Bristol-Myers Squibb, Pfizer to present 22 abstracts including new data on Eliquis at the ESC Congress 2015 in London
Bristol-Myers Squibb Company, a global biopharmaceutical company, and Pfizer Inc, one of the world's premier innovative biopharmaceutical companies, announced that 22 abstracts (late-breaking, rapid-fire, oral and poster presentations) including important Eliquis data from both clinical trials and real-world analyses will be presented at the ESC Congress 2015, to be held from August 29 to September 2 in London, United Kingdom.
The new data reinforce the alliance’s commitment to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE) patient populations. In addition, data from the AEGEAN (Assessment of an Educational and Guidance Programme for Eliquis Adherence in Nonvalvular Atrial Fibrillation) study evaluating adherence among NVAF patients further extends the alliance’s commitment to patient care.
“The Bristol-Myers Squibb and Pfizer alliance is pleased to share 22 abstracts, which include important Eliquis data from both clinical trials and real-world analyses, at one of the world’s largest and most influential cardiovascular meetings,” said Douglas Manion, M.D., head of specialty development, Bristol-Myers Squibb.
“Clinical trial data are important in evaluating a medication’s efficacy and safety under well-controlled circumstances, and their findings can be supplemented by real-world data on the use of a product for approved indications in routine clinical practice,” said Rory O’Connor, M.D., senior vice president and head of global medical affairs, global innovative pharma business, Pfizer Inc.
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood-clotting protein, Eliquisdecreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the US based on efficacy and safety data, including results from seven phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE following initial therapy.
The most common and most serious adverse reactions reported with Eliquis were related to bleeding.
ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) was designed to evaluate the efficacy and safety of Eliquis versus warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected patients, representing 4.7 percent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.
APPRAISE-2 (Apixaban for Prevention of Acute Ischemic Events – 2) evaluated Eliquis in patients at risk of ischemic events. It was designed to randomize approximately 10,800 patients with a recent acute coronary syndrome (ACS) toEliquis 5 mg twice daily or placebo, in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC). There was clear evidence of a clinically important increase in bleeding among patients randomized to Eliquis. This increase in bleeding was not offset by clinically meaningful reductions in ischemic events.