Zhang Jidong, Wang Yan, Hu Haijuan, Yang Xiaohong, Tian Zejun, Liu Demin, Gu Guoqiang, Zheng Hongmei, Xie Ruiqin, Cui Wei
Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.
Drug Des Devel Ther. 2016 Oct 18;10:3399-3406. doi: 10.2147/DDDT.S117221. eCollection 2016.
Nifedipine gastrointestinal therapeutic system (GITS) is used to treat angina and hypertension. The authors aimed to study the early intervention impact on arterial stiffness and pulse wave velocity (PWV) independent of its blood-pressure-(BP) lowering effect in mild hypertensive patients.
This single-center, single-arm, open-label, prospective, Phase IV study recruited patients with mild hypertension and increased PWV from December 2013 to December 2014 (N=138; age, 18-75 years; systolic blood pressure, 140-160 mmHg; diastolic BP, 90-100 mmHg; increased brachial-ankle pulse wave velocity [baPWV, ≥12 m/s]). Nifedipine GITS (30 mg/d) was administered for 24 weeks to achieve target BP of <140/90 mmHg. The dose was uptitrated at 60 mg/d in case of unsatisfactory BP reduction after 4 weeks. Primary study end point was the change in baPWV after nifedipine GITS treatment. Hemodynamic parameters (office BP, 24-hour ambulatory BP monitoring, and heart rate and adverse events) were evaluated at baseline and followed-up at 2, 4, 8, 12, 18, and 24 weeks.
Majority of patients (n=117; 84.8%) completed the study. baPWV decreased significantly at 4 weeks compared with baseline (1,598.87±239.82 vs 1,500.89±241.15 cm/s, <0.001), was stable at 12 weeks (1,482.24±215.14 cm/s, <0.001), and remained steady through 24 weeks (1,472.58±205.01 cm/s, <0.001). Office BP reduced from baseline to week 4 (154/95 vs 136/85 mmHg) and remained steady until 24 weeks. Nifedipine GITS significantly decreased 24-hour ambulatory BP monitoring (<0.001) after 24 weeks from baseline. Mean arterial pressure and pulse pressure were lowered significantly after 4, 12, and 24 weeks of treatment (<0.001). These changes in baPWV were significantly correlated with changes in systolic blood pressure, diastolic BP, and mean arterial pressure (<0.05), but not with changes in pulse pressure (>0.05). There were no other drug-related serious adverse events.
Nifedipine GITS was considerably effective in reducing baPWV and BP, indicating improvement in arterial stiffness as early as 4 weeks.
硝苯地平胃肠道治疗系统（GITS）用于治疗心绞痛和高血压。作者旨在研究早期干预对轻度高血压患者动脉僵硬度和脉搏波速度（PWV）的影响，且这种影响独立于其降压作用。
这项单中心、单臂、开放标签、前瞻性IV期研究于2013年12月至2014年12月招募了轻度高血压且PWV升高的患者（N = 138；年龄18 - 75岁；收缩压140 - 160 mmHg；舒张压90 - 100 mmHg；肱踝脉搏波速度[baPWV]升高，≥12 m/s）。给予硝苯地平GITS（30 mg/d）治疗24周，以使血压目标值<140/90 mmHg。若4周后血压降低不达标，则将剂量上调至60 mg/d。主要研究终点是硝苯地平GITS治疗后baPWV的变化。在基线以及第2、4、8、12、18和24周随访时评估血流动力学参数（诊室血压、24小时动态血压监测、心率和不良事件）。
大多数患者（n = 117；84.8%）完成了研究。与基线相比，baPWV在4周时显著降低（1598.87±239.82 vs 1500.89±241.15 cm/s，P<0.001），在12周时保持稳定（1482.24±215.14 cm/s，P<0.001），并在24周时一直保持稳定（1472.58±205.01 cm/s，P<0.001）。诊室血压从基线降至第4周（154/95 vs 136/85 mmHg），并一直保持稳定直至24周。硝苯地平GITS在24周后使24小时动态血压监测值显著降低（P<0.001）。治疗4、12和24周后，平均动脉压和脉压显著降低（P<0.001）。baPWV的这些变化与收缩压、舒张压和平均动脉压的变化显著相关（P<0.05），但与脉压变化无关（P>0.05）。未出现其他与药物相关的严重不良事件。
硝苯地平GITS在降低baPWV和血压方面相当有效，表明早在4周时动脉僵硬度就有所改善。
