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

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

  PR Newswire

  MUNICH, Germany, April 2, 2014

MUNICH, Germany, April 2, 2014 /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®. 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.Büller, 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)
 
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