KMID : 1142120230250020242
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Journal of Stroke 2023 Volume.25 No. 2 p.242 ~ p.250
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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
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Hong Keun-Sik
Bang Oh-Young Park Jong-Ho Jung Jin-Man Lee Sang-Hun Song Tae-Jin Nam Hyo-Suk Park Hee-Kwon Jung Keun-Hwa Heo Sung-Hyuk Koo Ja-Seong Yu Kyung-Ho Park Kwang-Yeol Kim Chi-Kyung Park Hong-Kyun Lee Ji-Yoon Lee June-Young Seo Woo-Keun
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Abstract
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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 ¡Ã50% 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¡¾34.7 mg/dL in the ROS10/EZT10 group and 131.0¡¾33.9 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 ¡Ã50% and 80% had an LDL-C <70 mg/dL at 90 days.
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KEYWORD
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Stroke, LDL cholesterol, Rosuvastatin, Ezetimibe, Target goal
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