BOEHRINGER INGELHEIM REPORTS FINDINGS ON ANTICOAGULANT

Boehringer Ingelheim Pharmaceuticals has presented results from RE-MODEL, a Phase III, randomized, parallel-group, double-blind, active, controlled study, at the meeting of the American Society of Hematology. The trial investigated the efficacy and safety of two different dosing strengths of orally administered dabigatran etexilate capsules compared with subcutaneous injection of the low-molecular-weight heparin, enoxaparin, in the prevention of venous thromboembolism in patients with primary elective total knee replacement surgery.

Dabigatran etexilate was discovered through internal research programs at Boehringer Ingelheim and is being investigated for the prevention and treatment of thromboembolic disease. In clinical trials, dabigatran etexilate is given in a fixed oral dose form and does not require coagulation monitoring. Results from the RE-MODEL study, which was conducted throughout the European Union, South Africa and Australia, demonstrate that dabigatran etexilate met the prespecified primary endpoint of non-inferiority compared with enoxaparin with no difference in bleeding rates in patients undergoing elective knee replacement surgery.

The primary efficacy endpoint results from the 2,076-patient study demonstrated non-inferiority for both dabigatran doses. Total venous thromboembolism (VTE) and all-cause mortality occurred in 40.5 percent of patients receiving 150 mg and 36.4 percent of patients receiving 220 mg dabigatran etexilate once daily, as compared with 37.7 percent of patients receiving 40 mg of enoxaparin. Secondary efficacy endpoint results showed that proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) (the collective term for DVT and PE is VTE) occurred at similar rates across treatment arms. VTE occurred in 3.8 percent of patients receiving 150 mg, 2.6 percent of patients receiving 220 mg of dabigatran etexilate, and 3.5 percent of patients receiving 40 mg of enoxaparin.

Safety evaluation results for all 2,076 patients receiving study treatment showed that similar bleeding rates were observed between the treatment groups. The rate of major bleeding was 1.3 percent of patients receiving 150 mg of dabigatran etexilate, 1.5 percent of patients receiving 220 mg of dabigatran etexilate and 1.3 percent of patients receiving enoxaparin.