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Exanta - pivitol data from largest ever phase III stroke prevention trial announced at ACC

52nd Scientific Session of the American College of Cardiology (ACC), Chicago: Results from the SPORTIF III* study demonstrate that ExantaTM (ximelagatran), the first in a new class of oral direct thrombin inhibitor (Oral DTI), has potential to be an effective and convenient replacement for warfarin in the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF), without the warfarin limitations of drug interactions, the need for coagulation monitoring and dose titration.

SPORTIF III, a multi-national, randomised, open-label, parallel-group study with blinded event assessment, was designed as a non-inferiority** study to compare Exanta with the current standard treatment, dose-adjusted warfarin. The primary efficacy endpoint was met, showing that fixed dose twice daily 36mg oral Exanta compares favourably with dose-adjusted warfarin, in preventing stroke and systemic embolic events (SEE) in atrial fibrillation. While the study was not aimed at demonstrating superiority, the incidence of stroke and systemic embolic events seen for Exanta compared with a well-controlled warfarin treatment (average study INR 2.5) was numerically lower (40 Exanta vs 56 warfarin) in the whole population (ITT - including those who stopped treatment). Furthermore, a statistically significant RRR of 41% (p=0.018) was demonstrated for Exanta compared with well-controlled warfarin in patients who remained on treatment for the duration of the study (OT population).

"The results of the SPORTIF III study suggest that Exanta can offer great improvement in preventing stroke in patients with atrial fibrillation. As a physician, this is a very exciting breakthrough, as we may be able to offer our patients a much-needed alternative to warfarin treatment and its associated complications, while knowing that we are not compromising on efficacy" comments Professor Bertil Olsson, SPORTIF III Key Investigator and Professor of Cardiology, University
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Contact: Liz Rickard
elizabeth.rickard@ketchum.com
44-207-611-3633
Ketchum
2-Apr-2003


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