One Year Data from the PREFER in AF Registry Show Significant Changes in Atrial Fibrillation (AF) Management in Europe and Implementation of Clinical Guidelines

BARCELONA, Spain, September 2, 2014 /PRNewswire/ --

Registry provides new insights into AF treatment decisions, including patients' quality of life and treatment satisfaction^[1],[2]

     (Photo: http://photos.prnewswire.com/prnh/20140902/703596 )

ESC Congress 2014, 02 September 2014, Barcelona, Spain: Daiichi Sankyo today announced one year results of the PREvention oF thromboembolic events-European Registry in Atrial Fibrillation (PREFER in AF), revealing significant changes to the treatment of AF patients in clinical practice following an update to the European Society of Cardiology (ESC) guidelines on AF management in 2012.^[3] While the results indicate that improvements have been made, further changes are needed to address key treatment challenges and patient concerns.^[1],[2]  

Data from the registry, sponsored by Daiichi Sankyo, reveals that the majority of patients with AF are being treated with oral anticoagulants (82.3% patients receiving OACs at baseline and 80% at one year follow up).^[2] The percentage of patients receiving novel oral anticoagulants (NOACs) has more than doubled in the past year (from 6.1% to 12.6%),^[2] and patients receiving vitamin K antagonists (VKAs) has reduced from 66.3% to 61.8%,^[2] indicating that recent ESC guideline updates, which recommend NOACs as broadly preferable to VKAs in the vast majority of patients with non-valvular AF, are being increasingly implemented in clinical practice.^[3] The registry also observed a reduction in AF patients receiving antiplatelet agents (APs),^[2] further supporting adherence to the latest guidance.^[3]

Helping physicians to make informed future therapeutic decisions based on real-life data, the PREFER in AF registry further reveals factors which may influence treatment satisfaction and patient complaints contributing to a treatment switch to NOACs (213 patients) compared to those stably treated on VKAs (2102 patients). These include mobility problems (13.3% vs. 7.3%), complaints around dose adjustment (9.8% vs. 5.4%), and discomfort with bruising or pain (8.5% vs. 5.1%). Anxiety and depression traits also appear to influence choice of treatment.^[1]

Raffaele De Caterina, Professor of Cardiology and Director, University Cardiology Division G. D'Annunzio University, Chieti Ospedale Clinicizzato SS. Annunziata: "One year results from PREFER in AF come at a pivotal time for AF management in Europe. The increase in NOAC uptake demonstrates that guideline recommendations are being implemented in clinical practice. NOACs may offer potential benefits over traditionally used VKAs, which are associated with several limitations like regular blood tests, frequent dose adjustments, interaction with a variety of foods and other medications. Because of this NOACs have the potential to offer patients an improved quality of life."

PREFER in AF enrolled 7,243 AF patients  across 461 centres in seven European countries, and collected one year follow up data from 6,412 patients, providing real-life insights into the key challenges faced by patients in AF and their physicians.^[1],[4] VKAs such as warfarin have traditionally been the mainstay of AF management, but can present significant challenges in clinical practice; including the need for routine monitoring and dose adjustment, a narrow therapeutic window and several drug and food interactions.^[5],[6]

AF is an important health concern in Europe, affecting over six million people and this figure is expected to double over the next 50 years.^[7] A recent update to European guidelines on AF management highlight the high incidence of stroke in AF patients and recommend anticoagulant therapy for all patients in AF, except those at low risk.^[3] By collating data on patient characteristics, prescription patterns, clinical outcomes, quality of life, treatment satisfaction and adherence to therapy, PREFER in AF helps to provide insight into the management of AF.^[1],[4],[8]

To gain further insight into the long-term management of AF, Daiichi Sankyo has initiated the Prolongation PREFER in AF registry, which will collect additional up-to-date real-life data from approximately 5,000 patients across approximately 325 centres in nine European countries.^[9]

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

Notes to editors: 

About PREFER in AF  

PREFER in AF is a multinational, multicentre disease registry, which enrolled 7,243 patients across 461 centres in Austria, France, Germany, Italy, Spain, Switzerland and the UK and collected one year follow up data from 6,412 AF patients.^[1],[4]

PREFER in AF has been designed to explore management of AF patients in clinical practice, in terms of outcomes, patient satisfaction and also from an economic perspective.^[8],[10] The registry provides information on the clinical outcomes of patients on different treatment regimens, as well as other important considerations such as management of AF patients, adherence to therapy, quality of life and treatment satisfaction.^[8]

The Prolongation PREFER in AF registry was designed to both prolong the registry to improve clinical understanding of AF management, as well as to extend this registry to two additional countries, Belgium and the Netherlands, to further improve clinical understanding of NOAC management.^[9] Enrolment of new patients will take place in all regions, and data will be collected from 5,000 patients across approximately 325 centres in nine European countries (Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland and the United Kingdom), over a 24 month period.^[9]

The observation criteria for PREFER in AF include:^[10]

• Site and physician characteristics
• Patient characteristics (including basic characteristics such as demography and medical history)
• Patient pathways (including referral details between primary and secondary care)
• Drug utilisation (including drug type, dosage and where applicable INR levels)
• Clinical events and hospitalisations
• Health related quality of life (including standardised tests and anecdotal feedback)
• Healthcare resource use (including diagnosis measures, number of medical appointments and productivity loss)

About AF 
Atrial fibrillation (AF) is a condition in which the heartbeat is rapid and irregular,^[11] and is the most common sustained cardiac arrhythmia.^[7] Up to 20% of patients with AF experience no symptoms.^[12]

The main complication of AF is an increased risk of stroke,^[11] and one in five of all strokes occur as a result of AF.^[7] Over six million Europeans suffer from AF and this figure is expected to at least double over the next 50 years.^[7]

AF is a leading cause of stroke and fatality across Europe,^[7] and it is estimated that the total cost burden of AF in Europe approaches €13.5 billion per year.^[13]

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, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research

and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. The Daiichi Sankyo Group has created a "Hybrid Business Model" to respond to market and customer diversity and optimize 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. De Caterina, R. et al. Quality of Life and patient satisfaction data in atrial fibrillation patients stably treated with a VKA vs patients switched from a VKA to NOAC. [PREFER in AF abstract P6250 for ESC Congress 2014]. 2014.
2. Zamorano, J.L. et al. Trends in antithrombotic management of atrial fibrillation after the last update of ESC guidelines: follow-up data from the PREFER in AF registry. [PREFER in AF abstract P6266 for ESC Congress 2014]. 2014.
3. Camm, A. et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. European Heart Journal. 2012;33:2719-2747.
4. 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.
5. Mavrakanas, T., Bounameaux, H. The potential role of new oral anticoagulants in the prevention and treatment of thromboembolism. Pharmacology & Therapeutics. 2011;130:46-58.
6. Furugohri, T. et al. DU-176b, a potent and orally active factor Xa inhibitor: in vitro and in vivo pharmacological profiles. Journal of Thrombosis and Haemostasis. 2008;6:1542-9.
7. 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.
8. Le Heuzey et al. Differences among western European countries in anticoagulation management of atrial fibrillation. Thromb Haemost. 2014;111(5):833-41.
9. Prolongation PREFER in AF. European Multinational Prolongation Registry on Prevention of Thromboembolic Events in Atrial Fibrillation. DSE-EAF-01-13. Data on file.
10. PREFER in AF. European Multinational Registry on Prevention of Thromboembolic Events in Atrial Fibrillation. DSE-EAF-01-11.  Data on file.
11. Patient.co.uk. Atrial Fibrillation. http://www.patient.co.uk/pdf/4198.pdf (2012). Last accessed July 2014.
12. Patient.co.uk. Professional reference. Atrial Fibrillation. http://www.patient.co.uk/doctor/atrial-fibrillation (2012). Last accessed July 2014.
13. Fuster, V. et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation-Executive Summary. Circulation. 2006; 114:700-752.

Date of preparation: August 2014
Job bag: EDX/14/0052

SOURCE Daiichi Sankyo Europe GmbH