Population analysis for the optimization of digoxin treatment in Japanese paediatric patients

Background and objectives: Information about the pharmacokinetics of digoxi n in paediatric patients is limited. We therefore aimed to investigate the effects of physiological factors on the digoxin clearance in Japanese paedi atric patients. Method: We used routinely collected therapeutic drug monitoring data (n = 5 44), derived from the steady-state serum concentrations of digoxin in 181 h ospitalized paediatric patients. Results: Of those physiological factors which have been examined in this st udy, age and total body weight were most closely correlated with digoxin cl earance. Data on neonates within the first postnatal month indicated a tend ency towards lower clearance for premature neonates than full-term neonates (P < 0.01). Digoxin clearance was reduced by spironolactone in patients yo unger than 4 months (P < 0.05). Patients with congestive heart failure show ed a lower digoxin clearance than the others (P < 0.001). Serum creatinine and gender did not have a statistically significant effect on digoxin clear ance. Conclusion: Age and total body weight are important factors influencing dig oxin clearance in children. Spironolactone affected digoxin clearance and n eeds to be considered when dosing paediatric subjects.