Bristol-Myers Squibb, Pfizer to present 12 new Eliquis abstracts at AHA Scientific Sessions 2016
Bristol-Myers Squibb Company and Pfizer Inc. announced that 12 Eliquis abstracts will be presented at the AHA Scientific Sessions 2016, to be held November 12-16 in New Orleans. Among these abstracts, the Bristol Myers-Squibb and Pfizer Alliance will present final data from the randomized AEGEAN (Assessment of an Educational and Guidance Program for Eliquis Adherence in Nonvalvular Atrial Fibrillation) study, highlighting adherence and persistence data for nonvalvular atrial fibrillation (NVAF) patients treated with Eliquis to reduce the risk of stroke. These data are based on an evaluation of an additional education program versus standard of care patient education. Additional post-hoc analyses from the pivotal ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) study and retrospective real-world data analyses from ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) will also be presented.
“We are proud to build on the growing body of clinical and real-world evidence for the use of Eliquis,” said Rory O’Connor, M.D., chief medical officer, Internal Medicine, Pfizer Innovative Health. “At this year’s AHA Scientific Sessions, we’ll also share data on patient adherence to anticoagulant therapy, which is critical for the reduction of stroke risk in patients with nonvalvular atrial fibrillation.”
“As part of our steadfast commitment to the ongoing evaluation of Eliquis, we continue to gather insights from real-world practice to complement the results we’ve seen in randomized clinical trials,” said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb. “These analyses form part of our ACROPOLIS global real-world data program, which evaluates data from regions around the world collected through medical records, insurance claims databases and national health data systems to further inform healthcare decision-making.”
The complete list of Bristol-Myers Squibb and Pfizer Alliance presentations is included below.
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the US based on efficacy and safety data 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 (NVAF); 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.
ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) is the Eliquis (apixaban) global real-world data program designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program will include retrospective, outcomes-based analyses from over 10 databases around the world, including medical records, medical and pharmacy health insurance claims data, and national health data systems.
Analyses of real-world data allow for a broader understanding of patient outcomes associated with Eliquis outside of the clinical trial setting, as well as insight into other measures of healthcare delivery, such as hospitalization and costs.
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.