Abstract
Thirty patients with drug-resistant epileptic seizures received vigabatrin as add-on treatment in a single-blind, placebo-controlled dose-modification study. After a 3-month baseline period (1 month run-in, 2 months placebo), the patients were given vigabatrin (2 g/day, fixed dose) for 2 months, followed by a 2- to 6-month dose-titration period to achieve the individual optimal dose. Mean monthly seizure frequency significantly decreased from 29.5 seizures during the placebo period to 12.2 while taking vigabatrin, 2 g daily fixed-dose, and to 8.7 during titration phase with vigabatrin, 3 g daily, on average. Sixteen (53%) patients experienced a 50% or greater reduction in seizure frequency compared with placebo, and 3 (10%) patients reported a relevant improvement in seizure severity and duration while on vigabatrin, 3 g daily; therefore, 19 (63%) patients were allowed to continue the treatment on a long-term basis. Adverse effects, mostly drowsiness and weight gain, occurred particularly at the highest vigabatrin dose, although also in any case of mild severity. Serum phenytoin and phenobarbital levels significantly decreased during vigabatrin treatment. These results suggest that vigabatrin in a dose of 2-3 g daily is an effective and safe antiepileptic drug.
| Original language | English |
|---|---|
| Pages (from-to) | 248-252 |
| Number of pages | 5 |
| Journal | Journal of Epilepsy |
| Volume | 5 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 1992 |
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Keywords
- Complex partial seizures
- Drug interaction
- Refractory epilepsy
- Vigabatrin
ASJC Scopus subject areas
- Clinical Neurology
- Neuroscience(all)
Cite this
Single-blind, placebo-controlled dose-modification study of vigabatrin in refractory epileptic patients. / Michelucci, Roberto; Cavaciocchi, Paolo; Riguzzi, Patrizia; Passarelli, Daniela; Parmeggiani, Lucio; Santangelo, Mario; Zamagni, Monica; Ludice, Alfonso; Tassinari, Carlo Alberto.
In: Journal of Epilepsy, Vol. 5, No. 4, 1992, p. 248-252.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Single-blind, placebo-controlled dose-modification study of vigabatrin in refractory epileptic patients
AU - Michelucci, Roberto
AU - Cavaciocchi, Paolo
AU - Riguzzi, Patrizia
AU - Passarelli, Daniela
AU - Parmeggiani, Lucio
AU - Santangelo, Mario
AU - Zamagni, Monica
AU - Ludice, Alfonso
AU - Tassinari, Carlo Alberto
PY - 1992
Y1 - 1992
N2 - Thirty patients with drug-resistant epileptic seizures received vigabatrin as add-on treatment in a single-blind, placebo-controlled dose-modification study. After a 3-month baseline period (1 month run-in, 2 months placebo), the patients were given vigabatrin (2 g/day, fixed dose) for 2 months, followed by a 2- to 6-month dose-titration period to achieve the individual optimal dose. Mean monthly seizure frequency significantly decreased from 29.5 seizures during the placebo period to 12.2 while taking vigabatrin, 2 g daily fixed-dose, and to 8.7 during titration phase with vigabatrin, 3 g daily, on average. Sixteen (53%) patients experienced a 50% or greater reduction in seizure frequency compared with placebo, and 3 (10%) patients reported a relevant improvement in seizure severity and duration while on vigabatrin, 3 g daily; therefore, 19 (63%) patients were allowed to continue the treatment on a long-term basis. Adverse effects, mostly drowsiness and weight gain, occurred particularly at the highest vigabatrin dose, although also in any case of mild severity. Serum phenytoin and phenobarbital levels significantly decreased during vigabatrin treatment. These results suggest that vigabatrin in a dose of 2-3 g daily is an effective and safe antiepileptic drug.
AB - Thirty patients with drug-resistant epileptic seizures received vigabatrin as add-on treatment in a single-blind, placebo-controlled dose-modification study. After a 3-month baseline period (1 month run-in, 2 months placebo), the patients were given vigabatrin (2 g/day, fixed dose) for 2 months, followed by a 2- to 6-month dose-titration period to achieve the individual optimal dose. Mean monthly seizure frequency significantly decreased from 29.5 seizures during the placebo period to 12.2 while taking vigabatrin, 2 g daily fixed-dose, and to 8.7 during titration phase with vigabatrin, 3 g daily, on average. Sixteen (53%) patients experienced a 50% or greater reduction in seizure frequency compared with placebo, and 3 (10%) patients reported a relevant improvement in seizure severity and duration while on vigabatrin, 3 g daily; therefore, 19 (63%) patients were allowed to continue the treatment on a long-term basis. Adverse effects, mostly drowsiness and weight gain, occurred particularly at the highest vigabatrin dose, although also in any case of mild severity. Serum phenytoin and phenobarbital levels significantly decreased during vigabatrin treatment. These results suggest that vigabatrin in a dose of 2-3 g daily is an effective and safe antiepileptic drug.
KW - Complex partial seizures
KW - Drug interaction
KW - Refractory epilepsy
KW - Vigabatrin
UR - http://www.scopus.com/inward/record.url?scp=0026448336&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0026448336&partnerID=8YFLogxK
U2 - 10.1016/S0896-6974(05)80125-2
DO - 10.1016/S0896-6974(05)80125-2
M3 - Article
AN - SCOPUS:0026448336
VL - 5
SP - 248
EP - 252
JO - Journal of Epilepsy
JF - Journal of Epilepsy
SN - 0896-6974
IS - 4
ER -