To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ESC: Exanta (Ximelagatran) Safe/Tolerable for Stroke Prevention in Atrial Fibrillation URL: http://www.pslgroup.com/dg/20563A.htm Doctor's Guide September 4, 2001
STOCKHOLM, SWEDEN -- September 4, 2001 -- New data on the use of the novel oral anticoagulant Exanta® (ximelagatran), 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 (Stroke Prevention by Oral Thrombin Inhibition in Atrial Fibrillation-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 percent in patients aged <50 years to 34.3 percent in those aged >90 years. More than two million people are estimated to be affected with atrial fibrillation in the US, and the risk of developing stroke is high.
A recent European survey also showed that 18 percent 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. 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. Under-treatment remains the major problem in stroke prevention for patients with atrial fibrillation."
The longer-term phase II, SPORTIF IV data in this important indication will be presented later this year. The phase III SPORTIF programme, comprising the SPORTIF III and V studies, is the largest-ever programme conducted in this indication with more than 6,200 patients enrolled.
Exanta is being investigated in a large clinical trials programme, including venous thromboembolism (VTE) prophylaxis in orthopaedic surgery, deep vein thrombosis (DVT) treatment, stroke prevention in atrial fibrillation and acute coronary syndrome. To date, more than 15,000 patients in 30 countries have been involved in clinical trials.
References:
1. Olsson B, Petersen P. Fixed dose oral direct thrombin inhibitor ximelagatran as an alternative for dose-adjusted warfarin in patients with non-valvular atrial fibrillation. Poster Number:1761 ESC Stockholm 2001.
2. Lamassa M, Di Carlo A, Pracucci G et al. Characteristics, outcome, and care of stroke associated with atrial fibrillation in Europe. Data from a multicenter multinational hospital-based registry (The European Community Stroke Project). Stroke 2001; 32:392-398.
3. Falk RH. Atrial fibrillation. N Engl J Med 2001; 344: 1067-1078.
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