Qiu Xiaohui, Liang Yeyuan, Wei Yunfei, Lu Mengru, Mei Yujia, Tang Shiting, Tang Jian, Liang Jinyu, Liang Junli
Department of Neurology, The Second Affiliated Hospital of Guangxi Medical University, Nanning, China.
Front Neurol. 2024 Dec 23;15:1454608. doi: 10.3389/fneur.2024.1454608. eCollection 2024.
Low-density lipoprotein cholesterol (LDL-C) has been determined as an established risk factor for acute ischemic stroke (AIS). Despite the recommendation for in-hospital initiation of high-intensity statin therapy in AIS patients, achieving the desired target LDL-C levels remains challenging. Evolocumab, a highly effective and quickly acting agent for reducing LDL-C levels, has yet to undergo extensively exploration in the acute phase of AIS. The aim was to assess the LDL-C reduction efficacy and safety of early application of evolocumab during the in-hospital phase of AIS patients.
An unblinded, single-center, prospective randomized controlled trial involving hospitalized AIS patients was conducted in the Second Affiliated Hospital of Guangxi Medical University in China. Patients were randomly assigned 1:1 to receive evolocumab 420 mg every 4 weeks or not, on top of standard of care (SOC) treatment (atorvastatin 40 mg/day and ezetimibe 10 mg/day), administered in-hospital until after 8 weeks. The primary outcome was the absolute change of LDL-C levels and the rate of achieving targeted lipid control at 8 weeks.
Totally, 120 patients were recruited from January 2023 to December 2023. Mean LDL-C levels decreased from 3.15 mmol/L to 0.85 mmol/L in the evolocumab group, and from 3.17 mmol/L to 2.22 mmol/L in the control group, with the difference in mean change from baseline was -1.37 [95% confidence interval (CI) = -1.70 to -1.04, < 0.001] at week 8. The rate of patients achieving targeted LDL-C <1.4 mmol/L was 81.67% in evolocumab group as compared with 13.33% in control group. Adverse events were similar in both groups.
Our study indicated that evolocumab added to high-intensity statin and ezetimibe therapy resulted in substantial reduction in LDL-C levels in early AIS patients and was well tolerated.
ClinicalTrials.gov, identifier NCT05697185.
低密度脂蛋白胆固醇（LDL-C）已被确定为急性缺血性卒中（AIS）的既定危险因素。尽管建议对AIS患者在住院期间开始高强度他汀类药物治疗，但要达到理想的LDL-C目标水平仍具有挑战性。依洛尤单抗是一种降低LDL-C水平的高效速效药物，在AIS急性期尚未得到广泛研究。本研究旨在评估在AIS患者住院期间早期应用依洛尤单抗降低LDL-C的疗效和安全性。
在中国广西医科大学第二附属医院进行了一项非盲、单中心、前瞻性随机对照试验，纳入住院的AIS患者。患者按1:1随机分组，在标准治疗（SOC）（阿托伐他汀40mg/天和依折麦布10mg/天）基础上，每4周接受一次420mg依洛尤单抗治疗或不接受该治疗，住院给药直至8周后。主要结局是8周时LDL-C水平的绝对变化以及达到目标血脂控制的比例。
2023年1月至2023年12月共招募120例患者。依洛尤单抗组的平均LDL-C水平从3.15mmol/L降至0.85mmol/L，对照组从3.17mmol/L降至2.22mmol/L，第8周时，与基线相比的平均变化差异为-1.37[95%置信区间（CI）=-1.70至-1.04，P<0.001]。依洛尤单抗组LDL-C<1.4mmol/L的患者比例为81.67%，而对照组为13.33%。两组不良事件相似。
我们的研究表明，在高强度他汀类药物和依折麦布治疗基础上加用依洛尤单抗可使早期AIS患者的LDL-C水平大幅降低，且耐受性良好。
ClinicalTrials.gov，标识符NCT05697185。
