Limcharoen Sutee, Pongchaidecha Manat, Pimsi Piyarat, Limprasert Sarawuth, Suphanklang Juthathip, Saelim Weerayuth, Santimaleeworagun Wichai, Boonmuang Pornwalai
Department of Pharmacy, Vajira Hospital, Bangkok 10300, Thailand.
The College of Pharmacotherapy of Thailand, Nonthaburi 11000, Thailand.
Biomedicines. 2022 Aug 18;10(8):2001. doi: 10.3390/biomedicines10082001.
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) and apixaban peak plasma levels (C), respectively. Stroke and bleeding were found in 8 (11.27%) and 14 patients (19.72%), respectively. There was no statistical significance for C and C in the stroke and non-stroke groups, respectively. The median of C (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 -value = 0.002) and C (OR: 1.01; 95%: CI 1.00-1.03; and -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.
从本研究开展的大型随机对照试验可以看出，阿哌沙班能够显著预防非瓣膜性心房颤动（NVAF）患者的中风事件。然而，亚洲人群中与阿哌沙班血浆水平相关的出血事件的真实世界证据有限。本研究旨在调查接受阿哌沙班治疗的NVAF患者的阿哌沙班血浆水平及临床结局，包括确定常规护理期间与出血相关的危险因素。该研究纳入了71名患者。阿哌沙班谷浓度（C）和阿哌沙班血浆峰浓度（C）的中位数分别为112.79（第5-95百分位数：68.69-207.8）μg/L和185.62（第5-95百分位数：124.06-384.34）μg/L。分别有8名（11.27%）和14名患者（19.72%）发生了中风和出血。C和C在中风组和非中风组中分别无统计学意义。出血患者的C中位数（139.15μg/L）高于非出血组（108.14μg/L），但无统计学意义。然而，多因素分析显示出血史（比值比（OR）：17.62；95%置信区间（CI）：3.54-176.64；P值=0.002）和C（OR：1.01；95%：CI 1.00-1.03；P值=0.038）与出血事件相关。几乎所有患者的阿哌沙班血浆水平都在预期范围内。有趣的是，出血事件与阿哌沙班血浆水平的谷浓度及出血史有关。
