Double‐Blind Dose Reduction Study of Vigabatrin in Complex Partial Epilepsy

Abstract

Seventy-five epilepsy patients with at least two complex partial seizures/month were treated with gamma-vinyl GABA (GVG) 3 g/day for 3 months. Forty-one patients (54%) showed a reduction of greater than or equal to 50% in seizures. The median monthly seizure frequency decreased from 11.5 to 4 seizures/month. Twenty percent of patients had an improvement in general performance without a significant reduction in seizures. The responders entered the second phase of the study, in which 28 patients were randomly allocated to 3 g/day and 25 patients to 1.5 g/day GVG under double-blind conditions. The dosage of 3 g/day appeared to be clearly more effective than 1.5 g/day. However, even with 1.5 g/day GVG the seizure frequency was significantly reduced as compared to baseline. Drowsiness was the most commonly observed side effect, and it diminished with continued treatment. In three cases side effects led to the withdrawal of GVG therapy.

Vigabatrin in epilepsy in mentally retarded patients.

“…In human epilepsy, GVG antagonizes seizures, especially those of focal onset, and apparently has relatively few side effects (Pedersen et al, 1985;Sivenius et al, 1987 In the present study GVG was administered to 21 patients in whom epilepsy was one manifestation of multiple, both anatomical and functional, cerebral defects. Other abnormalities were mental retardation, defects in communication, and motor and visual disturbances.…”

Effects of vigabatrin on partial seizures and cognitive function.

“…Forty three patients entered the open phase of the trial, 23 from the placebo group and 20 from the vigabatrin treated group. On entering the open phase of the trial, seven of the 10 responders to vigabatrin continued the drug at 3 g/day; three withdrew, two to try other drug regimens, one for surgical assessment).…”

“…Several groups have reported changes in subjectively assessed aggression, irritability, and other mood components, 3 20 21 but other studies have shown no effect of vigabatrin on mood'819 and an overall improvement in quality of life and subjective wellbeing as assessed by questionnaire. '8 [21][22][23] Methods…”

“…Several groups have reported changes in subjectively assessed aggression, irritability, and other mood components, 3 20 21 but other studies have shown no effect of vigabatrin on mood'819 and an overall improvement in quality of life and subjective wellbeing as assessed by questionnaire. '8 [21][22][23] Methods PATIENTS AND PROCEDURES Forty five outpatients with partial seizures refractory to optimal antiepileptic drug treatment were studied. Patients had shown an ability to keep an accurate seizure diary distinguishing between simple partial seizures, complex partial seizures, and secondary generalised seizures.…”

Effects of Vigabatrin on Cognitive Function and Mood When Used as Add‐on Therapy in Patients with Intractable Epilepsy

“…Commonly reported side effects include drowsiness, dizziness, and mood changes (Rimmer and Richens, 1984;Sivenius et al, 1987;Tassinari et al, 1987;Matilainen et al, 1988; Mumford and Dam, 1989).…”