Boehringer Ingelheim has voluntarily discontinued treatment with dabigatran (Pradaxa) in a Phase 2 clinical trial in patients with artificial heart valves. The company based its decision on interim results from the phase 2 RE-ALIGN trial, which suggested that the investigated dosing regimen did not achieve the desired results in this patient population.
Dabigatran is not approved and not recommended for use in patients with prosthetic heart valves. The presence of an artificial heart valve in patients is a clinical condition that is distinct from those for which dabigatran is an approved treatment. In view of the interim trial results, the company said it is currently in discussions with regulatory authorities to reinforce the product label text accordingly and to discuss appropriate communication to physicians and relevant healthcare providers.
In the U.S., dabigatran is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.