Observational study of inclisiran effectiveness in Moscow healthcare

Aim. To evaluate the effectiveness of PCSK9 inhibitors (alirocumab, inclisiran and evolocumab) in patients with atherosclerotic cardiovascular disease (ASCVD) and failure to achieve the target low-density lipoprotein cholesterol (LDL-C) level for the period from November 21, 2022 to December 31, 2023.

Material and methods. For the observational study, 50 patients were included in the inclisiran therapy group and 30 patients in the control group (patients with ASCVD receiving PCSK9 inhibitors (alirocumab, n=1; evolocumab, n=29)). All study participants had their anamnestic data analyzed, and initially underwent electrocardiography, echocardiography, extracranial and lower limb Doppler ultrasound, and laboratory tests (complete blood count, biochemical blood tests, lipid profile). Three medical organizations of the Moscow State Healthcare System participate in the study.

Results. Interim data are presented to evaluate the effectiveness of PCSK9 targeted therapy in patients with ASCVD, obtained 3 months from the study start. The comparison groups were comparable in main clinical characteristics. When analyzing the lipid-lowering effect of inclisiran in the examined patients with ASCVD, LDL-C level significantly decreased from 2,53±0,10 mmol/l to 110±0,08 mmol/l (by 56,5%), p<0,0001, while the target LDL-C level <1,4 mmol/l was achieved by 77,5% of the subjects. Analysis of the lipid-lowering effect of alirocumab/evolocumab showed a significant LDL-C decrease from 2,48±0,16 mmol/l to 1,07±0,11 mmol/l (by 56,8%), p<0,0001.

Conclusion. The use of PCSK9 targeted therapy (alirocumab or inclisiran or evolocumab) in patients with ASCVD in Moscow make it possible to achieve target LDL-C levels, which are indicated in clinical guidelines, by 3 months.

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