Boehringer Ingelheim reports positive long-term data for Pradaxa

Boehringer Ingelheim has presented new clinical trial data analyses that underline the long-term benefits offered by its novel anticoagulant therapy Pradaxa.

Results from a new combined analysis of the pivotal phase III RE-LY trial and its extension study RELY-ABLE reveal the efficacy and safety profiles of both doses of Pradaxa remain consistent after more than six years of treatment.

This data, which was presented at the American Heart Association's 2013 scientific sessions, was consistent with the results seen in the 18,000-patient RE-LY registration trial and further strengthens the clinical profile of Pradaxa.

It is currently approved in more than 100 countries worldwide for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the primary prevention of venous thromboembolism following total hip replacement or total knee replacement surgery.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "Especially for a chronic condition that requires lifelong treatment like stroke prevention in atrial fibrillation, results such as these provide key insights for physicians and patients."

The company is currently undertaking several additional Pradaxa research projects, including a study that will gather real-world evidence on its efficacy in patients with non-valvular atrial fibrillation.