New data support the efficacy and safety of the novel oral anticoagulant Exanta

(Mlndal, Sweden, 10 July 2001) The presentation of a wide range of data at the 18th International Society on Thrombosis and Haemostasis meeting (ISTH) in Paris this week, provided new evidence to support the efficacy and safety of Exanta, which is set to be the first new oral anticoagulant since warfarin was introduced over 50 years ago.

Exanta, an oral direct thrombin inhibitor, is currently under investigation in an extensive phase III clinical trials programme in a number of key therapeutic areas. The programme, which involves more than 15,000 patients in 30 countries, includes European and US phase III studies in the prevention of blood clot formation in the leg veins of patients undergoing orthopaedic surgery, presented at the ISTH. These blood clots in leg veins, or deep vein thrombosis (DVT), can dislodge and travel to the lung causing pulmonary embolism (PE). DVT and PE together are known as venous thromboembolism (VTE).

Dr Ian Watts, Global Product Director, said: "Over 20 abstracts were selected for oral and poster presentation at the ISTH meeting, including the phase III results from US and European trials of VTE prophylaxis in orthopaedic surgery. These data show that Exanta has efficacy and tolerability at least comparable to that of warfarin or a low molecular weight heparin compound, the standard anticoagulants in the US and Europe respectively."

The European phase III trial, one of the largest ever trials of VTE prophylaxis in orthopaedic surgery, included 2788 patients undergoing total hip or total knee replacement surgery, in centres across Europe. The study, which compared the efficacy and safety of Exanta to the low molecular weight heparin, enoxaparin showed it to be effective and well tolerated for VTE prevention, with efficacy comparable to that of enoxaparin. The earlier phase II trial also showed Exanta to be comparable to another low molecular weight heparin, dalteparin.

The US phase III trial,

Contact: Rina Amin

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