PMID- 31230262
OWN - NLM
STAT- MEDLINE
DCOM- 20200219
LR  - 20200225
IS  - 1573-742X (Electronic)
IS  - 0929-5305 (Linking)
VI  - 48
IP  - 3
DP  - 2019 Oct
TI  - Real-world assessment of off-label direct oral anticoagulant dosing for venous 
      thromboembolism.
PG  - 506-510
LID - 10.1007/s11239-019-01904-y [doi]
AB  - Preferred anticoagulation therapy for venous thromboembolism (VTE) has shifted 
      from warfarin to direct oral anticoagulants (DOACs). Adherence to DOAC 
      prescribing information is an important quality measure as off-label doses have 
      been associated with increased risk of adverse events (AEs). To identify the 
      prevalence, outcomes, and patient characteristics associated with off-label DOAC 
      dosing during VTE treatment. Patients receiving DOAC for VTE treatment discharged 
      from University of Utah Health (UUH) over a 90-day period were identified. Dosing 
      was classified as "labeled" or "off-label" based on concordance with manufacturer 
      prescribing information. AEs (thromboembolic events, bleeding, death) occurring 
      within 90 days after discharge were identified. Out of 195 patients, 154 (79.0%) 
      received labeled dosing, 31 (15.9%) received off-label dosing, and 10 (5.1%) were 
      indeterminate. Two-thirds of off-label doses were higher than recommended and 
      three-fourths occurred during extended treatment (more than 90 days post-VTE). 
      Off-label dosing rates dropped to 5.6% when 6-month dose reductions were not 
      required. Off-label dosing was associated with apixaban use and extended phase 
      treatment (p < 0.001). No association was found between off-label dosing and age, 
      renal function, prescriber rationale for dose selection, or Thrombosis Clinic 
      referral. AEs were experienced by 18 (11.7%) and 3 (9.7%) patients in the labeled 
      and off-label groups, respectively (p = 0.77). Bleeding events comprised 46.2% of 
      AEs. The rate of off-label DOAC dosing for VTE at UUH was within rates reported 
      in prior studies, occurred primarily with extended-duration apixaban, and did not 
      result in a higher rate of AEs.
FAU - Saunders, John A
AU  - Saunders JA
AD  - Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake 
      City, UT, USA.
FAU - Gustafson, Whitney L
AU  - Gustafson WL
AD  - Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake 
      City, UT, USA.
FAU - Vazquez, Sara R
AU  - Vazquez SR
AUID- ORCID: 0000-0002-9267-8980
AD  - Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake 
      City, UT, USA. sara.vazquez@hsc.utah.edu.
AD  - University of Utah Health Thrombosis Center, 50 N Medical Drive Room 1R211, Salt 
      Lake City, UT, 84132, USA. sara.vazquez@hsc.utah.edu.
FAU - Jones, Aubrey E
AU  - Jones AE
AD  - Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake 
      City, UT, USA.
AD  - University of Utah Health Thrombosis Center, 50 N Medical Drive Room 1R211, Salt 
      Lake City, UT, 84132, USA.
FAU - Witt, Daniel M
AU  - Witt DM
AD  - Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake 
      City, UT, USA.
AD  - University of Utah Health Thrombosis Center, 50 N Medical Drive Room 1R211, Salt 
      Lake City, UT, 84132, USA.
LA  - eng
PT  - Journal Article
PL  - Netherlands
TA  - J Thromb Thrombolysis
JT  - Journal of thrombosis and thrombolysis
JID - 9502018
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyridones)
RN  - 3Z9Y7UWC1J (apixaban)
SB  - IM
MH  - Factor Xa Inhibitors/*administration & dosage/adverse effects
MH  - Female
MH  - Hemorrhage/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Off-Label Use
MH  - Practice Patterns, Physicians'
MH  - Pyrazoles/therapeutic use
MH  - Pyridones/therapeutic use
MH  - Retrospective Studies
MH  - Venous Thromboembolism/*drug therapy
OTO - NOTNLM
OT  - Direct oral anticoagulant
OT  - Dosing
OT  - Off-label
OT  - Venous thromboembolism
EDAT- 2019/06/24 06:00
MHDA- 2020/02/20 06:00
CRDT- 2019/06/24 06:00
PHST- 2019/06/24 06:00 [pubmed]
PHST- 2020/02/20 06:00 [medline]
PHST- 2019/06/24 06:00 [entrez]
AID - 10.1007/s11239-019-01904-y [pii]
AID - 10.1007/s11239-019-01904-y [doi]
PST - ppublish
SO  - J Thromb Thrombolysis. 2019 Oct;48(3):506-510. doi: 10.1007/s11239-019-01904-y.