Aim. To evaluate the effect of PCSK9-targeted therapy on lipoprotein(a) (Lp(a)) levels in patients with atherosclerotic cardiovascular diseases who have not achieved the target low-density lipoprotein cholesterol (LDL-C) level (statins at maximum tolerated doses and/or ezetimibe).Material and methods. The study involved 3 Moscow medical facilities of the state healthcare system. The study included 50 people who received inclisiran therapy, 30 people — PCSK9 inhibitors (alirocumab, n=1; evolocumab, n=29). This analysis presents the results of Lp(a) level changes over 12-month inclisiran therapy. Lp(a) was determined by turbidimetry. Elevated Lp(a) level was defined as ≥50 mg/dL (125 nmol/L).Results. Normal Lp(a) levels were determined in 16 subjects (34,8%), moderate — in 9 subjects (19,6%), high — in 21 subjects (45,7%), and extremely high (>180 mg/dL) — in 8 subjects (17,4%). Inclisiran therapy was associated with a significant (p<0,001) decrease in both LDL-C and Lp(a) levels by 52% and 54,7%, respectively. During therapy, normal Lp(a) levels remained within baseline values. In almost half of the cases with moderate Lp(a) values, its concentration decreased to normal values, and in cases with elevated Lp(a), its level decreased in 9 out of 10 patients. The proportion of patients in the group with Lp(a) levels <30 mg/dl increased from 35% to 41%. No patient had extreme values by the end of the study.Conclusion. Lp(a) assessment may be appropriate with ongoing PSCK9-targeted therapy. Diagnosis of hyper-Lp(a) is important for early intensive combination lipid-lowering therapy and modification of risk factors in order to reduce the risk of cardiovascular diseases.
Aim. To assess the rate of adverse cardiovascular events (a combination of non-fatal myocardial infarction (MI), non-fatal stroke, cardiovascular death) within 12 months after MI in patients who were followed up in outpatient clinics in Moscow after the hospital discharge, as well as its association with antiplatelet therapy.Material and methods. This observational multicenter, open-label, prospective study that consecutively included patients after MI and came for further treatment and observation to the clinic after the hospital discharge, subject to providing informed consent. Data were obtained at four scheduled visits (an inclusion visit and 3 follow-up visits — 3, 6 and 12 months after the event). An analysis was carried out in the context of various antiplatelet therapy.Results. The study included 1576 patients in 27 Moscow clinics (mean age, 62,2±11,1 years; men — 69%; ST-segment elevation MI — 57,7%, non-ST elevation MI — 42,3%). At the time of study inclusion, 47,2% of patients received dual antiplatelet therapy with clopidogrel, 4,2% — prasugrel, 48,6% — ticagrelor, with a mean duration of 11,2 months. Incidence of adverse cardiovascular events over 12-month follow-up rate was low and amounted to 3,4% (cumulative incidence, 0,038). This indicator was significantly lower in the subgroup of patients who underwent percutaneous coronary intervention compared with patients who received conservative therapy for MI (p=0,0002).Conclusion. The study demonstrated a low incidence of adverse cardiovascular events over 12 months in patients followed up in outpatient clinics in Moscow after an MI, while percutaneous coronary intervention for MI was associated with a lower incidence of adverse cardiovascular events compared with conservative therapy.
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 12 th 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.
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.