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Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study

https://doi.org/10.47093/2218-7332.2020.11.4.15-22

Abstract

Aim. Evaluation of efficacy and safety of alirocumab in patients with atherogenic dyslipidemia in real clinical practice.

Materials and methods. Patients with atherogenic dyslipidemia and failure to achieve target lipid levels were included in a prospective, non-comparative study. For the final analysis, the data of 92 patients were studied: 61 men and 31 women; average age 59.8 ± 9.6 years. Alirokumab (Praluent, Sanofi) was administered at a dose of 150 mg subcutaneously once every 2 weeks for 3 months. The primary endpoint was the achievement of the target level of low-density lipoprotein cholesterol (LDL-C). Additionally, the level of lipoprotein(a) (LP(a)) and high-density lipoprotein cholesterol (HDL-C) was assessed. To assess safety, liver tests, creatinine levels and glycemia were examined; side effects have been studied. To test statistical hypotheses, a paired t-test and Wilcoxon’s test were used.

Results. After 3 months therapy, there was a statistically significant decrease in LDL-C: 1.45 [0.99; 2.14] vs 3.00 mmol / l [2.17; 3.81] initially (p < 0.0001); the median of the decline was –47% [–25; –65]; the target level of LDL-C was achieved in 40 (43%) patients. An increase in HDL-C was noted after 3 months treatment, their level was 1.36 ± 0.41 mmol / L vs 1.31 ± 0.38 mmol / L at baseline (p < 0.01). The concentration of LP(a) was re-measured in 21 patients with a baseline level > 30 mg / dL: a statistically significant decrease was achieved after 3 months: 67 mg / dL [46; 155] vs 85 mg / dL [58; 187] initially (p < 0.001). Indicators of liver function tests, creatinine and fasting glycemia did not change significantly. Side effects and undesirable effects were not recorded.

Conclusion. In real clinical practice, after 3 months treatment with alirokumab there was a significant decrease in the level of LDL-C, target levels were achieved in 43% of patients, there was a significant decrease in the level of LP(a) and an increase in HDL-C.

About the Authors

A. O. Bueverov
M.F. Vladimirsky Moscow Regional Research and Clinical Institute; Joint stock company “Group of companies “United medical systems”
Russian Federation

Alexey O. Bueverov, Dr. of Sci. (Medicine), Professor, Leading Researcher of the Hepatology Department; Deputy Chairman of the Board

61/2, bld 1, Shchepkina str., Moscow, 129110

Bolshaya Akademicheskaya str., 39, Moscow, 125008

+7 (916) 678-43-94



P. O. Bogomolov
M.F. Vladimirsky Moscow Regional Research and Clinical Institute; Joint stock company “Group of companies “United medical systems”
Russian Federation

Pavel O. Bogomolov, Cand. of Sci. (Medicine), Scientific Head of the Department of Hepatology; Chairman of the Board

61/2, bld 1, Shchepkina str., Moscow, 129110

Bolshaya Akademicheskaya str., 39, Moscow, 125008



A. A. Kucherov
Joint stock company “Group of companies “United medical systems”
Russian Federation

Alexey A. Kucherov, Head of the Cardiology Department of the Clinic 

Bolshaya Akademicheskaya str., 39, Moscow, 125008



V. E. Syutkin
N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Health Department
Russian Federation

Vladimir E. Syutkin, Dr. of Sci. (Medicine), leading researcher in the liver transplantation department

Bolshaya Sukharevskaya sq., 3, Moscow, 129090



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ISSN 2218-7332 (Print)
ISSN 2658-3348 (Online)