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Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan: A Randomized, Double-blind, Multicenter Study

Title
Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan: A Randomized, Double-blind, Multicenter Study
Authors
Park, Chang GyuTae Hun AhnCho, Eun JuKim, WonKim, Hyung SeobYang, Ju YeongRyu, Jae GeunKim, Cheol HoHyeon, Min SooTak, Seung JeIm, Se JungHa, Jong WonPyeon, Wook BeomJae, Je GeonHan, Gyu RokDoh, Jun HyungIm, Sang WookLee, Myeong Muk
Ewha Authors
편욱범
SCOPUS Author ID
편욱범scopus
Issue Date
2016
Journal Title
CLINICAL THERAPEUTICS
ISSN
0149-2918JCR Link1879-114XJCR Link
Citation
vol. 38, no. 10, pp. 2185 - 2194
Keywords
hypertensionS-amlodipinetelmisartansingle-pill combinationblood pressurefixed-dose combinations
Publisher
ELSEVIER
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
Purpose: The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy. Methods: this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/ IEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups. Findings: Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were 10.56 (7.23) nun Hg in the S-AM/TEL 2.5/40-mg group, -12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and 2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6%; S-AM/TEL 5/40-mg group, 20%; and TEL 80-mg group, 22.6%), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema. (C) 2016 Published by Elsevier HS Journals, Inc.
DOI
10.1016/j.clinthera.2016.09.006
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의학전문대학원 > 의학과 > Journal papers
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