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EXANTA (TM), an oral direct thrombin inhibitor, significantly reduces risk of VTE in major OS

17th International Congress on Thrombosis, Bologna, 26 October 2002: Important results from the EXPRESS clinical trial for the oral direct thrombin inhibitor (Oral DTI), EXANTA (oral ximelagatran and its active form, melagatran) show its superior efficacy in reducing risk of major venous thromboembolism (VTE), compared with a routinely used prophylactic treatment, enoxaparin, in major orthopaedic surgery.

Results show a significant 63 per cent relative risk reduction (2.3% vs 6.3%) in major venous thromboembolism (VTE) - proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) - when treated with EXANTA, compared to standard prophylaxis with enoxaparin (40mg od). The relative risk reduction in major VTE was 67 per cent (1.8% vs 5.5%) for total hip replacement and 60 per cent (3.3% vs 8.2%) for total knee replacement surgery.

EXPRESS is a randomised, double-blind study of 2,800 patients that compares the efficacy and safety of EXANTA (subcutaneous melagatran followed by oral ximelagatran), with that of the routinely used prophylactic treatment, subcutaneous enoxaparin (40mg od), for the prevention of venous thromboembolism (VTE) following major hip and knee replacement surgery.

"These results indicate that in the future, ximelagatran could more efficiently reduce this risk than current treatments. In addition, a treatment that can be taken orally and does not require coagulation monitoring, would improve the treatment benefit and patient acceptance," commented Associate Professor Bengt Eriksson, principal investigator of the EXPRESS trial. "Prophylactic treatment is needed before major orthopaedic surgery in order to prevent development of VTE, which can lead to serious complications."

Between 45-57 per cent of patients undergoing total hip replacement without thromboprophylaxis develop DVT1 (deep vein thrombosis), a potentially fatal condition. Similarly, the rate of DVT for patients undergoing total knee replacement is
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Contact: Liz Rickard
elizabeth.rickard@ketchum.com
44-207-611-3633
Ketchum
28-Oct-2002


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