Abstract Body: Introduction: Proper lipid management is vital for secondary prevention of ischemic stroke; however, not a few patients fail to reach target low-density lipoprotein cholesterol (LDL-C) levels with statin monotherapy. This study aimed to provide real-world data on LDL-C target achievement using rosuvastatin plus ezetimibe combination therapy (R+E) in stroke patients who did not achieve an LDL-C level of <70 mg/dL with statins alone.

Methods: This multicenter, prospective, observational study enrolled adult stroke patients with baseline LDL-C ≥70 mg/dL on statin monotherapy from 16 stroke centers in Korea. Participants were switched to R+E at doses of 5/10 mg, 10/10 mg, or 20/10 mg, at the investigators’ discretion. Lipid profiles were assessed at 3 and 6 months after initiating the combination therapy. The main outcome of interest was the proportion of participants achieving LDL-C <70 mg/dL at 6 months.

Results: Among the 1,519 participants enrolled between May 2021 and March 2023, 1,431 were eligible for analysis. The mean age was 65.3 ± 10.6 years, with 66.8% (n=956) being men. Of the 994 participants who completed follow-up, with a mean baseline LDL-C of 98.9 ± 22.4 mg/dL, 708 (71.2%) achieved LDL-C <70 mg/dL at 6 months. The mean LDL-C decreased to 62.7 ± 22.1 mg/dL at 3 months and to 62.0 ± 22.0 mg/dL at 6 months with R+E. The effectiveness of R+E remained consistent across three different dosages. R+E was particularly effective in participants with diabetes (OR [95% CI], 1.85 [1.32-2.59]; p<0.001) and those with baseline LDL-C 70-99 mg/dL (2.71 [2.04-3.59]; p<0.001). Other demographic and clinical factors, including prior statin dosages, did not affect the LDL-C lowering effect of R+E. Fewer participants met stricter targets, such as LDL-C <70 mg/dL plus 50% reduction (n=253, 25.5%) or LDL-C <55 mg/dL (n=395, 39.7%).

Conclusions: R+E effectively reduced LDL-C level to <70 mg/dL in stroke patients on statin monotherapy with baseline level above 70 mg/dL. For achieving stricter LDL-C targets, additional therapy may be necessary.

Funding: Hanmi Pharmaceutical.