ORLANDO, Florida (Reuters) – Far fewer patients with atrial fibrillation experienced strokes after taking preventive doses of AstraZeneca Plc's experimental drug ximelagatran (Exanta) than did patients who took warfarin, the company announced on Monday.
Interim results of a phase II trial were presented here at the 43rd annual meeting of the American Society of Hematology. The long-term trial involves 125 patients with non-valvular atrial fibrillation who received regular doses of ximelagatran and 42 patients who received warfarin.
Preliminary results show that patients taking ximelagatran experienced 0.9 strokes and 0.4 transient ischemic attacks per 100 treatment years. Treatment ranged from 21 to 24 months, the company said. In contrast, patients treated with warfarin (Coumadin) experienced 2.6 strokes and 2.6 transient ischemic attacks per 100 treatment years.
Astra said the incidence of major bleeding was 0.9 per 100 treatment years for ximelagatran compared with 2.6 per 100 treatment years for warfarin.
"Coumadin has so many issues, in terms of the drugs it interacts with and the extent to which it has to be monitored to be sure it's at the right level," analyst Catherine Arnold of Sanford C. Bernstein said. Therefore, "even if [ximelagatran] is the equivalent to Coumadin, it will still be used extensively in our view in these populations," she added.
AstraZeneca's chief executive officer said last week that ximelagatran, if cleared by the FDA, would be the first new anticoagulant pill in 50 years.