PMID- 33279589
OWN - NLM
STAT- MEDLINE
DCOM- 20210528
LR  - 20210528
IS  - 1874-1754 (Electronic)
IS  - 0167-5273 (Linking)
VI  - 328
DP  - 2021 Apr 1
TI  - Appropriateness of direct oral anticoagulant dosing in patients with atrial 
      fibrillation according to the drug labelling and the EHRA Practical Guide.
PG  - 97-103
LID - S0167-5273(20)34231-5 [pii]
LID - 10.1016/j.ijcard.2020.11.062 [doi]
AB  - BACKGROUND: This study aimed to evaluate the prevalence of potential drug-drug 
      interactions (DDIs) and the appropriateness of direct oral anticoagulant (DOAC) 
      dosing according to both the Summary of Product Characteristics (SmPC) and the 
      European Heart Rhythm Association (EHRA) Practical Guide in a 'real-world' sample 
      of non-valvular atrial fibrillation (NVAF) patients. METHODS AND RESULTS: Data of 
      a cross-sectional observational study in a primary care sample of 654 long-term 
      DOAC users were used for this sub-analysis. A total of 262 potential DDIs were 
      identified in 220 patients (33.6%). Pharmacodynamic DDIs were present in 163 
      patients (24.9%) and pharmacokinetic DDIs in 82 patients (12.5%). One-third of 
      patients (33.8%) received reduced DOAC dose. According to the dosing 
      recommendations in the SmPC, 81.7% of DOACs were dosed appropriately. According 
      to the EHRA recommendations, 76.6% of DOACs were dosed appropriately. Dosing 
      recommendations were consistent for 90.7% of patients, with both the SmPC and 
      EHRA Practical Guide considering DOACs dosed appropriately in 74.5% of patients, 
      overdosed in 7.8%, underdosed in 7.6% and contraindicated in 0.8%. However, for 
      the remaining 9.3% dosing recommendations differed between SmPC and EHRA. 
      CONCLUSIONS: This 'real-world' analysis of DOAC dosing demonstrated that in about 
      one-third of NVAF patients potential DDIs were present. In 18.3% and 23.4% of 
      patients, DOACs were dosed inappropriately according to the SmPC and EHRA 
      Practical Guide respectively. In almost 10% of the study population dosing advice 
      was inconsistent between both references. More research is needed to ensure 
      appropriate DOAC dosing in this 'grey zone' population.
CI  - Copyright (c) 2020 Elsevier B.V. All rights reserved.
FAU - Capiau, Andreas
AU  - Capiau A
AD  - Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, 
      Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: 
      Andreas.Capiau@UGent.be.
FAU - De Backer, Tine
AU  - De Backer T
AD  - Department of Cardiology, Heart Centre, Ghent University Hospital, C. Heymanslaan 
      10, 9000 Ghent, Belgium; Department of Internal Medicine and Pediatrics, Faculty 
      of Medicine and Health Sciences, Ghent University, C. Heymanslaan 10, 9000 Ghent, 
      Belgium.
FAU - Grymonprez, Maxim
AU  - Grymonprez M
AD  - Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, 
      Ottergemsesteenweg 460, 9000 Ghent, Belgium.
FAU - Lahousse, Lies
AU  - Lahousse L
AD  - Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, 
      Ottergemsesteenweg 460, 9000 Ghent, Belgium.
FAU - Van Tongelen, Inge
AU  - Van Tongelen I
AD  - Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, 
      Ottergemsesteenweg 460, 9000 Ghent, Belgium.
FAU - Mehuys, Els
AU  - Mehuys E
AD  - Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, 
      Ottergemsesteenweg 460, 9000 Ghent, Belgium.
FAU - Boussery, Koen
AU  - Boussery K
AD  - Pharmaceutical Care Unit, Faculty of Pharmaceutical Sciences, Ghent University, 
      Ottergemsesteenweg 460, 9000 Ghent, Belgium.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20201203
PL  - Netherlands
TA  - Int J Cardiol
JT  - International journal of cardiology
JID - 8200291
RN  - 0 (Anticoagulants)
SB  - IM
MH  - Administration, Oral
MH  - Anticoagulants/adverse effects
MH  - *Atrial Fibrillation/diagnosis/drug therapy/epidemiology
MH  - Cross-Sectional Studies
MH  - Drug Labeling
MH  - Humans
MH  - *Stroke/drug therapy
OTO - NOTNLM
OT  - Atrial fibrillation
OT  - Direct oral anticoagulants
OT  - Inappropriate prescribing
OT  - Pharmacology
COIS- Declaration of Competing Interest The authors report no relationships that could 
      be construed as a conflict of interest.
EDAT- 2020/12/07 06:00
MHDA- 2021/05/29 06:00
CRDT- 2020/12/06 20:43
PHST- 2020/09/25 00:00 [received]
PHST- 2020/11/11 00:00 [revised]
PHST- 2020/11/25 00:00 [accepted]
PHST- 2020/12/07 06:00 [pubmed]
PHST- 2021/05/29 06:00 [medline]
PHST- 2020/12/06 20:43 [entrez]
AID - S0167-5273(20)34231-5 [pii]
AID - 10.1016/j.ijcard.2020.11.062 [doi]
PST - ppublish
SO  - Int J Cardiol. 2021 Apr 1;328:97-103. doi: 10.1016/j.ijcard.2020.11.062. Epub 
      2020 Dec 3.