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%; > or =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.
Subject(s)
Anticonvulsants/therapeutic use , Epilepsies, Partial/drug therapy , Isoxazoles/therapeutic use , Adolescent , Adult , Aged , Analysis of Variance , Confidence Intervals , Dose-Response Relationship, Drug , Drug Administration Schedule , Drug Therapy, Combination , Epilepsies, Partial/psychology , Female , Humans , International Cooperation , Male , Middle Aged , Quality of Life , Severity of Illness Index , Treatment Outcome , Young Adult , ZonisamideABSTRACT
Autogenic therapy courses for patient with psychosomatic psychoneurotic disorders show a high dropout rate. A study among 38 ambulant patients analysed factors of the patients have influence on their compliance. Generally the dropout group, independent of the diagnosis, shows less striking deviations. Under autogenic therapy the compliance-positive group achieves a constructive change towards normality. Realisation of autogenic therapy is achieved by patients with more intensive psychoneurotic disorders. They experience a more distinct physical answer by the basic training. It is shown that it is easier for the compliant patient to learn the autogenic therapy, which is understood as conditional response. With reference to the experience in drug compliance the results recommend that autogenic therapy should be accompanied by a compliance therapy.
