Abstract
Vigabatrin is an antiepileptic drug, used in epilepsy since three decades ago, is indicated in the treatment of refractory complex partial seizures and infantile spasms, specially associated to tuberous sclerosis, but the Visual Fields Defects (VFD), has limited its use in some countries. Nevertheless in others such as United Kingdom, France, in Asia like Japan and Latinamerica, its use has continue, and now VGB was approved in the USA in August 2009 by the Food and Drug administration (FDA) as adjunctive therapy for the treatment of refractory complex partial seizures in adults and for the infantile spasm. The FDA implemented a Risk Evaluation and Mitigation Strategy to control for the possibility of adverse drug events. In this paper we review generalities, pharmacokinetic and pharmacologic properties and its role like antiepileptic drug, indications according to type of seizures and use limitations due to visual field defects.
References
Gram L, Blatt Lyon B, Dam M. Gamma-vinyl-GABA: a single-blind- trial in patients with epilepsy. Acta Neurol Scand 1983; 68: 34-39.Uso clínico de Vigabatrín en epilepsia
Schechter PJ, Hanke NF, Gove J et al. Biochemical and clinical effects of gamma-vinyl-GABA in patients with epilepsy. Neurology 1984; 34: 182-186.
Gram L, Klosterskov P, Dam M. Gamma-vinyl- GABA: a doble-blind placebo-controlled trial in partial epilepsy. Ann Neurol 1985; 17: 262-266.
Schechter PJ. Vigabatrin. In Meldrum BS, Porter RJ, editors, Current problems in epilepsy: New anticonvulsant drugs. London: Libby, 1986; (4): 265-275.
Richens A, Levy RH, Dreifuss FE et al. Potential antiepileptic drugs: vigabatrin. Antiepileptic drugs. Raven Press 1989; 937-946.
Reynolds HE. Vigabatrin rational treatment for chronic epilepsy. Br Med J 1990; 300: 277-278.
Reynolds EH, Ring HA, Farr IN, Heller AJ, Elwes RDC. Open, Double-Blind and Long-Term Study of Vigabatrin in Chronic Epilepsy. Vigabatrin. Epilepsia 1991; 32(4): 530-538.
Chiron C, Dulac O, Beaumont D, Palacios L, Pajot N, Mumford J. Terapeutic Trial of Vigabatrin in refractory Infantile spasms. Journal of Child Neurology 1991; 6(Supl 2): 52-58.
Gram L, Sabers A, Dulac O. Tratamiento de epilepsias pediátricas con Gamma-Vinil-Gaba (Vigabatrín). Epilepsia 1992; 33(Supl.5): 526-529.
Eke T, Talbot JF, Lawden MC. Severe persistent visual field constriction associated with Vigabatrin. BMJ 1997; 314: 180-181.
Wild JM, Martínez C, Reinshagen G, Harding GFA. Characteristics of a unique visual field defect attributed to vigabatrin. Epilepsia 1999; 40(12): 1784-1794.
Lawden MC, Eke T, Degg C, Harding GFA, Wild JM. Visual field defects associated with vigabatrin therapy. J Neurol Neurosurg Psychiatry 1999; 67: 716-722.
Commission on Classification and Terminology of the International League Against Epilepsy. Proposal for revised clinical and electroencephalographic classification of epileptic seizures. Epilepsia 1981; 22: 489-501.
Tolman J, Faulkner M. Vigabatrin: a comprehensive review of drug properties including clinical updates following recent FDA approval. Expert Opin Pharmacother 2009; 10(18): 3077-3089.
Ovation Pharmaceuticals, INC. Sabril (Vigabatrin) Advisory Committee briefing document. Peripheral and Central Nervous System Advisory Committee 2008: 197.
Department of Health & Human Services. NDA 20-427. Robert Temple, Office Director, Office of Drug Evaluation I. Center for Drug evaluation and Research; 2009.
Commission on Classification and Terminology of the International League Against Epilepsy. Proposal for a revised clinical and electroencephalographic classification of epilepsies and epileptic syndromes. Epilepsia 1989; 30: 389-399.
Grant SM, Heel RC. Vigabatrin: a review off its pharmacodynamic and pharmacokinetic properties and therapeutic potencial in epilepsy and disorders of motor control. Drugs 1991; 41: 889-926.
Willmore L, Abelson M, Ben-Menachem E, Pellock J, Donald Shields W. Vigabatrin: 2008 Update. Epilepsia 2009; 50(2):163-173.
Hemming K, Maguire MJ, Hutton JL, Marzon AG. Vigabatrin for refractory partial epilepsy. [Cochrane Database of Systematic Reviews 2008. Issue 3].
Karla H, Mellissa M, Jane H, Anthony M. Vigabatrin for Refractory partial Epilepsy. [Cochrane database of Sistematic Reviews 2009, Issue 3].
McKee PJ, Blacklaw J, Friel E, Thompson G, Gillham RA, Brodie MJ. Adjuant Vigabatrin in efractory Epilepsy: A Ceiling to Efective Dosage in Individual Patients? Epilepsia 1993; 34(5): 937-943.
Engel J Jr. Report of the ILAE. Classification Core Group. Epilepsia 2006; 47(9): 1558-1568.
Chiron C, Dumas C, Jambaque I et al. Roandomized trial comparing vigabatrin and hydrocortisone in infantile spasms due to tuberous sclerosis. Epilepsy Res 1997; 26: 389-395.
Guberman A, Bruni J and the Canadian Vigabatrin Study Group. Long-term open multicentre, add on trial of vigabatrin in adult resistant partial epilepsy. Seizure 2000; 9:112-118.
French JA, Mosier M, Walker S, Sommerville K, Sussman N and the Vigabatrin Protocol 024 Investigative Cohort. A double-blind, placebo-controlled study of vigabatrin three g/day in patients with uncontrolled complex partial seizures. Neurology 1996; 46: 54-61.
Dean C, Mosier M, Penry K. Dose-Response Study of Vigabatrin as Add-on Therapy in Patients with Uncontrolled Complex Partial Seizures. Epilepsia 1999; 40(1): 74-82.
Appleton RE, Peters ACB, Mundford JP, Shaw DE. Randomized, placebo-controlled study of vigabatrin as first-line treatment of infantile spasms. Epilepsia 1999; 40: 1627-33.
Beyenbiurg S, Stavem K, Schmidt D. Placebo-corrected efficacy of modern antiepileptic drugs for refractory epilepsy: Systematic review and meta-analisys. Epilepsia 2010; 51(1): 7-26.
Elterman RD, Shields WD, Masfield KS et al. Randomized trial of Vigabatrin in patients with infantile spasms. Neurology 2001; 57: 1416-21.
Ovation pharmaceutical, Inc. 2007 a (Data on file). Sabril (Vigabatrin). Table safety update NDA 20-427. December 28, 2007.
Acta Neurol Colomb Vol. 26 No. 1 Suplemento (1:1) Marzo 2010
Ylinen R, Kalvianein PJ, Rieckinnen SR. Eficacia a largo plazo y efectos cognoscitivos del vigabatrín. Acta Neurológica Scandinavica 1995; Suppl. 162: 47-50.
Pearl PL, Vezina LG, Saneto RP et al. Cerebral MRI anormalities associates with Vigabatrin therapy. Epilepsia 2009; 50(2): 184-94.
Wheless JW, Carmant L, Bebin M, Conry JA, Chiron C, Elterman RD, Frost M et al. Magnetic Resonance Imaging Abnormalities Associated with Vigabatrin in Patiens with Epilepsy. Epilepsia 2009; 50(2): 195-205.
Sabaniec W, Kulak W, Strzelecka J, Smigielska-Kuszia J, Bockowski L. A comparative study of vigabatrin vs carbamazepina in monotherapy of newly diagnosed partial seizures in children. Pharmacological Reports 2005; 57: 646-653.
Schmit T, Ruther K, Jokiel B, Pfeiffer S, Tiel-Wilck K, Schmitz B. Is visual field constriction in epilepsy patients treated with vigabatrin reversible? J Neurol 2002; 249: 1066-71.
Bruni J, Guberman A, Vachin L. Desforges and The Canadian Vigabatrin Study Group. Vigabatrin as add-on therapy for adult complex partial seizures: double-blind, placebo-controlled multicentre study: Seizure 2000; 9: 224-232
Johnson MA, Krauss GL, Miller NR, Medura M, Paul SR. Visual Funtion loss from vigabatrin: effect of stopping the drug. Neurology 2000; 55: 40-5.
Krakow K, Polizzi G, Riordan-Eva P, Holder G, MacLeod WN, Fish DR. Recovery of visual constriction following discontinuation of vigabatrin. Seizure 2000; 9: 287-90.
Fledelius HC. Vigabatrin associated visual field constriction in a longitudinal series. Reversibility suggested after drug withdrawal. Acta Oftalmol Scand 2003; 81: 41-46.
Versino M, Veggiotti P. Reversibility of Vigabatrin induced visual field defect. Lancet 1999; 354: 486.
Giordano L, Valseriati D, Vignoli A, Morescalchi F, Gandolfo E. Another case of resersibility of visual-defect induced by vigabatrin monotherapy: is young age a favorable factor? Neurol Sci 2000; 21: 185-186.
Kinirons P, Cacvalleri GL, O´Rourke D, Doherty CP, Reid I, Logan P, Liggan B et al. Vigabatrin retinopathy in an Irish Cohort: Lack of Correlation with Dose. Epilepsia 2006, 47(2): 311-317.
Jeong You S, Ahn H, Ko T. Vigabatrin and Visual Field Defects in Pediatric Epilepsy Patients. J Korean Med Sci 2006; 21: 728-732.
Wild J, Anh H, Baulac M, Bursztyn J, Chiron C, Gandolfo E, Safran A et al. Vigabatrin and Epilepsy: Lessons Learned. Epilepsia 2007; 48(7): 1318-1327.
Dulac O. Severe relapse of epilepsy after Vigabatrin withdrawal: for how long should we treat Symptomatic Infantile Spasms? Epilepsia, 2007; 48(3).
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.