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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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.
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.
참고문헌 (20)
- Rahalkar AR, "Clinical equivalence of proprietary and generic atorvastatin in lipid clinic patients", Can J Cardiol, 29, pp.418~422 (2013)
- Liao JK, "Safety and efficacy of statins in Asians", Am J Cardiol, 99, pp.410~414 (2007)
- Grundy SM, "2018 AHA", ACC, AAPA, pp.ABC, ACPM[DOI]
- Committee for the Korean Guidelines for the Management of Dyslipidemia, "2015 Korean Guidelines for the Management of Dyslipidemia: Executive Summary (English Translation)", Korean Circulation Journal, 46(3), pp.275~306 (2016), 대한심장학회[DOI]
- Adams SP, "Lipid-lowering efficacy of rosuvastatin", Cochrane Database Syst Rev, 11, pp.CD010254~ (2014)
- Lee SH, "Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia", Atherosclerosis, 221, pp.169~175 (2012)
- Kim KJ, "Effect of fixed-dose combinations of ezetimibe plus rosuvastatin in patients with primary hypercholesterolemia : MRS-ROZE(Multicenter Randomized Study of ROsuvastatin and eZEtimibe)", Cardiovasc Ther, 34, pp.371~382 (2016)
- Yang YJ, "Combination therapy of rosuvastatin and ezetimibe in patients with high cardiovascular risk", Clin Ther, 39, pp.107~117 (2017)
- Hong SJ, "A phase III, multicenter, randomized, double-blind, active comparator clinical trial to compare the efficacy and safety of combination therapy with ezetimibe and rosuvastatin versus rosuvastatin monotherapy in patients with hypercholesterolemia : I-ROSETTE(Ildong Rosuvastatin & Ezetimibe for Hypercholesterolemia)Randomized Controlled Trial", Clin Ther, 40, pp.226~241 (2018)
- Kim W, "Efficacy and safety of ezetimibe and rosuvastatin combination therapy versus those of rosuvastatin monotherapy in patients with primary hypercholesterolemia", Clin Ther, 40, pp.993~1013 (2018)
- Betto M, "Efficacy and safety of a generic rosuvastatin in a real-world setting : prospective, observational clinical study in Lebanese patients", Ann Saudi Med, 37, pp.366~374 (2017)
- You T, "Effect of statins on blood pressure : analysis on adverse events released by FDA", Clin Exp Hypertens, 39, pp.325~329 (2017)
- Presta V, "Effects of different statin types and dosages on systolic", diastolic blood pressure: retrospective analysis of 24-hour ambulatory blood pressure database, 2018, pp.20, 967~975
- 장지용, "Additive Beneficial Effects of Valsartan Combined with Rosuvastatin in the Treatment of Hypercholesterolemic Hypertensive Patients", Korean Circulation Journal, 45(3), pp.225~233 (2015), 대한심장학회
- Rhee MY, "The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia", BMC Pharmacol Toxicol, 18, pp.2~ (2017)
- Ooba N, "A prospective stratified case-cohort study on statins and multiple adverse events in Japan", PLoS One, 9, pp.e96919~ (2014)
- Zheng Z, "Perioperative rosuvastatin in cardiac surgery", N Engl J Med, 374, pp.1744~1753 (2016)
- Liang M, "Efficacy of short-term moderate or high-dose rosuvastatin in preventing contrast-induced nephropathy: a meta-analysis of 15 randomized controlled trials", Medicine(Baltimore), 96, pp.e7384~ (2017)
- Lewicki M, "HMG CoA reductase inhibitors(statins)for preventing acute kidney injury after surgical procedures requiring cardiac bypass", Cochrane Database Syst Rev, 11, pp.CD010480~ (2015)
- Park JS, "Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in Korean patients with mild to moderate hypertension and dyslipidemia : an 8-week, multicenter, randomized, double-blind, factorial-design study(OLSTA-D RCT : OLmesartan rosuvaSTAtin from Daewoong)", Drug Des Devel Ther, 10, pp.2599~2609 (2016)