Dabigatran etexilate: a review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation

Am J Cardiovasc Drugs. 2011;11(1):57-72. doi: 10.2165/11206400-000000000-00000.


The need for safe, effective, and easily administered and monitored antithrombotic treatments that do not have the issues common to warfarin treatment has led to the development of new anticoagulant drugs. Dabigatran etexilate (Pradaxa®, Pradax™) is a prodrug of the direct thrombin inhibitor dabigatran, a direct, reversible, potent inhibitor of thrombin. Dabigatran does not interact with food, and is associated with very few known drug interactions. Dabigatran etexilate, at dosages of 110 and 150 mg twice daily, was shown to be noninferior to warfarin with regard to the incidence of stroke or systemic embolism in a large, randomized, partially blinded, multicenter study in a wide spectrum of patients with atrial fibrillation. Moreover, the higher dosage was associated with significantly greater efficacy than warfarin in this regard. These results were supported by secondary endpoints and subgroup analyses. In general, dabigatran etexilate is well tolerated, although it is associated with a higher rate of dyspepsia than warfarin. Major bleeding was as common in recipients of the higher dosage as, and less common in recipients of the lower dosage of dabigatran etexilate than, that in recipients of warfarin, and intracranial bleeding, life-threatening major bleeding, and total bleeding were less common in recipients of either dabigatran etexilate dosage than in warfarin recipients. However, the higher dosage of dabigatran etexilate was associated with a higher rate of gastrointestinal bleeding than warfarin. The incidence of hepatotoxicity did not significantly differ across treatment groups. In conclusion, dabigatran etexilate 150 mg twice daily is more effective than warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation, and generally well tolerated, particularly with regard to bleeding endpoints compared with warfarin. It requires more frequent administration than warfarin, but provides multiple improvements to various issues associated with warfarin administration. Direct comparisons with other new anticoagulant drugs would be beneficial, as would further investigation into the effects in different patient populations, long-term effects, and the gastrointestinal bleeding and dyspepsia observed with dabigatran etexilate treatment. Dabigatran etexilate is a promising new option for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

MeSH terms

  • Antithrombins / therapeutic use*
  • Atrial Fibrillation / drug therapy*
  • Benzimidazoles / adverse effects
  • Benzimidazoles / pharmacokinetics
  • Benzimidazoles / pharmacology
  • Benzimidazoles / therapeutic use*
  • Dabigatran
  • Drug Interactions
  • Economics, Pharmaceutical
  • Embolism / prevention & control*
  • Humans
  • Prodrugs / therapeutic use*
  • Pyridines / adverse effects
  • Pyridines / pharmacokinetics
  • Pyridines / pharmacology
  • Pyridines / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Stroke / prevention & control*


  • Antithrombins
  • Benzimidazoles
  • Prodrugs
  • Pyridines
  • Dabigatran