Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS)
December 29th, 2009 Posted by: admin
Dupont S, Striano S, Trinka E, Springub J, Giallonardo AT, Smith P, Ellis S, Yeates A, Baker G. Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS).Acta Neurol Scand: DOI: 10.1111/j.1600-0404.2009.01311.x.© 2009 The Authors Journal compilation © 2009 Blackwell Munksgaard.Objectives [ndash] To assess the efficacy and tolerability of zonisamide in a study allowing flexible dosing in a more diverse and less refractory population than assessed in randomized controlled trials.Methods [ndash] This 19-week, non-comparative study of adjunctive zonisamide included 281 adults who had at least four partial-onset seizures within 8 weeks on one or two antiepileptic drugs. Alterations to zonisamide doses were allowed after titration, except during two fixed-dose periods (weeks 10[ndash]13 and 16[ndash]19).Results [ndash] At the end of the second fixed-dose period (median dose 300 mg/day), the median reduction in monthly seizure frequency was 33.3[ndash]41.1%; [ge]50% responder rate was 40.9[ndash]44.2%; and seizure freedom rate was 15.0[ndash]15.9%, depending on the analysis used. The most common adverse events were fatigue (16.7%) and somnolence (15.3%).Conclusions [ndash] Zonisamide demonstrated efficacy in a setting more reflective of clinical practice and was generally well tolerated.
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