Letters Section Editor: Robert M. Golub,
MD, Senior Editor.
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.
Gurewich V. Safety of Ximelagatran—Reply. JAMA. 2005;293(23):2859-2860. doi:10.1001/jama.293.23.2859-b