Section snippets

Methods

CHOLINET is a single-country, multicenter, observational, prospective, phase 4 registry of Italian patients initiating inclisiran as part of clinical management. Reimbursement criteria (Italian Medicines Agency [AIFA], GU 231-03.10.2022) include patients at very high cardiovascular (CV) risk with LDL-C of ≥70 mg/dL on statin ± ezetimibe. Lipids were assessed at median of 17 days before each inclisiran administration. CV risk categorization was performed according to the European Society of

Results

A total of 659 patients were enrolled across 31 Italian sites between November 2022 and February 2024. Of these, 529 patients reached the 3-month milestone, and 513 patients (97%) received their second dose and had lipid levels measured. Additionally, of the 178 patients who reached the 9-month milestone, 171 (96%) received the third dose and had their lipid levels measured. The mean age was 63 years, and the majority were male (69%). Inclisiran was mostly prescribed by cardiologists (98%) and

Discussion

In this study, a reduction in LDL-C levels was observed in patients receiving inclisiran, with most of them achieving the LDL-C target without significant side effects at 3 and 9 months.Our data confirm the efficacy observed in randomized studies, reporting an LDL-C reduction of 50% to 55%¹ at day 90 and of 57% to 60.2%^7,8 at 9 months, consistent with our findings showing a 51.2% LDL-C reduction at 3 months and 55.7% at 9 months.Recently, VICTORION-INITIATE⁴ reported an LDL-C reduction of 57.7%

Funding Support and Author Disclosures

Dr Corsini has received consulting fees and lecture fees from Algorithm, Amarin, Amgen, DOC, Fidia, Novartis, Merck Sharp & Dohme, Recordati Spa, Sanofi, Servier, and Viatris; and has received grant support from Daiichi-Sankyo. The other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Acknowledgments

The CHOLINET Investigators include Luca Gallo, MD, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy; Ermanno Nardi, MD, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy; Antonio Luca Maria Parlati, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy; Lucia Barbieri, MD, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy, and

中文翻译：

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Inclisiran 的真实世界疗效和安全性：一项单一国家、多中心、观察性研究 （CHOLINET Registry）

 部分片段

 方法

CHOLINET 是一项单一国家、多中心、观察性、前瞻性、4 期注册，针对作为临床管理一部分开始 inclisiran 的意大利患者。报销标准（意大利药品管理局 [AIFA]，GU 231-03.10.2022）包括服用他汀类药物±依折麦布的心血管 （CV） 风险非常高且 LDL-C 为 ≥70 mg/dL 的患者。在每次 inclisiran 给药前中位 17 天评估血脂。根据欧洲学会

 结果

2022 年 11 月至 2024 年 2 月期间，意大利 31 个地点共招募了 659 名患者。其中，529 名患者达到 3 个月里程碑，513 名患者 （97%） 接受了第二剂并测量了血脂水平。此外，在达到 9 个月里程碑的 178 名患者中，171 名 （96%） 接受了第三剂并测量了他们的血脂水平。平均年龄为 63 岁，大多数为男性 （69%）。Inclisiran 主要由心脏病专家开处方 （98%），并且

 讨论

在这项研究中，在接受 inclisiran 的患者中观察到 LDL-C 水平降低，其中大多数患者在 3 个月和 9 个月时达到 LDL-C 目标，没有明显的副作用。我们的数据证实了在随机研究中观察到的疗效，报告称 LDL-C 在 90 天降低 50% 至 55%¹，在 9 个月时降低 57% 至 60.2%⁷⁸，与我们的研究结果一致，显示 3 个月时 LDL-C 降低 51.2%，9 个月时降低 55.7%。最近，VICTORION-INITIATE⁴ 报告称 LDL-C 降低了 57.7%

资金支持和作者披露

Dr Corsini已经从Algorithm， Amarin， Amgen， DOC， Fidia， Novartis， Merck Sharp & Dohme， Recordati Spa， Sanofi， Servier和Viatris那里获得了咨询费和讲座费;并已获得 Daiichi-Sankyo 的赠款支持。其他作者报告说，他们与本文的内容没有任何关系需要披露。

 确认

CHOLINET 研究人员包括意大利那不勒斯那不勒斯费德里科二世大学高级生物医学科学系的 Luca Gallo 医学博士;Ermanno Nardi，医学博士，意大利那不勒斯费德里科二世大学高级生物医学科学系;Antonio Luca Maria Parlati，意大利那不勒斯费德里科二世大学高级生物医学科学系;Lucia Barbieri，医学博士，意大利米兰米兰大学临床科学与社区卫生系，以及