ArticleCNS drugs2014
Off-label prescribing of antiepileptic drugs in pharmacoresistant epilepsy: a cross-sectional drug utilization study of tertiary care centers in Italy.
Article in CNS drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 28 citations in OpenAlex.
- Physiologically-based pharmacokinetic modeling and simulation for initial dose optimization of levetiracetam in pediatrics.Frontiers in pharmacology · 2025Article
- GABAkines - Advances in the discovery, development, and commercialization of positive allosteric modulators of GABAPharmacology & therapeutics · 2022Review
- Treatment of Focal-Onset Seizures in Children: Should This Be More Etiology-Driven?Frontiers in neurology · 2022Review
- Article
- Advocacy for children with epilepsy: Leveraging the WHA resolution. Advocacy Task Force, Commission of Pediatrics, International League Against Epilepsy.Epilepsia open · 2018Review
- A Review of the New Antiepileptic Drugs for Focal-Onset Seizures in Pediatrics: Role of Extrapolation.Paediatric drugs · 2018Review
- Initial Treatment for Nonsyndromic Early-Life Epilepsy: An Unexpected Consensus.Pediatric neurology · 2017Article
- Systematic Adverse Drug Reaction Monitoring of Patients Under Newer Antiepileptic Drugs Using Routine Clinical Data of Inpatients.Drugs - real world outcomes · 2016Article
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Authors and funding
13 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo assess the extent of off-label prescribing of antiepileptic drugs (AEDs) and associated variables in a large population of patients with pharmacoresistant epilepsy.
methodsDescriptive analysis of data recorded from consecutively enrolled patients with pharmacoresistant epilepsy attending 11 tertiary referral centers in Italy. Off-label use was stratified by therapeutic indication, dose, and age. Multivariate logistic regression was used to identify variables associated with off-label prescription.
resultsOf a total of 1,124 patients enrolled between November 2006 and August 2007, 53 % (101/191) of children and 31 % (287/933) of adults were receiving at least one off-label AED prescription. Among adults, off-label use was related primarily to indication and was highest for clobazam (100 %) and ethosuximide (40 %), followed by lamotrigine (25 %), and vigabatrin (25 %). In children, clobazam (100 %), lamotrigine (79 %), vigabatrin (55 %), ethosuximide (46 %), and levetiracetam (43 %) were most frequently used off-label, with indication or age being the main causes depending on the specific AED. Logistic regression analysis indicated that higher rates of off-label use were associated with a polytherapy regimen (odds ratio [OR] 2.50, 95 % confidence interval [95 % CI], 1.55-4.03), pediatric age (2.49, 1.66-3.76), having failed ≥3 AEDs (2.16, 1.04-4.48), a diagnosis of generalized epilepsy with structural/metabolic or unknown etiology (2.97, 1.25-7.04), and increasing seizure frequency (1.07, 1.01-1.14).
conclusionsOff-label prescribing of AEDs is common among patients with pharmacoresistant epilepsy and is influenced by demographic and disease-related characteristics. Studies are needed to improve the quality of evidence guiding epilepsy treatment, and to evaluate the risks and benefits of off-label prescribing in epilepsy.
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