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The novel oral anticoagulant (NOAC) field is hotly contested, and drugmakers are turning to real-world data to gain their meds an advantage. Now, Boehringer Ingelheim may have one such advantage for its Pradaxa (dabigatran) over market leader Xarelto (rivaroxaban), thanks to a new observational study.

Patients on Xarelto–marketed by Johnson & Johnson and Bayer–may be more likely to experience serious bleeding events than patients taking Pradaxa, according to a study published this week in JAMA Internal Medicine.

Researchers sifted records on 118,000 Medicare patients with atrial fibrillation who started on one of the two meds.  When compared with Pradaxa therapy, Xarelto treatment was associated with significant increases in intracerebral hemorrhage and major extracranial bleeding, too–including major GI bleeding, they found.

The findings are ironic, researchers noted, considering that in 2014, Xarelto was used two to three times more often than Pradaxa by afib patients in the U.S. The reason? “Prescriber misperceptions about bleeding risks with dabigatran, arising from U.S. Food and Drug Administration receipt of a large number of postmarketing case reports following its approval,” they speculated, as quoted by MedPageToday.


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