Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai‐VTE trial

Abstract

Summary. Background: Direct oral anticoagulants have been evaluated for their efficacy and safety in the treatment of venous thromboembolism (VTE), which comprises deep vein thrombosis and pulmonary embolism. The randomized, double-blind Hokusai-VTE trial demonstrated that 60 mg of edoxaban once daily following initial heparin treatment is non-inferior to heparin overlapped with and followed by warfarin for the treatment of VTE, and is associated with significantly fewer bleeding events. Objectives: To assess the efficacy and safety of edoxaban versus warfarin among East Asian patients enrolled in the Hokusai-VTE trial. Patients/methods: The Hokusai-VTE trial enrolled 8292 patients from 439 centers worldwide, including 1109 patients from Japan, China, Korea, and Taiwan. The primary efficacy and safety outcomes were symptomatic recurrent VTE and clinically relevant bleeding, respectively. Results: In the overall East Asian population, the primary efficacy outcome of symptomatic recurrent VTE occurred in 16 of 563 (2.8%) patients in the edoxaban group versus 24 of 538 (4.5%) patients in the warfarin group (hazard ratio[HR] 0.64; 95% confidence interval [CI] 0.34-1.19; P = 0.1601). The primary safety outcome of clinically relevant bleeding occurred in 56 of 563 (9.9%) patients in the edoxaban group versus 93 of 538 (17.3%) patients in the warfarin group (HR 0.56; 95% CI 0.40-0.78; P < 0.001). Conclusions: Edoxaban is an effective and safer alternative to warfarin in East Asian patients with acute VTE who require anticoagulant therapy, consistent with overall study findings from the Hokusai-VTE trial.

Predictors of venous thromboembolism recurrence and the bleeding events identified using a Japanese healthcare database

“…Three recent studies of VTE conducted in Japan also provide insights into the patient characteristics and treatment patterns and comparative data to our analysis. The JAVA registry study [16] with 1076 VTE patients, the East Asian population (warfarin group) of the Hokusai study [17], and the UFH/warfarin group of the AMPLIFY-J study [18] found a similar distribution of patient characteristics as in our analysis: women (58. Comparing the three studies, the proportion of VTE recurrence was highest in our study (7.2 per 100 patient-years), followed by the JAVA study (4.0 per 100 patient-years) [16], and in the East Asian population of the Hokusai study (warfarin group: 4.5 per 100 patient-years) [17].…”

Edoxaban Was Effective for the Treatment of Deep Vein Thrombosis and Pulmonary Thromboembolism in a Cancer Patient with Antithrombin III Deficiency

“…Edoxaban reduced the risk of symptomatic recurrent VTE and clinically relevant bleeding in East Asian patients by 36% and 44%, respectively, in comparison to warfarin (6). …”

Reduced cardiac function and risk of venous thromboembolism in Asian countries

“…And in patients with right ventricular dysfunction with elevated NT-proBNP levels, a reduction in recurrences was observed in edoxaban group compared with that in warfarin group [47]. When paying attention to Hokusai-VTE trial of East Asia area, Asian patients might get extra benefit from edoxaban compared with warfarin than non-East Asian patients [48]. The major concern was that warfarin may be associated with a higher rate of bleeding in Asians and its efficacy in curing thrombosis was sometimes questioned [49, 50].…”