Incidence of major and clinically relevant non-major bleeding in patients prescribed rivaroxaban for stroke prevention in non-valvular atrial fibrillation in secondary care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) study

Although the direct oral anticoagulant rivaroxaban is recommended for stroke prevention in patients with non-valvular atrial fibrillation based on Phase III clinical trials, there is still a need for additional safety data from everyday clinical practice. The ROSE study was initiated to collect furt...

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Veröffentlicht in:PloS one Jg. 15; H. 10; S. e0240489
Hauptverfasser: Evans, Alison, Davies, Miranda, Osborne, Vicki, Roy, Debabrata, Shakir, Saad
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States Public Library of Science 09.10.2020
Public Library of Science (PLoS)
Schlagworte:
Administration, Oral
Aged
Aged, 80 and over
Anticoagulants
Atrial fibrillation
Atrial Fibrillation - drug therapy
Bleeding
Cardiac arrhythmia
Clinical trials
Diabetes
Disease prevention
Drug dosages
Drug therapy
Embolisms
England - epidemiology
Factor Xa Inhibitors - administration & dosage
Factor Xa Inhibitors - adverse effects
Female
Fibrillation
Health risks
Hemorrhage
Hemorrhage - chemically induced
Hemorrhage - epidemiology
Humans
Hypertension
Incidence
Male
Medical records
Medical research
Medicine and Health Sciences
Patient outcomes
Patients
Prevention
Primary care
Product safety
Questionnaires
Risk
Risk factors
Rivaroxaban
Rivaroxaban - administration & dosage
Rivaroxaban - adverse effects
Safety
Safety research
Secondary Care
Stroke
Stroke - prevention & control
Thrombosis
Wales - epidemiology
England
Wales
United Kingdom
United Kingdom > UK
ISSN:1932-6203, 1932-6203
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Zusammenfassung:Although the direct oral anticoagulant rivaroxaban is recommended for stroke prevention in patients with non-valvular atrial fibrillation based on Phase III clinical trials, there is still a need for additional safety data from everyday clinical practice. The ROSE study was initiated to collect further information on the safety and utilisation of rivaroxaban in a broader range of patient groups in routine clinical practice. The ROSE study was conducted in hospitals in England and Wales. Consenting adults with non-valvular atrial fibrillation newly started on rivaroxaban were eligible and followed up for 12 weeks. Data was derived through secondary use of medical records. The primary outcome was major bleeding within gastrointestinal, urogenital and intracranial sites. A total of 4846 patients were enrolled in the study September 2013 to January 2016, 965 of which were treated with rivaroxaban for non-valvular atrial fibrillation. The median age in the rivaroxaban non-valvular atrial fibrillation cohort was 76 years, 53.6% were male. The median HAS-BLED score was 2 and the median CHA2DS2-VASc score was 4. The risk of major bleeding within each of the primary sites of gastrointestinal, urogenital and intracranial during the 12 week observation period was low (0.2%; n = 2). The risk of major bleeding in all sites was 1.0% (n = 10) at a rate of 5.5 events per 100 patient years. In terms of the primary outcome risk of major bleeding within gastrointestinal, urogenital and intracranial sites during the 12 week observation period, the risk estimates in the non-valvular atrial fibrillation rivaroxaban user population were low (<1%), and consistent with risk estimated from clinical trial data and in routine clinical practice.
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Competing Interests: The authors have no competing interests however the Drug Safety Research Unit has received funding to conduct this study from Bayer AG (http://www.bayer.com). This does not alter our adherence to PLOS ONE policies on sharing data and materials and data from this study are available upon request.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0240489