Boehringer Ingelheim Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent deep venous thrombosis and pulmonary embolism in patients who have been previously treated. Deep venous thrombosis and pulmonary embolism are collectively referred to as venous thromboembolism.
“Venous thromboembolism is the third most common cardiovascular disease after myocardial infarction and stroke. About one-third of patients with a deep vein thrombosis or pulmonary embolism will suffer a recurrence within 10 years,” says Samuel Z Goldhaber, director of Brigham and Women’s Hospital’s Thrombosis Research Group and professor of medicine, Harvard Medical School. “Dabigatran has established efficacy and safety for stroke risk reduction in patients with non-valvular atrial fibrillation. This new FDA approval expands dabigatran’s indications to include treatment and the reduction of the risk of recurrence of deep venous thrombosis and pulmonary embolism.”
The approval is based on results from four global Phase III studies evaluating the efficacy and safety of Pradaxa in the treatment of deep venous thrombosis and pulmonary embolism.
The RE-COVER and RE-COVER II trials, which included patients with deep venous thrombosis and pulmonary embolism who were treated with parenteral anticoagulant therapy for five to 10 days, showed Pradaxa was non-inferior to warfarin in reducing deep venous thrombosis and pulmonary embolism after a median of 174 days of treatment, and was associated with lower rates of overall bleeding and a higher rate of any gastrointestinal bleeding (3.1% vs. 2.4%). RE-MEDY(SM), which included patients who had been previously treated for an acute deep venous thrombosis and pulmonary embolism with anticoagulant therapy for three to 12 months, showed Pradaxa was non-inferior to warfarin in reducing deep venous thrombosis and pulmonary embolism after a median of 534 days of treatment, and was associated with lower rates of overall bleeding and a higher rate of any gastrointestinal bleeding (3.1% vs. 2.2%).
RE-SONATE, which included patients who had been previously treated for an acute deep venous thrombosis and pulmonary embolism with anticoagulant therapy for six to 18 months, showed Pradaxa reduced the risk of deep venous thrombosis and pulmonary embolism recurrence by 92% compared to placebo after a median of 182 days of treatment: 0.4% vs. 5.6%; HR = 0.08 [CI 0.02, 0.25]. Pradaxa was associated with higher rates of any bleeding (10.5% vs. 6.1%; HR = 1.77 [CI 1.20, 2.61]), clinically relevant non-major bleeding (5.0% vs. 2.0%; HR = 2.54 [CI 1.34, 4.82]), and gastrointestinal bleeding (0.7% vs. 0.3%) compared to placebo.
