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

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.

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.

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.

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.