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

February 6, 2013 By PR Newswire

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.

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