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

Frontiers in Cardiovascular Medicine

Cardiovascular Medicine

Guang Ma¹  Xiaohong Gao²  Rui Xu³  Ping Yang⁴  Shuren Li⁵  Linchao Zhang⁶  Jianping Bin⁷  Chang Hong⁸  Shuyang Zhang⁹  Ying Li^1,10  Xiaodong Li^1,11  Xiang Gu^1,12  Xiaoqun Wan^1,13  Zhen Wang^1,14  Weidong Liang^1,15  Yong Liu^1,16  Yuemin Sun^1,17  Zhuhua Yao^1,18  Xin Xu^1,19  Xiping Xu^2,20  Min Jia^2,21 

[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

【 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.