J&J's Xarelto may cause more serious bleeding than BI's Pradaxa, real-world study shows

Boehringer Ingelheim

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.

Johnson & Johnson, for its part, pointed out in a statement to FiercePharma that “a true comparison of one NOAC to another can only be made through a randomized clinical trial” and noted that it’s “reassuring that rivaroxaban continues to demonstrate highly robust efficacy and safety data in the real world.”

In the absence of such a head-to-head trial--which NOAC drugmakers aren’t likely to sponsor--it’s not the first time that Xarelto’s trailing rivals have turned to real-world data. At last year’s European Society of Cardiology Congress, Pfizer and Bristol-Myers Squibb rolled out a real-world analysis showing that starting on Xarelto or warfarin posed “significantly greater” major bleeding risks compared with their horse in the race, Eliquis.

Still, Xarelto continues to maintain the market lead, thanks to a hefty clinical trial program that has it leading in the indications column.

Boehringer, which was the first to hit the scene when it rolled out Pradaxa, is hoping to fight its way back to the top, and last year it won FDA approval for Praxbind, a reversal agent it thinks can help it get there. By contrast, in August, the agency denied a Portola Pharmaceuticals med designed to undo the effects of Xarelto, Eliquis and Daiichi Sankyo’s Savaysa.

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