Clinicians and patient groups have welcomed today's announcement by the National Institute of Health and Clinical Excellence (NICE) recommending Pradaxa® (dabigatran etexilate) as an option for the primary prevention of venous thrombembolic events in adults who have undergone elective total hip or total knee replacement surgery.

(1) This positive NICE appraisal coincides with the recent publication of a government venous thromboembolism (VTE) risk assessment tool recommended for all patients admitted to hospital in England by the Department of Health.(2) Routine risk assessment is a fundamental step in ensuring patients at risk of developing VTE receive the appropriate therapy and management. VTE is a potentially fatal blood clotting disease which includes deep vein thrombosis (DVT) and pulmonary embolism (PE).

VTE is the most common cause of preventable hospital death in the UK.(3) Up to 32,000 patients die every year in the UK(4) after developing blood clots in hospital and a recent analysis by the All Party Parliamentary Thrombosis Group revealed that over 10,700 UK hospital patients may have died from blood clots in just seven months during 2007 as a result of clinical guidelines not being implemented.(3)

Until now, anticoagulant therapy to prevent blood clots after major orthopaedic surgery has generally required administration by injection. Pradaxa® is the first new oral anticoagulant to be launched in the UK for over 50 years. It is a fixed dose, once daily capsule that may be taken with or without food.(5) NICE concluded that Pradaxa®, as an oral therapy, without the need for monitoring, would reduce National Health Service (NHS) administration costs and may support adherence to treatment.(1)

The charity AntiCoagulation Europe welcomed NICE's recommendation. Chief Executive, Eve Knight, said:

"We are delighted with today's NICE announcement, and also very pleased that the long awaited Risk Assessment Tool has finally been published. It is appalling that patients are still developing and dying from VTE, which could be prevented by risk assessing every patient on admission to hospital and giving preventative treatment where needed. Pradaxa, a once daily oral therapy for use in post orthopaedic surgery, will enhance the treatment options available and enable clinicians and patients to make decisions on choice of treatment appropriate to their clinical needs."

Pradaxa® was approved by the EMEA for marketing in all EU member countries in March 2008 and since then swift progress has been made with positive recommendations from local Health Technology Assessment bodies in Scotland (Scottish Medicines Committee), Denmark (Danish Medicines Agency) and The Netherlands (The Health Care Insurance Board).(9-11) To date, Pradaxa® has been launched in a total of eleven countries.

Pradaxa® is one of a new class of drugs to tackle DVT and PE called direct thrombin inhibitors (DTI). DTIs directly block the enzyme thrombin which is central to the clotting process.(12)