First clinical experience with inclisiran in Slovakia – experience with administration, management and efficacy from one center
Authors:
Štefan Tóth; Patrik Buček; Richard David; Matej Šajty
Authors‘ workplace:
Kardiologická ambulancia, Kardiocomp s. r. o., Košice
1
Published in:
AtheroRev 2024; 9(1): 27-34
Category:
Reviews
Overview
Introduction: Inhibition of the cascade of proprotein convertase subtilisin kexin type 9 (PCSK9) has been shown to be an effective method of reducing LDL-C, which represents one of the most important risk factors for the development and progression of cardiovascular diseases. Inclisiran represents the first small interfering RNA (siRNA) inhibiting PCSK9, whose effectiveness in reducing LDL-C is reported in clinical studies by ± 50 %. The aim of this study was to describe the effect of inclisiran in real clinical conditions as well as the first clinical experience with administration in Slovakia. Methods: In this observational study, we indicated a total of 36 patients for inclisiran therapy within the framework of standard examinations, procedures and reimbursements from the public health insurance. Patients completed a standard lipid profile examination (LDL-C, HDL-C, TC, TG, Lp(a)) and hsCRP before submitting applications for therapy approval and then +1 month after 2 administrations of therapy. The mean change in lipid profile levels was determined for each patient who received the second dose of inclisiran. Results: A total of 31 patients, 22 patients with ACS/revaskularisation and 9 patients after stroke, were approved by health insurance companies. One patient with statin intolerance, 24 patients with the maximum statin dose and 6 patients with a reduced dose were included. From the total number of patients, we had LDL-C samples taken after 3 + 1 months from 22 patients. The average entry value of the selected parameters was: LDL-C 3.56 [3.01; 4.14] mmol/L, Lp(a) 14.28 [8.19; 21.05] mg/dL hsCRP 4.2 [2.9; 5.5] mg/dL. After 3+1 months of therapy, we recorded a decrease in LDL-C by 57.46 % [50.41; 76.82], hsCRP by 1.2 [0.5; 1.9] mg/dL, Lp(a) by 14.29 % [8.19; 21.05] mg/dL. Safety was similar to clinical studies, with mild pain at the injection site in 26 administrations and flu-like symptoms the next day in 3 administrations. Conclusion: Our first experience with inclisiran in the clinical setting showed a slightly more effective reduction in LDL-C levels compared to clinical studies, a decrease in hsCRP levels as well as Lp(a). However, the decrease in Lp(a) was not present, and there were patients with a better response to therapy, or non-responders. The safety profile was similar to the clinical studies.
Keywords:
lipoprotein(a) – inclisiran – hsCRP – LDL-C – reaching target values
Sources
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