Clinical Department of Cardiology and Cardiovascular Interventions, University Hospital, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland.
2nd Department of Cardiology, Jagiellonian University Medical College, Macieja Jakubowskiego 2 Street, 30-688 Krakow, Poland.
Medicina (Kaunas). 2024 Jul 12;60(7):1124. doi: 10.3390/medicina60071124.
Lowering low-density lipoprotein (LDL-C) levels is critical for preventing atherosclerotic cardiovascular disease, yet some patients fail to reach the LDL-C targets despite available intensive lipid-lowering therapies. This study assessed the effectiveness and safety profile of alirocumab, evolocumab, and inclisiran in lipid reduction. A cohort of 51 patients (median (Q1-Q3) age: 49.0 (39.5-57.5) years) was analyzed. Eligibility included an LDL-C level > 2.5 mmol/L while on the maximum tolerated dose of statin and ezetimibe, a diagnosis of familial hypercholesterolemia, or a very high risk of cardiovascular diseases following myocardial infarction within 12 months prior to the study. Follow-ups and lab assessments were conducted at baseline (51 patients), 3 months (51 patients), and 15 months (26 patients) after the treatment initiation. Median initial LDL-C levels 4.1 (2.9-5.0) mmol/L, decreasing significantly to 1.1 (0.9-1.6) mmol/L at 3 months and 1.0 (0.7-1.8) mmol/L at 15 months ( < 0.001). Total cholesterol also reduced significantly compared to baseline at both intervals ( < 0.001). No substantial differences in LDL-C or total cholesterol levels were observed between 3- and 15-month observations ( > 0.05). No statistically significant differences were noted in cholesterol reduction among the alirocumab, evolocumab, and inclisiran groups at 3 months. The safety profile was favorable, with no reported adverse cardiovascular events or significant changes in alanine transaminase, creatinine, or creatine kinase levels. Alirocumab, evolocumab, and inclisiran notably decreased LDL-C and total cholesterol levels without significant adverse effects, underscoring their potential as effective treatments in patients who do not achieve lipid targets with conventional therapies.
降低低密度脂蛋白胆固醇(LDL-C)水平对于预防动脉粥样硬化性心血管疾病至关重要,但一些患者尽管接受了强化降脂治疗,仍未能达到 LDL-C 目标。本研究评估了阿利西尤单抗、依洛尤单抗和inclisiran 在降脂方面的有效性和安全性。
分析了 51 例患者(中位数(Q1-Q3)年龄:49.0(39.5-57.5)岁)的资料。入选标准包括:在他汀类药物和依折麦布最大耐受剂量下 LDL-C 水平>2.5mmol/L、家族性高胆固醇血症诊断、或在研究前 12 个月内发生心肌梗死后心血管疾病极高危。在治疗开始后 3 个月(51 例患者)和 15 个月(26 例患者)进行随访和实验室评估。
中位初始 LDL-C 水平为 4.1(2.9-5.0)mmol/L,治疗 3 个月后显著降低至 1.1(0.9-1.6)mmol/L,15 个月后降低至 1.0(0.7-1.8)mmol/L(<0.001)。与基线相比,总胆固醇在两个时间点也显著降低(<0.001)。在 3 个月和 15 个月的观察中,LDL-C 和总胆固醇水平没有显著差异(>0.05)。在 3 个月时,阿利西尤单抗、依洛尤单抗和 inclisiran 组之间的胆固醇降低无统计学差异。安全性良好,无不良心血管事件报告,丙氨酸转氨酶、肌酐或肌酸激酶水平无显著变化。
阿利西尤单抗、依洛尤单抗和 inclisiran 显著降低 LDL-C 和总胆固醇水平,无显著不良反应,这表明它们在常规治疗未能达到血脂目标的患者中具有潜在的有效治疗作用。