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Safety of Ximelagatran
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To the Editor: In his Editorial about ximelagatran,1 Dr Gurewich discusses the significant limitations of vitamin K antagonists for anticoagulation and the need for a therapeutic alternative, particularly for long-term anticoagulation, and we acknowledge these limitations. Studies of ximelagatran for short-term (7-12 days) thromboprophylaxis in knee replacement surgery patients,2 long-term (18 months) secondary prevention of recurrent venous thromboembolism (VTE) following treatment of VTE,3 and long-term (average 1.4 years) stroke prevention in patients with atrial fibrillation4-5 were conducted, and the commercial marketing application for ximelagatran for these uses was discussed at the US Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee meeting on September 10, 2004.6 We were concerned about the liver and cardiovascular risk findings. Major bleeding rates were not shown to be different between ximelagatran and warfarin. Efficacy for long-term use compared with warfarin, studied solely in the atrial fibrillation trials, showed conflicting results.
In the long-term . . . [Full Text of this Article]
Allen Brinker, MD;
Ruyi He, MD;
Mehul Desai, MD;
Kate Gelperin, MD, MPH;
Kathy Robie-Suh, MD, PhD
robiesuh@cder.fda.gov
Office of New Drugs and Office of Drug Safety
Center for Drug Evaluation and Research
US Food and Drug Administration
Rockville, Md
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