Revista de neurologia · 2000
[Open study with tiagabine in partial epilepsy].
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Arroyo S
Аннотация
OBJECTIVE: Observational studies are necessary for evaluation of the efficacy and safety of the new anti-epileptic drugs. Unlike blind, randomised studies, observational studies are carried out in populations of less resistant patients in normal clinical practice. Therefore these trials give valuable information regarding the efficacy and safety of anti-epileptic drugs.
PATIENTS AND METHODS: A multicentre trial was carried out in Spain in which patients with partial epilepsy treated with one or more anti-epileptic drugs were also given tiagabine. Tiagabine was started at a dose of 5 mg per day and increased weekly by 5 mg until the dose considered suitable or a maximum of 70 mg per day was reached. Data were collected on the aetiology of the seizures, their frequency and type and the presence of side-effects. The study was planned to take place over one year, but this paper is being written after six months follow-up.
RESULTS: We studied 645 patients with an average age of 35.4 years. The average duration of their epilepsy was 18.3 years and 76.6% of patients had previously received three or more anti-epileptic drugs. The average dose of tiagabine reached during the maintenance period was 32.6 mg/day. After six months of treatment 29.4% of the patients had had no seizures during the last three months of the trial and 67% of the population had a reduction in seizures of over 50%. Some form of side-effect was seen in 52.4% of the patients during the study period. The commonest of these was somnolence (28.2% of the patients) but fainting (23.4%) and difficulty in paying attention/concentration were seen less frequently (15%). In most cases the side-effects were transient or slight (tolerable). No patient had non-convulsive illness. During the study tiagabine was stopped in 166 patients (25.7% of the total) due to lack of efficacy or intolerance.
CONCLUSION: Tiagabine is effective, well tolerated add-on therapy in patients with partial epilepsy.
PATIENTS AND METHODS: A multicentre trial was carried out in Spain in which patients with partial epilepsy treated with one or more anti-epileptic drugs were also given tiagabine. Tiagabine was started at a dose of 5 mg per day and increased weekly by 5 mg until the dose considered suitable or a maximum of 70 mg per day was reached. Data were collected on the aetiology of the seizures, their frequency and type and the presence of side-effects. The study was planned to take place over one year, but this paper is being written after six months follow-up.
RESULTS: We studied 645 patients with an average age of 35.4 years. The average duration of their epilepsy was 18.3 years and 76.6% of patients had previously received three or more anti-epileptic drugs. The average dose of tiagabine reached during the maintenance period was 32.6 mg/day. After six months of treatment 29.4% of the patients had had no seizures during the last three months of the trial and 67% of the population had a reduction in seizures of over 50%. Some form of side-effect was seen in 52.4% of the patients during the study period. The commonest of these was somnolence (28.2% of the patients) but fainting (23.4%) and difficulty in paying attention/concentration were seen less frequently (15%). In most cases the side-effects were transient or slight (tolerable). No patient had non-convulsive illness. During the study tiagabine was stopped in 166 patients (25.7% of the total) due to lack of efficacy or intolerance.
CONCLUSION: Tiagabine is effective, well tolerated add-on therapy in patients with partial epilepsy.