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AstraZeneca: New tablet hailed as major breakthrough in the prevention of strokes.

American Heart Association Congress, Orlando, USA, November 12 /PRNewswire/ --

A new tablet that will revolutionise treatment for up to half a million people in the UK at risk of a stroke from a blood clot has been welcomed by doctors as the most important therapeutic advance in stroke prevention for 60 years.

Data presented today, showed that the new tablet, called Exanta (ximelagatran), is as effective as warfarin at reducing strokes from blood clots in people with a common irregular heart rhythm called atrial fibrillation (AF). Ximelagatran, the first direct thrombin inhibitor, has a consistent and reliable effect, therefore does not need time-consuming and resource-intensive anticoagulation monitoring to ensure patients achieve safe levels of anticoagulation. In addition, the same dose can be given to all patients and unlike warfarin, the effects of ximelagatran are not significantly influenced by food and alcohol and it has a low potential for interactions with other drugs. Today's data from the North American arm of the SPORTIF programme (SPORTIF V) combined with results from the rest of the world (SPORTIF III) arm - including a total of 7329 patients - will complete the regulatory submission for the prevention of stroke in patients with AF indication for ximelagatran.

Until now, doctors treating patients at risk of stroke from a blood clot have had to rely on the blood thinner warfarin, an effective but often unstable drug, which requires frequent clinic attendance to keep the drug at safe levels. Warfarin also has complicated dosing requiring frequent adjustment and should not be taken with certain foods, alcohol and common medicines, such as pain killers, antibiotics and statins. However, because well-controlled warfarin is highly effective and reduces the risk of stroke caused by blood clots by 68% compared with placebo,(1) it is the current gold standard treatment, compared with aspirin at 21%.(2)

Professor Gary Ford, Consultant Stroke Physician the Freeman Hospital Stroke Service, Newcastle upon Tyne, and Principal Investigator in the SPORTIF programme in the UK said "These results show that ximelagatran is as effective in preventing stroke as extremely well-controlled warfarin and avoids the need for long-term monitoring. Ximelagatran, when licenced, could potentially transform our approach to the management of stroke prevention in atrial fibrillation, particularly in those patients where monitoring is difficult and where there are concerns about interactions of warfarin with other drugs, or anticoagulation responses to warfarin are highly variable."

A recent survey revealed that as the effect of warfarin is often difficult to control, 72% of GPs cited the risk of bleeding as their main reason for not recommending warfarin for patients at risk of stroke.(3) Moreover, a study suggested that approximately only half of the people eligible for warfarin treatment do not receive this highly effective stroke prevention treatment(4) possibly due to physician reticence and patient reluctance to use it.(5)

Patients with AF are at a five times greater risk of stroke than the general population. The major burden of stroke is chronic disability, rather than death; representing a personal catastrophe for victim, friends and family, and accounting for around 6% of total NHS and social services expenditure - GBP2.3 billion per year.(6)

The results of SPORTIF V a randomised, double-blind, double-dummy study involving 3922 patients with non-valvular atrial fibrillation across 409 North American centres show that a fixed, oral, twice-daily dose of ximelagatran 36 mg is as effective as dose-adjusted warfarin at preventing strokes (51 vs 37 events, p<0.13 - a non-significant difference). Furthermore, ximelagatran was associated with significantly fewer major and minor bleeding events compared with warfarin (37% vs 47%; p<0.0001). By the design of the study, patients receiving warfarin were extremely well-controlled due to close monitoring of their INR* value and resultant dose adjustment in order to maintain values within the ideal range of 2.0-3.0. However, in routine clinical practice, the proportion of time spent outside the target INR range is between 38-61%, thereby increasing the relative bleeding risk.(7)

Liver enzyme (ALT) elevations were also seen in this trial, but as in other studies, these ALT elevations decreased towards baseline with treatment continuation or discontinuation and were not typically associated with specific clinical symptoms. Elevated liver enzymes were seen in 6% of patients at the 36 mg twice-daily dose compared with 0.8% of patients in the warfarin group.

AstraZeneca is committed to the extensive clinical trial programme for Exanta (ximelagatran) and further studies have shown that the tablet is effective for the treatment and prevention of venous thromboembolism (VTE) following deep vein thrombosis (DVT).(8) Ximelagatran has been subject to the most extensive clinical study programme in anticoagulation to date, involving around 30,000 patients in over 25 countries worldwide.

Notes for editors

SPORTIF III - Stroke Prevention by ORal Thrombin Inhibitor in atrial Fibrillation

*INR, or international Normalised Ratio is a measure of the time taken for the blood to clot, and those patients on warfarin will have their INR value compared to normal blood, which has an INR of 1.0. For stroke prevention in atrial fibrillation patients, target INR is 2.0-3.0

In the SPORTIF V study, blinding was maintained by double-dummy study medication. Anticoagulation in patients assigned to warfarin had their dose adjusted on an on-going basis to achieve a consistent and appropriate level of anticoagulation in their blood according to true INR test values. Ximelagatran does not require this form of monitoring and was given at a fixed dose (36 mg, twice-a-day) in all patients, but in order to maintain blinding, sham INR values were generated for the patients assigned to ximelagatran using a validated algorithm.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of 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 US$17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

References

1) Lip GYH, Lowe GDO. ABC of atrial fibrillation: Antithrombotic treatment for atrial fibrillation. BMJ. 199;312: 45-49. 2) Atrial Fibrillation Investigators. The efficacy of aspirin in patients with atrial fibrillation. Analysis of pooled data from three randomised trials. Arch Intern Med. 1997;157:1237-1240. 3) Taylor Nelson Sofres. Omnimed Atrial Fibrillation Survey, July 2003. 4) Wheeldon NM, Tayler DI, Anagnostou E, et al. Screening for atrial fibrillation in primary care. Heart. 1998;79:50-55. 5) Lip GYH, Hart RG, Conway DSG. ABC of antithrombotic therapy. Antithrombotic therapy for atrial fibrillation. BMJ. 2002;325:1022-1025. 6) Rothwell PM. The high cost of not funding stroke research: a comparison with heart disease and cancer. Lancet. 2001;357:1612-1616. 7) Jones M, McEwan P, Peters JR, et al. Anticoagulation with warfarin in patients with atrial fibrillation: a record linkage study of control and outcomes in a UK population. Poster presentation at the annual meeting of the British Society for Haemostasis and Thrombosis (BSHT), September 2003, Cambridge, UK. 8) Huisman MV, on behalf of the THRIVE Treatment Study Investigators. Efficacy and safety of the oral direct thrombin inhibitor ximelagatran compared with current standard therapy for acute, symptomatic deep vein thrombosis, with or without pulmonary embolism: a randomised, double-blind, multinational study. Oral Presentation, XIX Congress of the International Society on Thrombosis and Haemostasis (ISTH), Birmingham, July 2003.

For more information, or to arrange an interview, please contact: Camilla Bull, Tel +44 (0)20 7318 8313 or Elaine Ferguson, Tel +44 (0)20 7318 8317, both of Chandler Chicco Agency
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