Dabigatran
In medicine, dabigatran is an anticoagulant that is a direct thrombin inhibitor[1] Like warfarin, dabigatran is given orgally, but unlike warfarin dabigatran is administered in fixed doses without the need for coagulation monitoring.
History
Dabigatran was approved for use by the European Medicines Agency in 2009 for "to prevent the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee."[2]
Dabigatran has not been approved by the Food and Drug Administration in the United States.
Pharmacology
Administration
Dabigatran is given orally and reaches peak plasma concentrations within 0.5-2 hours.[3]
Distribution
Metabolism
Excretion
Dabigatran is renally excreted.
Toxicity
Drug toxicity includes elevation in liver function tests.[3]
Clinical uses
According to the United States Food and Drug Administration, dabigatran is indicated to:
- "reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation"
Atrial fibrillation
| Intervention | Outcomes | ||
|---|---|---|---|
| Stroke or systemic embolism | Major bleeding | Mortality | |
| Dabigatran 110 mg twice daily | 1.53% | 2.71%† | 3.75% |
| Dabigatran 150 mg twice daily | 1.11%† | 3.11% | 3.64% |
| Warfarin | 1.69% | 3.36% | 4.13% |
| † p < 0.05 as compared to warfarin group | |||
In 2009, dabigatran, a direct thrombin inhibitors, was compared to warfarin in the RE-LY randomized controlled trial for the treatment of atrial fibrillation.[4]
Deep venous thrombosis
Dabigatran given 150 mg orally twice a day was as effective as warfarin for the treatment of deep venous thrombosis in the RE-COVER randomized controlled trial.[5]
External links
The most up-to-date information about Dabigatran and other drugs can be found at the following sites.
- Dabigatran - FDA approved drug information (drug label) from DailyMed (U.S. National Library of Medicine).
- Dabigatran - Drug information for consumers from MedlinePlus (U.S. National Library of Medicine).
- Dabigatran - Detailed information from DrugBank.
References
- ↑ Anonymous (2024), Dabigatran (English). Medical Subject Headings. U.S. National Library of Medicine.
- ↑ Anonymous (2009) EPARs for authorised medicinal products for human use European Medicines Agency
- ↑ 3.0 3.1 Baetz BE, Spinler SA (2008). "Dabigatran etexilate: an oral direct thrombin inhibitor for prophylaxis and treatment of thromboembolic diseases.". Pharmacotherapy 28 (11): 1354-73. DOI:10.1592/phco.28.11.1354. PMID 18956996. Research Blogging.
- ↑ 4.0 4.1 Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A et al. (2009). "Dabigatran versus Warfarin in Patients with Atrial Fibrillation.". N Engl J Med 361 (12): 1139-1151. DOI:10.1056/NEJMoa0905561. PMID 19717844. Research Blogging.
- ↑ Schulman, Sam; Clive Kearon, Ajay K. Kakkar, Patrick Mismetti, Sebastian Schellong, Henry Eriksson, David Baanstra, Janet Schnee, Samuel Z. Goldhaber, the RE-COVER Study Group (2009-12-06). "Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism". N Engl J Med: NEJMoa0906598. DOI:10.1056/NEJMoa0906598. Retrieved on 2009-12-06. Research Blogging.