title: [Comparability of efficacy and safety results among phase III trials of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation].
abstract: In this paper we demonstrate that among four phase III trials comparing warfarin and non-vitamin K antagonist oral anticoagulants (NOACs) vs warfarin in patients with non-valvular atrial fibrillation there was heterogeneity in the thromboembolic and bleeding risk of the included populations, variability in the definitions of primary endpoints, especially for safety, and different criteria for reducing NOAC dosage according to renal function. Therefore, findings from these four studies are not directly comparable and it is incorrect to conduct comparative evaluations between various NOACs. In each patient the antithrombotic strategy should be tailored taking into account NOAC characteristics, the individual thromboembolic and bleeding risk, presence of comorbidities, mental status and socio-economic conditions.
authors.affiliation: Dipartimento di Scienze Cardiovascolari, Università Campus Bio-Medico, Roma.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Patti
authors.affiliation: U.O. Cardiologia Ospedaliera, Azienda Ospedaliero-Universitaria Consorziale Policlinico, Bari.
authors.forename: Paolo
authors.initials: P
authors.lastname: Colonna
authors.affiliation: Dipartimento "Attilio Reale", Sapienza Università di Roma, Roma.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pelliccia
authors.affiliation: Dipartimento di Scienze Cardiache, Toraciche e Vascolari - Centro Trombosi, Università degli Studi, Padova.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Pengo
authors.affiliation: Dipartimento di Scienze Biomediche Avanzate, Università degli Studi "Federico II", Napoli.
authors.forename: Pasquale Perrone
authors.initials: PP
authors.lastname: Filardi
authors.affiliation: S.C. Medicina, Ospedale di Assisi, Assisi (PG).
authors.forename: Paolo
authors.initials: P
authors.lastname: Verdecchia
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000150:complications; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D014859:Warfarin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000925:Anticoagulants; D014859:Warfarin