November 30, 2017The Journal of Clinical Pharmacology
Impaired Rivaroxaban Clearance in Mild Renal Insufficiency With Verapamil Coadministration: Potential Implications for Bleeding Risk and Dose Selection
Why the study?
Does verapamil coadministration alter the pharmacokinetics and antithrombotic effects of rivaroxaban in subjects with mild renal insufficiency?
Structured PICO
Does verapamil coadministration alter the pharmacokinetics and antithrombotic effects of rivaroxaban in subjects with mild renal insufficiency?
P
Population
Subjects with mild renal insufficiency (mean creatinine clearance 71 mL/min) and age-matched controls with normal renal function (mean creatinine clearance 105 mL/min). Overall mean age 59 years.
I
Intervention
Single 20-mg oral dose of rivaroxaban coadministered with verapamil
C
Comparator
Single 20-mg oral dose of rivaroxaban without verapamil in subjects with normal renal function
O
Outcome
Rivaroxaban area under the curve (AUC)surrogate
Coadministration of verapamil and rivaroxaban in patients with mild renal insufficiency significantly increases rivaroxaban exposure, potentially necessitating dose modification to avoid bleeding.
Authors
Discussion
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Implication
May warrant caution with coadministration; leaves open need for dose-adjustment trials in mild renal insufficiency.
Cite This Study
Greenblatt et al. (2017) studied this question.