Real-world safety outcomes from one ongoing US study
13
of 27,467 nonvalvular AF patients
Results based on 15 months of data from an ongoing, 5-year postmarketing safety surveillance study to evaluate
major bleeding in patients receiving XARELTO® in a real-world clinical setting. Cases of major bleeding were
identified through electronic health records from the US Department of Defense database, from January 1, 2013, to
March 31, 2014.
RATES OF BLEEDING
COMORBID PATIENTS STUDIED
EVENT RATE/100 PATIENT-YEARS
20
15
10
5
0
2.86 0.08
major bleed (n=478) fatal bleed (n=14)
0.1% ICH (n=36)
1.5% GI bleed (n=423)
87%
Mean age: 76
with comorbidities
including:
diabetes
heart failure
renal disease
RESULTS ARE NOT INTENDED FOR DIRECT COMPARISON WITH CLINICAL TRIALS
A validated computer database algorithm developed by Cunningham et al, which identifies bleeding-related
hospitalizations from a primary discharge diagnosis, was used to identify major bleeding events in this study. The
definition of major bleeding is not an exact match with the ROCKET AF trial.
LIMITATIONS: This is a retrospective study and there is no comparator arm in the trial. Differences in study
design, patient populations, definition of safety outcomes, and data collection methods make it difficult to make
comparisons with clinical trials.13
RATES OF BLEEDING IN ROCKET AF (N=7,111)*14:
The event rate per 100 patient-years was 3.6 (n=395) for major bleed and 0.20 (n=27) for fatal bleed†
•
0.8% of patients experienced an ICH (n=55) and 3.1% of patients experienced a GI bleed (n=221)
AF = atrial fibrillation; GI = gastrointestinal; ICH = intracranial hemorrhage.
*XARELTO®
was evaluated versus dose-adjusted warfarin in more than 14,000 patients with nonvalvular AF at moderate to high risk for stroke in a rigorously designed, multicenter,
randomized, double-blind, double-dummy, event-driven phase III trial. XARELTO® demonstrated effective reduction in the risk of stroke and non-CNS systemic embolism in patients
with prior stroke or multiple comorbidities.14
†Major bleeding from ROCKET AF study was defined as clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, transfusion of ≥2 units of packed red blood cells
or whole blood, bleeding at a critical site, or with a fatal outcome.14
IMPORTANT SAFETY INFORMATION (cont’d)
CONTRAINDICATIONS
Active pathological bleeding
Severe hypersensitivity reaction to XARELTO®
(eg, anaphylactic reactions)
WARNINGS AND PRECAUTIONS
Increased Risk of Thrombotic Events After Premature
Discontinuation: Premature discontinuation of any
oral anticoagulant, including XARELTO®, in the absence
of adequate alternative anticoagulation increases the
risk of thrombotic events. An increased rate of stroke
was observed during the transition from XARELTO® to
warfarin in clinical trials in atrial fibrillation patients.
If XARELTO® is discontinued for a reason other than
pathological bleeding or completion of a course of
therapy, consider coverage with another anticoagulant.