New data support the efficacy and safety of the novel oral anticoagulant Exanta®

July 10, 2001

(Mölndal, Sweden, 10 July 2001) The presentation of a wide range of data at the 18th International Society on Thrombosis and Haemostasis meeting (ISTH) in Paris this week, provided new evidence to support the efficacy and safety of Exanta®, which is set to be the first new oral anticoagulant since warfarin was introduced over 50 years ago.

Exanta®, an oral direct thrombin inhibitor, is currently under investigation in an extensive phase III clinical trials programme in a number of key therapeutic areas. The programme, which involves more than 15,000 patients in 30 countries, includes European and US phase III studies in the prevention of blood clot formation in the leg veins of patients undergoing orthopaedic surgery, presented at the ISTH. These blood clots in leg veins, or deep vein thrombosis (DVT), can dislodge and travel to the lung causing pulmonary embolism (PE). DVT and PE together are known as venous thromboembolism (VTE).

Dr Ian Watts, Global Product Director, said: "Over 20 abstracts were selected for oral and poster presentation at the ISTH meeting, including the phase III results from US and European trials of VTE prophylaxis in orthopaedic surgery. These data show that Exanta® has efficacy and tolerability at least comparable to that of warfarin or a low molecular weight heparin compound, the standard anticoagulants in the US and Europe respectively."

The European phase III trial, one of the largest ever trials of VTE prophylaxis in orthopaedic surgery, included 2788 patients undergoing total hip or total knee replacement surgery, in centres across Europe. The study, which compared the efficacy and safety of Exanta® to the low molecular weight heparin, enoxaparin showed it to be effective and well tolerated for VTE prevention, with efficacy comparable to that of enoxaparin. The earlier phase II trial also showed Exanta® to be comparable to another low molecular weight heparin, dalteparin.

The US phase III trial, which included 680 patients in North American centres, also showed favourable results in patients undergoing total knee replacement surgery. This study which compared the efficacy and safety of Exanta® to warfarin in VTE prophylaxis showed that Exanta® is at least as effective as warfarin, and does not require routine coagulation monitoring or dose adjustment.

"There is no doubt that Exanta® works well and we are confident about its future" Dr Ian Watts continued. "We are currently committed to carrying out complementary phase III trials of VTE prophylaxis in orthopaedic surgery that will allow us to determine the optimal way of using Exanta® , as well as the ongoing phase III trials in the key indication of stroke prevention in atrial fibrillation. With a simple, fixed oral dosage and no need for routine coagulation monitoring, Exanta® offers the possibility of better anticoagulation for millions of patients."

Other data presented at the ISTH meeting included the results of important interaction studies. These studies, in conjunction with the wealth of clinical experience to date, confirm that there are no food or known drug-drug interactions with Exanta®.

The administration of Exanta® as a simple fixed oral dose, independent of age or ethnic origin, was also highlighted in comparison pharmacokinetic studies in young, old and ethnic origin groups (African, Asian and Caucasian). These data showed little variability in the pharmacokinetic profile within and between groups.

In addition to the positive Phase III trials of VTE prophylaxis in patients undergoing orthopaedic surgery, other promising data presented at the ISTH included data on the use of Exanta® in abdominal surgery and in DVT treatment. These studies both showed the efficacy of Exanta® to be comparable to the standard anticoagulant, dalteparin.

The key indication for Exanta® is stroke prevention in patients with the heart arrhythmia, atrial fibrillation. Three-month phase II, SPORTIF II, data on this major indication are to be presented at the 23rd European Society of Cardiology Meeting in Stockholm in September, and the longer-term phase II data, SPORTIF IV, should be presented later this year.

The phase III programme of research into the efficacy of Exanta® in stroke prevention in atrial fibrillation, comprising the SPORTIF III and V studies, is the largest-ever programme conducted in this indication with more than 6,200 patients enrolled.
-end-
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 over $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.

For further information please contact:

Jonathan Wilson
Ketchum
(T) 44-(0)- 207-611-3671
(M) 44-(0)-7968-799-349

Cathy Kernen
AstraZeneca
(T) 44- (0)-1625- 510-827
(M)44-(0)-7769-882-497

Ketchum UK

Related Atrial Fibrillation Articles from Brightsurf:

Atrial fibrillation less deadly than it used to be, but still cause for concern: BU study
A first-of-its-kind study by researchers from the Boston University School of Public Health (BUSPH) shows a decline in deaths related to atrial fibrillation (irregular heartbeat) over the last 45 years.

Postoperative atrial fibrillation does not impact on overall survival after esophagectomy
Volume 11, Issue 25 of Oncotarget reported that Administration of landiolol hydrochloride was found to be associated with reduced incidence of atrial fibrillation after esophagectomy for esophageal cancer in our previous randomized controlled trial.

People with atrial fibrillation live longer with exercise
More than 100,000 Norwegians have atrial fibrillation. They should be actively exercising for their health.

Atrial fibrillation among overweight people is not due to fat
In a recently published study, researchers from Aarhus University document that the risk of atrial fibrillation is not linked to the amount of body fat, but instead to large muscle mass, or more precisely, a high fat-free weight

Eating more protein could help ward off atrial fibrillation in women
Women who ate slightly more than the recommended daily amount of protein were significantly less likely to develop atrial fibrillation (AFib), a dangerous heart rhythm disorder that can lead to stroke and heart failure, when compared with those who consumed less protein, according to research being presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).

Zebrafish teach researchers more about atrial fibrillation
Genetic research in zebrafish at the University of Copenhagen has surprised the researchers behind the study.

Personalized medicine for atrial fibrillation
The study, published in Europace, uses signals from implantable devices -- pacemakers and defibrillators -- to analyze electrical signals in the heart during episodes of atrial fibrillation.

Prescribing anticoagulants in the ED for atrial fibrillation increases long-term use by 30%
Patients prescribed anticoagulants after a diagnosis of atrial fibrillation in the emergency department are more likely to continue long-term use of medications to treat the condition, according to research published in CMAJ (Canadian Medical Association Journal).

Anticoagulant benefits for atrial fibrillation decrease with age
The net clinical benefit of anticoagulants for atrial fibrillation (AF) -- one of the most important causes of irregular heartbeats and a leading cause of stroke -- decreases with age, as the risk of death from other factors diminishes their benefit in older patients, according to a study led by researchers at UC San Francisco.

Research improves understanding of mechanism of atrial fibrillation
Mouse model studies show that noncoding DNA regions linked to atrial fibrillation risk can display long-range regulatory functions directed at Pitx2 gene and in this way predispose to the condition.

Read More: Atrial Fibrillation News and Atrial Fibrillation Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.