News Release

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

Peer-Reviewed Publication

Ketchum UK

(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 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.

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AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca has more than 40 years experience in cardiovascular medicine and aims to increase lifespan and improve quality of life by reducing the risk, prevalence and impact of cardiovascular disease. AstraZeneca has a comprehensive cardiovascular portfolio including Atacand®, Zestril®, Seloken ZOK® / Toprol XL™and Plendil®. This heritage is complemented by an innovative pipeline including CRESTOR™, a new treatment for dyslipidaemia, the first oral direct thrombin inhibitor, Exanta®, and a novel treatment for type 2 diabetes / insulin resistance (AZ 242).

For further information please contact:

Jonathan Wilson Ketchum
(T) +44 (0) 207 611 3671
(M) +44 (0) 7968 799 349

Julia Walker
AstraZeneca
(T) +44 (0) 1625 510866
(M) +44 (0) 7718 801984

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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