Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation

Background: There is little evidence of the efficacy and safety of dabigatran in Japanese patients with non-valvular atrial fibrillation (NVAF). Methods and Results: We evaluated 300 consecutive patients with NVAF (68711 years old, 209 men, 180 paroxysmal) who received 220 mg/day (203 patients) or 300 mg/day dabigatran (97 patients) at our hospital. Most patients (84%) had lower CHADS₂ (congestive heart failure, hypertension, age > 75 years, diabetes, stroke/transient ischemic attack) scores of 0 (n=60), 1 (n=114), or 2 (n=78) and lower HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition) scores of 0 (n=39), 1 (n=114), or 2 (n=103). The estimated creatinine clearance was 77±24 mL/min, which was inversely correlated to age (r²±0.48, p<0.0001). Activated partial thromboplastin time was 42±9 s but was not dependent on sampling time. During follow-up of 263±160 days, an ischemic stroke occurred in 1 patient (0.3%), but no systemic embolism was observed. Some adverse events were reported for 70 (23%) patients, such as dyspepsia (n=42, 14%) or minor bleeding complications (n=11, 4%) resulting in discontinuation of dabigatran for 39 patients. However, no major complications were observed, and no patient died from adverse events or because of cardiovascular or stroke events. Conclusions: Dabigatran is safe and useful for the prevention of ischemic strokes in Japanese NVAF patients, but additional care should be taken for elderly patients.