[GEOS (Gabitril Epilepsy Observational Study) -- Polish results of the international study of tiagabine in partial epilepsy].
OBJECTIVE
Tiagabine (TGB) is a new antiepileptic drug with a unique mechanism of action, with efficacy and tolerance confirmed in many randomized, placebo-controlled add-on trials in patients with partial epilepsy. The main aim of the international GEOS study (Gabitril Epilepsy Observational Study) was to analyze the efficacy and safety of TGB as an add-on therapy in everyday clinical practice.


METHODS
260 patients from Poland (1227 in the whole study) were enrolled (mean age 35.0+/-13.7 years). 53% had symptomatic epilepsy, 25% idiopathic, 12% cryptogenic, in remaining 10% of patients the etiology of the epileptic syndrome had not been determined. 69% of patients had complex partial seizures (CPS), 60% of patients had secondary generalized tonic clonic seizures (SGTCS) and 32% of patients had simple partial seizures (SPS). The patients were observed for 12 months.


RESULTS
The full study was completed by 201 (76%) of patients. The mean TGB dose received at the end of the study was 31,3+/-12 mg/day. At the end of the study, i. e. after 12 months, 75% patients with SP, 67% patients with SGTCS and 48% patients with CPS were free of seizures. 94% of patients with SPS, 92% patients with SGTCS and 91% of patients with CPS had 50% or more reduction in seizures versus baseline. TGB was well-tolerated, adverse events appeared in 14% of patients and had mild or moderate severity.


CONCLUSIONS
The obtained results confirmed that TGB was effective and well-tolerated in everyday clinical practice when given as add-on therapy to patients with partial epilepsy.
Niedzielska
Krystyna
K
Zakład Neurofizjologii Klinicznej, Instytut Psychiatrii i Neurologii, ul. Sobieskiego 1/9, 02-912 Warszawa. niedziel@ipin.edu.pl
D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004828:Epilepsies, Partial / Q000145:classification / Q000188:drug therapy* / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D018755:GABA Agonists / Q000627:therapeutic use*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009557:Nipecotic Acids / Q000627:therapeutic use*; D011044:Poland / Q000453:epidemiology; D000078308:Tiagabine; D016896:Treatment Outcome
D000927:Anticonvulsants; D018755:GABA Agonists; D009557:Nipecotic Acids; D000078308:Tiagabine