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 Fast-tracking T cell therapies with immune-mimicking biomaterials
16.01.2018 | Wyss Institute for Biologically Inspired Engineering at Harvard

nachricht Dengue takes low and slow approach to replication
12.01.2018 | Duke University

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: Scientists decipher key principle behind reaction of metalloenzymes

So-called pre-distorted states accelerate photochemical reactions too

What enables electrons to be transferred swiftly, for example during photosynthesis? An interdisciplinary team of researchers has worked out the details of how...

Im Focus: The first precise measurement of a single molecule's effective charge

For the first time, scientists have precisely measured the effective electrical charge of a single molecule in solution. This fundamental insight of an SNSF Professor could also pave the way for future medical diagnostics.

Electrical charge is one of the key properties that allows molecules to interact. Life itself depends on this phenomenon: many biological processes involve...

Im Focus: Paradigm shift in Paris: Encouraging an holistic view of laser machining

At the JEC World Composite Show in Paris in March 2018, the Fraunhofer Institute for Laser Technology ILT will be focusing on the latest trends and innovations in laser machining of composites. Among other things, researchers at the booth shared with the Aachen Center for Integrative Lightweight Production (AZL) will demonstrate how lasers can be used for joining, structuring, cutting and drilling composite materials.

No other industry has attracted as much public attention to composite materials as the automotive industry, which along with the aerospace industry is a driver...

Im Focus: Room-temperature multiferroic thin films and their properties

Scientists at Tokyo Institute of Technology (Tokyo Tech) and Tohoku University have developed high-quality GFO epitaxial films and systematically investigated their ferroelectric and ferromagnetic properties. They also demonstrated the room-temperature magnetocapacitance effects of these GFO thin films.

Multiferroic materials show magnetically driven ferroelectricity. They are attracting increasing attention because of their fascinating properties such as...

Im Focus: A thermometer for the oceans

Measurement of noble gases in Antarctic ice cores

The oceans are the largest global heat reservoir. As a result of man-made global warming, the temperature in the global climate system increases; around 90% of...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

10th International Symposium: “Advanced Battery Power – Kraftwerk Batterie” Münster, 10-11 April 2018

08.01.2018 | Event News

See, understand and experience the work of the future

11.12.2017 | Event News

Innovative strategies to tackle parasitic worms

08.12.2017 | Event News

 
Latest News

White graphene makes ceramics multifunctional

16.01.2018 | Materials Sciences

Breaking bad metals with neutrons

16.01.2018 | Materials Sciences

ISFH-CalTeC is “designated test centre” for the confirmation of solar cell world records

16.01.2018 | Power and Electrical Engineering

VideoLinks
B2B-VideoLinks
More VideoLinks >>>