April 8, 2016 — New data from an ongoing post-marketing study confirm the safety profile of Xarelto (rivaroxaban) was generally consistent with the findings observed in the ROCKET AF Phase 3 study that supported approval of the medicine for prevention of stroke in patients with non-valvular atrial fibrillation (NVAF).
The real-world findings of the post-marketing study, which also confirm the rates and patterns of major bleeding in 12,039 patients with NVAF and concomitant diabetes, were presented at the American College of Cardiology's 65th Annual Scientific Session (ACC.16).
"We have closely examined the use of rivaroxaban in daily clinical practice for the last three years, and our findings continue to provide important insights about the safety of rivaroxaban, with a safety profile generally consistent with what was observed in clinical trials," said study investigator W. Frank Peacock, M.D., FACEP, associate chair and research director, emergency medicine, Baylor College of Medicine, Houston. "As part of our ongoing observational study, which now includes nearly 45,000 people with NVAF, we also examine the safety of rivaroxaban in those patients with concomitant chronic conditions.
Approximately 34 percent of people with NVAF also have diabetes, and our research also confirms the safety profile of rivaroxaban in this high-risk group."
The Post-Marketing Safety Surveillance (PMSS) study is Janssen's ongoing five-year observational study that evaluates major bleeding in people with NVAF in the United States taking once-daily Xarelto. As observed with previous data cuts, the 2.5-year data found the rates and patterns of major bleeding were generally consistent with ROCKET AF. Of the 32,754 people taking Xarelto in PMSS without diabetes, the incidence of major bleeding was observed at 2.51 per 100 person-years, with the most common bleeding site being gastrointestinal. Fatal bleeds were uncommon, with an incidence of 0.09 per 100 person-years.
In a sub-analysis of ROCKET AF, the incidence of major bleeding for Xarelto in patients with NVAF without diabetes was observed at 3.47 per 100 person-years.
PMSS researchers also examined major bleeding rates of in patients with NVAF with diabetes, and found the incidence rate to be generally consistent with the ROCKET AF sub-analysis. In PMSS, 12,039 people, or nearly 27 percent, also had diabetes, and the incidence of major bleeding was observed at 3.68 per 100 person-years, with the most common bleeding site being gastrointestinal. Fatal bleeds were uncommon, with an incidence of 0.09 per 100 person-years. In ROCKET AF, 2,878 people taking Xarelto, or 40 percent, also had diabetes. The ROCKET AF sub-analysis found the incidence of major bleeding to be 3.79 per 100 person-years.
For more information: www.acc.org