Objectives –  To investigate whether zonisamide remains effective and well tolerated in the treatment of refractory partial epilepsy during long‐term treatment and with flexible dosing in clinical practice. Materials and methods –  Patients with refractory partial epilepsy who completed a fixed‐dose, randomized, double‐blind clinical trial were recruited in an open‐label extension study with adjustment of zonisamide and other antiepileptic drug dosage according to the treating physician’s usual clinical practice. Results –  An intention‐to‐treat analysis of 317 patients showed that zonisamide was well tolerated with a predictable safety profile. Patient retention rates at 1, 2 and 3 years were 65.3%, 44.5% and 28.8%, respectively. Zonisamide treatment was associated with a maintained reduction in seizure frequency, with some patients achieving prolonged periods of seizure freedom. Conclusions –  Flexible dosing with zonisamide demonstrated a good safety profile and sustained efficacy in the long‐term adjunctive treatment of refractory partial epilepsy.

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. MethodsThis 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.

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The definition of treatment 'response' in a progressive neurodegenerative disease can encompass a variety of outcomes, including short-term improvement, longer-term stabilization and a slowed decline in one or more clinically relevant symptoms or symptom domains. The ability to identify groups of people who respond to donepezil underscores the clinical utility of the medication and may contribute to more focused assessments of the cost effectiveness of cholinesterase inhibitors.

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