Results of the phase III clinical trial ARISTOTLE (Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation) showed that oral direct Factor Xa inhibitor Eliquis (apixaban) as 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.
ARISTOTLE evaluated 18,201 patients with atrial fibrillation and at least one risk factor for stroke. It was conducted in 1,034 centres in 39 countries, and was coordinated by the Duke Clinical Research Institute, Durham, USA, and Uppsala Clinical Research Institute, Uppsala, Sweden.
“The risk for stroke in patients with atrial fibrillation is a major public health concern in an aging population,” said Christopher B Granger, professor of medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, USA, and lead investigator of the study. “We are therefore encouraged by the outcome of the ARISTOTLE trial, which showed that apixaban, as compared with warfarin, significantly reduced the risk of stroke or systemic embolism, major bleeding, and mortality.”
Eliquis is the approved trade name for apixaban in Europe and the proposed trade name in the USA. Eliquis is not approved for the prevention of stroke or systemic embolism in patients with atrial fibrillation in any country. Bristol-Myers Squibb and Pfizer recently announced the first regulatory approval for Eliquis in the European Union for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.
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. The Eliquis atrial fibrillation clinical trial programme, which includes ARISTOTLE and AVERROES, was designed to comprehensively evaluate Eliquis in approximately 24,000 patients with atrial fibrillation, including patients who are expected or demonstrated to be unsuitable for vitamin K antagonist therapy.
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 thromboembolism and its prevention in hospitalised acutely ill medical patients.