Key result
Co-prescription of P-gp inhibitors with dabigatran in octogenarians with atrial fibrillation significantly increased the risk of bleeding complications compared to dabigatran alone (30.4% vs 8.6%, OR 5.79).
Why the study?
Concerns have emerged that drug interactions with dabigatran may increase bleeding risks, especially in very elderly patients in usual conditions of care.
Does the co-prescription of P-gp inhibitors increase dabigatran plasma concentrations and bleeding events in very elderly patients with non-valvular atrial fibrillation?
Cohort (n=58)
No
Does the co-prescription of P-gp inhibitors increase dabigatran plasma concentrations and bleeding events in very elderly patients with non-valvular atrial fibrillation?
Odds Ratio: 5.79 (95% CI 1.04–32.11)
Absolute Event Rate: 30.4% vs 8.6%
p-value: p=0.04
In very elderly patients with atrial fibrillation, co-prescribing P-gp inhibitors like amiodarone with dabigatran significantly increases dabigatran plasma levels and the risk of bleeding.
Co-prescription of P-gp inhibitors with dabigatran was associated with higher bleeding in octogenarians; leaves open need for RCTs before practice change.
BACKGROUND: The direct oral anticoagulant dabigatran does not require any routine therapeutic drug monitoring. Yet, concerns about possible drug interactions susceptible to increase its inherent bleeding risk, especially in very elderly patients, have been raised recently. The aim of our study was to evaluate to what extent the co-prescription of P-gp inhibitors with dabigatran may increase its plasma levels and lead to bleeding complications, in usual conditions of care of the very elderly. METHODS: Fifty-eight patients over 85 years old with non valvular atrial fibrillation receiving dabigatran were included in a prospective cohort. Prescriptions were screened for the presence of P-gp inhibitors (Group A) or not (Group B). RESULTS: = 0.04). CONCLUSION: In our cohort of very elderly patients, at least, the co-prescription of dabigatran with P-gp inhibitors in usual conditions of care resulted in higher dabigatran plasma concentrations and more frequent bleeding occurrences.
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Bernier et al. (2019) conducted a cohort in Non-valvular atrial fibrillation (n=58). Co-prescription of P-gp inhibitors with dabigatran vs. Dabigatran without P-gp inhibitors was evaluated on Bleeding complications (OR 5.79, 95% CI 1.04-32.11, p=0.04). Co-prescription of P-gp inhibitors with dabigatran in octogenarians with atrial fibrillation significantly increased the risk of bleeding complications compared to dabigatran alone (30.4% vs 8.6%, OR 5.79).
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