Abstract

Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone.

Details

Title
Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment
Author
Soh, Moon-Seung 1 ; Won, Kyung-heon 2 ; Kim, Jae-Joong 3 ; Lee, Sung Yun 4 ; Hyon, Min Su 5 ; Youn, Ho-Joong 6 ; Rha, Seung-Woon 7 ; Kim, Doo-Il 8 ; Ahn, Youngkeun 9 ; Kim, Byung Jin 10 ; Choi, Dong-Ju 11 ; Park, Jong-Seon 12 ; Kim, Dae-Kyung 13 ; Park, Woo-Jung 14 ; Lim, Hong-Seok 1 ; Tahk, Seung-Jea 1 

 Ajou University School of Medicine, Department of Cardiology, Suwon, Republic of Korea (GRID:grid.251916.8) (ISNI:0000 0004 0532 3933) 
 Seoul Medical Center, Department of Internal Medicine, Seoul, Republic of Korea (GRID:grid.415520.7) (ISNI:0000 0004 0642 340X) 
 University of Ulsan College of Medicine, Division of Cardiology, Department of Internal Medicine, Asan Medical Center, Seoul, Republic of Korea (GRID:grid.267370.7) (ISNI:0000 0004 0533 4667) 
 Seoul Medical Center, Department of Cardiology, Seoul, Republic of Korea (GRID:grid.415520.7) (ISNI:0000 0004 0642 340X) 
 Soonchunhyang University Hospital, Division of Cardiology, Department of Internal Medicine, Seoul, Republic of Korea (GRID:grid.412678.e) (ISNI:0000 0004 0634 1623) 
 The Catholic University of Korea, Division of Cardiology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, Seoul, Republic of Korea (GRID:grid.411947.e) (ISNI:0000 0004 0470 4224) 
 Korea University Guro Hospital, Division of Cardiology, Seoul, Republic of Korea (GRID:grid.411134.2) (ISNI:0000 0004 0474 0479) 
 Inje University College of Medicine, Division of Cardiology, Department of Internal Medicine, Haeundae Paik Hospital, Busan, Republic of Korea (GRID:grid.411612.1) (ISNI:0000 0004 0470 5112) 
 Chonnam National University Hospital, Department of Cardiology, Gwangju, Republic of Korea (GRID:grid.411597.f) (ISNI:0000 0004 0647 2471) 
10  Sungkyunkwan University School of Medicine, Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul, Republic of Korea (GRID:grid.264381.a) (ISNI:0000 0001 2181 989X) 
11  Seoul National University Bundang Hospital, Division of Cardiology, Department of Internal Medicine, Seongnam, Republic of Korea (GRID:grid.412480.b) (ISNI:0000 0004 0647 3378) 
12  Yeungnam University Hospital, Division of Cardiology, Department of Internal Medicine, Daegu, Republic of Korea (GRID:grid.413028.c) (ISNI:0000 0001 0674 4447) 
13  Inje University Busan Paik Hospital, Division of Cardiology, Department of Internal Medicine, Busan, Republic of Korea (GRID:grid.411625.5) (ISNI:0000 0004 0647 1102) 
14  Hallym University Sacred Heart Hospital, Division of Cardiology, Anyang, Republic of Korea (GRID:grid.488421.3) (ISNI:0000 0004 0415 4154) 
Pages
22940
Publication year
2024
Publication date
2024
Publisher
Nature Publishing Group
e-ISSN
20452322
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3112281154
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.