Anticoagulant Options � Why the FDA Approved a Higher but Not a Lower Dose of Dabigatran

Beasley, B. Nhi; Unger, Ellis F.; Temple, Robert
May 2011
New England Journal of Medicine;5/12/2011, Vol. 364 Issue 19, p1788
Academic Journal
The authors explain the reason behind the U.S. Food and Drug Administration's (FDA) approval of a higher dose of the anticoagulant, dabigatran, for the reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. They stress that their study do not support the strategy of transitioning patients to the lower dose if they have a bleeding episode while receiving the higher dose. They also point out that their decision was based on pharmacokinetic and pharmacodynamic modeling and not on efficacy and safety data.


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