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| |  Ximelagatran Proves as Effective, Simpler, Than Warfarin for Preventing Stroke in Patients with Atrial Fibrillation CHICAGO, IL -- February 8, 2005 -- In a second study in this week's JAMA, Jonathan L. Halperin, M.D., of Mount Sinai Medical Center, New York, and colleagues compared the efficacy of ximelagatran with warfarin for prevention of stroke in patients with atrial fibrillation. Non-valvular atrial fibrillation is implicated in nearly 15 percent of strokes, according to background information in the article. Research has indicated that warfarin decreases stroke risk by 62 percent, though in practice, the risk of bleeding limits treatment with warfarin, particularly among the elderly. Underuse of warfarin in patients with atrial fibrillation at high risk of bleeding calls for safer, more dependable alternatives. Ximelagatran offers fixed oral dosing without need for coagulation monitoring, rapid onset and offset of action, stable pharmacokinetics with little potential for drug interactions, and no known food interactions. This trial, SPORTIF V (Stroke Prevention using an Oral Thrombin Inhibitor in Atrial Fibrillation), was conducted in 2000-2001 at 409 North American sites, involving 3,922 patients with non-valvular atrial fibrillation and additional stroke risk factors. Patients received warfarin or ximelagatran. The researchers found that the primary event rate (for strokes) with ximelagatran was 1.6 percent per year and with warfarin was 1.2 percent per year. When all-cause death was included in addition to stroke and systemic embolic events, the rate difference was 0.10 percent per year. There was no difference between treatment groups in rates of major bleeding, but total bleeding (major and minor) was lower with ximelagatran (37 percent vs. 47 percent per year). Serum alanine aminotransferase levels rose to greater than 3 times the upper limit of normal (an indication of liver toxicity) in 6.0 percent of patients treated with ximelagatran, usually within 6 months and typically declined whether or not treatment continued. "The SPORTIF V trial is the largest yet reported trial involving patients with atrial fibrillation for prevention of stroke and systemic embolism. Low rates of thromboembolism and bleeding occurred when ximelagatran was given in a fixed dose without anticoagulation monitoring. Further investigation is needed to clarify the risk of serious hepatic reactions and identify predictive features to select appropriate patients for treatment with ximelagatran. In the balance are a large number of potentially preventable fatal or disabling strokes that accumulate as a consequence of the limitations and underutilization of warfarin," the authors write. This study was funded by Astra-Zeneca. For financial disclosure information, please see the JAMA article.
SOURCE: JAMA/Archives Media Relations
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