Abstract
Polypharmacy is common in patients with atrial fibrillation (AF), making these patients vulnerable to the occurrence of potential drug-drug interactions (DDIs). We assessed the risk of ischemic stroke and major bleeding in the context of concomitant treatment with potential DDIs in patients with AF prescribed direct oral anticoagulants (DOACs). Using the common data model (CDM) based on an electronic health record (EHR) database, we included new users of DOACs from among patients treated for AF between January 2014 and December 2017 (n = 1938). The median age was 72 years, and 61.8% of the patients were males, with 28.2% of the patients having a CHA2DS2-VASc score in category 0–1, 49.4% in category 2–3, and 22.4% in category ≥ 4. The CHA2DS2-VASc score was significantly associated with ischemic stroke occurrence and hospitalization for major bleeding. Multiple logistic regression analysis showed that increased risk of ischemic stroke and hospitalization for major bleeding was associated with the number of DDIs regardless of comorbidities: ≥ 2 DDIs was associated with ischemic stroke (OR = 18.68; 95% CI, 6.22–55.27, P < 0.001) and hospitalization for major bleeding (OR = 5.01; 95% CI, 1.11–16.62, P < 0.001). DDIs can cause reduced antithrombotic efficacy or increased risk of bleeding in AF patients prescribed DOACs.
Highlights
Polypharmacy is common in patients with atrial fibrillation (AF), making these patients vulnerable to the occurrence of potential drug-drug interactions (DDIs)
Warfarin has over 200 identified drug interactions that must be considered before use[27]
Wang et al conducted meta-analysis based on low- to moderate-strength evidence supporting interaction between warfarin and a small group of medications leading to bleeding risk or thromboembolic outcomes[28]
Summary
Polypharmacy is common in patients with atrial fibrillation (AF), making these patients vulnerable to the occurrence of potential drug-drug interactions (DDIs). We assessed the risk of ischemic stroke and major bleeding in the context of concomitant treatment with potential DDIs in patients with AF prescribed direct oral anticoagulants (DOACs). Data on DDIs with DOACs and increased risk of bleeding have emerged from large claims database s tudies[16,17]. Our group reported an approximately fourfold increase in risk for major bleeding events in DOAC users concomitantly taking ≥ 2 potentially interacting drugs, regardless of c omorbidities[17]. OHDSI adopts a distributed research network with the Observational Medical Outcomes Partnership Common Data Model (OMOP-CDM), which allows for the systematic analysis of disparate observational databases for clinical research[19]. The purpose of this study was to assess whether potential DDIs affect the safety and efficacy of DOACs in patients with AF using a CDM at a single institution
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