J Stroke.  2023 May;25(2):242-250. 10.5853/jos.2022.02957.

Moderate-Intensity Rosuvastatin Plus Ezetimibe Versus High-Intensity Rosuvastatin for Target Low-Density Lipoprotein Cholesterol Goal Achievement in Patients With Recent Ischemic Stroke: A Randomized Controlled Trial

• Hong KS
• Bang OY
• Park JH
• Jung JM
• Lee SH
• Song TJ
• Nam HS
• Park HK
• Jung KH
• Heo SH
• Koo J
• Yu KH
• Park KY
• Kim CK
• Park HK
• Lee J
• Lee J
• Seo WK

• KMID: 2542475
• DOI: http://doi.org/10.5853/jos.2022.02957

Abstract

Background and Purpose
Moderate-intensity statin plus ezetimibe versus high-intensity statin alone may provide a greater low-density lipoprotein cholesterol (LDL-C) reduction in patients with recent ischemic stroke.
Methods
This randomized, open-label, controlled trial assigned patients with recent ischemic stroke <90 days to rosuvastatin/ezetimibe 10/10 mg once daily (ROS10/EZT10) or to rosuvastatin 20 mg once daily (ROS20). The primary endpoint was LDL-C reduction ≥50% from baseline at 90 days. Key secondary endpoints were LDL-C <70 mg/dL and multiple lipid goal achievement, and composite of major vascular events.
Results
Of 584 randomized, 530 were included in the modified intention-to-treat analysis. The baseline LDL-C level was 130.2±34.7 mg/dL in the ROS10/EZT10 group and 131.0±33.9 mg/dL in the ROS20 group. The primary endpoint was achieved in 198 patients (72.5%) in the ROS10/EZT10 group and 148 (57.6%) in the ROS20 group (odds ratio [95% confidence interval], 1.944 [1.352–2.795]; P= 0.0003). LDL-C level <70 mg/dL was achieved in 80.2% and 65.4% in the ROS10/EZT10 and ROS20 groups (P=0.0001). Multiple lipid goal achievement rate was 71.1% and 53.7% in the ROS10/EZT10 and ROS20 groups (P<0.0001). Major vascular events occurred in 1 patient in the ROS10/EZT10 group and 9 in the ROS20 group (P=0.0091). The adverse event rates did not differ between the two groups.
Conclusion
Moderate-intensity rosuvastatin plus ezetimibe was superior to high-intensity rosuvastatin alone for intensive LDL-C reduction in patients with recent ischemic stroke. With the combination therapy, more than 70% of patients achieved LDL-C reduction ≥50% and 80% had an LDL-C <70 mg/dL at 90 days.

Keyword

Stroke; LDL cholesterol; Rosuvastatin; Ezetimibe; Target goal

Figure

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  Figure 1. Trial flow. LDL-C, low-density lipoprotein cholesterol.

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  Figure 2. Subgroup analyses of primary endpoint, according to post hoc subgroups. LDL-C reduction ≥50% (the primary end point) at 90 days among patients in the ROS10/EZT10 group and in the ROS20 group, according to post hoc subgroups. LDL-C, low-density lipoprotein cholesterol; OR, odds ratio; CI, confidence interval; DM, diabetes mellitus.

Reference

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