期刊论文详细信息
Frontiers in Cardiovascular Medicine
Efficacy and safety of single-pill amlodipine/losartan versus losartan in patients with inadequately controlled hypertension after losartan treatment: a multicenter, double-blind, randomized phase III clinical trial
Cardiovascular Medicine
Guang Ma1  Xiaohong Gao2  Rui Xu3  Ping Yang4  Shuren Li5  Linchao Zhang6  Jianping Bin7  Chang Hong8  Shuyang Zhang9  Ying Li1,10  Xiaodong Li1,11  Xiang Gu1,12  Xiaoqun Wan1,13  Zhen Wang1,14  Weidong Liang1,15  Yong Liu1,16  Yuemin Sun1,17  Zhuhua Yao1,18  Xin Xu1,19  Xiping Xu2,20  Min Jia2,21 
[1] Department of Cardiology, Baoding NO.2 Central Hospital, Baoding, China;Department of Cardiology, Beijing Pinggu Hospital, Beijing, China;Department of Cardiology, Central Hospital Affiliated to Shandong First Medical University, Jinan, China;Department of Cardiology, Shandong Provincial Qianfoshan Hospital, Jinan, China;Department of Cardiology, China-Japan Union Hospital of Jilin University, Jilin, China;Department of Cardiology, Hebei General Hospital, Shijiazhuang, China;Department of Cardiology, Liuzhou Municipal Liutie Central Hospital, Liuzhou, China;Department of Cardiology, Liuzhou People’s Hospital, Liuzhou, China;Department of Cardiology, Nanfang Hospital, Guangzhou, China;Department of Cardiology, PKUCare Luzhong Hospital, Zibo, China;Department of Cardiology, Peking Union Medical College Hospital, Beijing, China;Department of Cardiology, Shanghai East Hospital, Shanghai, China;Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, China;Department of Cardiology, Subei People’s Hospital, Yangzhou, China;Department of Cardiology, The First Affiliated Hospital of Xiamen University, Xiamen, China;Department of Cardiology, The First Hospital of Hebei Medical University, Shijiazhuang, China;Department of Cardiology, The First People’s Hospital of Nanning, Nanning, China;Department of Cardiology, Tianjin 4th Center Hospital, Tianjin, China;Department of Cardiology, Tianjin Medical University General Hospital, Tianjin, China;Department of Cardiology, Tianjin People’s Hospital, Tianjin, China;Department of Cardiology, Wuxi No.2 People’s Hospital, Wuxi, China;Department of Cardiology, Yueyang Central Hospital, Yueyang, China;Department of Cardiology, Zaozhuang Municipal Hospital, Zaozhuang, China;
关键词: amlodipine besylate;    losartan;    inadequately controlled hypertension;    blood pressure;    safety;   
DOI  :  10.3389/fcvm.2023.1177166
 received in 2023-03-01, accepted in 2023-06-08,  发布年份 2023
来源: Frontiers
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【 摘 要 】

ObjectiveSingle-pill amlodipine besylate (AML) plus losartan (LOS) has been used to treat inadequately controlled hypertension after antihypertensive monotherapy; however, relevant data in China are limited. This study aimed to compare the efficacy and safety of single-pill AML/LOS and LOS alone in Chinese patients with inadequately controlled hypertension after LOS treatment.MethodsIn this multicenter, double-blind, randomized, controlled phase III clinical trial, patients with inadequately controlled hypertension after 4 weeks of LOS treatment were randomized to receive daily single-pill AML/LOS (5/100 mg, AML/LOS group, N = 154) or LOS (100 mg, LOS group, N = 153) tablets for 8 weeks. At weeks 4 and 8 of treatment, sitting diastolic and systolic blood pressure (sitDBP and sitSBP, respectively) and the BP target achievement rate were assessed.ResultsAt week 8, the sitDBP change from baseline was greater in the AML/LOS group than in the LOS group (−8.84 ± 6.86 vs. −2.65 ± 7.62 mmHg, P < 0.001). In addition, the AML/LOS group also showed greater sitDBP change from baseline to week 4 (−8.77 ± 6.60 vs. −2.99 ± 7.05 mmHg) and sitSBP change from baseline to week 4 (−12.54 ± 11.65 vs. −2.36 ± 10.33 mmHg) and 8 (−13.93 ± 10.90 vs. −2.38 ± 12.71 mmHg) (all P < 0.001). Moreover, the BP target achievement rates at weeks 4 (57.1% vs. 25.3%, P < 0.001) and 8 (58.4% vs. 28.1%, P < 0.001) were higher in the AML/LOS group than those in the LOS group. Both treatments were safe and tolerable.ConclusionSingle-pill AML/LOS is superior to LOS monotherapy for controlling BP and is safe and well tolerated in Chinese patients with inadequately controlled hypertension after LOS treatment.

【 授权许可】

Unknown   
© 2023 Zhang, Li, Xu, Xu, Zhang, Wan, Yao, Sun, Liu, Bin, Wang, Li, Yang, Xu, Liang, Gao, Li, Jia, Ma, Gu and Hong.

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