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Effectiveness and Safety of Very-Low-Dose Rosuvastatin-Ezetimibe Therapy in Korean Patients with Dyslipidaemia: A
Ji Woong Roh1, Moon-Hwa Park2, Ji-Won Son3
1Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine, Yongin Severance Hospital, Yongin, Republic of Korea.
Insights
Combining low-dose rosuvastatin with ezetimibe effectively lowers low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) in dyslipidaemia patients. This combination therapy demonstrated a favorable safety profile with infrequent adverse events.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Dyslipidaemia is a significant risk factor for atherosclerotic cardiovascular disease.
- Achieving target low-density lipoprotein cholesterol (LDL-C) levels is often challenging with high-dose statins due to adverse effects.
- This study investigates a combination therapy for dyslipidaemia management.
Purpose of the Study:
- To evaluate the real-world efficacy and safety of combining very-low-dose rosuvastatin (2.5 mg) with ezetimibe (10 mg).
- To assess lipid profile improvements and achievement of LDL-C and non-high-density lipoprotein cholesterol (non-HDL-C) targets in patients with varying cardiovascular risk.
- To monitor adverse events associated with this combination therapy.
Main Methods:
- A multicentre prospective study involving 2,388 patients in South Korea.
- Patients were stratified into low-, moderate-, and high-risk groups based on 2019 ESC/EAS guidelines.
- Lipid profiles and safety outcomes were assessed at baseline and after 12 weeks.
Main Results:
- Significant reductions in LDL-C and non-HDL-C were observed across all risk strata after 12 weeks.
- LDL-C target achievement rates were 82.6% (low-risk), 73.9% (moderate-risk), and 50.4% (high-risk).
- Adverse events were infrequent (0.6%), with only 0.2% discontinuing treatment due to medication-related concerns.
Conclusions:
- Very-low-dose rosuvastatin-ezetimibe combination therapy is effective in lowering LDL-C and improving lipid profiles in dyslipidaemia patients.
- The combination therapy exhibits a favorable safety profile, supporting its use as a well-tolerated treatment option.
- Further long-term studies are recommended to assess sustained lipid control and cardiovascular outcomes.
Background And Objectives:
Dyslipidaemia is a key modifiable risk factor for atherosclerotic cardiovascular disease. However, achieving recommended low-density lipoprotein cholesterol (LDL-C) target levels is challenging owing to dose-dependent adverse effects and limited tolerability of high-dose statins. This study evaluated the real-world efficacy and safety of combining very-low-dose rosuvastatin (2.5 mg) with ezetimibe (10 mg) in adult patients with dyslipidaemia across different cardiovascular risk strata.
Methods:
This multicentre prospective study in South Korea enrolled 2,388 patients. Participants were stratified into low-, moderate-, or high-risk groups on the basis of the 2019 European Society of Cardiology and European Atherosclerosis Society guidelines. Lipid profiles and safety outcomes were assessed at baseline and after 12 weeks. The primary and secondary outcomes were LDL-C and non-high-density lipoprotein cholesterol (non-HDL-C) target level achievements, respectively, and adverse events were monitored.
Results:
After 12 weeks, LDL-C target levels were achieved by 82.6% of low-risk (< 116 mg/dL), 73.9% of moderate-risk (< 100 mg/dL), and 50.4% of high-risk (< 70 mg/dL) patients. Non-HDL-C target level achievement followed a similar trend. Combination therapy with ezetimibe and low-dose statin resulted in significant LDL-C reductions, compared with statins alone. Adverse events were infrequent (0.6%), and only 0.2% of patients discontinued treatment owing to medication-related concerns.
Conclusions:
Very-low-dose rosuvastatin-ezetimibe combination therapy significantly lowered LDL-C levels and improved lipid profiles across various risk groups, demonstrating a favourable safety profile. These findings support its use as an effective, well-tolerated option for managing dyslipidaemia. Longer-term studies are warranted to evaluate sustained lipid control and cardiovascular outcomes.
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