Inclisiran Therapy and Lipid Profile Dynamics in Real-World Clinical Practice in Russia: Interim Results of an Observational Study

AIM: To evaluate the effect of inclisiran therapy on the blood lipid profile 90 days post-injection and to describe the baseline structural and ultrasound characteristics of carotid and femoral plaques in high- and very high-risk patients who failed to achieve low-density lipoprotein cholesterol goals despite ongoing lipid-lowering treatment. MATERIAL AND METHODS: This prospective observational single-center study included 22 patients (mean age 50.9±8.6 years, 50% men) with dyslipidemia and atherosclerotic plaques in peripheral arteries narrowing the lumen by 25-49%. Familial hypercholesterolemia was diagnosed in 59% of patients, and statin intolerance in 36%. Duplex scanning of the carotid and femoral arteries was performed. The gray-scale median (GSM) method is currently used for the quantitative assessment of carotid artery (CA) plaque echogenicity. Inclisiran was administered on day 1, day 90, and then every six months. Blood lipid profiles, including low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), triglycerides, and lipoprotein (a) [Lp(a)], were assessed. RESULTS: At baseline, median concentrations were 3.7 [2.5; 5.4] mmol/l for LDL-C, 5.4 [4.4; 6.8] mmol/l for TC, and 22.0 [5.0; 108.0] mg/dl for Lp(a). Carotid artery evaluation showed a median of 4.0 [2.0; 4.0] plaques, total stenosis of 110% [63.8; 118.8], and a GSM of 38.6 [28.6; 52.4], with a predominance of heterogeneous plaques (59%). Femoral artery assessment revealed a median of 2.0 [2.0; 3.0] plaques, 75% [42.5; 111.3] total stenosis, and a minimum echogenicity of 41.5 [33.4; 57.4] gray-scale units, with 65% heterogeneous plaques. Ninety days post-initiation of inclisiran, LDL-C was reduced by 65% (to 1.3 [1.2; 2.9] mmol/L, p