Intensification of lipid-lowering therapy in very high-risk patients: potential of combination with PCSK9 inhibitors
Aim. To assess the efficacy and safety of 6-month combined lipid-lowering therapy with a PCSK9 inhibitor in patients with very high cardiovascular risk (CVR).Material and methods. This prospective, open-label, single-center exploratory research study with active treatment included 5 outpatients with...
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«FIRMA «SILICEA» LLC
2022-07-01
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| Series: | Российский кардиологический журнал |
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| Online Access: | https://russjcardiol.elpub.ru/jour/article/view/5030 |
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| author | D. Yu. Sedykh V. V. Kashtalap O. N. Khryachkova T. S. Petrova O. L. Barbarash |
| author_facet | D. Yu. Sedykh V. V. Kashtalap O. N. Khryachkova T. S. Petrova O. L. Barbarash |
| author_sort | D. Yu. Sedykh |
| collection | DOAJ |
| description | Aim. To assess the efficacy and safety of 6-month combined lipid-lowering therapy with a PCSK9 inhibitor in patients with very high cardiovascular risk (CVR).Material and methods. This prospective, open-label, single-center exploratory research study with active treatment included 5 outpatients with very high CVR. So, 80% of patients had prior coronary artery disease, 20% peripheral arterial disease, and 60% old myocardial infarction. The key inclusion criterion was the failure to achieve the target low-density lipoprotein cholesterol (LDL-C) <1,4 mmol/l with high-intensity statin monotherapy at the maximal tolerated doses or combination therapy with ezetimibe. On a regular basis, all included patients took atorvastatin 40-80 mg/day or rosuvastatin 20-40 mg/day, or pitavastatin 2-4 mg/day. In addition, 2 patients received a statin in combination with ezetimibe 10 mg/day. Patients were followed up for 6 months as follows: every 2 weeks, with a lipid profile monitoring, subcutaneous injections of alirocumab at a dose of 150 mg/ml were performed. Additionally, clinical and laboratory indicators of the safety of therapy were evaluated.Results. After 6 months, with the combined lipid-lowering therapy with alirocumab, a decrease in median LDL-C from 4,3 (4,11-4,67) to 1,27 (1,06-1,47) (p=0,001) mmol/l, total cholesterol from 6,1 (6-7) to 3,7 (3,5-3,9) (p=0,018) mmol/l, atherogenic index from 3,2 (3-3,26) to 0,8% (0,8-1,5) (p=0,001). There was no significant decrease in median triglycerides and an increase in median high-density lipoprotein cholesterol. Six-month lipid-lowering therapy with a PCSK9 inhibitor had no adverse events and made it possible to achieve a maximum decrease in LDL-C by an average of 75,4% already by 4 months of treatment in actual clinical practice.Conclusion. Six-month combined lipid-lowering therapy with alirocumab 150 mg subcutaneously every 2 weeks in very high-risk patients allows the majority of patients to achieve target LDL-C values. |
| format | Article |
| id | doaj-art-20d327fc1e5a404bbeec2e4d0fe38c6e |
| institution | Kabale University |
| issn | 1560-4071 2618-7620 |
| language | Russian |
| publishDate | 2022-07-01 |
| publisher | «FIRMA «SILICEA» LLC |
| record_format | Article |
| series | Российский кардиологический журнал |
| spelling | doaj-art-20d327fc1e5a404bbeec2e4d0fe38c6e2025-08-20T03:57:22Zrus«FIRMA «SILICEA» LLCРоссийский кардиологический журнал1560-40712618-76202022-07-0127610.15829/1560-4071-2022-50303551Intensification of lipid-lowering therapy in very high-risk patients: potential of combination with PCSK9 inhibitorsD. Yu. Sedykh0V. V. Kashtalap1O. N. Khryachkova2T. S. Petrova3O. L. Barbarash4Research Institute for Complex Issues of Cardiovascular DiseasesResearch Institute for Complex Issues of Cardiovascular DiseasesResearch Institute for Complex Issues of Cardiovascular DiseasesResearch Institute for Complex Issues of Cardiovascular DiseasesResearch Institute for Complex Issues of Cardiovascular DiseasesAim. To assess the efficacy and safety of 6-month combined lipid-lowering therapy with a PCSK9 inhibitor in patients with very high cardiovascular risk (CVR).Material and methods. This prospective, open-label, single-center exploratory research study with active treatment included 5 outpatients with very high CVR. So, 80% of patients had prior coronary artery disease, 20% peripheral arterial disease, and 60% old myocardial infarction. The key inclusion criterion was the failure to achieve the target low-density lipoprotein cholesterol (LDL-C) <1,4 mmol/l with high-intensity statin monotherapy at the maximal tolerated doses or combination therapy with ezetimibe. On a regular basis, all included patients took atorvastatin 40-80 mg/day or rosuvastatin 20-40 mg/day, or pitavastatin 2-4 mg/day. In addition, 2 patients received a statin in combination with ezetimibe 10 mg/day. Patients were followed up for 6 months as follows: every 2 weeks, with a lipid profile monitoring, subcutaneous injections of alirocumab at a dose of 150 mg/ml were performed. Additionally, clinical and laboratory indicators of the safety of therapy were evaluated.Results. After 6 months, with the combined lipid-lowering therapy with alirocumab, a decrease in median LDL-C from 4,3 (4,11-4,67) to 1,27 (1,06-1,47) (p=0,001) mmol/l, total cholesterol from 6,1 (6-7) to 3,7 (3,5-3,9) (p=0,018) mmol/l, atherogenic index from 3,2 (3-3,26) to 0,8% (0,8-1,5) (p=0,001). There was no significant decrease in median triglycerides and an increase in median high-density lipoprotein cholesterol. Six-month lipid-lowering therapy with a PCSK9 inhibitor had no adverse events and made it possible to achieve a maximum decrease in LDL-C by an average of 75,4% already by 4 months of treatment in actual clinical practice.Conclusion. Six-month combined lipid-lowering therapy with alirocumab 150 mg subcutaneously every 2 weeks in very high-risk patients allows the majority of patients to achieve target LDL-C values.https://russjcardiol.elpub.ru/jour/article/view/5030dyslipidemiavery high cardiovascular riskcombination therapypcsk9 inhibitorsalirocumab |
| spellingShingle | D. Yu. Sedykh V. V. Kashtalap O. N. Khryachkova T. S. Petrova O. L. Barbarash Intensification of lipid-lowering therapy in very high-risk patients: potential of combination with PCSK9 inhibitors Российский кардиологический журнал dyslipidemia very high cardiovascular risk combination therapy pcsk9 inhibitors alirocumab |
| title | Intensification of lipid-lowering therapy in very high-risk patients: potential of combination with PCSK9 inhibitors |
| title_full | Intensification of lipid-lowering therapy in very high-risk patients: potential of combination with PCSK9 inhibitors |
| title_fullStr | Intensification of lipid-lowering therapy in very high-risk patients: potential of combination with PCSK9 inhibitors |
| title_full_unstemmed | Intensification of lipid-lowering therapy in very high-risk patients: potential of combination with PCSK9 inhibitors |
| title_short | Intensification of lipid-lowering therapy in very high-risk patients: potential of combination with PCSK9 inhibitors |
| title_sort | intensification of lipid lowering therapy in very high risk patients potential of combination with pcsk9 inhibitors |
| topic | dyslipidemia very high cardiovascular risk combination therapy pcsk9 inhibitors alirocumab |
| url | https://russjcardiol.elpub.ru/jour/article/view/5030 |
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