Bristol-Myers Squibb Company, a global biopharmaceutical company, and Pfizer Inc. announced that 15 abstracts have been accepted for presentation at the ESC Congress 2017, organized by the European Society of Cardiology, on August 26-30 in Barcelona, Spain. Investigational data from the EMANATE [Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with non-valvular atrial fibrillation (NVAF)] clinical trial will be presented during the Late-Breaking Science hot line session and official ESC press conference.
EMANATE is a phase 4 clinical trial exploring Eliquis (apixaban) versus standard of care (parenteral heparin and/or oral anticoagulation with a vitamin K antagonist) in patients with NVAF expected to undergo cardioversion to re-establish a regular heart rhythm.
In addition, analyses from ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) – the real-world data programme which aims to contribute to the growing body of evidence related to anticoagulation – will be presented at this year’s ESC Congress. These analyses focus on the use of Eliquis in routine clinical practice, including in NVAF patient populations considered at high risk or particularly vulnerable to stroke or major bleed due to age, risk prediction scores, and other cardiovascular comorbidities.
“We are proud to share both clinical trial results and real-world data analyses that continue to support the medical community in the advancement of patient care and add to the body of evidence for Eliquis as a treatment for DVT/PE and for reducing the risk of stroke in NVAF patients,” said Christoph Koenen, M.D., MBA, VP, Development Lead, Eliquis, Bristol-Myers Squibb. “These data supplement our pivotal trial results, providing additional insight into how Eliquis performs in specific clinical settings such as cardioversion and broad patient populations representing common clinical practice settings.”
“As physicians evaluate options for reducing stroke risk in patients with non-valvular atrial fibrillation, they often face questions about the effectiveness and safety of therapies in day-to-day practice,” said Rory O’Connor, M.D., chief medical officer, Pfizer Innovative Health. “Real-world data analyses, such as the results shared at this year’s ESC Congress, allow us to better understand the usage of Eliquis and other anticoagulants in a variety of settings and alongside clinical data, and have the potential to help healthcare providers make more informed decisions about their patient’s care.”
Initial findings from a Bristol-Myers Squibb (BMS)- and Pfizer- commissioned global policy research project conducted by The Economist Intelligence Unit (EIU), the research analysis division of The Economist Group, will also be presented at the ESC Congress. These findings bring attention to the global disparity of stroke risk reduction policies, and inadequate detection of risk factors for stroke – including NVAF – in clinical practice. The full report, which will be released by The EIU on September 21, is part of the BMS-Pfizer Alliance’s commitment to collaborating with patient advocacy and research organizations around the world to uncover barriers to atrial fibrillation screening and appropriate treatment to reduce the risk of stroke for patients with NVAF.
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 multiple 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 programme 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 per cent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an 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.
Bristol-myers squibb, , reducing risk of stroke caused, nvaf & treating dvt/pe, esc congress 2017
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