Lipid-lowering efficacy and safety of a new generic rosuvastatin in koreans: An 8-week randomized comparative study with a proprietary rosuvastatin

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, ChiYoung Shim, Sang Hak Lee

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)283-290
Number of pages8
JournalJournal of Lipid and Atherosclerosis
Volume9
Issue number2
DOIs
Publication statusPublished - 2020 May

Bibliographical note

Funding Information:
This work was supported by Whan In Pharm Co., Ltd., Seoul, Korea. The funder had no role in the design of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Publisher Copyright:
© 2020 The Korean Society of Lipid and Atherosclerosis.

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine

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