Data Reveals Changes in Management of Patients Living with Atrial Fibrillation in Europe

Ehra Europace 2013, Athens, Greece (ots/PRNewswire) -

[For European Media Only, Not for UK Media]

Baseline data from The PREvention oF thromboembolic events -
European Registry in Atrial Fibrillation (PREFER in AF) highlights
advances and existent gaps in

current management of thromboembolic events in people with AF

Daiichi Sankyo Europe GmbH today announced the first presentation
of baseline results from the PREFER in AF (The PREvention oF
thromboembolic events - European Registry in Atrial Fibrillation)
registry.[1] PREFER in AF has been designed with a unique patient
focus, collating 'real life' data from 7,243 atrial fibrillation (AF)
patients across 461 centers in Austria, France, Germany, Italy,
Spain, Switzerland and UK. Baseline data illustrate a change in
management of patients with AF following the publication of the 2010
ESC guidelines.[2]The PREFER in AF registry shows that anticoagulant
therapies are widely used, but also highlights that further advances
in this field are required in order to achieve better outcomes for
patients and European healthcare systems.

In patients with a CHA2DS2VASc score of 2 or higher, more than 85%
received oral anticoagulants according to current guidelines,
illustrating that evidence and guidelines are followed. The majority
of patients (n=4799, 66.3%) received a Vitamin K Antagonist (VKA) as
mono-therapy, 720 patients a VKA and Antiplatelet Agents (AP) in
combination (9.9%). New oral anticoagulant drugs (NOAC, dabigatran,
rivaroxaban or apixaban) were already being used in 442 patients
(6.1%).

AF is one of Europe's leading causes of stroke[2] and is
associated with an increased risk of death.[3] Vitamin K antagonists
(VKAs) like warfarin are the current standard of care, but require
frequent monitoring and dose adaptation to keep patients within
therapeutic range.[4] In PREFER in AF patients taking VKAs spend
about a quarter of the time outside the therapeutic range. As such,
it is widely recognised that more predictable and convenient
anticoagulants are needed.[4]Bleeding predisposition was the most
common contraindication recorded across the treatment groups,
followed by cancer and lack of compliance.[1]

PREFER in AF is exploring whether current treatment developments
are translating into better management in clinical practice, in terms
of outcomes, patient satisfaction and also from an economic
perspective. PREFER in AF will inform about anticoagulation and
rhythm control therapy. The registry is a multicentre, prospective
observational disease registry, with a one-year follow up -
monitoring AF management over a 12 month period. Baseline results
have shown that among registered patients; 30% had paroxysmal AF, 24%
had persistent AF, 7.2% had long-standing persistent AF, and 38.8%
had permanent AF.[1]The results support the concept that persistent
AF is a transient disease state, and that factors such as underlying
heart disease and advancing age contribute to the progression of AF
to a permanent disease state in most patients.[5],[6],[7]

"PREFER in AF illustrates changes in management of patients with
AF since the last 'Guidelines for the management of atrial
fibrillation: The Task Force for the Management of Atrial
Fibrillation of the European Society of Cardiology (ESC)' update in
2010. The registry shows that oral anticoagulant therapy is now much
more widely used than in the German Competence Network on Atrial
Fibrillation (AFNET) and the EuroHeartSurvey registries and suggests
that European clinicians are using guidelines well. The rapid uptake
of new oral anticoagulants suggests that these drugs are filling a
therapeutic gap", stated Professor Paulus Kirchhof, Chair in
Cardiovascular Medicine, University of Birmingham and Chair of the
PREFER in AF Steering Committee.

By measuring pharmacoeconomic data, the PREFER in AF registry will
provide a breakdown of the attributing cost of AF for European
healthcare systems. Incorporating economic data on drug treatment,
disease and treatment complications including hospitalisation, the
data will provide valuable insight into where improvements can be
made to optimise current practice.

Kirchhof explained: "The baseline data that we reported today
already provides new information on how evidence and guideline
recommendations translate into clinical practice. The one-year follow
up data will provide information on how these management patterns
relate to outcomes. We hope that this data set, together with other
emerging data, will provide a good basis to further improve
management of AF patients."

AF affects over 6 million people across Europe[2] and is the most
common form of clinically significant arrhythmia.[8] The annual cost
of AF per patient worldwide is approximately EUR3,000,[8] with the
total cost across Europe approximately EUR13.5 billion per year.[8]
By recording clinical outcomes, patient quality of life and
satisfaction scores and healthcare costs, the PREFER in AF registry
will allow an evaluation of the suitability and economic burden of
current treatment practices and measure the efficiency of new oral
anticoagulants. The PREFER in AF registry will generate unbiased data
on stroke prevention management approaches, patient satisfaction
scores regarding anticoagulant treatment and management, and quality
of life markers to help shape ongoing developments and optimum
outcomes for both patients and European healthcare systems.

Daiichi Sankyo, a global leader in cardiovascular medicine, is the
sponsor of this registry study. "Our company is dedicated to the
advancement of cardiovascular medicine in disease areas such as AF.
By taking a patient focused, real life approach, PREFER in AF will
provide a detailed snapshot highlighting current management of this
disease and where ongoing development and innovation is required to
optimise patient care", confirmed Dr. Jan van Ruymbeke, CEO Daiichi
Sankyo Europe.

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).[9],[10]
Edoxaban is studied with two distinct dosages in ENGAGE AF-TIMI 48,
the largest atrial fibrillation trial to date, with more than 20,500
patients.[10] Hokusai-VTE is the largest single phase 3 clinical
study in the treatment and prevention of recurrence of VTE, with more
than 8,250 patients.[9],[11]

Notes to editors:

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 AF

AF is an abnormal rhythm of the heart.[12] The heart has four
chambers - two atria and two ventricles.[13] The atria pump blood
into the ventricles and the right ventricle pumps blood around the
body; they therefore have to work in sequence for the heart to pump
blood most effectively with each heartbeat.[13] A normal heart pumps
blood with a regular rhythm - it can beat quickly or slowly but the
interval between beats is the same.[13]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.[13]
When this happens, the atria contract rapidly, but only partially,
and as a result pump blood less effectively.[13] 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 e.g. to the brain, where they have
the potential to cause a stroke.[13]

About Edoxaban

Edoxaban is licensed only in Japan for the prevention of venous
thromboembolism (VTE) after major orthopaedic surgery, under the
brand name Lixiana(R). Elsewhere, including Europe and the U.S.,
edoxaban is currently in phase 3 of clinical development and has not
yet been approved. Daiichi Sankyo continues to develop edoxaban at a
global level as a potential new treatment for the prevention of SEE
in patients with NVAF and for the treatment and prevention of
recurrence of VTE in patients with acute DVT and/or PE.

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 optimise 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. Trends in management of patients with atrial fibrillation in 5
European countries: Primary results of the PREFER in AF Registry.
Presented at the Europace Congress, Late Breaking Trials session II,
26 June 2013.

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. Pedersen, O. D. et al. Increased risk of sudden and non-sudden
cardiovascular death in patients with atrial fibrillation/flutter
following acute myocardial infarction. European Heart Journal.
2006;27:290-5.

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. Kirchhof, P., Lip, G.Y., Van Gelder, I.C. et al. Comprehensive
risk reduction in patients with atrial fibrillation: Emerging
diagnostic and therapeutic options. Executive summary of the report
from the 3rd AFNET/EHRA consensus conference. Thromb Haemost
2011;106:1012-9.

6. de Vos, C.B., Pisters, R., Nieuwlaat, R. et al. Progression
from paroxysmal to persistent atrial fibrillation clinical correlates
and prognosis. J Am Coll Cardiol 2010;55:725-31.

7. Jahangir, A., Lee, V., Friedman, P.A. et al. Long-term
progression and outcomes with aging in patients with lone atrial
fibrillation: a 30-year follow-up study. Circulation 2007;115:3050-6.

8. Fuster, V. et al. ACC/AHA/ESC 2006 Guidelines for the
Management of Patients With Atrial Fibrillation-Executive Summary.
Circulation. 2006;114:700-752.

9. Raskob, G. et al. Edoxaban for the long-term treatment of
venous thromboembolism: rationale and design of the Hokusai-VTE
study. 2013.

10. Ruff, C et al. Evaluation of the novel factor Xa inhibitor
Edoxaban compared with warfarin in patients with atrial fibrillation:
Design and rationale for the Effective aNticoaGulation with factor xA
next Generation in Atrial Fibrillation-Thrombolysis In Myocardial
Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J.
2010;160:635-641.

11. Clinicaltrials.gov: NCT00986154. Comparative Investigation of
Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus
(LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein
Blood Clots and/or Lung Blood Clots.(The Edoxaban Hokusai-VTE
Study).[Last accessed: May 2013]. Available at:http://clinicaltrials.
gov/ct2/show/study/NCT00986154?show_locs=Y#locn

12. NHS Choices. Atrial Fibrillation. Available at http://www.nhs.
uk/conditions/atrial-fibrillation/pages/treatment.aspx. Last accessed
April 2013.

13. Patient.co.uk http://www.patient.co.uk/pdf/pilsL10.pdf. Last
accessed April2013

.

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

ots Originaltext: DAIICHI SANKYO EUROPE GmbH
Im Internet recherchierbar: http://www.presseportal.de