*Real-World Experience with Inclisiran at a Large Academic Lipid Clinic

IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Michael Wilkinson MD, Tommy Chiou MD, Pam Taub MD, Donya Mazdeyasnan BS
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引用次数: 0

Abstract

Background/Synopsis

Inclisiran is an siRNA that targets PCSK9 and lowers LDL-C by approximately 50%. Inclisiran is unique among lipid-lowering therapies (LLTs) available for LDL-C reduction as it is administered via subcutaneous injection by a healthcare professional every 6 months. Real-world data examining inclisiran use in US clinical practice are limited.

Objective/Purpose

Examine patient characteristics and LDL-C reduction during the initial two-year experience with inclisiran at a large academic lipid clinic.

Methods

We performed a retrospective chart review of 60 patients at a large academic lipid clinic who were prescribed inclisiran between March 2022 to November 2023 and had follow-up LDL-C measurements taken ≥ 30 days after initiating treatment as part of routine care. Background LLT was extracted from the medical record and reflects treatment at time of inclisiran initiation. Absolute and percent LDL-C reduction was examined during follow-up. LDL-C reduction from baseline was assessed within group using a paired samples t-test with two-sided p < 0.05 considered significant.

Results

Among 60 patients, mean (± SD) age was 71 ± 9.2 years (52% women, 90% White, 2% Hispanic/Latino, 8% Asian), 87% with history of ASCVD, 70% with statin intolerance, 20% with HeFH, and 50% on background statin therapy (Table). During the 4.4 ± 2.8 months of follow-up from first dose of inclisiran to first LDL-C measurement, 2 patients had received three doses of inclisiran, 34 patients had received two doses, and 24 patients had received one dose. LDL-C decreased from 107 ± 47 mg/dL at baseline to 67 ± 42 mg/dL at first follow up (-37%, p < 0.001). Excluding patients that switched from a PCSK9i monoclonal antibody (mAb) within approximately one month prior to starting inclisiran (n=12) or patients on no background LLT at time of inclisiran initiation (n=9), patients saw a decrease in mean LDL-C from 102 ± 42 mg/dL at baseline to 54 ± 40 mg/dL at first follow-up ((n=39) -47%, p <0.001) (Figure).

Conclusions

Patients that remained on background lipid-lowering therapy and did not switch from PCSK9i mAb to inclisiran observed LDL-C reductions of approximately 50%, consistent with inclisiran clinical trials. Additional real-world data examining the impact of inclisiran on LDL-C are needed, across multiple centers and among patients on various background LLT regimens.

*一家大型学术血脂诊所使用英克利西兰的实际经验
背景/简介Inclisiran 是一种 siRNA,能靶向 PCSK9 并将低密度脂蛋白胆固醇(LDL-C)降低约 50%。在可用于降低 LDL-C 的降脂疗法(LLT)中,Inclisiran 是独一无二的,因为它是由专业医护人员通过皮下注射给药,每 6 个月一次。我们对一家大型学术血脂诊所的 60 名患者进行了回顾性病历审查,这些患者在 2022 年 3 月至 2023 年 11 月期间接受了 inclisiran 治疗,并在开始治疗后作为常规护理的一部分进行了≥30 天的随访 LDL-C 测量。背景 LLT 从病历中提取,反映了开始使用 inclisiran 时的治疗情况。随访期间检查 LDL-C 的绝对降幅和降幅百分比。结果60名患者中,平均(± SD)年龄为71±9.2岁(52%为女性,90%为白人,2%为西班牙/拉丁美洲人,8%为亚洲人),87%有ASCVD病史,70%对他汀类药物不耐受,20%有HeFH,50%正在接受背景他汀类药物治疗(表)。从首次服用 inclisiran 到首次测量 LDL-C 的 4.4 ± 2.8 个月随访期间,2 名患者服用了 3 次 inclisiran,34 名患者服用了 2 次,24 名患者服用了 1 次。低密度脂蛋白胆固醇从基线时的 107 ± 47 mg/dL 降至首次随访时的 67 ± 42 mg/dL(-37%,p <0.001)。剔除在开始使用 inclisiran 前约一个月内从 PCSK9i 单克隆抗体 (mAb) 转用的患者(12 人)或在开始使用 inclisiran 时未服用背景 LLT 的患者(9 人),患者的平均 LDL-C 从基线时的 102 ± 42 mg/dL 降至首次随访时的 54 ± 40 mg/dL((39 人)-47%,p <0.001)。结论仍在接受背景降脂治疗且未从 PCSK9i mAb 转为 inclisiran 的患者观察到 LDL-C 降低了约 50%,这与 inclisiran 临床试验一致。还需要更多的真实世界数据,以检查多个中心和接受各种背景 LLT 方案治疗的患者使用 inclisiran 对 LDL-C 的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
7.00
自引率
6.80%
发文量
209
审稿时长
49 days
期刊介绍: Because the scope of clinical lipidology is broad, the topics addressed by the Journal are equally diverse. Typical articles explore lipidology as it is practiced in the treatment setting, recent developments in pharmacological research, reports of treatment and trials, case studies, the impact of lifestyle modification, and similar academic material of interest to the practitioner. While preference is given to material of immediate practical concern, the science that underpins lipidology is forwarded by expert contributors so that evidence-based approaches to reducing cardiovascular and coronary heart disease can be made immediately available to our readers. Sections of the Journal will address pioneering studies and the clinicians who conduct them, case studies, ethical standards and conduct, professional guidance such as ATP and NCEP, editorial commentary, letters from readers, National Lipid Association (NLA) news and upcoming event information, as well as abstracts from the NLA annual scientific sessions and the scientific forums held by its chapters, when appropriate.
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