The fifth anniversary of clinical use of new oral anticoagulants in non-valvular atrial fibrillation

The possibilities of antithrombotic therapy for prevention of thromboembolic events in non-valvular atrial fibrillation (AF) have been significantly expanded after the development and introduction of new oral anticoagulants (NOACs) into clinical practice. Starting the clinical use of NOACs has opened a new page in oral anticoagulant therapy aimed at preventing thromboembolic events in AF. Dabigatran etexilate is the first NOAC that was registered in 2010. After completion of the RE-LY trial, the positive safety and efficacy profile of dabigatran has been confirmed in real practice of over 5 years of clinical use in more than 200,000 patients from nearly 100 countries. An observational cohort study of oral anticoagulants used in more than 134,000 patients was one of the largest independent studies of the Food and Drug Administration (FDA) in the Medicare system. In the dabigatran group, the risk of ischemic stroke, intracranial and intracerebral hemorrhage, and death was statistically significantly lower than in the warfarin group. The incidence of major and all hemorrhages requiring hospitalization, as well as myocardial infarction was comparable. Profuse gastrointestinal bleeding was more common with dabigatran. This study in the Medicare system has demonstrated a favorable benefit/risk ratio for this drug and this requires no additional changes in the current instructions and recommendations for its use.