Abstract
Background: This study aimed to evaluate the population pharmacokinetics of digoxin in Japanese patients and establish a dosage regimen based on the pharmacokinetic data. Methods: We analyzed 287 serum digoxin samples from 192 individuals by using the nonlinear mixed effects model. We used simulations to optimize the dosage regimen of digoxin to achieve a high likelihood of the target concentration (0.5-0.8 ng/mL). Results: The total body clearance (CL/F ([L/h]) was calculated using the following formula: CL/F=(1.21i¼0.0532 × CLcr [(mL/min]) × (1+0.787 × AMD), where CLcr is the creatinine clearance and AMD is 0 in the case of concomitant administration of amiodarone and 1 otherwise. To achieve the target concentration (0.5–0.8 ng/mL), the dosage of digoxin was 0.0625 mg/day (CLcr <35 mL/min and AMD=0); 0.125 mg/day (CLcr, 35–65 mL/min and AMD=0); 0.1875 mg/day (CLcr, 65–100 mL/min and AMD=0); 0.0625 mg/every other day (CLcr <30 mL/min and AMD=1); and 0.0625 mg/day (CLcr, 30–85 mL/min and AMD=1). Conclusion: Our findings suggest that population parameters are useful for evaluating digoxin pharmacokinetics.
Highlights
This study aimed to evaluate the population pharmacokinetics of digoxin in Japanese patients and establish a dosage regimen based on the pharmacokinetic data
Our findings suggest that population parameters are useful for evaluating digoxin pharmacokinetics
Population pharmacokinetic data indicate that clearance of digoxin is influenced by demographic variables such as age, total body weight, and serum creatinine levels [57]
Summary
This study aimed to evaluate the population pharmacokinetics of digoxin in Japanese patients and establish a dosage regimen based on the pharmacokinetic data. Population pharmacokinetic data indicate that clearance of digoxin is influenced by demographic variables such as age, total body weight, and serum creatinine levels [57]. Population pharmacokinetics has not been studied far to evaluate the influence of concomitant administration of drugs such as amiodarone, verapamil, and tolvaptan on relative digoxin clearance. The therapeutic range for digoxin in patients with heart failure with a normal sinus rhythm has been revised to a low and narrow range (0.5-0.8 ng/mL) based on the findings from the digitalis investigation group trial [8]. We aimed to analyze the population pharmacokinetics of digoxin in the presence of concomitant administration of other drugs. We determined initial dosing regimens to achieve concentrations (0.5-0.8 ng/mL) according to our population pharmacokinetic data
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