Bristol-Myers Squibb Company (BMS) and Pfizer report that preliminary results from the phase 3 AVERROES clinical trial of the investigational drug apixaban compared with acetylsalicylic acid (ASA, or aspirin) in patients with atrial fibrillation expected to be or demonstrated to be unsuitable for warfarin therapy will be presented at the European Society of Cardiology Congress 2010. The results will be presented during the “Hot Line” session on August 31, 2010, in Stockholm, Sweden.
Atrial fibrillation (AF) is the most common serious chronic arrhythmia, affecting about 4.5 million people in Europe and 2.2 million people in the United States.
Patients with AF are at five times greater risk for stroke compared with the general population. Fifteen percent of all strokes are attributable to AF, and one quarter of all strokes in persons older than 80 years are attributable to AF.
In addition to treatments for heart rate and rhythm, treatment guidelines recommend that AF patients at moderate to high risk of stroke receive anticoagulation therapy with a vitamin K antagonist (VKA), such as warfarin. However, surveys of practice patterns in developed countries demonstrate that 40 per cent to 50 per cent of patients with AF who are at moderate or high risk for stroke do not receive VKA. The most common reason for not treating AF patients with a VKA appears to be concern about bleeding. Difficulties managing and maintaining therapeutic warfarin dosing, as well as the use of other prescription drugs that interfere with warfarin therapy are additional concerns. Currently, guidelines for the management of patients with AF recommend the use of aspirin for those who cannot take oral anticoagulants.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.