Comparative safety and efficacy of combination lipid lowering therapy versus high-intensity statin in elderly patients with atherosclerotic cardiovascular disease

초록

Background: High-intensity statin therapy has been shown to significantly reduce mortality and cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD). However, elderly patients are more susceptible to statin intolerance, leading to a preference for moderate-intensity statins. Objective: This study aims to evaluate the incidence of statin-associated muscle symptoms (SAMS) and the effectiveness in lowering low-density lipoprotein cholesterol (LDL-C) levels among elderly ASCVD patients treated with either a moderate-intensity statin plus ezetimibe combination or high-intensity statin monotherapy. Methods: In this prospective, multicenter, open-label trial conducted in South Korea, 561 patients aged 70 years or older with ASCVD were randomly assigned to receive either a combination of moderate-intensity statin (rosuvastatin 5 mg) and ezetimibe (10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg) for six months. The primary endpoint was the incidence of SAMS, while the key secondary endpoint was the proportion of patients achieving target LDL-C levels (<70 mg/dL) within the study period. Results: The incidence of SAMS was significantly lower in the combination therapy group (0.7%) compared to the high-intensity statin monotherapy group (5.7%, p=0.005). Both treatment regimens were effective in LDL-C reduction, with 75.4% of patients in the combination therapy group and 68.7% in the monotherapy group achieving target LDL-C levels. Conclusion: In elderly patients with ASCVD, moderate-intensity statin combined with ezetimibe demonstrated a lower risk of SAMS while achieving comparable LDL-C reduction compared to high-intensity statin monotherapy. This combination may serve as a safer and equally effective alternative for lipid management in this population.