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Effect of Exenatide on the Steady-State Pharmacokinetics of Digoxin

From the Lilly-NUS Centre for Clinical Pharmacology, Singapore (Dr Soon, Mr Chan, Ms Yeo, Ms Lim, Dr Wise); Eli Lilly and Company Limited, Lilly Research Centre, Windlesham, Surrey, United Kingdom (Dr Linnebjerg); and Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana (Dr Kothare, Dr Park, Dr Mace).

This open-label study investigated the effect of exenatide coadministration on the steady-state plasma pharmacokinetics of digoxin. A total of 21 healthy male subjects received digoxin (day 1, 0.5 mg twice daily; days 2-12, 0.25 mg once daily) and exenatide (days 8-12, 10 µg twice daily). Digoxin plasma and urine concentrations were measured on days 7 and 12. Exenatide coadministration did not change the overall 24-hour steady-state digoxin exposure (AUC_,ss) and C_min,ss but caused a 17% decrease in mean plasma digoxin C_max,ss (1.40 to 1.16 ng/mL) and an increase in digoxin t_max,ss (median increase, 2.5 hours). Although the decrease in digoxin C_max,ss was statistically significant, peak concentrations were within the therapeutic concentration range in all subjects. Digoxin urinary pharmacokinetic parameters were not altered. Gastrointestinal symptoms, the most common adverse effects of exenatide, decreased over time. Exenatide administration does not cause any changes in digoxin steady-state pharmacokinetics that would be expected to have clinical sequelae; thus, dosage adjustment does not appear warranted, based on pharmacokinetic considerations.

Key Words: Exenatide • digoxin • gastric emptying • interaction • pharmacokinetics

Address for reprints: Prajakti A. Kothare, PhD, Global PK/PD and Trial Simulations, Eli Lilly and Company, Indianapolis, IN 46285.

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