Objective There is concern about long-term safety of direct oral coagulants (DOACs) in clinical practice. Our aim was to investigate whether the introduction of DOACs compared with vitamin-K antagonists in England was associated with a change in admissions for bleeding or thromboembolic complications.
Setting 5508 General practitioner (GP) practices in England between 2011 and 2016.
Participants All GP practices in England with a registered population size of greater than 1000 that had data for all 6 years.
Main outcome measure The rate of emergency admissions to hospital for bleeding or thromboembolism, per 100 000 population for each GP practice in England.
Main exposure measure The annual number of DOAC items prescribed for each GP practice population as a proportion of all anticoagulant items prescribed.
Design This longitudinal ecological study used panel regression models to investigate the association between trends in DOAC prescribing within GP practice populations and trends in emergency admission rates for bleeding and thromboembolic conditions, while controlling for confounders.
Results For each additional 10% of DOACs prescribed as a proportion of all anticoagulants, there was a 0.9% increase in bleeding complications (rate ratio 1.008 95% CI 1.003 to 1.013). The introduction of DOACs between 2011 and 2016 was associated with additional 4929 (95% CI 2489 to 7370) emergency admissions for bleeding complications. Increased DOAC prescribing was associated with a slight decline in admission for thromboembolic conditions.
Conclusion Our data show that the rapid increase in prescribing of DOACs after changes in National Institute for Health and Care Excellence guidelines in 2014 may have been associated with a higher rate of emergency admissions for bleeding conditions. These consequences need to be considered in assessing the benefits and costs of the widespread use of DOACs.
- clinical pharmacology
- primary care
- public health
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Contributors AA: substantial contributions to the conception and design of the work, drafting a manuscript. Agreed to be accountable for all aspects of the work ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. BB: substantial contribution to the design of the work, the acquisition, analysis and interpretation of data. Agreed to be accountable for all aspects of the work ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. MP: substantial contribution to the interpretation of the results, critical revision of the manuscript for important intellectual content and final approval of the manuscript .JD: critical revision of the manuscript for important intellectual content and final approval of the manuscript. KD: substantial contribution to data acquisition, data analysis and interpretation of data for the work. Critical revision of the manuscript for important intellectual content and final approval of the manuscript. TC: critical revision of the manuscript for important intellectual content and final approval of the manuscript. Preparation of plain language summary for dissemination of findings.
Funding This work was supported by the National Institute for Health Research, Collaboration for Leadership and Health Research and Care North West Coast (NIHR CLAHRC NWC) and the state Department of Health and Social Care.
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Competing interests We have read and understood BMJ policy on declaration of interests and declare the following: all authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work (or describe if any); no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years (or describe if any); no other relationships or activities that could appear to have influenced the submitted work (or describe if any).
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Ethics approval Ethical approval was not required for this ecological study data analyses.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. The dataset from this study will be made available on request to firstname.lastname@example.org.
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