Dabigatran: Difference between revisions

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==Clinical uses==
==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===
===Atrial fibrillation===
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{| class="wikitable" align="right"
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| url = http://content.nejm.org/cgi/content/abstract/NEJMoa0906598v1
| url = http://content.nejm.org/cgi/content/abstract/NEJMoa0906598v1
}}</ref>
}}</ref>
==External links==
==External links==
{{CZMed}}
{{CZMed}}

Revision as of 12:44, 7 January 2011

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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

Dabigatran versus warfarin for atrial fibrillation[4]
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.


References

  1. Anonymous (2024), Dabigatran (English). Medical Subject Headings. U.S. National Library of Medicine.
  2. Anonymous (2009) EPARs for authorised medicinal products for human use European Medicines Agency
  3. 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. 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.
  5. 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.