MODERATE-INTENSITY ROSUVASTATIN PLUS EZETIMIBE VERSUS HIGH-INTENSITY ROSUVASTATIN FOR LDL-C REDUCTION IN RECENT ISCHEMIC STROKE; A RANDOMIZED CONTROLLED TRIAL (ROSETTA-STROKE)

Abstract

Background and Aims: Ezetimibe added to moderate-intensity rosuvastatin versus high-intensity rosuvastatin alone may provide a greater 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 10 mg plus ezetimibe 10 mg once daily (ROS/EZT 10/10) or to rosuvastatin 20 mg once daily (ROS 20). Key inclusion criteria were statin therapy indicated by guidelines and no pre-stroke statin use. The primary endpoint was the rate of LDL-C reduction >50% at 3 months. Key secondary endpoints were the rate of achieving LDL-C <70 mg/dL, the absolute LDL-C level change, 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 ROS/EZT-10/10 group and 132.2±39.6 mg/dL and in the ROS-20 group. The ROS/EZT-10/10 group versus the ROS-20 group had a greater rate of LDL-C reduction >50% (72.5% vs 58.0%, p=0.0004). The rate of achieving LDL-C <70 mg/dL (80.2% vs 65.4%, p<0.0001) and the absolute LDL-C level reduction (72.7±37.0 mg/dL vs 65.9±40.1 mg/dL, p=0.0080) were greater in the ROS/EZT-10/10 group than in the ROS-20 group. The composite events occurred in 1 patient the ROS/EZT-10/10 group and 9 in the ROS-20 group (p=0.0080). The adverse event rates did not differ between the two groups.

Conclusions: Moderate-intensity rosuvastatin plus ezetimibe was superior to high-intensity rosuvastatin in LDL-C reduction, achieving LDL-C reduction >50% in more than 70% and LDL-C <70 mg/dL in 80% of patients. (Funded by Hanmi Pharm; ClinicalTrials.gov: NCT03993236)