Bioequivalence of Areplex to Plavix in Patients with Coronary Artery Disease: A Comparative Clinical Study.
Abstract
Background. To evaluate the antiaggregation activity and clinical tolerability of Areplex (75 mg, ADAMED, Poland) compared to Plavix (75 mg, Sanofi-Winthrop Industrie, France) in CAD patients.
Materials and methods. A blinded, randomized, two-parallel-group study included 40 patients with stable angina (FC I-IV). Platelet aggregation was assessed using the AP 2110 analyzer (SOLAR) with ADP (5 µmol/L) and arachidonic acid (0.5 mg/mL) inducers after a 300 mg loading dose.
Results. At 24 hours post-dose, both groups showed significant reductions in aggregation degree and rate (p<0.05), with no intergroup differences (p>0.05). Safety profiles were comparable, with no adverse events reported.
Conclusion. Areplex demonstrated bioequivalence to Plavix, with good tolerability, supporting its use as an effective antiplatelet agent in CAD patients.
About the Authors
List of references
Akhmetova A.I., Kleymenova E.B., The use of pharmacogenetic testing for CYP2C19 to personalize the choice of antiplatelet agents in acute coronary syndrome in real clinical practice. Rational Pharmacotherapy in Cardiology 2017; https://cyberleninka.ru/article/n/ispolzovanie-farmakogeneticheskogo-testirovaniya- po-cyp2c19-dlya-personalizatsii-vybora-antiagregantov-pri-ostrom-koronarnom. in Russian: Ах- метова А.И., Клейменова Е.Б., Использование фармакогенетического тестирования по CYP2C19 для персонализации выбора антиагрегантов при остром коронарном синдроме в условиях реальной клинической практики. Рациональная Фармакотерапия в Кардиологии 2017; https://cyberleninka.ru/article/n/ispolzovanie-farmakogeneticheskogo-testirovaniya-po-cyp2c19- dlya-personalizatsii-vybora-antiagregantov-pri-ostrom-koronarnom.
Acute Coronary Syndrome Without ST-Segment Elevation: Russian Clinical Guidelines. 2024 https:
//scardio.ru/content/Guidelines/2020/Clinic_rekom_OKS_bST. in Russian: Острый коронарный синдром без подъема сегмента ST электрокардиограммы. Российские Клинические рекомендации. 2024 https://scardio.ru/content/Guidelines/2020/Clinic_rekom_OKS_bST.
Panchenko E.P. Mechanisms of development of acute coronary syndrome. RMJ. 2000;8:359. https:
//www.rmj.ru/articles/kardiologiya/Mehanizmy_razvitiya_ostrogo_koronarnogo_sindroma. in Russian: Панченко Е.П. Механизмы развития острого коронарного синдрома. РМЖ. 2000;8:359. https:
//www.rmj.ru/articles/kardiologiya/Mehanizmy_razvitiya_ostrogo_koronarnogo_sindroma.
Samorodskaya I.V., Klyuchnikov I.V., Shepel R.N., Kakorina E.P., Drapkina O.M. Regional variability of male and female mortality from three forms of ischemic heart disease (comparison of two periods 2017–2019 and 2020–2022). Cardiovascular Therapy and Prevention. 2024;23(4):3984. https://doi. org/10.15829/1728-8800-2024-3984. in Russian: Самородская И.В., Ключников И.В., Шепель Р.Н., Какорина Е.П., Драпкина О.М. Региональная вариабельность мужской и женской смертности от трех форм ишемической болезни сердца (сравнение двух периодов 2017-2019 и 2020-2022гг). Кардиоваскулярная терапия и профилактика. 2024;23(4):3984. https://doi.org/10.15829/1728-8800-2
024-3984.
Fateeva V.V., Vorobyeva O.V. Markers of endothelial dysfunction in chronic brain ischemia. Journal of Neurology and Psychiatry named after S.S. Korsakov. 2017;117(4):107-111. https://doi.org/10.171 16/jnevro201711741107-111. in Russian: Фатеева В.В., Воробьева О.В. Маркеры эндотелиальной дисфункции при хронической ишемии мозга. Журнал неврологии и психиатрии им. С.С. Корсакова. 2017;117(4):107-111 https://doi.org/10.17116/jnevro201711741107-111.
Caldeira D, Fernandes RM, Costa J, et al. Branded versus generic clopidogrel in cardiovascular diseases: a systematic review. J Cardiovasc Pharmacol. 2013;61(4):277-82. https://doi.org/10.1097/FJC.0b013e318 27e5c60.
Cameron A, Mantel-Teeuwisse AK, Leufkens HGM, Laing RO. Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved? Value Health. 2012;15(5):664-73. https://doi.org/10.1016/j.jval.2012.04.004.
World Health Organization (WHO). Generic drugs. Geneva: WHO, 2015.
Di Girolamo G, Czerniuk P, Bertuola R, Keller GA. Bioequivalence of two tablet formulations of clopidogrel in healthy Argentinian volunteers: a single-dose, randomized-sequence, open-label crossover study https://pubmed.ncbi.nlm.nih.gov/20171421.
Wang L, Di Y, Guo T, Ming JE, Kong F, Yin H, Zhang L, Xie F, Yang N, Ping C, Li Y, Hou J. Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study. Adv Ther. 2020 Jun;37(6):2696-2709. https://doi.org/10.1007/s12325-020-01369-z. Epub 2020 May 16. PMID: 32418143
Tong Pei , Jing Yang, Chaoying Hu, Xiaoping Chen, Shili Gong, Xiao Hu, Lin Li, Lan Zhang Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Fed and Fasted Conditions: An Open-Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers 2020 Oct;9(7):813-820. https://doi.org/10.1002/cpdd.804. Epub 2020 May 26.
Copyright (c) 2025 Guzal U.Mullabaeva, Umid T.Khairullaev
This work is licensed under a Creative Commons Attribution 4.0 International License.