Two studies show benefits of Xarelto (rivaroxaban) in treating venous thromboembolism- Janssen/Bayer Healthcare

Janssen Pharmaceuticals and Bayer 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. 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. This was without an increased risk of major bleeding, compared to those who discontinued Xarelto after three months. At three months, recurrent VTE occurred in 0.57 percent of people in the continued cohort and 1.19 percent in the discontinued cohort. Major bleeding occurred in 0.51 percent and 0.72 percent, respectively. At six months, recurrent VTE occurred in 1.07 percent of people in the continued cohort and 2.10 percent in the discontinued cohort. Major bleeding occurred in 0.79 percent and 0.72 percent, respectively. At 12 months, recurrent VTE occurred in 1.45 percent of people in the continued cohort and 2.60 percent in the discontinued cohort. Major bleeding occurred in 1.06 percent and 1.13 percent, respectively.

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. Of the 9,638 people taking Xarelto, 130 (1.3 percent) experienced a major bleeding event, translating into an incidence rate of 2.47 per 100 person-years2, primarily in gastrointestinal sites. With DVT, major bleeding events in PMSS were observed in 74 people with DVT (1.4 percent), translating into an incidence rate of 2.74 per 100 person-years. With PE, major bleeding events in PMSS were observed in 56 people with PE (1.3 percent), translating into an incidence rate of 2.18 per 100 person-years. People who experienced major bleeding were typically older, female and had more comorbidities; fatal outcomes were rare. Results of both studies were presented at the American College of Chest Physicians (CHEST) Annual Meeting 2016.