Effectiveness of inclisiran lipid-lowering therapy in patients with atherosclerotic cardiovascular disease in Moscow healthcare

Abstract

Aim. To evaluate the effectiveness of PCSK9-targeted therapy (inclisiran, alirocumab, and evolocumab) in patients with atherosclerotic cardiovascular disease (ASCVD) and who did not achieve the target low-density lipoprotein cholesterol (LDL-C) level on basic therapy (statins in maximum tolerated doses and/or ezetimibe).Material and methods. This observational study included 50 patients receiving the inclisiran and 30 patients of the control group with ASCVD treated with PCSK9 inhibitors (alirocumab, n=1; evolocumab, n=29). In all participants, we assessed medical history data and initially performed electrocardiography, echocardiography, Doppler ultrasound of extracranial and lower limb arteries, and laboratory tests (complete blood count, biochemical and lipid profile). Three Moscow public health facilities took part in the study.Results. Data on achievement of primary and secondary endpoints by the 12th month are presented. The study groups were comparable in basic clinical characteristics. In inclisiran group, a significant decrease in LDL-C level was found from 2,53±0,7 mmol/l initially to 1,29±0,5 mmol/l (by 49%), p=0,0002; the target LDL-C <1,4 mmol/l was achieved by 73,9% of the subjects. Alirocumab/ evolocumab showed significant lipid-lowering effect with a LDL-C decrease from 2,4±0,9 mmol/l to 1,32±0,7 mmol/l (by 45%), p<0,0001.Conclusion. The final results are consistent with the intermediate data and indicate not only the possibility of early achievement of target LDL-C levels in PCSK9targeted combination therapy, but their maintenance with a favorable tolerability and safety profile.