Characterizing Major Bleeding in Patients With Nonvalvular Atrial Fibrillation: A Pharmacovigilance Study of 27 467 Patients Taking Rivaroxaban
Population
27,467 patients with nonvalvular atrial fibrillation from the US Department of Defense electronic health…
Design
Cohort
Follow-up
January 1, 2013, to March 31, 2014 (query period)
Authors
Discussion
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Member takes
Implication
Reassures on major bleeding risk with rivaroxaban in routine NVAF care; extends trial data to real-world settings but leaves comparative effectiveness open.
Structured PICO
P
Population
27,467 patients with nonvalvular atrial fibrillation (NVAF) from the US Department of Defense electronic health care records
I
Intervention
Rivaroxaban (10 mg, 15 mg, or 20 mg)
O
Outcome
Major bleeding (MB) rates and demographicssafety
In a real-world cohort of NVAF patients taking rivaroxaban, the major bleeding rate was 2.86 per 100 person-years, which is consistent with registration trial results, and fatal bleeds were rare.
Cite This Study
Tamayo et al. (2015) studied this question.