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Apixaban meets primary endpoint in phase 3 trial

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A press release issued by Bristol-Myers Squibb and Pfizer, manufacturers of apixaban, has stated that the new oral, direct factor Xa inhibitor has met its primary endpoint, as well as key secondary endpoints, of the phase 3 ARISTOTLE trial.

According to the release, apixaban (Eliquis) in a population of 18,201 patients with atrial fibrillation was noninferior to warfarin regarding the combined outcome of stroke (ischemic, hemorrhagic or unspecified type) and systemic embolism, the study’s primary endpoint. Additionally, key secondary endpoints were also met with apixaban, including superiority on efficacy and major bleeding compared with warfarin.

Also stated in the release, the manufacturers expect to submit regulatory filings in AF in the United States and Europe in the third or fourth quarter of 2011.

Detailed results of the ARISTOTLE trial will be presented on Aug. 28 during the “Hot Line” session at the European Society of Cardiology Congress 2011 in Paris.

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