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宾夕法尼亚大学医疗系统中inclisiran处方的真实世界经验。

Real-world experience of inclisiran prescription at the University of Pennsylvania Health Systems.

作者信息

Wei Nicole M, Tobin Robert F, Jacoby Douglas S, Bajaj Archna

机构信息

Division of Translational Medicine & Human Genetics, University of Pennsylvania, Philadelphia, PA.

Infusion Services, Penn Medicine, Philadelphia, PA.

出版信息

J Clin Lipidol. 2024 Nov-Dec;18(6):e1096-e1100. doi: 10.1016/j.jacl.2024.07.008. Epub 2024 Jul 27.

DOI:10.1016/j.jacl.2024.07.008
PMID:39322525
Abstract

Inclisiran is a novel small interfering RNA targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) that was approved by the US Food and Drug Administration in December 2021. After two doses 3 months apart, it is administered biannually as a subcutaneous injection and has been shown to lower low-density lipoprotein cholesterol (LDL-C) by ∼50% in clinical trials. Here, we present real-world data on the prescription and administration of inclisiran at the University of Pennsylvania Health Systems. Over a 2-year period, there were 243 patients who were prescribed inclisiran, of whom 153 were approved by insurance and initiated therapy. Approved patients were disproportionately Medicare enrollees and more likely to have a history of atherosclerotic cardiovascular disease (ASCVD). Mean post-treatment LDL-C for patients who received at least two doses was 74.7 ± 45.6 mg/dL. For patients new to PCSK9-targeted therapy, a reduction in LDL-C of ∼50% was observed after initiating inclisiran, supporting clinical trial results. 60% of patients with ASCVD achieved an LDL-C level of < 70 mg/dL after adding inclisiran.

摘要

英克西兰是一种新型的小干扰RNA,靶向9型前蛋白转化酶枯草溶菌素/kexin(PCSK9),于2021年12月获得美国食品药品监督管理局批准。在间隔3个月注射两剂后,每半年进行一次皮下注射,临床试验表明其可使低密度脂蛋白胆固醇(LDL-C)降低约50%。在此,我们展示了宾夕法尼亚大学医疗系统中关于英克西兰处方和给药的真实世界数据。在两年时间里,有243名患者被处方使用英克西兰,其中153名获得保险批准并开始治疗。获批患者中医疗保险参保者占比过高,且更有可能有动脉粥样硬化性心血管疾病(ASCVD)病史。接受至少两剂治疗的患者治疗后LDL-C的平均值为74.7±45.6mg/dL。对于初次接受PCSK9靶向治疗的患者,开始使用英克西兰后观察到LDL-C降低约50%,这支持了临床试验结果。60%的ASCVD患者在加用英克西兰后LDL-C水平降至<70mg/dL。

相似文献

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Real-world experience of inclisiran prescription at the University of Pennsylvania Health Systems.宾夕法尼亚大学医疗系统中inclisiran处方的真实世界经验。
J Clin Lipidol. 2024 Nov-Dec;18(6):e1096-e1100. doi: 10.1016/j.jacl.2024.07.008. Epub 2024 Jul 27.
2
Effect of an siRNA Therapeutic Targeting PCSK9 on Atherogenic Lipoproteins: Prespecified Secondary End Points in ORION 1.靶向 PCSK9 的 siRNA 治疗对动脉粥样硬化脂蛋白的影响:ORION 1 的预先指定次要终点。
Circulation. 2018 Sep 25;138(13):1304-1316. doi: 10.1161/CIRCULATIONAHA.118.034710.
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Inclisiran creates unique opportunities and challenges for patient access to therapy: early experience in a United States Lipid Clinic.inclisiran为患者获得治疗带来了独特的机遇和挑战:美国一家脂质诊所的早期经验。
J Clin Lipidol. 2023 Jan-Feb;17(1):73-77. doi: 10.1016/j.jacl.2022.10.009. Epub 2022 Nov 1.
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Lipid-lowering therapy with inclisiran in the real-world setting: Initial data from a national health care service.降脂治疗中依洛尤单抗的真实世界数据:来自国家医疗服务的初步数据。
J Clin Lipidol. 2024 Sep-Oct;18(5):e809-e816. doi: 10.1016/j.jacl.2024.05.003. Epub 2024 May 24.
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Effect of inclisiran, the small-interfering RNA against proprotein convertase subtilisin/kexin type 9, on platelets, immune cells, and immunological biomarkers: a pre-specified analysis from ORION-1.针对前蛋白转化酶枯草杆菌蛋白酶/ kexin 9型的小干扰RNA英克西兰对血小板、免疫细胞和免疫生物标志物的影响:来自ORION-1的预先指定分析。
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The clinical effects of inclisiran, a first-in-class LDL-C lowering siRNA therapy, on the LDL-C levels in Chinese patients with hypercholesterolemia.降脂新药 inclisiran 在中国高胆固醇血症患者中降低 LDL-C 水平的临床效果。
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Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol.依洛尤单抗在 LDL 胆固醇升高的高心血管风险患者中的应用。
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Pooled Patient-Level Analysis of Inclisiran Trials in Patients With Familial Hypercholesterolemia or Atherosclerosis.家族性高胆固醇血症或动脉粥样硬化患者依洛尤单抗临床试验的汇总患者水平分析。
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Inclisiran: A First-in-Class siRNA Therapy for Lowering Low-Density Lipoprotein Cholesterol.英克西兰:一种用于降低低密度脂蛋白胆固醇的首创小干扰RNA疗法。
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引用本文的文献

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Inclisiran: Efficacy in Real World-Systematic Review and Meta-Analysis.英克西兰:真实世界中的疗效——系统评价与荟萃分析
J Clin Med. 2025 Jun 12;14(12):4163. doi: 10.3390/jcm14124163.