title: Direct oral anticoagulants in atrial fibrillation: can data from randomized clinical trials be safely transferred to the general population? Yes.
abstract: Atrial fibrillation is the most common arrhythmia and is associated with significant morbidity and mortality. The current therapeutic options for patients at high thromboembolic risk include the vitamin K antagonists and the direct oral anticoagulants. These novel agents have been evaluated in more than 40,000 patients enrolled in four large randomized controlled trials for stroke prevention in non-valvular atrial fibrillation. When these results were pooled together, a greater efficacy profile, as well as a consistent reduction in life-threatening bleeding was shown in comparison to vitamin K antagonists. Randomized controlled trials offer the highest level of evidence on the efficacy and safety of an intervention; however, their results may not be directly applicable to the general population. The results of a number of post-marketing observational studies from the United States and Europe have been published. The results of these studies substantially confirm the findings of the randomized trials and show a favorable safety profile with the use of the direct oral anticoagulants even in unselected populations.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Insubria, Via Guicciardini 9, 21100, Varese, Italy.
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Riva
authors.forename: Walter
authors.initials: W
authors.lastname: Ageno
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000453:epidemiology / Q000401:mortality*; D000069604:Dabigatran / Q000009:adverse effects / Q000627:therapeutic use; D004617:Embolism / Q000517:prevention & control*; D005060:Europe / Q000453:epidemiology; D005260:Female; D006470:Hemorrhage; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000517:prevention & control; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D000069604:Dabigatran