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• W2892665712 abstract "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 < 25% change in apixaban exposure vs. the reference NVAF subject (non‐Asian, male, aged 65 years, weighing 70 kg without concomitant CYP 3A4/P‐gp inhibitors), except for severe renal impairment, which resulted in 55% higher exposure than the reference subject. The dose‐reduction algorithm resulted in a ~27% lower median exposure, with a large overlap between the 2.5‐mg and 5‐mg groups. The impact of Asian race on apixaban exposure was < 15% and not considered clinically significant." @default.
• W2892665712 created "2018-10-05" @default.
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• W2892665712 date "2018-09-30" @default.
• W2892665712 modified "2023-10-05" @default.
• W2892665712 title "Population Pharmacokinetics of Apixaban in Subjects With Nonvalvular Atrial Fibrillation" @default.
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• W2892665712 doi "https://doi.org/10.1002/psp4.12347" @default.
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