REAL-WORLD LIPID-LOWERING EFFICACY AND GOAL ATTAINMENT WITH ATORVASTATIN/EZETIMIBE FIXED-DOSE COMBINATION THERAPY

초록

BACKGROUND Despite the proven superior efficacy of Atorvastatin/ ezetimibe fixed-dose combination (Ato/Eze FDC) in dyslipidemia, large prospective real-world data that account for cardiovascular risk status remain limited. We investigated the lipid lowering effect, target goal attainment, and safety of Ato/Eze FDC tablet (Litorvazet�, Daewoong Pharmaceutical Co., South Korea) in a real-world setting. METHODS This multicenter, prospective 24-week observational study enrolled 2,988 patients with dyslipidemia from 26 centers in Korea. The primary endpoint was change in low-density lipoprotein cholesterol (LDL-C) from baseline to week 24. RESULTS At 24 weeks, LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C), triglycerides, and total cholesterol were significantly reduced from baseline (all p<0.01), while HDL-C increased (p<0.05), regardless of administered dose (Figure). Over 70% of patients achieved LDL-C target levels across all doses. Effectiveness was consistent across subgroups, including sex, baseline HbA1c, and concomitant lipid-lowering therapy. For safety aspect, HbA1c changes were not statistically significant in any dose group, and there was no evidence of hepatotoxicity. CONCLUSION In routine clinical practice, Ato/Eze FDC was effective and well tolerated, supporting its role as an alternative for patients intolerant to high-intensity statins and reinforcing the value of statinezetimibe combination therapy in real-world dyslipidemia management.