Bristol-Myers Squibb Company and Pfizer announced topline results of the phase III ARISTOTLE trial of Eliquis. In this study of patients with atrial fibrillation and at least one additional risk factor for stroke, Eliquis met the primary efficacy objective of non-inferiority to warfarin on the combined outcome of stroke (ischaemic, haemorrhagic or unspecified type) and systemic embolism. In addition, Eliquis met the key secondary endpoints of superiority on efficacy and on ISTH (International Society on Thrombosis and Haemostasis) major bleeding compared to warfarin.
Eliquis, a new oral direct Factor Xa inhibitor, is being developed by the alliance of Bristol-Myers Squibb and Pfizer. The companies expect to submit regulatory filings in atrial fibrillation in the USA and Europe in the third or fourth quarter of 2011.
The detailed results of the ARISTOTLE study will be presented during the “Hot Line” session on 28 August 2011, at the European Society of Cardiology Congress 2011 in Paris.
ARISTOTLE, a double-blind, multicentre, head-to-head phase III trial, randomised 18,201 patients with atrial fibrillation from over 1,000 centres in about 40 countries. Patients were randomised to receive either Eliquis 5 mg twice daily (2.5 mg twice daily in selected patients) or dose-adjusted warfarin (titrated to a target INR range of 2.0 to 3.0).
Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the US and other countries. Eliquis is not approved for the prevention of stroke in patients with atrial fibrillation. Bristol-Myers Squibb and Pfizer recently announced the first regulatory approval for Eliquis for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery in the 27 countries of the European Union.
Eliquis is being investigated within the EXPANSE clinical trials programme, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomised, double-blind phase III trials, including ARISTOTLE.
In addition to stroke prevention in patients with atrial fibrillation and the prevention of venous thromboembolic events in patients who have undergone total hip or total knee replacement surgery, Eliquis is being investigated in phase III trials for the treatment of venous thromboembolic events and the prevention of them in hospitalised acutely ill medical patients.