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The Italian Journal of Neurological Sciences

, Volume 17, Issue 6, pp 429–432 | Cite as

Efficacy and safety of topiramate in refractory epilepsy: a long-term prospective trial

  • Tartara A. 
  • Sartori I. 
  • Manni R. 
  • Galimberti C. A. 
  • Fazio M. Di 
  • Perucca E. 
Original Articles

Abstract

The effects of topiramate in 15 patients with drug refractory partial epilepsy or Lennox-Gastaut syndrome were assessed in an open, add-on prospective study. After a follow-up of 14–21 months, six patients are still on topiramate (mean dosage 583 mg/day, range 400–800 mg/day), and nine have discontinued treatment because of adverse events (n=6), inefficacy (n=2) or poor compliance (n=1). Nine patients (69%) continued to have a ≥50% reduction in seizure frequency during the last two months of treatment, and one has been seizure-free for the last 19 months. The most common adverse events were somnolence, weight loss, mental slowing, fatigue, ataxia and irritability. Most of these events were reversible, but withdrawal of treatment was required in six cases as a result of ataxia (two patients), somnolence, metabolic acidosis, irritability or psychotic symptoms (one patient each). It is concluded that topiramate is a valuable agent for the long-term management of refractory epilepsy.

Key words

Topiramate Epilepsy Clinical trial 

Sommario

Gli effetti di topiramato utilizzato in aggiunta alla terapia preesistente sono stati valutati nell'ambito di uno studio prospettico in aperto in 15 pazienti farmacoresistenti affetti da epilessia parziale o sindrome Lennox-Gastaut. Dopo un follow-up di 14–21 mesi, 6 pazienti sono tuttora in trattamento (posologia media di topiramato 583 mg/die, range 400–800 mg/die), mentre 9 hanno sospeso il farmaco a causa di eventi avversi (n=6), inefficacia (n=2) o scarsa compliance (n=1). Nove pazienti (69%) continuavano a presentare una riduzione di almeno il 50% della frequenza delle crisi durante gli ultimi 2 mesi di trattamento e un paziente è libero da crisi da 19 mesi. Gli eventi avversi più frequenti erano costituiti da sonnolenza, calo ponderale, rallentamento mentale, astenia, atassia e irritabilità. La maggior parte di questi eventi è risultata reversibile, ma in 6 pazienti si è resa necessaria la sospensione del trattamento a causa di atassia (2 casi), sonnolenza, acidosi metabolica, irritabilità e sintomi psicotici (1 caso ciascuno). Sulla base di questi dati, il topiramato può essere ritenuto un utile presidio nel trattamento a lungo termine dell'epilessia farmacoresistente.

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Copyright information

© Masson S.p.A 1996

Authors and Affiliations

  • Tartara A. 
    • 3
  • Sartori I. 
    • 3
  • Manni R. 
    • 3
  • Galimberti C. A. 
    • 3
  • Fazio M. Di 
    • 2
  • Perucca E. 
    • 1
  1. 1.Unità di Farmacologia ClinicaUniversità di PaviaItaly
  2. 2.Janssen-Cilag S.p.A., Cologno MonzeseMilanoItaly
  3. 3.Istituto Neurologico “C. Mondino”PaviaItaly

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