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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
- Source :
- Journal of Lipid and Atherosclerosis
- Publication Year :
- 2019
-
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.
- Subjects :
- medicine.medical_specialty
Endocrinology, Diabetes and Metabolism
chemistry.chemical_compound
Pharmacotherapy
Internal medicine
Internal Medicine
medicine
Rosuvastatin
Adverse effect
Alanine transaminase
biology
Cholesterol
business.industry
Incidence (epidemiology)
nutritional and metabolic diseases
Cholesterol, LDL
Hematology
Rosuvastatin Calcium
Blood pressure
chemistry
Rosuvastatin calcium
biology.protein
lipids (amino acids, peptides, and proteins)
Original Article
Cardiology and Cardiovascular Medicine
business
medicine.drug
Subjects
Details
- ISSN :
- 22872892
- Volume :
- 9
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Journal of lipid and atherosclerosis
- Accession number :
- edsair.doi.dedup.....9a0625ca1810884d9c25ce59aa4dea9f