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Daiichi to build European atrial fibrillation trial registry

Will use ‘real life data’ from 5,000 patients with the heart condition

Daiichi Sankyo Europe is to use 'real life data' to build a European patient registry for atrial fibrillation (AF), one of the most common causes of stroke.

Existing records of 5,000 AF patients from seven European countries will be used to gather comprehensive data on the condition, which is categorised as an abnormal rhythm of the heart, across a wide range of AF severity.

Daiichi anticipates its study will fill 'knowledge gaps' identified in a 2010 World Heart Foundation paper that determined large areas of information were missing regarding AF management and outcomes.

This includes data about both the difference valvular and non valvular forms of the condition, as well as the impact of new anticoagulant therapies on stroke prevention.

Patient satisfaction will also play a large role in the study, with Daiichi attempting to gain insight into a patient's management of AF as well as the impact of the condition and its effect on quality of life.

Professor José Luis Zamorano is co-chair of the study's steering committee and professor of cardiology at the University Clinic San Carlos, Madrid, Spain.

He said: "This essential patient registry is important as it is focused on patients' quality of life and treatment satisfaction, which are key factors when considering optimal patient care.

“AF is a condition associated with high morbidity and mortality and when patients are satisfied with their treatment, they stay on treatment." 

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.

The registry will collect data from Austria, France, Germany, Italy, Spain, Switzerland and UK, generating nationally representative data on stroke prevention management approaches, patient satisfaction scores regarding anticoagulant treatment and management, and quality of life markers.

Health economic data will also be collected to assess the true cost of AF for European healthcare systems.

It is hoped the data gathered will help establish whether current treatment developments are translating into effective patients outcomes for a condition that affects one to two per cent of the general population in Europe.

The use of 'real life data' follows AstraZeneca's deal with IMS Health to access existing anonymised electronic health records to understand better how its medicines perform once they reach the market.

Data obtained outside a clinical environment has also been supported by Stephen Whitehead, CEO of the UK's Association of the British Pharmaceutical Industry (ABPI).

In a speech last year, he said the benefits of such research would mean better management of chronic conditions and avoidances of preventable hospitalisations.

16th January 2012

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