Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation

Namsik Chung, Hui Kyung Jeon, Li-Ming Lien, Wen Ter Lai, Hung Fat Tse, Wook Sung Chung, Tsong Hai Lee, Shih Ann Chen

Research output: Contribution to journalArticle

75 Citations (Scopus)

Abstract

Edoxaban is an oral, reversible, direct factor Xa inhibitor in phase III clinical development for the prevention of stroke in atrial fibrillation (AF). A phase II study was undertaken to evaluate the safety and efficacy of edoxaban in Asian patients with non-valvular AF with CHADS 2 score ≥1. In a multicentre, active-controlled, double-blind edoxaban and open-label warfarin, parallel-group study, a total of 235 patients from four Asian countries were randomly assigned to edoxaban 30 mg qd, 60 mg qd or warfarin dose adjusted to international normalised ratio of 2-3 for three months. The primary endpoint was the incidence of centrally adjudicated all bleeding events (major, clinically relevant non-major and minor). Secondary endpoints included thromboembolic events, biomarkers of thrombus formation and all adverse events (AEs). The incidence of all bleeding events (95% CI) was 20.3% (12.9, 30.4) for edoxaban 30 mg, 23.8% (15.8, 34.1) for edoxaban 60 mg, and 29.3% (20.2, 40.4) for warfarin. A subgroup analysis suggested low body weight (≤60 kg) may affect the incidence of bleeding events with edoxaban. The incidence of study drug-related AEs was 22% for edoxaban 30 mg, 29% for edoxaban 60 mg and 33% for warfarin. No thromboembolic events occurred in any treatment group. In conclusion, this phase II study found a trend for a reduction in the incidence of all bleeding events in Asian AF patients with edoxaban 30 mg and 60 mg compared with warfarin. Adverse events were similar between the edoxaban 60-mg and warfarin groups and were lower with the edoxaban 30-mg group.

Original languageEnglish
Pages (from-to)535-545
Number of pages11
JournalThrombosis and Haemostasis
Volume105
Issue number3
DOIs
Publication statusPublished - Mar 2011
Externally publishedYes

Fingerprint

Atrial Fibrillation
Safety
Warfarin
Hemorrhage
Incidence
edoxaban
Factor Xa Inhibitors
International Normalized Ratio
Drug-Related Side Effects and Adverse Reactions
Thrombosis
Cohort Studies
Biomarkers
Stroke
Body Weight

Keywords

  • Anticoagulant
  • Edoxaban
  • Factor Xa inhibitor
  • Non-valvular atrial fibrillation
  • Warfarin

ASJC Scopus subject areas

  • Hematology

Cite this

Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation. / Chung, Namsik; Jeon, Hui Kyung; Lien, Li-Ming; Lai, Wen Ter; Tse, Hung Fat; Chung, Wook Sung; Lee, Tsong Hai; Chen, Shih Ann.

In: Thrombosis and Haemostasis, Vol. 105, No. 3, 03.2011, p. 535-545.

Research output: Contribution to journalArticle

Chung, Namsik ; Jeon, Hui Kyung ; Lien, Li-Ming ; Lai, Wen Ter ; Tse, Hung Fat ; Chung, Wook Sung ; Lee, Tsong Hai ; Chen, Shih Ann. / Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation. In: Thrombosis and Haemostasis. 2011 ; Vol. 105, No. 3. pp. 535-545.
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abstract = "Edoxaban is an oral, reversible, direct factor Xa inhibitor in phase III clinical development for the prevention of stroke in atrial fibrillation (AF). A phase II study was undertaken to evaluate the safety and efficacy of edoxaban in Asian patients with non-valvular AF with CHADS 2 score ≥1. In a multicentre, active-controlled, double-blind edoxaban and open-label warfarin, parallel-group study, a total of 235 patients from four Asian countries were randomly assigned to edoxaban 30 mg qd, 60 mg qd or warfarin dose adjusted to international normalised ratio of 2-3 for three months. The primary endpoint was the incidence of centrally adjudicated all bleeding events (major, clinically relevant non-major and minor). Secondary endpoints included thromboembolic events, biomarkers of thrombus formation and all adverse events (AEs). The incidence of all bleeding events (95{\%} CI) was 20.3{\%} (12.9, 30.4) for edoxaban 30 mg, 23.8{\%} (15.8, 34.1) for edoxaban 60 mg, and 29.3{\%} (20.2, 40.4) for warfarin. A subgroup analysis suggested low body weight (≤60 kg) may affect the incidence of bleeding events with edoxaban. The incidence of study drug-related AEs was 22{\%} for edoxaban 30 mg, 29{\%} for edoxaban 60 mg and 33{\%} for warfarin. No thromboembolic events occurred in any treatment group. In conclusion, this phase II study found a trend for a reduction in the incidence of all bleeding events in Asian AF patients with edoxaban 30 mg and 60 mg compared with warfarin. Adverse events were similar between the edoxaban 60-mg and warfarin groups and were lower with the edoxaban 30-mg group.",
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