Abstract Body (Do not enter title and authors here): Background: Carotid atherosclerosis is a significant risk factor for ischemic stroke, with plaque instability contributing to stroke risk regardless of stenosis severity. For patients with non-calcified plaques and <50% stenosis, particularly those with statin intolerance, no standardized lipid-lowering approach exists. Xuezhikang, a red yeast rice-derived agent, has demonstrated potential in lowering LDL-C and stabilizing plaques, offering a promising alternative for this patient group.
Objective: To evaluate the safety and efficacy of Xuezhikang in improving lipid profiles and stabilizing carotid plaques in patients with mild stenosis and statin intolerance.
Methods: This prospective study included 52 statin-intolerant patients with non-calcified carotid plaques and stenosis <50%，who received 600 mg of Xuezhikang twice daily for 36 months. Lipid profiles and plaque stability biomarkers were assessed at baseline and at 3, 12, 24, and 36 months. Carotid plaque size, stability, and stenosis degree were evaluated using ultrasonography. Adverse events, including major cardiovascular events (MACEs) and new-onset diabetes, were monitored throughout the study.
Results: After 3 months, significant reductions were observed in total cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), and plaque instability biomarkers. LDL-C levels decreased from approximately 2.9 mmol/L to 2.2 mmol/L, contributing to improved plaque property. By 12 months, the largest plaque decreased in size, and hyperechoic plaques increased. At 24 months, stenosis was significantly reduced, and by 36 months, plaque area and volume remained stable. Plaque changes at study end were: 42.5% regression, 22.5% stabilization, and 35% progression. LDL-C reduction to 2.2 mmol/L was identified as a key threshold for patient benefit in this population. No MACEs, severe side effects, or new-onset diabetes were reported.
Conclusions: Xuezhikang (600 mg twice daily) effectively reduced atherogenic lipid parameters and stabilized carotid plaques in statin-intolerant patients with mild stenosis. A reduction in LDL-C to 2.2 mmol/L was associated with improved plaque stability. The treatment was well-tolerated, with no MACEs or severe adverse effects during the 36-month follow-up. These findings suggest Xuezhikang as a safe and effective alternative for lipid-lowering and plaque stabilization in this patient population.