- In the study, designed to show non-inferiority (2), Exanta was shown to be as effective as the current standard of care, enoxaparin/warfarin, in treatment of acute VTE over six months in order to prevent recurrent VTE events (26 Exanta vs 24 enoxaparin/warfarin, ITT population).
- A favourable trend for Exanta over enoxaparin/warfarin was seen with respect to risk of major bleeding (14 Exanta vs 25 enoxaparin/warfarin, OT population) and mortality (28 Exanta vs 42 enoxaparin/warfarin, ITT population).
- Laboratory blood tests showed transient liver enzyme elevations in 9.8% of patients receiving Exanta, compared with 2% of patients receiving enoxaparin/warfarin. These elevations spontaneously decreased with treatment continuation or discontinuation and, as has been seen in previous studies, were not typically associated with specific clinical symptoms.
THRIVE Treatment, together with THRIVE III, will form the basis for the regulatory submission for Exanta in the treatment and long-term prevention of VTE and contribute to the overall benefit-risk profile for the drug. This submission remains on track to be submitted in Europe in the fourth quarter of this year.
Exanta is the first of a new class of oral anticoagulants called direct thrombin inhibitors (oral DTIs). The drug is currently under phase III investigation and is the first oral anticoagulant to reach late clinical development in more than 50 years – since the development of warfarin.
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.
|
Steve Brown
+44 (0)20 7304 5033
Emily Denney
+44 (0)20 7304 5034
|
|
Mina Blair-Robinson
+44 (0)20 7304 5084
Jonathan Hunt
+44 (0)20 7304 5087
|
|
|
- (1) The THRIVE Treatment study was established from study groups from the THRIVE II & V studies.
- (2) The rationale for ‘non-inferiority’ studies: As many highly effective treatments are now available in various therapeutic areas, placebo-controlled trials are often now considered unethical. Therefore, the concept of non-inferiority testing is now increasingly common where objective of these studies is to demonstrate that a treatment is ‘not inferior to’ or 'as effective as' a gold standard treatment. This can then enable treatments to be differentiated in terms of their respective additional advantages to the patient and physician, such as predictability and convenience. Exanta met all non-inferiority endpoints in the THRIVE Treatment study.
- THRIVE III was presented at the 44th Annual Meeting of the American Society of Hematology (ASH) on 9 December 2002.
- Following data presentation, AstraZeneca media materials will be available on www.astrazenecapressoffice.com where further information on Exanta can also be found.
|
EXANTA is a trademark, property of the AstraZeneca group of companies.