Effect of tramadol and DOACs with special attention to dabigatran on concomitant use, on the risk of mayor bleeding using BIFAP database in Spain

Impacto

Downloads

Downloads per month over past year

Burgos González, Airam de and Huerta Álvarez, Consuelo and Peñalver, María José and Sordo del Castillo, Luis and Pulido Manzanero, José and Cea Soriano, Lucía (2022) Effect of tramadol and DOACs with special attention to dabigatran on concomitant use, on the risk of mayor bleeding using BIFAP database in Spain. Pharmacoepidemiology and Drug Safety . ISSN 1053-8569

[thumbnail of Pharmacoepidemiology and Drug - 2022 - Burgos‐Gonzalez - Effect of tramadol and DOACs with special attention to dabigatran.pdf] PDF
Creative Commons Attribution Non-commercial No Derivatives.

1MB

Official URL: https://doi.org/10.1002/pds.5525




Abstract

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.


Item Type:Article
Additional Information:

CRUE-CSIC (Acuerdos Transformativos 2022)

Uncontrolled Keywords:bleeds, drug safety, interaction, oral anticoagulants, tramadol
Subjects:Medical sciences > Medicine > Pharmacology
Medical sciences > Medicine > Hematology
ID Code:74603
Deposited On:16 Sep 2022 12:53
Last Modified:07 Nov 2022 09:56

Origin of downloads

Repository Staff Only: item control page