Objectives - 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 - 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 10-13 and 16-19). Results - At the end of the second fixed-dose period (median dose 300 mg/day), the median reduction in monthly seizure frequency was 33.3-41.1%; >= 50% responder rate was 40.9-44.2%; and seizure freedom rate was 15.0-15.9%, depending on the analysis used. The most common adverse events were fatigue (16.7%) and somnolence (15.3%). Conclusions - Zonisamide demonstrated efficacy in a setting more reflective of clinical practice and was generally well tolerated.
Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS) / S., Dupont; S., Striano; E., Trinka; J., Springub; Giallonardo, Anna Teresa; P., Smith; S., Ellis; A., Yeates; G., Baker; Acta Neurol Scand, Mar; Epub, Dec; Pmid Pubmed Indexed For, Medline; Related, Citations. - In: ACTA NEUROLOGICA SCANDINAVICA. - ISSN 0001-6314. - 121:3(2010), pp. 141-148. [10.1111/j.1600-0404.2009.01311.x]
Flexible dosing of adjunctive zonisamide in the treatment of adult partial-onset seizures: a non-comparative, open-label study (ZEUS)
GIALLONARDO, Anna Teresa;
2010
Abstract
Objectives - 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 - 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 10-13 and 16-19). Results - At the end of the second fixed-dose period (median dose 300 mg/day), the median reduction in monthly seizure frequency was 33.3-41.1%; >= 50% responder rate was 40.9-44.2%; and seizure freedom rate was 15.0-15.9%, depending on the analysis used. The most common adverse events were fatigue (16.7%) and somnolence (15.3%). Conclusions - Zonisamide demonstrated efficacy in a setting more reflective of clinical practice and was generally well tolerated.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.