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ESC Congress 2004: Efficacy and safety of ximelagatran confirmed for stroke prevention in atrial fibrillation

August 29, 2004

European Society of Cardiology Congress (ESC), Munich, Germany: Results presented today from the final pooled analysis of SPORTIF III and V1,2 confirm that ximelagatran - the first oral direct thrombin inhibitor (oral DTI) - is as effective as well-controlled warfarin, the current standard anticoagulant treatment for the prevention of stroke in patients with atrial fibrillation (AF), but without the need for coagulation monitoring or individual dose titration.

Patients with AF, an erratic heartbeat which increases the chance of developing a thrombus, are five times more likely to suffer a stroke than those with normal heart rhythm. Studies show that the risk of stroke can be reduced by 62% in AF patients by taking anticoagulant therapy3, but that only half of eligible patients currently receive appropriate anticoagulant treatment4.

Although existing anticoagulant treatments are effective, they have limitations. Vitamin K antagonists (VKAs), for example warfarin, are associated with extensive drug and food interactions and require coagulation monitoring and dose titration.
"The findings from this detailed analysis of the SPORTIF study programme results are very encouraging as they further demonstrate in two independent studies that ximelagatran is both safe and effective in the prevention of stroke for people with atrial fibrillation. This treatment offers a welcome and long awaited advance in anticoagulation therapy and should see a significantly larger proportion of patients who require treatment actually receiving it - reducing the incidence of stroke," commented Professor Bertil Olsson, co-chairman of the executive steering committee of SPORTIF III & V, Department of Cardiology, Lund University, Sweden.

Use of ximelagatran was in some patients associated with an elevation of liver enzymes (ALAT >3XULN) which were typically transient, not associated with specific clinical symptoms, and decreased towards normal whether or not treatment was continued or stopped.

Ximelagatran is currently under regulatory review in the EU and US for key chronic-use indications including the prevention of stroke and other thromboembolic complications associated with AF. It is now available in Germany, Sweden, Portugal and Finland in its first indication: the prevention of venous thromboembolic events (VTE) in patients undergoing elective hip or knee replacement surgery (orthopaedic surgery). A submission for prevention of VTE in major elective orthopaedic surgery (knee replacement) has also been filed in the US to the FDA.

B Olsson (Lund, SE)

*****

This press release accompanies both a presentation and an ESC press conference given at the ESC Congress 2004. Written by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology

European Society of Cardiology (ESC)

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