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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
Author(s) -
Patti Giuseppe,
Di Gioia Giuseppe,
Cavallari Ilaria,
Nenna Antonio
Publication year - 2017
Publication title -
diabetes/metabolism research and reviews
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.307
H-Index - 110
eISSN - 1520-7560
pISSN - 1520-7552
DOI - 10.1002/dmrr.2876
Subject(s) - medicine , warfarin , atrial fibrillation , diabetes mellitus , stroke (engine) , embolism , randomized controlled trial , cardiology , endocrinology , mechanical engineering , engineering
Summary 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.