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
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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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.
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