Klin Farmakol Farm. 2025;39(1):14-21 | DOI: 10.36290/far.2025.017
Background: Inhibiting proprotein convertase subtilisin/kexin type 9 activity is an effective strategy to lower LDL cholesterol (LDL-C), a major cardiovascular risk factor. Inclisiran, the first small interfering RNA targeting PCSK9, has shown a 50% LDL-C reduction in clinical trials.
Aims: The aim of this study was to describe the effects of inclisiran in real-world clinical settings, along with the first clinical experiences of its use in Slovakia.
Methods: In this observational study, 36 patients were selected for inclisiran therapy as part of standard clinical assessments, procedures, and reimbursement from public health insurance. Each patient underwent a standard lipid profile assessment and high-sensitivity C-reactive protein (hsCRP) testing before submitting applications for therapy approval, and again one month after receiving two doses of inclisiran. The average change in lipid profile levels was calculated for each patient who completed the third dose of inclisiran.
Results: Inclisiran therapy was approved for 36 patients, including 27 with atherosclerotic coronary artery disease and 9 with prior strokes. The cohort included 1 statin-intolerant patient, 28 on maximum statin doses, and 7 on reduced doses. After 3 months, LDL-C dropped by 57.5 %, hsCRP to 1.2 mg/dL, and lipoprotein(a) by 14.3 ± 6.4 %. Safety outcomes mirrored clinical trials, with mild injection-site pain in 26 cases and flu-like symptoms in 3.
Conclusions: Inclisiran demonstrated an effective reduction in LDL-C and hsCRP levels, slightly exceeding clinical trial outcomes, but lipoprotein(a) reductions varied among patients. Safety was consistent with expectations, confirming inclisiran‘s potential for broader clinical use.
Accepted: April 15, 2025; Published: April 29, 2025 Show citation