Population Pharmacokinetics of Apixaban in Subjects With Nonvalvular Atrial Fibrillation

Population Pharmacokinetics of Apixaban in Subjects With Nonvalvular Atrial Fibrillation

This analysis describes the population pharmacokinetics (PPK) of apixaban in nonvalvular atrial fibrillation (NVAF) subjects, and quantifies the impact of intrinsic and extrinsic factors on exposure. The PPK model was developed using data from phase I–III studies. Apixaban exposure was characterized...

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Veröffentlicht in:CPT: pharmacometrics and systems pharmacology 2018-11, Vol.7 (11), p.728-738
Hauptverfasser: Cirincione, Brenda, Kowalski, Kenneth, Nielsen, Jace, Roy, Amit, Thanneer, Neelima, Byon, Wonkyung, Boyd, Rebecca, Wang, Xiaoli, Leil, Tarek, LaCreta, Frank, Ueno, Takayo, Oishi, Masayo, Frost, Charles
Format: Artikel
Sprache:eng
Schlagworte:
Age
Cardiac arrhythmia
Clinical trials
Embolisms
Employees
Pharmacokinetics
Studies
Thrombosis
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Zusammenfassung:This analysis describes the population pharmacokinetics (PPK) of apixaban in nonvalvular atrial fibrillation (NVAF) subjects, and quantifies the impact of intrinsic and extrinsic factors on exposure. The PPK model was developed using data from phase I–III studies. Apixaban exposure was characterized by a two‐compartment PPK model with first‐order absorption and elimination. Predictive covariates on apparent clearance included age, sex, Asian race, renal function, and concomitant strong/moderate cytochrome P450 (CYP)3A4/P‐glycoprotein (P‐gp) inhibitors. Individual covariate effects generally resulted in
ISSN:2163-8306
2163-8306
DOI:10.1002/psp4.12347