Efficacy and safety of adjunctive zonisamide therapy for refractory partial seizures

Epilepsy Research

Volumn 75, Issue 2-3, 2007, Pages 75-83

  Baulac, Michel ^a   Leppik, Ilo E ^b  

^a SORBONNE UNIVERSITÉ   (France)

^b UNIVERSITY OF MINNESOTA   (United States)

Author keywords

Adjunctive therapy; Partial seizures; Review; Zonisamide

Indexed keywords

CARBAMAZEPINE; LAMOTRIGINE; PHENYTOIN; PLACEBO; VALPROIC ACID; ZONISAMIDE;

ABDOMINAL PAIN; AGITATION; ATAXIA; CLINICAL TRIAL; COMPLEX PARTIAL SEIZURE; CONFUSION; DECREASED APPETITE; DEPRESSION; DIARRHEA; DIPLOPIA; DISEASE SEVERITY; DIZZINESS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; EUROPE; FATIGUE; FOCAL EPILEPSY; HUMAN; INFECTION; INSOMNIA; IRRITABILITY; JAPAN; NAUSEA; NEPHROLITHIASIS; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; SOMNOLENCE; TERATOGENICITY; UNITED STATES; WEIGHT REDUCTION;

ANIMALS; ANTICONVULSANTS; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG RESISTANCE; EPILEPSIES, PARTIAL; HUMANS; ISOXAZOLES; RANDOMIZED CONTROLLED TRIALS;

EID: 34447275710     PISSN: 09201211     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eplepsyres.2007.04.007     Document Type: Review

References (72)

1. Adab N., Tudur S.C., Vinten J., Williamson P., and Winterbottom J. Common antiepileptic drugs in pregnancy in women with epilepsy. Cochrane Database Syst. Rev. 3 (2004). http://www3.interscience.wiley.com/cgi-bin/mrwhome/106568753/HOME CD004848
2. Alapati A., Hall-Bell C., and Faught E.R. Safety and efficacy of zonisamide adjunctive therapy for refractory complex partial seizures: an open label study. Epilepsia 41 Suppl. 7 (2000) 225
3. Beghi E. Efficacy and tolerability of the new antiepileptic drugs: comparison of two recent guidelines. Lancet Neurol. 3 (2004) 618-621
4. Beghi E., Annegers J.F., and Collaborative Group for the Pregnancy Registries in Epilepsy. Pregnancy registries in epilepsy. Epilepsia 42 (2001) 1422-1425
5. Beitinjaneh F., Guido M., Patel M.B., Vitale S.P., and Andriola M.R. The use of zonisamide in varieties of epilepsy patients: clinical spectrum. Epilepsia 42 Suppl. 7 (2001) 176 Abstract 2.233
6. Biton V. Effect of antiepileptic drugs on bodyweight. CNS Drugs 17 (2003) 781-791
7. Breen D.P., and Davenport R.J. Teratogenicity of antiepileptic drugs. BMJ 333 (2006) 615-616
8. Brodie M.J. Zonisamide as adjunctive therapy for refractory partial seizures. Epilepsy Res. 68 Suppl. 2 (2006) 11-16
9. Brodie M.J., Duncan R., Vespignani H., Solyom A., Bitenskyy V., and Lucas C. Dose-dependent safety and efficacy of zonisamide: a randomized, double-blind, placebo-controlled study in patients with refractory partial seizures. Epilepsia 46 (2005) 31-41
10. Brodie M.J. Zonisamide clinical trials: European experience. Seizure 13 Suppl. 1 (2004) 66-70
11. Brodie M.J. Management strategies for refractory localisation-related seizures. Epilepsia 42 (2001) 27-30
12. Brodie M.J., and Mumford J.P. Double-blind substitution of vigabatrin and valproate in carbamazepine-resistant partial epilepsy. Epilepsy Res. 34 (1999) 199-205
13. Chadwick D.W., Marson A.G., 2005. Zonisamide add-on for drug-resistant partial epilepsy. Cochrane Database Syst. Rev. 2005, Issue 4, CD001416 http://www.thecochranelibrary.com.
14. Conry J.A., Ramsay R.E., Vossler D., and Glauser T.A. Efficacy and safety of zonisamide as adjunctive therapy for primary generalized epilepsy. Epilepsia 46 Suppl. 7 (2005) (Abs 2.350)
15. Eisai Ltd. Data on file(a). Clinical Study Report for study 302, Table 2.7.4.6, 22 September 2003.
16. ®) as adjunctive therapy in subject with refractory partial epilepsy, Summary of Clinical Safety, Tables 2.7.4.8; 2.7.4.9, September 2005.
17. ® 25 mg, 50 mg, 100 mg hard capsules. April 2006 http://www.emea.europa.eu/humandocs/PDFs/EPAR/zonegran/H-577-PI-en.pdf#search=%22emea%20zonisamide%22.
18. ® capsules package insert, December 2004. http://www.zonegran.com/utilities/pi.pdf.
19. Faught E. Review of United States and European clinical trials of zonisamide in the treatment of refractory partial-onset seizures. Seizure. 13 Suppl. 1 (2004) 59-65
20. Faught E., Ayala R., Montouris G., Leppik I., and The Zonisamide 922 Trial Group. Randomized controlled trial of zonisamide for the treatment of refractory partial-onset seizures. Neurology 57 (2001) 1774-1779
21. French J.A., Kanner A.M., Bautista J., Abou-Khalil B., Browne T., Harden C.L., Theodore W.H., Bazil C., Stern J., Schachter S.C., Bergen D., Hirtz D., Montouris G.D., Nespeca M., Gidal B., Marks Jr. W.J., Turk W.R., Fischer J.H., Bourgeois B., Wilner A., Faught Jr. R.E., Sachdeo R.C., Beydoun A., and Glauser T.A. Efficacy and tolerability of the new antiepileptic drugs. II. Treatment of refractory epilepsy. Neurology 62 (2004) 1261-1273. http://www.aan.com/professionals/practice/index.cfm (Available at the American Academy of Neurology Practice Guidelines on Epilepsy)
22. French J.A., and Ruelle A.D. Zonisamide reduces seizure frequency over time in long-term continuation studies. Epilepsia 43 Suppl. 7 (2002) 241
23. Glauser T.A., and Pellock J.M. Zonisamide in pediatric epilepsy: review of the Japanese experience. J. Child Neurol. 17 2 (2002) 87-96
24. Glauser T., and Pellock J.M. Efficacy and safety of zonisamide in pediatric epilepsy: the Japanese experience. Epilepsia 41 Suppl. 7 (2000) 190
25. Greenblatt D.J. Basic pharmacokinetic principles and their application to psychotropic drugs. J Clin Psychiatry 54 Suppl. 8-13 (1993) 55-56 (erratum in: J. Clin. Psychiatry. 54(11), 442)
26. Henning S., and Eriksson A.-S. Use of zonisamide in 50 pediatric patients with medically refractory epilepsy: a retrospective chart review. Epilepsia 45 Suppl. 7 (2004) Abs 2.383
27. Hirsch E., and Duncan R. Zonisamide improves seizure control in a dose-dependent manner in patients with refractory partial epilepsy. Eur. Neurol. 45 Suppl. 2 (2005) 15 (Abstract 045)
28. Karceski S., Morrell M.J., and Carpenter D. Treatment of epilepsy in adults: expert opinion. Epilepsy Behav. 7 Suppl. 1 (2005) S1-S64
29. Kawai M., Hiramatsu M., Endo A., Kinno I., Endo Y., Suh M., and Mori A. Effect of zonisamide on release of aspartic acid and gamma-aminobutyric acid from hippocampal slices of E1 mice. Neurosciences 20 (1994) 115-119
30. Knudsen J.F., Thambi L.R., Kapcala L.P., and Racoosin J.A. Oligohydrosis and fever in pediatric patients treated with zonisamide. Pediatr. Neurol. 28 (2003) 184-189
31. Kwan P., and Brodie M.J. Combination therapy in epilepsy. Drugs 66 (2006) 1817-1829
32. Lee B.I. Zonisamide: adverse effects. In: Levy R., Mattson R., Meldrim B., and Perucca E. (Eds). Antiepileptic Drugs. 5th ed. (2002), Lippincott, Williams & Wilkins Healthcare, Philadelphia 96-102
33. Leppik I.E. Monotherapy and polypharmacy. Neurology 55 Suppl. 3 (2000) S25-S29
34. Leppik I.E., Willmore L.J., Homan R.W., Fromm G., Oommen K.J., Penry J.K., Sackellares J.C., Smith D.B., Lesser R.P., and Wallace J.D. Efficacy and safety of zonisamide: results of a multicenter study. Epilepsy Res. 14 (1993) 165-173
35. Levisohn P.M. The safety and pharmacokinetics of zonisamide in pediatric patients with epilepsy. Epilepsia 46 Suppl. 7 (2005) Abs 2.320
36. Levy R.H., Ragueneau-Majlessi I., Brodie M.J., Smith D.F., Shah J., and Pan W.J. Lack of clinically significant pharmacokinetic interactions between zonisamide and lamotrigine at steady state in patients with epilepsy. Ther. Drug Monit. 27 2 (2005) 193-198
37. Levy R.H., Ragueneau-Majlessi I., Garnett W.R., Schmerler M., Rosenfeld W., Shah J., and Pan W.J. Lack of a clinically significant effect of zonisamide on phenytoin steady-state pharmacokinetics in patients with epilepsy. J. Clin. Pharmacol. 44 (2004) 1230-1234
38. Low P.A., James S., Peschel T., Leong R., and Rothstein A. Zonisamide and associated oligohidrosis and hyperthermia. Epilepsy Res. 62 (2004) 27-34
39. Macdonald R.L. Is there a mechanistic basis for rationale polypharmacy?. Epilepsy Res. Suppl. 11 (1996) 79-93
40. Masuda Y., and Karasawa T. Inhibitory effect of zonisamide on human carbonic anhydrase in vitro. Arzneimittelforschung 43 (1993) 416-418
41. Mullin P., Stern J.M., Delgado-Escueta A.V., and Eliashiv D. Effectiveness of open-label zonisamide in juvenile myoclonic epilepsy. Epilepsia 42 Suppl. 7 (2001) 184 (abs 2.260)
42. National Institute for Clinical Excellence. Clinical Guideline 20. The epilepsies: the diagnosis and management of epilepsies in adults and children in primary and secondary care. October (2004) (http://www.nice.org.uk/CG020NICEguideline).
43. +, carbamazepine and zonisamide on hippocampal extracellular glutamate monitored with a microdialysis electrode. Br. J. Pharmacol. 124 (1998) 1277-1285
44. Ono T., Yagi K., and Seino M. Clinical efficacy and safety of a new antiepileptic drug, zonisamide. A multi-institutional phase three study. Clin. Psychiatry 30 (1988) 471-482 (In Japanese)
45. O'Rourke D., Flynn C., White M., Doherty C., and Delanty N. Potential efficacy of zonisamide in frefractory juvenile myoclonic epilepsy. Epilepsia 46 Suppl. 6 (2005) 301 (Abstract p950)
46. Penovich P.E., Shear N.H., and Leyden J.J. Incidence of rash in clinical trials: how many cases are attributable to zonisamide?. Epilepsia 44 Suppl. 9 (2003) 280 (Abstract 2.305)
47. Perucca E., and Levy R. Combination therapy and drug interactions. In: Levy R., Mattson R., Meldrim B., and Perucca E. (Eds). Antiepileptic Drugs. 5th ed. (2002), Lippincott, Williams & Wilkins Healthcare, Philadelphia 96-102
48. Racoosin J.A., and Knudsen J.F. Safety of newer antiepileptic drugs. JAMA 291 (2004) 2074
49. Ragueneau-Majlessi I., Levy R.H., Brodie M., Smith D., Shah J., and Grundy J.S. Lack of pharmacokinetic interactions between steady-state zonisamide and valproic acid in patients with epilepsy. Clin. Pharmacokinet. 44 5 (2005) 517-523
50. Ragueneau-Majlessi I., Levy R.H., Bergen D., Garnett W., Rosenfeld W., Mather G., Shah J., and Grundy J.S. Carbamazepine pharmacokinetics are not affected by zonisamide: in vitro mechanistic study and in vivo clinical study in epileptic patients. Epilepsy Res. 62 (2004) 1-11
51. Richards K.C., Smith M.C., and Verma A. Continued use of zonisamide following development of renal calculi. Neurology 64 4 (2005) 763-764
52. Sackellares J.C., Ramsay R.E., Wilder B.J., Browne III T.R., and Shellenberger M.K. Randomized, controlled clinical trial of zonisamide as adjunctive treatment for refractory partial seizures. Epilepsia 45 (2004) 610-617
53. Saleh F.G., Mousli H., Bruno J., and Andriola M.R. Zonisamide efficacy as adjunctive therapy in adults with intractable seizures. Epilepsia 44 Suppl. 9 (2003) 262 (Abstract 2.250)
54. Schacht H.W., Gates J.R., Ankenbauer J.L., Moriarty G.L., and Penovich P.E. Tolerability of rapid zonisamide (ZNS) titration in hospital setting. Epilepsia 43 Suppl. 7 (2002) 199 (Abstract 2.208)
55. Schauf C.L. Zonisamide enhances slow sodium inactivation in Myxicola. Brain Res. 413 (1987) 185-188
56. Schmidt D., Jacob R., Loiseau P., Deisenhammer E., Klinger D., Despland A., Egli M., Bauer G., Stenzel E., and Blankenhorn V. Zonisamide for add-on treatment of refractory partial epilepsy: a European double-blind trial. Epilepsy Res. 15 (1993) 67-73
57. Seino M., and Fujitani B. Zonisamide: clinical efficacy and use in epilepsy. In: Levy R.H. (Ed). Antiepileptic Drugs. 5th ed. (2002), Lippincott, Williams & Wilkins, Philadelphia 885-891
58. Seino M., Ohkuma T., Miyasaka M., Manaka S., Takahashi R., Murasaki M., and Sakuma A. Efficacy evaluation of AD-810 (zonisamide), results of a double blind comparison with carbamazepine (CBZ). J. Clin. Exp. Med. 144 (1988) 275-291
59. Semah F., Picot M.C., Adam C., Broglin D., Arzimanoglou A., Bazin B., Cavalcanti D., and Baulac M. Is the underlying cause of epilepsy a major prognostic factor for recurrence?. Neurology 51 (1998) 1256-1262
60. Strom B.L., Schinnar R., Apter A.J., Margolis D.J., Lautenbach E., Hennessey S., Bilker W.B., and Pettitt D. Absence of cross-reactivity between sulfonamide antibiotics and sulfonamide nonantibiotics. N. Engl. J. Med. 349 (2003) 1628-1635
61. Suzuki S., Kawakami K., Nishimura S., Watanabe Y., Yagi K., Seino M., and Miyamoto K. Zonisamide blocks T-type calcium channel in cultured neurons of rat cerebral cortex. Epilepsy Res. 12 (1992) 21-27
62. Thomas G., and McCabe P.H. Clinical use of zonisamide in generalized seizure disorders. Epilepsia 46 Suppl. 7 (2005) (Abs 2.294)
63. Tilles S.A. Practical issues in the management of hypersensitivity reactions: sulfonamides. South Med. J. 94 (2001) 817-824
64. Tosches W.A., and Tisdell J. Efficacy and safety of long-term zonisamide monotherapy and adjunctive therapy. Epliepsia 46 Suppl. 6 (2005) 143 (Abs. p346)
65. Tosches W.A., and Tisdell J. Long-term zonisamide therapy in geriatric patients: efficacy and safety. Epilepsia 46 Suppl. 7 (2005) (Abs 2.295)
66. Tran T.A., Leppik I.E., White J.R., Walczak T.S., Gumnit R.J., and Rarick J.O. The effect of zonisamide on weight. Epilepsia 43 Suppl. 7 (2002) 211 (Abstract 2.239)
67. Valeriano J., and Lane C. Efficacy and tolerability of zonisamide in generalized seizures. Epilepsia 42 Suppl. 7 (2001) 188 (Abstract 2.275)
68. Vossler D.G., and The Zonisamide PME Study Group. Multicenter, open-label, safety and efficacy study of zonisamide in patients with progressive myoclonic epilepsy. Neurology 58 Suppl. 3 (2002) A296-A297 (Abstract)
69. Welty T.E., Kuzniecky R., and Faught E. Outcomes of using new AED in juvenile myoclonic epilepsy. Neurology 60 Suppl. 1 (2003) A147 (Abstract P02.129)
70. Wroe S., and Brodie M.J. Zonisamide maintains or improves seizure control and is well tolerated over 2 years in patients with refractory partial epilepsy: interim analysis of an open-label extension study. Eur. Neurol. 252 Suppl. 2 (2005) 14 (Abstract 040)
71. Yagi K., and Seino M. Methodological requirements for clinical trials in refractory epilepsies-our experience with zonisamide. Prog. Neuropsychopharmacol. Biol. Psychiatry 16 (1992) 79-85
72. Zhu W.J., and Rogawski M.A. Zonisamide depresses excitatory synaptic transmission by a presynaptic action. Epilepsia 40 Suppl. 7 (1999) 245