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Original research
Gastrointestinal bleeding risk following concomitant treatment with oral glucocorticoids in patients on non-vitamin K oral anticoagulants
  1. Anders Holt1,
  2. Paul Blanche2,
  3. Bochra Zareini1,
  4. Peter Vibe Rasmussen1,3,
  5. Jarl Emanuel Strange1,
  6. Deepthi Rajan1,
  7. Mads Hashiba Jensen1,
  8. Mohammed El-Sheikh1,
  9. Anne-Marie Schjerning4,5,
  10. Morten Schou1,
  11. Gunnar Gislason1,5,
  12. Christian Torp-Pedersen6,7,
  13. Patricia McGettigan8,
  14. Morten Lamberts1
  1. 1Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark
  2. 2Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark
  3. 3Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
  4. 4Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark
  5. 5The Danish Heart Foundation, Copenhagen, Denmark
  6. 6Department of Clinical Research, North Zealand University Hospital, Hillerød, Denmark
  7. 7Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark
  8. 8William Harvey Research Institue, Queen Mary University of London, London, UK
  1. Correspondence to Dr Anders Holt, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; holt.anders{at}gmail.com

Abstract

Objective Gastrointestinal bleeding (GIB) risk in relation to concomitant treatment with non-vitamin K oral anticoagulants (NOAC) and oral glucocorticoids is insufficiently explored. We aimed to investigate the short-term risk following coexposure.

Methods This is a register-based, nationwide Danish study including patients with atrial fibrillation on NOACs during 2012–2018. Patients were defined as exposed to oral glucocorticoids if they claimed a prescription within 60 days prior to GIB. We investigated the associations between GIB and oral glucocorticoid exposure, reporting HRs via a nested case–control design and absolute risk via a cohort design. Matching terms were age, sex, calendar year, follow-up time and NOAC agent.

Results 98 376 patients on NOACs (median age: 75 years (IQR: 68–82), 44% female) were included, and 16% redeemed at least one oral glucocorticoid prescription within 3 years. HRs of GIB were increased comparing exposed with non-exposed patients (<20 mg daily dose, HR 1.54 (95% CI 1.29 to 1.84); ≥20 mg daily dose, HR 2.19 (95% CI 1.81 to 2.65)). 60-day standardised absolute risk of GIB following first claimed oral glucocorticoid prescription increased compared with non-exposed: 60-day absolute risk: 0.71% (95% CI 0.58% to 0.85%) vs 0.38% (95% CI 0.32% to 0.43%). The relative risk was elevated as well: risk ratio of 1.89 (95% CI 1.43 to 2.36).

Conclusions Concomitant treatment with NOACs and oral glucocorticoids was associated with a short-term rate and risk increase of GIB compared with patients only on NOACs. This could have implications for clinical management, necessitating closer monitoring or other risk mitigation strategies during episodes of cotreatment with oral glucocorticoids.

  • atrial fibrillation
  • drug interactions
  • pharmacology
  • epidemiology

Data availability statement

No data are available. It is not allowed by Danish law to share the data used for this study.

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Data availability statement

No data are available. It is not allowed by Danish law to share the data used for this study.

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Footnotes

  • Twitter @andersholt6, @mohaelsheikh

  • Contributors AH, A-MS, GG, PM and ML conceived the study idea. AH, PB and ML decided on statistical methodology and analysed the data. All authors contributed to the interpretation of the data. AH and ML wrote the first draft of the manuscript. All authors critically revised the manuscript and approved the final version of this manuscript.

  • Funding The lead investigator (AH) and this study have been funded by external, independent grants from 'Ib Mogens Kristiansens Almene Fond' (J. nr. 30 206–383), 'Helsefonden' (20-B-0035) and 'Snedkermester Sophus Jacobsen og hustru Astrid Jacobsen Fond' (J 167/1).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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