Although they showed some merits, overall there was disappointment with trial results from the Phase III MARINER and COMMANDER HF (heart failure) studies, which were presented this week at the European Society of Cardiology (ESC) Congress 2018 and simultaneously published in The New England Journal of Medicine.
In both studies, there was no significant difference found between Xarelto (rivaroxaban) and placebo for the primary efficacy endpoints. Xarelto did, however, demonstrate a consistent safety profile, said Johnson & Johnson (NYSE: JNJ) subsidiary Janssen, which has US marketing rights to the drug from Germany’s Bayer *BAYN: DE).
MARINER demonstrated that Xarelto did not reduce the composite endpoint of venous thromboembolism (VTE), or blood clots, and VTE-related death in acute medically ill patients following hospital discharge. However, Xarelto did significantly reduce VTE with consistent safety, reinforcing the medicine's positive benefit-risk profile. An earlier clinical trial ( MAGELLAN) evaluated the use of Xarelto in the same population of acute medically ill patients as in MARINER.
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