Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study
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 analy...
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| Format: | Article |
| Language: | Russian |
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Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
2021-04-01
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| Series: | Сеченовский вестник |
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| Online Access: | https://www.sechenovmedj.com/jour/article/view/297 |
| _version_ | 1797873624614436864 |
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| author | A. O. Bueverov P. O. Bogomolov A. A. Kucherov V. E. Syutkin |
| author_facet | A. O. Bueverov P. O. Bogomolov A. A. Kucherov V. E. Syutkin |
| author_sort | A. O. Bueverov |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-10T01:19:12Z |
| format | Article |
| id | doaj.art-10ec8549dc694eed872a0400b34e4451 |
| institution | Directory Open Access Journal |
| issn | 2218-7332 2658-3348 |
| language | Russian |
| last_indexed | 2024-04-10T01:19:12Z |
| publishDate | 2021-04-01 |
| publisher | Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) |
| record_format | Article |
| series | Сеченовский вестник |
| spelling | doaj.art-10ec8549dc694eed872a0400b34e44512023-03-13T09:51:34ZrusFederal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)Сеченовский вестник2218-73322658-33482021-04-01114152210.47093/2218-7332.2020.11.4.15-22161Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective studyA. O. Bueverov0P. O. Bogomolov1A. A. Kucherov2V. E. Syutkin3M.F. Vladimirsky Moscow Regional Research and Clinical Institute; Joint stock company “Group of companies “United medical systems”M.F. Vladimirsky Moscow Regional Research and Clinical Institute; Joint stock company “Group of companies “United medical systems”Joint stock company “Group of companies “United medical systems”N.V. Sklifosovsky Research Institute for Emergency Medicine of the Moscow Health DepartmentAim. 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.https://www.sechenovmedj.com/jour/article/view/297atherogenic dyslipidemiatreatmentalirocumablipoprotein (a)liver transplantation |
| spellingShingle | A. O. Bueverov P. O. Bogomolov A. A. Kucherov V. E. Syutkin Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study Сеченовский вестник atherogenic dyslipidemia treatment alirocumab lipoprotein (a) liver transplantation |
| title | Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study |
| title_full | Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study |
| title_fullStr | Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study |
| title_full_unstemmed | Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study |
| title_short | Alirokumab in the practice of a multidisciplinary outpatient hospital: results of an open, noncomparative prospective study |
| title_sort | alirokumab in the practice of a multidisciplinary outpatient hospital results of an open noncomparative prospective study |
| topic | atherogenic dyslipidemia treatment alirocumab lipoprotein (a) liver transplantation |
| url | https://www.sechenovmedj.com/jour/article/view/297 |
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