ASH: Oral Edoxaban Noninferior to Dalteparin for CA-Linked VTE
Oral edoxaban found noninferior for recurrent venous thromboembolism or major bleeding
TUESDAY, Dec. 12, 2017 (HealthDay News) -- For patients with cancer-associated venous thromboembolism, oral edoxaban is noninferior to subcutaneous dalteparin for recurrent venous thromboembolism or major bleeding, according to a study published online Dec. 12 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 9 to 12 in Atlanta.
Gary E. Raskob, Ph.D., from the University of Oklahoma Health Sciences Center in Oklahoma City, and colleagues conducted a noninferiority trial involving patients with cancer who had acute symptomatic or incidental venous thromboembolism and were randomized to receive low-molecular-weight heparin for at least five days followed by oral edoxaban or subcutaneous dalteparin. A total of 1,046 patients were included in the modified intention-to-treat analysis.
The researchers found that a primary-outcome event occurred in 12.8 and 13.5 percent of patients in the edoxaban and dalteparin groups, respectively (hazard ratio, 0.97; 95 percent confidence interval, 0.70 to 1.36; P = 0.006 for noninferiority; P = 0.87 for superiority). Recurrent venous thromboembolism occurred in 7.9 and 11.3 percent of patients in the edoxaban and dalteparin groups (difference in risk, −3.4 percentage points; 95 percent confidence interval, −7.0 to 0.2). Major bleeding occurred in 6.9 and 4.0 percent of patients, respectively (difference in risk, 2.9 percentage points; 95 percent confidence interval, 0.1 to 5.6).
"Oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding," the authors write.
The study was funded by Daiichi Sankyo, the manufacturer of edoxaban.