Pradaxa Study Involving Patients with Mechanical Valves has Setback Due to Reports of Stroke

0
74

Pradaxa Study Involving Patients with Mechanical Valves has Setback Due to Reports of StrokeOverview: A study evaluating the effects of Pradaxa in patients who have received a mechanical valve has experienced a setback, as one arm of the clinical trials has been discontinued due to reports of stroke and other thromboembolic events. In the US, Pradaxa is only approved for patients who suffer from atrial fibrillation.

  • One arm of the RE-ALIGN trials has been discontinued due to reports of stroke
  • RE-ALIGN is designed to compare Pradaxa versus warfarin in patients who have had a mechanical valve surgery; currently, Pradaxa is not approved for this use in the US
  • Warfarin is currently the only approved anticoagualant for these patients; Pradaxa has intended to replace warfarin, but has raised safety concerns due to the risk of uncontrollable bleeding

Product: Pradaxa (dabigatran)

Manufacturer: Boehringer Ingelheim Pharmaceuticals

Side Effects & Complications

  • Cerebral hemorrhaging
  • Gastrointestinal (GI) hemorrhaging
  • All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas

RE-ALIGN Trial Halted

According to an article in Forbes, the RE-ALIGN trials are clinical studies comparing the effects warfarin versus Pradaxa in patients who have received a mechanical valve. Boehringer Ingelheim, the manufacturer of Pradaxa, announced the trials last year. RE-ALIGN involves two “arms”; the first arm randomizes patients to either warfarin or Pradaxa during their initial hospital stay while the second arm randomizes patients 3 months after the operation. The first arm, which is also referred to as the post-surgery arm, has now been discontinued due to “lower than projected plasma levels of dabigatran in this population, and an imbalance in reports of thromboembolic events (primarily strokes).” The second arm of the trials will continue, the company said.    

Pradaxa Side Effects

Pradaxa manufacturers are hoping that the drug will replace warfarin, which patients tend to see as burdensome due to the regular blood testing and dietary restrictions. Safety issues and lack of data, however, have partially prevented Pradaxa from replacing the older anticoagulant. Unlike warfarin, there is no antidote for a patient who hemorrhages while taking Pradaxa.