[Open multicenter study of the effectiveness and safety of gabitril in epileptic patients with partial seizures].
The paper presents the results obtained by 53 investigators implementing the first Polish multicentre study of the effectiveness and safety of tiagabine (Gabitril). The study included 81 patients with refractory epilepsy with partial seizures. The duration of the study was 16 weeks. For the initial 6 weeks, Gabitril was gradually introduced till a dose of 30 mg/day was achieved. Within the subsequent 10 weeks the treatment effectiveness was observed and monitored, with the provision that the dose could be increased. The final analysis included 62 patients, while in 12 subjects the treatment was discontinued in less than 16 weeks. The results indicate a very beneficial effect of Gabitril on the frequency of seizures in patients with drug-resistant epilepsy. Almost 1 of the analyzed patients were seizure free. The most beneficial effects with respect to seizure number and intensity reduction were noted in subjects with partial complex and partial seizures with secondary generalization. The dynamic character of the decrease in seizure frequency was best observed between the first and third month of therapy. In 2/3 of patients the recommended dose was achieved and maintained. Less than 15% of subjects were excluded from the study, mainly due to lack of therapeutic effects. The number and character of adverse effects observed in the course of the present study did not differ from these noted in long-term Gabitril trials. The drug was demonstrated to exert no effect on vital functions and laboratory parameters. The results confirm the high effectiveness of Gabitril in treatment of patients with partial seizures and a good tolerance of this agent.
Kliniki Neurologii Collegium Medicum UJ w Krakowie.
P
P
Czapiński
J
J
Jedrzejczak
A
A
Kozik
W
W
Sobaniec
J
J
Wendorff
P
P
Grygolec
D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000145:classification / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D009557:Nipecotic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D000078308:Tiagabine; D016896:Treatment Outcome
D000927:Anticonvulsants; D009557:Nipecotic Acids; D000078308:Tiagabine