Both doses of Xarelto (10mg and 20mg) were superior to aspirin (100mg) in lowering the risk of recurrent VTE after ≥6 months of standard anticoagulation.
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Study of newer medications finds 16 percent receive too much or too little
The new sNDA submission is supported by the ‘Einstein Choice’ study, which included 3,365 patients in a Phase 3 randomized, double-blind study that compared Xarelto once daily to aspirin.
The researchers found the risk of GI bleeding was lower for apixaban versus dabigatran or rivaroxaban.
The researchers searched the U.S. Medicare database for NVAF patients 65 years of age and older who were newly prescribed one of the following medications: apixaban, dabigatran, rivaroxaban, or warfarin.
Janssen announced that the Phase 3 trial, COMPASS, is stopping earlier than planned based on the recommendation of the study’s Independent Data Monitoring Committee (DMC), as the primary major adverse cardiovascular events (MACE) endpoint has reached its pre-specified criteria for superiority.
At the 2016 American Society of Hematology (ASH) Annual Meeting, researchers from Janssen and Bayer presented data showing that cancer patients treated with Xarelto (rivaroxaban) for blood clots had significantly fewer emergency room (ER) visits and lower healthcare costs at start of therapy vs. patients given standard treatment.
A study published in JAMA reports that anticoagulants, antibiotics, diabetes drugs, and opioids are the most common drug classes related to emergency department visits for adverse drug events in the country.
Janssen and Bayer announced new data from two real-world studies that confirmed the positive benefit-risk profile of Xarelto (rivaroxaban) for the treatment of venous thromboembolism (VTE) and reducing the risk of recurrence.
For acute major bleeding within 18 hours after factor Xa inhibitor administration, a bolus and infusion of andexanet alfa (andexanet) reduces factor Xa activity, according to a study published online in the New England Journal of Medicine. The research was published to coincide with the annual European Society of Cardiology Congress.