Six-year follow-up study on the efficacy and safety of vigabatrin in patients with epilepsy.
Twenty-five patients with epilepsy (mostly with partial seizures) who had responded favourably to a short-term trial of add-on vigabatrin entered maintenance treatment. After 52 to 78 months, 15 patients continue to take the drug with good therapeutic response. Median monthly seizure frequency during the last 2 months on vigabatrin in all patients, including drop-outs, was 3.5 (range 0-74) as compared with 10 (range 3-98) during an initial placebo period (p < 0.01). Drop-outs were caused by adverse events in 2 cases (ataxia and psychotic symptoms respectively), seizure breakthrough in 4 cases and reasons unrelated to treatment in 4 patients. In most patients, side effects were absent or mild, the most frequent complaint being weight gain. It is concluded that the antiepileptic efficacy and good clinical tolerability of vigabatrin are generally maintained during long-term treatment for up to 6 years.
Tartara
A
A
Institute of Neurology C. Mondino, Department of Medical Pharmacology, University of Pavia, Italy.
Manni
R
R
Galimberti
C A
CA
Morini
R
R
Mumford
J P
JP
Iudice
A
A
Perucca
E
E
D000293:Adolescent; D000328:Adult; D000614:Aminocaproates / Q000009:adverse effects / Q000627:therapeutic use*; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D001933:Brain Stem / Q000187:drug effects / Q000503:physiopathology; D002540:Cerebral Cortex / Q000187:drug effects / Q000503:physiopathology; D004569:Electroencephalography / Q000187:drug effects; D004828:Epilepsies, Partial / Q000188:drug therapy / Q000503:physiopathology; D004827:Epilepsy / Q000188:drug therapy* / Q000503:physiopathology; D004832:Epilepsy, Absence / Q000188:drug therapy / Q000503:physiopathology; D017029:Epilepsy, Complex Partial / Q000188:drug therapy / Q000503:physiopathology; D004829:Epilepsy, Generalized / Q000188:drug therapy / Q000503:physiopathology; D004830:Epilepsy, Tonic-Clonic / Q000188:drug therapy / Q000503:physiopathology; D005071:Evoked Potentials / Q000187:drug effects / Q000502:physiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D020888:Vigabatrin
D000614:Aminocaproates; D000927:Anticonvulsants; D020888:Vigabatrin