Ezogabine: An evaluation of its efficacy and safety as adjunctive therapy for partial-onset seizures in adults;Ezogabina: Una evaluación de su eficacia y seguridad como tratamiento adyuvante para convulsiones parciales en adultos

Annals of Pharmacotherapy

Volumn 46, Issue 10, 2012, Pages 1358-1367

  Yamada, Mikiko ^a   Welty, Timothy E ^a  

^a UNIVERSITY OF KANSAS   (United States)

Author keywords

Antiepileptic drugs; Ezogabine; Partial seizure; Potassium channel; Retigabine

Indexed keywords

4 AMINOBUTYRIC ACID; LAMOTRIGINE; PHENOBARBITAL; PLACEBO; RETIGABINE; VOLTAGE GATED POTASSIUM CHANNEL;

ABNORMAL THINKING; AMNESIA; ANTICONVULSANT THERAPY; ANXIETY DISORDER; ARTICLE; ASTHENIA; ATAXIA; ATTENTION DISTURBANCE; BLURRED VISION; CONFUSION; CONSTIPATION; COORDINATION DISORDER; DIPLOPIA; DISORIENTATION; DIZZINESS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG CONTRAINDICATION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG FORMULARY; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DYSARTHRIA; DYSURIA; FATIGUE; FOCAL EPILEPSY; GAIT DISORDER; HEADACHE; HUMAN; IN VITRO STUDY; INFLUENZA; MAXIMUM PLASMA CONCENTRATION; MEMORY DISORDER; MULTIPLE CYCLE TREATMENT; NAUSEA; NONHUMAN; PATIENT COUNSELING; PRIORITY JOURNAL; PROSPECTIVE STUDY; SINGLE DRUG DOSE; SOMNOLENCE; SPEECH DISORDER; TIME TO MAXIMUM PLASMA CONCENTRATION; TREMOR; URINARY TRACT INFECTION; VOMITING;

ADULT; ANIMALS; ANTICONVULSANTS; CARBAMATES; DRUG INTERACTIONS; EPILEPSIES, PARTIAL; HUMANS; PHENYLENEDIAMINES; TREATMENT OUTCOME;

EID: 84867756263     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1R153     Document Type: Article

References (38)

1. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000;342:314-9. doi: 10.1056/nejm200002033420503
2. EMEA/Committee for Proprietary Medicinal Products. Note for guid-ance on clinical investigation of medicinal products in the treatment of epileptic disorders. In: EMEA/CPMP, ed. London, UK: EMEA/Committee for Proprietary Medicinal Products, 2000:1-12.
3. Anderson GD. Pharmacogenetics and enzyme induction/inhibition prop-erties of antiepileptic drugs. Neurology 2004;63:S3-8.
4. European Medicines Agency. Trobalt: EPAR-summary for the public. www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001245/human_med_001431.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124 (accessed 2011 Jun 20).
5. Food and Drug Administration. FDA approves Potiga to treat seizures in adults. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258834.htm (accessed 2011 Jun 13).
6. Food and Drug Administration Center for Drug Evaluation and Re-search. Printed labeling. www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm (accessed 2011 Nov 16).
7. Edlund W, Gronseth G, So Y, Franklin G. Definition for classification of evidence. Clinical practice guideline process manual 2004 edition. St. Paul, MN: American Academy of Neurology, 2005:49.
8. Kapetanovic IM, Yonekawa WD, Kupferberg HJ. The effects of D-23129, a new experimental anticonvulsant drug, on neurotransmitter amino acids in the rat hippocampus in vitro. Epilepsy Res 1995;22:167-73.
9. Tober C, Rostock A, Rundfeldt C, Bartsch R. D-23129: a potent anticon-vulsant in the amygdala kindling model of complex partial seizures. Eur J Pharmacol 1996;303:163-9.
10. Wickenden AD, Yu W, Zou A, Jegla T, Wagoner PK. Retigabine, a novel anti-convulsant, enhances activation of KCNQ2/Q3 potassium channels. Mol Pharmacol 2000;58:591-600.
11. Punke MA, Friederich P. Retigabine stimulates human KCNQ2/Q3 chan-nels in the presence of bupivacaine. Anesthesiology 2004;101:430-8.
12. Blackburn-Munro G, Dalby-Brown W, Mirza NR, Mikkelsen JD, Black-burn-Munro RE. Retigabine: chemical synthesis to clinical application. CNS Drug Rev 2005;11:1-20.
13. Rostock A, Tober C, Rundfeldt C, et al. D-23129: a new anticonvulsant with a broad spectrum activity in animal models of epileptic seizures. Epilepsy Res 1996;23:211-23.
14. Maljevic S, Wuttke TV, Seebohm G, Lerche H. KV7 channelopathies. Pflugers Arch 2010;460:277-88. doi: 10.1007/s00424-010-0831-3
15. Maljevic S, Wuttke TV, Lerche H. Nervous system KV7 disorders: breakdown of a subthreshold brake. J Physiol 2008;586:1791-801. doi: 10.1113/jphysiol.2008.150656
16. Rundfeldt C, Netzer R. The novel anticonvulsant retigabine activates M-currents in Chinese hamster ovary-cells transfected with human KCNQ2/3 subunits. Neurosci Lett 2000;282:73-6.
17. Yonekawa WD, Kapetanovic IM, Kupferberg HJ. The effects of anticon-vulsant agents on 4-aminopyridine induced epileptiform activity in rat hippocampus in vitro. Epilepsy Res 1995;20:137-50.
18. Rundfeldt C, Netzer R. Investigations into the mechanism of action of the new anticonvulsant retigabine. Interaction with GABAergic and glu-tamatergic neurotransmission and with voltage gated ion channels. Arzneimittelforschung 2000;50:1063-70.
19. Food and Drug Administration Center for Drug Evaluation and Re-search. Clinical pharmacology and biopharmaceutics review(s). www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm (accessed 2011 Nov 15).
20. Ferron GM, Paul J, Fruncillo R, et al. Multiple-dose, linear, dose-propor-tional pharmacokinetics of retigabine in healthy volunteers. J Clin Pharma-col 2002;42:175-82.
21. Hempel R, Schupke H, McNeilly PJ, et al. Metabolism of retigabine (D-23129), a novel anticonvulsant. Drug Metab Dispos 1999;27:613-22.
22. Hiller A, Nguyen N, Strassburg CP, et al. Retigabine N-glucuronidation and its potential role in enterohepatic circulation. Drug Metab Dispos 1999;27:605-12.
23. Ferron GM, Patat A, Parks V, Rolan P, Troy SM. Lack of pharmacoki-netic interaction between retigabine and phenobarbitone at steady-state in healthy subjects. Br J Clin Pharmacol 2003;56:39-45.
24. Hermann R, Borlak J, Munzel U, et al. The role of Gilbert's syndrome and frequent NAT2 slow acetylation polymorphisms in the pharmacoki-netics of retigabine. Pharmacogenomics J 2006;6:211-9. doi: 10.1038/sj.tpj.6500359
25. Hermann R, Ferron GM, Erb K, et al. Effects of age and sex on the dis-position of retigabine. Clin Pharmacol Ther 2003;73:61-70. doi: 10.1067/mcp.2003.12
26. Hermann R, Knebel NG, Niebch G, Richards L, Borlak J, Locher M. Pharmacokinetic interaction between retigabine and lamotrigine in healthy subjects. Eur J Clin Pharmacol 2003;58:795-802. doi: 10.1007/s00228-003-0558-6
27. Porter RJ, Partiot A, Sachdeo R, Nohria V, Alves WM. Randomized, mul-ticenter, dose-ranging trial of retigabine for partial-onset seizures. Neurolo-gy 2007;68:1197-204. doi: 10.1212/01.wnl.0000259034.45049.00
28. French JA, Abou-Khalil BW, Leroy RF, et al. Randomized, double-blind, placebo-controlled trial of ezogabine (retigabine) in partial epilepsy. Neurology 2011. doi: 10.1212/WNL.0b013e3182194bd3
29. Brodie MJ, Lerche H, Gil-Nagel A, et al. Efficacy and safety of adjunc-tive ezogabine (retigabine) in refractory partial epilepsy. Neurology 2010;75:1817-24. doi: 10.1212/WNL.0b013e3181fd6170
30. French JA. Refractory epilepsy: clinical overview. Epilepsia 2007; 48(suppl 1):3-7. doi: 10.1111/j.1528-1167.2007.00992.x
31. Chung S, Sperling MR, Biton V, et al. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia 2010; 51:958-67. doi: 10.1111/j.1528-1167.2009.02496.x
32. Faught E, Holmes GL, Rosenfeld WE, et al. Randomized, controlled, dose-ranging trial of carisbamate for partial-onset seizures. Neurology 2008;71:1586-93. doi: 10.1212/01.wnl.0000334751.89859.7f
33. European Medicines Agency. Annex I summary of product characteris-tics. www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001245/human_med_001431.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d124&jsenabled=true (accessed 2011 Jun 20).
34. Food and Drug Administration Center for Drug Evaluation and Re-search. Risk assessment and risk mitigation review(s). www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm (accessed 2011 Nov 16).
35. Streng T, Christoph T, Andersson KE. Urodynamic effects of the K+ channel (KCNQ) opener retigabine in freely moving, conscious rats. J Urol 2004;172:2054-8.
36. Food and Drug Administration Center for Drug Evaluation and Re-search. Medical review. www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm (accessed 2011 Jan 8).
37. Davit BM, Nwakama PE, Buehler GJ, et al. Comparing generic and in-novator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother 2009;43: 1583-97. doi: 10.1345/aph.1M141
38. Food and Drug Administration. Major human transporters. www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm#classInhibit (accessed 2012 Apr 2).