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Clinical Pharmacology: Advances and Applications

Clinical Articles, News & Views

Apixaban unaffected by patient ethnicity

Apixaban was safe and well-tolerated in healthy Chinese subjects, with pharmacokinetics (PK), and pharmacodynamics (PD) predictable and consistent with findings from previous studies in Asian and non-Asian subjects, according to a study1 published recently in Clinical Pharmacology: Advances and Applications.

18 subjects 18–45 years of age were randomly assigned (2:1 ratio) to receive apixaban or matched placebo. Subjects received a single 10 mg dose of apixaban or placebo on day 1, followed by 10 mg apixaban or placebo twice daily for 6 days (days 4–9). The PK and PD of apixaban were assessed by collecting plasma samples for 72 hours following the dose on day 1 and the morning dose on day 9, and measuring apixaban concentration and anti-Xa activity. The authors assessed safety via physical examinations, vital sign measurements, electrocardiograms, and clinical laboratory evaluations.

PK analysis showed similar characteristics of apixaban after single and multiple doses, including a median time to maximum concentration of ~3 hours, mean elimination half-life of ~11 hours, and renal clearance of ~1.2 L/hour.

The accumulation index was 1.7, consistent with twice-daily dosing and the observed elimination half-life. Single-dose data predict multiple-dose PK, therefore apixaban PK are time-independent, the authors concluded. The relationship between anti-Xa activity and plasma apixaban concentrations appears to be linear, they found, with apixaban proving safe and well tolerated. No bleeding-related adverse events were reported.

The administration of apixaban does not require any dose modification based on race, the authors concluded.

References

1. Cui Y, Song Y, Wang J, Yu Z, Schuster A, Barrett YC, Frost C. Single- and multiple-dose pharmacokinetics, pharmacodynamics, and safety of apixaban in healthy Chinese subjects. Clin Pharmacol Adv Appl 2013;5:177–84. http://dx.doi.org/10.2147/CPAA.S51981

Published on: December 20, 2013

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