Non-valvular atrial fibrillation is implicated in nearly15 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 sys
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Contact: Bruce L. Davidson, M.D.
206-215-2500
JAMA and Archives Journals
8-Feb-2005