The Effect of Proton Pump Inhibitor Withdrawal on Dabigatran Etexilate Plasma Levels in Patients With Atrial Fibrillation: A Washout Study.
Aged
Aged, 80 and over
Antithrombins
/ administration & dosage
Atrial Fibrillation
/ blood
Dabigatran
/ administration & dosage
Drug Administration Schedule
Drug Interactions
Drug Monitoring
Female
Humans
Male
Middle Aged
Omeprazole
/ administration & dosage
Pantoprazole
/ administration & dosage
Pilot Projects
Prospective Studies
Proton Pump Inhibitors
/ administration & dosage
Time Factors
Treatment Outcome
Journal
Journal of cardiovascular pharmacology
ISSN: 1533-4023
Titre abrégé: J Cardiovasc Pharmacol
Pays: United States
ID NLM: 7902492
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
pubmed:
3
1
2020
medline:
3
11
2020
entrez:
3
1
2020
Statut:
ppublish
Résumé
Several studies demonstrated that proton pump inhibitors (PPIs) co-administrated with dabigatran in patients with atrial fibrillation (AF) decreased dabigatran trough and peak plasma levels. However, it is still unknown whether this interaction is reversible or not, and whether the withdrawal of PPI would lead to normalization of dabigatran plasma levels. The aim of this study was to determine the effect of PPI withdrawal on dabigatran plasma levels in patients with AF. This pilot prospective study enrolled 23 AF patients on long-term dabigatran and PPI therapy (omeprazole 20 mg twice daily or pantoprazole 40 mg once daily). Dabigatran trough and peak levels (ng/mL) were tested on PPI and after a 2-week period of PPI withdrawal with Hemoclot Thrombin Inhibitor Assay. The analysis of dabigatran plasma levels demonstrated significant elevation in trough dabigatran levels after 2 weeks of PPI withdrawal (97.2 ± 79.7 vs. 163.8 ± 105.5 ng/mL; P < 0.05). Moreover, significantly higher peak dabigatran levels were observed after 2 weeks of PPI withdrawal (142.4 ± 102.8 vs. 255 ± 129.5 ng/mL; P ≤ 0.001). This study showed that a 2-week period of PPI withdrawal lead to a significant increase in dabigatran trough and peak plasma levels in patients with AF.
Sections du résumé
BACKGROUND
Several studies demonstrated that proton pump inhibitors (PPIs) co-administrated with dabigatran in patients with atrial fibrillation (AF) decreased dabigatran trough and peak plasma levels. However, it is still unknown whether this interaction is reversible or not, and whether the withdrawal of PPI would lead to normalization of dabigatran plasma levels.
AIM OF STUDY
The aim of this study was to determine the effect of PPI withdrawal on dabigatran plasma levels in patients with AF.
METHODS
This pilot prospective study enrolled 23 AF patients on long-term dabigatran and PPI therapy (omeprazole 20 mg twice daily or pantoprazole 40 mg once daily). Dabigatran trough and peak levels (ng/mL) were tested on PPI and after a 2-week period of PPI withdrawal with Hemoclot Thrombin Inhibitor Assay.
RESULTS
The analysis of dabigatran plasma levels demonstrated significant elevation in trough dabigatran levels after 2 weeks of PPI withdrawal (97.2 ± 79.7 vs. 163.8 ± 105.5 ng/mL; P < 0.05). Moreover, significantly higher peak dabigatran levels were observed after 2 weeks of PPI withdrawal (142.4 ± 102.8 vs. 255 ± 129.5 ng/mL; P ≤ 0.001).
CONCLUSIONS
This study showed that a 2-week period of PPI withdrawal lead to a significant increase in dabigatran trough and peak plasma levels in patients with AF.
Identifiants
pubmed: 31895873
doi: 10.1097/FJC.0000000000000791
pii: 00005344-202004000-00009
doi:
Substances chimiques
Antithrombins
0
Proton Pump Inhibitors
0
Pantoprazole
D8TST4O562
Dabigatran
I0VM4M70GC
Omeprazole
KG60484QX9
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
333-335Références
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