The post-marketing safety profile of Xarelto (rivaroxaban; Janssen) was consistent with the findings seen in the Phase 3 study, ROCKET AF, that supported the approval for Xarelto in the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). The full findings were presented at the American College of Cardiology’s 65th Annual Scientific Session.
The ongoing 5-year post-marketing observational study, called PMSS (Post-Marketing Safety Surveillance), has enrolled nearly 45,000 patients with NVAF. The 2.5-year PMSS data (from January 1, 2013–June 30, 2015) showed that among the 32,754 patients taking Xarelto without diabetes, the incidence of major bleeding was 2.51 per 100 person-years. The incidence of major bleeding for patients with NVAF without diabetes taking Xarelto in the ROCKET AF sub-analysis was 3.47 per 100 person-years.
The data presented also confirmed the rates and patterns of major bleeding in 12,039 patients with NVAF and concomitant diabetes. The incidence rate was generally consistent with the ROCKET AF sub-analysis with 3.68 per 100 person-years seen in the PMSS study vs. 3.79 per 100 person-years in the ROCKET AF sub-analysis. The PMSS data also showed the incidence of fatal bleeds was uncommon with a rate of 0.09 per 100 person-years.
The PMSS study was developed by Janssen along with the U.S. Department of Defense and Health Research Tx LLC, and in agreement with the Food and Drug Administration (FDA) as part of post-marketing requirement to analyze and report major bleeding events, associated risk factors and bleeding-related clinical outcomes in NVAF patients taking Xarelto (10mg, 15mg, 20mg).
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