In much anticipated research news, US drug majors Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) have now announced the main results of the Phase III clinical trial ARISTOTLE, which evaluated Eliquis (apixaban) compared to warfarin for the prevention of stroke or systemic embolism in 18,201 patients with atrial fibrillation and at least one risk factor for stroke, with the findings exceeding already high expectations.
In the ARISTOTLE trial, Eliquis compared with warfarin significantly reduced the risk of stroke or systemic embolism by 21%, major bleeding by 31% and mortality by 11%. Results were presented during the Hot Line session at the European Society of Cardiology Congress in Paris, France, and published in The New England Journal of Medicine.
The European Commission this spring was the first regulatory authority to approve Eliquis in the 27 countries of the European Union for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery (The Pharma Letter May 23).
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