New data presented at the American Geriatrics Society 2015 Annual Scientific meeting suggests that the rates of major bleeding and fatal outcomes in elderly patients with non-valvular atrial fibrillation (NVAF) treated with Xarelto (rivaroxaban; Janssen) are consistent with those reported in Phase 3 clinical trials.

In the study, nearly 10 million electronic healthcare records (EHRs) from the U.S. Department of Defense (DoD) were reviewed to determine rates of major bleeding in NVAF patients treated with Xarelto in a real-world setting. Of the 31,883 patients taking Xarelto, an incidence of major bleeding was observed at 2.85 per 100 person-years with 74.1% of these events occurring in those aged ≥75 years of age. This is consistent with findings from the ROCKET-AF clinical trial that noted a correlation between increased age and bleeding risk. Comorbidities were more common in the major bleeding group vs. those who did not experience major bleeding across all ages. Gastrointestinal bleeding was the most common bleeding event in all age groups, followed by intracranial hemorrhage (ICH); the rate of ICH also increased with age. Fatal outcomes due to major bleeding were low and the mean age of those who died was 82.1 years.

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These results are part of an ongoing five-year observational study of the safety of Xarelto, including in elderly patients at an increased risk of adverse events like major bleeding.

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