학술논문
Abstract 10999: Outcomes Associated With Under-Dosing of Rivaroxaban for Management of Non-Valvular Atrial Fibrillation in Real World Clinical Setting From the XAPASS (Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients With Atrial Fibrillation)
Document Type
Article
Author
Source
Subject
*ATRIAL fibrillation
*RIVAROXABAN
*STROKE
*MYOCARDIAL infarction
*NERVOUS system
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Language
ISSN
0009-7322
Abstract
Background and Objective: Recent real-world studies demonstrate that prescription of under-dosed Factor Xa inhibitor rivaroxaban is seen in the clinical management of non-valvular atrial fibrillation (NVAF). However, its effect on the outcomes of safety and effectiveness remains unclear. To clarify this, we examined the incidence of clinical events from the XAPASS, a Japanese real-world, prospective, single-arm, observational study conducted as post-marketing surveillance mandated by the health authority. Methods: A total 11,308 patients were enrolled in the XAPASS from 1,419 hospitals. Of these, 9,578 patients who completed a 1-year follow up (mean treatment period 300 ± 119 days) were included in the analysis. Of these, 6,521 patients had no renal impairment (creatinine clearance [CrCl] ≥ 50 mL/min). In Japan, the approved rivaroxaban dose for stroke prevention in NVAF patients is 15 mg once daily (od), with 10 mg od recommended in patients with CrCl 15-49 mL/min; these doses are lower than those approved in other countries (20 mg od and 15 mg od, respectively). Results: Baseline characteristics and 1-year outcomes were compared among patients. Of 6,521 patients, 4,185 (mean CHADS2 score 1.8) received 15 mg od (recommended dose) and 2,336 (mean CHADS2 score 2.3) received 10 mg od (under-dosed). After adjusting for baseline characteristics by propensity scoring and inverse probability of treatment weighting, incidence rates (events/100 patient-years) were 1.48 in patients receiving the recommended doses and 2.14 in those who were under-dosed (hazard ratio [HR] for under-dosed versus recommended dose: 1.44; 95% confidence interval [CI] 1.10-1.90; P = 0.009), for the composite of stroke (ischemic and hemorrhagic), non-central nervous system systemic embolism, and myocardial infarction. Corresponding incidence rates were 1.63 and 1.34 (HR 0.82; 95% CI 0.609-1.11; P = 0.197), respectively, for major bleeding. Conclusion: We revealed that in real-world clinical practice, rivaroxaban doses prescribed to NVAF patients are often inconsistent with the recommendation. This prescription pattern is associated with increased risk for clinical outcomes, particularly for effectiveness events, in the Japanese population. (XAPASS; NCT01582737) [ABSTRACT FROM AUTHOR]