Press Release

Press Release
[For European Media Only]
PREFER in VTE registry reveals new insights into use of Novel Oral
Anticoagulants (NOACs) in the treatment and management of venous
thromboembolism (VTE)
VTE is a leading cause of morbidity and mortality worldwide and the annual number of VTE-related
deaths has been estimated at more than 500,000 across the EU1
ESC Congress, 30 August - 03 Sept 2014, Barcelona, Spain: Daiichi Sankyo Europe GmbH today
announced snapshot results from the PREvention oF thromboembolic events - European Registry in
Venous ThromboEmbolism (PREFER in VTE), including initial baseline analysis of the management
and use of Novel Oral Anticoagulants (NOACs) across Europe.2,3
Closing the current gap in understanding regarding the management of patients with VTE across
Europe, the baseline data reveals that although NOACs are used frequently throughout Europe for
the treatment of VTE, usage varies greatly from country to country and is associated with variable
patient characteristics.2 Germany, Austria and Switzerland are leading the way in uptake of NOAC
use with 46.7% of patients compared with 8% in Spain and 3.2% in Italy, 2 where the blood thinners
have recently been made available.
At the time of analysis patient enrolment was still ongoing, with the preliminary results evaluating
1,843 VTE patients (62.8% with Deep Vein Thrombosis [DVT] and 37.2% suffering from Pulmonary
Embolism [PE])3 showing that NOAC use in DVT and PE patients is in the same ballpark (DVT 23.9% vs.
PE 18.4%).2 Initial baseline analysis highlighted that NOACs are currently used more frequently in
younger patients; 26.8% in those aged < 65 years, compared with 19.8% in those aged 65 to 74 and
14.3% in those > 75 years,2 with the mean age of the evaluable patient population currently being
61.6 years of age.3
Within a clinical trial setting, current data supports NOAC efficacy and safety including a significantly
reduced risk of bleeding events compared to standard of care heparin/warfarin treatment,4 yet the
PREFER in VTE baseline data shows limited use of NOACs in practice with patients registered at a
lower weight (≤60 kg vs >60kg; 13.4% vs 23.3%), with renal impairment (22.7% vs 11.1% in patients
with CRCL levels >60 ml/min vs. ≤60ml/min), diabetes (22.9% vs 13.5% in patients without/with
diabetes) and those at risk of bleeding (HAS-BLED low 27.1%, medium 17.8%, high 12.5%).2
PREFER in VTE is a registry investigating the management and use of NOACs in the treatment and
management of VTE2 and has been designed with a unique patient focus gathering comprehensive
data on the quality of life and treatment satisfaction of patients with VTE.5 It collates real-life data
from VTE patients across 388 recruiting hospitals and specialised centres in Austria, France, Germany,
Italy, Spain, Switzerland, and the UK.2,3
Date of preparation: August 2014
Job bag: EDX/14/0053
Commenting on the importance of this registry, Dr. Alexander T. Cohen Consultant Vascular
Physician, Department of Haematology, Guys and St Thomas' Hospitals and King’s College London, ,
Co-Chairman of the PREFER Study said: “PREFER in VTE is the first registry of its kind that will
provide detailed insight into the patient’s perspective. Relying on patient interviews and diaries
rather than focusing purely on a doctor’s assessment of VTE, will give us important patient data
outside of a clinical trial setting. The ability to assess current management of VTE in practice and
monitor its development over a 12 month period will help establish whether current treatment
developments are translating into optimal management in practice, and support ongoing
developments to give patients the best possible outcomes.”
In Europe there are over one million VTE events annually,1,3 causing more than double the number of
deaths among Europeans than breast cancer, prostate cancer, HIV/AIDS and road traffic accidents
combined each year.1 Despite this, there is a paucity of data regarding current, real-life case-mix and
management of the disease.3,6
Discussing the need for real-life insights, Professor Giancarlo Agnelli , Professor of Internal Medicine
at the University of Perugia, Director of the Department of Internal and Cardiovascular Medicine and
Stroke-Unit at the University Hospital in Perugia, commented: “We are delighted to announce the
baseline data from PREFER in VTE. The registry enables us to assess genuine outcomes for patients
with deep vein thrombosis or pulmonary embolism and for the first time will demonstrate the true
impact of VTE on patient quality of life in Europe. It’s important that we have registries such as this
to provide us with data outside of a clinical setting for variable patient populations including those at
higher risk. As such, these insights need to be considered in therapeutic pathways moving forward.”
PREFER in VTE will go on to provide detailed insights into the characteristics and management of
patients with VTE. Exploring geographic variations in the management of VTE patients will provide
demographic data, along with key insights into risk factors, management of diagnosis and treatment
modalities within this patient population.
Dr. Juan Carlos Jaramillo, Head of Market Access and Medical, Daiichi Sankyo Europe GmbH, said:
“By focusing on patients perspectives, real life approach, PREFER in VTE will give a detailed snapshot
highlighting current management of this disease and insight into further improving patient care.”
Daiichi Sankyo, a global leader in cardiovascular medicine, is sponsor of this registry and is dedicated
to support advancement in cardiovascular medicine and related indications such as VTE.
-EndsFor more information, please contact:
Daria Munsel
Daiichi Sankyo Europe GmbH
Tel: +49 (89) 7808728 (Office)
Date of preparation: August 2014
Job bag: EDX/14/0053
Notes to editors:
About PREFER in VTE
The PREFER in VTE registry is a multicentre, prospective observational disease registry, with a oneyear follow up, enrolling patients with VTE, in particular deep vein thrombosis (DVT) and/or
pulmonary embolism (PE).2,3
PREFER in VTE is the first registry of its kind to collate comprehensive data on the management of
patients with VTE with key insight into patient satisfaction and quality of life.2,3 In addition to the
clinical outcomes, PREFER in VTE has been set up to capture real life data regarding quality of life,
patient satisfaction and the economic burden of VTE treatment across Europe.5
All patients taking part in the study are at least 18 years of age and have all been diagnosed with
acute initial or recurrent VTE. The observation criteria for PREFER in VTE include:5
 Site and physician characteristics
 Patient characteristics (including basic characteristics such as demography and medical
history)
 Patient pathways (including referral details between primary and secondary care)
 Drug utilisation (including drug type, dosage and where applicable INR levels)
 Health related quality of life (including standardised tests and anecdotal feedback)
 Healthcare resource use (including diagnosis measures, number of medical appointments
and productivity loss).
Baseline visits are conducted by investigators and standardised patient telephone follow-up calls will
be performed at 1, 3, 6 and 12 months.2
About VTE
VTE is a leading cause of morbidity and mortality worldwide7 and the annual number of VTE-related
deaths has been estimated at more than 500,000 across the EU.1 Thirty per cent of people with VTE
die within one month of diagnosis.8
VTE is the term for the generation of a blood clot within a vein, or the subsequent breaking off of
that clot into a pulmonary (lung) artery.9
DVT and PE are the two sub-types of VTE.6 DVT is caused by a blood clot anywhere in the deep veins
of the legs, pelvis or arms.10 PE is caused by a clot that detaches from the vein and travels to the
lungs, lodging in the pulmonary arteries causing a potentially fatal condition.11,12 PE is often
accompanied by DVT and a DVT can develop into a PE suddenly.13
Results of literature reviews have shown that VTE, and its consequences, have considerable
economic impacts on healthcare systems.14
Traditional therapies are often inconvenient and cumbersome, due to food and drug interactions, as
well as the need for strict international normalized ratio (INR) monitoring. The conventional
treatment of VTE in Europe has been use of heparin and vitamin K antagonists (VKA), and although
effective, they have numerous limitations.2
Date of preparation: August 2014
Job bag: EDX/14/0053
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, dyslipidemia and
bacterial infections used by patients around the world, the Group has also launched treatments for
thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research
and development is focused on bringing forth novel therapies in oncology and cardiovascularmetabolic diseases, including biologics. The Daiichi Sankyo Group has created a "Hybrid Business
Model" to respond to market and customer diversity and optimize growth opportunities across the
value chain. For more information, please visit: 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: 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 forwardlooking 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. Cohen AT, Agnelli G, Anderson FA et al. Venous thromboembolism (VTE) in Europe. Thromb
Haemost 2007; 98:756-64.
2. Agnelli, G. et al. The Current use of direct oral anticoagulants (DOACs) for the treatment of
VTE in Europe-PREFER in VTE. [PREFER in VTE abstract 86264 for ESC]. 2014.
3. Cohen, AT. Et al. Venous Thromboembolism management in European countries: baseline
characteristics, risk factors, and comorbidity data from PREFER in VTE registry. (PREFER in
VTE abstract 86707 for ESC). 2014.
4. Cohen, A. et al. Phase III Trials of New Oral Anticoagulants in the Acute Treatment and
Secondary Prevention of VTE: Comparison and Critique of Study Methodology and Results.
Adv Ther 2014; 31:473–493.
5. PREFER in VTE. Prevention of thromboembolic events – European registry in venous
thromboembolism. DSE-VTE-01-12. Data on file. Registered at Deutsches Register für
Klinische Studien; ID=DRKS00004795
Date of preparation: August 2014
Job bag: EDX/14/0053
6. The Coalition to Prevent VTE. Available at:
http://www.coalitiontopreventvte.org/INDEX_CFM/T/THE_BURDEN_OF_VTE/OBJECTID/866
876ED_1422_16B3_78D29387FBC3/VID/9E7D3566_C09F_296A_6111019937AE/CONTAINER
ID/666415AA_C09F_296A_61DB66942768/DISPLAYMETHOD/DISPLAY_ARTICLE.HTM. Last
accessed August 2014.
7. Bramlage, P., Pittrow, D. & Kirch, W. Current concepts for the prevention of venous
thromboembolism. European Journal of Clinical Investigation. 2005;35(1):4–11.
8. Beckman, MG., Critchley, SE., Hooper, WC., Grant, AM., Kulkarni, R. CDC Division of Blood
Disorders: public health research activities in venous thromboembolism. Arteriosclerosis,
Thrombosis, and Vascular Biology. 2008;28:394–5.
9. Loue and Sajatovic Encyclopedia of Aging and Public Health 2008, XXIII, 843 p. 10 illus.
10. Cleveland Clinic (2011) Deep Vein Thrombosis (DVT). Available at:
http://my.clevelandclinic.org/disorders/blood_clots/hic_deep_vein_thrombosis_dvt.aspx.
Last accessed June 2014.
11. NHS Choices (2012) Deep vein thrombosis. Available at:
http://www.nhs.uk/conditions/Deep-vein-thrombosis/Pages/Introduction.aspx.
Last accessed June 2014.
12. Ozaki, A. Cleveland Clinic (2012). Venous thromboembolism. Available at:
http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology/veno
us-thromboembolism/#s0010.Last accessed July 2014.
13. Zagaria, M. Venous Thrombosis: Pathogenesis and Potential for Embolism. US Pharm.
2009;34:22-24.
14. Ruppert, A. et al. Economic burden of venous thromboembolism: a systematic review.
Journal of Medical Economics Vol. 14, No. 1, 2011: 65–74.
Date of preparation: August 2014
Job bag: EDX/14/0053

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