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Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin

DC FieldValueLanguage
dc.contributor.author심지영-
dc.contributor.author이상학-
dc.contributor.author이찬주-
dc.contributor.author김중선-
dc.contributor.author김병극-
dc.contributor.author홍그루-
dc.contributor.author최동훈-
dc.contributor.author안철민-
dc.date.accessioned2020-09-28T11:12:24Z-
dc.date.available2020-09-28T11:12:24Z-
dc.date.issued2020-05-
dc.identifier.issn2287-2892-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/179191-
dc.description.abstractObjective: The aim of this study was to investigate whether a new generic rosuvastatin is non-inferior to a proprietary one in terms of lipid-lowering efficacy. We also evaluated its non-lipid effects including adverse events. Methods: One-hundred and fifty-eight patients with cardiovascular risks requiring pharmacological lipid-lowering therapy were screened. After a 4-week run-in period, 126 individuals who met the lipid criteria for drug therapy were randomly assigned to receive the new generic or proprietary rosuvastatin 10 mg daily for 8 weeks. The primary outcome variables were low-density lipoprotein-cholesterol (LDL-C) reduction and LDL-C target achievement. Hematological and biochemical parameters and adverse events were assessed. Results: After 8 weeks of drug treatment, the mean percentage change in LDL-C was not different between the groups (-45.5%±19.9% and -45.1%±19.0% for generic and proprietary rosuvastatin, respectively; p=0.38). The LDL-C target achievement rate was similar between the groups (75.0% and 77.1% for generic and proprietary rosuvastatin, respectively; p=0.79). The percentage change in the other lipid profiles was not significantly different. Although generic- and proprietary rosuvastatins modestly affected creatine kinase and blood pressure, respectively, the changes were all within normal ranges. Incidence of adverse events did not differ between the receivers of the 2 formulations. Conclusion: The new generic rosuvastatin was non-inferior to the proprietary rosuvastatin in terms of lipid-lowering efficacy. The rosuvastatin formulations did not exhibit clinically significant non-lipid effects with good safety profiles. Our study provides comprehensive data regarding 2 rosuvastatin formulations in East Asian subjects. Trial registration: ClinicalTrials.gov Identifier: NCT03949374.-
dc.description.statementOfResponsibilityopen-
dc.languageKorean-
dc.publisher한국지질동맥경화학회-
dc.relation.isPartOfJournal of Lipid and Atherosclerosis-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleLipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorHyoeun Kim-
dc.contributor.googleauthorChan Joo Lee-
dc.contributor.googleauthorDonghoon Choi-
dc.contributor.googleauthorByeong-Keuk Kim-
dc.contributor.googleauthorIn-Cheol Kim-
dc.contributor.googleauthorJung-Sun Kim-
dc.contributor.googleauthorChul-Min Ahn-
dc.contributor.googleauthorGeu-Ru Hong-
dc.contributor.googleauthorIn-Jeong Cho-
dc.contributor.googleauthorChi-Young Shim-
dc.contributor.googleauthorSang-Hak Lee-
dc.identifier.doi10.12997/jla.2020.9.2.283-
dc.contributor.localIdA02213-
dc.contributor.localIdA02833-
dc.contributor.localIdA02833-
dc.contributor.localIdA03238-
dc.contributor.localIdA03238-
dc.contributor.localIdA00961-
dc.contributor.localIdA00961-
dc.contributor.localIdA00493-
dc.contributor.localIdA00493-
dc.contributor.localIdA04386-
dc.contributor.localIdA04386-
dc.contributor.localIdA04053-
dc.contributor.localIdA04053-
dc.contributor.localIdA02269-
dc.contributor.localIdA02269-
dc.relation.journalcodeJ01562-
dc.identifier.eissn2288-2561-
dc.identifier.pmid32821737-
dc.subject.keywordAlanine transaminase-
dc.subject.keywordBlood pressure-
dc.subject.keywordCholesterol, LDL-
dc.subject.keywordHematology-
dc.subject.keywordRosuvastatin calcium-
dc.contributor.alternativeNameShim, Chi Young-
dc.contributor.affiliatedAuthor심지영-
dc.contributor.affiliatedAuthor이상학-
dc.contributor.affiliatedAuthor이상학-
dc.contributor.affiliatedAuthor이찬주-
dc.contributor.affiliatedAuthor이찬주-
dc.contributor.affiliatedAuthor김중선-
dc.contributor.affiliatedAuthor김중선-
dc.contributor.affiliatedAuthor김병극-
dc.contributor.affiliatedAuthor김병극-
dc.contributor.affiliatedAuthor홍그루-
dc.contributor.affiliatedAuthor홍그루-
dc.contributor.affiliatedAuthor최동훈-
dc.contributor.affiliatedAuthor최동훈-
dc.contributor.affiliatedAuthor안철민-
dc.contributor.affiliatedAuthor안철민-
dc.citation.volume9-
dc.citation.number2-
dc.citation.startPage283-
dc.citation.endPage290-
dc.identifier.bibliographicCitationJournal of Lipid and Atherosclerosis, Vol.9(2) : 283-290, 2020-05-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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