Real-World Efficacy and Safety of Inclisiran: A Single-Country, Multicenter, Observational Study (CHOLINET Registry)

IF 21.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of the American College of Cardiology Pub Date : 2024-12-11 DOI:10.1016/j.jacc.2024.10.106

Paola Gargiulo, Federica Marzano, Mario Crisci, Rossella Marcucci, Dario Bruzzese, Alessandro Maloberti, Filippo Maria Sarullo, Gennaro Galasso, Ciro Indolfi, Giuseppe Musumeci, Antonella Corleto, Paolo Calabrò, Stefano Carugo, Gavino Casu, Amedeo Picciolo, Marco Matteo Ciccone, Claudio Bilato, Alberto Polimeni, Francesco Giallauria, Angelo Catalano, Pasquale Perrone Filardi

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Abstract

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

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来源期刊

Journal of the American College of Cardiology 医学-心血管系统

CiteScore

42.70

自引率

3.30%

发文量

5097

审稿时长

2-4 weeks

期刊介绍： The Journal of the American College of Cardiology (JACC) publishes peer-reviewed articles highlighting all aspects of cardiovascular disease, including original clinical studies, experimental investigations with clear clinical relevance, state-of-the-art papers and viewpoints. Content Profile: -Original Investigations -JACC State-of-the-Art Reviews -JACC Review Topics of the Week -Guidelines & Clinical Documents -JACC Guideline Comparisons -JACC Scientific Expert Panels -Cardiovascular Medicine & Society -Editorial Comments (accompanying every Original Investigation) -Research Letters -Fellows-in-Training/Early Career Professional Pages -Editor’s Pages from the Editor-in-Chief or other invited thought leaders