Effectiveness of fixed-dose ezetimibe+simvastatin in real-life hypercholesterolaemia treatment: a retrospective observational study in Taiwan

Background: Combining statins with ezetimibe synergistically enhances lipid lowering, thereby reducing the need to prescribe maximal statin doses to achieve low-density lipoprotein cholesterol (LDL-C) goals. Real-world data on concurrent ezetimibe + statin therapy in Asians are sparse. Therefore, we evaluated the effectiveness of a single combined tablet of ezetimibe + simvastatin 10.0 + 20.0 mg (EZE + SIM) in Taiwanese patients with hypercholesterolaemia. Methods: We analysed retrospective data from patients who received EZE + SIM at a community hospital in New Taipei City, Taiwan, took EZE + SIM continuously for ≥24 weeks, and had before and after lipid data. Outcomes including lipid lowering, LDL-C goal attainment and safety (non-lipid serum biochemistry), were compared between diabetic versus non-diabetic patients and subgroups prescribed different EZE + SIM doses. Results: Among 157 EZE + SIM users, more than half had diabetes (64.3%) and/or hypertension (52%) and 24.1% had coronary artery disease. A mean EZE + SIM dose of 6.5 + 13.0 (median 5.0 + 10.0) mg/day for a mean of 51.6 weeks, significantly reduced total cholesterol (−30.4%), LDL-C (−36.2%) and triglycerides (−14.5%); consequently, attainment rates of LDL-C ≤ 100 mg/dl and ≤70 mg/dl goals were significantly higher after EZE + SIM treatment. There were no clinically significant changes in biomarkers of hepatic or renal function. Consistent with other reports, we observed indications of greater lipid-lowering efficacy and LDL-C goal attainment among patients with diabetes versus those without, at equivalent EZE + SIM doses. Conclusions: Our findings affirm the lipid-lowering efficacy of single-tablet fixed-dose EZE + SIM in real-world Taiwanese-Chinese patients with hypercholesterolaemia, especially at the recommended dose. Trends towards greater efficacy in diabetic than non-diabetic patients suggest that EZE + SIM may be a rational choice for treating patients with hypercholesterolaemia and diabetes.