European patient registry in venous thromboembolism (VTE) - PREFER in VTE - enrols first patient

MUNICH, February 6, 2013 /PRNewswire/ --

The registry plans to gather data from more than 4,000 patients with VTE across seven European countries, providing insights into the clinical management of a disease that is a leading cause of morbidity and mortality^[1]

Daiichi Sankyo Europe GmbH announced the enrolment of the first patient into the PREvention oF thromboembolic events - European Registry in Venous ThromboEmbolism (PREFER in VTE).  PREFER in VTE is the first patient registry to gather comprehensive data on the quality of life and treatment satisfaction of patients with VTE. It will also provide detailed insights into the process of patient management in the acute treatment phase, as well as in the prevention of repeat thromboembolic events. In addition, the PREFER in VTE registry will investigate the economic burden of VTE treatment.  

Discussing the importance of this registry, Dr. Alexander T. Cohen, Honorary Consultant Vascular Medicine, Department of Vascular Surgery, King's College Hospital, London, said, "The enrolment of the first patient in this registry is an exciting milestone. 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."

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 EU.^[1] Results of literature reviews have shown that VTE, and its consequences, have considerable economic impacts on healthcare systems.^[2]

The PREFER in VTE registry plans to enrol more than 4,000 patients with VTE (deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) across approximately 400 recruiting hospitals and specialised centres, in seven major European countries (Austria, France, Germany, Italy, Spain, Switzerland and the UK). By collecting key data from different geographies, the registry will highlight important risk factors, as well as demonstrate diagnosis pathways and treatment modalities in this patient population. The review of current therapy and healthcare resource use will allow an evaluation of the relationship between the use of anticoagulants and approximate therapy costs. In contrast to other registries in this setting, PREFER in VTE is the first of its kind to also analyse the relationship between VTE treatment, a patient's quality of life and treatment satisfaction.

In 2012, Daiichi Sankyo Europe GmbH started another large registry, focussing on patients suffering from atrial fibrillation (AF) - the PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF). The company has now completed the enrolment of more than 7,100 patients who will be followed up for 12 months. The first set of data will be available in the summer of 2013.

The PREFER in VTE and PREFER in AF registries reinforce Daiichi Sankyo's leadership in cardiovascular medicine.^[3] Dr. Jan van Ruymbeke, CEO of Daiichi Sankyo Europe GmbH, stated, "Daiichi Sankyo is committed to improve patient outcomes which means applying our expertise and innovation to provide best- in-class medicine for our patients."

Daiichi Sankyo discovered and is currently studying edoxaban, a novel once-daily oral factor Xa inhibitor, as a potential new treatment option for the prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). It is also being developed for the potential treatment and prevention of recurrence of VTE in patients with DVT and/or PE.^[4],[5]

About PREFER in VTE

The PREFER in VTE registry enrolled the first patient in January, 2013. The registry is a multi-centre, prospective observational disease registry, with a one-year follow up. The patient sample will represent patients with acute initial or recurrent VTE (PE and/or DVT) with no exclusion criteria. Baseline visits will be conducted by investigators and standardised patient telephone follow-up interviews will be performed in regular intervals up to 12 months.

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 VTE
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.^[6] DVT and PE are the two sub-types of VTE.^[7] DVT is caused by a blood clot anywhere in the deep veins of the legs, pelvis or arms.^[8] PE is caused by a clot that detaches from the vein and travels to the lungs,^[8] lodging in the pulmonary arteries causing a potentially fatal condition.^[8],[9] PE is often accompanied by DVT and a DVT can develop into a PE suddenly.^[9] It is estimated that VTE is the cause of approximately 12% of annual deaths across Europe.^[1]

As demonstrated by data from six major European countries, VTE affects more than 750,000 people annually.^[1] 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.  

About AF

AF is an abnormal rhythm of the heart.^[10] The heart has four chambers - two atria and two ventricles.^[11] 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.^[11]

A normal heart pumps blood with a regular rhythm - it can beat quickly or slowly but the interval between beats is the same.^[11] 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.^[11] When this happens, the atria contract rapidly, but only partially, and as a result pump blood less effectively.^[11]

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.^[11]

About Edoxaban

Edoxaban is licensed only in Japan for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery, under the brand name Lixiana^®.

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

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 infectious diseases, the Group is engaged in the development of innovative treatments for thrombotic disorders and focused on the discovery of novel therapies in the designated priority research areas of oncology and cardiovascular-metabolic therapies.

Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," encompassing innovative pharmaceuticals (new drugs), established pharmaceuticals (generics), vaccines, and OTC products, which will globally respond to market and customer diversity and optimize growth opportunities across the value chain.

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.

1. Cohen AT, Agnelli G, Anderson FA et al. Venous thromboembolism (VTE) in Europe. Thromb Haemost 2007; 98:756-64.

2. Ruppert A et al. Economic burden of venous thromboembolism: a systematic review. Journal of Medical Economics Vol. 14, No. 1, 2011: 65-74.

3. PREFER in AF Observational Plan - Daiichi Sankyo data on file. August 2011

4. Clinicaltrials.gov: NCT00781391. Global Study to Assess the Safety and Effectiveness of DU-176b vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation (EngageAFTIMI48) [Last accessed May 2012]. Available at: http://clinicaltrials.gov/ct2/show/NCT00781391?term=ENGAGE++AF-TIMI+48&rank=1

5. 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: July 2012]. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00986154?term=hokusai&rank=1 

6. Loue and Sajatovic Encyclopedia of Aging and Public Health 2008, XXIII, 843 p. 10 illus.

7. The Coalition to Prevent VTE. Available at: http://www.coalitiontopreventvte.org/ . Accessed January 2013

8. Lung Disorders 2007 By Peter B. Terry, M.D.

9. Cleveland Clinic. Venous Thromboembolism. Available at: http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/cardiology/venous-thromboembolism/. Accessed April 2012

10. NHS Choices. Atrial Fibrillation. Available at http://www.nhs.uk/conditions/Atrial-fibrillation/Pages/Introduction.aspx. Last accessed January 2013

11. Patient.co.uk http://www.patient.co.uk/pdf/pilsL10.pdf. Last accessed January 2013

SOURCE Daiichi Sankyo Europe GmbH