An FDA advisory panel has recommended that dabigatran etexilate, an oral direct thrombin inhibitor, be approved for use in reducing the risk of stroke from atrial fibrillation. The doses studied included a 110 mg does and a 150 mg dose. The FDA has subsequently approved the medication.
The newly approved drug works as well as warfarin in stroke prevention, and perhaps a 150 mg dose was more effective than warfarin.
There was more GI bleeding with both doses of dabigatran, and also more myocardial infarctions, but there was a reduced risk of hemorrhagic stroke.
The study was an open label study of 18,113 patients with nonvalvular atrial fibrillation and one other risk factor for stroke. The study was ongoing for two years, and patients were followed for at least one year. Therapeutic INR's were obtained in 65% of patients on warfarin.
Iit will be known as Pradaxa, and is the first new oral anticoagulant approved in 50 years.
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