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題名 | Amlodipine/Valsartan Fixed-dose Combination Treatment in the Management of Hypertension: A Double-blind, Randomized Trial |
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作 者 | Wang, Kang-ling; Yu, Wen-chung; Lu, Tse-min; Chen, Lung-ching; Leu, Hsin-bang; Chiang, Chern-en; | 書刊名 | Journal of the Chinese Medical Association |
卷期 | 83:10 2020.10[民109.10] |
頁次 | 頁900-905 |
分類號 | 418.221 |
關鍵詞 | Amlodipine; Fixed-dose combination; Hypertension; Valsartan; |
語文 | 英文(English) |
英文摘要 | Background: To compare the fixed-dose combination (FDC) of amlodipine/valsartan 5/80mg with valsartan 160mg monotherapy for efficacy and safety in hypertensive patients. Methods: 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 5/80mg FDC or valsartan 160mg 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. Results: 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 5/80mg FDC and –6.9 ± 11.4 mmHg (p = 0.012) with valsartan 160mg 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 5/80mg FDC than with valsartan 160mg. Overall, 27 and 23 adverse events occurred in the amlodipine/valsartan 5/80mg FDC group and in the valsartan 160mg monotherapy group, respectively. The majority were mild and were not related to study medications. There were no significant differences in safety between two treatments. Conclusion: Efficacy of amlodipine/valsartan 5/80mg FDC was superior to that of valsartan 160mg monotherapy while both treatments were well-tolerated. |
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