Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin
10.12997/jla.2020.9.2.283
- Author:
Hyoeun KIM
1
;
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
Author Information
1. Department of Health Promotion, Yonsei University College of Medicine, Seoul, Korea
- Publication Type:Original Article
- From:Journal of Lipid and Atherosclerosis
2020;9(2):283-290
- CountryRepublic of Korea
- Language:0
-
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.
