3.1 Effect of non-adherence on PK/PD of edoxaban
According to the PK/PD simulation, the effect of non-adherence was dependent on the delay time, as the risk of patients outside the on-therapy range increased with increasing delay time. Under the same non-adherent scenario, the percentage of patients out of range based on iFXa was slightly lower than the percentage of patients out of ranged based on edoxaban concentration (Figure 3).
For example, based on edoxaban concentration, 16.3% and 39.1% of patients with normal renal function who took 60 mg of edoxaban daily were out of range when delayed for 12 and 24 h, respectively. Similar results were observed in patients with impaired renal function taking 30 mg of edoxaban daily (15.3% and 36.9% when delayed for 12 and 24 h, respectively). Moreover, based on iFXa activity, 8.7% and 24.1% of patients with normal renal function were out-of-range when delayed for 12 and 24 h, respectively, and 7.8% and 24.1% of patients with impaired renal function were out of range when delayed for 12 and 24 h .