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


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:

More articles from Health and Medicine:

nachricht Resolving the mystery of preeclampsia
21.10.2016 | Universitätsklinikum Magdeburg

nachricht New potential cancer treatment using microwaves to target deep tumors
12.10.2016 | University of Texas at Arlington

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: New 3-D wiring technique brings scalable quantum computers closer to reality

Researchers from the Institute for Quantum Computing (IQC) at the University of Waterloo led the development of a new extensible wiring technique capable of controlling superconducting quantum bits, representing a significant step towards to the realization of a scalable quantum computer.

"The quantum socket is a wiring method that uses three-dimensional wires based on spring-loaded pins to address individual qubits," said Jeremy Béjanin, a PhD...

Im Focus: Scientists develop a semiconductor nanocomposite material that moves in response to light

In a paper in Scientific Reports, a research team at Worcester Polytechnic Institute describes a novel light-activated phenomenon that could become the basis for applications as diverse as microscopic robotic grippers and more efficient solar cells.

A research team at Worcester Polytechnic Institute (WPI) has developed a revolutionary, light-activated semiconductor nanocomposite material that can be used...

Im Focus: Diamonds aren't forever: Sandia, Harvard team create first quantum computer bridge

By forcefully embedding two silicon atoms in a diamond matrix, Sandia researchers have demonstrated for the first time on a single chip all the components needed to create a quantum bridge to link quantum computers together.

"People have already built small quantum computers," says Sandia researcher Ryan Camacho. "Maybe the first useful one won't be a single giant quantum computer...

Im Focus: New Products - Highlights of COMPAMED 2016

COMPAMED has become the leading international marketplace for suppliers of medical manufacturing. The trade fair, which takes place every November and is co-located to MEDICA in Dusseldorf, has been steadily growing over the past years and shows that medical technology remains a rapidly growing market.

In 2016, the joint pavilion by the IVAM Microtechnology Network, the Product Market “High-tech for Medical Devices”, will be located in Hall 8a again and will...

Im Focus: Ultra-thin ferroelectric material for next-generation electronics

'Ferroelectric' materials can switch between different states of electrical polarization in response to an external electric field. This flexibility means they show promise for many applications, for example in electronic devices and computer memory. Current ferroelectric materials are highly valued for their thermal and chemical stability and rapid electro-mechanical responses, but creating a material that is scalable down to the tiny sizes needed for technologies like silicon-based semiconductors (Si-based CMOS) has proven challenging.

Now, Hiroshi Funakubo and co-workers at the Tokyo Institute of Technology, in collaboration with researchers across Japan, have conducted experiments to...

All Focus news of the innovation-report >>>



Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

Agricultural Trade Developments and Potentials in Central Asia and the South Caucasus

14.10.2016 | Event News

World Health Summit – Day Three: A Call to Action

12.10.2016 | Event News

Latest News

Resolving the mystery of preeclampsia

21.10.2016 | Health and Medicine

Stanford researchers create new special-purpose computer that may someday save us billions

21.10.2016 | Information Technology

From ancient fossils to future cars

21.10.2016 | Materials Sciences

More VideoLinks >>>