Real-World Efficacy and Safety of Inclisiran

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 a median of 17 days before each inclisiran administration. CV risk categorization was performed according to the European Society of Cardiology. 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%). 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.