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Edoxaban, The G..

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Venous thromboembolism (VTE) relates to two types of blood clots: deep vein thrombosis (DVT) and pulmonary embolism (PE). It is estimated that up to 900,000 Americans are affected by VTE each year and approximately 60,000-100,000 die of VTE annually.1 The American College of Chest Physicians (ACCP) 2012 guidelines recommend initial parenteral anticoagulation therapy for a minimum of 5 days with low molecular heparin (LMWH), unfractionated heparin, or fondaparinux followed by a vitamin K antagonist (warfarin) for at least 3 months for either provoked or unprovoked VTE in patients without cancer.2 Due to the delayed time to achieve a therapeutic international normalized ratio (INR) between 2.0 and 3.0, it is recommended to start warfarin at the same time as the initial parenteral anticoagulant therapy. Currently, two oral factor Xa inhibitors are FDA-approved, rivaroxaban (Xarelto®) and apixaban (Eliquis®); however, only rivaroxaban has an approved indication for VTE treatment.3 In the clinical trials that investigated these two drugs for the treatment of VTE, they both were found to be non-inferior to warfarin.4,5 Edoxaban is another oral factor X­a inhibitor with a fast onset of action that is administered once daily.6 It is currently not available in the United States. The Hokusai-VTE study was conducted to investigate the efficacy and safety of edoxaban for patients with symptomatic VTE.

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The Hokusai-VTE study was a randomized, multi-centered, double-blinded, double-dummy, non-inferiority trial that evaluated edoxaban 60 mg orally daily compared to warfarin targeted to an INR between 2.0-3.0. All patients received initial parenteral treatment with either enoxaparin or UFH for at least 5 days. The edoxaban group had the drug initiated following the 5 days of initial treatment. Patients continued on edoxaban or warfarin for 3-12 months, at the discretion of the physician. For patients with a creatinine clearance (CrCl) between 30-50 mL/min or weighing ≤ 60 kg, edoxaban was adjusted to 30 mg daily. Patients included were at least 18 years of age and objectively diagnosed with an acute, symptomatic DVT and/or PE. Patients with cancer, treated with heparin or warfarin for more than 48 hours, or with a CrCl < 30 mL/min were excluded. The primary efficacy outcome was the incidence of symptomatic recurrent VTE defined as DVT or non-fatal or fatal PE. The primary safety outcome was the incidence of clinically relevant bleeding, defined as a composite of major or clinically relevant non-major bleed. A major bleed was defined as a decrease in hemoglobin of > 2 g/dL or transfusion of at least 2 units of blood, or fatal bleed. A clinically relevant non-major bleed was defined as overt bleeding that required medical attention, but did not meet the criteria of major bleed.6

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A total of 8240 patients were included in the modified intention-to-treat analysis. Baseline characteristics were similar between the treatment groups with the mean age of 55 years, 60% of patients with DVT, 40% with PE, and 24% with concomitant DVT and PE. The rate of first recurrent VTE or VTE related death for the edoxaban group (3.2%) was non-inferior to 3.5% of patients treated with warfarin (HR 0.89, 95% CI, 0.70-1.13). The rate of the composite safety outcome was significantly less in the edoxaban group (8.5%) compared to 10.3% in the warfarin group (HR 0.81, 95% CI, 0.71-0.94, p = 0.004 for superiority). ...

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