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. 2025 Aug 4;14(15):5480.
doi: 10.3390/jcm14155480.

Real-World Effectiveness of Rosuvastatin-Ezetimibe Single Pill (Rovazet®) in Korean Dyslipidemia Patients

Hack-Lyoung Kim  1 , Hyun Sung Joh  1 , Sang-Hyun Kim  1 , Myung-A Kim  1
Affiliations

Real-World Effectiveness of Rosuvastatin-Ezetimibe Single Pill (Rovazet®) in Korean Dyslipidemia Patients

Hack-Lyoung Kim et al. J Clin Med. .

Abstract

Background: Fixed-dose combinations of rosuvastatin and ezetimibe are increasingly used in clinical practice, but real-world data on their effectiveness and safety in large populations remain limited. Methods: This prospective, single-group, open-label, non-interventional observational study was conducted in the Republic of Korea to evaluate the effectiveness and safety of Rovazet® (a fixed-dose combination of rosuvastatin and ezetimibe). Patients were prospectively enrolled from 235 institutions (50 general hospitals and 185 private clinics) as part of routine clinical practice over a five-year period. Lipid profiles and medication compliance questionnaire results were collected at baseline, 12 weeks, and 24 weeks of treatment. Results: A total of 5527 patients with dyslipidemia, the majority were men (53.0%), and the mean age was 60.4 years. Rovazet® significantly reduced low-density lipoprotein cholesterol (LDL-C) by 23.5% at 12 weeks (from 117.47 ± 50.65 mg/dL to 81.14 ± 38.20 mg/dL; p < 0.0001) and by 27.4% at 24 weeks (from 117.47 ± 50.65 mg/dL to 74.52 ± 33.36 mg/dL; p < 0.0001). Total cholesterol was significantly reduced by 17.7% at 12 weeks and by 19.8% at 24 weeks. Rovazet® treatment reduced triglycerides by 4.1% at 12 weeks and by 7.2% at 24 weeks. High-density lipoprotein cholesterol increased by 4.5% at 12 weeks and by 7.9% at 24 weeks following Rovazet® treatment. These changes in lipid profiles were consistent, regardless of cardiovascular risk profiles. By 24 weeks of treatment with Rovazet®, 91.8% of patients had reached their target LDL-C goals. Adverse drug reactions were reported in 2.81% of patients, most of which were minor, indicating that Rovazet® was well tolerated. Conclusions: Rovazet® was effective in improving lipid profiles and well tolerated in Korean adults with dyslipidemia.

Keywords: dyslipidemia; ezetimibe; observational study; rosuvastatin; safety.

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Conflict of interest statement

The authors declare no conflicts of interest. This study was supported by a research grant from HK inno.N Corporation, which was involved in the study design statistical planning, and data collection and analysis. The study conduct, interpretation of results, and manuscript preparation were carried out independently by the authors without sponsor influence.

Figures

Figure 1
Figure 1
Flow chart for study enrollment. NCEP-ATP, National Cholesterol Education Program Adult Treatment Panel.
Figure 2
Figure 2
Changes in mean lipid profile values after 12 and 24 weeks of treatment with Rovazet®. LDL, low-density lipoprotein; HDL, high-density lipoprotein.
Figure 3
Figure 3
Percent changes in lipid profiles after 12 and 24 weeks of treatment with Rovazet®. LDL, low-density lipoprotein; HDL, high-density lipoprotein.
Figure 4
Figure 4
Percent of achieving LDL-C goal. LDL, low-density lipoprotein; HDL, high-density lipoprotein.
See this image and copyright information in PMC

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