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      Clinical Guidelines for Drug-Related Peptic Ulcer, 2020 Revised Edition

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          Abstract

          Korean guidelines for nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcer were previously developed in 2009 with the collaboration of the Korean College of Helicobacter and Upper Gastrointestinal Research and Korean Society of Gastroenterology. However, the previous guidelines were based mainly upon a review of the relevant literature and expert opinion. Therefore, the guidelines need to be revised. We organized a guideline Development Committee for drug-related peptic ulcer under the auspices of the Korean College of Helicobacter and Upper Gastrointestinal Research in 2017 and developed nine statements, including four for NSAIDs, three for aspirin and other antiplatelet agents, and two for anticoagulants through a de novo process founded on evidence-based medicine that included a literature search and a meta-analysis, A consensus was reached through the application of the modified Delphi method. The primary target of these guidelines is adult patients undergoing long-term treatment with NSAIDs, aspirin or other antiplatelet agents and anticoagulants. The revised guidelines reflect the expert consensus and is intended to assist clinicians in the management and prevention of drug-induced peptic ulcer and associated conditions.

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          Apixaban versus Warfarin in Patients with Atrial Fibrillation

          Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. 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. In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. 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. The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42). In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).
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            Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report.

            Important progress has been made in the management of Helicobacter pylori infection and in this fifth edition of the Maastricht Consensus Report, key aspects related to the clinical role of H. pylori were re-evaluated in 2015. In the Maastricht V/Florence Consensus Conference, 43 experts from 24 countries examined new data related to H. pylori in five subdivided workshops: (1) Indications/Associations, (2) Diagnosis, (3) Treatment, (4) Prevention/Public Health, (5) H. pylori and the Gastric Microbiota. The results of the individual workshops were presented to a final consensus voting that included all participants. Recommendations are provided on the basis of the best available evidence and relevance to the management of H. pylori infection in the various clinical scenarios.
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              Testing a tool for assessing the risk of bias for nonrandomized studies showed moderate reliability and promising validity.

              To develop and validate a new risk-of-bias tool for nonrandomized studies (NRSs). We developed the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS). A validation process with 39 NRSs examined the reliability (interrater agreement), validity (the degree of correlation between the overall assessments of RoBANS and Methodological Index for Nonrandomized Studies [MINORS], obtained by plotting the overall risk of bias relative to effect size and funding source), face validity with eight experts, and completion time for the RoBANS approach. RoBANS contains six domains: the selection of participants, confounding variables, the measurement of exposure, the blinding of the outcome assessments, incomplete outcome data, and selective outcome reporting. The interrater agreement of the RoBANS tool except the measurement of exposure and selective outcome reporting domains ranged from fair to substantial. There was a moderate correlation between the overall risks of bias determined using RoBANS and MINORS. The observed differences in effect sizes and funding sources among the assessed studies were not correlated with the overall risk of bias in these studies. The mean time required to complete RoBANS was approximately 10 min. The external experts who were interviewed evaluated RoBANS as a "fair" assessment tool. RoBANS shows moderate reliability, promising feasibility, and validity. The further refinement of this tool and larger validation studies are required. Copyright © 2013 Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                Gut Liver
                Gut Liver
                Gut and Liver
                Editorial Office of Gut and Liver
                1976-2283
                2005-1212
                15 November 2020
                15 November 2020
                : 14
                : 6
                : 707-726
                Affiliations
                [1 ]Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
                [2 ]Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea
                [3 ]Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
                [4 ]Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
                [5 ]Department of Gastroenterology, Asan Medical Center, Asan Digestive Disease Research Institute, University of Ulsan College of Medicine, Seoul, Korea
                [6 ]Departments of Internal Medicine, Pusan National University School of Medicine, Busan, Korea
                [7 ]Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
                [8 ]Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
                [9 ]Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
                [10 ]Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
                [11 ]Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
                Author notes
                Correspondence to: Yong Chan Lee, Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea, Tel: +82-2-2228-1960, Fax: +82-2-393-6884, E-mail: leeyc@ 123456yuhs.ac
                Author information
                https://orcid.org/0000-0001-6050-3695
                https://orcid.org/0000-0003-3824-3481
                https://orcid.org/0000-0001-9158-1012
                https://orcid.org/0000-0002-1534-7467
                https://orcid.org/0000-0002-0030-3744
                https://orcid.org/0000-0003-2734-2134
                https://orcid.org/0000-0002-0778-7585
                https://orcid.org/0000-0002-0265-672X
                https://orcid.org/0000-0002-7297-6577
                https://orcid.org/0000-0003-4908-5431
                https://orcid.org/0000-0002-0938-6697
                https://orcid.org/0000-0002-6653-5214
                https://orcid.org/0000-0002-2290-4954
                https://orcid.org/0000-0001-8800-6906
                Article
                GNL-14-707
                10.5009/gnl20246
                7667931
                33191311
                8b586a49-4122-4007-b41e-012026d97a41
                Copyright © 2020 by The Korean Society of Gastroenterology, the Korean Society of Gastrointestinal Endoscopy, the Korean Society of Neurogastroenterology and Motility, Korean College of Helicobacter and Upper Gastrointestinal Research, Korean Association the Study of Intestinal Diseases, the Korean Association for the Study of the Liver, Korean Pancreatobiliary Association, and Korean Society of Gastrointestinal Cancer.

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 3 August 2020
                : 31 August 2020
                : 4 September 2020
                Categories
                Review

                Gastroenterology & Hepatology
                peptic ulcer,non-steroidal anti-inflammatory agents,antiplatelet agent,anticoagulants,guideline

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