Evaluation of the Dose-Response Relationship of Amlodipine and Losartan Combination in Patients with Essential Hypertension An 8-Week, Randomized, Double-Blind, Factorial, Phase II, Multicenter Study
- Authors
- Park, Chang-Gyu; Youn, Ho-Joong; Chae, Shung-Chull; Yang, Joo-Young; Kim, Moo-Hyun; Hong, Taek-Jong; Kim, Cheol Ho; Kim, Jae Joong; Hong, Bum-Kee; Jeong, Jin-Won; Park, Si-Hoon; Kwan, Jun; Choi, Young-Jin; Cho, Seung-Yun
- Issue Date
- 2012
- Publisher
- ADIS INT LTD
- Keywords
- amlodipine; hypertension; losartan.
- Citation
- AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, v.12, no.1, pp.35 - 47
- Indexed
- SCIE
SCOPUS
- Journal Title
- AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS
- Volume
- 12
- Number
- 1
- Start Page
- 35
- End Page
- 47
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/109336
- DOI
- 10.2165/11597170-000000000-00000
- ISSN
- 1175-3277
- Abstract
- Background: Despite recommendations for more intensive treatment and the availability of several effective treatments, hypertension remains uncontrolled in many patients. Objective: The aim of this study was to determine the dose-response relationship and assess the efficacy and safety of amlodipine or losartan monotherapy and amlodipine camsylate/losartan combination therapy in patients with essential hypertension. Methods: This was an 8-week, randomized, double-blind, factorial design, phase II, multicenter study conducted in outpatient hospital clinics among adult patients aged 18-75 years with essential hypertension. At screening, patients received placebo for 2-4 weeks. Eligible patients (n = 320) were randomized to one of eight treatment groups: amlodipine 5 mg or 10 mg, losartan 50 mg or 100 mg, amlodipine camsylate/losartan 5 mg/50 mg, 5 mg/100 mg, 10 mg/50 mg, or 10 mg/100 mg. Main Outcome Measures: The assumption of strict superiority was estimated using the mean change in sitting diastolic blood pressure (DBP) at 8 weeks. Safety was monitored through physical examinations, vital signs, laboratory test results, ECG, and adverse events. Results: The reduction in DBP at 8 weeks was significantly greater in patients treated with the combination therapies compared with the respective monotherapies for all specified comparisons except amlodipine camsylate/losartan 10 mg/100 mg versus amlodipine 10 mg. The incidence of adverse events in the group of patients treated with the amlodipine camsylate/losartan 10 mg/50 mg combination tended to be higher than for any other group (27.9%, 12/43); however, the effect was not statistically significant. Conclusion: Combination amlodipine camsylate/losartan (5 mg/50 mg, 5 mg/100 mg and 10 mg/50 mg) resulted in significantly greater BP lowering compared with amlodipine or losartan monotherapy, and was determined to be generally safe and tolerable in patients with essential hypertension.
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