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Pan-European Stroke Prevention in Atrial Fibrillation Registry - PREFER in AF - Enrols First Patient

Geschrieben am 16-01-2012

Munich (ots/PRNewswire) -

- For European Media Only

-- Collection of real life data from 5,000 atrial fibrillation
patients (AF) across seven countries will generate invaluable
insights into one of Europe's leading causes of stroke(1,2) --

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: http://www.daiichisankyo.com
or 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, 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.

References:

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
http://www.cks.nhs.uk/atrial_fibrillation/view_whole_topic. Last
accessed August 2011

7. Patient.co.uk http://www.patient.co.uk/pdf/pilsL10.pdf last
accessed December 2011

For more information, please contact:

Tetsuya Ohira Daria Munsel
Daiichi Sankyo Europe GmbH Daiichi Sankyo Europe GmbH
+49-89-7808694 (Office) +49(89)7808728 (Office)

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
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