Abstract
1 A meta-analysis has been performed on nine placebo controlled trials of vigabatrin (GVG) administered as add-on therapy to patients suffering from drug resistant epilepsy.
2 There were two pilot placebo-controlled dose ranging studies, six double-blind crossover studies and a multicentre response controlled study.
3 There were a total of 398 patients entered and 390 have been evaluated for safety and 337 for efficacy.
4 In spite of the difficulties in the clinical evaluation of new antiepileptic drugs, a reduction in seizure frequency was reported following the addition of vigabatrin to the concomitant medication in all studies. This was statistically significant in the larger of the two pilot studies, the multicentre study and three of the six double-blind studies.
5 There was a statistically significant reduction in seizures of in all six double-blind studies when the 98 patients suffering from complex partial seizures with or without generalisation were considered. Seventy two percent of these patients showed a greater than 25% reduction in seizure frequency.
6 Vigabatrin was well tolerated. The frequency of adverse events was similar to that reported elsewhere.
Keywords: vigabatrin, placebo-controlled studies, efficacy, safety
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Selected References
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- Browne T. R., Mattson R. H., Penry J. K., Smith D. B., Treiman D. M., Wilder B. J., Ben-Menachem E., Napoliello M. J., Sherry K. M., Szabo G. K. Vigabatrin for refractory complex partial seizures: multicenter single-blind study with long-term follow-up. Neurology. 1987 Feb;37(2):184–189. doi: 10.1212/wnl.37.2.184. [DOI] [PubMed] [Google Scholar]
- Dollery C. T. A bleak outlook for placebos (and for science) Eur J Clin Pharmacol. 1979 May 21;15(4):219–221. doi: 10.1007/BF00618508. [DOI] [PubMed] [Google Scholar]
- Feinstein A. R. Should placebo-controlled trials be abolished? Eur J Clin Pharmacol. 1980 Jan;17(1):1–4. doi: 10.1007/BF00561669. [DOI] [PubMed] [Google Scholar]
- Gram L., Klosterskov P., Dam M. gamma-Vinyl GABA: a double-blind placebo-controlled trial in partial epilepsy. Ann Neurol. 1985 Mar;17(3):262–266. doi: 10.1002/ana.410170307. [DOI] [PubMed] [Google Scholar]
- Gram L., Lyon B. B., Dam M. Gamma-vinyl-GABA: a single-blind trial in patients with epilepsy. Acta Neurol Scand. 1983 Jul;68(1):34–39. doi: 10.1111/j.1600-0404.1983.tb04812.x. [DOI] [PubMed] [Google Scholar]
- Loiseau P., Hardenberg J. P., Pestre M., Guyot M., Schechter P. J., Tell G. P. Double-blind, placebo-controlled study of vigabatrin (gamma-vinyl GABA) in drug-resistant epilepsy. Epilepsia. 1986 Mar-Apr;27(2):115–120. doi: 10.1111/j.1528-1157.1986.tb03512.x. [DOI] [PubMed] [Google Scholar]
- Reynolds E. H., Elwes R. D., Shorvon S. D. Why does epilepsy become intractable? Prevention of chronic epilepsy. Lancet. 1983 Oct 22;2(8356):952–954. doi: 10.1016/s0140-6736(83)90462-2. [DOI] [PubMed] [Google Scholar]
- Rimmer E. M., Richens A. Double-blind study of gamma-vinyl GABA in patients with refractory epilepsy. Lancet. 1984 Jan 28;1(8370):189–190. doi: 10.1016/s0140-6736(84)92112-3. [DOI] [PubMed] [Google Scholar]
- Schechter P. J., Hanke N. F., Grove J., Huebert N., Sjoerdsma A. Biochemical and clinical effects of gamma-vinyl GABA in patients with epilepsy. Neurology. 1984 Feb;34(2):182–186. doi: 10.1212/wnl.34.2.182. [DOI] [PubMed] [Google Scholar]
- Tartara A., Manni R., Galimberti C. A., Hardenberg J., Orwin J., Perucca E. Vigabatrin in the treatment of epilepsy: a double-blind, placebo-controlled study. Epilepsia. 1986 Nov-Dec;27(6):717–723. doi: 10.1111/j.1528-1157.1986.tb03600.x. [DOI] [PubMed] [Google Scholar]
- Tassinari C. A., Michelucci R., Ambrosetto G., Salvi F. Double-blind study of vigabatrin in the treatment of drug-resistant epilepsy. Arch Neurol. 1987 Sep;44(9):907–910. doi: 10.1001/archneur.1987.00520210009010. [DOI] [PubMed] [Google Scholar]