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.

Highlights

  • Ключевые слова: острый коронарный синдром с подъемом сегмента ST, антиагрегантная терапия, функциональная активность тромбоцитов, дженерик, оригинальный лекарственный препарат

  • In ST elevation acute coronary syndrome patients (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

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Summary

Conclusion

In STEACS patients the level of aggregation activity of platelets does significantly differ from the kind of antiplatelet treatment. Syvolap VV, et al описали статистически значимое снижение функциональной активности тромбоцитов (ФАТ) в течение 2-х недель с момента замены дженерика на оригинальный препарат клопидогрела у больных после интракоронарного стентирования, что также можно расценить как свидетельство не полной эквивалентности дженериков и оригинальных препаратов в особых клинических ситуациях [13]. Доказательная база клинической эквивалентности оригинальных антиагрегантов и их дженериков скудна, особенно при ОКС, что обусловливает необходимость дальнейшего изучения фармакодинамики брендированных и дженерических ААП в условиях реальной клинической практики у больных с острым коронарным синдром. Все указанное определило цель исследования: оценить динамику ФАТ на фоне антиагрегантной (антитромбоцитарной) терапии (ААТ) оригинальными (брендированными) и воспроизведёнными (дженериками) ААП у больных ОКС с подъемом сегмента ST (ОКСпST) в условиях реальной клинической практики.

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