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August 20, 2019Journal of Thrombosis and ThrombolysisOpen Access

Outcomes associated with under-dosing of rivaroxaban for management of non-valvular atrial fibrillation in real-world Japanese clinical settings

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Why the study?

NVAF patients with creatinine clearance ≥ 50 mL/min often receive less than the recommended rivaroxaban dose due to bleeding concerns, but the effect of under-dosing on safety and effectiveness remains unclear.

Does under-dosing rivaroxaban (10 mg vs 15 mg) increase thromboembolic events or reduce bleeding in Japanese patients with NVAF and CrCl ≥ 50 mL/min?

Population

6521 NVAF patients with creatinine clearance ≥ 50 mL/min who completed 1-year follow-up in Japan

Comparison

Rivaroxaban 10 mg od (under-dose) vs 15 mg od (recommended dose)

Design

Sub-analysis of a prospective single-arm observational study

Follow-up

1-year

Authors

TITakanori IkedaSOSatoshi OgawaTKTakanari Kitazono

Discussion

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Member takes

Overview

Under-dosing may raise ischemic risk despite fewer bleeds; leaves open optimal real-world dosing strategies in Japanese NVAF.

Structured PICO

Does under-dosing rivaroxaban (10 mg vs 15 mg) increase thromboembolic events or reduce bleeding in Japanese patients with NVAF and CrCl ≥ 50 mL/min?

P
Population
6,521 Japanese patients with non-valvular atrial fibrillation (NVAF) and creatinine clearance ≥ 50 mL/min who completed a 1-year follow-up in the XAPASS observational study.
I
Intervention
Rivaroxaban 10 mg once daily (under-dose)
C
Comparator
Rivaroxaban 15 mg once daily (recommended dose)
O
Outcome
Any bleeding and a composite of stroke/non-central nervous system systemic embolism (non-CNS SE)/myocardial infarction (MI)composite

Under-dosing rivaroxaban in Japanese NVAF patients with CrCl ≥ 50 mL/min increases thromboembolic risk without significantly reducing major bleeding, supporting adherence to recommended dosing.

Cite This Study

Ikeda et al. (2019) studied this question.

synapsesocial.com/papers/6a7bfd3d24f98b6d3fc2a8fdhttps://doi.org/10.1007/s11239-019-01934-6
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Outcomes associated with non-recommended dosing of rivaroxaban: results from the XANTUS study2018 · 33 citations
  2. 2The EXPAND study: Efficacy and safety of rivaroxaban in Japanese patients with non-valvular atrial fibrillation2018 · 48 citations
  3. 3Optimal Rivaroxaban Dose in Asian Patients With Atrial Fibrillation and Normal or Mildly Impaired Renal Function2019 · 49 citations
  4. 4Non–Vitamin K Antagonist Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Renal Dysfunction2017 · 472 citations
  5. 5Design and baseline characteristics of the Xarelto Post‐Authorization Safety &amp; Effectiveness Study in Japanese Patients with Atrial Fibrillation (<scp>XAPASS</scp>)2018 · 16 citations