Pradaxa Approved to Prevent Stroke in AF Patients

The FDA has approved dabigatran, an oral direct thrombin inhibitor that offers key advantages over warfarin for patients at risk for stroke.

The FDA has approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with atrial fibrillation.

“People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, MD, PhD, director of the FDA’s Division of Cardiovascular and Renal Products, in a statement.

The safety and efficacy of dabigatran, an oral direct thrombin inhibitor, was studied in a recent trial comparing Pradaxa with the anticoagulant warfarin. In the trial—which was published in the New England Journal of Medicine—the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) investigators randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran (110 mg or 150 mg twice daily) or, in an unblinded fashion, adjusted-dose warfarin.

The team of researchers, led by Stuart J. Connolly, MD, of the Population Health Research Institute, found that the rate of major bleeding was 3.36% per year in the warfarin group, compared with 2.71% in the group receiving 110 mg of dabigatran and 3.11% per year in the group receiving 150 mg of dabigatran. The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, compared with 0.12% per year with 110 mg of dabigatran and 0.10% per year with 150 mg of dabigatran. Mortality rates were also higher (4.13% per year) in the warfarin group than in patients taking 110 mg of dabigatran (3.75% per year) and 150 mg of dabigatran (3.64% per year).

“The most devastating complication of warfarin therapy is intracranial hemorrhage, especially hemorrhagic stroke,” said the authors, noting that the risk of intracranial hemorrhage with warfarin is double that of aspirin. Therefore, “our finding that the rate of this complication with both doses of dabigatran was less than one third the rate with warfarin, without a reduction in the efficacy against ischemic stroke, suggests an important advantage of dabigatran.”

Another key finding from the research, according to the FDA, is the fact that dabigatran, which has already been approved in Europe, doesn’t require international normalized ratio (INR) monitoring.

“Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” Stockbridge said.

As with other approved anti-clotting drugs, bleeding—including life-threatening and fatal bleeding—was among the most common adverse reactions reported by patients treated with Pradaxa. Gastrointestinal symptoms were also reported, including dyspepsia, stomach pain, nausea, heartburn.

According to the FDA, the drug will come with a guide warning patients of the risk of serious bleeding.

To read the NJEM study, click here.

Will you recommend this drug to patients with atrial fibrillation, or are you hesitant because of the risks involved? Do the benefits outweigh the risks?

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