Atrial fibrillation weight loss
Methods Study Oversight The trial was designed and led by a steering committee that included academic investigators and representatives of the sponsors (Bristol-Myers Squibb and Pfizer). D. , M. Methods Study Oversight The trial was designed and led by an executive committee, in coordination with an international steering committee (see the Supplementary Appendix, available with the full text of this article at NEJM. D. An independent data and safety monitoring committee performed multiple safety reviews. All the authors participated in the design of the trial and the planning of the analyses. , Christian T. Approval by the appropriate ethics committees was obtained at all sites. H. Methods In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2. The primary efficacy end point was stroke or systemic embolism. 8 years). Halperin, M. Original Article Edoxaban versus Warfarin in Patients with Atrial Fibrillation Robert P. The trial protocol and statistical analysis plan are available with the full text of this article at NEJM. 0 to 3. , Albert L. D. Table 1 Demographic and Clinical Characteristics of the Patients. The first author wrote the first draft of the manuscript, and all the authors participated in subsequent drafts and made the decision to submit the manuscript for publication. D. 0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. P. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. , Stephen D. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism.
Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. Wiviott, M. org). The protocol and amendments were approved by the ethics committee at each participating center. The principal safety end point was major bleeding. Quintiles, a contract research organization, managed the database and monitored the study sites. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. D. The Thrombolysis in Myocardial Infarction Study Group coordinated the trial and performed all the analyses independently using raw data. D. Methods We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2. , Jonathan L. The primary analyses were performed both at Bristol-Myers Squibb and at the Duke Clinical Research Institute. P. All the authors participated in the design of the trial and in the analysis of the data. , Sabina A. Article Activity 2153 articles have cited this article Article Patients with atrial fibrillation are at increased risk for stroke. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. All the authors vouch for the accuracy and completeness of the data and the fidelity of the study to the protocol, which is available at NEJM. Figure 2 Relative Risks of the Primary Efficacy and Safety Outcomes, According to Major Prespecified Subgroups. Abstract Background Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. , Michael D. Abstract Background Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. , Eugene Braunwald, M. Murphy, M. Waldo, M. H. Giugliano, M. Ruff, M. The first author wrote the first draft of the manuscript, and all the authors participated in subsequent revisions (with no writing assistance other than copy editing) and approved the final version of the manuscript.
