Key result
Rivaroxaban 15 and 20 mg yield similar anti-Xa peaks but 15 mg overshoots in moderate renal impairment.
Why the study?
Rivaroxaban dosing in Asian patients with NVAF is complex due to high interindividual variability and bleeding risk, requiring exploration of influencing factors and biomarker-bleeding relationships.
What are the pharmacokinetics and pharmacodynamics of standard- or low-dose rivaroxaban in Chinese patients with NVAF, and how do they correlate with bleeding events?
Population
304 healthy volunteers and 223 patients with NVAF
Comparison
Standard- or low-dose rivaroxaban regimens
Design
Pharmacometric PK/PD modeling study
Follow-up
1 year
Authors
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May warrant anti-Xa monitoring for 15 mg rivaroxaban in Chinese NVAF patients with moderate renal impairment; leaves open optimal dosing pending randomized trials.
Observational (n=527)
Yes
What are the pharmacokinetics and pharmacodynamics of standard- or low-dose rivaroxaban in Chinese patients with NVAF, and how do they correlate with bleeding events?
Fixed doses of rivaroxaban can be prescribed for Chinese patients with NVAF without adjustment for bodyweight, BMI, and total cholesterol, though low-dose regimens warrant further randomized evaluation.
Zhao et al. (2022) conducted an observational in Nonvalvular Atrial Fibrillation (n=527). Rivaroxaban was evaluated on Incidence of clinically relevant bleeding (BARC 2, 3a, 3b, 3c, and 5) within 1 year. In Chinese patients with nonvalvular atrial fibrillation, peak anti-Xa values for 20 mg and 15 mg rivaroxaban were similar and within expected ranges, but 15 mg exceeded expected ranges in those with moderate renal impairment.
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