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Home » Drug Information » FDA Approved Drugs » 2010
Medical Areas: Cardiology/Vascular Diseases | Family Medicine

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Pradaxa (dabigatran etexilate mesylate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Boehringer Ingelheim
Approval Status: Approved October 2010
Treatment Area: risk reduction of stroke and embolism due to atrial fibrillation

General Information

Pradaxa (dabigatran etexilate mesylate) is a competitive, direct thrombin inhibitor. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.

Pradaxa is specifically indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Pradaxa is supplied as a tablet for oral administration. The recommended initial dose for patients with creatinine clearance (CrCl) >30 mL/min is 150 mg taken orally, twice daily, with or without food. For patients with CrCl 15-30 mL/min, the recommended dose is 75 mg twice daily. Special consideration should be given when converting from or to Warfarin, converting from or to parenteral anticoagulants and in patients scheduled to undergo surgical interventions.

Clinical Results

FDA Approvals
The FDA approval of Pradaxa was based on a multi-center, multinational, randomized parallel group trial dubbed RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy). The trial compared two blinded doses of Pradaxa (110 mg twice daily and 150 mg twice daily) with open-label warfarin (dosed to target INR of 2 to 3). A total of 18,113 patients with non-valvular, persistent, paroxysmal, or permanent atrial fibrillation were enrolled. All had one or more of the following additional risk factors: previous stroke, transient ischemic attack (TIA), or systemic embolism; left ventricular ejection fraction <40%; symptomatic heart failure, older than 75 years and older than 65 years and one of the following: diabetes mellitus, coronary artery disease (CAD), or hypertension. The primary objective of this study was to determine if Pradaxa was non-inferior to warfarin in reducing the occurrence of the composite endpoint, stroke (ischemic and hemorrhagic) and systemic embolism. Pradaxa 150 mg twice daily significantly reduced the primary composite endpoint of stroke and systemic embolism when compared to warfarin and to Pradaxa 110 mg twice daily (p0.004). Pradaxa 150 mg twice daily significantly reduced both ischemic and hemorrhagic strokes relative to warfarin.

Side Effects

Adverse events associated with the use of Pradaxa may I nclude, but are not limited to, the following:

  • bleeding
  • gastrointestinal events (dyspepsia, nausea, upper abdominal pain, gastrointestinal hemorrhage, and diarrhea)

Mechanism of Action

Pradaxa (dabigatran etexilate mesylate) is a competitive, direct thrombin inhibitor. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.

Literature References

Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, Pais P, Dans A, Eikelboom J, Oldgren J, Pogue J, Reilly PA, Yang S, Connolly SJ; RE-LY investigators Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. The Lancet 2010 Sep 18;376(9745):975-83

Additional Information

For additional information regarding Pradaxa or the risk of stroke and embolism due to atrial fibrillation, please visit the Pradaxa web page.