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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

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dc.contributor.authorPark, CG-
dc.contributor.authorAhn, TH-
dc.contributor.authorCho, EJ-
dc.contributor.authorKim, W-
dc.contributor.authorKim, HS-
dc.contributor.authorYang, JY-
dc.contributor.authorRyu, JG-
dc.contributor.authorKim, CH-
dc.contributor.authorHyeon, MS-
dc.contributor.authorTak, SJ-
dc.contributor.authorIm, SJ-
dc.contributor.authorHa, JW-
dc.contributor.authorPyeon, WB-
dc.contributor.authorJae, JG-
dc.contributor.authorHan, GR-
dc.contributor.authorDoh, JH-
dc.contributor.authorIm, SW-
dc.contributor.authorLee, MM-
dc.date.accessioned2018-06-12T04:30:42Z-
dc.date.available2018-06-12T04:30:42Z-
dc.date.issued2016-
dc.identifier.issn0149-2918-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/15334-
dc.description.abstractPURPOSE: 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.language.isoen-
dc.subject.MESHAmlodipine-
dc.subject.MESHAntihypertensive Agents-
dc.subject.MESHBenzimidazoles-
dc.subject.MESHBenzoates-
dc.subject.MESHBlood Pressure-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Combinations-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHHypertension-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.titleComparison 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.typeArticle-
dc.identifier.pmid27720505-
dc.contributor.affiliatedAuthor탁, 승제-
dc.type.localJournal Papers-
dc.identifier.doi10.1016/j.clinthera.2016.09.006-
dc.citation.titleClinical therapeutics-
dc.citation.volume38-
dc.citation.number10-
dc.citation.date2016-
dc.citation.startPage2185-
dc.citation.endPage2194-
dc.identifier.bibliographicCitationClinical therapeutics, 38(10). : 2185-2194, 2016-
dc.embargo.liftdate9999-12-31-
dc.embargo.terms9999-12-31-
dc.identifier.eissn1879-114X-
dc.relation.journalidJ001492918-
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Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
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