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Pharmacokinetics and safety of evogliptin in hepatically impaired patients

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dc.contributor.author김도영-
dc.contributor.author김범경-
dc.contributor.author김춘옥-
dc.contributor.author류병원-
dc.contributor.author박민수-
dc.contributor.author박준용-
dc.contributor.author안상훈-
dc.contributor.author이정일-
dc.date.accessioned2022-02-23T01:31:15Z-
dc.date.available2022-02-23T01:31:15Z-
dc.date.issued2021-07-
dc.identifier.issn0306-5251-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/187751-
dc.description.abstractAims: Evogliptin is a potent and selective dipeptidyl peptidase-4 inhibitor for glycaemic control in patients with type 2 diabetes mellitus. Since evogliptin is mainly eliminated through hepatic metabolism, we investigated the pharmacokinetics (PKs) and safety characteristics of evogliptin in Korean patients with mild or moderate hepatic impairment. Methods: An open-label, parallel-group study was conducted in patients with mild or moderate hepatic impairment and healthy control subjects matched to each patient for sex, age and body mass index. A single dose (5 mg) of evogliptin was administered orally, and serial blood samples were collected over 120 h to assess the PK profile of evogliptin and its main metabolites (M7 and M8). Results: Patients with mild hepatic impairment and their matched healthy controls showed similar maximum concentration (Cmax ) and area under the concentration-time curve values from 0 to 120 h (AUClast ); the geometric mean ratio (GMR) and 90% confidence interval (CI) were 1.04 (0.80, 1.35) and 1.01 (0.90, 1.14), respectively. Exposure to evogliptin (Cmax and AUClast ) was increased by about 40% in patients with moderate hepatic impairment-the GMR and 90% CI were 1.37 (1.09, 1.72) and 1.44 (1.18, 1.75), respectively. The metabolic ratios of M7 and M8 were lower in patients with moderate hepatic impairment than in matched healthy controls. Evogliptin was well tolerated by both patients and healthy subjects. Conclusion: Although evogliptin exposure was increased in patients with moderate hepatic impairment, the increase is unlikely to affect safety and efficacy adversely, and no dose adjustment is warranted.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherWiley-Blackwell-
dc.relation.isPartOfBRITISH JOURNAL OF CLINICAL PHARMACOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHArea Under Curve-
dc.subject.MESHDiabetes Mellitus, Type 2* / drug therapy-
dc.subject.MESHDipeptidyl-Peptidase IV Inhibitors* / adverse effects-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHHypoglycemic Agents / adverse effects-
dc.subject.MESHLiver Diseases*-
dc.subject.MESHMale-
dc.subject.MESHPiperazines-
dc.titlePharmacokinetics and safety of evogliptin in hepatically impaired patients-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorTaegon Hong-
dc.contributor.googleauthorByung Hak Jin-
dc.contributor.googleauthorChoon Ok Kim-
dc.contributor.googleauthorByung Won Yoo-
dc.contributor.googleauthorDasohm Kim-
dc.contributor.googleauthorJung Il Lee-
dc.contributor.googleauthorBeom Kyung Kim-
dc.contributor.googleauthorSang Hoon Ahn-
dc.contributor.googleauthorDo Young Kim-
dc.contributor.googleauthorJun Yong Park-
dc.contributor.googleauthorMin Soo Park-
dc.identifier.doi10.1111/bcp.14680-
dc.contributor.localIdA00385-
dc.contributor.localIdA00487-
dc.contributor.localIdA04735-
dc.contributor.localIdA02468-
dc.contributor.localIdA01468-
dc.contributor.localIdA01675-
dc.contributor.localIdA02226-
dc.contributor.localIdA03122-
dc.relation.journalcodeJ00407-
dc.identifier.eissn1365-2125-
dc.identifier.pmid33245796-
dc.identifier.urlhttps://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.14680-
dc.subject.keywordDPP-4 inhibitor-
dc.subject.keywordType 2 diabetes mellitus-
dc.subject.keywordevogliptin-
dc.subject.keywordhepatic impairment-
dc.subject.keywordpharmacokinetics-
dc.contributor.alternativeNameKim, Do Young-
dc.contributor.affiliatedAuthor김도영-
dc.contributor.affiliatedAuthor김범경-
dc.contributor.affiliatedAuthor김춘옥-
dc.contributor.affiliatedAuthor류병원-
dc.contributor.affiliatedAuthor박민수-
dc.contributor.affiliatedAuthor박준용-
dc.contributor.affiliatedAuthor안상훈-
dc.contributor.affiliatedAuthor이정일-
dc.citation.volume87-
dc.citation.number7-
dc.citation.startPage2.757-
dc.citation.endPage2.766-
dc.identifier.bibliographicCitationBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Vol.87(7) : 2.757-2.766, 2021-07-
Appears in Collections:
6. Others (기타) > Dept. of Clinical Pharmacology (임상시험센터) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers

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