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Plasma concentrations of dabigatran, an active principle of prodrug dabigatran etexilate ( DABE ), are increased by renal impairment ( RI ) or coadministration of a P‐glycoprotein inhibitor. Because the combined effects of drug–drug interactions and  RI  have not been evaluated by means of clinical studies, the decision of  DABE  dosing for  RI  patients receiving P‐glycoprotein inhibitors is empirical at its best. We conducted virtual  drug–drug interactions  studies between  DABE  and the P‐glycoprotein inhibitor verapamil in  RI  populations using physiologically based pharmacokinetic modeling. The developed  physiologically based pharmacokinetic  model for  DABE  and  dabigatran  was used to predict trough  dabigatran  concentrations in the presence and absence of verapamil in virtual  RI  populations. The population‐based  physiologically based pharmacokinetic  model provided the most appropriate dosing regimen of  DABE  for likely clinical scenarios, such as drug–drug interactions in this  RI  population based on available knowledge of the systems changes and in the absence of actual clinical studies.

cpt: pharmacometrics and systems pharmacology

Assessing Potential Drug–Drug Interactions Between Dabigatran Etexilate and a P‐Glycoprotein Inhibitor in Renal Impairment Populations Using Physiologically Based Pharmacokinetic Modeling