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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

Authors
 Hyoeun Kim  ;  Chan Joo Lee  ;  Donghoon Choi  ;  Byeong-Keuk Kim  ;  In-Cheol Kim  ;  Jung-Sun Kim  ;  Chul-Min Ahn  ;  Geu-Ru Hong  ;  In-Jeong Cho  ;  Chi-Young Shim  ;  Sang-Hak Lee 
Citation
 Journal of Lipid and Atherosclerosis, Vol.9(2) : 283-290, 2020-05 
Journal Title
 Journal of Lipid and Atherosclerosis 
ISSN
 2287-2892 
Issue Date
2020-05
Keywords
Alanine transaminase ; Blood pressure ; Cholesterol, LDL ; Hematology ; Rosuvastatin calcium
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.
Files in This Item:
T202001907.pdf Download
DOI
10.12997/jla.2020.9.2.283
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) ORCID logo https://orcid.org/0000-0003-2263-3274
Shim, Chi Young(심지영) ORCID logo https://orcid.org/0000-0002-6136-0136
Ahn, Chul-Min(안철민) ORCID logo https://orcid.org/0000-0002-7071-4370
Lee, Sang Hak(이상학) ORCID logo https://orcid.org/0000-0002-4535-3745
Lee, Chan Joo(이찬주) ORCID logo https://orcid.org/0000-0002-8756-409X
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Geu Ru(홍그루) ORCID logo https://orcid.org/0000-0003-4981-3304
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/179191
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