XALIA trial of Xarelto (rivaroxaban) has success in real world study for DVT. -Bayer + Janssen
Bayer and partner Janssen Pharmaceuticals, Inc. announced results the non-interventional XALIA study in patients with deep vein thrombosis (DVT) showing low rates of major bleeding and recurrent venous thromboembolism (VTE) with Xarelto (rivaroxaban). Results from the study was presented at the 2015 ASH Annual Meeting .
XALIA is the first large-scale, prospective, observational, real world study to evaluate the safety and effectiveness of a non-VKA oral anticoagulant (NOAC) in patients with DVT in routine clinical practice. As an oral single-drug therapy, rivaroxaban demonstrated low rates of major bleeding, recurrent VTE and all-cause mortality in a broad range of patients. To help address differences in baseline characteristics between the two treatment groups, a propensity score analysis was pre-specified in the protocol. In this analysis, major bleeding was observed in 0.8% of patients in the rivaroxaban group and 2.1% of patients in the standard anticoagulation group (propensity score-adjusted HR 0.77; 95% CI 0.40-1.50; p=0.44; n.s.), while recurrent VTE occurred in 1.4% and 2.3% of patients respectively (propensity score-adjusted HR 0.91; 95% CI 0.54-1.54; p=0.72; n.s.). All-cause mortality occurred in 0.4% of patients in the rivaroxaban group compared with 3.4% of patients in the standard anticoagulation group (propensity score-adjusted HR 0.51; 95% CI 0.24-1.07; p=0.07; n.s.).
Furthermore, XALIA confirmed shorter hospital stays with rivaroxaban compared to standard anticoagulation therapy, suggesting an economic benefit by providing simplified treatment management from hospital to home without the need for injections or routine coagulation monitoring.
The prospective, non-interventional study, designed by Bayer HealthCare and in agreement with the European Medicines Agency (EMA), included 5,142 patients with DVT from 19 countries in Europe, as well as Canada and Israel, and each patient was followed up for at least 12 months. Propensity score-adjusted analyses were performed for 2,505 patients treated with rivaroxaban and 2,010 patients treated with standard anticoagulation therapy, to account for potential imbalances between the two groups. All reported outcome events were adjudicated by a blinded Central Committee.
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