Efficacy and Tolerability of Combination Therapy Versus Monotherapy with Candesartan and/or Amlodipine for Dose Finding in Essential Hypertension: A Phase II Multicenter, Randomized, Double-blind Clinical Trial
- Authors
- Sohn, Il Suk; Kim, Chong-Jin; Ahn, Taehoon; Youn, Ho-Joong; Jeon, Hui-Kyung; Ihm, Sang Hyun; Cho, Eun Joo; Chung, Woo-Baek; Chae, Shung Chull; Kim, Woo-Shik; Nam, Chang-Wook; Park, Seong-Mi; Choi, Ji-Yong; Kim, Young-Kwon; Hong, Taek-Jong; Lee, Hae-Young; Cho, Jang-Hyun; Shin, Eun-Seok; Yoon, Jung-Han; Yang, Tae-Hyun; Jeong, Myung-Ho; Lee, Jun-Hee; Park, Joong-Il
- Issue Date
- Aug-2017
- Publisher
- ELSEVIER
- Keywords
- amlodipine; candesartan; combination; hypertension
- Citation
- CLINICAL THERAPEUTICS, v.39, no.8, pp.1628 - 1638
- Indexed
- SCIE
SCOPUS
- Journal Title
- CLINICAL THERAPEUTICS
- Volume
- 39
- Number
- 8
- Start Page
- 1628
- End Page
- 1638
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/82690
- DOI
- 10.1016/j.clinthera.2017.06.014
- ISSN
- 0149-2918
- Abstract
- Purpose: Intensive blood pressure (BP) lowering is important for the treatment of hypertension; however, it has been a challenge to achieve target BP in many patients. The purpose of this study was to explore the optimal dosage of a fixed-dose combination of candesartan cilexetil (CAN) and amlodipine besylate (AML), by examining the tolerability and efficacy of CAN/AML combination therapy compared with those of monotherapy with either drug in patients with essential hypertension. Methods: This Phase II multicenter, randomized, double-blind clinical trial enrolled patients aged 19 years or older with essential hypertension, defined as a mean sitting diastolic BP (msDBP) between 95 and 115 mm Hg, and a mean sitting systolic BP (msSBP) of <200 mm Hg after a 2-week placebo run-in period. A total of 635 ilatients were screened, of whom 439 were randomized to receive treatment; 425 patients were included in the full analysis set (combination therapy, 212; monotherapy, 213). Participants were randomly assigned to receive 1 of 8 treatments: CAN (8 or 16 mg), AML (5 or 10 mg), CAN/AML (8 mg/5 mg, 8 mg/10 mg, 16 mg/5 mg, or 16 mg/10 mg), once daily for 8 weeks. Findings: After 8 weeks of treatment, changes in msDBP were significantly greater in the groups receiving CAN/AML combination therapies compared with monotherapies at matched doses, with the exception of CAN 8 mg/AML 10 mg versus AML 10 mg. The response to treatment and the achievement of target BP (both msSBP and msDBP) at week 8 were significantly greater overall in the groups that received combination therapy versus monotherapy. All medications were relatively well tolerated in each group. (C) 2017 Published by Elsevier HS Journals, Inc.
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - College of Medicine > Department of Medical Science > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholar.korea.ac.kr/handle/2021.sw.korea/82690)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.