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New data support the safety and tolerability of the novel oral anticoagulant Exanta for stroke prevention in patients with atrial fibrillation

(Stockholm, Sweden, 3 September 2001) New data on the use of the novel oral anticoagulant Exanta, for stroke prevention in patients with non-valvular atrial fibrillation, were presented today at the 23rd European Society of Cardiology (ESC) meeting in Stockholm.¹ The three-month phase II, SPORTIF II, data show that Exanta is well tolerated in patients over an extended period of time, with comparable efficacy to warfarin, and without the need for dosage adjustment or routine coagulation monitoring. Exanta , an oral direct thrombin inhibitor, is set to be the first new oral anticoagulant since warfarin was introduced over 50 years ago.

Atrial fibrillation is the most common cardiac arrhythmia in clinical practice,² with incidence approximately doubling with each decade of adult life.³ Frequency has been shown to increase from 3.8% in patients aged <50 years to 34.3% in those aged >90 years.2 More than two million people are estimated to be affected with atrial fibrillation in the US1 and the risk of developing stroke is high. A recent European survey also showed that 18% of patients presenting with a first stroke were found to have atrial fibrillation.²

'The SPORTIF II results are very promising' said Professor Bertil Olsson, Department of Cardiology, University Hospital, Lund, Sweden, a lead investigator in the SPORTIF II trial. 'Fixed doses of Exanta were well tolerated without the need for dose adjustment or coagulation monitoring in patients with medium to high risk for stroke and systemic embolism. Exanta truly offers the possibility of better, simpler, anticoagulation for millions of patients.'

Professor Olsson continued 'Anticoagulation treatment with warfarin can be very effective in preventing strokes in patients with atrial fibrillation. However, doctors are often reluctant to treat patients because of the high burden of warfarin treatment. Undertreatment remains the major problem in stroke prevention for pat
'"/>

Contact: Jonathan Wilson
jonathan.wilson@ketchum.com
44-7968-799-349
Ketchum
3-Sep-2001


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