medwireNews: The oral factor Xa inhibitor edoxaban is as good as subcutaneous dalteparin for the prevention of recurrent venous thromboembolism (VTE) or major bleeding in patients with cancer, show results of the Hokusai VTE cancer trial.
For the trial, conducted at 114 centers in 13 countries, patients with cancer who had acute symptomatic or incidentally detected VTE were randomly assigned to receive either low-molecular-weight heparin for at least 5 days followed by oral edoxaban 60 mg once daily (n=522) or subcutaneous dalteparin 200 IU/kg once daily for 1 month followed by 150 IU/kg daily (n=524). Each treatment was given for 6–12 months.
In the 12 months after randomization, 12.8% of patients in the edoxaban group and 13.5% of those in the dalteparin group experienced either recurrent VTE or major bleeding. This difference was not statistically significant and therefore met the criteria for noninferiority of edoxaban to dalteparin but not superiority.
When the two outcomes were analyzed separately, Gary Raskob (University of Oklahoma Health Sciences Center, Oklahoma City, USA) and colleagues found that the rate of recurrent VTE was lower with edoxaban than with dalteparin (7.9 vs 11.3%), but not significantly so. This difference was due to a lower rate of deep vein thrombosis in the edoxaban group (3.6 vs 6.7%), whereas the rate of pulmonary embolism did not differ between the groups (5.2 vs 5.3%).
The rate of major bleeding was significantly higher with edoxaban than with dalteparin, at 6.9% versus 4.0%, giving a corresponding hazard ratio of 1.77.
The researchers report that this difference was mainly due to a higher rate of upper gastrointestinal bleeding with edoxaban in patients with gastrointestinal cancer.
But they also note that the frequency of severe (category 3 or 4) major bleeding was lower with edoxaban than with dalteparin (33.3 vs 61.9%).
The study findings are published in The New England Journal of Medicine and were presented at the 2017 American Society of Hematology Annual Meeting in Atlanta, Georgia, USA.
By Laura Cowen
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