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Reference ranges for antiepileptic drugs revisited : A practical approach to establish national guidelines

Reimers, Arne LU orcid ; Berg, Jon Andsnes ; Burns, Margrete Larsen ; Brodtkorb, Eylert ; Johannessen, Svein I. and Landmark, Cecilie Johannessen (2018) In Drug Design, Development and Therapy 12. p.271-280
Abstract

Background and objective: Laboratories sometimes use different reference ranges for the same antiepileptic drug (AED), particularly for new and poorly investigated drugs. This may contribute to misunderstandings, concerns or inappropriate dose changes, which in turn may affect therapeutic effect, drug safety or treatment adherence. Therefore, the Norwegian Association of Clinical Pharmacology wished to update and harmonize the reference ranges for AEDs and establish national guidelines for Norway. Methods: A working group collected information on the reference ranges used by Norwegian laboratories for all commonly used AEDs. These reference ranges were compared to recent recommendations by the International League Against Epilepsy,... (More)

Background and objective: Laboratories sometimes use different reference ranges for the same antiepileptic drug (AED), particularly for new and poorly investigated drugs. This may contribute to misunderstandings, concerns or inappropriate dose changes, which in turn may affect therapeutic effect, drug safety or treatment adherence. Therefore, the Norwegian Association of Clinical Pharmacology wished to update and harmonize the reference ranges for AEDs and establish national guidelines for Norway. Methods: A working group collected information on the reference ranges used by Norwegian laboratories for all commonly used AEDs. These reference ranges were compared to recent recommendations by the International League Against Epilepsy, current literature, applicable clinical studies, reference ranges used by leading Northern European epilepsy centers outside of Norway, and routine data derived from Norwegian laboratory databases. Results: Reference ranges varied between laboratories for four of 23 available AEDs (lamotrigine, valproate, eslicarbazepine and oxcarbazepine). For four AEDs (brivaracetam, perampanel, stiripentol and sulthiame), reference ranges had not previously been established. In total, 13 reference ranges were either harmonized, updated or newly established. No changes were applied to the remaining 10 AEDs. Conclusion: Updated and harmonized reference ranges are now available for 22 of the 23 AEDs available in Norway. The exception is vigabatrin (reference range not applicable). Revision of reference ranges is an important part of pharmacovigilance of AEDs and must be a continuous process based on current literature and clinical experience.

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author
; ; ; ; and
publishing date
type
Contribution to journal
publication status
published
keywords
Antiepileptic drug, Reference range, Serum concentration, Therapeutic drug monitoring
in
Drug Design, Development and Therapy
volume
12
pages
271 - 280
publisher
Dove Medical Press Ltd.
external identifiers
  • scopus:85042153323
  • pmid:29467570
ISSN
1177-8881
DOI
10.2147/DDDT.S154388
language
English
LU publication?
no
additional info
Publisher Copyright: © 2018 Reimers et al.
id
8ce33684-4050-4f27-9c66-3ff1d370550f
date added to LUP
2024-08-31 14:41:48
date last changed
2025-07-07 09:17:00
@article{8ce33684-4050-4f27-9c66-3ff1d370550f,
  abstract     = {{<p>Background and objective: Laboratories sometimes use different reference ranges for the same antiepileptic drug (AED), particularly for new and poorly investigated drugs. This may contribute to misunderstandings, concerns or inappropriate dose changes, which in turn may affect therapeutic effect, drug safety or treatment adherence. Therefore, the Norwegian Association of Clinical Pharmacology wished to update and harmonize the reference ranges for AEDs and establish national guidelines for Norway. Methods: A working group collected information on the reference ranges used by Norwegian laboratories for all commonly used AEDs. These reference ranges were compared to recent recommendations by the International League Against Epilepsy, current literature, applicable clinical studies, reference ranges used by leading Northern European epilepsy centers outside of Norway, and routine data derived from Norwegian laboratory databases. Results: Reference ranges varied between laboratories for four of 23 available AEDs (lamotrigine, valproate, eslicarbazepine and oxcarbazepine). For four AEDs (brivaracetam, perampanel, stiripentol and sulthiame), reference ranges had not previously been established. In total, 13 reference ranges were either harmonized, updated or newly established. No changes were applied to the remaining 10 AEDs. Conclusion: Updated and harmonized reference ranges are now available for 22 of the 23 AEDs available in Norway. The exception is vigabatrin (reference range not applicable). Revision of reference ranges is an important part of pharmacovigilance of AEDs and must be a continuous process based on current literature and clinical experience.</p>}},
  author       = {{Reimers, Arne and Berg, Jon Andsnes and Burns, Margrete Larsen and Brodtkorb, Eylert and Johannessen, Svein I. and Landmark, Cecilie Johannessen}},
  issn         = {{1177-8881}},
  keywords     = {{Antiepileptic drug; Reference range; Serum concentration; Therapeutic drug monitoring}},
  language     = {{eng}},
  month        = {{02}},
  pages        = {{271--280}},
  publisher    = {{Dove Medical Press Ltd.}},
  series       = {{Drug Design, Development and Therapy}},
  title        = {{Reference ranges for antiepileptic drugs revisited : A practical approach to establish national guidelines}},
  url          = {{http://dx.doi.org/10.2147/DDDT.S154388}},
  doi          = {{10.2147/DDDT.S154388}},
  volume       = {{12}},
  year         = {{2018}},
}