Off-label prescribing of antiepileptic drugs in pharmacoresistant epilepsy: A cross-sectional drug utilization study of tertiary care centers in Italy

Valentina Franco, Maria Paola Canevini, Giuseppe Capovilla, Giovambattista De Sarro, Carlo Andrea Galimberti, Giuliana Gatti, Renzo Guerrini, Angela La Neve, Eleonora Rosati, Luigi Maria Specchio, Salvatore Striano, Paolo Tinuper, Emilio Perucca

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Abstract

Purpose: To assess the extent of off-label prescribing of antiepileptic drugs (AEDs) and associated variables in a large population of patients with pharmacoresistant epilepsy. Methods: Descriptive 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. Results: Of 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). Conclusions: Off-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.

Original languageEnglish
Pages (from-to)939-949
Number of pages11
JournalCNS Drugs
Volume28
Issue number10
DOIs
Publication statusPublished - Jul 24 2014

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Drug Utilization
Off-Label Use
Tertiary Care Centers
Anticonvulsants
Italy
Epilepsy
Ethosuximide
Vigabatrin
etiracetam
Logistic Models
Drug Prescriptions
Generalized Epilepsy
Prescriptions
Seizures
Odds Ratio
Regression Analysis
Demography
Confidence Intervals
Pediatrics
Therapeutics

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Psychiatry and Mental health
  • Clinical Neurology
  • Medicine(all)

Cite this

Off-label prescribing of antiepileptic drugs in pharmacoresistant epilepsy : A cross-sectional drug utilization study of tertiary care centers in Italy. / Franco, Valentina; Canevini, Maria Paola; Capovilla, Giuseppe; De Sarro, Giovambattista; Galimberti, Carlo Andrea; Gatti, Giuliana; Guerrini, Renzo; La Neve, Angela; Rosati, Eleonora; Specchio, Luigi Maria; Striano, Salvatore; Tinuper, Paolo; Perucca, Emilio.

In: CNS Drugs, Vol. 28, No. 10, 24.07.2014, p. 939-949.

Research output: Contribution to journalArticle

Franco, Valentina ; Canevini, Maria Paola ; Capovilla, Giuseppe ; De Sarro, Giovambattista ; Galimberti, Carlo Andrea ; Gatti, Giuliana ; Guerrini, Renzo ; La Neve, Angela ; Rosati, Eleonora ; Specchio, Luigi Maria ; Striano, Salvatore ; Tinuper, Paolo ; Perucca, Emilio. / Off-label prescribing of antiepileptic drugs in pharmacoresistant epilepsy : A cross-sectional drug utilization study of tertiary care centers in Italy. In: CNS Drugs. 2014 ; Vol. 28, No. 10. pp. 939-949.
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abstract = "Purpose: To assess the extent of off-label prescribing of antiepileptic drugs (AEDs) and associated variables in a large population of patients with pharmacoresistant epilepsy. Methods: Descriptive 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. Results: Of 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). Conclusions: Off-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.",
author = "Valentina Franco and Canevini, {Maria Paola} and Giuseppe Capovilla and {De Sarro}, Giovambattista and Galimberti, {Carlo Andrea} and Giuliana Gatti and Renzo Guerrini and {La Neve}, Angela and Eleonora Rosati and Specchio, {Luigi Maria} and Salvatore Striano and Paolo Tinuper and Emilio Perucca",
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T2 - A cross-sectional drug utilization study of tertiary care centers in Italy

AU - Franco, Valentina

AU - Canevini, Maria Paola

AU - Capovilla, Giuseppe

AU - De Sarro, Giovambattista

AU - Galimberti, Carlo Andrea

AU - Gatti, Giuliana

AU - Guerrini, Renzo

AU - La Neve, Angela

AU - Rosati, Eleonora

AU - Specchio, Luigi Maria

AU - Striano, Salvatore

AU - Tinuper, Paolo

AU - Perucca, Emilio

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N2 - Purpose: To assess the extent of off-label prescribing of antiepileptic drugs (AEDs) and associated variables in a large population of patients with pharmacoresistant epilepsy. Methods: Descriptive 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. Results: Of 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). Conclusions: Off-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.

AB - Purpose: To assess the extent of off-label prescribing of antiepileptic drugs (AEDs) and associated variables in a large population of patients with pharmacoresistant epilepsy. Methods: Descriptive 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. Results: Of 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). Conclusions: Off-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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