Dabigatran: Experience in standard clinical practice.

Abstract Introduction and objectives Dabigatran is an anticoagulant drug and a direct thrombin inhibitor and has been approved for the prevention of ischemic stroke secondary to nonvalvularauricular auricular fibrillation. The aim of this study was to determine the efficacy of dabigatran in clinical practice for preventing cerebral ischemic events associated with nonvalvularauricular auricular fibrillation, as well as its tolerance and safety profile. Material and methods A descriptive and retrospective study was conducted, which included all patients who started anticoagulant treatment with dabigatran between November 2011 and September 2012. Follow-up was performed from the start of treatment until June 2013. The incidence of ischemic events of cerebral, cardiac and peripheral origin was recorded, as was the onset of adverse effects and hemorrhagic complications, whose location and severity were determined. Results We analyzed 316 patients, with a mean age of 76.46 ± 8.37 years, of whom 53.5% were men. Two patients (0.55/100 patient-years) presented ischemic stroke (including one amaurosis fugax). Eight (2.18/100 patient-years) patients had an adverse ischemic event, whose origin was cardiac in 5 (1.36/100 patient-years) cases and peripheral in 3 (0.81/100 patient-years). Forty (10.91/100 patient-years) patients had a hemorrhagic complication: 32 minor (8.73/100 patient-years) and 8 major (2.18/100 patient-years) hemorrhages. Conclusions Dabigatran is effective in standard clinical practice in preventing stroke and has a safety profile similar to that reported in the clinical trials.