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 Cystic fibrosis alters the structure of mucus in airways
29.06.2017 | University of Iowa Health Care

nachricht Mice provide insight into genetics of autism spectrum disorders
28.06.2017 | University of California - Davis

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: Making Waves

Computer scientists use wave packet theory to develop realistic, detailed water wave simulations in real time. Their results will be presented at this year’s SIGGRAPH conference.

Think about the last time you were at a lake, river, or the ocean. Remember the ripples of the water, the waves crashing against the rocks, the wake following...

Im Focus: Can we see monkeys from space? Emerging technologies to map biodiversity

An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.

Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...

Im Focus: Climate satellite: Tracking methane with robust laser technology

Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.

Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...

Im Focus: How protons move through a fuel cell

Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.

As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...

Im Focus: A unique data centre for cosmological simulations

Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.

With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Plants are networkers

19.06.2017 | Event News

Digital Survival Training for Executives

13.06.2017 | Event News

Global Learning Council Summit 2017

13.06.2017 | Event News

 
Latest News

Nanostructures taste the rainbow

29.06.2017 | Physics and Astronomy

New technique unveils 'matrix' inside tissues and tumors

29.06.2017 | Life Sciences

Cystic fibrosis alters the structure of mucus in airways

29.06.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>