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Drug Evaluations

Vigabatrin: a comprehensive review of drug properties including clinical updates following recent FDA approval

, PharmD PhD & , PharmD
Pages 3077-3089 | Published online: 02 Dec 2009

Bibliography

  • Walsh S. Sabril approved by FDA to treat spasms in infants and epileptic seizures. 2009. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179855.htm [Last accessed 25 August 2009]
  • Gidal BE, Garnett WR. Epilepsy. In: DiPiro JT, Talbert RL, Yee GC, , editors, Pharmacotherapy: a pathophysiological approach. 6th edition. Chicago, IL: McGraw–Hill; 2005. pp. 1023-1048
  • Murro AM. Complex partial seizures. 2006. Available from: www.emedicine.com/neuro/topic74.htm [Last accessed 24 July 2009]
  • Wheless JW, Ramsay RE, Collins SD. Vigabatrin. Neurother 2007;4:163-72
  • Hemming K, Maguire MJ, Hutton JL, Marson AG. Vigabatrin for refractory partial epilepsy. Cochrane Database Syst Rev 2008;3:CD007302
  • Gaily E, Liukkonen E, Paetau R, Infantile spasms: diagnosis and assessment of treatment response by video-EEG. Dev Med Child Neurol 2001;43:658-67
  • Parisi P, Bombardieri R, Curatolo P. Current role of vigabatrin in infantile spasms. Eur J Paediatr Neurol 2007;11:331-6
  • Mackay MT, Weiss SK, Adams-Webber T, Practice parameter: medical treatment of infantile spasms. Report of the American academy of neurology and the child neurology society. Neurology 2004;62:1668-81
  • Chiron C, Dumas C, Jambaque I, Randomized trial comparing vigabatrin and hydrocortisone in infantile spasms due to tuberous sclerosis. Epilepsy Res 1997;26:389-95
  • Hancock EC, Osborne JP, Edwards SW. Treatment of infantile spasms. Cochrane Database Syst Rev 2008;4:CD001770
  • Lippert B, Metcalf BW, Jung MJ, Casara P. 4-Amino-hex-5-enoic acid, a selective catalytic inhibitor of 4-aminobutyric-acid aminotransferase in mammalian brain. Eur J Biochem 1977;74:441-5
  • Schechter PJ, Tranier Y. The pharmacology of enzyme-activated inhibitors of GABA-transaminase. Enzyme-act irreversible inhibitors. Proc Int Symp 1978:149-62
  • NDAs 20-427 & 22-006: Sabril Advisory Committee Backgrounder. 2008. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/ucm153750.htm [Last accessed 24 July 2009]
  • Young SB. Sabril® now available in US for patients with two difficult-to-treat epilepsies. 2009. Available from: http://www.lundbeckinc.com/USA/media/press-releases/2009/09_Sept21_SabrilLaunch.asp [Last accessed 25 September 2009]
  • Ovation Pharmaceuticals, Inc. Sabril (vigabatrin) Advisory Committee briefing document. Peripheral and Central Nervous System Advisory Committee, 2008:197
  • Ngo D-KH, Goldstein LB. Summary Minutes of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting, 7 January 2009. Peripheral and Central Nervous System Drugs Advisory Committee. Rockville, MD: US Food and Drug Administration, 2009
  • Ngo D-KH, Goldstein LB. Summary Minutes of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting 8 January 2009. Peripheral and Central Nervous System Drugs Advisory Committee. Rockville, MD: US Food and Drug Administration, 2009
  • Lundbeck, Inc. Lundbeck's acquisition of Ovation Pharmaceuticals cleared by US Federal Trade Commission. 2009. Available from: http://www.lundbeckinc.com/USA/media/press-releases/2009/09_March16_FTCclose.asp [Last accessed 29July 2009]
  • Grant SM, Heel RC. Vigabatrin: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in epilepsy and disorders of motor control. Drugs 1991;41:889-926
  • Gidal BE, Privitera MD, Sheth RD, Gilman JT. Vigabatrin: a novel therapy for seizure disorders. Ann Pharmacother 1999;33:1277-86
  • Mumford J, Dulac O. Vigabatrin: a new antiepileptic medication. J Child Neurol 1991;6(Suppl 2):S3-6
  • Willmore LJ, Abelson MB, Ben-Menachem E, Vigabatrin: 2008 update. Epilepsia 2009;50:163-73
  • Rey E, Pons G, Olive G. Vigabatrin. Clinical pharmacokinetics. Clin Pharmacokinet 1992;23:267-78
  • Shields WD, Sankar R. Vigabatrin. Semin Pediatr Neurol 1997;4:43-50
  • Schechter PJ. Vigabatrin. Curr Probl Epilepsy 1986;4:265-75
  • Sankar R, Derdiarian AT. Vigabatrin. CNS Drug Rev 1998;4:260-74
  • Reynolds EH. Vigabatrin. BMJ 1990;300:277-8
  • Mumford JP, Lewis PJ. Vigabatrin. Epilepsy Res Suppl 1991;3:161-8
  • Mumford JP, Cannon DJ. Vigabatrin. Epilepsia 1994;35:(Suppl 5):S25-8
  • Lewis H, Wallace SJ. Vigabatrin. Developmental medicine and child neurology 2001;43:833-5
  • French JA. Vigabatrin. Epilepsia 1999;40:(Suppl 5):S11-16
  • Connelly JF. Vigabatrin. Ann Pharmacother 1993;27:197-204
  • Calli J, Farrington E. Vigabatrin. Pediatr Nurs 1998;24:357-61
  • Ben-Menachem E. Vigabatrin. Handb Exp Pharmacol 1999;138:375-94
  • Ben-Menachem E. Vigabatrin. Epilepsia 1995;36:(Suppl 2):S95-104
  • Vigabatrin. Lancet 1989;1:532-3
  • Sabers A, Gram L. Pharmacology of vigabatrin. Pharmacol Toxicol 1992;70:237-43
  • Patsalos PN, Duncan JS. The pharmacology and pharmacokinetics of vigabatrin. Rev Contemp Pharmacother 1995;6:447-56
  • Richens A. Pharmacology and clinical pharmacology of vigabatrin. J Child Neurol 1991;6(Suppl 2):S7-10
  • Monaco F. Cognitive effects of vigabatrin: a review. Neurology 1996;47:(Suppl 1):S6-11
  • Schechter PJ. Clinical pharmacology of vigabatrin. Br J Clin Pharmacol 1989;27:(Suppl 1):19-22S
  • Yogeeswari P, Sriram D, Vaigundaragavendran J. The GABA shunt: an attractive and potential therapeutic target in the treatment of epileptic disorders. Curr Drug Metab 2005;6:127-39
  • Jakobs C, Jaeken J, Gibson KM. Inherited disorders of GABA metabolism. J Inherit Metab Dis 1993;16:704-15
  • Meldrum BS. GABAergic mechanisms in the pathogenesis and treatment of epilepsy. Br J Clin Pharmacol 1989;27:(Suppl 1):3-11S
  • Gale K. GABA and epilepsy: basic concepts from preclinical research. Epilepsia 1992;33:(Suppl 5):S3-12
  • Tillakaratne NJK, Medina-Kauwe L, Gibson KM. Gamma-aminobutyric acid (GABA) metabolism in mammalian neural and non-neural tissues. Comp Biochem Physiol A Physiol 1995;112A:247-63
  • Czuczwar SJ, Patsalos PN. The new generation of GABA enhancers: potential in the treatment of epilepsy. CNS Drugs 2001;15:339-50
  • Treiman DM. GABAergic mechanisms in epilepsy. Epilepsia 2001;42:(Suppl 3):8-12
  • Sarup A, Larsson OM, Schousboe A. GABA transporters and GABA-transaminase as drug targets. Curr Drug Targets CNS Neurol Disord 2003;2:269-77
  • Madsen KK, Larsson OM, Schousboe A. Regulation of excitation by GABA neurotransmission: focus on metabolism and transport. Results Probl Cell Differ 2008;44:201-21
  • Landmark CJ. Targets for antiepileptic drugs in the synapse. Med Sci Monit 2007;13:RA1-7
  • Draguhn A, Axmacher N, Kolbaev S. Presynaptic lonotropic GABA receptors. Results Probl Cell Differ 2008;44:69-85
  • Richerson GB. Looking for GABA in all the wrong places: the relevance of extrasynaptic GABA(A) receptors to epilepsy. Epilepsy Curr 2004;4:239-42
  • Sheean G, Schramm T, Anderson DS, Eadie MJ. Vigabatrin–plasma enantiomer concentrations and clinical effects. Clin Exp Neurol 1992;29:107-16
  • Riekkinen PJ, Ylinen A, Halonen T, Cerebrospinal fluid GABA and seizure control with vigabatrin. Br J Clin Pharmacol 1989;27:(Suppl 1):87-94S
  • Henczi M, Nagy J, Weaver DF. Determination of octanol-water partition coefficients by an HPLC method for anticonvulsant structure-activity studies. J Pharm Pharmacol 1995;47:345-7
  • Petroff OA, Rothman DL. Measuring human brain GABA in vivo: effects of GABA-transaminase inhibition with vigabatrin. Mol Neurobiol 1998;16:97-121
  • Pow DV, Baldridge W, Crook DK. Activity-dependent transport of GABA analogs into specific cell types demonstrated at high resolution using a novel immunocytochemical strategy. Neuroscience 1996;73:1129-43
  • Espie P, Whomsley R, Benedetti MS, Antiepileptic drugs as substrates, inhibitors and inducers of the multidrug resistance-associated proteins (MRPs): implications for endo- and xenobiotic interactions. New Res Epilepsy Behav 2007:33-55
  • Jacqz-Aigrain E, Guillonneau M, Rey E, Pharmacokinetics of the S(+) and R(-) enantiomers of vigabatrin during chronic dosing in a patient with renal failure. Br J Clin Pharmacol 1997;44:183-5
  • Storici P, De Biase D, Bossa F, Structures of γ-aminobutyric acid (GABA) aminotransferase, a pyridoxal 5′-phosphate, and [2Fe-2S] cluster-containing enzyme, complexed with γ-ethynyl-GABA and with the antiepilepsy drug vigabatrin. J Biol Chem 2004;279:363-73
  • Valdizan EM, Armijo JA. Effects of single and multiple increasing doses of vigabatrin on brain GABA metabolism and correlation with vigabatrin plasma concentration. Biochem Pharmacol 1992;43:2143-50
  • Ben-Menachem E, Persson LI, Mumford J, Effect of long-term vigabatrin therapy on selected neurotransmitter concentrations in cerebrospinal fluid. J Child Neurol 1991;6(Suppl 2):S11-6
  • Ben-Menachem E, Persson LI, Schechter PJ, The effect of different vigabatrin treatment regimens on CSF biochemistry and seizure control in epileptic patients. Br J Clin Pharmacol 1989;27:(Suppl 1):79-85S
  • Frisk-Holmberg M, Kerth P, Meyer P. Effect of food on the absorption of vigabatrin. Br J Clin Pharmacol 1989;27:(Suppl 1):23-5S
  • Hoke JF, Yuh L, Antony KK, Pharmacokinetics of vigabatrin following single and multiple oral doses in normal volunteers. J Clin Pharmacol 1993;33:458-62
  • Durham SL, Hoke JF, Chen TM. Pharmacokinetics and metabolism of vigabatrin following a single oral dose of [14C]vigabatrin in healthy male volunteers. Drug Metab Dispos 1993;21:480-4
  • Haegele KD, Schechter PJ. Kinetics of the enantiomers of vigabatrin after an oral dose of the racemate or the active S-enantiomer. Clin Pharmacol Ther 1986;40:581-6
  • Rey E, Pons G, Richard MO, Pharmacokinetics of the individual enantiomers of vigabatrin (gamma-vinyl GABA) in epileptic children. Br J Clin Pharmacol 1990;30:253-7
  • Bialer M. Comparative pharmacokinetics of the newer antiepileptic drugs. Clin Pharmacokinet 1993;24:441-52
  • Perucca E. Pharmacokinetic variability of new antiepileptic drugs at different ages. Ther Drug Monit 2005;27:714-17
  • Bourgeois BF. Important pharmacokinetic properties of antiepileptic drugs. Epilepsia 1995;36:(Suppl 5):S1-7
  • Haegele KD, Huebert ND, Ebel M, Pharmacokinetics of vigabatrin: implications of creatinine clearance. Clin Pharmacol Ther 1988;44:558-65
  • Yu DK, Hutcheson SJ, Wei G, A comparison of population and standard two-stage pharmacokinetic analyses of vigabatrin data. Biopharm Drug Dispos 1994;15:473-84
  • Lacerda G, Krummel T, Sabourdy C, Optimizing therapy of seizures in patients with renal or hepatic dysfunction. Neurology 2006;67:(Suppl 4):S28-33
  • Tong X, Ratnaraj N, Patsalos PN. The pharmacokinetics of vigabatrin in rat blood and cerebrospinal fluid. Seizure 2007;16:43-9
  • Sanchez-Alcaraz A, Quintana MB, Lopez E, Effect of vigabatrin on the pharmacokinetics of carbamazepine. J Clin Pharm Ther 2002;27:427-30
  • Browne TR, Mattson RH, Penry JK, Vigabatrin for refractory complex partial seizures: multicenter single-blind study with long-term follow-up. Neurology 1987;37:184-9
  • Tartara A, Manni R, Galimberti CA, Vigabatrin in the treatment of epilepsy: a long-term follow-up study. J Neurol Neurosurg Psychiatry 1989;52:467-71
  • Loscher W, Schmidt D. Experimental and clinical evidence for loss of effect (tolerance) during prolonged treatment with antiepileptic drugs. Epilepsia 2006;47:1253-84
  • Browne TR, Mattson RH, Penry JK, A multicentre study of vigabatrin for drug-resistant epilepsy. Br J Clin Pharmacol 1989;27:(Suppl 1):95-100S
  • Remy C, Beaumont D. Efficacy and safety of vigabatrin in the long-term treatment of refractory epilepsy. Br J Clin Pharmacol 1989;27:(Suppl 1):125-9S
  • Petroff OA, Rothman DL, Behar KL, Mattson RH. Human brain GABA levels rise after initiation of vigabatrin therapy but fail to rise further with increasing dose. Neurology 1996;46:1459-63
  • French JA, Mosier M, Walker S, A double-blind, placebo-controlled study of vigabatrin three g/day in patients with uncontrolled complex partial seizures. Vigabatrin Protocol 024 Investigative Cohort. 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;40:74-82
  • Mumford JP, Dam M. Meta-analysis of European placebo controlled studies of vigabatrin in drug resistant epilepsy. Br J Clin Pharmacol 1989;27:(Suppl 1):101-7S
  • Appleton RE, Peters ACB, Mumford JP, Shaw DE. Randomized, placebo-controlled study of vigabatrin as first-line treatment of infantile spasms. Epilepsia 1999;40:1627-33
  • Elterman RD, Shields WD, Mansfield KA, Randomized trial of vigabatrin in patients with infantile spasms. Neurology 2001;57:1416-21
  • Hancock E, Osborne J, Milner P. Treatment of infantile spasms. Cochrane Database Syst Rev 2003;3:CD001770
  • Jackson GD, Grunewald RA, Connelly A, Duncan JS. Quantitative MR relaxometry study of effects of vigabatrin on the brains of patients with epilepsy. Epilepsy Res 1994;18:127-37
  • Cohen JA, Fisher RS, Brigell MG, The potential for vigabatrin-induced intramyelinic edema in humans. Epilepsia 2000;41:148-57
  • Pearl PL, Vezina LG, Saneto RP, Cerebral MRI abnormalities associated with vigabatrin therapy. Epilepsia 2009;50:184-94
  • Kalviainen R, Nousiainen I. Visual field defects with vigabatrin: epidemiology and therapeutic implications. CNS Drugs 2001;15:217-30
  • Trimble MR. The psychosis of epilepsy. New York: Raven Press; 1991
  • Levinson DF, Devinsky O. Psychiatric adverse events during vigabatrin therapy. Neurology 1999;53:1503-11
  • Ferrie CD, Robinson RO, Panayiotopoulos CP. Psychotic and severe behavioral reactions with vigabatrin: a review. Acta Neurol Scand 1996;93:1-8
  • Thomas L, Trimble M. Schmitz B, Ring H. Vigabatrin and behavior disorders: A retrospective survey. Epilepsy Res 1996;25(1):21-7
  • Wong ICK. Retrospective study of vigabatrin and psychiatric behavioral disturbances. Epilepsy Res 1995;21:227-30
  • Lundbeck, Inc. Support, help and resources for epilepsy: a comprehensive resource for healthcare professionals and their patients with severe or uncontrolled epilepsies. 2009. Available from: http://www.lundbeckshare.com/Default.aspx [Last accessed 15 October 2009]
  • Storici P, Capitani G, De Biase D, Crystal structure of GABA-aminotransferase, a target for antiepileptic drug therapy. Biochemistry 1999;38:8628-34
  • Storici P, Capitani G, De Biase D, 4-aminobutyrate-aminotransferase from pig. 1999. Available from: http://www.rcsb.org/pdb/explore.do?structureId=1OHV [Last accessed 28 July 2009]
  • Storici P, De Biase D, Bossa F, 4-aminobutyrate-aminotransferase inactivated by gamma-vinyl GABA. 2004. Available from: http://www.rcsb.org/pdb/explore/explore.do?structureId=1OHW [Last accessed 27 July 2009]

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