Janssen and Bayer announced new data from two real-world studies that confirmed the positive benefit-risk profile of Xarelto (rivaroxaban) for the treatment of venous thromboembolism (VTE) and reducing the risk of recurrence.
In one study, patients with VTE treated with Xarelto for >3 months exhibited a lower risk of VTE recurrence without an increase in major bleeding vs. patients taking Xarelto for only 3 months. At 3 months, recurrent VTE was seen in 0.57% of patients in the continued cohort and 1.19% in the discontinued cohort (P<0.05). At 6 months, recurrent VTE was seen in 1.07% of patients in the continued cohort and 2.10% in the discontinued cohort (P<0.05). At 12 months, recurrent VTE was seen in 1.45% of patients in the continued cohort and 2.60% in the discontinued cohort (P<0.05).
The second study based on the ongoing Janssen’s Post-Marketing Safety Surveillance (PMSS) study in VTE showed that major bleeding rates and patterns in patients taking Xarelto for VTE in routine clinical practice were consistent to data reported in clinical trials. The first data readout that included 9,638 patients with VTE showed 1.3% had a major bleeding event (2.47 per 100 person-years).
With DVT, major bleeding events in PMSS were seen in 1.4% of patients, translating to an incidence rate of 2.74 per 100 person-years. With pulmonary embolism (PE), major bleeding events in PMSS were seen in 1.3% of patients, translating to an incidence rate of 2.18 per 100 person-years.
Xarelto, a Factor Xa inhibitor, is currently approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; to treat DVT, PE; to reduce the risk of recurrence of DVT, PE following 6 months treatment for DVT, PE; and as prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
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