Are older adults taking direct oral anticoagulants at higher risk of hospital admission for hemorrhage with clarithromycin than with azithromycin?

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Why is this study important?

Antibiotics and direct oral anticoagulants (DOACs) are frequently prescribed medications in emergency departments (EDs). This combination is seen especially in the older population who are at risk for polypharmacy, drug interactions and increased risk of bleeding. In fact, the rate of anticoagulant-associated hemorrhage requiring hospitalization doubles those older than 75 years.[1] DOACs are metabolized primarily via P-glycoprotein (P-gp) cell transporters or the cytochrome P450 enzyme CYP3A4.[2] Clarithromycin is a greater inhibitor of P-gp and CYP3A4 than azithromycin and while many studies report drug-drug interactions as effects on area under the curve (AUC) or peak drug levels, this study compares the adverse effects of clarithromycin to azithromycin in patients prescribed DOACs for the clinical outcome of major hemorrhage.

Which, if any, threats to validity are most likely to have an impact on the results and how?

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