Dabigatran: an oral direct thrombin inhibitor for use in atrial fibrillation.
Author(s): Bendel SD, Bona R, Baker WL.
Affiliation(s): Schools of Pharmacy and Medicine, Storrs and Farmington CT & Department of
Hematology-Oncology, University of Connecticut, Farmington, USA.
Publication date & source: 2011, Adv Ther. , 28(6):460-72
Atrial fibrillation (AF) is well known as one of the leading causes of stroke and
systemic embolism. Anticoagulation therapy is recommended in all patients at
moderate-to-high risk of stroke. The vitamin K antagonist warfarin has
traditionally been used in these patients but presents challenges in dosing and
monitoring in these patients. The oral direct thrombin inhibitor dabigatran
etexilate (Pradaxa®; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT,
USA) was recently approved for use in the US for preventing stroke and systemic
embolism in patients with nonvalvular AF. Clinical trials have shown it to reduce
the risk of stroke and systemic embolism when compared with warfarin (goal
international normalized ratio [INR] 2-3) with a similar risk for severe
bleeding. It can be given twice daily, with the dose adjusted for renal function.
It does not have any dietary restrictions, has few drug interactions (except
involving permeability [P]-glycoprotein [P-gp] agents), and does not require
routine laboratory monitoring. Patients may experience significant dyspepsia with
its use. Compared with warfarin there is increased risk for gastrointestinal
bleeding and perhaps myocardial infarction. Currently, no reversal agent exists
for use in situations of overdose or severe bleeding although some strategies
have been suggested. Despite its high acquisition cost compared with warfarin,
analysis using theoretical models has shown it to be cost-effective. Dabigatran
offers a unique alternative to warfarin in patients with nonvalvular AF and can
be beneficial in patients requiring anticoagulation therapy.
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