Classification and characteristics of on-label and off-label apixaban use in Denmark and Sweden

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DOI

  • Nicklas Vinter
  • Marie Linder, Centre for Pharmacoepidemiology, Department of Medicine, Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
  • ,
  • Morten Andersen, Centre for Pharmacoepidemiology, Department of Medicine, Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden., Department of Drug Design and Pharmacology, University of Copenhagen, Denmark
  • ,
  • Alma B Pedersen
  • Morten Madsen
  • Stephen E Schachterle, Department of Epidemiology and Biostatistics, School of Public Health and Health Policy, City University of New York, New York, USA.
  • ,
  • Quazi Ataher, Epidemiology, Worldwide Safety and Regulatory, Pfizer Inc., New York, USA.
  • ,
  • Jingping Mo, Epidemiology, Worldwide Safety and Regulatory, Pfizer Inc., New York, USA.
  • ,
  • Søren Paaske Johnsen
  • ,
  • Vera Ehrenstein

PURPOSE: To estimate the proportion of apixaban users who received the drug for on-label indications and characterise the patients using apixaban for on-label and off-label indications.

METHODS: We report results from two independently conducted studies in Denmark and Sweden, with 19,709 Danish and 17,592 Swedish patients, who received at least one outpatient dispensing of apixaban as identified through nationwide prescription registries. Indications, inferred from inpatient and hospital diagnoses recorded at the initial apixaban dispensing, were classified as on-label, off-label, or unclassified according to the Summary of Product Characteristics. All diagnoses were retrieved using inpatient or outpatient hospital diagnoses at the first outpatient dispensing during the study period.

RESULTS: Men comprised 52% of the users in both Denmark and Sweden. The median age was 76 years (interquartile range [IQR]: 68-83 years) among Danish patients and 74 years (IQR: 67-82 years) among Swedish patients. An on-label indication could be assigned to 82.6% (95% confidence interval [CI]: 82.1%-83.1%) of the Danish patients and 86.4% (95% CI: 85.9%-86.9%) of the Swedish patients. The main on-label indication for apixaban was non-valvular atrial fibrillation (NVAF), which accounted for 76.1% of the indications in Denmark and 69.1% of the indications in Sweden. Off-label indications were assigned to 10.8% (95% CI: 10.3-11.2) of the Danish patients (main indication possible mechanical heart valve) and 7.7% (95% CI: 7.3-8.1) of the Swedish patients (main indication off-label atrial fibrillation).

CONCLUSION: The majority of apixaban initiators in Denmark and Sweden received apixaban for an on-label indication, primarily for NVAF.

Original languageEnglish
JournalPharmacoepidemiology and Drug Safety
Volume28
Issue6
Pages (from-to)867-878
Number of pages12
ISSN1053-8569
DOIs
Publication statusPublished - Jun 2019

    Research areas

  • NOAC, apixaban, off-label, on-label, pharmacoepidemiology, utilization

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