Dabigatran

It is being studied for various clinical indications, for some of which it may replace warfarin as the preferred anticoagulant. It is orally administered as the prodrug dabigatran etexilate (marketed as Pradaxa since April 2008 in European countries and Pradax in Canada).The warfarin arm was open label, but adverse events were adjudicated by reviewers blinded to treatment. The primary outcome was stroke or systemic embolism, which was lowest in the 150 mg dabigatran arm.The rate of major bleeding was lowest in the dabigatran 110 mg arm. The rate of myocardial infarction and dyspepsia/abdominal pain was greatest in the dabigatran arms.
Absorption is unrelated to food but may be decreased with co-administration of proton pump inhibitors. Metabolism is slowed in patients taking quinidine, verapamil, or amiodarone.
Approval and usage
On March 18, 2008, the European Medicines Agency granted marketing authorisation for dabigatran.
The National Health Service in Britain have authorised the use of dabigatran for use in preventing blood clots in hip and knee surgery patients.Charities, including the British Heart Foundation, are campaigning for the drug to be widely prescribed in place of Warfarin, which has the down side of having to be taken for up to a week before reaching a target INR level, and heparin, which is administered intravenously or subcutaneously in its low molecular weight form. Dabigatran will cost the NHS £4.20 per day, which is equivalent to several other anticoagulants, but more than ten times the cost of warfarin.
In Canada, approval came on June 13, 2008.
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