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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

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Author(s)
Hyoeun KimChan Joo LeeDonghoon ChoiByeong-Keuk KimIn-Cheol KimJung-Sun KimChul-Min AhnGeu-Ru HongIn-Jeong ChoChi-Young ShimSang-Hak Lee
Publication Year
2020
Keyword
Rosuvastatin calciumCholesterolLDLBlood pressureHematologyAlanine transaminase
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.
Department
Dept. of Internal Medicine (내과학)
Publisher
School of Medicine (의과대학)
Citation
지질·동맥경화학회지, Vol.9(2) : 283-290, 2020
Type
Article
ISSN
2288-2561
URI
http://kumel.medlib.dsmc.or.kr/handle/2015.oak/42795
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