Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study
Objectives To evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-11-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e038102.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850221433369657344 |
|---|---|
| author | Vicki Osborne Miranda Davies Debabrata Roy Saad Shakir Alison Evans |
| author_facet | Vicki Osborne Miranda Davies Debabrata Roy Saad Shakir Alison Evans |
| author_sort | Vicki Osborne |
| collection | DOAJ |
| description | Objectives To evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in England and Wales.Design An observational cohort study using the technique of Specialist Cohort Event Monitoring.Setting The Rivaroxaban Observational Safety Evaluation study was conducted across 87 participating National Health Service secondary care trusts in England and Wales.Participants 1532 patients treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism from September 2013 to January 2016.Interventions Non-interventional postauthorisation safety study of rivaroxaban.Primary and secondary outcome measures (1) Risk of major bleeding in gastrointestinal, intracranial, and urogenital sites and (2) risk of all major and clinically relevant non-major bleeds.Results Of a total of 4846 patients enrolled in the study from September 2013 to January 2016, 1532 were treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism. The median age of the deep vein thrombosis/pulmonary embolism cohort was 63 years, and 54.6% were men. The risk of major bleeding within the gastrointestinal, urogenital and intracranial primary sites was 0.7% (n=11), 0.3% (n=5) and 0.1% (n=1), respectively. The risk of major bleeding in all sites was 1.5% (n=23) at a rate of 8.3 events per 100 patient-years.Conclusions In terms of the primary outcome risk of major bleeding in gastrointestinal, intracranial and urogenital sites, the risk estimates in the population using rivaroxaban for deep vein thrombosis/pulmonary embolism were low (<1%) and consistent with the risk estimated from clinical trial data and in routine clinical practice.Trial registration numbers ClinicalTrials.gov Registry (NCT01871194); ENCePP Registry (EUPAS3979). |
| format | Article |
| id | doaj-art-b5337af014994b7594951ea488e1b3ee |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-b5337af014994b7594951ea488e1b3ee2025-08-20T02:06:43ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-038102Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort studyVicki Osborne0Miranda Davies1Debabrata Roy2Saad Shakir3Alison Evans42 School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UKDrug Safety Research Unit, Southampton, UKDrug Safety Research Unit, Southampton, UKDrug Safety Research Unit, Southampton, UK4 Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UKObjectives To evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in England and Wales.Design An observational cohort study using the technique of Specialist Cohort Event Monitoring.Setting The Rivaroxaban Observational Safety Evaluation study was conducted across 87 participating National Health Service secondary care trusts in England and Wales.Participants 1532 patients treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism from September 2013 to January 2016.Interventions Non-interventional postauthorisation safety study of rivaroxaban.Primary and secondary outcome measures (1) Risk of major bleeding in gastrointestinal, intracranial, and urogenital sites and (2) risk of all major and clinically relevant non-major bleeds.Results Of a total of 4846 patients enrolled in the study from September 2013 to January 2016, 1532 were treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism. The median age of the deep vein thrombosis/pulmonary embolism cohort was 63 years, and 54.6% were men. The risk of major bleeding within the gastrointestinal, urogenital and intracranial primary sites was 0.7% (n=11), 0.3% (n=5) and 0.1% (n=1), respectively. The risk of major bleeding in all sites was 1.5% (n=23) at a rate of 8.3 events per 100 patient-years.Conclusions In terms of the primary outcome risk of major bleeding in gastrointestinal, intracranial and urogenital sites, the risk estimates in the population using rivaroxaban for deep vein thrombosis/pulmonary embolism were low (<1%) and consistent with the risk estimated from clinical trial data and in routine clinical practice.Trial registration numbers ClinicalTrials.gov Registry (NCT01871194); ENCePP Registry (EUPAS3979).https://bmjopen.bmj.com/content/10/11/e038102.full |
| spellingShingle | Vicki Osborne Miranda Davies Debabrata Roy Saad Shakir Alison Evans Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study BMJ Open |
| title | Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study |
| title_full | Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study |
| title_fullStr | Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study |
| title_full_unstemmed | Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study |
| title_short | Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study |
| title_sort | evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in uk secondary care an observational cohort study |
| url | https://bmjopen.bmj.com/content/10/11/e038102.full |
| work_keys_str_mv | AT vickiosborne evaluationoftheincidenceofbleedinginpatientsprescribedrivaroxabanforthetreatmentandpreventionofdeepveinthrombosisandpulmonaryembolisminuksecondarycareanobservationalcohortstudy AT mirandadavies evaluationoftheincidenceofbleedinginpatientsprescribedrivaroxabanforthetreatmentandpreventionofdeepveinthrombosisandpulmonaryembolisminuksecondarycareanobservationalcohortstudy AT debabrataroy evaluationoftheincidenceofbleedinginpatientsprescribedrivaroxabanforthetreatmentandpreventionofdeepveinthrombosisandpulmonaryembolisminuksecondarycareanobservationalcohortstudy AT saadshakir evaluationoftheincidenceofbleedinginpatientsprescribedrivaroxabanforthetreatmentandpreventionofdeepveinthrombosisandpulmonaryembolisminuksecondarycareanobservationalcohortstudy AT alisonevans evaluationoftheincidenceofbleedinginpatientsprescribedrivaroxabanforthetreatmentandpreventionofdeepveinthrombosisandpulmonaryembolisminuksecondarycareanobservationalcohortstudy |