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Comparison of efficacy and safety between two different irbesartan, generic vs branded, in the treatment of Korean patients with mild-to-moderate hypertension: an 8-week, multicenter, randomized, open-label, Phase IV clinical study
DC Field | Value | Language |
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dc.contributor.author | 권혁문 | - |
dc.date.accessioned | 2019-03-15T02:25:04Z | - |
dc.date.available | 2019-03-15T02:25:04Z | - |
dc.date.issued | 2018 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/167461 | - |
dc.description.abstract | Purpose: This study aimed to compare the efficacy and safety of generic and branded irbesartan for 8 weeks in patients with mild-to-moderate essential hypertension. Patients and methods: We screened 221 patients with mild-to-moderate hypertension. After exclusion per study criteria, 177 subjects were randomized to receive 150 mg generic irbesartan (n=91) or branded irbesartan (n=86) as the intention to treat set. The primary efficacy endpoint of this study was the change in mean sitting diastolic blood pressure (SiDBP) from baseline to 8 weeks between the generic and branded irbesartan groups. The secondary efficacy endpoints were the change in mean SiDBP at Week 4 from baseline and the change in mean sitting systolic blood pressure (SiSBP) at Weeks 4 and 8 from baseline in both groups. All safety issues were evaluated. Results: At Week 8, the generic and branded irbesartan groups showed significantly reduced SiDBP (-10.3±8.0, -10.7±7.7 mmHg, all P<0.0001) compared with baseline values, and the mean between-group difference in SiDBP change after 8 weeks of treatment was -0.4±1.2 mmHg, showing the non-inferiority of generic irbesartan vs branded irbesartan. Furthermore, secondary efficacy, which was the mean change of SiDBP from baseline at 4 weeks, was comparable between the two groups (-9.4±8.1 vs -9.9±7.4 mmHg, P=0.69). There were no between-group differences in mean changes of SiSBP after 4 or 8 weeks of treatment (P=0.78, P=0.97, respectively), or in the incidence of adverse effects (16.7 vs 24.4%, P=0.20). Conclusion: Generic irbesartan treatment in patients with mild-to-moderate essential hypertension has shown effective antihypertensive effects comparable with the branded irbesartan treatment, with similar incidence of adverse effects. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Dove Press Limited | - |
dc.relation.isPartOf | DRUG DESIGN DEVELOPMENT AND THERAPY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | Comparison of efficacy and safety between two different irbesartan, generic vs branded, in the treatment of Korean patients with mild-to-moderate hypertension: an 8-week, multicenter, randomized, open-label, Phase IV clinical study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Seung Hwan Han | - |
dc.contributor.googleauthor | Gyu Chul Oh | - |
dc.contributor.googleauthor | Hyuck Moon Kwon | - |
dc.contributor.googleauthor | Chang Gyu Park | - |
dc.contributor.googleauthor | In Jai Kim | - |
dc.contributor.googleauthor | Gyo-Seung Hwang | - |
dc.contributor.googleauthor | Byung Su Yoo | - |
dc.contributor.googleauthor | Seong Hoon Park | - |
dc.contributor.googleauthor | Kwang Je Lee | - |
dc.contributor.googleauthor | Hyo-soo Ki | - |
dc.identifier.doi | 10.2147/DDDT.S172046 | - |
dc.contributor.localId | A00260 | - |
dc.relation.journalcode | J02859 | - |
dc.identifier.eissn | 1177-8881 | - |
dc.identifier.pmid | 30587918 | - |
dc.subject.keyword | anti-hypertensive | - |
dc.subject.keyword | generic medicine | - |
dc.subject.keyword | hypertension | - |
dc.subject.keyword | irbesartan | - |
dc.contributor.alternativeName | Kwon, Hyuck Moon | - |
dc.contributor.affiliatedAuthor | 권혁문 | - |
dc.citation.volume | 12 | - |
dc.citation.startPage | 4217 | - |
dc.citation.endPage | 4229 | - |
dc.identifier.bibliographicCitation | DRUG DESIGN DEVELOPMENT AND THERAPY, Vol.12 : 4217-4229, 2018 | - |
dc.identifier.rimsid | 48800 | - |
dc.type.rims | ART | - |
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