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Randomized Controlled Trial
. 2025 Apr;297(4):400-408.
doi: 10.1111/joim.20029. Epub 2024 Dec 22.

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

Jung-Joon Cha  1 , Ju Hyeon Kim  1 , Soon Jun Hong  1 , Subin Lim  1 , Hyung Joon Joo  1 , Jae Hyoung Park  1 , Cheol Woong Yu  1 , Pil Hyung Lee  2 , Seung Whan Lee  2 , Cheol Whan Lee  2 , Jae Youn Moon  3 , Jong-Young Lee  4 , Jung-Sun Kim  5 , Jae Suk Park  6 , Do-Sun Lim  1
Affiliations
Randomized Controlled Trial

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

Jung-Joon Cha et al. J Intern Med. 2025 Apr.

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.

Keywords: atherosclerotic cardiovascular disease; combination therapy; elderly patients; ezetimibe; hydroxymethylglutaryl‐CoA reductase inhibitors; statin‐associated muscle symptoms.

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