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April 02, 2003, AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran) continues to show evidence of its potential as a future alternative to warfarin as an oral anticoagulant in a variety of high profile clinical scenarios. SPORTIF III data presented at the American College of Cardiology 52nd Annual Scientific Session more definitively establishes stroke prevention for patients with atrial fibrillation as a likely future clinical indication for the agent. EXULT (EXanta Used to Lessen Thrombosis) had earlier established Exanta’s potential as a warfarin alternative in the prevention of venous thromboembolism in patients undergoing total knee replacement. Exanta has consistently generated high-powered data supporting approval as an improvement to Bristol Myers Squibb’s (NYSE: BMY) Coumadin and other effective but clinically cumbersome warfarin formulations.
SPORTIF III is an open-label, randomized, non-inferiority trial of Exanta or warfarin in subjects with atrial fibrillation. 1,704 study subjects received fixed-dose Exanta (36 mg bid), while 1,703 subjects received dose-adjusted warfarin (to an INR of 2-3).
For strokes and other systemic embolic events, a 29% relative risk reduction was observed favoring Exanta. Overall, 4.6% of Exanta recipients, compared to 6.1% of warfarin recipients, experienced the composite one–year endpoint of stroke, major bleeding, or death.
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