Health Insurance

Efficacy Of Tecarfarin Mirrors Earlier Studies While Primary Endpoint Missed

group but a lesser proportion of these events were ascribed to being associated with "drug therapy" compared to the warfarin group. About Historic Warfarin Usage The design of the EmbraceAC trial took into account previous large-scale warfarin studies and their methodologies to insure an adequate warfarin response in EmbraceAC, validating the head-to-head comparison in the primary endpoint. A 2005 study measuring the ability to maintain patients within the target therapeutic range (2.0 to 3.0) by utilizing a home monitoring device and centralized dosing regimen achieved time within therapeutic range of 67.2% (JTT 2005; 19(3); 163-72). This treatment and dosing methodology closely mirrored the methodology used in EmbraceAC. A number of other studies have been published over many years documenting the percent time within therapeutic range achieved with warfarin patients in various settings. In SPORTIFF III, 1,703 patients were randomized to warfarin in an open-label study comparing warfarin to a competing anticoagulation therapy. Warfarin patients were maintained within the INR target therapeutic range (2.0 to 3.0) 66% of the time (Lancet 2003; 362: 1691-98). In a double-blind, centrally controlled companion study, SPORTIFF V, 1,962 patients were randomized to warfarin. In this study, using a monitoring and dosing design to maximize the time within therapeutic range, patients were within the target INR range (2.0 to 3.0) 68% of the time (JAMA, 2005; 293:6; 690-98). Based upon the data we have reviewed, it appears that the only large-scale clinical trials measuring warfarin"s ability to maintain patients within a target therapeutic range that exceeds 68% of the time are ones in which the target range is expanded beyond 2.0 to 3.0. About Oral Anti-coagulation In the United States, there are 3.6 million patients being chronically treated with warfarin for the treatment or prevention of life threatening blood clots for a variety of indications including atrial fibrillation, venous thromboembolic disease (DVT/PE), implanted prosthetic heart valve; congestive heart failure/cardiomyopathy, and other indications. Atrial fibrillation is the most common form of cardiac arrhythmia, with approximately 2.4 million people in the United States diagnosed with this condition in 2006. Approximately 1.5 million of these patients are chronic users of oral anticoagulants, since clotted blood can dislodge from the atria and flow to the brain, causing a stroke. It is estimated that atrial fibrillation is responsible for more than 75,000 strokes per year in the United States alone. Valvular heart disease is any disease that involves one or more of the heart"s four valves and frequently leads to valve replacement with either tissue or mechanical valves. Patients with mechanical heart valves are at great risk of clotting and must have their level of anticoagulation managed with particular diligence for the remainder of their lives. There are an estimated 340,000 patients with mechanical heart valves in the United States. Venous thromboembolism is the formation of a blood clot, or thrombus, in the veins, that may travel to other parts of the body and block blood flow. This condition includes both deep vein thrombosis and pulmonary embolism. There were approximately 510,000 patients being treated for venous thromboembolism in the United States in 2005. About Tecarfarin Tecarfarin (previously ATI-5923) is modeled on the drug warfarin as an oral anticoagulation therapy for patients who are in danger of forming life-threatening blood clots as a result of atrial fibrillation, prosthetic heart valve replacement or venous thromboembolism. There are at least an estimated 3.5 million patients requiring anticoagulation therapy in the United States alone. Patients with implanted mechanical heart valves are also amongst those requiring anticoagulation therapy. Tecarfarin, like warfarin, is a selective inhibitor of VKOR, or vitamin K epoxide reductase enzyme, and has the same mechanism of anticoagulation action as warfarin. Unlike warfarin, which is dependent upon cytochrome P450 enzymes for metabolism, tecarfarin was designed to avoid drug-drug interactions through its alternative metabolic pathway. ARYx believes the avoidance of cytochrome P450 metabolism will cause the dosing and response to tecarfarin to be more predictable than with warfarin, avoiding the dangers of over-or-under therapeutic anticoagulation long associated with that therapy. ARYx Therapeutics, Inc.

Pages: 1 [2] 

Add your comment:

Name:
Site address:	http://
Your message:
Enter today\\\\'s date, 2 digits (spam protection):