Is a separate monotherapy indication warranted for antiepileptic drugs?

Scott Mintzer, Jacqueline A. French, Emilio Perucca, Joyce A. Cramer, John A. Messenheimer, David E. Blum, Michael A Rogawski, Michel Baulac

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Antiepileptic drugs (AEDs) are the only neurotherapeutics for which regulatory approval is consistently separated into monotherapy or adjunctive-therapy indications. Because head-to-head comparisons of AEDs (used in the European Union to approve drugs for monotherapy) have not shown substantial differences in efficacy between drugs, FDA approval for use of an AED as monotherapy has typically been based on trials with novel designs that have been criticised for reasons of ethics and clinical relevance. Many new-generation AEDs have not been approved for monotherapy, causing drug labelling and real-world use to be increasingly inconsistent, with negative consequences for patients. The regulatory requirement for separate monotherapy and adjunctive-therapy indications in epilepsy is unnecessarily restrictive. We recommend that regulatory agencies approve AEDs for the treatment of specific seizure types or epilepsy syndromes, irrespective of concomitant drug use.

Original languageEnglish (US)
Pages (from-to)1229-1240
Number of pages12
JournalThe Lancet Neurology
Volume14
Issue number12
DOIs
StatePublished - Dec 1 2015

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Anticonvulsants
Epilepsy
Drug Labeling
Clinical Ethics
Drug Approval
European Union
Pharmaceutical Preparations
Seizures
Therapeutics

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Mintzer, S., French, J. A., Perucca, E., Cramer, J. A., Messenheimer, J. A., Blum, D. E., ... Baulac, M. (2015). Is a separate monotherapy indication warranted for antiepileptic drugs? The Lancet Neurology, 14(12), 1229-1240. https://doi.org/10.1016/S1474-4422(15)00229-X

Is a separate monotherapy indication warranted for antiepileptic drugs? / Mintzer, Scott; French, Jacqueline A.; Perucca, Emilio; Cramer, Joyce A.; Messenheimer, John A.; Blum, David E.; Rogawski, Michael A; Baulac, Michel.

In: The Lancet Neurology, Vol. 14, No. 12, 01.12.2015, p. 1229-1240.

Research output: Contribution to journalArticle

Mintzer, S, French, JA, Perucca, E, Cramer, JA, Messenheimer, JA, Blum, DE, Rogawski, MA & Baulac, M 2015, 'Is a separate monotherapy indication warranted for antiepileptic drugs?', The Lancet Neurology, vol. 14, no. 12, pp. 1229-1240. https://doi.org/10.1016/S1474-4422(15)00229-X
Mintzer S, French JA, Perucca E, Cramer JA, Messenheimer JA, Blum DE et al. Is a separate monotherapy indication warranted for antiepileptic drugs? The Lancet Neurology. 2015 Dec 1;14(12):1229-1240. https://doi.org/10.1016/S1474-4422(15)00229-X
Mintzer, Scott ; French, Jacqueline A. ; Perucca, Emilio ; Cramer, Joyce A. ; Messenheimer, John A. ; Blum, David E. ; Rogawski, Michael A ; Baulac, Michel. / Is a separate monotherapy indication warranted for antiepileptic drugs?. In: The Lancet Neurology. 2015 ; Vol. 14, No. 12. pp. 1229-1240.
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