Stroke. 2019;50(5):1140-1148.
Optimal Rivaroxaban Dose in Asian Patients With Atrial Fibrillation and Normal or Mildly Impaired Renal Function.
제1저자 이소령 · 교신저자 최의근
소속 (4)
- From the Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Republic of Korea (S.-R.L.).
- Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Republic of Korea (E.-K.C., S.O.).
- Department of Medical Statistics, College of Medicine, Catholic University of Korea, Seoul (K.-D.H., J.-H.J.).
- Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Chest and Heart Hospital, United Kingdom (G.Y.H.L.); and Department of Clinical Medicine, Aalborg University, Denmark (G.Y.H.L.).
Abstract
Background and Purpose- Although rivaroxaban 15 mg (R15) was only given to patients with creatinine clearance (CrCl) ≤50 mL/min in the pivotal clinical trial, this dose has been commonly prescribed in Asian patients with nonvalvular atrial fibrillation regardless of renal function. There is a paucity of information on the clinical outcomes of R15 compared with rivaroxaban 20 mg (R20) in patients with CrCl ≥50 mL/min. This study aimed to examine the effectiveness and safety of 2 doses of rivaroxaban in Asian patients with atrial fibrillation and CrCl ≥50 mL/min. Methods- Using the Korean National Health Insurance Service database, patients with atrial fibrillation and normal or mildly impaired renal function (CrCl ≥50 mL/min) and naive to rivaroxaban or warfarin were included from January 2014 to December 2016. Three separate 1:1 propensity score-matched cohorts were conducted: R20 versus warfarin (n=15 584), R15 versus warfarin (n=11 554), and R20 versus R15 (n=10 392). Hazard ratios for ischemic stroke, intracranial hemorrhage, gastrointestinal bleeding, major bleeding, all-cause death, and composite clinical outcome were analyzed. Results- Compared with warfarin, both R20 and R15 showed significantly lower risk for ischemic stroke, major bleeding (mainly through reduction of intracranial hemorrhage), and all-cause death. Compared with R15, R20 showed better results for the composite clinical outcome (hazard ratio, 0.852; 95% CI, 0.735-0.988). This benefit was consistently observed in patients aged ≥80 years and those <50 kg. R20 was associated with higher risk of major bleeding than R15 in patients with marginal CrCl (50-60 mL/min). Conclusions- Among Asians with atrial fibrillation and CrCl ≥50 mL/min, both R20 and R15 were associated with reduced risk of ischemic stroke, intracranial hemorrhage, major bleeding, and all-cause death without significantly increased risk of gastrointestinal bleeding compared with warfarin. In patients with CrCl ≥50 mL/min, on-label R20 showed better results for the composite clinical outcome compared with off-label R15.
Keywords
anticoagulantsatrial fibrillationcreatinineoptimal dosagerivaroxabanwarfarin
그 밖의 정보
- 출판 형태
- Journal Article, Observational Study, Research Support, Non-U.S. Gov't
- 저널
- Stroke · eISSN 1524-4628
- MeSH
- Aged · Aged, 80 and over · Asian People* · Atrial Fibrillation / diagnosis / drug therapy / epidemiology · Cohort Studies · Factor Xa Inhibitors / administration & dosage · Female · Follow-Up Studies · Humans · Male · Middle Aged · Renal Insufficiency / diagnosis / drug therapy / epidemiology · Republic of Korea / epidemiology · Retrospective Studies · Rivaroxaban / administration & dosage
- Substances
- Factor Xa Inhibitors · Rivaroxaban