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US Label – Apixaban Effects on
Body Weight
Executive Summary
Body
Weight–Related
Definitions
Effects of Body Weight on Pharmacokinetics
Healthy Volunteers
Study design
Pharmacokinetics
Apixaban conc. vs. time
and vs. antiXa activity
NVAF
VTE
US Label – Apixaban Effects on Body Weight
Dosing Recommendations
Guidance Recommendations
2021 ISTH SCC Guidance
Expert Consensus Panel
Baseline Weight
in Pivotal studies
Studies by Indication
NVAF
NVAF study overview
Apixaban Randomized Controlled Clinical Trial Data
ARISTOTLE Weight Subgroup Analysis (post hoc) Hohnloser et al.
ARISTOTLE BMI Analysis (post hoc) Sandhu et al.
Real-World Data
ARISTOPHANES 2020
Objective
Study design
Results
Deitelzweig VA and Medicare 2022
Briasoulis 2021
O'Kane 2022
Kushnir 2019
VTE
VTE study overview
Apixaban Randomized Clinical Trial Data
AMPLIFY
AMPLIFY Post hoc Analysis
AMP-EXT
Real-World Data
Cohen 2021 (BMI ≥ 30 kg/m2)
Perino 2021 (BMI ≥ 40 kg/m2 or ≥ 120 kg)
Crouch 2022 (BMI ≥ 40 kg/m2 or ≥ 120 kg)
Kushnir 2019 (BMI ≥ 40 kg/m2)
Hip/Knee Replacement
ADVANCE-1
ADVANCE-2
ADVANCE-3
ADVANCE-2 and ADVANCE-3 weight and BMI Subgroup Analysis.
Appendix
Limitations/Disclaimers
References
CRE, carbapenem-resistant Enterobacterales; ESBL, extended-spectrum β-lactamase; KPC, Klebsiella pneumoniae carbapenemases; OXA, oxacillinase
CRE, carbapenem-resistant Enterobacterales; ESBL, extended-spectrum β-lactamase; KPC, Klebsiella pneumoniae carbapenemases; OXA, oxacillinase
