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
.