Cha Jung-Joon, Kim Ju Hyeon, Hong Soon Jun, Lim Subin, Joo Hyung Joon, Park Jae Hyoung, Yu Cheol Woong, Lee Pil Hyung, Lee Seung Whan, Lee Cheol Whan, Moon Jae Youn, Lee Jong-Young, Kim Jung-Sun, Park Jae Suk, Lim Do-Sun
Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
J Intern Med. 2025 Apr;297(4):400-408. doi: 10.1111/joim.20029. Epub 2024 Dec 22.
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.
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.
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.
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.
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.
高强度他汀类药物治疗可显著降低动脉粥样硬化性心血管疾病（ASCVD）患者的死亡率和心血管事件。然而，由于老年患者对高强度他汀类药物不耐受的风险较高，中度强度他汀类药物通常更受青睐。
比较接受高强度他汀类药物单药治疗的老年ASCVD患者与接受中度强度他汀类药物与依折麦布联合治疗的患者中他汀类药物相关肌肉症状（SAMS）的发生率以及对低密度脂蛋白胆固醇（LDL-C）水平的影响。
在韩国进行的一项前瞻性、多中心、开放标签试验中，561例70岁及以上的ASCVD患者被随机分配接受中度强度他汀类药物与依折麦布联合治疗（瑞舒伐他汀5毫克与依折麦布10毫克）或高强度他汀类药物单药治疗（瑞舒伐他汀20毫克），为期6个月。主要终点是SAMS的发生率，关键次要终点是在6个月内达到目标LDL-C水平（<70毫克/分升）。
主要终点显示，联合治疗组的SAMS发生率（0.7%）低于高强度他汀类药物单药治疗组（5.7%，p = 0.005）。两组的LDL-C水平相似，联合治疗组75.4%的患者和单药治疗组68.7%的患者达到目标水平。
与高强度他汀类药物单药治疗相比，中度强度他汀类药物与依折麦布联合治疗在老年ASCVD患者中SAMS风险较低，且降低LDL-C的效果相似。
