China-Japan Friendship Hospital, Beijing, China.
Curr Med Res Opin. 2010 Jul;26(7):1705-13. doi: 10.1185/03007995.2010.487391.
The antihypertensive efficacy of amlodipine/valsartan combination has not been evaluated in Asian patients as previous large-scale studies enrolled very few patients. This multicentre, randomised, double-blind study assessed the efficacy and safety of a single-pill combination of amlodipine/valsartan versus amlodipine in Asian hypertensive patients.
After a 1-4-week washout period, patients (mean sitting diastolic BP [msDBP]: >or=95-<110 mmHg) were treated with amlodipine 5 mg for 4 weeks. Patients inadequately controlled on amlodipine (msDBP >or=90 and <110 mmHg) were randomised to receive amlodipine/valsartan 5/80 mg (n = 349) or amlodipine 5 mg (n = 349) for 8 weeks. Efficacy variables were change in msDBP, mean sitting systolic BP (msSBP) from baseline (at randomisation) to week 8 endpoint, and BP control rate (<140/90 mmHg) at week 8 endpoint. Safety assessments included monitoring and recording of adverse events (AEs).
Baseline characteristics were comparable between the groups. Most patients were Chinese (86.4%), men (65.1%), with a baseline BP 139.5/94.5 mmHg. At week 8 endpoint, the least square mean reduction in BP was significantly greater with amlodipine/valsartan combination than amlodipine monotherapy (-11.4/-9.7 vs. -7.4/-7.1 mmHg; p < 0.0001) with a higher BP control rate (69.2 vs. 57.6%; p = 0.0013). Ambulatory BP monitoring in a subgroup of patients (n = 82), showed a significant 24-h mean BP reduction from baseline with amlodipine/valsartan (-7.3/-6.3 mmHg; p < 0.0001), whereas the reduction was not significant with amlodipine (-0.2/+0.3 mmHg; p > 0.05). The overall incidence of AEs was similar in both groups. Peripheral oedema occurred only in the amlodipine group n = 4 (1.1%) and not in the amlodipine/valsartan combination. Hypotension was reported in only one patient in the amlodipine/valsartan combination. Six patients (0.9%) experienced serious AEs, of which only one SAE, i.e. gastric ulcer, was reported to be related to amlodipine treatment.
The single-pill combination of amlodipine/valsartan was efficacious and well-tolerated in Asian hypertensive patients who were inadequately controlled on amlodipine alone. As with all clinical trials, the entry criteria may limit the extrapolation of these results to a broader population. ClinicalTrials.gov Identifier: NCT00413049.
在亚洲患者中，氨氯地平和缬沙坦联合治疗的降压疗效尚未得到评估，因为之前的大型研究纳入的患者很少。这项多中心、随机、双盲研究评估了氨氯地平/缬沙坦单一片剂与氨氯地平单独治疗在亚洲高血压患者中的疗效和安全性。
经过 1-4 周的洗脱期后，患者（平均坐位舒张压[msDBP]：>或=95-<110mmHg）接受氨氯地平 5mg 治疗 4 周。对氨氯地平控制不佳的患者（msDBP>或=90和<110mmHg）随机接受氨氯地平/缬沙坦 5/80mg（n=349）或氨氯地平 5mg（n=349）治疗 8 周。疗效变量为 msDBP 的变化、基线（随机时）至第 8 周终点时的平均坐位收缩压（msSBP）和第 8 周终点时的血压控制率（<140/90mmHg）。安全性评估包括监测和记录不良事件（AE）。
两组的基线特征相当。大多数患者为中国人（86.4%），男性（65.1%），基线血压为 139.5/94.5mmHg。第 8 周终点时，与氨氯地平单药治疗相比，氨氯地平/缬沙坦联合治疗的血压降低幅度明显更大（-11.4/-9.7 对-7.4/-7.1mmHg；p<0.0001），血压控制率更高（69.2%对 57.6%；p=0.0013）。在亚组患者（n=82）中进行的动态血压监测显示，与基线相比，氨氯地平/缬沙坦组 24 小时平均血压显著降低（-7.3/-6.3mmHg；p<0.0001），而氨氯地平组的降低不显著（-0.2/+0.3mmHg；p>0.05）。两组的总体不良事件发生率相似。仅在氨氯地平组发生 4 例（1.1%）外周水肿，而在氨氯地平/缬沙坦联合组未发生。仅在氨氯地平/缬沙坦联合组报告了 1 例低血压。6 例（0.9%）患者发生严重不良事件，其中仅 1 例严重不良事件（即胃溃疡）与氨氯地平治疗有关。
氨氯地平/缬沙坦单一片剂在单独使用氨氯地平控制不佳的亚洲高血压患者中是有效和耐受良好的。与所有临床试验一样，纳入标准可能限制了这些结果在更广泛人群中的外推。临床试验标识符：NCT00413049。
