Cardiology Letters 2025, 34(4):210-220

Innovative hypolipidemic therapy in the secondary prevention of cardiovascular diseases - the experience of one centre

Ján Kmec¹, Martin Kmec², Daniel Alušík², Miroslav Slanina², Michaela Zigová³

FESC, Kardiocentrum FNsP J. A. Reimana Prešov, Hollého 14, 081 81 Prešov, Slovenská republika

Elevated LDL cholesterol (LDL-C) levels are among the major risk factors for atherosclerotic cardiovascular disease. Inclisiran is the first small interfering RNA (siRNA) that reduces plasma LDL-C levels by inhibiting the PCSK9 protein in the liver.

Aim: The aim of this study was to evaluate the efficacy and safety of inclisiran administered as monotherapy or in combination with other lipid-lowering therapy in patients with very high cardiovascular risk.

Methods: An observational, retrospective, monocentric study enrolled 80 consecutive patients at high cardiovascular risk treated with lipid-lowering drugs, including inclisiran. The efficacy of therapy was assessed based on absolute and relative reductions in LDL-C levels after nine months and achievement of target LDL-C values according to ESC/EAS (European Society of Cardiology/ European Atherosclerosis Society) recommendations. The safety of therapy was assessed, based on the occurrence of side effects or discontinuation of therapy.

Results: The mean baseline LDL-C value was 3.29 ± 0.64 mmol/L and decreased to 1.42 ± 0.62 mmol/L after nine months (p ≤ 0.001). The mean percentage decrease in LDL-C levels was 56.21% regardless of the therapeutic regimen. Target LDL-C values ≤ 1.4 mmol/L were achieved by 52.20% of the entire cohort, with higher success rates in the case of combination therapy. Target values and a reduction of LDL-C ≥ 50% were achieved in 42.25% of patients, the lowest in the case of inclisiran monotherapy (23.81% of patients). A poor response to treatment was confirmed in 6.25% of patients. Non-serious adverse effects (injection site reactions) were recorded in 6.25% of patients. Adherence to treatment was complete.

Conclusion: The results of the study confirm the relatively high efficacy of inclisiran in lowering LDL-C levels, both for monotherapy and combination therapy. The treatment was well tolerated, with minimal incidence of adverse effects and a high rate of adherence. The observed variability in therapeutic response among patients highlights the need for an individualized approach in the management of hyperlipidemia to effectively prevent cardiovascular events.

Keywords: cardiovascular risk; inclisiran; LDL-cholesterol; adherence

Published: April 1, 2025  Show citation