New data support the safety and tolerability of the novel oral anticoagulant Exanta® in a range of life threatening clinical indications

December 10, 2001

The presentation of a range of data at the 43rd American Society of Hematology (ASH) meeting in Orlando this week, provides encouraging evidence to support the efficacy and safety of the novel oral anticoagulant Exanta® in both the long term prevention of blood clot* formation and its treatment.

Exanta is set to be the first new oral anticoagulant since the introduction of warfarin over 50 years ago and is currently under investigation in an extensive clinical trials programme for a number of key therapeutic areas. The programme, involving more than 20,000 patients in over 30 countries, includes the important SPORTIF II and IV, and THRIVE I and IV, trials presented at ASH.

Long term SPORTIF IV data, in the key indication of stroke prevention in patients with non-valvular chronic atrial fibrillation, show Exanta is well tolerated in patients for up to 24 months, with comparable efficacy to warfarin and the added benefit of no need for dose titration or routine coagulation monitoring.

SPORTIF IV is an open-label continuation of the 12-week randomised phase II dose guiding study SPORTIF II, presented at the European Society of Cardiology (ESC) meeting, September 2001. The phase III SPORTIF programme, comprising the SPORTIF III and V studies, is the largest-ever programme conducted in atrial fibrillation, with more than 7,200 patients enrolled.

Atrial fibrillation is the most common cardiac arrhythmia in clinical practice,1 with incidence approximately doubling with each decade of adult life.3 It presents as a rhythm disturbance in the atria of the heart, causing an uneven heart beat.

Frequency has been shown to increase from 3.8% in patients aged <50 years to 34.3% in those aged>90 years. More than two million people are estimated to have atrial fibrillation in the US1 and the associated 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 IV results are very promising,' said Dr Palle Petersen, Division of Neurological Rehabilitation, Hvidovre University Hospital, Denmark, a lead investigator in the SPORTIF IV trial. 'The fixed dose regimen of Exanta was well tolerated for up to 24 months, without the need for dose adjustment or coagulation monitoring in patients with a medium to high risk of stroke and systemic thromboembolic complications.'

Dr Petersen continued, 'Anticoagulation treatment with warfarin is effective in reducing the risk of stroke in patients with atrial fibrillation. Doctors, however, are often reluctant to treat patients because of the drawbacks of using warfarin. Under-treatment remains the major problem in stroke prevention for patients with atrial fibrillation.'

In addition to the SPORTIF results, data from the THRIVE programme were also presented at ASH. The THRIVE programme investigates the effect of Exanta in the treatment of venous thromboembolism (VTE). THRIVE I, which investigated Exanta in the treatment of acute deep vein thrombosis (DVT), confirmed that it is a promising effective alternative to warfarin in preventing the progression of a DVT. THRIVE IV, which examines Exanta in the treatment of pulmonary embolism (PE), also highlighted its promise in the treatment of a stable PE.

Together, these results show that Exanta is effective both in preventing blood clot formation and treatment.

Data were also presented on a US trial investigating the prevention of venous thromboembolism (VTE) after a total hip replacement. These data for Exanta resulted in safety and tolerability for this patient population. A pre-clinical study on the use of Exanta as a preventative treatment after acute coronary syndrome also showed positive results.

Dr Ian Watts, Global Product Director, said 'The data presented here at ASH highlight the extensive clinical programme currently ongoing with Exanta. We believe that with fixed oral dose regimen and no need for routine coagulation monitoring, Exanta could offer the possibility of simpler anticoagulation for millions of patients.'
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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).

Note to editors

* Exanta has now been shown to be effective in the prevention of blood clot formation, VTE prophylaxis in orthopaedic surgery, stroke prevention in atrial fibrillation and treatment of VTE (DVT and PE).

References

1 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.

2 Falk RH. Atrial fibrillation. N Engl J Med 2001; 344: 1067-1078.

Ketchum UK

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