Pradaxa Superior to Warfarin in “Real World” Study

Efficacy and safety improved in patients with nonvalvular atrial fibrillation

Results from a “real world” analysis have shown that dabigatran etexilate mesylate (Pradaxa, Boehringer-Ingelheim) was associated with improved safety and efficacy outcomes compared with warfarin in patients with nonvalvular atrial fibrillation (NVAF). The results were presented at the International Stroke Conference 2017.

The study analyzed 7,245 dabigatran-treated patients and 14,490 warfarin-treated patients with NVAF who had no exposure to oral anticoagulants, using data from an administrative claims database from October 1, 2010, to April 30, 2014. The patients were mostly male (56%), with a mean age of 74 years and a mean CHADS2 stroke-risk score of 2.2.

Compared with warfarin, dabigatran was associated with a 26% reduced risk of stroke (hazard ratio [HR], 0.74) and a 20% reduced risk of major bleeding (HR, 0.80). Dabigatran was also associated with a reduced risk of serious secondary outcomes, including a 68% reduced risk of hemorrhagic stroke (HR, 0.32); an 18% reduced risk of major extracranial bleeding (HR, 0.82), a 48% reduced risk of venous thromboembolism (HR, 0.52); and a 27% reduced risk of death (HR, 0.73).

Dabigatran is indicated:

  • To reduce the risk of stroke and systemic embolism in patients with NVAF
  • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days.
  • To reduce the risk of recurrence of DVT and PE in patients who have been previously treated.
  • For the prophylaxis of DVT and PE in patients who have undergone hip-replacement surgery

Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. 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.

Dabigatran can cause serious or fatal bleeding. It should not be used in patients with prosthetic heart valves.

Sources: Boehringer-Ingelheim; February 24, 2017; and Pradaxa Prescribing Information; November 2015.