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- Title
Clinical implications of assessment of apixaban levels in elderly atrial fibrillation patients: J-ELD AF registry sub-cohort analysis.
- Authors
Suzuki, Shinya; Yamashita, Takeshi; Akao, Masaharu; Okumura, Ken
- Abstract
Purpose: To investigate the distribution of plasma apixaban levels and their relationships with clinical outcomes in elderly patients with atrial fibrillation (AF). Method: The J-ELD AF Registry is a multicenter prospective observational study of Japanese non-valvular AF patients aged ≥75 years taking an on-label dose of apixaban (3015 patients from 110 institutions). Among them, plasma apixaban levels at trough were estimated by anti-Xa assay (Api-AXA) in 943 patients. Patients with standard (5 mg bid; n = 431) and reduced (2.5 mg bid; n = 512) dose were further divided into two groups with low and high Api-AXA levels (boundary: median value). Results: The incidence rates (per 100 person-years) of events in the low- and high-Api-AXA groups were as follows: 1.48 and 1.99 (log-rank test, P = 0.695) for stroke or systemic embolism, 0.98 and 1.49 (P = 0.652) for bleeding requiring hospitalization, and 0.49 and 0.99 (P = 0.565) for total deaths in patients with standard dose, versus 0.84 and 1.68 (P = 0.414), 0.42 and 4.64 (P = 0.004), and 2.52 and 6.65 (P = 0.035) in patients with a reduced dose, respectively. In multivariate Cox regression analysis among patients with a reduced dose, a high Api-AXA level was independently associated with bleeding requiring hospitalization (HR 12.12, 95% CI: 1.56–94.22) and nonsignificantly with total deaths. Conclusions: A high trough apixaban level in patients indicated for standard dose was not associated with adverse events, while a high apixaban level in patients indicated for a reduced dose was associated with bleeding requiring hospitalization.
- Subjects
EMBOLISM risk factors; HEMORRHAGE risk factors; STROKE risk factors; ANTICOAGULANTS; ATRIAL fibrillation; BLOOD plasma; CONFIDENCE intervals; HOSPITAL care; LONGITUDINAL method; MEDICAL cooperation; MULTIVARIATE analysis; SCIENTIFIC observation; RESEARCH; TREATMENT effectiveness; PROPORTIONAL hazards models; DESCRIPTIVE statistics; LOG-rank test; OLD age
- Publication
European Journal of Clinical Pharmacology, 2020, Vol 76, Issue 8, p1111
- ISSN
0031-6970
- Publication type
Article
- DOI
10.1007/s00228-020-02896-y