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MUNICH, Germany, January 10, 2012 - Daiichi Sankyo Europe GmbH today announced the enrolment of the first patient into the PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF).(1) Taking a comprehensive approach to the patient registry, PREFER in AF will gather data on the full spectrum of AF patients including those with valvular and non valvular forms of the condition.(1) The registry will also track the impact of new anticoagulant therapies on stroke prevention, (1) in addition to collating insights into patients' satisfaction with their entire AF management, the impact of AF and its management on patient quality of life, (1) and the overall health economic burden of AF across Europe.(1)
In 2010, the World Heart Federation highlighted the need for new multi-national registries to help fill knowledge gaps around AF management and outcomes.(3) Enrolling 5,000 patients from across seven European countries, PREFER in AF will tackle this need by generating robust data on patient attitudes and management approaches, across a broad spectrum of different AF severities.(1) As the AF treatment paradigm continues to change rapidly, these data will also help to establish whether current treatment developments are translating into optimally-balanced anticoagulation in practice, to give patients the best chance of a normal life.
Endorsing the urgent need for this study, Professor José Luis Zamorano, co-Chair of the PREFER in AF Steering Committee and Professor of Cardiology at the University Clinic San Carlos, Madrid, Spain, said, "The potential impact of AF to Europeans is staggering, with numbers affected estimated to rise over the coming years. PREFER in AF is a timely patient registry, which will give us highly valuable insights into the current management of AF patients and the health economic impact of the condition, whilst informing us about how to move forward with patient treatment."
Collecting data from Austria, France, Germany, Italy, Spain, Switzerland and UK, the size of the PREFER in AF registry will generate nationally representative data on stroke prevention management approaches, patient satisfaction scores regarding anticoagulant treatment and management, and quality of life markers. Additionally, health economic data on drug treatment, disease and treatment complications including hospitalisation will be collected to estimate the true cost of AF for the European healthcare systems.
Professor José Luis Zamorano further comments on the registry: "This essential patient registry is important as it is focused on patients' quality of life and treatment satisfaction, which are key factors when considering optimal patient care. AF is a condition associated with high morbidity and mortality and when patients are satisfied with their treatment, they stay on treatment."
AF is a leading cause of hospitalisation amongst all cardiac diseases(2) and is the most frequent cardiac arrhythmia in clinical practice,(4) with approximately one to two per cent of the general population being affected.(2) AF is also a major cause of stroke(2) and strokes associated with AF are more severe and have a poorer prognosis than non-AF related strokes.(5)
Daiichi Sankyo, a global leader in cardiovascular medicine, is the sponsor of this registry study. Reinhard Bauer, CEO of Daiichi Sankyo Europe GmbH, comments on the start of the study today: "Daiichi Sankyo is proud to support such a valuable pan-European patient registry and we are very excited that the first patient has enrolled in this important observational study. This registry is an example of our on-going commitment to cardio-vascular medicine striving to further improve the treatment of AF patients and to better understand the real impact of AF on patients, physicians and the health care system."
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 atrial fibrillation (AF)
AF is an abnormal rhythm of the heart.(6) The heart has four chambers - two atria and two ventricles.(7) The atria pump blood into the ventricles and the ventricles pump blood around the body; they therefore have to work in sequence for the heart to pump blood most effectively with each heartbeat.(7)
A normal heart pumps blood with a regular rhythm - it can beat quickly or slowly but the interval between beats is the same.(7) 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.(7) When this happens, the atria contract rapidly, but only partially, and as a result pump less effectively.(7)
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 to the brain, where they have the potential to cause a stroke.(7)
About Daiichi Sankyo
The 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 optimize growth opportunities across the value chain.
The company's world headquarters are in Tokyo. Its European base is located in Munich. Daiichi Sankyo Europe has affiliates in 12 European countries in addition to a global manufacturing site located in Pfaffenhofen, Germany.
For more information, please visit: www.daiichisankyo.com or www.daiichi-sankyo.eu
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO, Co. Ltd, DAIICHI SANKYO, Inc., and 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, Co. Ltd, DAIICHI SANKYO, Inc., and DAIICHI SANKYO EUROPE GmbH assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
1. PREFER in AF Observational Plan - Daiichi Sankyo data on file. August 2011
2. Camm JA et al. Guidelines for the Management of Atrial Fibrilation, European Heat Journal 2010, 31:2369 - 429
3. Barham L. AF Aware, Atrial Fibrillation in Europe: How Aware Are You? World Heart Federation and Stroke Alliance for Europe, November 2010
4. Go AS, Hylek EM, Phillips KA, et al. Prevalence of Diagnosed Atrial Fibrillation in Adults: National Implications for Rhythm Management and Stroke Prevention: the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study. JAMA 2001;285(18):2370-75
5. Lamassa M, DiCarlo A, Pracucci G et al. Characteristics, outcomes and care of stroke associated with atrial fibrillation in Europe: Data from a multicenter multinational hospital-based registry (the European community stroke project). Stroke. 2001;32:392-398
6. NHS Clinical Knowledge Summaries. Available at www.cks.nhs.uk. Last accessed August 2011
7. Patient.co.uk www.patient.co.uk last accessed December 2011
Daiichi Sankyo Europe GmbH
Tetsuya Ohira, Daiichi Sankyo Europe GmbH
Tel.:+ 49 89 780-86-94 (Office)
Daria Munsel, Daiichi Sankyo Europe GmbH
Tel.: +49 (89) 780-87 28 (Office)