Mazdeyasnan Donya, Birs Antoinette, Chiou Tommy, Diano Lara, Wilkinson Michael J
Department of Medicine, Division of Cardiovascular Medicine, University of California San Diego, San Diego, CA, USA.
Department of Medicine, Division of Cardiovascular Medicine, University of California San Diego, San Diego, CA, USA.
J Clin Lipidol. 2025 Jun 18. doi: 10.1016/j.jacl.2025.06.015.
Inclisiran is a Food and Drug Administration-approved small interfering RNA targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) that lowers low-density lipoprotein cholesterol (LDL-C) by ∼50% in clinical trials. Real-world studies with inclisiran are limited.
Examine patient characteristics and the real-world safety and efficacy of inclisiran.
From 3/2022 to 11/2023, 60 patients at University of California San Diego Health met inclusion criteria of at least one follow-up LDL-C measurement ≥30 days after initiating inclisiran. Patients were examined for baseline characteristics and follow-up lipid levels measured as part of routine medical care.
Patients were a mean (± SD) age of 71 ± 9.2 years, 31 (52%) were women, and 54 (90%) were White individuals. A total of 52 (87%) had a history of atherosclerotic cardiovascular disease. Mean ± SD LDL-C decreased 38% from 107 ± 47 mg/dL at baseline to 66 ± 41 mg/dL at first follow-up (P < .001). Excluding patients who switched from a PCSK9 inhibitor monoclonal antibody (PCSK9i mAb) within 1 month prior to starting inclisiran treatment (n = 12), a 45% decrease in LDL-C was observed (114 ± 45 mg/dL to 62 ± 41 mg/dL, P < .001). Excluding patients who switched from a PCSK9i mAb (n = 12) and patients on no background lipid-lowering therapy at time of inclisiran initiation (n = 9), LDL-C decreased 47% (102 ± 42 mg/dL to 54 ± 40 mg/dL, P < .001). Three patients (5%) reported mild side-effects that resolved by their second injection.
Inclisiran in real-world practice was well-tolerated and patients on background lipid-lowering therapy who were not switching from a PCSK9i mAb to inclisiran observed LDL-C reductions of approximately 50%, consistent with clinical trials.
英克西兰是一种经美国食品药品监督管理局批准的小干扰RNA，靶向前蛋白转化酶枯草溶菌素/克新9型（PCSK9），在临床试验中可使低密度脂蛋白胆固醇（LDL-C）降低约50%。关于英克西兰的真实世界研究有限。
研究患者特征以及英克西兰在真实世界中的安全性和疗效。
2022年3月至2023年11月，加利福尼亚大学圣地亚哥分校医疗中心的60例患者符合纳入标准，即在开始使用英克西兰后至少有一次随访LDL-C测量，且随访时间≥30天。对患者进行基线特征检查，并将随访血脂水平作为常规医疗护理的一部分进行测量。
患者的平均（±标准差）年龄为71±9.2岁，31例（52%）为女性，54例（90%）为白人。共有52例（87%）有动脉粥样硬化性心血管疾病史。平均±标准差LDL-C从基线时的107±47mg/dL降至首次随访时的66±41mg/dL，下降了38%（P<.001）。排除在开始英克西兰治疗前1个月内从PCSK9抑制剂单克隆抗体（PCSK9i mAb）转换过来的患者（n=12）后，观察到LDL-C下降了45%（从114±45mg/dL降至62±41mg/dL，P<.001）。排除从PCSK9i mAb转换过来的患者（n=12）以及在开始使用英克西兰时未接受背景降脂治疗的患者（n=9）后，LDL-C下降了47%（从102±42mg/dL降至54±40mg/dL，P<.001）。3例患者（5%）报告有轻度副作用，在第二次注射后症状缓解。
在真实世界实践中，英克西兰耐受性良好，未从PCSK9i mAb转换至英克西兰的接受背景降脂治疗的患者，其LDL-C降低了约50%，与临床试验结果一致。
