Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan.
School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
Clin Pharmacol Ther. 2020 Jan;107(1):278-286. doi: 10.1002/cpt.1601. Epub 2019 Sep 14.
This study aims to measure the plasma levels of rivaroxaban and apixaban among Asian patients with atrial fibrillation and compare the results with expected drug levels from clinical studies. A total of 73 patients taking rivaroxaban and 105 patients taking apixaban were enrolled. Peak and trough levels were measured using ultra-high performance liquid chromatography with tandem mass spectrometry. The percentage of those with drug levels within the expected range reported in clinical studies was significantly higher in the apixaban group than in the rivaroxaban group, both for trough (84.8% vs. 64.4%; P = 0.002) and peak levels (76.9% vs. 33.8%; P < 0.001). After adjusting for age, sex, kidney function, appropriate dose, and adherence, patients taking rivaroxaban were still less likely to have peak and trough levels within the expected drug levels. Our real-world data suggests that Asian patients taking rivaroxaban are more likely to have out-of-expected drug levels than those taking apixaban.
本研究旨在测量亚洲房颤患者的利伐沙班和阿哌沙班的血浆水平，并将结果与临床研究中的预期药物水平进行比较。共纳入 73 例服用利伐沙班和 105 例服用阿哌沙班的患者。使用超高效液相色谱-串联质谱法测量达峰和谷浓度。与利伐沙班组相比，阿哌沙班组谷浓度（84.8%比 64.4%；P=0.002）和达峰浓度（76.9%比 33.8%；P<0.001）在预期范围内的患者比例显著更高，且这些数据均来自临床研究。在校正年龄、性别、肾功能、合适剂量和依从性后，服用利伐沙班的患者仍更可能出现超出预期药物水平的达峰和谷浓度。我们的真实世界数据表明，与服用阿哌沙班的患者相比，亚洲服用利伐沙班的患者更可能出现药物水平超出预期。
