0 39

Cited 0 times in

Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study

DC FieldValueLanguage
dc.contributor.author홍범기-
dc.contributor.author강석민-
dc.date.accessioned2020-11-17T05:03:02Z-
dc.date.available2020-11-17T05:03:02Z-
dc.date.issued2017-
dc.identifier.issn0149-2918-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/179868-
dc.description.abstractPurpose: The goal of this study was to compare the efficacy and safety of fixed-dose combinations of amlodipine/losartan potassium/chlorthalidone (A/L/C) and A/L in Korean patients with stage 2 hypertension inadequately controlled by A/L. Methods: This study was an 8-week, randomized double-blind, multicenter, phase III clinical trial. Three hundred forty volunteer patients with stage 2 hypertension were randomized to receive A/L/C or A/L. The primary end point was a change in sitting systolic blood pressure (SitSBP) after 8 weeks of treatment. As secondary end points, the change in SitSBP after 2 weeks of treatment and the change in sitting diastolic blood pressure (SitDBP) were compared between treatment groups. All patients were assessed for adverse events, clinical laboratory data, and vital signs. Findings: Of 330 patients from 33 medical centers, 328 patients who had available efficacy data were analyzed. After 8 weeks of double-blind treatment, the mean (SD) changes in SitSBP at 8 weeks were -16.4 (0.9) mm Hg and -6.9 (1.0) mm Hg in the A/L/C and A/L groups, respectively. A/L/C had a statistically superior blood pressure-lowering effect compared with that of A/L (mean [SD] difference, 9.5 [1.3] mm Hg; P < 0.001). The mean (SD) change in SitDBP at 8 weeks was significantly greater with A/L/C (-8.0 [0.6] mm Hg) than with A/L (-3.6 [0.6] mm Hg) (P < .001). In terms of the mean (SD) change in SitDBP at 2 weeks compared with baseline, A/L/C (-5.9 [0.5] mm Hg) was statistically different from A/L (-2.9 [0.5] mm Hg) (P < .001). Mean (SD) SitSBP change from baseline to week 2 was -13.2 (0.9) and -5.5 (0.9) in the A/L/C and A/L groups, respectively, with a statistically significant blood pressure-lowering effect (P < 0.001). The number of participants who achieved target blood pressure at week 8 was significantly higher in the A/L/C group (93 patients [55.7%]) than in the A/L group (48 [29.8%]) (P < 0.001). Adverse drug reactions were observed in 23 patients (7.0%), and the incidence of dizziness was significantly higher in the A/L/C group than in the A/L group (4.8% vs 0.6%, P = 0.037) There were no serious adverse events associated with the study drugs. Implications: The results of this study suggest that A/L/C had a significantly increased blood pressure-lowering efficacy compared with that of A/L and had a good safety profile. ClinicalTrials.gov identifier: NCT02916602.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherExcerpta Medica-
dc.relation.isPartOfCLINICAL THERAPEUTICS-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAmlodipine / administration & dosage*-
dc.subject.MESHAmlodipine / therapeutic use-
dc.subject.MESHAntihypertensive Agents / administration & dosage*-
dc.subject.MESHAntihypertensive Agents / therapeutic use-
dc.subject.MESHBlood Pressure / drug effects-
dc.subject.MESHChlorthalidone / administration & dosage*-
dc.subject.MESHChlorthalidone / therapeutic use-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Combinations-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHHypertension / drug therapy*-
dc.subject.MESHHypertension / physiopathology-
dc.subject.MESHLosartan / administration & dosage*-
dc.subject.MESHLosartan / therapeutic use-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHYoung Adult-
dc.titleComparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorSoon Jun Hong-
dc.contributor.googleauthorHan Saem Jeong-
dc.contributor.googleauthorSeung Hwan Han-
dc.contributor.googleauthorKi Yuk Chang-
dc.contributor.googleauthorBum Kee Hong-
dc.contributor.googleauthorBong Ki Lee-
dc.contributor.googleauthorShung Chull Chae-
dc.contributor.googleauthorWoo Shik Kim-
dc.contributor.googleauthorChang Gyu Park-
dc.contributor.googleauthorJung Ho Heo-
dc.contributor.googleauthorSeung Uk Lee-
dc.contributor.googleauthorYoung Dae Kim-
dc.contributor.googleauthorKee Sik Kim-
dc.contributor.googleauthorJung Hyun Choi-
dc.contributor.googleauthorHyun Jae Kang-
dc.contributor.googleauthorJae Joong Kim-
dc.contributor.googleauthorSeok Min Kang-
dc.contributor.googleauthorYoung Jin Choi-
dc.contributor.googleauthorJoon Han Shin-
dc.contributor.googleauthorKook Jin Chun-
dc.contributor.googleauthorDong Gu Shin-
dc.contributor.googleauthorSeong Hoon Park-
dc.contributor.googleauthorJun Kwan-
dc.contributor.googleauthorYu Jeong Choi-
dc.contributor.googleauthorMyung Ho Jeong-
dc.contributor.googleauthorJei Keon Chae-
dc.contributor.googleauthorDong Woon Kim-
dc.contributor.googleauthorJung Rae Cho-
dc.contributor.googleauthorKyoo Rok Han-
dc.contributor.googleauthorKyung Heon Won-
dc.contributor.googleauthorSang Ho Park-
dc.contributor.googleauthorSang Kon Lee-
dc.contributor.googleauthorSang Hoon Kim-
dc.contributor.googleauthorJina Jung-
dc.contributor.googleauthorCheol Ho Kim-
dc.identifier.doi10.1016/j.clinthera.2017.08.013-
dc.contributor.localIdA04394-
dc.contributor.localIdA00037-
dc.contributor.localIdA00037-
dc.relation.journalcodeJ00614-
dc.identifier.eissn1879-114X-
dc.identifier.pmid28939406-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0149291817309025-
dc.subject.keywordamlodipine-
dc.subject.keywordchlorthalidone-
dc.subject.keywordhypertension-
dc.subject.keywordlosartan-
dc.subject.keywordsingle-pill combination-
dc.contributor.alternativeNameHong, Bum Kee-
dc.contributor.affiliatedAuthor홍범기-
dc.contributor.affiliatedAuthor강석민-
dc.contributor.affiliatedAuthor강석민-
dc.citation.volume39-
dc.citation.number10-
dc.citation.startPage2049-
dc.citation.endPage2060-
dc.identifier.bibliographicCitationCLINICAL THERAPEUTICS, Vol.39(10) : 2049-2060, 2017-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.