TY  - JOUR
A1  - Just, Katja S.
A1  - Scholl, Catharina
A1  - Boehme, Miriam
A1  - Kastenmüller, Kathrin
A1  - Just, Johannes M.
A1  - Bleckwenn, Markus
A1  - Holdenrieder, Stefan
A1  - Meier, Florian
A1  - Weckbecker, Klaus
A1  - Stingl, Julia C.
T1  - Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (the IDrug randomized controlled trial) – never change a running system?
JF  - Pharmaceuticals
N2  - 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 1.02–2.63]) 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.
KW  - adverse drug reactions
KW  - pharmacogenetics
KW  - pharmacogenomics
KW  - personalized medicine
KW  - phenprocoumon
KW  - DOACs
KW  - older adults
KW  - bleeding
KW  - thromboembolism
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-248557
SN  - 1424-8247
VL  - 14
IS  - 10
ER  - 
TY  - JOUR
A1  - Mc Laughlin, Anna M.
A1  - Schmulenson, Eduard
A1  - Teplytska, Olga
A1  - Zimmermann, Sebastian
A1  - Opitz, Patrick
A1  - Groenland, Stefanie L.
A1  - Huitema, Alwin D. R.
A1  - Steeghs, Neeltje
A1  - Müller, Lothar
A1  - Fuxius, Stefan
A1  - Illerhaus, Gerald
A1  - Joerger, Markus
A1  - Mayer, Frank
A1  - Fuhr, Uwe
A1  - Holdenrieder, Stefan
A1  - Hempel, Georg
A1  - Scherf-Clavel, Oliver
A1  - Jaehde, Ulrich
A1  - Kloft, Charlotte
T1  - Developing a nationwide infrastructure for therapeutic drug monitoring of targeted oral anticancer drugs: the ON-TARGET study protocol
JF  - Cancers
N2  - Exposure-efficacy and/or exposure-toxicity relationships have been identified for up to 80% of oral anticancer drugs (OADs). Usually, OADs are administered at fixed doses despite their high interindividual pharmacokinetic variability resulting in large differences in drug exposure. Consequently, a substantial proportion of patients receive a suboptimal dose. Therapeutic Drug Monitoring (TDM), i.e., dosing based on measured drug concentrations, may be used to improve treatment outcomes. The prospective, multicenter, non-interventional ON-TARGET study (DRKS00025325) aims to investigate the potential of routine TDM to reduce adverse drug reactions in renal cell carcinoma patients receiving axitinib or cabozantinib. Furthermore, the feasibility of using volumetric absorptive microsampling (VAMS), a minimally invasive and easy to handle blood sampling technique, for sample collection is examined. During routine visits, blood samples are collected and sent to bioanalytical laboratories. Venous and VAMS blood samples are collected in the first study phase to facilitate home-based capillary blood sampling in the second study phase. Within one week, the drug plasma concentrations are measured, interpreted, and reported back to the physician. Patients report their drug intake and toxicity using PRO-CTCAE-based questionnaires in dedicated diaries. Ultimately, the ON-TARGET study aims to develop a nationwide infrastructure for TDM for oral anticancer drugs.
KW  - therapeutic drug monitoring
KW  - oral anticancer drugs
KW  - renal cell carcinoma
KW  - volumetric absorptive microsampling
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-252196
SN  - 2072-6694
VL  - 13
IS  - 24
ER  -