Post-marketing study of Xarelto (rivaroxaban) confirms bleeding rates in patients with atrial fibrillation- Bayer HealthCare/Janssen

New data from an ongoing post-marketing study in nearly 45,000 people with non-valvular atrial fibrillation (NVAF) confirm the safety profile of Xarelto (rivaroxaban), from Bayer HealthCare and Janssen, was generally consistent with the findings observed in ROCKET AF, the Phase III study that supported the approval of the medicine for prevention of stroke in patients with NVAF. The real-world findings, which also confirm the rates and patterns of major bleeding in 12,039 patients with NVAF and concomitant diabetes.

The study, called PMSS (Post-Marketing Safety Surveillance), is Janssen's ongoing five-year observational study that evaluates major bleeding in people with NVAF in the U.S. 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-years1, 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 Xarelto 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. Data were presented at the American College of Cardiology's 65th Annual Scientific Session.

Comment: Based on data of Medicare beneficiaries, an estimated 34 percent of people with NVAF also have diabetes; other data found 84 percent have hypertension, 74 percent are at advanced age (75 years or older), 36 percent have heart failure and 30 percent have cerebrovascular disease.