Comparative clinical effectiveness of generic and original apixaban in anticoagulant therapy for patients with arterial hypertension and permanent atrial fibrillation
Abstract
Background. The purpose of this study was to compare the tolerability, safety, and clinical efficacy of generic and original apixaban in patients with arterial hypertension (AH) and permanent non-valvular atrial fibrillation (AF).
Materials and methods. This prospective study included 50 patients with hypertension stages 1-3 and permanent non-valvular atrial fibrillation. The patients were divided into two groups: Group 1 (n=25) received generic apixaban, and Group 2 (n=25) received the original apixaban. Both groups were administered 10 mg of apixaban daily, in combination with standard antihypertensive therapy. Clinical and laboratory evaluations were performed before and after one month of treatment, including measurements of blood pressure, echocardiography, biochemical blood tests, and coagulogram.
Results. A significant reduction in systolic and diastolic blood pressure was observed in both groups. No significant changes were detected in echocardiographic parameters. Biochemical tests revealed a decrease in creatinine and uric acid levels, and an increase in the prothrombin ratio, indicating a positive anticoagulant effect.
Conclusion. Both generic and original apixaban showed similar safety and clinical efficacy in patients with arterial hypertension and permanent atrial fibrillation, demonstrating significant reductions in blood pressure and positive anticoagulant effects.
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List of references
Alexandrovich G.V. and Konstantinova I.E., Cardiovascular morbidity: One of the most important problems of healthcare, Meditsina i organizatsiya zdravookhraneniya, 2019, 1, 04, 56–63, In Russian: Александрович Г.В., Константинова И.Е. (2019). Сердечно-сосудистая заболеваемость - одна из важнейших проблем здравоохранения. Медицина и организация здравоохранения, 1(4), 56–63.
Alexin A.A., Postoperative atrial fibrillation in thoracic surgery, Vestnik anesteziologii i reanimatologii, 2014, 2, 71–78, In Russian: Алексин А.А. (2014). Послеоперационная фибрилляция предсердий в торакальной хирургии. Вестник анестезиологии и реаниматологии, 2, 71–78.
Benjamin E.J., Independent risk factors for atrial fibrillation in a population-based cohort: The Framingham Heart Study, JAMA, 1994, 271, 011, 840–844, In Russian: Benjamin E.J., и др. (1994). Независимые факторы риска фибрилляции предсердий в популяционном когортном исследовании: Исследование сердца Фрэмингема. JAMA, 271(11), 840–844., 10.1001/jama.1994.03510350040036.
Connolly S.J., Apixaban in patients with atrial fibrillation, The New England Journal of Medicine, 2011, 364, 09, 806–817, In Russian: Connolly S.J., и др. (2011). Апиксабан у пациентов с фибрилляцией предсердий. The New England Journal of Medicine, 364(9), 806–817., 10.1056/NEJMoa1007432.
Ezekowitz M.D., Atrial fibrillation: Outpatient presentation and management, Circulation, 2011, 124, 01, 95–99, In Russian: Ezekowitz M.D., и др. (2011). Фибрилляция предсердий: Амбулаторное представление и управление. Circulation, 124(1), 95–99., 10.1161/CIRCULATIONAHA.110.956839.
ESC Cardiovascular Realities 2022, 2022, Flipsnack, https://www.flipsnack.com/escardio/esc- cardiovascular-realities-2022/full-view.html, Accessed: 2025-01-04.
Granger C.B., Apixaban versus warfarin in patients with atrial fibrillation, The New England Journal of Medicine, 2011, 365, 011, 981–992, In Russian: Granger C. B., и др. (2011). Апиксабан против варфарина у пациентов с фибрилляцией предсердий. The New England Journal of Medicine, 365(11), 981–992., 10.1056/NEJMoa1107039.
Kannel W.B., Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: Population-based estimates, The American Journal of Cardiology, 1998, 82, 08A, 2N–9N, In Russian: Kannel W.B., и др. (1998). Распространенность, заболеваемость, прогноз и предрасположенные состояния для фибрилляции предсердий: Оценки на основе популяции. The American Journal of Cardiology, 82(8A), 2N–9N., 10.1016/S0002-9149(98)00583-9.
Novikova T.N., Stroke prevention in patients with atrial fibrillation in real clinical practice, emphasis on efficacy and safety of anticoagulant therapy, Kardiologiia, 2020, 60, 04, 54–61, In Russian: Novikova T.N., и др. (2020). Профилактика инсульта у пациентов с фибрилляцией предсердий в реальной клинической практике, акцент на эффективность и безопасность антикоагулянтной терапии. Кардиология, 60(4), 54–61., 10.18087/cardio.2020.4.n1116.
P.K., 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS, European Heart Journal, 2016, 38, 037, In Russian: P.K., и др. (2016). Руководство ESC по лечению фибрилляции предсердий, разработанное в сотрудничестве с EACTS. European Heart Journal, 38(37)., 10.1093/eurheartj/ehw210.
Schoonderwoerd B.A., New risk factors for atrial fibrillation: Causes of “not-so-lone atrial fibrillation”, Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology, 2008, 10, 06, 668–673, In Russian: Schoonderwoerd B.A., и др. (2008). Новые факторы риска для фибрилляции предсердий: Причины «не столь одиночной фибрилляции предсердий». Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology, 10(6), 668–673., 10.1093/europace/eun132.
Risk factors and prescribed antithrombotic therapy in patients with newly diagnosed nonvalvular atrial fibrillation in Russian population: Data from the GARFIELD-AF Registry, 2024, https://www.researchgate.net/publication/318849486_Risk_factors_and_prescribed_antithrombotic_ therapy_in_patients_with_newly_diagnosed_nonvalvular_atrial_fibrillation_in_Russian_population_ Data_from_the_GARFIELD-AF_Registry.
Prevention of stroke in patients with atrial fibrillation: The role of modern anticoagulants [Electronic resource] 2013, https://www.mediasphera.ru/issues/zhurnal-nevrologii-i-psikhiatrii-im-s-s-korsakova- 2/2013/9/031997-72982013931, In Russian: Профилактика инсульта у пациентов с фибрилляцией предсердий: Роль современных антикоагулянтов [Электронный ресурс]. Получено с указанного URL.
Upstream therapies to prevent atrial fibrillation, European Heart Journal Supplements, 2008, https:
//academic.oup.com/eurheartjsupp/article/10/suppl_H/H11/500743?login=false, In Russian: Upstream therapies to prevent atrial fibrillation | European Heart Journal Supplements | Oxford Academic [Элек- тронный ресурс]. Получено с указанного URL.
2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS), European Heart Journal, 2020, 10.1093/eurheartj/ehaa612, In collaboration with the European Association of Cardio-Thoracic Surgery (EACTS).
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