{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,5,9]],"date-time":"2024-05-09T00:14:14Z","timestamp":1715213654170},"reference-count":34,"publisher":"The Society for Free Radical Research Japan","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Clin. Biochem. Nutr."],"published-print":{"date-parts":[[2021]]},"DOI":"10.3164\/jcbn.21-9","type":"journal-article","created":{"date-parts":[[2021,6,22]],"date-time":"2021-06-22T22:07:04Z","timestamp":1624399624000},"page":"311-316","source":"Crossref","is-referenced-by-count":2,"title":["High incidence of major bleeding with off-label use of edoxaban"],"prefix":"10.3164","volume":"69","author":[{"given":"Rika","family":"Fukui","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Shiga University of Medical Science Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daiki","family":"Hira","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shiga University of Medical Science Hospital"},{"name":"College of Pharmaceutical Sciences, Ritsumeikan University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuki","family":"Kunitsu","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shiga University of Medical Science Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuichiro","family":"Isono","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shiga University of Medical Science Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yohei","family":"Tabuchi","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shiga University of Medical Science Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshihiro","family":"Ikuno","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shiga University of Medical Science Hospital"},{"name":"Medical Safety Section, Shiga University of Medical Science Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Ueshima","sequence":"additional","affiliation":[{"name":"College of Pharmaceutical Sciences, Ritsumeikan University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideki","family":"Itoh","sequence":"additional","affiliation":[{"name":"Division of Patient Safety, Hiroshima University Hospital"},{"name":"Department of Cardiovascular Medicine, Shiga University of Medical Science Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshihiro","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Medical Safety Section, Shiga University of Medical Science Hospital"},{"name":"Department of Dermatology, Shiga University of Medical Science Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomohiro","family":"Terada","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Shiga University of Medical Science Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1739","reference":[{"key":"1","doi-asserted-by":"crossref","unstructured":"1 Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med 1999; 131: 492\u2013501.","DOI":"10.7326\/0003-4819-131-7-199910050-00003"},{"key":"2","doi-asserted-by":"crossref","unstructured":"2 Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008; 133 (6 Suppl): 160S\u2013198S.","DOI":"10.1378\/chest.08-0670"},{"key":"3","doi-asserted-by":"crossref","unstructured":"3 Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883\u2013891.","DOI":"10.1056\/NEJMoa1009638"},{"key":"4","doi-asserted-by":"crossref","unstructured":"4 Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139\u20131151.","DOI":"10.1056\/NEJMoa0905561"},{"key":"5","doi-asserted-by":"crossref","unstructured":"5 Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981\u2013992.","DOI":"10.1056\/NEJMoa1107039"},{"key":"6","doi-asserted-by":"crossref","unstructured":"6 Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369: 2093\u20132104.","DOI":"10.1056\/NEJMoa1310907"},{"key":"7","doi-asserted-by":"crossref","unstructured":"7 Fleddermann AM, Hayes CH, Magalski A, Main ML. Efficacy of direct acting oral anticoagulants in treatment of left ventricular thrombus. Am J Cardiol 2019; 124: 367\u2013372.","DOI":"10.1016\/j.amjcard.2019.05.009"},{"key":"8","doi-asserted-by":"crossref","unstructured":"8 Suzuki R, Nakamura Y, Miyazaki K, Ishii M, Shimokawa T, Okamoto H. A case report of a multi-cerebral infarction associated with trousseau syndrome before the diagnosis of ALK-positive lung adenocarcinoma. Japanese J Lung Cancer 2019; 59: 384\u2013389.","DOI":"10.2482\/haigan.59.384"},{"key":"9","doi-asserted-by":"crossref","unstructured":"9 Nagaoki Y, Aikata H, Daijyo K, et al. Efficacy and safety of edoxaban for treatment of portal vein thrombosis following danaparoid sodium in patients with liver cirrhosis. Hepatol Res 2018; 48: 51\u201358.","DOI":"10.1111\/hepr.12895"},{"key":"10","doi-asserted-by":"crossref","unstructured":"10 Hanafy AS, Abd-Elsalam S, Dawoud MM. Randomized controlled trial of rivaroxaban versus warfarin in the management of acute non-neoplastic portal vein thrombosis. Vascul Pharmacol 2019; 113: 86\u201391.","DOI":"10.1016\/j.vph.2018.05.002"},{"key":"11","doi-asserted-by":"crossref","unstructured":"11 Intagliata NM, Henry ZH, Maitland H, et al. Direct oral anticoagulants in cirrhosis patients pose similar risks of bleeding when compared to traditional anticoagulation. Dig Dis Sci 2016; 61: 1721\u20131727.","DOI":"10.1007\/s10620-015-4012-2"},{"key":"12","doi-asserted-by":"crossref","unstructured":"12 Yamashita Y, Uozumi R, Hamatani Y, et al. Current status and outcomes of direct oral anticoagulant use in real-world atrial fibrillation patients\u2014Fushimi AF Registry\u2014. Circ J 2017; 81: 1278\u20131285.","DOI":"10.1253\/circj.CJ-16-1337"},{"key":"13","doi-asserted-by":"crossref","unstructured":"13 Timp JF, Braekkan SK, Versteeg HH, Cannegieter SC. Epidemiology of cancer-associated venous thrombosis. Blood 2013; 122: 1712\u20131723.","DOI":"10.1182\/blood-2013-04-460121"},{"key":"14","doi-asserted-by":"crossref","unstructured":"14 Khorana AA. Venous thromboembolism and prognosis in cancer. Thromb Res 2010; 125: 490\u2013493.","DOI":"10.1016\/j.thromres.2009.12.023"},{"key":"15","doi-asserted-by":"crossref","unstructured":"15 Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest 2016; 149: 315\u2013352.","DOI":"10.1016\/j.chest.2015.11.026"},{"key":"16","doi-asserted-by":"crossref","unstructured":"16 Key NS, Khorana AA, Kuderer NM, et al. Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical practice guideline update. J Clin Oncol 2020; 38: 496\u2013520.","DOI":"10.1200\/JCO.19.01461"},{"key":"17","unstructured":"17 Streiff MB, Holmstrom B, Bockenstedt PL, et al. Cancer-associated venous thromboembolic disease: NCCN clinical practice guidelines in oncology (NCCN guidelines) version 1.2020. The National Comprehensive Cancer Network. https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/vte.pdf. Accessed 9 Jan 2021."},{"key":"18","doi-asserted-by":"crossref","unstructured":"18 Raskob GE, van Es N, Verhamme P, et al. Edoxaban for the treatment of cancer-associated venous thromboembolism. N Engl J Med 2018; 378: 615\u2013624.","DOI":"10.1056\/NEJMoa1711948"},{"key":"19","doi-asserted-by":"crossref","unstructured":"19 Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692\u2013694.","DOI":"10.1111\/j.1538-7836.2005.01204.x"},{"key":"20","doi-asserted-by":"crossref","unstructured":"20 Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010; 138: 1093\u20131100.","DOI":"10.1378\/chest.10-0134"},{"key":"21","doi-asserted-by":"crossref","unstructured":"21 Lip GY, Frison L, Halperin JL, Lane DA. Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (hypertension, abnormal renal\/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drug. J Am Coll Cardiol 2011; 57: 173\u2013180.","DOI":"10.1016\/j.jacc.2010.09.024"},{"key":"22","doi-asserted-by":"crossref","unstructured":"22 Aisenberg J, Chatterjee-Murphy P, Friedman Flack K, et al. Gastrointestinal bleeding with edoxaban versus warfarin: results from the ENGAGE AF-TIMI 48 trial (effective anticoagulation with factor Xa next generation in atrial fibrillation-thrombolysis in myocardial infarction). Circ Cardiovasc Qual Outcomes 2018; 11: e003998.","DOI":"10.1161\/CIRCOUTCOMES.117.003998"},{"key":"23","doi-asserted-by":"crossref","unstructured":"23 Saiyed MM, Ong PS, Chew L. Off-label drug use in oncology: a systematic review of literature. J Clin Pharm Ther 2017; 42: 251\u2013258.","DOI":"10.1111\/jcpt.12507"},{"key":"24","unstructured":"24 Tan E, Stewart K, Pearce C, Chapman CB, Liaw ST. Understanding off-label and unlicensed prescribing: combining qualitative and quantitative methodologies. Clin Exp Pharmacol Physiol 2004; 31 (Suppl): A84."},{"key":"25","doi-asserted-by":"crossref","unstructured":"25 Eguale T, Buckeridge DL, Verma A, et al. Association of off-label drug use and adverse drug events in an adult population. JAMA Intern Med 2016; 176: 55\u201363.","DOI":"10.1001\/jamainternmed.2015.6058"},{"key":"26","doi-asserted-by":"crossref","unstructured":"26 Priyanka P, Kupec JT, Krafft M, Shah NA, Reynolds GJ. Newer oral anti\u00adcoagulants in the treatment of acute portal vein thrombosis in patients with and without cirrhosis. Int J Hepatol 2018; 2018: 8432781.","DOI":"10.1155\/2018\/8432781"},{"key":"27","unstructured":"27 The relief system for sufferers from adverse drug reactions, etc. Ministry of Health Labour and Welfare. https:\/\/www.mhlw.go.jp\/english\/wp\/wp-hw4\/dl\/health_and_medical_services\/P95.pdf. Accessed 2 Aug 2020."},{"key":"28","doi-asserted-by":"crossref","unstructured":"28 Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med 2010; 362: 823\u2013832.","DOI":"10.1056\/NEJMra0901512"},{"key":"29","doi-asserted-by":"crossref","unstructured":"29 Bathala MS, Masumoto H, Oguma T, He L, Lowrie C, Mendell J. Pharmacokinetics, biotransformation, and mass balance of edoxaban, a selective, direct factor xa inhibitor, in humans. Drug Metab Dispos 2012; 40: 2250\u20132255.","DOI":"10.1124\/dmd.112.046888"},{"key":"30","doi-asserted-by":"crossref","unstructured":"30 Qamar A, Antman EM, Ruff CT, et al. Edoxaban versus warfarin in patients with atrial fibrillation and history of liver disease. J Am Coll Cardiol 2019; 74: 179\u2013189.","DOI":"10.1016\/j.jacc.2019.04.061"},{"key":"31","doi-asserted-by":"crossref","unstructured":"31 Krekels EH, Niebecker R, Karlsson MO, et al. Population pharmacokinetics of edoxaban in patients with non-valvular atrial fibrillation in the ENGAGE AF-TIMI 48 study, a phase III clinical trial. Clin Pharmacokinet 2016; 55: 1079\u20131090.","DOI":"10.1007\/s40262-016-0378-3"},{"key":"32","doi-asserted-by":"crossref","unstructured":"32 Hira D, Terada T. BCRP\/ABCG2 and high-alert medications: biochemical, pharmacokinetic, pharmacogenetic, and clinical implications. Biochem Pharmacol 2018; 147: 201\u2013210.","DOI":"10.1016\/j.bcp.2017.10.004"},{"key":"33","doi-asserted-by":"crossref","unstructured":"33 Lentz SR. Genetic testing to guide warfarin dosing: impact of direct oral anticoagulants. Clin Pharmacol Ther 2016; 100: 128\u2013130.","DOI":"10.1002\/cpt.395"},{"key":"34","doi-asserted-by":"crossref","unstructured":"34 Par\u00e9 G, Eriksson N, Lehr T, et al. Genetic determinants of dabigatran plasma levels and their relation to bleeding. Circulation 2013; 127: 1404\u20131412.","DOI":"10.1161\/CIRCULATIONAHA.112.001233"}],"container-title":["Journal of Clinical Biochemistry and Nutrition"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/jcbn\/69\/3\/69_21-9\/_pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T04:39:31Z","timestamp":1715143171000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/jcbn\/69\/3\/69_21-9\/_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021]]},"references-count":34,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.3164\/jcbn.21-9","relation":{},"ISSN":["0912-0009","1880-5086"],"issn-type":[{"value":"0912-0009","type":"print"},{"value":"1880-5086","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021]]},"article-number":"21-9"}}