5PSQ-029 Evaluation of the efficacy of inclisiran for the treatment of primary hypercholesterolaemia mixed dyslipidaemia: analysis of AIFA monitoring registers
Year: 2025
Type: conference-paper
Study design: Observational Study
Abstract: Background and Importance 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. Aim and Objectives 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). Material and Methods 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. Results 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. Conclusion and Relevance 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. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: L Silva, C Galuppi, G Babaglioni, C Grumi, D Paganotti, TE Testa
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408377127