BACKGROUND AND AIMS: The bleeding risk of using non-steroidal anti-inflammatory drugs (NSAIDs) in patients treated with oral anticoagulants for venous thromboembolism (VTE) remains unclear.
METHODS: A nationwide cohort study of 51 794 VTE patients initiating oral anticoagulants between 1 January 2012 and 31 December 2022 was conducted. Time-dependent multivariate cause-specific Cox regression was used to compute adjusted hazard ratios between NSAID use and hospital-diagnosed bleeding episodes.
RESULTS: Event rates for any bleeding per 100 person-years were 3.5 [95% confidence interval (CI), 3.4-3.7] during periods without NSAID use and 6.3 (95% CI, 5.1-7.9) during periods with NSAID use (number needed to harm = 36 patients treated for 1 year). Compared with non-use, the adjusted hazard ratios for any bleeding associated with NSAID use were 2.09 (95% CI, 1.67-2.62) overall, 1.79 (95% CI, 1.36-2.36) for ibuprofen, 3.30 (95% CI, 1.82-5.97) for diclofenac, and 4.10 (95% CI, 2.13-7.91) for naproxen. Compared with non-use, the adjusted hazard ratios associated with NSAID use were 2.24 (95% CI, 1.61-3.11) for gastrointestinal bleeding, 3.22 (95% CI, 1.69-6.14) for intracranial bleeding, 1.36 (95% CI, .67-2.77) for thoracic and respiratory tract bleeding, 1.57 (95% CI, .98-2.51) for urinary tract bleeding, and 2.99 (95% CI, 1.45-6.18) for anaemia caused by bleeding. Results were consistent for anticoagulant and VTE subtypes.
CONCLUSIONS: Patients treated with oral anticoagulants for VTE had a more than two-fold increased bleeding rate when using NSAIDs. This increased bleeding rate was not restricted to the gastrointestinal tract.
| Discipline Area | Score |
|---|---|
| Internal Medicine |  |
| Hematology | |
| Family Medicine (FM)/General Practice (GP) | |
| General Internal Medicine-Primary Care(US) | |
This article is highly relevant to my clinical practice. It highlights the significant bleeding risks associated with NSAID use in patients on anticoagulants for VTE, which is a common scenario I encounter. The detailed breakdown of bleeding risks across different NSAIDs and anticoagulants provides a critical evidence base for safer prescribing practices. This information is especially valuable for patient education and risk assessment during multidisciplinary care planning. The findings challenge us to prioritize alternative pain management strategies and to assess bleeding risks comprehensively when NSAIDs are necessary.
Be nice to have the absolute risk vs the RR. Clinical significance is not the same as statistical. Another useful point would be the morbidity or QOL for the patients if they had not taken the med vs the bleeding risk.
