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KMID : 1036020200090020283
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지질.동맥경화학회지
2020 Volume.9 No. 2 p.283 ~ p.290
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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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Kim Hyo-Eun
Lee Chan-Joo
Choi Dong-Hoon
Kim Byeong-Keuk
Kim In-Cheol
Kim Jung-Sun
Ahn Chul-Min
Hong Geu-Ru
Cho In-Jeong
Shim Chi-Young
Lee Sang-Hak
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Abstract
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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.
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KEYWORD
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Rosuvastatin calcium, Cholesterol, LDL, Blood pressure, Hematology, Alanine transaminase
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FullTexts / Linksout information
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Listed journal information
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