ANTIPLATELET TREATMENT IN ST ELEVATION ACUTE CORONARY SYNDROME UNDER REAL CLINICAL CIRCUMSTANCES: THE DYNAMICS OF THROMBOCYTE FUNCTION
https://doi.org/10.15829/1560-4071-2017-1-82-88
Abstract
Aim. To evaluate the dynamics of thrombocyte functional activity (TFA) under antiplatelet treatment conditions which include the branded, and generic compounds as well, in ST elevation acute coronary syndrome patients (STEACS) in routine clinical practice.
Material and methods. The open-label prospective study was done, including STEACS patients stratified according to the kind of antiplatelet in-patient treatment (original and/or generics). As an endpoint, we used the surrogate — functional activity of thrombocytes (TFA), measured by impedance and luminescent aggregatometry at 1 and 7 day from STEACS onset.
Results. By the inclusion, baseline point all patients were comparable by TFA. On double antiplatelet therapy (DAT) by the 7th day of STEACS there was statistically significant difference of all ADP-induced thrombocyte aggregation. There was difference in ADP-induced platelet aggregation depending on the DAT variant, which included the original drug and generic.
Conclusion. In STEACS patients the level of aggregation activity of platelets does significantly differ from the kind of antiplatelet treatment. Usage of the branded and generic compounds of the came antiplatelet agent by the same regimen does differ by different grade and dynamics of platelets activeness suppression.
About the Authors
L. I. MalinovaRussian Federation
Saratov
N. V. Furman
Russian Federation
Saratov
P. V. Dolotovskaya
Russian Federation
Saratov
N. F. Puchinian
Russian Federation
Saratov
I. Yu. Radaeva
Russian Federation
Saratov
References
1. Roffi M, Patrono C, Collet J-P, et al. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2015; 36 (44): 3075-128.
2. Steg PG, James SK, Atar D, et al. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J 2012; 33(20): 2569-619.
3. Belousov YuB. Generics — myths and realities. Remedium 2003; 7-8: 4-10. Russian (Белоусов Ю.Б. Дженерики — мифы и реалии. Ремедиум Журнал о российском рынке лекарств и медицинской технике 2003; 7-8: 4-10).
4. Martsevich SY, Tolpygina SN. Original drugs and their generics: a problem of choice. Arterial hypertension 2009; 15(2): 209-13. Russian (Марцевич С.Ю., Толпыгина С.Н. Оригинальные лекарственные препараты и их копии: Проблема выбора. Артериальная гипертензия 2009; 15(2): 209-13).
5. Guseva GN, Pavlova TV, Voronova IL, et al. Dual antiplatelet therapy in the real clinical practice. Rational Pharmacotherapy in Cardiology. 2014; 10(5): 500-4. Russian (Гусева Г.Н., Павлова Т.В., Воронова И.Л. и др. Двойная антитромбоцитарная терапия в реальной клинической практике Рациональная фармакотерапия в кардиологии 2014; 10(5): 500-4).
6. Maksimov ML. Original Drugs vs Generic Drugs in Everyday Practice. Lechebnoe delo (General medicine). 2012; 1: 10-5. Russian (Максимов М.Л. Выбор между оригиналом и генериком в повседневной практике. Лечебное дело 2012; 1: 10-5).
7. Khoseva EN, Morozova TE. Economic strengths and weaknesses of generics in the system of medical provision of population in Russia and abroad. Good clinical practice 2013; 2: 63-6. Russian (Хосева Е.Н., Морозова Т.Е. Экономические преимущества и слабые стороны генериков в системе лекарственного обеспечения населения в России и за рубежом. Качественная клиническая практика 2013; 2: 63-6).
8. Manzoli L, Flacco ME, Boccia S, et al. Generic versus brand-name drugs used in cardiovascular diseases. Eur J Epidemiol 2015; Nov 30 (online before print).
9. Martsevich SYu, Kutishenko NP, Ginzburg ML, et al. The KARDIOKANON study: a way to settle the subject of clinical equivalence of generic and original drugs. Rational Pharmacotherapy in Cardiology 2012; 8(2): 179-84. Russian (Марцевич С., Кутишенко Н.П., Гинзбург М.Л. и др. Исследование КАРДИОКАНОН: Способ решения вопроса о клинической эквивалентности оригинальных и воспроизведенных препаратов. Рациональная фармакотерапия в кардиологии 2012; 8(2): 179-84).
10. Marcucci R, Paniccia R, Gori AM, et al. Bioequivalence in the real world is a complex challenge: the case of clopidogrel. J Am Coll Cardiol 2013; 61(5): 594-5.
11. Tsoumani ME, Ntalas IV, Goudevenos JA, et al. Evaluating the bioequivalence of clopidogrel generic formulations. Curr Med Res Opin 2015; 31(5): 861-4
12. Kovacic JC, Mehran R, Sweeny J, et al. Clustering of acute and subacute stent thrombosis related to the introduction of generic clopidogrel. J Cardiovasc Pharmacol Ther 2014; 19(2): 201-8.
13. Syvolap VV, Franskavichene LV, Golukhova EZ, et al. Switching from generic to brand clopidogrel in male patients after ST-elevated myocardial infarction. Cardiology 2014; 129(2): 103-5.
14. Gomez Y, Adams E, Hoogmartens J. Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand. J Pharm Biomed Anal 2004; 34(2): 341-8.
15. Seo KW, Tahk SJ, Yang HM, et al. Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate. Clin Ther. 2014; 1; 36(11): 1588-94.
16. Tsoumani ME, Kalantzi KI, Dimitriou AA, et al. Antiplatelet efficacy of long-term treatment with clopidogrel besylate in patients with a history of acute coronary syndrome: comparison with clopidogrel hydrogen sulfate. Angiology 2012 Oct; 63(7): 547-51.
17. Tsoumani ME, Kalantzi KI, Dimitriou AA, et al. Effect of clopidogrel besylate on platelet reactivity in patients with acute coronary syndromes. Comparison with clopidogrel hydrogen sulfate. Expert Opin Pharmacother 2012; 13(2): 149-58.
18. Sabouret P, Rushton-Smith SK, Kerneis M, et al. Dual antiplatelet therapy: optimal timing, management, and duration. European Heart Journal — Cardiovascular Pharmacotherapy. 2015; 1(3): 198-2049.
19. Bolduyeva SA, Oblavatskii DV, Samokhvalova MV. Development of myocardial infarction after making changes in double antiagregant therapy. Clinical observation. Emergency Cardiology 2014; 4: 16-20. Russian (Болдуева С.А, Облавацкий Д.В., Самохвалова М.В. Развитие инфаркта миокарда после изменения характера двойной антиагрегантной терапии. Клиническое наблюдение. Неотложная кардиология 2014; 4: 16-20).
20. Dankovtseva EN, Zateyshchikov DA. The modern aspects of clopidogrel use. Rational Pharmacotherapy in Cardiology 2010; 6(2): 185-91. Russian (Данковцева Е. Н., Затейщиков Д.А. Современные аспекты применения клопидогрела. Рациональная фармакотерапия в кардиологии 2010; 6(2): 185-91).
21. Poponina TM, Poponina YuS, Kapilevitch NA, et al. Modern approaches of trombotic complications prevention in patients with acute coronary syndrome without ST elevation. Cardiovascular diseases 2009; 4: 4-16. Russian (Попонина Т.М., Попонина Ю.С., Капилевич Н.А. и др. Современные подходы к профилактике тромботичеcких осложнений у больных острым коронарным синдромом без подъема ST. Болезни сердца и сосудов 2009; 4: 4-16).
Supplementary files
![]() |
1. Сканированная первая страница рукописи | |
Subject | ||
Type | Исследовательские инструменты | |
Download
(2MB)
|
Indexing metadata ▾ |
![]() |
2. Сопроводительное письмо | |
Subject | ||
Type | Other | |
Download
(3MB)
|
Indexing metadata ▾ |
![]() |
3. Этические нормы | |
Subject | ||
Type | Other | |
Download
(12KB)
|
Indexing metadata ▾ |
![]() |
4. Рисунок 1 | |
Subject | ||
Type | Результаты исследования | |
Download
(13KB)
|
Indexing metadata ▾ |
![]() |
5. Рисунок 2 | |
Subject | ||
Type | Анализ данных | |
Download
(14KB)
|
Indexing metadata ▾ |
![]() |
6. Рисунок 3 | |
Subject | ||
Type | Анализ данных | |
Download
(14KB)
|
Indexing metadata ▾ |
![]() |
7. Рисунок 4 | |
Subject | ||
Type | Анализ данных | |
Download
(15KB)
|
Indexing metadata ▾ |
![]() |
8. Конфликт интересов | |
Subject | ||
Type | Other | |
Download
(12KB)
|
Indexing metadata ▾ |
![]() |
9. Участие авторов в создании статьи | |
Subject | ||
Type | Other | |
Download
(12KB)
|
Indexing metadata ▾ |
![]() |
10. Текст статьи слепое рецендирование | |
Subject | Удаление торговых названий препаратов из текста | |
Type | Материалы исследования | |
Download
(195KB)
|
Indexing metadata ▾ |
![]() |
11. Рисунок 1 | |
Subject | ||
Type | Анализ данных | |
Download
(13KB)
|
Indexing metadata ▾ |
![]() |
12. Рисунок 2 | |
Subject | ||
Type | Анализ данных | |
Download
(14KB)
|
Indexing metadata ▾ |
![]() |
13. Рисунок 3 | |
Subject | ||
Type | Сравнительный анализ динамики AUC агрегатограммы пациентов с различными схемами антиагрегатной терапии | |
Download
(14KB)
|
Indexing metadata ▾ |
![]() |
14. Рисунок 4 | |
Subject | ||
Type | Анализ данных | |
Download
(15KB)
|
Indexing metadata ▾ |
![]() |
15. текст статьи слепое рецензирование правки после рецензии | |
Subject | ||
Type | текст статьи | |
Download
(196KB)
|
Indexing metadata ▾ |
Review
For citations:
Malinova L.I., Furman N.V., Dolotovskaya P.V., Puchinian N.F., Radaeva I.Yu. ANTIPLATELET TREATMENT IN ST ELEVATION ACUTE CORONARY SYNDROME UNDER REAL CLINICAL CIRCUMSTANCES: THE DYNAMICS OF THROMBOCYTE FUNCTION. Russian Journal of Cardiology. 2017;(1):82-88. (In Russ.) https://doi.org/10.15829/1560-4071-2017-1-82-88