Boehringer Ingelheim reports positive phase III anticoagulant results

Boehringer Ingelheim has announced the results of a phase III clinical trial comparing the administration of dabigatran etexilate over 33 days with enoxaparin as a preventative treatment for venous thromboembolism (VTE) following hip replacement surgery.

The company reported positive results of the Re-Novate trial to the congress of the International Society on Thrombosis and Haematosis, with dabigatran etexilate showing a lower rate of bleeding than that seen with enoxaparin.

A reversible orally-administered direct thrombin inhibitor, dabigatran etexilate is an innovative anticoagulant that acts by inhibiting thrombin, a vital enzyme involved in the formation of blood clots.

Bengt Eriksson, of the Department of Orthapaedic Surgery at University Hospital Sahlgrenska, said: “The positive efficacy and safety data for dabigatran etexilate in preventing potentially life-threatening VTE after hip and knee replacement surgery signals a therapeutic advance which will be welcomed by both physicians and patients in the future.”

Boehringer Ingelheim noted that an extension of prohylaxis is clinically proven to offer improved protection from potentially-fatal blood clots, with dabigatran etexilate offering a prospective treatment option for effective thromboprophylaxis over the recommended period of treatment.

In December 2006, Boehringer Ingelheim presented the results of the Re-Model trial showing the efficacy of the compound as a preventative treatment for VTE in knee replacement surgery patients.