Home health remedies AHA: Johnson & Johnson, Bayer still looking for answers in aborted Xarelto...

AHA: Johnson & Johnson, Bayer still looking for answers in aborted Xarelto study

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PHILADELPHIA––More than a year after Johnson & Johnson and Bayer pulled the plug on an open-label study for anticoagulant Xarelto in patients after a rare valve replacement procedure, the drugmaker is still grasping at straws for what exactly happened. 

Patients treated with a Xarelto-added regimen after a transcatheter aortic valve replacement (TAVR) showed higher rates of bleeding, thromboembolic events and all-cause mortality than patients treated with standard-of-care aspirin. Those data led the pair to prematurely end their comparative Galileo study in October 2018, citing “imbalanced” safety results in the Xarelto arm of the studies. J&J and Bayer also recommended physicians not prescribe Xarelto for TAVR patients.

Now, more than a year later, Xarelto is still looking for answers with late-breaking data presented Saturday at the American Heart Association Scientific Sessions. For James List, Janssen R&D’s global therapeutic area head of cardiovascular and metabolism, the results––particularly patient deaths––are still somewhat of a mystery. 

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“We don’t totally understand the results,” List said Friday. “We’re being very careful and cautious in stopping the study, but when you look at the events that occurred, most of the deaths came long after the study was discontinued.”

Patients in Galileo were treated with a double therapy of Xarelto and aspirin one week after a TAVR before aspirin was dropped after three months. Patients then continued on Xarelto alone at a median follow-up duration of 17 months. From the beginning, the Xarelto arm of the study showed higher risks of bleeding, but the companies said subanalyses of Galileo did not show a direct relationship between those deaths and higher bleeding risks.

An imaging substudy dubbed Galileo-4D also showed that Xarelto reduced the risk of hypo-attenuated leaflet thickening in TAVR patients not indicated for an oral anticoagulant. However, due to the deleterious safety results, J&J and Bayer still do not recommend Xarelto for TAVR patients and have no plans to pursue that indication in the future. 

“Sometimes negative studies come in when you’re doing science––and that’s important,” he said. 

RELATED: J&J, Bayer’s Xarelto scores FDA nod to treat acutely ill patients during and after hospitalization

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