Background

Chromogenic anti-factor Xa activity (AXA) assay is used to measure the pharmacodynamics of factor Xa inhibitors, including edoxaban. Although AXA concentrations in patients with non-valvular atrial fibrillation using edoxaban have been reported, the impact of renal function on AXA concentrations with edoxaban use in patients with non-valvular atrial fibrillation has not been fully assessed.

Methods

Trough and peak AXA concentrations were measured in 93 patients with non-valvular atrial fibrillation taking edoxaban (73.6 ± 11.2 years, 48 were male). The patients were divided into three groups: patients with moderate renal dysfunction (creatinine clearance 15–49 mL/min), mild renal dysfunction (creatinine clearance 50–95 mL/min), and normal renal function (creatinine clearance > 95 mL/min). Both trough and peak AXA concentrations were assessed among the groups according to the edoxaban dose (30 or 60 mg).

Results

At a 30-mg dose, patients with moderate renal dysfunction showed significantly higher trough AXA concentrations than patients with mild renal dysfunction or normal renal function. At a 60-mg dose, patients with mild renal dysfunction showed significantly higher trough AXA concentrations than patients with normal renal function. Peak AXA concentrations were not significantly different between the groups. Creatinine clearance was significantly and negatively correlated with trough AXA concentrations at a 60-mg dose, whereas the correlation of creatinine clearance with AXA concentrations was borderline significant at a 30-mg dose. No correlation was found between creatinine clearance and peak AXA concentrations at either dose.

Conclusions

Creatinine clearance tends to be negatively correlated with trough AXA concentrations in patients with non-valvular atrial fibrillation taking edoxaban, while renal function is not correlated with peak AXA concentrations.

中文翻译：

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非瓣膜性心房颤动患者使用依度沙班后肾功能对抗因子 Xa 活性浓度的影响

背景

显色抗因子 Xa 活性 (AXA) 测定用于测量因子 Xa 抑制剂（包括依度沙班）的药效学。尽管已经报道了使用艾多沙班的非瓣膜性心房颤动患者的 AXA 浓度，但肾功能对非瓣膜性心房颤动患者使用艾多沙班的 AXA 浓度的影响尚未得到充分评估。

方法

测量了 93 名服用依多沙班的非瓣膜性心房颤动患者的 AXA 谷值和峰值浓度（73.6 ± 11.2 岁，48 名男性）。患者分为三组：中度肾功能不全（肌酐清除率 15-49 mL/min）、轻度肾功能不全（肌酐清除率 50-95 mL/min）和肾功能正常（肌酐清除率 > 95 mL/min） ). 根据艾多沙班剂量（30 或 60 毫克）评估各组的 AXA 谷浓度和峰浓度。

结果

在 30 mg 剂量下，中度肾功能不全患者的 AXA 谷浓度明显高于轻度肾功能不全或肾功能正常患者。在 60 mg 剂量下，轻度肾功能不全患者的 AXA 谷浓度明显高于肾功能正常患者。各组之间的 AXA 峰值浓度没有显着差异。在 60 mg 剂量下，肌酐清除率与 AXA 谷浓度显着负相关，而在 30 mg 剂量下，肌酐清除率与 AXA 浓度的相关性接近显着。在任一剂量下，肌酐清除率与 AXA 峰值浓度之间均未发现相关性。

结论

在服用依度沙班的非瓣膜性心房颤动患者中，肌酐清除率往往与 AXA 谷浓度呈负相关，而肾功能与 AXA 峰值浓度无关。