Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

EXANTA™, an oral direct thrombin inhibitor, significantly reduces risk of VTE in major OS

28.10.2002


17th International Congress on Thrombosis, Bologna, 26 October 2002: Important results from the EXPRESS clinical trial for the oral direct thrombin inhibitor (Oral DTI), EXANTA™ (oral ximelagatran and its active form, melagatran) show its superior efficacy in reducing risk of major venous thromboembolism (VTE), compared with a routinely used prophylactic treatment, enoxaparin, in major orthopaedic surgery.
Results show a significant 63 per cent relative risk reduction (2.3% vs 6.3%) in major venous thromboembolism (VTE) - proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) - when treated with EXANTA, compared to standard prophylaxis with enoxaparin (40mg od). The relative risk reduction in major VTE was 67 per cent (1.8% vs 5.5%) for total hip replacement and 60 per cent (3.3% vs 8.2%) for total knee replacement surgery.

EXPRESS is a randomised, double-blind study of 2,800 patients that compares the efficacy and safety of EXANTA (subcutaneous melagatran followed by oral ximelagatran), with that of the routinely used prophylactic treatment, subcutaneous enoxaparin (40mg od), for the prevention of venous thromboembolism (VTE) following major hip and knee replacement surgery.


"These results indicate that in the future, ximelagatran could more efficiently reduce this risk than current treatments. In addition, a treatment that can be taken orally and does not require coagulation monitoring, would improve the treatment benefit and patient acceptance," commented Associate Professor Bengt Eriksson, principal investigator of the EXPRESS trial. "Prophylactic treatment is needed before major orthopaedic surgery in order to prevent development of VTE, which can lead to serious complications."

Between 45-57 per cent of patients undergoing total hip replacement without thromboprophylaxis develop DVT1 (deep vein thrombosis), a potentially fatal condition. Similarly, the rate of DVT for patients undergoing total knee replacement is 40-84 per cent1.

Both first and second stage primary endpoints of EXPRESS were met, including a 24 per cent (20.3% vs 26.6%) reduction in the risk of total VTE (proximal and distal DVT and PE) seen following prophylactic treatment (thromboprophylaxis) with EXANTA, compared to enoxaparin.

The EXANTA treatment regimen in EXPRESS shows a good balance between efficacy and safety. A small increase in surgery-related bleeding was observed compared to enoxaparin, although importantly, there were no differences between treatments in clinically important bleeding events (defined as fatal, critical organ or requiring re-operation).

EXANTA is the first Oral DTI to be submitted for regulatory approval and works by inhibiting thrombin, a key enzyme involved in the blood clotting (coagulation) process. AstraZeneca submitted a filing for a European licence for EXANTA (ximelagatran/melagatran) in prevention of VTE following major orthopaedic surgery in July 2002. This was the first regulatory submission for EXANTA. In the United States, the orthopaedic surgery trial programme, EXULT, remains on track.

"These important results confirm the efficacy and potential benefits of EXANTA," said Hamish Cameron, Vice President and Head of Cardiovascular Therapy Area, AstraZeneca. "EXANTA, once approved, could offer advantages over existing products in the anticoagulant market and strengthens the AstraZeneca cardiovascular portfolio. We see these results as a key step in introducing a fundamentally new approach to oral anti-coagulation."

EXANTA represents a potential medical breakthrough in the prevention and treatment of thromboembolism and meets a clearly defined unmet medical need for anticoagulation treatment, without coagulation monitoring and dosage titration.

Thrombosis is one of the largest causes of morbidity and mortality in the Western world. There are nearly four million events of thromboembolic disease (including stroke, deep vein thrombosis/pulmonary embolism and myocardial infarction) each year throughout the EU and Japan.

Liz Rickard | alfa
Further information:
http://www.ketchumcomms.co.uk/

More articles from Health and Medicine:

nachricht Laser activated gold pyramids could deliver drugs, DNA into cells without harm
24.03.2017 | Harvard John A. Paulson School of Engineering and Applied Sciences

nachricht What does congenital Zika syndrome look like?
24.03.2017 | University of California - San Diego

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Giant Magnetic Fields in the Universe

Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.

The results will be published on March 22 in the journal „Astronomy & Astrophysics“.

Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...

Im Focus: Tracing down linear ubiquitination

Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.

Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...

Im Focus: Perovskite edges can be tuned for optoelectronic performance

Layered 2D material improves efficiency for solar cells and LEDs

In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...

Im Focus: Polymer-coated silicon nanosheets as alternative to graphene: A perfect team for nanoelectronics

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...

Im Focus: Researchers Imitate Molecular Crowding in Cells

Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to simulate these confined natural conditions in artificial vesicles for the first time. As reported in the academic journal Small, the results are offering better insight into the development of nanoreactors and artificial organelles.

Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

International Land Use Symposium ILUS 2017: Call for Abstracts and Registration open

20.03.2017 | Event News

CONNECT 2017: International congress on connective tissue

14.03.2017 | Event News

ICTM Conference: Turbine Construction between Big Data and Additive Manufacturing

07.03.2017 | Event News

 
Latest News

Argon is not the 'dope' for metallic hydrogen

24.03.2017 | Materials Sciences

Astronomers find unexpected, dust-obscured star formation in distant galaxy

24.03.2017 | Physics and Astronomy

Gravitational wave kicks monster black hole out of galactic core

24.03.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>