Key result
Concomitant proton pump inhibition significantly reduced dabigatran trough (58.86 vs 110.72 ng/mL, P<0.05) and peak levels (88.0 vs 174.4 ng/mL, P<0.05) in patients with atrial fibrillation.
Why the study?
Does concomitant proton pump inhibitor therapy reduce dabigatran plasma levels in patients with nonvalvular atrial fibrillation?
Cohort (n=31)
Does concomitant proton pump inhibitor therapy reduce dabigatran plasma levels in patients with nonvalvular atrial fibrillation?
Absolute Event Rate: 58.86% vs 110.72%
p-value: p=< 0.05
Concomitant use of proton pump inhibitors significantly reduces dabigatran trough and peak plasma levels in patients with nonvalvular atrial fibrillation, which may potentially impact its anticoagulant efficacy.
Clinical relevance of PPI-dabigatran interaction remains uncertain; hypothesis-generating and requires larger outcome trials.
BACKGROUND: Proton pump inhibition (PPI) administrated together with dabigatran reduces the risk of gastrointestinal hemorrhage. However, there is a discussion regarding possible PPI-dabigatran interaction that may reduce the efficacy of this therapy. STUDY QUESTION: To determine the impact of concomitant PPI on dabigatran plasma levels in patients with nonvalvular atrial fibrillation (NV-AF). STUDY DESIGN: A pilot prospective study in patients with NV-AF on dabigatran therapy was performed; 31 patients were enrolled. PPI with either omeprazole or pantoprazole was administrated in 19 patients. MEASURES AND OUTCOMES: Blood samples were taken for the assessment of the dabigatran trough and peak levels. Dabigatran concentration was measured with the Hemoclot Thrombin Inhibitor Assay. RESULTS: There were significant differences in dabigatran trough level comparing patients treated with PPI and patients without PPI (58.86 ± 36.76 ng/mL vs. 110.72 ± 88.47 ng/mL, P < 0.05). Similarly, there were significant differences in dabigatran peak level between compared groups (88.0 ± 20.5 ng/mL vs. 174.4 ± 139.64 ng/mL, P < 0.05). CONCLUSIONS: This pilot study demonstrated the interaction between PPI and dabigatran levels in patients with NV-AF.
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Bolek et al. (2017) conducted a cohort in Nonvalvular atrial fibrillation (NV-AF) (n=31). Proton pump inhibition (omeprazole or pantoprazole) vs. No proton pump inhibition was evaluated on Dabigatran trough level (ng/mL) (p=< 0.05). Concomitant proton pump inhibition significantly reduced dabigatran trough (58.86 vs 110.72 ng/mL, P<0.05) and peak levels (88.0 vs 174.4 ng/mL, P<0.05) in patients with atrial fibrillation.
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