The first data cut of 9,638 people with VTE (5,426 with DVT 4,212 with PE) showed: Like Janssen's PMSS study in non-valvular atrial fibrillation (NVAF), this retrospective, observational study evaluates major bleeding in these patients in a real-world, post-approval setting, using electronic health records from the U.S. Study Confirms Safety Profile of XARELTO ® in VTEĪlso presented were the first results from Janssen's ongoing PMSS VTE study, which follows people with DVT and PE in the U.S. There was no difference in major bleeding between the two groups. The EINSTEIN-Extension study found continuing treatment with XARELTO ® for an additional six to 12 months beyond the initial treatment period resulted in significantly fewer VTE recurrences (1.3 percent) versus placebo (7.1 percent), p<0.001. This study builds on findings from the Phase 3 EINSTEIN clinical program, which was used by regulatory authorities worldwide to approve XARELTO ® for the treatment of DVT and PE and reduction in the risk of recurrence of DVT and PE. "Extended treatment with rivaroxaban showed a decrease in recurrent VTE without an increase in major bleeding and is consistent with a previous clinical trial." Scott Kaatz, lead study investigator and hospitalist, Henry Ford Hospital. "This study in a broad real-world setting affirms the ACCP guidelines for the extended treatment of an unprovoked VTE," said Dr. However, the risk still remains after treatment ends and up to 10 percent of people will have a recurrent event within the first year. At 12 months, recurrent VTE occurred in 1.45 percent of people in the continued cohort and 2.60 percent in the discontinued cohort (p0.05).Ĭlinical guidelines recommend people diagnosed with VTE be treated with an anticoagulant, such as rivaroxaban, for a minimum of three months when they are at the highest risk of experiencing a recurrence.At six months, recurrent VTE occurred in 1.07 percent of people in the continued cohort and 2.10 percent in the discontinued cohort (p0.05).At three months, recurrent VTE occurred in 0.57 percent of people in the continued cohort* and 1.19 percent in the discontinued cohort** (p0.05).In nearly 5,000 people who were diagnosed with their first VTE, researchers examined the long-term safety and effectiveness of XARELTO ® and found those who continued taking XARELTO ® for up to one year had significantly lower rates of VTE recurrence at all measured time points, without an increased risk of major bleeding, compared to those who discontinued XARELTO ® after three months. Real-World Study Confirms Benefit of Extended Use of XARELTO ® in VTE Once a person experiences VTE, they are at increased risk of it occurring again. VTE affects more than 900,000 Americans each year, and one-third of these occurrences will be fatal. VTE is a collective term encompassing deep vein thrombosis (DVT), a blood clot in a deep vein (usually the leg), and pulmonary embolism (PE), when a clot travels to the lung. Results of both studies were presented at the American College of Chest Physicians (CHEST) Annual Meeting 2016. The second was the first readout from Janssen's Post-Marketing Safety Surveillance (PMSS) study in VTE, which showed the rates and patterns of major bleeding in people taking XARELTO ® for VTE in routine clinical practice were consistent with those reported in clinical trials. One study showed that people with VTE taking XARELTO ® for longer than three months had a lower risk of VTE recurrence, without an increase in major bleeding, compared to those taking the medicine for only three months. (Janssen) and its development partner, Bayer, today announced results of two new real-world studies confirming the positive benefit-risk profile of XARELTO ® (rivaroxaban) in treating venous thromboembolism (VTE), or blood clots, and reducing the risk of recurrence. TITUSVILLE, N.J., Octo– Janssen Pharmaceuticals, Inc.
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