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Association Between Anticoagulants and Interacting Drugs and Risk of Major Bleeding in Nonvalvular Atrial
M Giner-Soriano1, L A Carrasco-Ribelles2, S Fernández-García3
1Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Insights
Drug interactions increase bleeding risk in patients taking anticoagulants. This study found higher hemorrhage risk with interacting drugs, particularly for vitamin K antagonists, highlighting the need for careful medication management.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Patient Safety
Background:
- Anticoagulant therapy is crucial for preventing thromboembolic events.
- Drug-drug interactions can significantly alter anticoagulant efficacy and safety.
- Increased anticoagulant effect heightens the risk of major hemorrhage.
Purpose of the Study:
- To assess the risk of major hemorrhage in anticoagulated patients exposed to potentially interacting drugs.
- To analyze the association between specific drug interactions and bleeding events.
Main Methods:
- A case-control study nested within a cohort of anticoagulated patients (2011-2020).
- Cases were hospitalized for major cerebral or gastrointestinal hemorrhage, matched with controls.
- Data sourced from primary care electronic records and hospital discharge diagnoses; multivariate logistic regression used.
Main Results:
- A significant association was found between hemorrhage and interacting drugs in vitamin K antagonist users (OR 1.30).
- All interaction types increased bleeding risk across anticoagulants.
- Proton pump inhibitors showed a protective effect against gastrointestinal bleeding (OR 0.55) but not cerebral bleeding (OR 1.18).
Conclusions:
- Drug interactions pose a significant risk for major hemorrhage in anticoagulated patients.
- The findings emphasize the clinical impact of drug interactions on both cerebral and gastrointestinal bleeding.
- Careful consideration of potential interactions is vital for anticoagulated patient safety.
Purpose:
Interactions with anticoagulants causing an increase in their effect may potentially enhance the bleeding risk. We aimed to analyze the risk of major hemorrhage in anticoagulated patients simultaneously exposed to potentially interacting drugs which may enhance the bleeding risk.
Methods:
Case-control study nested in a cohort of anticoagulated patients in 2011-2020. Cases were all people hospitalized for a major hemorrhage (cerebral or gastrointestinal), matched to individuals without bleeding. The index date was the day of hospital admission for cases and the same date for the matched controls.
Data Sources:
SIDIAP database, containing information from primary health care electronic records, and the database of diagnoses at hospital discharge in Catalonia, Spain. We analyzed exposure to interacting drugs during 3 months prior to the index date. The association between hemorrhage and exposure to interacting drugs was calculated through multivariate logistic regression models.
Findings:
We included 2,811 cases (77.9% cerebral and 22.1% gastrointestinal hemorrhages), matched to 28,054 controls. We found association between hemorrhage in patients receiving vitamin K antagonists (OR 1.30, 95% CI 1.16-1.47). All types of interactions resulted in higher bleeding risk for all anticoagulants. Proton pump inhibitors were found protective for gastrointestinal (OR 0.55, 95% CI 0.46-0.65) but not for cerebral bleeding (OR 1.18, 95% CI 1.08-1.30).
Implications:
We estimated the risk of major hemorrhage in anticoagulated patients simultaneously exposed to potentially interacting drugs which may enhance bleeding risk. Our study underscores the potential impact of interactions on cerebral and gastrointestinal bleeding risk in anticoagulated patients.
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