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
Clinical therapeutics
2017Jul ; 11 ( 1 ) :.
PMID : 28734660
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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 -
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 patients 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. IMPLICATIONS: Eight-week administration of CAN/AML (8 mg/5 mg, 16 mg/5 mg, and 16 mg/10 mg) resulted in a significantly greater BP reduction than that with CAN or AML monotherapy, and was determined to be well tolerated. ClinicalTrials.gov identifier:?NCT02944734. CI - Copyright ??2017. Published by Elsevier Inc.
amlodipine; candesartan; combination; hypertension
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