Daiichi Sankyo extends the PREFER in AF patient registry to provide additional insights into the long-term management of patients with atrial fibrillation

Munich, Germany (ots/PRNewswire) -

For European Media Only, Not for UK Media

Atrial fibrillation (AF) is the most common heart rhythm
disorder[1] resulting in a five-fold increased risk of stroke
compared with the general population[2]

Daiichi Sankyo today announced its commitment to extend the
PREvention oF thromboembolic events - European Registry in Atrial
Fibrillation (PREFER in AF). The extension of the registry will
include a specific focus on the use of Novel Oral Anticoagulant
(NOAC) therapy including prescribing patterns, providing new insight
into the long-term management of patients with atrial fibrillation
(AF).

The PREFER in AF Registry was initially conducted in seven
European countries with over 7,000 patients to gain detailed insight
into the characteristics and management of AF, with a focus on the
prevention of thromboembolic events, and in particular, stroke.[3]
Baseline results released at EHRA EUROPACE in June 2013 illustrated
recent changes in the management of AF and some uptake of NOACs
following their inclusion in the updated ESC guidelines.[3] This
extension to the registry will collect additional up to date real
life data from approximately 5,000 patients across more than 320
centres in nine European countries, including the addition of two new
countries; Belgium and The Netherlands.

"Despite the introduction of a number of new oral anticoagulants
there remains a lack of data on current management of AF patients in
clinical practice settings. The PREFER in AF registry enables us to
observe and understand different anticoagulation treatment patterns,
giving us a valuable and much needed insight into the long-term
management of patients with AF and specifically the use of NOACs,"
explains Professor Paulus Kirchhof, Chair in Cardiovascular Medicine,
University of Birmingham and Chair of the PREFER in AF Steering
Committee. "It is critical that patients with AF who are at risk of
experiencing stroke and thromboembolism maintain effective
anticoagulation - and this extended registry will provide vital data
to support clinicians with their prescribing decisions."

The extended registry places a special focus on the use of NOACs
and corresponding treatment patterns; including the reasons for
switching AF patients to NOACs from vitamin K antagonists (VKAs).
VKAs, such as warfarin, are the current standard of care but require
frequent monitoring and dose adaptation to keep patients within
therapeutic range.[4] For patients with AF who are at risk of
experiencing stroke and thromboembolism, it is critical to maintain
effective anticoagulation.

AF is the most common type of heart rhythm disorder[1], and a
major cause of morbidity and mortality across Europe.[5] Patients
with AF have a five-fold increased risk of stroke compared with the
general population,[2] and stroke in those suffering with AF is more
severe, more likely to cause disability,[2] and nearly twice as
likely to be fatal than in those without AF.[6] AF also places a
considerable burden on European health systems, with inpatient care
and interventional procedures accounting for the majority of
costs.[7]

"As part of Daiichi Sankyo's commitment to the advancement of
cardiovascular medicine, multi-national registries are now underway
in both AF and VTE," comments Dr. Jan van Ruymbeke, CEO Daiichi
Sankyo Europe. "Through these we aim to provide clinicians with data
that can improve future management of AF and VTE and support them in
delivering the best outcomes for patients while effectively managing
resources."

Further results from the PREFER in AF initial registry period are
due to be presented later this year.

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).[8],[9]

Notes to editors:

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, to provide 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.[3]

The Prolongation of PREFER in AF Registry is designed to both
prolong the currently ongoing PREFER in AF 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 over a 24
month period. Enrolment of new patients will take place in all
regions. Data will be collected from 5,000 patients across 325
centres in nine European countries (Austria, Belgium, France,
Germany, Italy, Netherlands, Spain, Switzerland and the United
Kingdom).

About PREFER in VTE

Daiichi Sankyo has also recently analysed the first baseline data
of the PREFER in VTE registry, covering information from 1,783 VTE
patients. PREFER in VTE is the first registry of its kind to collate
comprehensive data on the disease management in patients with VTE
with key insight into patient satisfaction and quality of life. First
results from the first study period of PREFER in VTE registry are due
to be presented later this year.

About Edoxaban

Edoxaban is an investigational, oral, once-daily anticoagulant
that specifically inhibits factor Xa, which is an important factor in
the coagulation system that leads to blood clotting.[10] 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). The results
from these trials form the basis of the MAA for edoxaban for the
prevention of stroke and SEE in patients with NVAF, as well as for
the treatment of DVT or PE and prevention of recurrence of
symptomatic VTE.

Edoxaban is currently approved only in Japan, since April 2011,
for the prevention of VTE after major orthopaedic surgery, and was
launched in July 2011 under the brand name LIXIANA(R). Elsewhere,
including Europe and the U.S., edoxaban is currently in phase 3
clinical development and has not been approved in any indication.

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 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) Iqbal, M. B., Taneja, A. K., Lip, G. Y. H. & Flather, M. Recent
developments in atrial fibrillation. BMJ. 2005;330:238-43.
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) 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) 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) National Institute for Health and Care Excellence. Atrial fibrillation: the
management of atrial fibrillation. Clinical guideline: Methods, evidence and
recommendations. January 2014. Available at:
http://www.nice.org.uk/nicemedia/live/13590/66267/66267.pdf [Last accessed: March
2014]
6) Lin, H., Wolf, P. A., Kelly-Hayes, M. & Benjamin, E. J. Stroke Severity in
Atrial Fibrillation. Stroke. 1996;27:1760-1764.
7) Ringborg A, Nieuwlaat R, Lindgren P, et al. Costs of atrial fibrillation in
five European countries: results from the Euro Heart Survey on atrial fibrillation.
Europace. 2008;10(4):403-11.
8) Bueller, H et al. Edoxaban versus Warfarin for the Treatment of Symptomatic
Venous Thromboembolism. N Engl J Med 2013;369:1406-1415.
9) Giugliano, R et al. Edoxaban versus Warfarin in Patients with Atrial
Fibrillation. N Engl J Med 2013;369:2093-2104.
10) Ogata, K et al. Clinical Safety, Tolerability, Pharmacokinetics, and
Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy Volunteers. J
Clin Pharmacol 2010;50:743-753.

For more information, please contact:

Daria Munsel
Daiichi Sankyo Europe GmbH
Tel: +49-(89)-7808728 (Office)

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
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