Do Apixaban Plasma Levels Relate to Bleeding? The Clinical Outcomes and Predictive Factors for Bleeding in Patients with Non-Valvular Atrial Fibrillation

Apixaban can significantly prevent stroke events in patients with non-valvular atrial fibrillation (NVAF), as can be observed from the large, randomized, controlled trial conducted in the present study. However, the real-world evidence of bleeding events related to the apixaban plasma levels in Asia...

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Main Authors: Sutee Limcharoen, Manat Pongchaidecha, Piyarat Pimsi, Sarawuth Limprasert, Juthathip Suphanklang, Weerayuth Saelim, Wichai Santimaleeworagun, Pornwalai Boonmuang
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Language:English
Published: MDPI AG 2022-08-01
Series:Biomedicines
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Online Access:https://www.mdpi.com/2227-9059/10/8/2001
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author Sutee Limcharoen
Manat Pongchaidecha
Piyarat Pimsi
Sarawuth Limprasert
Juthathip Suphanklang
Weerayuth Saelim
Wichai Santimaleeworagun
Pornwalai Boonmuang
author_facet Sutee Limcharoen
Manat Pongchaidecha
Piyarat Pimsi
Sarawuth Limprasert
Juthathip Suphanklang
Weerayuth Saelim
Wichai Santimaleeworagun
Pornwalai Boonmuang
author_sort Sutee Limcharoen
collection DOAJ
description Apixaban can significantly prevent stroke events in patients with non-valvular atrial fibrillation (NVAF), as can be observed from the large, randomized, controlled trial conducted in the present study. However, the real-world evidence of bleeding events related to the apixaban plasma levels in Asian populations is limited. This study aimed to investigate the apixaban plasma levels and clinical outcomes among NVAF patients receiving apixaban, including determining the risk factors associated with bleeding during routine care. Seventy-one patients were included in the study. The median values were 112.79 (5–95th percentiles: 68.69–207.8) μg/L and 185.62 (5–95th percentiles: 124.06–384.34) μg/L for the apixaban trough (C<sub>trough</sub>) and apixaban peak plasma levels (C<sub>peak</sub>), respectively. Stroke and bleeding were found in 8 (11.27%) and 14 patients (19.72%), respectively. There was no statistical significance for C<sub>trough</sub> and C<sub>peak</sub> in the stroke and non-stroke groups, respectively. The median of C<sub>trough</sub> (139.15 μg/L) in patients with bleeding was higher than that in the non-bleeding group (108.14 μg/L), but there was no statistical significance. However, multivariate analyses showed that bleeding history (odds ratio (OR): 17.62; 95% confidence interval (CI): 3.54–176.64; and <i>p</i>-value = 0.002) and C<sub>trough</sub> (OR: 1.01; 95%: CI 1.00–1.03; and <i>p</i>-value = 0.038) were related to bleeding events. Almost all of the patients presented apixaban plasma levels within the expected range. Interestingly, bleeding events were associated with the troughs of the apixaban plasma levels and bleeding history.
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spelling doaj.art-ad45d7b22c794c48972d7da49a4df0302023-12-01T23:28:29ZengMDPI AGBiomedicines2227-90592022-08-01108200110.3390/biomedicines10082001Do Apixaban Plasma Levels Relate to Bleeding? The Clinical Outcomes and Predictive Factors for Bleeding in Patients with Non-Valvular Atrial FibrillationSutee Limcharoen0Manat Pongchaidecha1Piyarat Pimsi2Sarawuth Limprasert3Juthathip Suphanklang4Weerayuth Saelim5Wichai Santimaleeworagun6Pornwalai Boonmuang7Department of Pharmacy, Vajira Hospital, Bangkok 10300, ThailandDepartment of Pharmaceutical Care, Silpakorn University, Nakhon Pathom 73000, ThailandDepartment of Pharmaceutical Care, Silpakorn University, Nakhon Pathom 73000, ThailandDivision of Cardiology, Department of Medicine, Phramongkutklao Hospital, Bangkok 10400, ThailandDepartment of Pharmaceutical Care, Silpakorn University, Nakhon Pathom 73000, ThailandDepartment of Pharmaceutical Care, Silpakorn University, Nakhon Pathom 73000, ThailandDepartment of Pharmaceutical Care, Silpakorn University, Nakhon Pathom 73000, ThailandDepartment of Pharmaceutical Care, Silpakorn University, Nakhon Pathom 73000, ThailandApixaban can significantly prevent stroke events in patients with non-valvular atrial fibrillation (NVAF), as can be observed from the large, randomized, controlled trial conducted in the present study. However, the real-world evidence of bleeding events related to the apixaban plasma levels in Asian populations is limited. This study aimed to investigate the apixaban plasma levels and clinical outcomes among NVAF patients receiving apixaban, including determining the risk factors associated with bleeding during routine care. Seventy-one patients were included in the study. The median values were 112.79 (5–95th percentiles: 68.69–207.8) μg/L and 185.62 (5–95th percentiles: 124.06–384.34) μg/L for the apixaban trough (C<sub>trough</sub>) and apixaban peak plasma levels (C<sub>peak</sub>), respectively. Stroke and bleeding were found in 8 (11.27%) and 14 patients (19.72%), respectively. There was no statistical significance for C<sub>trough</sub> and C<sub>peak</sub> in the stroke and non-stroke groups, respectively. The median of C<sub>trough</sub> (139.15 μg/L) in patients with bleeding was higher than that in the non-bleeding group (108.14 μg/L), but there was no statistical significance. However, multivariate analyses showed that bleeding history (odds ratio (OR): 17.62; 95% confidence interval (CI): 3.54–176.64; and <i>p</i>-value = 0.002) and C<sub>trough</sub> (OR: 1.01; 95%: CI 1.00–1.03; and <i>p</i>-value = 0.038) were related to bleeding events. Almost all of the patients presented apixaban plasma levels within the expected range. Interestingly, bleeding events were associated with the troughs of the apixaban plasma levels and bleeding history.https://www.mdpi.com/2227-9059/10/8/2001non-valvular atrial fibrillationnon-vitamin-K antagonist oral anticoagulantsbleedingthromboembolic
spellingShingle Sutee Limcharoen
Manat Pongchaidecha
Piyarat Pimsi
Sarawuth Limprasert
Juthathip Suphanklang
Weerayuth Saelim
Wichai Santimaleeworagun
Pornwalai Boonmuang
Do Apixaban Plasma Levels Relate to Bleeding? The Clinical Outcomes and Predictive Factors for Bleeding in Patients with Non-Valvular Atrial Fibrillation
Biomedicines
non-valvular atrial fibrillation
non-vitamin-K antagonist oral anticoagulants
bleeding
thromboembolic
title Do Apixaban Plasma Levels Relate to Bleeding? The Clinical Outcomes and Predictive Factors for Bleeding in Patients with Non-Valvular Atrial Fibrillation
title_full Do Apixaban Plasma Levels Relate to Bleeding? The Clinical Outcomes and Predictive Factors for Bleeding in Patients with Non-Valvular Atrial Fibrillation
title_fullStr Do Apixaban Plasma Levels Relate to Bleeding? The Clinical Outcomes and Predictive Factors for Bleeding in Patients with Non-Valvular Atrial Fibrillation
title_full_unstemmed Do Apixaban Plasma Levels Relate to Bleeding? The Clinical Outcomes and Predictive Factors for Bleeding in Patients with Non-Valvular Atrial Fibrillation
title_short Do Apixaban Plasma Levels Relate to Bleeding? The Clinical Outcomes and Predictive Factors for Bleeding in Patients with Non-Valvular Atrial Fibrillation
title_sort do apixaban plasma levels relate to bleeding the clinical outcomes and predictive factors for bleeding in patients with non valvular atrial fibrillation
topic non-valvular atrial fibrillation
non-vitamin-K antagonist oral anticoagulants
bleeding
thromboembolic
url https://www.mdpi.com/2227-9059/10/8/2001
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