FRIDAY, Nov. 4, 2022 (HealthDay News) -- Once-daily edoxaban seems safe and effective for pediatric patients with cardiac disease, according to a study presented at the American Heart Association Scientific Sessions 2022, held from Nov. 5 to 7 in Chicago.
Michael A. Portman, M.D., from Seattle Children's Hospital, and colleagues conducted a phase 3 trial in patients younger than 18 years with cardiac diseases who had an increased risk for thromboembolism. One hundred sixty-eight children were randomly assigned in a 2:1 ratio to either age- and weight-based oral edoxaban once daily or standard-of-care (SOC) anticoagulation for three months. Both groups continued in a one-year extension with edoxaban.
The researchers found that the clinically relevant bleeding (CRB) event rates were similar between the groups during the main period. In each group, one patient experienced a nonmajor CRB. Treatment-emergent adverse events occurred in 46.8 and 41.4 percent of patients treated with edoxaban and SOC, respectively. Two thromboembolism events were experienced by one patient treated with SOC. A total of 152 participants continued in the extension phase; one CRB event occurred (0.7 percent; trauma-related) and four thromboembolisms occurred (2.8 percent).
"If a child is having difficulty with anticoagulant treatment -- for instance becoming tired of the twice-daily injections -- it would be reasonable to discuss with the child's physician or health care team about whether edoxaban is an option," Portland said in a statement.
Several authors disclosed ties to pharmaceutical companies, including Daiichi Sankyo, which manufactures edoxaban and funded the study.