww.com/HJH/B172。
