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Letters
June 15, 2005

Safety of Ximelagatran—Reply

Author Affiliations
 

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;293(23):2859-2860. doi:10.1001/jama.293.23.2859-b

In Reply: While Dr Brinker and colleagues from the Food and Drug Administration acknowledge the significant limitations of the vitamin K antagonists, the consequence of concern is that a substantial number of patients at serious risk of thrombembolism are left untreated. The resulting impact on mortality and lifelong disabilities may be less visible than a direct drug adverse effect.

Brinker et al state that the 2 long-term atrial fibrillation studies “showed conflicting results.” This seems misleading, considering that for the major end points of stroke and systemic embolism, the efficacy of ximelagatran was remarkably consistent, being 2.3% and 2.6%, compared with 3.3% and 1.9%, respectively, for warfarin,1,2 the latter figure giving warfarin a nonsignificantly superior efficacy in one of the studies. Moreover, this result can probably be attributed to the control of warfarin in this study being exceptionally optimal and unlikely to be duplicated in clinical practice. For the second end point, major bleeding, the incidence was less for ximelagatran than for warfarin in both studies, although this difference was also not statistically significant.

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