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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.

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。

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