title: Safety and efficacy of nonvitamin K antagonist oral anticoagulants versus warfarin in diabetic patients with atrial fibrillation: A study-level meta-analysis of phase III randomized trials.
abstract: In patients with atrial fibrillation (AF), the safety and efficacy of nonvitamin K antagonist oral anticoagulants (NOACs) vs warfarin according to diabetes mellitus (DM) status are not completely characterized. We performed a meta-analysis to clarify whether in these patients the strategy of oral anticoagulation should be tailored to diabetes status. In this study-level meta-analysis, we included 4 randomized phase III trials comparing NOACs and warfarin in patients with nonvalvular AF; a total of 18 134 patients with DM and 40 454 without DM were overall considered. Incidence of the following outcome measures was evaluated during the follow-up: stroke or systemic embolism, ischemic stroke, major bleeding, intracranial bleeding, and vascular death. Use of NOACs compared with warfarin reduced stroke/systemic embolism in diabetic (Risk Ratios [RR] 0.80, 95% CI 0.68-0.93; P = .004) and nondiabetic patients (RR 0.83, 0.73-0.93; P = .001) (P for interaction .72). No interaction between diabetes status and benefits of NOACs was found for the occurrence of ischemic stroke, major bleeding, or intracranial bleeding (P for interaction >.05 for each comparison). Reduction of vascular death rates with NOACs was significant in diabetic patients (4.97% vs 5.99% with warfarin; RR 0.83, 0.72-0.96; P = .01), in whom absolute the reduction of this outcome measure was higher than in nondiabetics (1.02% vs 0.27%), although no interaction was present (P = .23). Results of this meta-analysis support the safety and efficacy of NOACs compared with warfarin in diabetic patients with nonvalvular AF.
authors.affiliation: Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Patti
authors.affiliation: Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Gioia
authors.affiliation: Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Cavallari
authors.affiliation: Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Nenna
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D017326:Clinical Trials, Phase III as Topic; D048909:Diabetes Complications / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D003920:Diabetes Mellitus / Q000503:physiopathology*; D006801:Humans; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D012449:Safety; D020521:Stroke / Q000517:prevention & control*; D014812:Vitamin K / Q000037:antagonists & inhibitors*; D014859:Warfarin / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D014812:Vitamin K; D014859:Warfarin
keywords: adult diabetes; anticoagulation; atrial fibrillation; bleeding; stroke