New data from an ongoing post-marketing study evaluating the safety of once-daily XARELTO® (rivaroxaban) in patients with non-valvular atrial fibrillation (NVAF) were presented at the American Geriatrics Society 2015 Annual Scientific Meeting.
“The data from this ongoing five-year observational study reaffirms the safety profile of XARELTO®, including in elderly patients who are at a particularly increased risk for adverse events, like bleeding,” said study investigator W. Frank Peacock, M.D., FACEP, associate chair and research director, Emergency Medicine, Baylor College of Medicine, Houston, TX. “These real-world results are important as clinicians evaluate treatment options for high-risk non-valvular atrial fibrillation patients who are also at the greatest risk of having a stroke.”
Researchers reviewed data from almost 10 million electronic healthcare records from the U.S. Department of Defense (DoD), via a collaboration with Health ResearchTx LLC (HRTX), to evaluate major bleeding rates in NVAF patients treated with XARELTO® in the real-world setting. Of the 31,883 patients using XARELTO®, an incidence of major bleeding was observed at 2.85 per 100 person-years, with 74.1 percent of these events occurring in those 75 years of age and older. Gastrointestinal bleeding was the most common bleeding event in all age groups, followed by intracranial hemorrhage (ICH). The rate of ICH increased with age. Fatal outcomes as a result of major bleeding were low, and the mean age of those who died was 82.1 years, according to Janssen.