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Published on: February 26, 2013
Dabigatran Levels in Elderly Patients with Atrial Fibrillation: First Post-Marketing Experiences
Tomáš Bolek1, Matej Samoš2, Ingrid Škorňová3
1Department of Internal Medicine I, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, Kollarova 2, 036 59, Martin, Slovak Republic.
Insights
Elderly patients with non-valvular atrial fibrillation (NV-AF) on reduced dabigatran doses show higher drug levels than younger patients on the same dose. These levels are comparable to younger patients on standard dabigatran doses.
Area of Science:
- Pharmacology
- Geriatrics
- Cardiology
Background:
- The prevalence of non-valvular atrial fibrillation (NV-AF) is increasing in the elderly population.
- Pharmacokinetics of oral anticoagulants may differ in elderly patients.
- This study investigates dabigatran levels in elderly NV-AF patients.
Purpose of the Study:
- To assess dabigatran plasma concentrations in elderly patients with NV-AF.
- To compare dabigatran levels between elderly and younger NV-AF patients on different dosage regimens.
- To evaluate the impact of age on dabigatran pharmacokinetics.
Main Methods:
- Pilot prospective post-marketing study design.
- Inclusion of 21 elderly (≥75 years) and 29 younger (≤70 years) NV-AF patients.
- Measurement of dabigatran trough and peak levels using Hemoclot® Thrombin Inhibitor Assay.
Main Results:
- Elderly patients on reduced dabigatran (110 mg BID) had significantly higher trough (99.3 ± 73.6 ng/mL) and peak (173.4 ± 116.2 ng/mL) levels compared to younger patients on reduced doses (51.6 ± 25.6 ng/mL and 116.1 ± 19.1 ng/mL, respectively).
- No significant differences in dabigatran levels were observed between elderly patients on reduced doses and younger patients on standard doses (150 mg BID).
Conclusions:
- Elderly patients on reduced dabigatran regimens exhibit higher drug exposure than younger patients on similar reduced doses.
- Dabigatran exposure in elderly patients on reduced doses is comparable to younger patients on standard doses.
- These findings highlight potential pharmacokinetic differences in elderly patients requiring anticoagulation therapy.
Background:
The number of elderly individuals with non-valvular atrial fibrillation (NV-AF) requiring long-term anticoagulation is rising. The pharmacokinetics of oral anticoagulants in elderly individuals may differ from that for younger patients. The aim of this study was to assess the dabigatran levels in elderly patients with NV-AF.
Patients And Methods:
A pilot prospective post-marketing study in patients with NV-AF on dabigatran therapy was performed; we enrolled 21 consecutive elderly patients (aged ≥ 75 years) on a reduced dabigatran regimen (110 mg twice daily) and compared them with 13 younger (≤ 70 years) individuals on reduced dabigatran therapy due to renal impairment and with 16 younger patients on standard dabigatran therapy (150 mg twice daily). Blood samples were taken for the assessment of dabigatran trough and peak levels. Dabigatran levels were measured with the Hemoclot® Thrombin Inhibitor Assay.
Results:
There were significant differences in dabigatran trough levels when comparing elderly patients on reduced dabigatran with non-elderly patients on reduced dabigatran (99.3 ± 73.6 vs 51.6 ± 25.6 ng/mL; p < 0.01). Similarly, the detected dabigatran peak levels were significantly higher in elderly patients on reduced dabigatran compared with non-elderly patients on reduced dabigatran (173.4 ± 116.2 vs 116.1 ± 19.1 ng/mL; p < 0.01). No significant differences in dabigatran trough and peak levels were found when comparing elderly patients on reduced dabigatran with non-elderly patients on standard dabigatran therapy.
Conclusion:
This pilot study demonstrated that elderly patients on reduced dabigatran exhibit significantly higher dabigatran levels than younger individuals on a reduced regimen, and similar levels compared with younger individuals on standard dabigatran.
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