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Population Pharmacokinetics of Apixaban in Subjects with Non-valvular Atrial Fibrillation.

著者 Cirincione B , Kowalski K , Nielsen J , Roy A , Thanneer N , Byon W , Boyd R , Wang X , Leil T , LaCreta F , Ueno T , Oishi M , Frost C この記事をPubMed上で見るPubMedで表示
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This analysis describes the population pharmacokinetics (PPK) of apixaban in non-valvular atrial fibrillation (NVAF) subjects, and quantifies the impact of intrinsic and extrinsic factors on exposure. The PPK model was developed using data from Phase 1-3 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 CYP3A4/P-gp inhibitors. Individual covariate effects generally resulted in <25% change in apixaban exposure versus the reference NVAF subject (non-Asian, male, aged 65 years, weighing 70 kg without concomitant CYP3A4/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- and 5-mg groups. The impact of Asian race on apixaban exposure was <15% and not considered clinically significant. This article is protected by copyright. All rights reserved.
PMID: 30259707 [PubMed - as supplied by publisher]
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