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Impact of direct oral anticoagulant off-label doses on clinical outcomes of atrial fibrillation patients: A systematic review.

Authors
  • Santos, Joana1
  • António, Natália2, 3, 4
  • Rocha, Marília5
  • Fortuna, Ana1, 6, 7
  • 1 Laboratory of Pharmacology and Pharmaceutical Care, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal. , (Portugal)
  • 2 Laboratory of Pharmacology, Faculty of Medicine, University of Coimbra, Portugal. , (Portugal)
  • 3 Cardiology Department, Coimbra Hospital and Universitary Centre, Portugal. , (Portugal)
  • 4 Coimbra Institute for Clinical and Biomedical Research (iCBR), Coimbra, Portugal. , (Portugal)
  • 5 Pharmaceutical Service, Coimbra Hospital and Universitary Centre, Portugal. , (Portugal)
  • 6 Center for Neuroscience and Cell Biology, University of Coimbra, Coimbra, Portugal. , (Portugal)
  • 7 CIBIT/ICNAS - Coimbra Institute for Biomedical Imaging and Translational Research, University of Coimbra, Coimbra, Portugal. , (Portugal)
Type
Published Article
Journal
British Journal of Clinical Pharmacology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Mar 01, 2020
Volume
86
Issue
3
Pages
533–547
Identifiers
DOI: 10.1111/bcp.14127
PMID: 31631392
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Worldwide observational studies are evidencing discordance between guidelines and real-world practice regarding direct oral anticoagulant drug (DOAC) doses. This systematic review summarizes and evaluate DOACs use in real-world practice. This review was performed following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines searching PubMed (MEDLINE) and Medscape databases. Data from 75 studies showed that most of the patients treated with DOACs for stroke prevention in atrial fibrillation received doses in accordance to the guidelines. However, a significant number of patients received off-label doses (25-50% in most of the studies evaluated). DOAC overdosing was associated with increased all-cause mortality and worse bleeding events while underdosing was associated with increased cardiovascular hospitalization and, particularly for apixaban, with a nearly 5-fold increased risk of stroke. Patients prescribed with off-label DOAC doses did not receive the full benefit of anticoagulation and presented an increased risk of stroke, bleeding and/or adverse effects. © 2019 The British Pharmacological Society.

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