BILIZE trial, recruited 2615 patients who randomly clopidogrel received treatment with either dose of dabigatran etexilate for 12 to 15 days. The rate of VTE in dabigatran group was statistically higher compared to a similar duration of treatment with enoxaparin. The incidence of major bleeding did not differ significantly among the 3 groups.49 In a pool analysis of 3 major prospective, randomized, double blind noninferiority trials comparing the efficacy and safety of dabigatran starting postoperatively with enoxaparin sc in patients undergoing hip or knee arthroplasty,50 the outcomes occurred in 3.3% of the enoxaparin group versus 3.0% of the dabigatran 220 mg group and 3.8% of the 150 mg group. Major bleeding occurred in 1.4% of the enoxaparin group versus 1.4% of the dabigatran 220 mg group and 1.1% of the 150 mg group. In summary, oral dabigatran was effective as sc enoxaparin in decreasing the risk of major VTE and VTE related mortality after hip or knee replacement with similar risk of bleeding complication. Treatment of VTE. Dabigatran was compared to warfarin in terms of the efficacy and safety for acute symptomatic VTE in chemical catalogs RECOVER 1 trial.51 This study randomized 2564 patients with acute VTE to 150 mg twice daily of dabigatran etexilate or warfarin for 6 months after initial parenteral anticoagulation therapy for a median of 9 days.
The rate of primary outcome, subsequent phospholipases symptomatic VTE and any VTE related death, was 2.4% among patients assigned to receive dabigatran as compared with 2.1% in those assigned to receive warfarin. Rates of major bleeding were 1.6% and 1.9% in the dabigatran and warfarin groups, respectively, and rates of any bleeding were 16.1% and 21.9%, respectively. The number of patients who had acute coronary syndromes, abnormal liver function tests,and the number of death was similar in the 2 groups. Adverse events leading to study drug discontinuation occurred in 9.0% of patients assigned to dabigatran and in 6.8% of patients assigned to warfarin. These data suggest that a fixed dose of dabigatran is as effective as warfarin and has a similar safety profile in the treatment of DVT and PE. Atrial fibrillation. The Dabigatran With or Without Concomitant Aspirin capecitabine Compared With Warfarin Alone in Patients With Nonvalvular Atrial Fibrillation trial52 was a phase II trial designed to determine a safe dose of dabigatran etexilate in 502 patients with a diagnosis of chronic atrial fibrillation as determined by the risk of bleeding and major clinical events.
This study also monitored dabigatran plasma concentrations, aPTT, D dimer, urinary 11 dehydrothromboxane B2, and liver function. Patients were randomly assigned to receive blinded doses of 50, 150, or 300 mg dabigatran twice daily alone or combined with 81 or 325 mg aspirin or open label warfarin monotherapy. The primary outcome was the frequency of major and/or clinically terms relevant bleeding events. Major bleeding events were exclusively limited to the group received dabigatran etexilate 300 mg twice daily plus aspirin and were significantly more common than monotherapy. As a result, aspirin was discontinued in the former group and those patients were merged with the 300 mg twice daily monotherapy group. At the final analysis, the total bleeding events were more frequent.