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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
DC Field | Value | Language |
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dc.contributor.author | 임세중 | - |
dc.contributor.author | 하종원 | - |
dc.date.accessioned | 2017-10-26T08:11:32Z | - |
dc.date.available | 2017-10-26T08:11:32Z | - |
dc.date.issued | 2016 | - |
dc.identifier.issn | 0149-2918 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/153098 | - |
dc.description.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/TEL 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) mm 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. IMPLICATIONS: Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients' medication adherence. ClinicalTrials.gov identifier: NCT011426100. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Excerpta Medica | - |
dc.relation.isPartOf | CLINICAL THERAPEUTICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.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 | - |
dc.type | Article | - |
dc.publisher.location | United States | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Chang Gyu Park | - |
dc.contributor.googleauthor | Tae Hun Ahn | - |
dc.contributor.googleauthor | Eun Ju Cho | - |
dc.contributor.googleauthor | Won Kim | - |
dc.contributor.googleauthor | Hyung Seob Kim | - |
dc.contributor.googleauthor | Ju Yeong Yang | - |
dc.contributor.googleauthor | Jae Geun Ryu | - |
dc.contributor.googleauthor | Cheol Ho Kim | - |
dc.contributor.googleauthor | Min Soo Hyeon | - |
dc.contributor.googleauthor | Seung Je Tak | - |
dc.contributor.googleauthor | Se Jung Im | - |
dc.contributor.googleauthor | Jong Won Ha | - |
dc.contributor.googleauthor | Wook Beom Pyeon | - |
dc.contributor.googleauthor | Je Geon Jae | - |
dc.contributor.googleauthor | Gyu Rok Han | - |
dc.contributor.googleauthor | Jun Hyung Doh | - |
dc.contributor.googleauthor | Sang Wook Im | - |
dc.contributor.googleauthor | Myeong Muk Lee | - |
dc.identifier.doi | 10.1016/j.clinthera.2016.09.006 | - |
dc.contributor.localId | A04257 | - |
dc.contributor.localId | A03372 | - |
dc.relation.journalcode | J00614 | - |
dc.identifier.eissn | 1879-114X | - |
dc.identifier.pmid | 27720505 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S0149291816307287?via%3Dihub | - |
dc.contributor.alternativeName | Rim, Se Joong | - |
dc.contributor.alternativeName | Ha, Jong Won | - |
dc.contributor.affiliatedAuthor | Ha, Jong Won | - |
dc.contributor.affiliatedAuthor | Rim, Se Joong | - |
dc.citation.volume | 38 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 2185 | - |
dc.citation.endPage | 2194 | - |
dc.identifier.bibliographicCitation | CLINICAL THERAPEUTICS, Vol.38(10) : 2185-2194, 2016 | - |
dc.date.modified | 2017-10-24 | - |
dc.identifier.rimsid | 41100 | - |
dc.type.rims | ART | - |
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