Ptomatic recurrent VTE. Results: Fourteen publications were included in the analysis. > 자유게시판

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Ptomatic recurrent VTE. Results: Fourteen publications were included in the analysis. Recurrent VTE occurred in 25 (1.5 ) out of 1715 patients who received current standard of care and in 157 (9.2 ) out of 1711 patients who received placebo, PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/14960617 `no treatment' or `less intensive treatment', for an odds ratio of 0.18 (95 confidence interval, 0.14-0.25; test for heterogeneity, p=0.87). In order to preserve 50 or 75 of the established treatment effect using a linear scale, the corresponding thresholds for non-inferiority equalled 2.50 and 1.75, respectively. Conclusions: This systematic review and statistical approach determined non-inferiority margins suitable for use in studies of direct oral anticoagulants for the treatment of DVT and/or PE. Keywords: Non-inferiority margin, Oral anticoagulants, Venous thromboembolismBackground Adjusted-dose unfractionated heparin or bodyweightadjusted low molecular weight heparin overlapping with and followed by laboratory-titrated vitamin K antagonists (VKAs) is widely accepted as the standard treatment for patients presenting with acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) [1]. Although highly efficacious and relatively safe, this treatment regimen is associated with a considerable number of disadvantages, including the need for parenteral administration of heparin and frequent laboratory monitoring of the* Correspondence: mh.prins@maastrichtuniversity.nl 1 Maastricht University Medical Center, Maastricht, The Netherlands Full list of author information is available at the end of the articlepharmacodynamic effects of VKAs with subsequent dose adjustments. Recently, small molecules have been developed that directly inhibit a single component of the coagulation cascade (such as Factor Xa PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/10572343 or thrombin), can be taken orally and have a predictable pharmacokinetic/pharmacodynamic profile [2-4]. Although this eliminates the need for parenteral administration and routine coagulation monitoring, it is essential that these new compounds are demonstrated to be clinically as efficacious as the current standard treatment. Demonstration of similar efficacy requires randomised trials involving patients Fmoc-Oic-OH with symptomatic DVT and/or PE that compare the incidences of recurrent venous thromboembolism (VTE) between the new compounds and the current standard treatment.?2013 Prins and Lensing; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Prins and Lensing Thrombosis Journal 2013, 11:13 http://www.thrombosisjournal.com/content/11/1/Page 2 ofTo exclude a clinically relevant excess of recurrent VTE, the direct oral anticoagulants need to satisfy a noninferiority margin that is based on the documented efficacy of current standard treatments [5,6]. In this paper, we systematically reviewed all studies that have evaluated the efficacy of the current standard treatment for DVT and/or PE and calculated accompanying non-inferiority margins from the meta-analysis.Statistical analysisMethodsLiterature searchA PubMed search was undertaken for articles reporting the results of controlled randomised trials between the dates of 1959 and 2013 to identify studies that compared the 4-Bromopicolinaldehyde currently recommended anticoagulant treatment approach with placebo, `no treatment' or a `.