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  - Reis, Stefanie
A1  - Popp, Maria
A1  - Schmid, Benedikt
A1  - Stegemann, Miriam
A1  - Metzendorf, Maria-Inti
A1  - Kranke, Peter
A1  - Meybohm, Patrick
A1  - Weibel, Stephanie
T1  - Safety and efficacy of intermediate- and therapeutic-dose anticoagulation for hospitalised patients with COVID-19: a systematic review and meta-analysis
JF  - Journal of Clinical Medicine
N2  - Background: COVID-19 patients are at high thrombotic risk. The safety and efficacy of different anticoagulation regimens in COVID-19 patients remain unclear. Methods: We searched for randomised controlled trials (RCTs) comparing intermediate- or therapeutic-dose anticoagulation to standard thromboprophylaxis in hospitalised patients with COVID-19 irrespective of disease severity. To assess efficacy and safety, we meta-analysed data for all-cause mortality, clinical status, thrombotic event or death, and major bleedings. Results: Eight RCTs, including 5580 patients, were identified, with two comparing intermediate- and six therapeutic-dose anticoagulation to standard thromboprophylaxis. Intermediate-dose anticoagulation may have little or no effect on any thrombotic event or death (RR 1.03, 95% CI 0.86–1.24), but may increase major bleedings (RR 1.48, 95% CI 0.53–4.15) in moderate to severe COVID-19 patients. Therapeutic-dose anticoagulation may decrease any thrombotic event or death in patients with moderate COVID-19 (RR 0.64, 95% CI 0.38–1.07), but may have little or no effect in patients with severe disease (RR 0.98, 95% CI 0.86–1.12). The risk of major bleedings may increase independent of disease severity (RR 1.78, 95% CI 1.15–2.74). Conclusions: Certainty of evidence is still low. Moderately affected COVID-19 patients may benefit from therapeutic-dose anticoagulation, but the risk for bleeding is increased.
KW  - anticoagulant therapy
KW  - coronavirus disease 2019
KW  - thrombosis
KW  - bleeding
KW  - death
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-252285
SN  - 2077-0383
VL  - 11
IS  - 1
ER  -