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Press Release Source: AstraZeneca LP
AstraZeneca's Investigational Oral Anticoagulant Exanta(TM) (ximelagatran) Reduced Risk of Blood Clots Following Orthopedic Surgery By 63 Percent Compared to Enoxaparin in Clinical Trial
Monday October 28, 8:09 am ET
WILMINGTON, Del., Oct. 28 /PRNewswire-FirstCall/ -- Results of a Phase III clinical trial of AstraZeneca's investigational oral anticoagulant EXANTA(TM) (ximelagatran) showed that treatment with EXANTA significantly reduced by 63 percent the risk of proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) after orthopedic surgery compared with the low-molecular-weight heparin, enoxaparin (2.3 percent vs 6.3 percent, p=0.0000018). Results of EXPRESS (EXpanded PRophylaxis Evaluation Surgery Study), were presented at the 17th International Congress on Thrombosis meeting in Bologna, Italy.
In addition, treatment with EXANTA showed a 67 percent risk reduction (1.8 percent vs. 5.5 percent, p=0.00009) for total hip replacement (THR) and a 60 percent risk reduction (3.3 percent vs. 8.2 percent, p=0.006) for total knee replacement (TKR). EXPRESS also showed a 23.6 percent reduction in the risk of total DVT/PE following preventative treatment (thromboprophylaxis) with EXANTA, compared with enoxaparin (20.3 percent vs. 26.6 percent, p=0.0003).
EXPRESS was a randomized, double-blind, double-dummy study that included nearly 2,800 patients undergoing either total knee replacement or total hip replacement surgery in 12 European countries and South Africa. In the study, 1,377 patients received EXANTA, and 1,387 received enoxaparin. Study treatment was given for 8-11 days with bilateral venography performed on the final day of treatment.
The objective of the study was to compare the efficacy and safety of subcutaneous melagatran (2 mg immediately before surgery and 3 mg the evening after surgery) followed by the oral prodrug ximelagatran (24 mg twice daily) with once-daily injections of enoxaparin (40 mg) started the evening before surgery for the prevention of DVT/PE following total knee or hip replacement surgery.
There were no fatal or critical-site bleeding events in either group. Excessive bleeding at the operative site, as judged by the investigator was more common in the group receiving EXANTA than the group receiving enoxaparin (3 percent vs. 1.2 percent).
Each year in the United States, approximately 300,000 people experience symptomatic deep vein thrombosis (DVT), a commonly occurring condition where a clot forms in the deep veins, usually in the leg, impeding, or even blocking, blood flow. Many conditions predispose patients to DVT, and patients undergoing the more than 600,000 hip or knee replacement surgeries in the United States each year are a group at highest risk of developing DVT.
If a section of a clot in a patient with DVT breaks off, it may travel through the blood stream to the lungs and lodge in a pulmonary artery. This is known as pulmonary embolism (PE), a serious condition that can cause death. PE remains the most common preventable cause of death in hospital patients and causes up to 20 percent of early deaths after hip surgery.
EXANTA is the first oral direct thrombin inhibitor under Phase III investigation and the first investigational oral anticoagulant to reach Phase III in more than 50 years. The intended mechanism of action of EXANTA is to inhibit the activity of an enzyme called thrombin, which is critical to the final step in the formation of blood clots. Ongoing clinical studies with EXANTA utilize a fixed dose without routine coagulation monitoring.
AstraZeneca submitted a filing for a European license for EXANTA on July 24, 2002 for the prevention of DVT/PE in major elective orthopedic surgery. This was the first regulatory submission for EXANTA. In the United States, the parallel Phase III clinical trial program in orthopedic surgery, EXULT, remains on schedule.
AstraZeneca (NYSE: AZN - News) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of cardiovascular, gastrointestinal, oncology, anesthesia (including pain management), central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 10,000 employees.
For more information about AstraZeneca please visit astrazeneca-us.com.
This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2001.
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