Switching to rosuvastatin plus ezetimibe in statin-treated stroke patients with low-density lipoprotein cholesterol levels above 70 mg/dL (SWITCH): a prospective observational study

Abstract

Background Effective lipid management is critical for secondary stroke prevention, however, many patients fail to achieve target low-density lipoprotein cholesterol (LDL-C) levels with statin monotherapy. This study evaluated the real-world effectiveness and safety of switching from statin monotherapy to rosuvastatin plus ezetimibe combination therapy (REZ) in patients with stroke. Methods This multicenter, prospective, observational study enrolled patients with stroke and baseline LDL-C >= 70 mg/dL despite statin monotherapy from 16 Korean stroke centers. Participants were switched to REZ at doses of 5/10 mg, 10/10 mg, or 20/10 mg at the investigators'discretion. Lipid profiles were assessed at three and six months. The primary outcome was achieving LDL-C < 70 mg/dL at six months. Results In total, 1,431 participants enrolled between May 2021 and March 2023 were eligible (mean age 65.3 +/- 10.6 years; 66.8% male). Among 994 participants completing follow-up, the mean baseline LDL-C was 98.9 +/- 22.4 mg/dL. At six months, 708 (71.2%) achieved LDL-C < 70 mg/dL. Mean LDL-C decreased to 62.7 +/- 22.1 mg/dL at three months and to 62.0 +/- 22.0 mg/dL at six months. The effectiveness of REZ remained consistent across different REZ dosages and regardless of changes in statin intensity during the switch. REZ was particularly effective in patients with diabetes (odds ratio [95% confidence interval], 1.85 [1.32-2.59]; P < 0.001) and baseline LDL-C 70-99 mg/dL (2.71 [2.04-3.59]; P < 0.001). Fewer participants achieved stricter targets (LDL-C < 55 mg/dL or LDL-C < 70 mg/dL plus 50% reduction). Conclusions Switching to REZ effectively reduced LDL-C in patients with stroke receiving statin monotherapy with LDL-C >= 70 mg/dL, offering potential benefits for secondary cardiovascular prevention in real-world practice.