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Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (the IDrug randomized controlled trial) – never change a running system?
Please always quote using this URN: urn:nbn:de:bvb:20-opus-248557
- 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 definedThe 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 1.02–2.63]) with multiple adjustments. The OR was higher in patients on phenprocoumon treatment (OR 1.99 [95%CI 1.05–3.76]), and not significant on DOAC treatment (OR 1.52 [95%CI 0.63–3.69]). 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.…
Author: | Katja S. Just, Catharina Scholl, Miriam Boehme, Kathrin Kastenmüller, Johannes M. Just, Markus Bleckwenn, Stefan Holdenrieder, Florian Meier, Klaus Weckbecker, Julia C. Stingl |
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URN: | urn:nbn:de:bvb:20-opus-248557 |
Document Type: | Journal article |
Faculties: | Medizinische Fakultät / Institut für Systemimmunologie |
Language: | English |
Parent Title (English): | Pharmaceuticals |
ISSN: | 1424-8247 |
Year of Completion: | 2021 |
Volume: | 14 |
Issue: | 10 |
Article Number: | 1056 |
Source: | Pharmaceuticals (2021) 14:10, 1056. https://doi.org/10.3390/ph14101056 |
DOI: | https://doi.org/10.3390/ph14101056 |
Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
Tag: | DOACs; adverse drug reactions; bleeding; older adults; personalized medicine; pharmacogenetics; pharmacogenomics; phenprocoumon; thromboembolism |
Release Date: | 2023/05/26 |
Date of first Publication: | 2021/10/18 |
EU-Project number / Contract (GA) number: | 668353 |
OpenAIRE: | OpenAIRE |
Licence (German): | CC BY: Creative-Commons-Lizenz: Namensnennung 4.0 International |