Key result
Moderate rosuvastatin plus ezetimibe yields ~94% higher odds of ≥50% LDL-C reduction vs high-intensity rosuvastatin.
Why the study?
Moderate-intensity statin plus ezetimibe versus high-intensity statin alone may provide a greater LDL-C reduction in patients with recent ischemic stroke.
Does rosuvastatin 10 mg plus ezetimibe 10 mg once daily improve LDL-C reduction ≥50% from baseline at 90 days compared to rosuvastatin 20 mg once daily in patients with recent ischemic stroke?
RCT (n=584)
Open-label
1:1
Yes
Does rosuvastatin 10 mg plus ezetimibe 10 mg once daily improve LDL-C reduction ≥50% from baseline at 90 days compared to rosuvastatin 20 mg once daily in patients with recent ischemic stroke?
Odds Ratio: 1.944 (95% CI 1.352–2.795)
Absolute Event Rate: 72.5% vs 57.6%
p-value: p=0.0003
Moderate-intensity rosuvastatin plus ezetimibe is superior to high-intensity rosuvastatin alone for achieving intensive LDL-C reduction goals in patients with recent ischemic stroke.
Supports moderate-intensity rosuvastatin plus ezetimibe over high-intensity statin for LDL-C goals after ischemic stroke; extends combination therapy evidence in secondary prevention.
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.
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Hong et al. (2023) conducted an RCT in Recent ischemic stroke (n=584). Rosuvastatin plus ezetimibe vs. Rosuvastatin 20 mg once daily was evaluated on LDL-C reduction ≥50% from baseline at 90 days (OR 1.944, 95% CI 1.352-2.795, p=0.0003). Moderate-intensity rosuvastatin plus ezetimibe significantly increased the proportion of patients achieving ≥50% LDL-C reduction compared to high-intensity rosuvastatin alone (72.5% vs 57.6%, OR 1.944).
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