24.08.2016 – 09:01
Data from Phase 3b ENSURE-AF Study Investigating Once-Daily LIXIANA® (edoxaban)in Patients with Atrial Fibrillation Undergoing Cardioversion Among 13 Daiichi Sankyo Clinical Presentations at ESC Congress 2016
- ENSURE-AF results to be featured during a late-breaking clinical trial session - Five abstracts highlighting analyses from the global phase 3 ENGAGE AF-TIMI 48 study to be presented - Seven abstracts to reveal new findings from the PREFER in AF and VTE European patient registries
Daiichi Sankyo Europe GmbH Group (hereafter, Daiichi Sankyo) today announced the presentation of 13 abstracts at the ESC Congress 2016, taking place from August 27-31 in Rome, Italy. The first results from ENSURE-AF, the largest prospective randomized clinical trial to date evaluating a non-vitamin K antagonist oral anticoagulant (NOAC) compared to a current standard of care in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion, which included nearly 2,200 patients from 19 countries, will be featured in a late-breaking clinical trial presentation. In addition, five analyses from the global phase 3 ENGAGE AF-TIMI 48 study of edoxaban (known by the brand name LIXIANA® outside the US and SAVAYSA® in the US) will be presented, including clinical outcomes associated with dose interruption in patients with NVAF compared to warfarin, relationship between body mass index and clinical outcomes, and a novel risk prediction score for net clinical outcome assessment.
Furthermore, six analyses from the PREFER in atrial fibrillation (AF) registry and one analysis from the PREFER in venous thromboembolism (VTE) registry will be presented, with new insights into the use of NOAC therapy, including prescribing patterns and trends in acute and long-term management of patients with AF and VTE.
Details of the presentations are included below:
Presentation Title Presenter Session Details Late-breaking Oral Presentation Edoxaban for Cardioversion of Andreas Goette, MD, Tuesday, August 30, Atrial Fibrillation: The Edoxaban St. Vincenz-Hospital, 2:00-2:15 PM CET Versus Warfarin in Subjects Paderborn, Germany Location: Rome - Undergoing Cardioversion of Main Auditorium Atrial Fibrillation (ENSURE-AF) Study Poster Presentations Evolution of Symptoms, Rate, and Yanish Purmah, MD, Sunday, August 28, Rhythm Control Therapy in AF City Hospital, 8:30 AM-12:30 PM CET Patients in Europe: A Comparison Birmingham, United Location: of the PREFER in AF and PREFER in Kingdom Poster Area AF Prolongation Data Sets Insulin-requiring Versus Elisabetta Ricottini, Sunday, August 28, Non-insulin Requiring Diabetes MD, University Campus 2:00-6:00 PM CET and Thromboembolic Risk in Bio-Medico, Rome, Location: Patients with Atrial Italy Poster Area Fibrillation: A PREFER in AF Registry Sub-study Antithrombotic Management of Giulia Renda, MD, PhD Sunday, August 28, Atrial Fibrillation: Follow-up G. d'Annunzio University 2:00-6:00 PM CET Data from the PREFER in AF of Chieti-Pescara Location: Registry Chieti, Italy Poster Area The HAS-BLED Score for Prediction Miklos Rohla, MD, Sunday, August 28, of Stroke and Systemic Embolism: Medical University of 2:00-6:00 PM CET Insights from the PREvention oF Vienna, Vienna, Austria Location: thromboembolic events - European Poster Area Registry in Atrial Fibrillation (PREFER in AF) Patients' Convenience and Raffaele De Caterina, MD, Sunday, August 28, Satisfaction as Important Factors PhD, FESC, G. d'Annunzio 2:00-6:00 PM CET Related to Switching from Vitamin University of Chieti- Location: K Antagonists to NOACs - A PREFER Pescara Chieti, Italy Poster Area in AF Registry Analysis Moderated Poster Presentation Hospitalization-Related Costs Elizabeth A. Magnuson, ScD, Tuesday, August 30, Among Patients with Atrial Saint Lukes Hospital, 10:25-10:35 AM CET Fibrillation Treated with the Kansas City, Missouri, Location: Moderated Factor Xa Inhibitor Edoxaban vs United States of America Poster Station - Warfarin: Results from the ENGAGE Poster Area AF-TIMI 48 Trial Rapid Fire Abstracts Linking Intrinsic Factor X Ophelia Q. Yin, Phd, FCP, Sunday, August 28, Activity, a Biologically Relevant Daiichi Sankyo, Edison, 11:36-11:45 AM CET Pharmacodynamic Marker, to New Jersey, United Location: Agora 1 - Edoxaban Plasma Concentration and States of America Poster Area Clinical Outcomes in the ENGAGE AF-TIMI 48 Trial Gender Differences in Clinical Renate B. Schnabel, MD, Monday, August 29, Presentation and Predictors of MSc University Heart Center 9:15-9:24 AM CET One-Year Outcomes in Atrial Hamburg, Hamburg, Germany Location: Agora 1 - Fibrillation Poster Area Relationship Between Body Mass Giuseppe Boriani, MD, PhD, Tuesday, August 30, Index and Outcomes in 21,028 University of Modena, 2:09-2:18 PM CET Patients with Atrial Fibrillation Modena, Italy Location: Agora 2 - Treated with Edoxaban or Warfarin Poster Area in ENGAGE AF-TIMI 48 Trial Management of Acute Venous Rupert Bauersachs, MD, Tuesday, August 30, Thromboembolism in Europe - Max Ratschow Clinic for 5:06-5:15 PM CET Follow-up Data at 1 Month from Angiology, Darmstadt, Location: Galileo - the PREFER in VTE Registry Germany The Hub Young Investigator Awards Presentations Clinical Events After Ilaria Cavallari, MD, Sunday, August 28, Interruption of Anticoagulation Brigham and Women's 2:57-1:15 PM CET in Patients With Atrial Hospital, Boston, Location: Raphael - Fibrillation: A Subgroup Analysis Massachusetts, United The Hub From the ENGAGE AF-TIMI 48 Trial States of America A Novel Risk Prediction Score in Christina Fanola, MD, Sunday, August 28, Atrial Fibrillation for a Net Boston Medical Center, 1:32-1:50 PM CET Clinical Outcome from the ENGAGE Brookline, Boston, Location: Galileo - AF-TIMI 48 Randomized Clinical Massachusetts, United The Hub Trial States of America
About ENSURE-AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation) ENSURE-AF is a Prospective, R andomized, Open-Label, Blinded Endpoint evaluation (PROBE), parallel-group phase 3b study evaluating the efficacy and safety of once-daily edoxaban versus enoxaparin/warfarin in patients with NVAF undergoing electrical cardioversion. The primary efficacy endpoint was the composite of stroke, systemic embolism, myocardial infarction, and cardiovascular mortality. The primary safety endpoint was the composite of major and clinically-relevant non-major bleeding. A total of 2,199 NVAF patients undergoing electrical cardioversion were enrolled at 239 clinical sites across North America and Europe. Patients were randomized to receive edoxaban 60 mg (or a reduced dose of edoxaban 30 mg for specific patients with renal impairment or low body weight or P-glycoprotein inhibitor use) or enoxaparin/warfarin for 28-49 days.
About the ENGAGE AF-TIMI 48 Study
The ENGAGE AF-TIMI 48 global phase 3 study investigated once-daily edoxaban in comparison to warfarin in 21,105 patients with NVAF at moderate-to-high risk of thromboembolic events. This represented the largest and longest trial with a NOAC in patients with AF performed to date, with a median follow-up of 2.8 years. Edoxaban demonstrated non-inferiority for stroke or systemic embolism in comparison to warfarin. For the principal safety endpoint, edoxaban was found to significantly reduce major bleeding compared to warfarin.
About PREFER in AF
The initial PREFER in AF registry enrolled 7,243 AF patients across 461 centres in Austria, France, Germany, Italy, Spain, Switzerland and the UK. The aim of this registry is to provide information on the characteristics and management of patients with AF with focus on prevention of thromboembolic events, specifically stroke, together with other important patient-focused considerations such as management, quality of life and treatment satisfaction of patients with AF.
The Prolongation of PREFER in AF Registry was designed to extend the ongoing PREFER in AF registry to gain further insights on AF management. The extension to the PREFER in AF registry includes two additional countries (Belgium and the Netherlands). Data is being collected from 5,000 patients across 325 centres in the nine European countries.
About PREFER in VTE
The PREFER in VTE registry enrolled patients in seven European countries, including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the real-life acute mid-term management of patients with VTE, the use of healthcare resources, and to provide data to estimate the costs for 12 months of treatment following a first-time and/or recurrent VTE diagnosis. In addition, PREFER in VTE is the first registry of its kind to capture comprehensive real-world data regarding quality of life, patient satisfaction and the economic burden of VTE treatment across Europe.
About Atrial Fibrillation
AF is a condition where the heart beats irregularly and rapidly. When this happens, blood can pool and thicken in the chambers of the heart causing an increased risk of blood clots. These blood clots can break off and travel through the blood stream to the brain (or sometimes to another part of the body), where they have the potential to cause a stroke.
AF is the most common type of heart rhythm disorder, and is associated with substantial morbidity and mortality. More than six million Europeans are diagnosed with AF, and this figure is expected to at least double over the next 50 years., Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke. One in five of all strokes are as a result of AF.
VTE is an umbrella term for two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a disease caused by a blood clot found in deep veins, usually within the lower leg, thigh or pelvis, although they can occur in other parts of the body as well. PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.
VTE is a major cause of morbidity and mortality. A 2007 study of morbidity and mortality from VTE in six European countries (France, Germany, Italy, Spain, Sweden and the UK) estimated a total of approximately 762,000 VTE episodes and a further 370,000 VTE-related deaths each year. There is a high rate of recurrence after a first VTE event, which is reduced with anticoagulant treatment. Without anticoagulant treatment, approximately half of patients who experience an initial VTE event have recurrent VTE within three months.
Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components in the coagulation cascade responsible for blood clotting. Inhibition of factor Xa reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: http://www.daiichisankyo.com.
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1. Lip, GY. A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study. Am Heart J. 2015 May;169(5):597-604. 2. Giugliano R, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369(22):2093-2104. 3. Kirchhof P, et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF). Europace. 2013. doi: 10.1093/europace/eut263. 4. Prolongation PREFER in AF Registry. European Multinational Prolongation Registry on Prevention of Thromboembolic Events in Atrial Fibrillation. DSE-EAF-01-13. Data on file. 5. Agnelli G, et al. The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry. Thromb J. 2015 doi: 10.1186/s12959-015-0071. 6. National Heart, Lung and Blood Institute - What is Atrial Fibrillation. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/af/af_diagnosis.html . [Last accessed: March 2016]. 7. Iqbal MB, et al. Recent developments in atrial fibrillation. BMJ. 2005;330(7485):238-43. 8. Krijthe BP, et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013;34(35):2746-2751. 9. Camm A, et al. Guidelines for the management of atrial fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31(19):2369-2429. 10. Ball J, et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Card. 2013;167:1807-1824. 11. Deep Vein Thrombosis (DVT) / Pulmonary Embolism (PE) - Blood Clot Forming in a Vein. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/ncbddd/dvt/facts.html . [Last accessed: March 2016]. 12. Van Beek E, et al. Deep vein thrombosis and pulmonary embolism. New York: John Wiley & Sons, 2009. Print. 13. Cohen A, et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost. 2007;98(4):756-764. 14. Kearon C. Natural history of venous thromboembolism. Circulation. 2003;107(23 suppl 1):I-22-30.
Contact Lydia Worms (Europe) Daiichi Sankyo Europe GmbH Edoxaban Communications & Product PR Europe +49(89)7808751
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