{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T03:38:35Z","timestamp":1791517115996,"version":"4.3.4"},"reference-count":0,"publisher":"Georg Thieme Verlag KG","issue":"02","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Semin Thromb Hemost"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The aim of this study was to evaluate the adverse drug reaction (ADR) incidence rate and new signals thereof for classic compared with new anticoagulants in real-life ambulatory settings. The authors performed an observational cross-sectional study in two cohorts of surveyed patients treated with vitamin K antagonists (VKAs; acenocoumarol or warfarin) or nonvitamin K antagonist oral anticoagulants (NOACs; apixaban, edoxaban, rivaroxaban, dabigatran etexilate). Descriptive, clinical, and ADRs data were reported and analyzed through a bivariate analysis (odds ratio [OR]) to compare the ADRs incidence rate and an adaptation of Bayesian methodology (false discovery rate [FDR]\u2009&lt;\u20090.05) to detect new signals. A total of 334 patients were surveyed\u2014average international normalized ratio (INR) of 2.6\u2014and 45.4% taking new anticoagulants. Note that 835 ADRs were reported; 2.5 per patient (2.8 in the VKA cohort, 2.1 in the NOAC cohort). The authors obtained higher risk of epistaxis (OR, 2.18; 95% confidence interval [CI], 1.01\u20134.74) and hematoma (OR, 2.43; 95% CI, 1.39\u20134.25) with VKAs and lower risk of global bleeding symptoms with NOACs (OR, 0.45; 95% CI, 0.28\u20130.71). After standardizing the data, a significant risk of diarrhea with VKAs was observed (OR, 3.37; 95% CI, 1.09\u201310.41). They also detected an intense positive signal regarding the use of VKAs and osteoporosis (FDR\u2009&lt;\u20090.001), specifically acenocoumarol (FDR\u2009&lt;\u20090.002). NOACs presented lower risk of bleeding, especially dabigatran (FDR\u2009&lt;\u20090.031), and of dermatological pathologies with apixaban being the safest (FDR\u2009=\u20090.050). The lower risk of global bleeding and a potential protective effect against osteoporosis in patients treated with NOACs postulate them as safer than VKAs.<\/jats:p>","DOI":"10.1055\/s-0038-1657783","type":"journal-article","created":{"date-parts":[[2018,6,4]],"date-time":"2018-06-04T18:53:01Z","timestamp":1528138381000},"page":"196-204","source":"Crossref","is-referenced-by-count":15,"title":["New Anticoagulant Agents: Incidence of Adverse Drug Reactions and New Signals Thereof"],"prefix":"10.1055","volume":"45","author":[{"given":"Mar\u00eda-Isabel","family":"Jim\u00e9nez-Serran\u00eda","sequence":"first","affiliation":[{"name":"Consejo de Colegios Profesionales de Farmac\u00e9uticos de Castilla y Le\u00f3n, Castilla y Le\u00f3n, Spain"},{"name":"Departamento de Ciencias de la Salud, Facultad de Ciencias de la Salud, Universidad Europea Miguel de Cervantes (UEMC), Valladolid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raquel","family":"Mart\u00ednez-Garc\u00eda","sequence":"first","affiliation":[{"name":"Consejo de Colegios Profesionales de Farmac\u00e9uticos de Castilla y Le\u00f3n, Castilla y Le\u00f3n, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco","family":"Corzo-Delibes","sequence":"first","affiliation":[{"name":"Consejer\u00eda de Sanidad de la Junta de Castilla y Le\u00f3n, Direcci\u00f3n General de Salud P\u00fablica (DGSP), Valladolid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Mart\u00edn Arias","sequence":"first","affiliation":[{"name":"Centro Regional de Farmacovigilancia de Castilla y Le\u00f3n, Centro de Estudios sobre la Seguridad de los Medicamentos (CESME), Facultad de Medicina, Universidad de Valladolid, Valladolid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Trece\u00f1o-Lobato","sequence":"additional","affiliation":[{"name":"Consejo de Colegios Profesionales de Farmac\u00e9uticos de Castilla y Le\u00f3n, Castilla y Le\u00f3n, Spain"},{"name":"Departamento de Ciencias de la Salud, Facultad de Ciencias de la Salud, Universidad Europea Miguel de Cervantes (UEMC), Valladolid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2018,6,4]]},"container-title":["Seminars in Thrombosis and Hemostasis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/s-0038-1657783.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,3,1]],"date-time":"2019-03-01T19:00:50Z","timestamp":1551466850000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/s-0038-1657783"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,6,4]]},"references-count":0,"journal-issue":{"issue":"02","published-online":{"date-parts":[[2019,3,1]]},"published-print":{"date-parts":[[2019,3]]}},"URL":"https:\/\/doi.org\/10.1055\/s-0038-1657783","relation":{},"ISSN":["0094-6176","1098-9064"],"issn-type":[{"value":"0094-6176","type":"print"},{"value":"1098-9064","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,6,4]]}}}