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| 2 September 2003 | 2003-09-02T00:00:00.0000000+01:00 |
| LARGEST-EVER STROKE PREVENTION STUDY IN ATRIAL FIBRILLATION SHOWS POTENTIAL FOR EXANTA™ (XIMELAGATRAN) IN MAJOR INDICATION
Latest data from the full presentation today of the SPORTIF III study at the European Society of Cardiology (ESC), Vienna, Austria, shows clinical benefit for Exanta (ximelagatran), the first in a new class of oral direct thrombin inhibitors (oral DTIs), compared with the current standard treatment, dose-adjusted warfarin, in preventing stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF). | In an assessment of the combined rates of deaths, primary events and major bleeding while on treatment, 104 events (4.6 per cent) were seen with Exanta compared with 143 (6.1 per cent) with warfarin, a statistically significant reduction (p=0.022). This important finding illustrates that patients can derive benefit from an effective treatment to prevent morbidity and mortality, while also avoiding the limitations that are associated with currently available treatments.
The primary endpoint of SPORTIF III was met in demonstrating that fixed dose twice daily 36mg oral Exanta compares favourably with well-controlled dose-adjusted warfarin in prevention of stroke and SEE in patients with AF (40 Exanta vs 56 warfarin events, ITT population). The efficacy results were also consistently reflected across all sub-populations and secondary composite endpoints, demonstrating the potential for Exanta as an effective and convenient replacement for warfarin in this indication, particularly in light of the high level of warfarin control in the study (average INR 2.5).
“These results offer real hope for people with atrial fibrillation, who are at five times greater risk of stroke. Half of patients with atrial fibrillation who are at risk of stroke go untreated due to the limitations of current therapies, such as warfarin which, although effective, requires coagulation monitoring, dose titration and dietary restrictions”, comments Professor Bertil Olsson, co-lead investigator of SPORTIF III and Professor of Cardiology, University Hospital, Lund, Sweden. “Therefore, a new drug, such as ximelagatran, represents a distinct innovation in anticoagulant therapy that could fill this treatment gap and help to reduce the burden which stroke currently places on patients and health services all over the world.”
SPORTIF III, a multi-national, randomised, open-label parallel-group study with blinded event assessment, involved 3407 patients from 259 centres across Europe, Australia and Asia. Patients were treated for an average of 17 months, providing important safety data to support the emerging benefit-risk profile for Exanta.
Despite no coagulation monitoring or dose titration in the Exanta group, neither stroke nor bleeding rates were increased relative to well-controlled warfarin. Furthermore, the combined rate of major and minor (total) bleedings was also significantly lower for Exanta compared with warfarin (p=0.007).
Transient elevations in the levels of liver enzymes (alanine aminotransferase, ALAT) were observed in 6.3 per cent of patients receiving Exanta and an incidence of elevated bilirubin > 2XULN combined with ALAT > 3XULN was seen in 0.4 per cent of Exanta patients compared with 0.1 per cent of warfarin patients. As in other Exanta phase III studies, these ALAT elevations decreased towards baseline with treatment continuation or discontinuation and were not typically associated with specific clinical symptoms. These findings are under evaluation together with all safety results from the full Exanta clinical study programme in order to establish the overall benefit-risk profile for the product.
“Data reported from SPORTIF III have underlined the overall clinical benefit and potential of Exanta in this important area of unmet medical need,” comments Hamish Cameron, Vice President, Head of Exanta, AstraZeneca. “The results of SPORTIF III enhance the emerging benefit-risk profile for Exanta and will be complemented by the presentation of the second major study in this indication, SPORTIF V, at the American Heart Association (AHA) Congress later this year.”
Exanta is in phase III investigation in several indications for venous thrombosis and is the first oral anticoagulant to reach late clinical development in 60 years – since the development of warfarin. The potential of Exanta in the treatment of arterial thrombosis has also been highlighted in the phase II ESTEEM study, presented at the ESC Congress 2003 yesterday. ESTEEM is the first study to evaluate an oral DTI in long-term treatment for patients at high risk of arterial disease and provides a strong foundation for possible future development for Exanta in arterial indications. The current worldwide market for antithrombotics is $9.6 billion.
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Notes to Editors
Exanta is a trademark of the AstraZeneca group of companies.
SPORTIF stands for Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation. SPORTIF III is part of the world’s largest clinical study programme for AF-related stroke and was designed as a non-inferiority study to compare Exanta with the current standard treatment, dose-adjusted warfarin. 36mg fixed dose oral Exanta twice daily was compared with dose-adjusted warfarin (INR 2.0-3.0) once daily. Patients in the study had non-valvular atrial fibrillation (AF) and at least one additional risk factor for stroke, which included: previous cerebral ischaemic attack; previous systemic embolism; hypertension; left ventricular dysfunction; age > 75 years; age > 65 and coronary artery disease. SPORTIF III was first presented at a hotline session at the American College of Cardiology Congress (ACC) 52nd Scientific Session; Chicago, MA, April 2003
ESTEEM stands for Efficacy and Safety of the oral Thrombin inhibitor ximelagatran in combination with aspirin, in patiEnts with rEcent Myocardial damage.
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 $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.
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