5PSQ-029 Evaluation of the efficacy of inclisiran for the treatment of primary hypercholesterolaemia mixed dyslipidaemia: analysis of AIFA monitoring registers

<h3>Background and Importance</h3> Hypercholesterolaemia is a significant challenge in the management of cardiovascular disease, with considerable implications for public health and the National Health System. Inclisiran, a synthetic oligonucleotide complementary to the mRNA encoding the PCSK9 protein, has the potential to reduce intra-individual variability in LDL-C levels over time. With its twice-yearly administration, it can offer an optimal solution to ensure adherence to therapy, ultimately lowering the risk of cardiovascular events in high-risk patients. <h3>Aim and Objectives</h3> This analysis aims to assess the efficacy of inclisiran in patients suffering from primary heterozygous familial hypercholesterolaemia (HeHF), non-familial hypercholesterolaemia (noHF) or mixed dyslipidaemia (MD). <h3>Material and Methods</h3> AIFA Monitoring Registers of patients treated with inclisiran were analysed. The considered period was January 2023 to September 2024. The indicators of effectiveness were levels of LDL-C and HDL-C after 15 months (i.e. three administrations of inclisiran), compared to the pre-treatment values. <h3>Results</h3> After evaluating 168 AIFA Monitoring Registers, 35 patients (74% male, 26% female) with available follow-up data at 15 months were included. The mean age of the cohort was 66 years (range: 45–81), with 16 patients suffering from MD, 17 from no HF, and two from HeHF. The efficacy of Inclisiran is promising, with significant reductions in LDL-C levels: 24% at 3 months, 30% at 9 months, and 46% at 15 months. Average LDL-C reductions were 42.7 mg/dL after the first two administrations and 64.8 mg/dL after the third. Furthermore, HDL-C levels increased, rising from 7% to 19% after three administrations of inclisiran. No cardiovascular events were reported and adherence to the treatment was high. <h3>Conclusion and Relevance</h3> In the considered sample of patients treated with inclisiran, a consistent reduction in LDL-C levels over time has been proven, with peak efficacy (−46%) observed after three doses, alongside a steady increase in HDL-C levels, thus contributing to prevent cardiovascular risks. The 6 month dosing schedule was a strong point that increased therapeutic adherence. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest