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January 1, 2013Drug Metabolism and Pharmacokinetics

Pharmacokinetic and pharmacodynamic modeling of 597 Japanese patients with non-valvular atrial fibrillation confirmed that the rivaroxaban dose selected for the phase III study was appropriate.

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Why the study?

Is the model-based dose selection of rivaroxaban appropriate for Japanese patients with non-valvular atrial fibrillation?

Population

597 Japanese patients with non-valvular atrial fibrillation (NVAF) from the J-ROCKET AF phase III study

Design

Other

Key result

Pharmacokinetic and pharmacodynamic modeling of 597 Japanese patients with non-valvular atrial fibrillation confirmed that the rivaroxaban dose selected for the phase III study was appropriate.

Authors

MKMasato KanekoTTTakahiko TanigawaKHKensei Hashizume

Discussion

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Overview

Supports rivaroxaban dose selection for Japanese NVAF patients; confirms consistency with global phase III data.

Key Points

  • To confirm the appropriateness of simulation-based rivaroxaban dose selection in Japanese patients with non-valvular atrial fibrillation using Phase III trial data.
  • Rebuilt and optimized an oral one-compartment mixed-effects PK/PD model using NONMEM on data from 597 subjects in the Japanese Phase III J-ROCKET AF study.
  • Quantified inter-individual and inter-occasion variability and evaluated covariates to derive empirical Bayes estimates of AUC and Cmax.
  • Empirical Bayes estimates of AUC and Cmax matched simulated exposure results previously generated from Japanese Phase II study data.
  • Individual estimated drug exposures showed no clear relationship with safety-related events and aligned with exposure levels observed in global Phase III trials.

Structured PICO

Is the model-based dose selection of rivaroxaban appropriate for Japanese patients with non-valvular atrial fibrillation?

P
Population
597 Japanese patients with non-valvular atrial fibrillation (NVAF) from the J-ROCKET AF phase III study
I
Intervention
Rivaroxaban (evaluation of dose selection using pharmacokinetic/pharmacodynamic modeling)
O
Outcome
Pharmacokinetic and pharmacodynamic parameters (AUC and Cmax) to confirm appropriateness of dose settingsurrogate

Pharmacokinetic/pharmacodynamic modeling confirmed that the rivaroxaban dose selected for Japanese NVAF patients in the J-ROCKET AF trial was appropriate and consistent with global phase III data.

Cite This Study

Kaneko et al. (2013) studied Non-valvular atrial fibrillation (NVAF) (n=597). Rivaroxaban was evaluated on Pharmacokinetic and pharmacodynamic parameters (AUC and Cmax) and relationship to safety-related events. Pharmacokinetic and pharmacodynamic modeling of 597 Japanese patients with non-valvular atrial fibrillation confirmed that the rivaroxaban dose selected for the phase III study was appropriate.

synapsesocial.com/papers/6a0cfa1fb31ab1d6e01e7373https://doi.org/10.2133/dmpk.dmpk-12-rg-109
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Also Consider

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

  1. 1Model-based Dose Selection for Phase III Rivaroxaban Study in Japanese Patients with Non-valvular Atrial Fibrillation2012 · 108 citations
  2. 2Rationale and design of a prospective study evaluating population pharmacokinetics and pharmacodynamics of rivaroxaban in Chinese patients with non-valvular atrial fibrillation2022 · 4 citations
  3. 3Development and Clinical Application of a Real-World Population Pharmacokinetic Model of Rivaroxaban in Asian Patients with Atrial Fibrillation2026
  4. 4Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non‐valvular atrial fibrillation: Results from ROCKET AF2014 · 109 citations
  5. 5Population Pharmacokinetics and Dose Optimization Based on Renal Function of Rivaroxaban in Thai Patients with Non-Valvular Atrial Fibrillation2022 · 11 citations