General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.
School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.
J Chin Med Assoc. 2020 Oct;83(10):900-905. doi: 10.1097/JCMA.0000000000000386.
To compare the fixed-dose combination (FDC) of amlodipine/valsartan 5/80 mg with valsartan 160 mg monotherapy for efficacy and safety in hypertensive patients.
We designed this double-blind, randomized, and noninferiority trial in which patients with elevated systolic blood pressure (SBP) and/or diastolic blood pressure (DBP) were randomly assigned to receive amlodipine/valsartan 5/80 mg FDC or valsartan 160 mg monotherapy for 8 weeks. The primary endpoint was changes in office SBP and DBP from baseline to 8 weeks. Twenty-four-hour blood pressure (BP) and the incidence of adverse events were recorded.
A total of 42 patients underwent randomization. At 8 weeks, office SBP changes were -16.5 ± 15.5 mmHg (p < 0.001) with amlodipine/valsartan 5/80 mg FDC and -6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160 mg monotherapy while corresponding changes in office DBP were -9.8 ± 7.7 mmHg (p < 0.001) and -2.5 ± 6.6 mmHg (p = 0.095), respectively. The between-group differences were -9.6 mmHg (95% CI, -18.1 to -1.1; p = 0.028) for SBP and -7.3 mmHg (95% CI, -11.8 to -2.8; p = 0.002) for DBP. Furthermore, reductions in both 24-hour SBP (-9.2 mmHg; 95% CI, -16.4 to -2.1; p = 0.013) and DBP (-4.6 mmHg; 95% CI, -9.2 to -0.1; p = 0.048) were consistently greater with amlodipine/valsartan 5/80 mg FDC than with valsartan 160 mg. Overall, 27 and 23 adverse events occurred in the amlodipine/valsartan 5/80 mg FDC group and in the valsartan 160 mg monotherapy group, respectively. The majority were mild and were not related to study medications. There were no significant differences in safety between two treatments.
Efficacy of amlodipine/valsartan 5/80 mg FDC was superior to that of valsartan 160 mg monotherapy while both treatments were well-tolerated.
比较氨氯地平/缬沙坦 5/80mg 固定剂量复方制剂与缬沙坦 160mg 单药治疗高血压患者的疗效和安全性。
我们设计了这项双盲、随机、非劣效性试验，将血压升高的患者（收缩压[SBP]和/或舒张压[DBP]）随机分配接受氨氯地平/缬沙坦 5/80mg 固定剂量复方制剂或缬沙坦 160mg 单药治疗 8 周。主要终点为从基线到 8 周时诊室 SBP 和 DBP 的变化。记录 24 小时血压（BP）和不良反应的发生情况。
共有 42 名患者接受了随机分组。8 周时，氨氯地平/缬沙坦 5/80mg 固定剂量复方制剂组 SBP 下降-16.5±15.5mmHg（p<0.001），缬沙坦 160mg 单药组 SBP 下降-6.9±11.4mmHg（p=0.012），相应的 DBP 下降分别为-9.8±7.7mmHg（p<0.001）和-2.5±6.6mmHg（p=0.095）。组间差异在 SBP 为-9.6mmHg（95%可信区间，-18.1 至-1.1；p=0.028）和 DBP 为-7.3mmHg（95%可信区间，-11.8 至-2.8；p=0.002）。此外，氨氯地平/缬沙坦 5/80mg 固定剂量复方制剂组 24 小时 SBP（-9.2mmHg；95%可信区间，-16.4 至-2.1；p=0.013）和 DBP（-4.6mmHg；95%可信区间，-9.2 至-0.1；p=0.048）的降幅均明显大于缬沙坦 160mg 单药组。氨氯地平/缬沙坦 5/80mg 固定剂量复方制剂组和缬沙坦 160mg 单药组分别发生 27 次和 23 次不良反应。大多数不良反应为轻度，与研究药物无关。两种治疗方法的安全性无显著差异。
氨氯地平/缬沙坦 5/80mg 固定剂量复方制剂的疗效优于缬沙坦 160mg 单药治疗，且两者均具有良好的耐受性。
