(New Orleans, Louisiana March 8) Researchers at Mount Sinai School of Medicine announced an analysis of pooled data from two Phase III stroke prevention trials today at the American College of Cardiology (ACC) annual meeting in New Orleans, Louisiana. Pooled data demonstrated that ximelagatran, a new type of anti-clotting medication currently under FDA review, is as effective as current treatment warfarin for the prevention of stroke and systemic embolic events in men and women with nonvalvular atrial fibrillation (AF).

Although more men are affected with AF than women, the risk of AF-related strokes is greater among women. Warfarin is effective in preventing stroke but can be associated with bleeding, which occurs more often in women than men. Pooled data presented today on the SPORTIF (Stroke Prevention by ORal Thrombin Inhibitor in atrial Fibrillation) III and V studies are the first to compare ximelagatran in the men and women subgroup population.

This analysis on SPORTIF III and V compared the efficacy and safety of 5,075 men and 2,257 women treated with either ximelagatran or dose-adjusted warfarin, and showed that EXANTA is at least as effective as warfarin in preventing strokes and systemic embolic events. During 11,233 patient-years (mean 19 months) exposure, 72 primary events (2.2 percent per year treated with ximelagatran vs. 2.0 percent per year treated with warfarin) occurred in women and 112 primary events (1.4 percent per year treated with ximelagatran vs. 1.5 percent per year treated with warfarin) occurred in men. Ximelagatran was also associated with lower bleeding rates than warfarin, and the incidence of major and minor bleeding was greater among women than men (35.4 percent per year in women and 30.1 percent per year in men on ximelagatran vs. 44.8 percent per year in women vs. 36.3 percent per year in men on warfarin).

"Pooled analysis of this study reinforces the potential benefits of ximelagatran as a treatmen
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Contact: Mount Sinai Press Office
NewsMedia@mssm.edu
212-241-9200
The Mount Sinai Hospital / Mount Sinai School of Medicine
8-Mar-2004

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