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Zonisamide in epilepsy: a pilot study.

A J Wilensky, P N Friel, L M Ojemann

    Epilepsia
    |May 1, 1985
    PubMed
    Summary
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    Zonisamide demonstrated antiepileptic effects in adults with partial seizures, with some patients responding better than to phenytoin or carbamazepine. However, toxicity and adverse events limited its use in others.

    Area of Science:

    • Neurology
    • Clinical Pharmacology

    Background:

    • Partial seizures are a common form of epilepsy.
    • Established antiepileptic drugs (AEDs) like phenytoin and carbamazepine are widely used.
    • Newer AEDs are continually investigated for efficacy and safety.

    Purpose of the Study:

    • To evaluate the efficacy and tolerability of zonisamide monotherapy in adults with uncontrolled partial seizures.
    • To compare zonisamide's effectiveness against baseline phenytoin and during concurrent carbamazepine therapy.

    Main Methods:

    • An open-label, crossover pilot study involving eight adult participants.
    • Participants initially received 8 weeks of phenytoin monotherapy, followed by 12 weeks of zonisamide monotherapy, and then 12 weeks of carbamazepine monotherapy.
    • Seizure control and adverse events were monitored.

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    Main Results:

    • Zonisamide showed antiepileptic activity in five out of eight subjects.
    • Two subjects exhibited a superior response to zonisamide compared to phenytoin or carbamazepine.
    • One subject achieved seizure freedom with zonisamide but was withdrawn due to Stevens-Johnson syndrome.
    • Three subjects were withdrawn due to drug toxicity, primarily cognitive impairment and seizure exacerbation.
    • Optimal zonisamide response occurred at doses around 6 mg/kg/day with plasma levels of 20-30 mg/L.
    • Plasma levels above 30 mg/L were linked to toxicity.
    • Zonisamide exhibits complex, nonlinear pharmacokinetics, with steady-state levels higher than predicted.

    Conclusions:

    • Zonisamide possesses definite antiepileptic properties for partial seizures.
    • Its efficacy can be superior to established drugs in some individuals.
    • Toxicity, particularly cognitive effects and potential for severe reactions like Stevens-Johnson syndrome, are significant concerns.
    • Careful dose titration and plasma level monitoring are crucial for zonisamide therapy.