Cited 2 times in
Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin
DC Field | Value | Language |
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dc.contributor.author | 심지영 | - |
dc.contributor.author | 이상학 | - |
dc.contributor.author | 이찬주 | - |
dc.contributor.author | 김중선 | - |
dc.contributor.author | 김병극 | - |
dc.contributor.author | 홍그루 | - |
dc.contributor.author | 최동훈 | - |
dc.contributor.author | 안철민 | - |
dc.date.accessioned | 2020-09-28T11:12:24Z | - |
dc.date.available | 2020-09-28T11:12:24Z | - |
dc.date.issued | 2020-05 | - |
dc.identifier.issn | 2287-2892 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/179191 | - |
dc.description.abstract | Objective: 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.statementOfResponsibility | open | - |
dc.language | Korean | - |
dc.publisher | 한국지질동맥경화학회 | - |
dc.relation.isPartOf | Journal of Lipid and Atherosclerosis | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Hyoeun Kim | - |
dc.contributor.googleauthor | Chan Joo Lee | - |
dc.contributor.googleauthor | Donghoon Choi | - |
dc.contributor.googleauthor | Byeong-Keuk Kim | - |
dc.contributor.googleauthor | In-Cheol Kim | - |
dc.contributor.googleauthor | Jung-Sun Kim | - |
dc.contributor.googleauthor | Chul-Min Ahn | - |
dc.contributor.googleauthor | Geu-Ru Hong | - |
dc.contributor.googleauthor | In-Jeong Cho | - |
dc.contributor.googleauthor | Chi-Young Shim | - |
dc.contributor.googleauthor | Sang-Hak Lee | - |
dc.identifier.doi | 10.12997/jla.2020.9.2.283 | - |
dc.contributor.localId | A02213 | - |
dc.contributor.localId | A02833 | - |
dc.contributor.localId | A03238 | - |
dc.contributor.localId | A00961 | - |
dc.contributor.localId | A00493 | - |
dc.contributor.localId | A04386 | - |
dc.contributor.localId | A04053 | - |
dc.contributor.localId | A02269 | - |
dc.relation.journalcode | J01562 | - |
dc.identifier.eissn | 2288-2561 | - |
dc.identifier.pmid | 32821737 | - |
dc.subject.keyword | Alanine transaminase | - |
dc.subject.keyword | Blood pressure | - |
dc.subject.keyword | Cholesterol, LDL | - |
dc.subject.keyword | Hematology | - |
dc.subject.keyword | Rosuvastatin calcium | - |
dc.contributor.alternativeName | Shim, Chi Young | - |
dc.contributor.affiliatedAuthor | 심지영 | - |
dc.contributor.affiliatedAuthor | 이상학 | - |
dc.contributor.affiliatedAuthor | 이찬주 | - |
dc.contributor.affiliatedAuthor | 김중선 | - |
dc.contributor.affiliatedAuthor | 김병극 | - |
dc.contributor.affiliatedAuthor | 홍그루 | - |
dc.contributor.affiliatedAuthor | 최동훈 | - |
dc.contributor.affiliatedAuthor | 안철민 | - |
dc.citation.volume | 9 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 283 | - |
dc.citation.endPage | 290 | - |
dc.identifier.bibliographicCitation | Journal of Lipid and Atherosclerosis, Vol.9(2) : 283-290, 2020-05 | - |
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