{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T16:12:43Z","timestamp":1764000763913,"version":"build-2065373602"},"reference-count":41,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2021,10,18]],"date-time":"2021-10-18T00:00:00Z","timestamp":1634515200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000780","name":"European Union","doi-asserted-by":"publisher","award":["668353"],"award-info":[{"award-number":["668353"]}],"id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002347","name":"Federal Ministry of Education and Research","doi-asserted-by":"publisher","award":["01GY1333A"],"award-info":[{"award-number":["01GY1333A"]}],"id":[{"id":"10.13039\/501100002347","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>The aim of this study was to compare effects of an individualized with a standardized risk assessment for adverse drug reactions to improve drug treatment with antithrombotic drugs in older adults. A randomized controlled trial was conducted in general practitioner (GP) offices. Patients aged 60 years and older, multi-morbid, taking antithrombotic drugs and at least one additional drug continuously were randomized to individualized and standardized risk assessment groups. Patients were followed up for nine months. A composite endpoint defined as at least one bleeding, thromboembolic event or death reported via a trigger list was used. Odds ratios (OR) and 95% confidence intervals (CI) were calculated. In total, N = 340 patients were enrolled from 43 GP offices. Patients in the individualized risk assessment group met the composite endpoint more often than in the standardized group (OR 1.63 [95%CI 1.02\u20132.63]) with multiple adjustments. The OR was higher in patients on phenprocoumon treatment (OR 1.99 [95%CI 1.05\u20133.76]), and not significant on DOAC treatment (OR 1.52 [95%CI 0.63\u20133.69]). Pharmacogenenetic variants of CYP2C9, 2C19 and VKORC1 were not observed to be associated with the composite endpoint. The results of this study may indicate that the time point for implementing individualized risk assessments is of importance.<\/jats:p>","DOI":"10.3390\/ph14101056","type":"journal-article","created":{"date-parts":[[2021,10,20]],"date-time":"2021-10-20T03:01:13Z","timestamp":1634698873000},"page":"1056","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Individualized versus Standardized Risk Assessment in Patients at High Risk for Adverse Drug Reactions (The IDrug Randomized Controlled Trial)\u2013Never Change a Running System?"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6782-8078","authenticated-orcid":false,"given":"Katja S.","family":"Just","sequence":"first","affiliation":[{"name":"Institute of Clinical Pharmacology, University Hospital RWTH Aachen, 52074 Aachen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1463-5619","authenticated-orcid":false,"given":"Catharina","family":"Scholl","sequence":"additional","affiliation":[{"name":"Research Department, Federal Institute for Drugs and Medical Devices, 53175 Bonn, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam","family":"Boehme","sequence":"additional","affiliation":[{"name":"Research Department, Federal Institute for Drugs and Medical Devices, 53175 Bonn, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathrin","family":"Kastenm\u00fcller","sequence":"additional","affiliation":[{"name":"Max-Planck Research Group, W\u00fcrzburg Institute of Systems Immunology, University of W\u00fcrzburg, 97078 W\u00fcrzburg, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johannes M.","family":"Just","sequence":"additional","affiliation":[{"name":"Department of General Practice and Interprofessional Care, Medical Faculty of the University of Witten\/Herdecke, 58448 Witten, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1975-5369","authenticated-orcid":false,"given":"Markus","family":"Bleckwenn","sequence":"additional","affiliation":[{"name":"Department of General Practice, Medical Faculty, Leipzig University, 04103 Leipzig, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Holdenrieder","sequence":"additional","affiliation":[{"name":"Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, 53127 Bonn, Germany"},{"name":"Institute of Laboratory Medicine, German Heart Centre Munich, Technical University Munich, 80636 Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florian","family":"Meier","sequence":"additional","affiliation":[{"name":"Wilhelm Loehe University of Applied Sciences (WLH), 90763 F\u00fcrth, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Klaus","family":"Weckbecker","sequence":"additional","affiliation":[{"name":"Department of General Practice and Interprofessional Care, Medical Faculty of the University of Witten\/Herdecke, 58448 Witten, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1566-8156","authenticated-orcid":false,"given":"Julia C.","family":"Stingl","sequence":"additional","affiliation":[{"name":"Institute of Clinical Pharmacology, University Hospital RWTH Aachen, 52074 Aachen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,10,18]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2002","DOI":"10.1056\/NEJMsa1103053","article-title":"Emergency hospitalizations for adverse drug events in older Americans","volume":"365","author":"Budnitz","year":"2011","journal-title":"N. 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