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Peer-reviewedCC BYPharmacotherapy

A Model for Estimating the Risk of Gastrointestinal Bleeding for Patients on Oral Anticoagulants and Interacting Medications.

  • Ainhoa Gomez-Lumbreras1
  • Abdelrahman G Tawfik1
  • Thomas Reese2
  • Daniel M Witt1
  • Guilherme Del Fiol3
  • Daniel C Malone1
  1. 1Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, Utah, USA.
  2. 2Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  3. 3Department of Biomedical Informatics, School of Medicine, University of Utah, Salt Lake City, Utah, USA.
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Abstract

Introduction

Pharmacodynamic drug-drug interactions (DDI) in patients receiving oral anticoagulants (OAC) may increase the risk of gastrointestinal bleeding (GIB). The purpose of this study was to develop and validate a GIB model for patients receiving OACs.Methods

A risk model, Drug Interactions in Oral AntiCoagulants for Risk of Gastrointestinal Bleeding (DIOAC-GIB), was developed to predict GIB based on interacting medications and other patient-specific risk factors for patients on OAC. Inputs for the model were obtained using random-effect meta-analysis or from the literature for the following attributes: exposure to nonsteroidal anti-inflammatory drugs (NSAIDs); selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors (SSRI/SNRIs); aspirin, antiplatelet medications, and proton pump inhibitors (PPIs); age; and GIB history. The model was correlated to existing OAC models (HAS-BLED and DOAC score).Results

GIB risk for OACs was based on pivotal trials (1.16% for apixaban; 3.15% for rivaroxaban; 3.00% for dabigatran; 3.31% for edoxaban; and 2.00% for warfarin). The odds ratio (OR) of GIB for NSAIDs ranged from 1.16 (95% confidence interval [CI]: 0.84-1.61) for celecoxib to 20.67 (95% CI: 14.56-29.34) for ketorolac. ORs for GIB among SSRI/SNRIs ranged from 1.31 (95% CI: 1.07-1.62) for paroxetine to 1.50 (95% CI: 1.32-1.70) for venlafaxine. Risk of GIB also included persons > 65 years of age (relative risk = 2.50, 95% CI: 1.2-5.5); history of GIB (OR = 5.14, 95% CI: 3.92-6.73); exposure to aspirin (OR = 1.31, 95% CI: 0.93-1.85), antiplatelet medications (OR = 1.97, 95% CI: 1.73-2.25), and corticosteroids (OR = 1.69, 95% CI: 1.53-1.87); and PPIs reduced GIB risk (OR = 0.67, 95% CI: 0.62-0.74). Correlations between the DIOAC-GIB and HAS-BLED and DOAC scores were 0.5 for both (p < 0.01).Conclusion

DIOAC-GIB is a novel GIB-risk model that incorporates pharmacodynamic OAC DDIs to assist clinicians and patients to determine a therapeutic plan while accounting for GIB risk. DIOAC-GIB correlates with other bleeding risk scores and may help identify high-risk patients who may benefit from tailored prescribing.

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Cite

BibTeXRIS
BibTeX
@article{gomezlumbreras2026model,
  title = {{A Model for Estimating the Risk of Gastrointestinal Bleeding for Patients on Oral Anticoagulants and Interacting Medications.}},
  author = {Ainhoa Gomez-Lumbreras and Abdelrahman G Tawfik and Thomas Reese and Daniel M Witt and Guilherme Del Fiol and Daniel C Malone},
  journal = {Pharmacotherapy},
  year = {2026},
  month = oct,
  doi = {10.1002/phar.70205},
  url = {https://europepmc.org/article/MED/42927649},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - A Model for Estimating the Risk of Gastrointestinal Bleeding for Patients on Oral Anticoagulants and Interacting Medications.
AU  - Ainhoa Gomez-Lumbreras
AU  - Abdelrahman G Tawfik
AU  - Thomas Reese
AU  - Daniel M Witt
AU  - Guilherme Del Fiol
AU  - Daniel C Malone
PY  - 2026
DA  - 2026/10/30
JO  - Pharmacotherapy
DO  - 10.1002/phar.70205
UR  - https://europepmc.org/article/MED/42927649
AB  - Introduction  Pharmacodynamic drug-drug interactions (DDI) in patients receiving oral anticoagulants (OAC) may increase the risk of gastrointestinal bleeding (GIB). The purpose of this study was to develop and validate a GIB model for patients receiving OACs.Methods  A risk model, Drug Interactions in Oral AntiCoagulants for Risk of Gastrointestinal Bleeding (DIOAC-GIB), was developed to predict GIB based on interacting medications and other patient-specific risk factors for patients on OAC. Inputs for the model were obtained using random-effect meta-analysis or from the literature for the following attributes: exposure to nonsteroidal anti-inflammatory drugs (NSAIDs); selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors (SSRI/SNRIs); aspirin, antiplatelet medications, and proton pump inhibitors (PPIs); age; and GIB history. The model was correlated to existing OAC models (HAS-BLED and DOAC score).Results  GIB risk for OACs was based on pivotal trials (1.16% for apixaban; 3.15% for rivaroxaban; 3.00% for dabigatran; 3.31% for edoxaban; and 2.00% for warfarin). The odds ratio (OR) of GIB for NSAIDs ranged from 1.16 (95% confidence interval [CI]: 0.84-1.61) for celecoxib to 20.67 (95% CI: 14.56-29.34) for ketorolac. ORs for GIB among SSRI/SNRIs ranged from 1.31 (95% CI: 1.07-1.62) for paroxetine to 1.50 (95% CI: 1.32-1.70) for venlafaxine. Risk of GIB also included persons > 65 years of age (relative risk = 2.50, 95% CI: 1.2-5.5); history of GIB (OR = 5.14, 95% CI: 3.92-6.73); exposure to aspirin (OR = 1.31, 95% CI: 0.93-1.85), antiplatelet medications (OR = 1.97, 95% CI: 1.73-2.25), and corticosteroids (OR = 1.69, 95% CI: 1.53-1.87); and PPIs reduced GIB risk (OR = 0.67, 95% CI: 0.62-0.74). Correlations between the DIOAC-GIB and HAS-BLED and DOAC scores were 0.5 for both (p < 0.01).Conclusion  DIOAC-GIB is a novel GIB-risk model that incorporates pharmacodynamic OAC DDIs to assist clinicians and patients to determine a therapeutic plan while accounting for GIB risk. DIOAC-GIB correlates with other bleeding risk scores and may help identify high-risk patients who may benefit from tailored prescribing.
SN  - 0277-0008
SN  - 1875-9114
ER  -