Credit: Kevin MacKenzie
The US Food and Drug Administration (FDA) has approved dabigatran etexilate (Pradaxa) to prevent strokes and thrombosis in patients with atrial fibrillation (AF).
Dabigatran is an oral direct thrombin inhibitor that can be administered at a fixed oral dose, with no need for coagulation monitoring.
“Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.
The FDA has approved dabigatran based on results of the RE-LY trial, in which investigators compared dabigatran to warfarin in more than 18,000 AF patients.
Results suggested that, overall, dabigatran is noninferior to warfarin for preventing stroke and systemic embolism. And, at a 150 mg dose, dabigatran is actually more effective than warfarin.
Bleeding, including life-threatening and fatal bleeding, was among the most common adverse events observed in patients treated with dabigatran. Gastrointestinal symptoms, including dyspepsia, stomach pain, nausea, heartburn, and bloating were reported as well.
Dabigatran was approved with a medication guide that informs patients of the risk of serious bleeding. The guide will be distributed each time a patient fills a prescription for the medication.
Dabigatran will be marketed as Pradaxa by Boehringer Ingelheim Pharmaceuticals, Inc. It will be available in 75 mg and 150 mg capsules.
