Patient-Oriented Evidence That Matters

Low-Dose Edoxaban Effective for Stroke Prevention in Older Patients with Atrial Fibrillation


Am Fam Physician. 2021 Mar 1;103(5):312-313.

Clinical Question

Is low-dose edoxaban (Savaysa) safe and effective for stroke prevention in older patients with atrial fibrillation?

Bottom Line

A lower dose of edoxaban is effective in decreasing stroke and systemic embolism in older patients with atrial fibrillation compared with placebo (number needed to treat = 23). Although the difference in major bleeding rates with edoxaban vs. placebo did not reach statistical significance, edoxaban use led to higher rates of gastrointestinal bleeding (number needed to harm = 83) and clinically significant nonmajor bleeding (number needed to harm = 18). This study was completed in Japan, and the mean body mass index of participants was 22 kg per m2, which may not generalize to the population in the United States. (Level of Evidence = 2b)


Many older patients with atrial fibrillation may not be prescribed standard doses of anticoagulation for stroke prevention because of a perceived higher risk of bleeding. In this Japanese study, investigators enrolled patients 80 years and older with nonvalvular atrial fibrillation and a CHADS2 (congestive heart failure; hypertension; age 75 years or older; diabetes mellitus; prior stroke, transient ischemic attack, or thromboembolism [doubled]) score of 2 or more for whom standard doses of oral anticoagulants were considered inappropriate (e.g., those with a history of critical bleeding, severe renal impairment, low body weight, continuous nonsteroidal anti-inflammatory drug use, or antiplatelet drug use). A total of 984 patients were randomized to receive edoxaban, 15 mg daily (standard dose is 60 mg or 30 mg daily), or a matched placebo. The two groups had similar baseline characteristics: mean age of 86.6 years, mean body weight of 111.5 lb (50.6 kg), and a mean CHADS2 score of 3. The annualized rate of stroke or systemic embolism was lower in the edoxaban group than in the placebo group (2.3% vs. 6.7%; hazard ratio [HR] = 0.34; 95% CI, 0.19 to 0.61; P < .001). The incidence of major bleeding

POEMs (patient-oriented evidence that matters) are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, see http://www.essentialevidenceplus.com. Copyright Wiley-Blackwell. Used with permission.

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