Small Doses of Edoxaban Reduces Stroke Risk in Elderly Patients, Says Study
Atrial fibrillation (AF) is the most common arrhythmia in the elderly population; this condition increases your risk for strokes, heart failure, and other heart-related complications. A significant concern with atrial fibrillation is the risk of developing blood clots within the upper chambers of the heart. These clots may travel to other organs and cause blocked blood flow (ischemia).
Once this has been diagnosed, antithrombotic therapy is the only treatment that has been shown to have an improved survival rate.
Since age increases the risk for bleeding and thromboembolic complications, the use of anticoagulants outweighs the risk of bleeding.
In the ELDERCARE-AF trial, adults aged 80 years and older who has atrial fibrillation, taking a once-daily, low-dose edoxaban were superior to placebo. It showed stroke or systemic embolism prevention and did not significantly increase bleeding.
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A randomized trial conducted in Japan demonstrates that an ultra-low dose of direct oral anticoagulant (DOAC) may safely reduce the risk for stroke in elderly patients with atrial fibrillation since the use of standard dosages increases the risk of bleeding.
Japanese patients more than 80 years of age who had nonvalvular atrial fibrillation and in whom standard oral anticoagulants were not recommended were subjected to trial to assess the safety and efficacy of low-dose edoxaban.
Ken Okumura, of Saiseikai Kumamoto Hospital, Kumamoto, Japan, presented this study on August 30 during the virtual European Society of Cardiology (ESC) Congress 2020. For high-risk patients with nonvalvular AF and wouldn't be given an oral anticoagulant, edoxaban 15 mg can be an acceptable treatment option. However, it may increase the risk of gastrointestinal bleeding, which is why precautionary measures should be given to every patient.
The rate of gastrointestinal bleeding indeed tripled among the patients who received edoxaban compared to those given placebo, at about 2.3% per year vs. 0.8% per year. It may make people stop taking edoxaban, but for the most part, it doesn't kill people. This is according to Daniel E. Singer, MD, Massachusetts General Hospital, Boston. He also added that low-dose edoxaban doesn't add to the risk of intracranial hemorrhage, and also shows a steep reduction in thromboembolic risk.
Okumura mentioned that there is no standard of practice in Japan for patients like those in the present trial. Still, he believes that with this current study it opens a new possible path of thromboprophylaxis in such high-risk patients.
Interpretation
The results of this trial indicate that very low dose edoxaban (15 mg) was superior to placebo in reducing stroke or systemic embolism among Japanese AF patients more than 80 years of age. Bleeding was found to be overall higher with the use of edoxaban, primarily GI bleeding. Since this trial focused mostly in Asian with a median bodyweight of ~50 kg and all patients were east Asian. It is unclear whether this same dosage would exhibit the same efficacy among similar elderly patients in the United States.
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Sep 02, 2020 07:00 AM EDT