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Observational, Multicenter study on long-term Effectiveness and tolerability of aliROcumab (OMERO): an Italian real-life experience

Year: 2025

Type: article

Abstract: Background: The OMERO study (Observational Multicenter study on Effectiveness and tolerability of aliROcumab in real-world) aimed to evaluate the long-term effectiveness, safety and adherence of alirocumab in a cohort of Italian patients with elevated cholesterol at high- or very-high cardiovascular risk. Methods: Italian patients with elevated cholesterol received alirocumab for at least six months before the inclusion visit and were monitored for up to five years. The achievement of the recommended LDL-Cholesterol (LDL-C) goal (70 mg/dL in high-risk patients; 100 mg/dL in very-high-risk patients) after one year, regardless of modifications of concurrent lipid-lowering therapy or treatment adherence, was the primary endpoint of the study. The evaluation of the lipid profile, the concomitant use of lipid-lowering therapies, the treatment adherence and the occurrence of adverse events were also investigated. Results: 517 (68.6 %) of the 754 FAS patients met the primary endpoint 12 months after beginning their treatment with alirocumab. Median (mean ± SD) LDL-C reductions at the final visit (median or mean follow-up period) were -60.7 % (-57.4 % ± 19.3 %) compared to baseline. The primary endpoint was achieved by 341(70.7%) of the 482 patients with an LDL-C measurement 3 years after initiating alirocumab. Adherence to the alirocumab regimen was approximately 100 % during the observation period. Eighteen (2.3 %) of the 797 patients included in the safety population experienced at least one adverse drug reaction. Conclusion: The effectiveness of alirocumab in reducing LDL-C and its favorable safety and tolerability profile have been consistently confirmed in a real-world setting among Italian patients treated for up to 3 years.

Source: International Journal of Cardiology Cardiovascular Risk and Prevention

DOI: 10.1016/j.ijcrp.2025.200549

Authors: Alberico L. Catapano, Aldo Pietro Maggioni, Francesco Rossi, Eleonora Consolo, Lucia Notarianni, Giancarlo Agnelli