Key result
Concomitant tramadol and dabigatran shows a non-significant trend toward increased hospitalized major bleeds.
Why the study?
A suspected interaction between dabigatran and tramadol might trigger an excess bleeding risk, but there is a gap in knowledge on this topic.
Does concomitant use of tramadol and dabigatran increase the risk of hospitalized major bleeds in adults with non-valvular atrial fibrillation?
Case-Control
Does concomitant use of tramadol and dabigatran increase the risk of hospitalized major bleeds in adults with non-valvular atrial fibrillation?
Concomitant use of tramadol and oral anticoagulants, particularly dabigatran, in patients with non-valvular atrial fibrillation may increase the risk of hospitalized major bleeding.
Answers are grounded in this paper and cite their sources.
Concomitant tramadol-dabigatran use may warrant bleeding vigilance in NVAF; leaves open a clinically relevant interaction.
BACKGROUND: Tramadol, a weak opioid, inhibits the reuptake of serotonin, a key feature on vascular homeostasis. A suspected interaction exists between dabigatran and tramadol, which might trigger an excess on risk of bleeding however, there is a gap in knowledge on this topic. PURPOSE: To estimate the effects of tramadol, dabigatran and concomitant use on the risk of hospitalized major bleeds (Gastrointestinal bleeding and intra-extracranial bleeds). METHODS: Among a validated established cohort of new users of oral anticoagulants for non-valvular atrial fibrillation (NVAF) aged 18 years or older, we identified all hospitalized bleed episodes (GIB and extra/intracranial bleeds) within 2008-2015. A nested case-control analysis was conducted using conditional logistic regression. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were calculated for dabigatran, tramadol, and concomitant use. Several sensitivity analyses were carried out. RESULTS: aORs (95%CIs) for current use of only dabigatran, only tramadol and concomitant users were 1.73 (1.37-2.18) and 1.38 (1.13-1.67) and 2.04 (0.74-5.67) compared with non-users of both drugs (>365 days). aORs for current continuers and non-continuer users of dabigatran were 1.36 (1.00-1.86) and 2.19 (1.61-2.98), respectively. For the latter, non-continuer users with a short duration of dabigatran cumulated the highest risk (3.36 [1.88-5.99]). There also was an increased risk with concomitant use of tramadol and rivaroxaban (2.24 [1.19-4.21]), or antagonist of vitamin K (1.30 [1.00-1.69]). CONCLUSION: There was a trend towards and increased risk of excess bleeds when using concomitantly with dabigatran. The effect decreases with a narrower definition of current use.
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Burgos‐Gonzalez et al. (2022) conducted a case-control in Non-valvular atrial fibrillation (NVAF). Concomitant use of tramadol and dabigatran vs. Non-users of both drugs (>365 days) was evaluated on Hospitalized major bleeds (gastrointestinal bleeding and intra-extracranial bleeds) (aOR 2.04, 95% CI 0.74-5.67). Concomitant use of tramadol and dabigatran showed a trend towards an increased risk of hospitalized major bleeds compared to non-users.
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