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Related Experiment Videos

Ximelagatran--recent comparisons with warfarin.

Sheila A Doggrell1

  • 1Health Practice Division, Auckland University of Technology, Akoranga Campus, Northcote, Auckland, New Zealand. s.doggrell@xtra.co.nz

Expert Opinion on Pharmacotherapy
|September 8, 2005
PubMed
Summary

Ximelagatran demonstrated noninferiority to warfarin for stroke prevention and venous thromboembolism treatment. However, significantly higher rates of elevated liver enzymes (alanine aminotransferase) with ximelagatran raise hepatic safety concerns.

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Area of Science:

  • Cardiology
  • Pharmacology
  • Hepatology

Background:

  • Atrial fibrillation and venous thromboembolism (VTE) necessitate effective anticoagulant therapies.
  • Warfarin is a standard oral anticoagulant, but requires regular monitoring.
  • Novel oral anticoagulants aim to improve safety and efficacy profiles.

Purpose of the Study:

  • To compare the efficacy and safety of ximelagatran versus warfarin for stroke prevention in non-valvular atrial fibrillation (SPORTIF V trial).
  • To evaluate ximelagatran compared to enoxaparin/warfarin for the treatment of deep vein thrombosis (THRIVE trial).

Main Methods:

  • SPORTIF V: Randomized trial comparing ximelagatran and warfarin in atrial fibrillation patients.
  • THRIVE: Randomized trial comparing ximelagatran with enoxaparin/warfarin in VTE patients.

Related Experiment Videos

  • Primary endpoints assessed stroke/systemic embolism (SPORTIF V) and recurrent VTE (THRIVE).
  • Secondary analysis focused on major bleeding and liver enzyme elevations (alanine aminotransferase).

    • Main Results:

    • In SPORTIF V, stroke/systemic embolism rates were similar between ximelagatran and warfarin groups.
    • In THRIVE, recurrent VTE rates were comparable between ximelagatran and enoxaparin/warfarin groups.
    • Major bleeding rates did not differ significantly between treatment arms in either trial.
    • Elevated alanine aminotransferase levels (>3x ULN) were significantly higher with ximelagatran (6% in SPORTIF V, 9.6% in THRIVE) compared to controls (0.8% and 2.0%, respectively).

    Conclusions:

    • Ximelagatran is non-inferior to warfarin for stroke prevention in atrial fibrillation and for VTE treatment.
    • Despite comparable efficacy and bleeding risk, ximelagatran is associated with a higher incidence of liver enzyme elevations.
    • Hepatic safety remains a significant concern for ximelagatran use in these indications.