AstraZeneca's Novel Oral Anticoagulant Studied as Alternative to Warfarin
Results Presented at International Society on Thrombosis and Haemostasis Meeting
WILMINGTON, Del., July 9 /PRNewswire/ -- An oral direct thrombin inhibitor under development by AstraZeneca shows promise in reducing the incidence of blood clots in patients undergoing knee replacement surgery, according to Phase III data presented yesterday at the XVIII Congress of the International Society on Thrombosis and Haemostasis in Paris, France.
Results of the study comparing the efficacy and safety of EXANTA(TM) (ximelagatran), (formerly known as H 376/95) with warfarin for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after total knee replacement (TKR) surgery, showed an overall DVT/PE incidence of 19.2 percent with EXANTA and 25.7 percent with warfarin. The incidence of major bleeding and total bleeding was 1.7 and 9 percent respectively with EXANTA and 0.9 and 7 percent respectively with warfarin. While there were no statistically significant differences, the findings of this study have been sufficient for the company to initiate another clinical study called EXULT. The EXULT study will further evaluate the safety and efficacy of EXANTA 24 mg and 36 mg given twice daily in reducing the incidence of blood clots following orthopedic surgery.
The objective of the study was to compare the efficacy and safety of EXANTA with warfarin for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after total knee replacement (TKR) surgery. The randomized, double-blind study involved 680 patients who received 7-12 days of either dose-adjusted warfarin once-a-day starting the evening of surgery or ximelagatran 24 mg given twice-a-day starting on the morning after surgery. DVT/PE was assessed either by imaging studies (venography) of veins in the operated leg or symptoms noted by the patients' physicians.
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 blood flow or even blocking the flow of blood. Patients undergoing the more than 600,000 hip or knee replacement surgeries in the US each year may be at high 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.
EXANTA is the first oral direct thrombin inhibitor under investigation. The mechanism of action of EXANTA is to inhibit the activity of a clot-forming 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.
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