Safety and efficacy of moderate‐intensity statin with ezetimibe in elderly patients with atherosclerotic cardiovascular disease

Abstract Background High‐intensity statin therapy significantly reduces mortality and cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD). However, moderate‐intensity statins are often preferred for elderly patients due to their higher risk of intolerance to high‐intensity statins. Objective To compare the incidence of statin‐associated muscle symptoms (SAMS) and the effect on low‐density lipoprotein cholesterol (LDL‐C) levels between elderly ASCVD patients receiving high‐intensity statin monotherapy and those receiving moderate‐intensity statin with ezetimibe in a combination therapy. Method In a prospective, multicenter, open‐label trial conducted in South Korea, 561 patients aged 70 years or above with ASCVD were randomly assigned to receive either moderate‐intensity statin with ezetimibe combination therapy (rosuvastatin 5 mg with ezetimibe 10 mg) or high‐intensity statin monotherapy (rosuvastatin 20 mg) over 6 months. The primary endpoint was the incidence of SAMS, and the key secondary endpoint was the achievement of target LDL‐C levels (<70 mg/dL) within 6 months. Results The primary endpoint showed a lower incidence of SAMS in the combination therapy group (0.7%) compared to the high‐intensity statin monotherapy group (5.7%, p = 0.005). Both groups achieved similar LDL‐C levels, with 75.4% in the combination therapy group and 68.7% in the monotherapy group reaching target levels. Conclusion Moderate‐intensity statin with ezetimibe combination therapy offers a lower risk of SAMS and similar LDL‐C reduction in elderly patients with ASCVD, compared to high‐intensity statin monotherapy.