Xarelto Safety, Efficacy for DVT Confirmed in Real-World Data

Janssen and Bayer announced the results from their real-world study XALIA, showing that the rates of major bleeding and recurrent blood clots for Xarelto (rivaroxaban) in routine clinical practice were generally consistent with Phase 3 data in patients with deep vein thrombosis (DVT), with shorter hospital stays than standard anticoagulation. Findings were presented at the 2015 American Society of Hematology (ASH) Annual Meeting and published in Lancet Hematology.

XALIA (XA inhibition with rivaroxaban for Long-term and Initial Anticoagulation in venous thromboembolism) was a prospective, non-interventional, observational, Phase 4 study evaluating the safety and efficacy of Xarelto for DVT treatment in routine clinical practice as compared to standard anticoagulation [heparin, low-molecular-weight heparin (LMWH) or fondaparinux, typically overlapping with and followed by warfarin]. The study enrolled 5,142 patients with DVT, or DVT with concomitant pulmonary embolism (PE) between June 2012 and March 2014, and followed for at least 12 months. The primary endpoint was the incidence of adverse events (major bleeding, recurrent blood clots and all-cause mortality) with additional outcomes evaluated, including length of hospital stay.

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Treatment with Xarelto was associated with a 0.8% rate of major bleeding compared to 2.1% for standard anticoagulation (HR 0.77; CI 0.40–1.50; P=0.44). No fatal bleeding events were found in the Xarelto group vs. 2 in the standard anticoagulation group. Recurrent blood clots occurred in 1.4% of patients receiving Xarelto vs. 2.3% of those receiving standard anticoagulation (HR 0.91; CI 0.54-1.54; P=0.72). All-cause mortality occurred in 0.4% of Xarelto-treated patients compared to 3.4% in patients treated with standard anticoagulation (HR 0.51; CI 0.24-1.07; P=0.07). In comparison, rates of major bleeding, recurrent blood clots, and all-cause mortality in Xarelto-treated patients in the Phase 3 EINSTEIN-DVT study were 0.8%, 2.1%, 2.2%, respectively. The additional outcome of length of hospital stay was also evaluated and was found to be shorter for patients treated with Xarelto (mean 5 days) vs. standard anticoagulation (mean 7.7 days) [geometric means ratio 0.66; CI 0.61-0.72].

Xarelto is a Factor Xa inhibitor currently approved for the treatment of DVT/PE, for the prophylaxis of DVT/PE post hip or knee replacement surgery, for the reduction in the risk of recurrent DVT/PE after initial 6-month treatment, and for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

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