%0 Journal Article %A Burgos González, Airam De %A Huerta Álvarez, María Consuelo Yolanda %A Peñalver, María José %A Sordo Delcastillo, Luis %A Pulido Manzanero, José %A Cea Soriano, Trinidad Lucía %T Effect of tramadol and DOACs with special attention to dabigatran on concomitant use, on the risk of mayor bleeding using BIFAP database in Spain %D 2022 %@ 1053-8569 %U https://hdl.handle.net/20.500.14352/71997 %X BackgroundTramadol, 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.PurposeTo estimate the effects of tramadol, dabigatran and concomitant use on the risk of hospitalized major bleeds (Gastrointestinal bleeding and intra-extracranial bleeds).MethodsAmong 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.ResultsaORs (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)).ConclusionThere 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. %~