The U.S. Food and Drug Administration (FDA) has approved the anticoagulant dabigatran (Pradaxa) "for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated," according to a press release from Boehringer Ingelheim Pharmaceuticals, Inc.

According to the release, the approval is based on results from four global Phase III studies evaluating the efficacy and safety of dabigatran in the treatment of DVT and PE: RE-COVER, RE-COVER II, RE-MEDY, and RE-SONATE.

The RE-COVER and RE-COVER II trials, which included patients with DVT and PE who were treated with parenteral anticoagulant therapy for five to 10 days, showed dabigatran "was non-inferior to warfarin in reducing DVT and PE after a median of 174 days of treatment. "On pooled analysis, major or clinically relevant non-major bleeding was lower in the dabigatran arm (5.3 percent vs. 8.5 percent, HR 0.62; 95 percent CI 0.50-0.76). Further, it was associated with a higher rate of any gastrointestinal bleeding (3.1 percent vs. 2.4 percent).

The RE-MEDY trial, which included patients who had been previously treated for an acute DVT and PE with anticoagulant therapy for three to 12 months, showed dabigatran "was non-inferior to warfarin in reducing DVT and PE after a median of 534 days of treatment." Major or clinically relevant bleeding events (5.6 percent vs. 10.2 percent, p < 0.001) and any bleeding event (19.4 percent vs. 26.2 percent, p < 0.001) were significantly reduced in the dabigatran arm. In addition, it was associated with a higher rate of any GI bleeding (3.1 percent vs. 2.2 percent).”

Meanwhile, RE-SONATE included patients who had been previously treated for an acute DVT and PE with anticoagulant therapy for six to 18 months, and showed dabigatran "reduced the risk of DVT and PE recurrence by 92 percent compared to placebo after a median of 182 days of treatment: 0.4 percent vs. 5.6 percent; HR = 0.08 [CI 0.02, 0.25]. [Dabigatran] was associated with higher rates of any bleeding (10.5 percent vs. 6.1 percent; HR = 1.77 [CI 1.20, 2.61]), clinically relevant non-major bleeding (5.0 percent vs. 2.0 percent; HR = 2.54 [CI 1.34, 4.82]), and gastrointestinal bleeding (0.7 percent vs. 0.3 percent) compared to placebo."

This approval expands the indications of dabigatran, which was approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation in 2010.

Keywords: Anticoagulants, Atrial Fibrillation, Benzimidazoles, beta-Alanine, Pulmonary Embolism, Pyridines, Stroke, United States Food and Drug Administration, Venous Thrombosis

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