Daiichi Sankyo Europe GmbH

Data Reveals Changes in Management of Patients Living with Atrial Fibrillation in Europe

Ehra Europace 2013, Athens, Greece (ots/PRNewswire) - [For European Media Only, Not for UK Media]

Baseline data from The PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF) highlights advances and existent gaps in

current management of thromboembolic events in people with AF

Daiichi Sankyo Europe GmbH today announced the first presentation of baseline results from the PREFER in AF (The PREvention oF thromboembolic events - European Registry in Atrial Fibrillation) registry.[1] PREFER in AF has been designed with a unique patient focus, collating 'real life' data from 7,243 atrial fibrillation (AF) patients across 461 centers in Austria, France, Germany, Italy, Spain, Switzerland and UK. Baseline data illustrate a change in management of patients with AF following the publication of the 2010 ESC guidelines.[2]The PREFER in AF registry shows that anticoagulant therapies are widely used, but also highlights that further advances in this field are required in order to achieve better outcomes for patients and European healthcare systems.

In patients with a CHA2DS2VASc score of 2 or higher, more than 85% received oral anticoagulants according to current guidelines, illustrating that evidence and guidelines are followed. The majority of patients (n=4799, 66.3%) received a Vitamin K Antagonist (VKA) as mono-therapy, 720 patients a VKA and Antiplatelet Agents (AP) in combination (9.9%). New oral anticoagulant drugs (NOAC, dabigatran, rivaroxaban or apixaban) were already being used in 442 patients (6.1%).

AF is one of Europe's leading causes of stroke[2] and is associated with an increased risk of death.[3] Vitamin K antagonists (VKAs) like warfarin are the current standard of care, but require frequent monitoring and dose adaptation to keep patients within therapeutic range.[4] In PREFER in AF patients taking VKAs spend about a quarter of the time outside the therapeutic range. As such, it is widely recognised that more predictable and convenient anticoagulants are needed.[4]Bleeding predisposition was the most common contraindication recorded across the treatment groups, followed by cancer and lack of compliance.[1]

PREFER in AF is exploring whether current treatment developments are translating into better management in clinical practice, in terms of outcomes, patient satisfaction and also from an economic perspective. PREFER in AF will inform about anticoagulation and rhythm control therapy. The registry is a multicentre, prospective observational disease registry, with a one-year follow up - monitoring AF management over a 12 month period. Baseline results have shown that among registered patients; 30% had paroxysmal AF, 24% had persistent AF, 7.2% had long-standing persistent AF, and 38.8% had permanent AF.[1]The results support the concept that persistent AF is a transient disease state, and that factors such as underlying heart disease and advancing age contribute to the progression of AF to a permanent disease state in most patients.[5],[6],[7]

"PREFER in AF illustrates changes in management of patients with AF since the last 'Guidelines for the management of atrial fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC)' update in 2010. The registry shows that oral anticoagulant therapy is now much more widely used than in the German Competence Network on Atrial Fibrillation (AFNET) and the EuroHeartSurvey registries and suggests that European clinicians are using guidelines well. The rapid uptake of new oral anticoagulants suggests that these drugs are filling a therapeutic gap", stated Professor Paulus Kirchhof, Chair in Cardiovascular Medicine, University of Birmingham and Chair of the PREFER in AF Steering Committee.

By measuring pharmacoeconomic data, the PREFER in AF registry will provide a breakdown of the attributing cost of AF for European healthcare systems. Incorporating economic data on drug treatment, disease and treatment complications including hospitalisation, the data will provide valuable insight into where improvements can be made to optimise current practice.

Kirchhof explained: "The baseline data that we reported today already provides new information on how evidence and guideline recommendations translate into clinical practice. The one-year follow up data will provide information on how these management patterns relate to outcomes. We hope that this data set, together with other emerging data, will provide a good basis to further improve management of AF patients."

AF affects over 6 million people across Europe[2] and is the most common form of clinically significant arrhythmia.[8] The annual cost of AF per patient worldwide is approximately EUR3,000,[8] with the total cost across Europe approximately EUR13.5 billion per year.[8] By recording clinical outcomes, patient quality of life and satisfaction scores and healthcare costs, the PREFER in AF registry will allow an evaluation of the suitability and economic burden of current treatment practices and measure the efficiency of new oral anticoagulants. The PREFER in AF registry will generate unbiased data on stroke prevention management approaches, patient satisfaction scores regarding anticoagulant treatment and management, and quality of life markers to help shape ongoing developments and optimum outcomes for both patients and European healthcare systems.

Daiichi Sankyo, a global leader in cardiovascular medicine, is the sponsor of this registry study. "Our company is dedicated to the advancement of cardiovascular medicine in disease areas such as AF. By taking a patient focused, real life approach, PREFER in AF will provide a detailed snapshot highlighting current management of this disease and where ongoing development and innovation is required to optimise patient care", confirmed Dr. Jan van Ruymbeke, CEO Daiichi Sankyo Europe.

To address the common and significant limitations of existing therapies, Daiichi Sankyo is currently investigating a novel oral anticoagulant. Edoxaban, the once-daily factor Xa inhibitor, is currently being evaluated for the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF), as well as for preventing recurrent VTE complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE). The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation).[9],[10] Edoxaban is studied with two distinct dosages in ENGAGE AF-TIMI 48, the largest atrial fibrillation trial to date, with more than 20,500 patients.[10] Hokusai-VTE is the largest single phase 3 clinical study in the treatment and prevention of recurrence of VTE, with more than 8,250 patients.[9],[11]

Notes to editors:

About PREFER in AF

The PREFER in AF registry is a multi-centre, prospective observational disease registry, with a one-year follow up. The patient sample will represent all AF patient groups with no exclusion criteria and irrespective of whether they receive antithrombotic therapy or not.

About AF

AF is an abnormal rhythm of the heart.[12] The heart has four chambers - two atria and two ventricles.[13] The atria pump blood into the ventricles and the right ventricle pumps blood around the body; they therefore have to work in sequence for the heart to pump blood most effectively with each heartbeat.[13] A normal heart pumps blood with a regular rhythm - it can beat quickly or slowly but the interval between beats is the same.[13]When a patient suffers from AF, numerous electrical pulses that fire from the heart muscles in the atria override the normal controlling 'timer' in the heart.[13] When this happens, the atria contract rapidly, but only partially, and as a result pump blood less effectively.[13] Consequently, blood is not pumped effectively from the atria, which may cause the blood to stagnate and form clots. These blood clots can break off and travel through the blood stream e.g. to the brain, where they have the potential to cause a stroke.[13]

About Edoxaban

Edoxaban is licensed only in Japan for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery, under the brand name Lixiana(R). Elsewhere, including Europe and the U.S., edoxaban is currently in phase 3 of clinical development and has not yet been approved. Daiichi Sankyo continues to develop edoxaban at a global level as a potential new treatment for the prevention of SEE in patients with NVAF and for the treatment and prevention of recurrence of VTE in patients with acute DVT and/or PE.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimise growth opportunities across the value chain. For more information, please visit: http://www.daiichisankyo.com

About Daiichi Sankyo Europe

Daiichi Sankyo's European base is located in Munich and has affiliates in 12 European countries in addition to a global manufacturing site located in Pfaffenhofen, Germany. For more information, please visit: http://www.daiichi-sankyo.eu

Forward-looking statements

This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of Daiichi Sankyo Europe GmbH. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. Daiichi Sankyo Europe GmbH assumes no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

References:

1. Trends in management of patients with atrial fibrillation in 5 European countries: Primary results of the PREFER in AF Registry. Presented at the Europace Congress, Late Breaking Trials session II, 26 June 2013.

2. 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). European Heart Journal. 2010;31:2369-429.

3. Pedersen, O. D. et al. Increased risk of sudden and non-sudden cardiovascular death in patients with atrial fibrillation/flutter following acute myocardial infarction. European Heart Journal. 2006;27:290-5.

4. Jones, M. et al. Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record linkage study in a large British population. Heart. 2005;91:472-7.

5. Kirchhof, P., Lip, G.Y., Van Gelder, I.C. et al. Comprehensive risk reduction in patients with atrial fibrillation: Emerging diagnostic and therapeutic options. Executive summary of the report from the 3rd AFNET/EHRA consensus conference. Thromb Haemost 2011;106:1012-9.

6. de Vos, C.B., Pisters, R., Nieuwlaat, R. et al. Progression from paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J Am Coll Cardiol 2010;55:725-31.

7. Jahangir, A., Lee, V., Friedman, P.A. et al. Long-term progression and outcomes with aging in patients with lone atrial fibrillation: a 30-year follow-up study. Circulation 2007;115:3050-6.

8. Fuster, V. et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation-Executive Summary. Circulation. 2006;114:700-752.

9. Raskob, G. et al. Edoxaban for the long-term treatment of venous thromboembolism: rationale and design of the Hokusai-VTE study. 2013.

10. Ruff, C et al. Evaluation of the novel factor Xa inhibitor Edoxaban compared with warfarin in patients with atrial fibrillation: Design and rationale for the Effective aNticoaGulation with factor xA next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010;160:635-641.

11. Clinicaltrials.gov: NCT00986154. Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots.(The Edoxaban Hokusai-VTE Study).[Last accessed: May 2013]. Available at:http://clinicaltrials.gov/ct2/show/study/NCT00986154?show_locs=Y#locn

12. NHS Choices. Atrial Fibrillation. Available at http://www.nhs.uk/conditions/atrial-fibrillation/pages/treatment.aspx. Last accessed April 2013.

13. Patient.co.uk http://www.patient.co.uk/pdf/pilsL10.pdf. Last accessed April2013

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For more information, please contact:
Daria Munsel
Daiichi Sankyo Europe GmbH
Tel: +49(89)-7808728 (Office)
 



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