title: Comparison of the Incidence of Major Bleeding With Rivaroxaban Use Among Nonvalvular Atrial Fibrillation Patients With Versus Without Diabetes Mellitus.
abstract: Diabetes mellitus (DM) is a common co-morbidity in those with nonvalvular atrial fibrillation (NVAF). Most patients with DM and NVAF have a CHA2DS2-VASc score of ≥1 and should be considered for oral anticoagulation therapy for stroke prevention per treatment guidelines. The most important risk associated with anticoagulation is bleeding, which may be higher in those with NVAF plus DM. Our objective was to evaluate the incidence and characteristics of major bleeding (MB) in rivaroxaban users diagnosed with NVAF, further comparing those with DM versus those without DM, in a real-world clinical setting. Electronic medical records of >10 million patients from the Department of Defense Military Health System were queried to identify rivaroxaban users with NVAF over a 2.5-year period. Major bleeding-related hospitalization was identified by a validated case-finding algorithm. Patient characteristics, incidence and management of MB, and fatal outcomes were assessed by DM status. Of 44,793 rivaroxaban users with NVAF, 12,039 (26.9%) had DM, who were more likely men, younger, with more co-morbidity and higher CHA2DS2-VASc scores. Major bleeding incidence was higher among those with DM compared with those without, 3.68 (95% confidence interval [CI] 3.37 to 4.03) versus 2.51 (95% CI 2.34 to 2.69) per 100 person-years, and intracranial bleeding incidence was 0.19 (95% CI 0.13 to 0.28) versus 0.25 (95% CI 0.20 to 0.31) per 100 person-years. Fatal outcomes were rare for both cohorts, 0.09 per 100 person-years. In conclusion, in this post-marketing study of 44,793 rivaroxaban users with NVAF, patients with DM had more co-morbidities and higher incidence of MB compared with those without DM.
authors.affiliation: Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas. Electronic address: Frankpeacock@gmail.com.
authors.forename: W Frank
authors.initials: WF
authors.lastname: Peacock
authors.affiliation: Department of Cardiology, United States Naval Medical Center, Portsmouth, Virginia.
authors.forename: Sally
authors.initials: S
authors.lastname: Tamayo
authors.affiliation: Clinical Epidemiology, Health ResearchTx LLC, Trevose, Pennsylvania.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Sicignano
authors.affiliation: Clinical Epidemiology, Health ResearchTx LLC, Trevose, Pennsylvania.
authors.forename: Kathleen P
authors.initials: KP
authors.lastname: Hopf
authors.affiliation: Janssen Research and Development, LLC, Titusville, New Jersey.
authors.forename: Zhong
authors.initials: Z
authors.lastname: Yuan
authors.affiliation: Duke University Health System and Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Manesh
authors.initials: M
authors.lastname: Patel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D003920:Diabetes Mellitus / Q000453:epidemiology*; D065427:Factor Xa Inhibitors / Q000009:adverse effects*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D020300:Intracranial Hemorrhages / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D012189:Retrospective Studies; D000069552:Rivaroxaban / Q000009:adverse effects*; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*
chemical_list: D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban