Efficacy and safety study of olmesartan medoxomil, amlodipine, and hydrochlorothiazide combination therapy in patients with hypertension not controlled with olmesartan medoxomil and hydrochlorothiazide combination therapy: Results of a randomized, double-blind, multicenter trial
DC Field | Value | Language |
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dc.contributor.author | Sohn, I.S. | - |
dc.contributor.author | Kim, C.-J. | - |
dc.contributor.author | Oh, B.-H. | - |
dc.contributor.author | Hong, T.-J. | - |
dc.contributor.author | Park, C.-G. | - |
dc.contributor.author | Kim, B.-S. | - |
dc.contributor.author | Chung, W.-B. | - |
dc.contributor.author | Nam, C.-W. | - |
dc.contributor.author | Kim, C.-H. | - |
dc.contributor.author | Choi, D.-J. | - |
dc.contributor.author | Baek, S.-H. | - |
dc.contributor.author | Kim, W.-S. | - |
dc.contributor.author | Ahn, T.-H. | - |
dc.contributor.author | Cho, J.-H. | - |
dc.contributor.author | Hwang, H.-K. | - |
dc.contributor.author | Shin, E.-S. | - |
dc.contributor.author | Shin, J.-H. | - |
dc.contributor.author | Jeong, M.-H. | - |
dc.contributor.author | Jeong, J.-O. | - |
dc.contributor.author | Bae, J.-H. | - |
dc.contributor.author | Lee, S.-H. | - |
dc.contributor.author | Rim, S.-J. | - |
dc.contributor.author | Rhew, J.-Y. | - |
dc.contributor.author | Kim, D.-I. | - |
dc.contributor.author | Kim, D.-K. | - |
dc.contributor.author | Kim, S.-K. | - |
dc.contributor.author | Seo, H.-S. | - |
dc.contributor.author | Kang, D.-H. | - |
dc.contributor.author | Kim, Y.-D. | - |
dc.contributor.author | Kim, D.-W. | - |
dc.contributor.author | Ha, J.-W. | - |
dc.contributor.author | Park, W.-J. | - |
dc.contributor.author | Kim, T.H. | - |
dc.contributor.author | Kim, K.-S. | - |
dc.contributor.author | Park, S.-W. | - |
dc.contributor.author | Shim, W.-J. | - |
dc.contributor.author | Yang, J.-Y. | - |
dc.contributor.author | Choi, J.-W. | - |
dc.contributor.author | Lee, S.-H. | - |
dc.contributor.author | Ahn, J.-C. | - |
dc.contributor.author | Lee, K. | - |
dc.date.accessioned | 2023-03-08T16:46:51Z | - |
dc.date.available | 2023-03-08T16:46:51Z | - |
dc.date.issued | 2016-12 | - |
dc.identifier.issn | 1175-3277 | - |
dc.identifier.issn | 1179-187X | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/64109 | - |
dc.description.abstract | Background: This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/ AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/ HCTZ 20/12.5). Methods: In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥ 100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP > 140/90 mmHg or msSBP/msDBP > 130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/ HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/ 12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period. Results: A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p<0.0001 vs. baseline p<0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p<0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated. Conclusion: In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850). © The Author(s) 2015. | - |
dc.format.extent | 10 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Springer International Publishing | - |
dc.title | Efficacy and safety study of olmesartan medoxomil, amlodipine, and hydrochlorothiazide combination therapy in patients with hypertension not controlled with olmesartan medoxomil and hydrochlorothiazide combination therapy: Results of a randomized, double-blind, multicenter trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1007/s40256-015-0156-x | - |
dc.identifier.bibliographicCitation | American Journal of Cardiovascular Drugs, v.16, no.2, pp 129 - 138 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.scopusid | 2-s2.0-84961214965 | - |
dc.citation.endPage | 138 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 129 | - |
dc.citation.title | American Journal of Cardiovascular Drugs | - |
dc.citation.volume | 16 | - |
dc.type.docType | Article | - |
dc.publisher.location | 뉴질랜드 | - |
dc.subject.keywordPlus | amlodipine | - |
dc.subject.keywordPlus | hydrochlorothiazide | - |
dc.subject.keywordPlus | olmesartan | - |
dc.subject.keywordPlus | placebo | - |
dc.subject.keywordPlus | amlodipine | - |
dc.subject.keywordPlus | antihypertensive agent | - |
dc.subject.keywordPlus | hydrochlorothiazide | - |
dc.subject.keywordPlus | olmesartan | - |
dc.subject.keywordPlus | adult | - |
dc.subject.keywordPlus | aged | - |
dc.subject.keywordPlus | Article | - |
dc.subject.keywordPlus | chronic kidney disease | - |
dc.subject.keywordPlus | constipation | - |
dc.subject.keywordPlus | controlled study | - |
dc.subject.keywordPlus | coughing | - |
dc.subject.keywordPlus | diabetes mellitus | - |
dc.subject.keywordPlus | diastolic blood pressure | - |
dc.subject.keywordPlus | dizziness | - |
dc.subject.keywordPlus | double blind procedure | - |
dc.subject.keywordPlus | drug efficacy | - |
dc.subject.keywordPlus | drug safety | - |
dc.subject.keywordPlus | drug withdrawal | - |
dc.subject.keywordPlus | faintness | - |
dc.subject.keywordPlus | fatigue | - |
dc.subject.keywordPlus | female | - |
dc.subject.keywordPlus | generalized edema | - |
dc.subject.keywordPlus | headache | - |
dc.subject.keywordPlus | heart palpitation | - |
dc.subject.keywordPlus | human | - |
dc.subject.keywordPlus | hypertension | - |
dc.subject.keywordPlus | hypotension | - |
dc.subject.keywordPlus | Korean (people) | - |
dc.subject.keywordPlus | major clinical study | - |
dc.subject.keywordPlus | male | - |
dc.subject.keywordPlus | multicenter study | - |
dc.subject.keywordPlus | open study | - |
dc.subject.keywordPlus | peripheral edema | - |
dc.subject.keywordPlus | presyncope | - |
dc.subject.keywordPlus | priority journal | - |
dc.subject.keywordPlus | pruritus | - |
dc.subject.keywordPlus | randomized controlled trial | - |
dc.subject.keywordPlus | systolic blood pressure | - |
dc.subject.keywordPlus | tonsillitis | - |
dc.subject.keywordPlus | treatment response | - |
dc.subject.keywordPlus | adverse effects | - |
dc.subject.keywordPlus | blood pressure | - |
dc.subject.keywordPlus | clinical trial | - |
dc.subject.keywordPlus | combination drug therapy | - |
dc.subject.keywordPlus | drug effects | - |
dc.subject.keywordPlus | hypertension | - |
dc.subject.keywordPlus | middle aged | - |
dc.subject.keywordPlus | procedures | - |
dc.subject.keywordPlus | young adult | - |
dc.subject.keywordPlus | Adult | - |
dc.subject.keywordPlus | Aged | - |
dc.subject.keywordPlus | Amlodipine | - |
dc.subject.keywordPlus | Antihypertensive Agents | - |
dc.subject.keywordPlus | Blood Pressure | - |
dc.subject.keywordPlus | Double-Blind Method | - |
dc.subject.keywordPlus | Drug Therapy, Combination | - |
dc.subject.keywordPlus | Female | - |
dc.subject.keywordPlus | Humans | - |
dc.subject.keywordPlus | Hydrochlorothiazide | - |
dc.subject.keywordPlus | Hypertension | - |
dc.subject.keywordPlus | Male | - |
dc.subject.keywordPlus | Middle Aged | - |
dc.subject.keywordPlus | Olmesartan Medoxomil | - |
dc.subject.keywordPlus | Young Adult | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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