Proven Safety Profile in DVT, PE, and Risk Reduction
The safety profile of XARELTO® as a single, oral agent was proven in three phase 3 clinical trials for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for reducing the risk of recurrence of DVT and PE in more than 9400 patients. Safety data was also shown in a pooled subgroup analysis of DVT and PE patients.1,2
Patient Population Studied in the EINSTEIN–DVT and EINSTEIN–PE Clinical Trials
46% relative risk reduction in major bleeding versus standard of care (enoxaparin + warfarin)1
Principal safety outcome: comparable rates of the composite of major bleeding and clinically relevant nonmajor bleeding across treatment groups1
Pooled subgroup analysis of the EINSTEIN–DVT and –PE randomized trials
A pooled analysis of the safety data of both trials was conducted, including key prespecified subgroups, such as patients with cancer, patients with previous VTE, and fragile** patients. Both studies used identical designs, treatment regimens, outcome definitions, and adjudication processes to facilitate pooled analyses.1,2
**Fragility was defined as one or more of these criteria: age >75 years, CrCl <50 mL/min, or body weight ≤50 kg.1
Proven safety profile when extending treatment to reduce risk of recurrence
Does the risk persist?
VTE risk continues after treatment concludes.‡‡
Continuing XARELTO® therapy beyond initial regimen with proven safety profile||||
EINSTEIN–EXT, a randomized, double-blind, event-driven, superiority trial, was part of the largest DVT and PE phase 3 clinical trial program ever conducted (N=9477).¶¶
All patients had already undergone 6 to 14 months## of anticoagulation therapy and were at clinical equipoise with respect to the need for continued anticoagulation2
Patients were randomized on either XARELTO® 20 mg once daily or placebo
There were no fatal or critical-organ bleeding events
‡‡VTE treatment guidelines suggest ongoing treatment could begin any time after 3 months of initial treatment.6,7
||||Longer than 6 months.
¶¶Composed of the EINSTEIN–DVT (N=3449), EINSTEIN–PE (N=4832), and EINSTEIN–EXT (N=1196) trials.
##Although the EINSTEIN–EXT trial was designed to evaluate patients who had previously completed 6 to 12 months of treatment with either rivaroxaban or warfarin before trial enrollment, some of the patients could have received up to 14 months of anticoagulation treatment before enrollment.2