Topiramate monotherapy in the treatment of newly or recently diagnosed epilepsy

Clinical Therapeutics

Volumn 30, Issue 7, 2008, Pages 1180-1195

  Ben Menachem, Elinor ^a,d   Sander, Josemir W ^b,d   Stefan, Hermann ^c,d   Schwalen, Susanne ^d   Schäuble, Barbara ^d  

^a SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^d JANSSEN CILAG GMBH   (Germany)

Author keywords

dosage; epilepsy; monotherapy; topiramate

Indexed keywords

CARBAMAZEPINE; GABAPENTIN; LAMOTRIGINE; OXCARBAZEPINE; TOPIRAMATE; VALPROIC ACID;

ABDOMINAL PAIN; ADENOCARCINOMA; ALOPECIA; ANOREXIA; ARTICLE; ATAXIA; BIOSIS; BRAIN TUMOR; CLINICAL TRIAL; COCHRANE LIBRARY; CONCENTRATION LOSS; CONSTIPATION; COST EFFECTIVENESS ANALYSIS; DECREASED APPETITE; DEPRESSION; DIZZINESS; DRUG BLOOD LEVEL; DRUG COST; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; EMBASE; EPILEPSY; FATIGUE; FOCAL EPILEPSY; GASTRITIS; HAIR LOSS; HEADACHE; HUMAN; HYPESTHESIA; INJURY; INSOMNIA; KAPLAN MEIER METHOD; MEDLINE; MEMORY; MONOTHERAPY; MOOD CHANGE; NAUSEA; NEPHROLITHIASIS; PARESTHESIA; PATIENT SATISFACTION; PEER REVIEW; PROPORTIONAL HAZARDS MODEL; PUBLICATION; QUALITY OF LIFE; ROLANDIC EPILEPSY; SALIVARY DUCT OBSTRUCTION; SCISEARCH; SIDE EFFECT; SOMNOLENCE; THERAPY EFFECT; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; TREMOR; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WECHSLER INTELLIGENCE SCALE; WEIGHT GAIN; WEIGHT REDUCTION;

ANTICONVULSANTS; EPILEPSY; FRUCTOSE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 48549100556     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(08)80045-8     Document Type: Article

References (83)

1. Shank R.P., Gardocki J.F., Vaught J.L., et al. Topiramate: Preclinical evaluation of structurally novel anticonvulsant. Epilepsia 35 (1994) 450-460
2. Maryanoff B.E., Nortey S.O., Gardocki J.F., et al. Anticonvulsant O-alkyl sulfamates. 2,3:4, 5-Bis-O-(1methylethylidene)-beta-D-fructopyranose sulfamate and related compounds. J Med Chem 30 (1987) 880-887
3. Zona C., Ciotti M.T., and Avoli M. Topiramate attenuates voltage-gated sodium currents in rat cerebellar granule cells. Neurosci Lett 231 (1997) 123-126
4. Taverna S., Sancini G., Mantegazza M., et al. Inhibition of transient and persistent Na+ current fractions by the new anticonvulsant topiramate. J Pharmacol Exp Ther 288 (1999) 960-968
5. Zhang X., Velumian A.A., Jones O.T., and Carlen P.L. Modulation of highvoltage-activated calcium channels in dentate granule cells by topiramate. Epilepsia 41 Suppl 1 (2000) S52-S60
6. A-mediated responses and activation of a potassium conductance. Neuropharmacology 42 (2002) 210-220
7. White H.S., Brown S.D., Woodhead J.H., et al. Topiramate enhances GABA-mediated chloride flux and GABA-evoked chloride currents in murine brain neurons and increases seizure threshold. Epilepsy Res 28 (1997) 167-179
8. White H.S., Brown S.D., Woodhead J.H., et al. Topiramate modulates GABA-evoked currents in murine cortical neurons by a nonbenzodiazepine mechanism. Epilepsia 41 Suppl 1 (2000) S17-S20
9. Petroff O.A., Hyder F., Rothman D.L., and Mattson R.H. Topiramate rapidly raises brain GABA in epilepsy patients. Epilepsia 42 (2001) 543-548
10. Gibbs III J.W., Sombati S., DeLorenzo R.J., and Coulter D.A. Cellular actions of topiramate: Blockade of kainateevoked inward currents in cultured hippocampal neurons. Epilepsia 41 Suppl 1 (2000) S10-S16
11. Shank R.P., Gardocki J.F., Streeter A.J., and Maryanoff B.E. An overview of the preclinical aspects of topiramate: Pharmacology, pharmacokinetics, and mechanism of action. Epilepsia 41 Suppl 1 (2000) S3-S9
12. Glauser T.A. Topiramate. Epilepsia 40 Suppl 5 (1999) S71-S80
13. Pitkänen A., and Kubova H. Antiepileptic drugs in neuroprotection. Expert Opin Pharmacother 5 (2004) 777-798
14. Waugh J., and Goa K.L. Topiramate: As monotherapy in newly diagnosed epilepsy. CNS Drugs 17 (2003) 985-992
15. Johannessen S.I. Pharmacokinetics and interaction profile of topiramate: Review and comparison with other newer antiepileptic drugs. Epilepsia 38 Suppl 1 (1997) S18-S23
16. Wu W.N., Heebner J.B., and Streeter A.J. Evaluation of the absorption, excretion, pharmacokinetics and metabolism of the anticonvulsant topiramate in healthy men. Pharm Res 11 Suppl (1994) S336 Abstract.
17. Doose D.R., Walker S.A., Venkataramanan R., et al. Topiramate pharmacokinetics in subjects with liver impairment. Pharm Res 11 Suppl (1994) S446 Abstract.
18. Gisclon L.G., Riffitts J.M., Sica D.A., et al. The pharmacokinetics (PK) of topiramate (T) in subjects with renal impairment (RI) as compared to matched subjects with normal renal function (NRF). Pharm Res 10 Suppl (1993) S397 Abstract.
19. Gisclon L.G., and Curtin C.R. The pharmacokinetics (PK) of topiramate (T) in subjects with end-stage renal disease undergoing hemodialysis. Clin Pharmacol Ther 55 (1994) 196 Abstract.
20. Bialer M., Doose D.R., Murthy B., et al. Pharmacokinetic interactions of topiramate. Clin Pharmacokinet 43 (2004) 763-780
21. Doose D.R., Walker S.A., Pledger G., et al. Evaluation of phenobarbital and primidone/phenobarbital (primidone's active metabolite) plasma concentrations during administration of add-on topiramate therapy in five multicenter, double blind, placebo controlled trials in outpatients with partial seizures. Epilepsia 36 Suppl 3 (1995) S158 Abstract.
22. Sachdeo R.C., Sachdeo S.K., Levy R.H., et al. Topiramate and phenytoin pharmacokinetics during repetitive monotherapy and combination therapy to epileptic patients [published correction appears in Epilepsia. 2002;43:1273]. Epilepsia 43 (2002) 691-696
23. Sachdeo R.C., Sachdeo S.K., Walker S.A., et al. Steady-state pharmacokinetics of topiramate and carbamazepine in patients with epilepsy during monotherapy and concomitant therapy. Epilepsia 37 (1996) 774-780
24. Berry D.J., Besag F.M., Pool F., et al. Lack of an effect of topiramate on lamotrigine serum concentrations. Epilepsia 43 (2002) 818-823
25. Doose D.R., Brodie M.J., Wilson E.A., et al. Topiramate and lamotrigine pharmacokinetics during repetitive monotherapy and combination therapy in epilepsy patients. Epilepsia 44 (2003) 917-922
26. Rosenfeld W.E., Liao S., Kramer L.D., et al. Comparison of the steadystate pharmacokinetics of topiramate and valproate in patients with epilepsy during monotherapy and concomitant therapy. Epilepsia 38 (1997) 324-333
27. Hamer H.M., Knake S., Schomburg U., and Rosenow F. Valproate-induced hyperammonemic encephalopathy in the presence of topiramate. Neurology 54 (2000) 230-232
28. Doose D., Jacobs D., Squires L., et al. Oral contraceptive-AED interactions: No effect of topiramate as monotherapy at clinically effective doses of 200 mg or less. Epilepsia 43 Suppl 7 (2002) 205 Abstract 2.223.
29. Doose D.R., Jacobs D., Squires L., and Bialer M. Clinically effective topiramate (TPM) monotherapy dosages (50200 mg/day): No pharmacokinetic interaction with oral contraceptives (OCs). Epilepsia 43 Suppl 8 (2002) 146 Abstract P459.
30. Doose D.R., Wang S.S., Padmanabhan M., et al. Effect of topiramate or carbamazepine on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in healthy obese and nonobese female subjects. Epilepsia 44 (2003) 540-549
31. Faught E., Wilder B.J., Ramsay R.E., et al., For the Topiramate YD Study Group. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Neurology 46 (1996) 1684-1690
32. Privitera M., Fincham R., Penry J., et al., For the Topiramate YE Study Group. Topiramateplacebo-controlleddoseranging trial in refractory partial epilepsy using 600-, 800-, and 1,000-mg daily dosages. Neurology 46 (1996) 1678-1683
33. Sharief M., Viteri C., Ben-Menachem E., et al. Double-blind, placebocontrolled study of topiramate in patients with refractory partial epilepsy. Epilepsy Res 25 (1996) 217-224
34. Tassinari C.A., Michelucci R., Chauvel P., et al. Double-blind, placebocontrolled trial of topiramate (600 mg daily) for the treatment of refractory partial epilepsy. Epilepsia 37 (1996) 763-768
35. Ben-Menachem E., Henriksen O., Dam M., et al. Double-blind, placebocontrolled trial of topiramate as add-on therapy in patients with refractory partial seizures. Epilepsia 37 (1996) 539-543
36. Elterman R.D., Glauser T.A., Wyllie E., et al., For the Topiramate YP Study Group. A double-blind, randomized trial of topiramate as adjunctive therapy for partial-onset seizures in children. Neurology 52 (1999) 1338-1344
37. Sachdeo R.C., Glauser T.A., Ritter F., et al., For the Topiramate YL Study Group. A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome. Neurology 52 (1999) 1882-1887
38. Biton V., Montouris G.D., Ritter F., et al., For the Topiramate YTC Study Group. A randomized, placebocontrolled study of topiramate in primary generalized tonic-clonic seizures [published correction appears in Neurology. 1999;53:1162]. Neurology 52 (1999) 1330-1337
39. Gilliam F.G., Veloso F., Bomhof M.A., et al. A dose-comparison trial of topiramate as monotherapy in recently diagnosed partial epilepsy. Neurology 60 (2003) 196-202
40. Ramsey E.R., Veloso F., Bomhof M., et al. Patient factors affecting response to early AED monotherapy in partialonset seizures: Observations from a randomized controlled trial with topiramate (TPM). Epilepsia 40 Suppl 7 (1999) 111 Abstract 2.108.
41. Ritter F., Gilliam F., Neto W., et al. 1-Year and 2-year seizure remission with topiramate monotherapy in newly/recently diagnosed localization related epilepsy. Epilepsia 42 Suppl 7 (2001) 212-213 Abstract F.06.
42. Wannamaker B.B., Neto W., Pledger G., and Wu S.C. Seizure remission with topiramate monotherapy in newly/recently diagnosed localization-related epilepsy. Neurology 58 Suppl 3 (2002) A298 Abstract P04.101.
43. Arroyo S., Dodson W.E., Privitera M.D., et al., For the EPMN-106/INT-28 Investigators. Randomized dosecontrolled study of topiramate as first-line therapy in epilepsy. Acta Neurol Scand 112 (2005) 214-222
44. Kanner A.M., Arroyo S., Squires L., et al. Response to topiramate monotherapy in newly diagnosed epilepsy: Partial-onset vs generalized seizures. Neurology 60 Suppl 1 (2003) 476-477 Abstract P06.096.
45. Glauser T.A., Dlugos D.J., Dodson W.E., et al., For the EPMN-106/INT-28 Investigators. Topiramate monotherapy in newly diagnosed epilepsy in children and adolescents. J Child Neurol 22 (2007) 693-699
46. Privitera M.D., Brodie M.J., Mattson R.H., et al., For the EPMN 105 Study Group. Topiramate, carbamazepine and valproate monotherapy: Doubleblind comparison in newly diagnosed epilepsy. Acta Neurol Scand 107 (2003) 165-175
47. Wheless J.W., Neto W., Wang S., et al., For the EPMN-105 Study Group. Topiramate, carbamazepine, and valproate monotherapy: Doubleblind comparison in children with newly diagnosed epilepsy. J Child Neurol 19 (2004) 135-141
48. Marson A.G., Al-Kharusi A.M., Alwaidh M., et al., For the SANAD Study Group. The SANAD study of effectiveness of carbamazepine, gabapentin, lamotrigine, oxcarbazepine, or topiramate for treatment of partial epilepsy: An unblinded randomized controlled trial. Lancet 369 (2007) 1000-1015
49. Marson A.G., Al-Kharusi A.M., Alwaidh M., et al., For the SANAD Study Group. The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalized and unclassifiable epilepsy: An unblinded randomized controlled trial. Lancet 369 (2007) 1016-1026
50. French J.A. Can evidence-based guidelines and clinical trials tell us how to treat patients?. Epilepsia 48 (2007) 1264-1267
51. Cross H., Ferrie C., Lascelles K., et al. Old versus new antiepileptic drugs: The SANAD study. Lancet 370 (2007) 314-316
52. Perucca E., Alexandre Jr. V., and Tomson T. Old versus new antiepileptic drugs: The SANAD study. Lancet 370 (2007) 313
53. Panayiotopoulos C.P. Old versus new antiepileptic drugs: The SANAD study. Lancet 370 (2007) 313-314
54. Panayiotopoulos C.P. Evidencebased epileptology, randomized controlled trials, and SANAD: A critical clinical view. Epilepsia 48 (2007) 1268-1274
55. Guerrini R., Carpay J., Groselj J., et al., For the TOP-INT-51 Investigators' Group. Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting. Seizure 14 (2005) 371-380
56. Groselj J., Guerrini R., Van Oene J., et al., For the TOP-INT-51 Investigators' Group. Experience with topiramate monotherapy in elderly patients with recent-onset epilepsy. Acta Neurol Scand 112 (2005) 144-150
57. Faught E., Squires L., Wang S., and Thienel U. Topiramate monotherapy in newly/recently diagnosed epilepsy: Adverse event profile in 1000+ participating in double-blind trials. Neurology 60 Suppl 1 (2003) A475 Abstract P06.093.
58. Mattson R., Wang S., and Neto W. The effect of age on the tolerability of topiramate. Epilepsia 42 Suppl 7 (2001) 183 Abstract 2.255.
59. Frank M.L. Topiramate monotherapy: Tolerability and safety in children, adults, and elderly patients. Neurology 58 Suppl 3 (2002) A297 Abstract P04.097.
60. De Araujo Filho G.M., Pascalicchio T.F., Lin K., et al. Neuropsychiatric profiles of patients with juvenile myoclonic epilepsy treated with valproate or topiramate. Epilepsy Behav 8 (2006) 606-609
61. Kang H.C., Eun B.L., Wu Lee C., et al., For the Korean Pediatric Topiramate Study Group. The effects on cognitive function and behavioral problems of topiramate compared to carbamazepine as monotherapy for children with benign rolandic epilepsy. Epilepsia 48 (2007) 1716-1723
62. Ben-Menachem E., Axelsen M., Johanson E.H., et al. Predictors of weight loss in adults with topiramatetreated epilepsy. Obes Res 11 (2003) 556-562
63. Majkowski J., Neto W., Wapenaar R., and van Oene J. Time course of adverse events in patients with localizationrelated epilepsy receiving topiramate added to carbamazepine. Epilepsia 46 (2005) 648-653
64. Ben-Zeev B., Watemberg N., Augarten A., et al. Oligohydrosis and hyperthermia: Pilot study of a novel topiramate adverse effect. J Child Neurol 18 (2003) 254-257
65. Arcas J., Ferrer T., Roche M.C., et al. Hypohidrosis related to the administration of topiramate to children. Epilepsia 42 (2001) 1363-1365
66. de Carolis P., Magnifico F., Pierangeli G., et al. Transient hypohidrosis induced by topiramate. Epilepsia 44 (2003) 974-976
67. Cerminara C., Seri S., Bombardieri R., et al. Hypohidrosis during topiramate treatment: A rare and reversible side effect. Pediatr Neurol 34 (2006) 392-394
68. Reife R., Pledger G., and Wu S.C. Topiramate as add-on therapy: Pooled analysis of randomized controlled trials in adults. Epilepsia 41 Suppl 1 (2000) S66-S71
69. Vermeulen J., and Aldenkamp A.P. Cognitive side-effects of chronic antiepileptic drug treatment: A review of 25 years of research. Epilepsy Res 22 (1995) 65-95
70. Meador K. Cognitive effects of antiepileptic drugs. In: Ettinger A., and Kanner A. (Eds). Psychiatric Issues in Epilepsy (2001), Wolters Kluwer Health, Philadelphia, Pa 83-93
71. Meador K.J., Loring D.W., Hulihan J.F., et al., For the CAPSS-027 Study Group. Differential cognitive and behavioral effects of topiramate and valproate. Neurology 60 (2003) 1483-1488
72. Aldenkamp A.P., Baker G., Mulder O.G., et al. A multicenter, randomized clinical study to evaluate the effect on cognitive function of topiramate compared with valproate as add-on therapy to carbamazepine in patients with partial-onset seizures. Epilepsia 41 (2000) 1167-1178
73. Fritz N., Glogau S., Hoffmann J., et al. Efficacy and cognitive side effects of tiagabine and topiramate in patients with epilepsy. Epilepsy Behav 6 (2005) 373-381
74. Blum D., Meador K., Biton V., et al. Cognitive effects of lamotrigine compared with topiramate in patients with epilepsy. Neurology 67 (2006) 400-406
75. Meador K.J., Loring D.W., Vahle V.J., et al. Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology 64 (2005) 2108-2114
76. Salinsky M.C., Storzbach D., Spencer D.C., et al. Effects of topiramate and gabapentin on cognitive abilities in healthy volunteers. Neurology 64 (2005) 792-798
77. Martin R., Kuzniecky R., Ho S., et al. Cognitive effects of topiramate, gabapentin, and lamotrigine in healthy young adults. Neurology 52 (1999) 321-327
78. Werz M.A., Schoenberg M.R., Meador K.J., et al. Subjective preference for lamotrigine or topiramate in healthy volunteers: Relationship to cognitive and behavioral functioning. Epilepsy Behav 8 (2006) 181-191
79. French J.A., Kanner A.M., Bautista J., et al., For the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Efficacy and tolerability of the new antiepileptic drugs I: Treatment of new onset epilepsy: Report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 62 (2004) 1252-1260
80. Topamax 25 mg, 50 mg, 100 mg, 200 mg tablets and sprinkle capsules 15, 25 or 50 mg [electronic Medicines Compendium Web site].
81. (June 16, 2008). http://www.emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=6768 Accessed
82. Epilim [electronic Medicines Compendium Web site]
83. (June 16, 2008). http://www.emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=6781 Accessed