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NICE recommends Pradaxa

The National Institute for Health and Clinical Excellence (NICE) has issued a draft recommendation in favour of Boehringer Ingelheim's Pradaxa
The National Institute for Health and Clinical Excellence (NICE) has issued a draft recommendation in favour of Boehringer Ingelheim's Pradaxa for use in adults who have undergone elective total hip or knee replacement surgery.

According to Boehringer, Pradaxa is the first oral anticoagulant for preventing venous thromboembolism (VTE) to be licensed in the UK for more the 50 years. The drug was given marketing authoristaion for use in all 27 EU Member States by the European Medicines Agency (EMEA) in March 2008. With correct use of thromboprophylaxis including anticoagulation therapy, VTE is preventable.

NICE recently reported that approximately 30 per cent of all surgical patients are affected by deep vein thrombosis and a House of Commons Health Committee report said that up to 32,000 patients die every year after developing blood clots in hospital. Procedures such as hip and knee replacement surgery carry a high risk of VTE and as a result effective anticoagulation is needed to protect patients from fatal blood clots.

"A key reason patients at risk of blood clots after surgery do not receive adequate protection is that existing appropriate anticoagulants may be perceived to be associated with poor compliance, in particular injectable thromboprophylactics," said Eve Knight, executive director of AntiCoagulation Europe (ACE), a charity which works to prevent VTE. "An oral anticoagulant that does not require anticoagulation monitoring is a major advance and will enable patients to continue with important preventative therapy after surgery and hospital discharge."
Pradaxa is a novel direct thrombin inhibitor with a rapid onset and offset of action and a predictable anticoagulation effect. It prevents thrombus formation by specifically and selectively inhibiting thrombin, the final and essential enzyme in the coagulation cascade that enables conversion of fibrinogen into fibrin.
Final NICE guidance for NHS clinical practice is expected shortly.

29th July 2008


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