According to a study published in the New England Journal of Medicine, edoxaban was shown to be better than placebo in preventing stroke and systemic embolism in very elderly Japanese patients with non-valvular atrial fibrillation.
A total of 984 patients (mean age 86.6 ± 4.2 years; 42.6% men) with non-valvular atrial fibrillation who were not suitable candidates for standard-dose oral anticoagulants were enrolled in this multicentre, randomized, double-blind phase 3 placebo recorded -controlled attempt. The study’s primary efficacy endpoint was stroke or systemic embolism combination, and the primary safety endpoint was profuse bleeding. Participants received a daily dose of 15 mg edoxaban (n = 492) or placebo (n = 492). A total of 681 patients completed the study.
The annualized rate of stroke or systemic embolism was 2.3% in the edoxaban group and 6.7% in the placebo group (hazard ratio) [HR]0.34; 95% CI, 0.19-0.61; P <0.001), and the annualized major bleeding rate was 3.3% in the compared edoxaban group and 1.8% in the placebo group (HR 1.87; 95% CI 0.90-3.89; P = 0.09).
The rate of gastrointestinal bleeding was higher with edoxaban compared to the placebo group (14 events; 2.3% per patient-year versus 5 events; 0.8% per patient-year; HR 2.85; 95% CI 1.03-7.88) . . In addition, there were 66 deaths from any cause in the edoxaban group compared to 69 in the placebo group (9.9% per patient-year versus 10.2% per patient-year; HR 0.97; 95% CI 0.69- 1.36).
One of the limitations of the study is the fact that a significant number of patients dropped out of the study, in large part due to adverse events unrelated to bleeding.
“In very elderly Japanese patients with non-valvular atrial fibrillation who were not suitable candidates for a standard oral anticoagulation regimen, a once-daily dose of 15 mg edoxaban was superior to placebo in preventing stroke or systemic embolism and did not result in a significantly higher score Incidence of major bleeding than placebo, ”the investigators concluded.
Information: This study was funded by Daiichi Sankyo. Some of the study’s authors reported links with pharmaceutical and medical device companies. See the original reference for a full list of specifications.
Okumura K., Akao M., Yoshida T. et al. Low-dose edoxaban in the very elderly with atrial fibrillation. N Engl J Med. 2020; 383 (18): 1735- 1745.
This article originally appeared on The Cardiology Advisor