Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS)
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.