Topiramate. A review of its pharmacodynamic and pharmacokinetic properties and clinical efficacy in the management of epilepsy

Drugs

Volumn 54, Issue 5, 1997, Pages 752-773

  Langtry, Heather D ^a   Gillis, Jane C ^a   Davis, Rick ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

4 AMINOBUTYRIC ACID; CARBAMAZEPINE; DIGOXIN; FRUCTOSE; MONOSACCHARIDE; ORAL CONTRACEPTIVE AGENT; PHENOBARBITAL; PHENYTOIN; PRIMIDONE; TOPIRAMATE; VALPROIC ACID;

ACTION POTENTIAL; ATAXIA; BENIGN CHILDHOOD EPILEPSY; BODY WEIGHT DISORDER; CLINICAL TRIAL; CONFUSION; DEPRESSION; DIPLOPIA; DRUG ABSORPTION; DRUG COST; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG METABOLISM; DRUG WITHDRAWAL; EPILEPSY; FOCAL EPILEPSY; GRAND MAL EPILEPSY; HUMAN; LENNOX GASTAUT SYNDROME; NAUSEA; NEPHROLITHIASIS; NERVOUSNESS; NONHUMAN; NYSTAGMUS; ORAL DRUG ADMINISTRATION; PARESTHESIA; PSYCHOMOTOR DISORDER; PSYCHOSIS; REVIEW; SEIZURE; SOMNOLENCE; SPEECH DISORDER; TREMOR; VERTIGO; WEIGHT REDUCTION;

ATAXIA;

EID: 0030710582     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-199754050-00009     Document Type: Review

References (104)

1. Coulter DA, Sombati S, DeLorenzo RJ. Selective effects of topiramate on sustained repetitive firing and spontaneous bursting in cultured hippocampal neurons [abstract]. Epilepsia 1993; 34 Suppl. 2: 123
2. Harden CL. New antiepileptic drugs. Neurology 1994 May; 44: 787-95
3. Coulter DA, Sombati S, DeLorenzo RJ. Topiramate effects on excitatory amino acid-mediated responses in cultured hippocampal neurons: selective blockade of kainate currents [abstract]. Epilepsia 1995; 36 Suppl. 3: S40
4. Kanda T, Nakamura J, Kurokawa M, et al. Inhibition of excessive releases of excitatory amino acids in hippocampus of spontaneously epileptic rat (SER) by topiramate (KW-6485). Jpn J Pharmacol 1992; 58 Suppl. 1: 92P
5. Shank RP, Gardocki JF, Vaught JL, et al. Topiramate: preclinical evaluation of a structurally novel anticonvulsant. Epilepsia 1994 Mar-Apr; 35: 450-60
6. Shank RP, Vaught JL, Raffa RB, et al. Investigation of the mechanism of topiramate's anticonvulsant activity [abstract]. Epilepsia 1991; 32 Suppl. 3: 7
7. White HS, Brown D, Skeen GA, et al. The anticonvulsant topiramate displays a unique ability to potentiate GABA-evoked chloride currents [abstract]. Epilepsia 1995; 36 Suppl. 3: 39-40
8. White HS. Clinical significance of animal seizure models and mechanism of action studies of potential antiepileptic drugs. Epilepsia 1997; 38 Suppl. 1: S9-17
9. Graves NM, Leppik IE. Antiepileptic medications in development. DICP 1991; 25: 978-86
10. Kimishima K, Wang Y, Tanabe K. Anticonvulsant activities and properties of topiramate [abstract]. Jpn J Pharmacol 1992; 58 Suppl. 1: 211P
11. Wauquier A, Zhou S. Topiramate: a potent anticonvulsant in the amygdala-kindled rat. Epilep Res 1996 Jun; 24: 73-7
12. Nakamura F, Hiyoshi T, Kudo T, et al. Anticonvulsant effect of topiramate (2, 3:4, 5-bis-O-(1-methylethylidene-beta-D-fructopyranose sulfate) on amygdaloid kindled seizures in the cat. Jpn J Psychiatry Neurol 1993 Jun; 47: 394-5
13. Nakamura J, Tamura S, Kanda T, et al. Inhibition by topiramate of seizures in spontaneously epileptic rats and DBA/2 mice. Eur J Pharmacol 1994 Mar 11; 254: 83-9
14. Edmonds Jr HL, Jiang D, Zhang YP, et al. Topiramate as a neuroprotectant and anticonvulsant in postischemic injury [abstract]. Epilepsia 1992; 33 Suppl. 3: 118-9
15. Edmonds H, Jiang D, Zhang P, et al. Topiramate in a rat model of posttraumatic epilepsy [abstract]. Epilepsia 1991; 32 Suppl. 3: 15
16. Kälviäinen R, Äikiä M, Riekkinen Sr PJ. Cognitive adverse effects of antiepileptic drugs: incidence, mechanisms and therapeutic implications. CNS Drugs 1996 May; 5: 358-68
17. Rosenfeld WE, Holmes GB, Hunt TL, et al. Topiramate - effective dosaging enhances potential for success [abstract]. Epilepsia 1992; 33 Suppl. 3: 118
18. Burton L, Harden CL. Effects of topiramate on attention over lime [abstract]. Epilepsia 1994; 35 Suppl. 8: 116
19. Burton LA, Harden C. Effect of topiramate on attention. Epilep Res 1997 Apr; 27: 29-32
20. Privitera M. Long-term cognitive effects of topiramate [abstract]. Epilepsia 1995; 36 Suppl. 3: S152
21. Wasserstein AG, Rak I, Reife RA. Investigation of the mechanistic basis for topiramate-associated nephrolithiasis: examination of urinary and serum constituents [abstract]. Epilepsia 1995; 36 Suppl. 3: S153
22. Ben-Menachem E, Abrahamsson H. Gastroscopic evaluation of patients with complex partial seizures treated with topiramate [abstract]. Epilepsia 1994; 35 Suppl. 8: 116
23. Janssen-Cilag. (Data on file)
24. Reife RA. Topiramate - a novel antiepileptic agent. R.W. Johnson Pharmaceutical Research Institute. (Data on file)
25. Doose DR, Walker SA, Gisclon LG, et al. Single-dose pharmacokinetics and effect of food on the bioavailability of topiramate, a novel antiepileptic drug. J Clin Pharmacol 1996 Oct; 36: 884-91
26. Doose DR, Scott VV, Margul BL, et al. Multiple-dose pharmacokinetics of topiramate in healthy male subjects [abstract]. Epilepsia 1988; 29 (5): 662
27. Wu WN, Heebner JB, Streeter AJ, et al. Evaluation of the absorption, excretion, pharmacokinetics and metabolism of the anticonvulsant, topiramate in healthy men [abstract]. Pharm Res 1994 Oct; 11 Suppl.: S-336
28. Johannessen SI. Pharmacokinetics and interaction profile of topiramate: review and comparison with other newer antiepileptic drugs. Epilepsia 1997; 38 Suppl. 1: S18-23
29. Gisclon LG, Riffitts JM, Sica DA, et al. The pharmacokinetics (PK) of topiramate (T) in subjects with renal impairment (RI) as compared to matched subjects with normal renal function (NRF) [abstract]. Pharm Res 1993; 10 Suppl. 10: S397
30. Doose DR, Walker SA, Venkataramanan R, et al. Topiramate pharmacokinetics in subjects with liver impairment [abstract]. Pharm Res 1994 Oct; 11 Suppl.: S446
31. Gisclon LG, Curtin CR, et al. The pharmacokinetics (PK) of topiramate (T) in subjects with end-stage renal disease undergoing hemodialysis [abstract]. In: 95th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics: 1994: 196
32. Rosenfeld WE, Doose DR, Walker SA, et al. Steady-state pharmacokinetics of topiramate as adjunctive therapy in pediatric subjects with epilepsy [abstract]. Epilepsia 1993; 36 Suppl. 3: S158
33. Levy RH, Bishop F, Streeter AJ, et al. Explanation and prediction of drug interactions with topiramate using a CYP450 inhibition spectrum [abstract]. Epilepsia 1995; 36 Suppl. 4: 47
34. Bourgeois BFD. Drug interaction profile of topiramate. Epilepsia 1996; 37 Suppl. 2: S14-7
35. Sachdeo RC, Sachdeo SK, Walker SA, et al. Steady-state pharmacokinetics of topiramate and carbamazepine in patients with epilepsy during monotherapy and concomitant therapy. Epilepsia 1996 Aug; 37: 774-80
36. Doose DR, Walker SA, 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 [abstract]. Epilepsia 1995; 36 Suppl. 3: S158
37. Rosenfeld WE, Liao S, Kramer LD, et al. Comparison of the steady-state pharmacokinetics of topiramate and valproate in patients with epilepsy during monotherapy and concomitant therapy. Epilepsia 1997 Mar; 38: 324-33
38. Gisclon LG, Curtin CR, Kramer LD. The steady-state (SS) pharmacokinetics (PK) of phenytoin (Dilantin [Rm]) and topimarate (Topamax [Rm]) in epileptic patients on monotherapy, and during combination therapy [abstract]. Epilepsia 1994; 35 Suppl. 8: 54
39. Lian S, Rosenfeld WE, Palmer M, et al. Steady-state pharmacokinetics of topiramate and valproic acid in patients with epilepsy on monotherapy, and during combination therapy [abstract]. Epilepsia 1994; 35 Suppl. 8: 117
40. Rosenfeld WE, Doose DR, Walker SA, et al. Effect of topiramate on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in patients with epilepsy. Epilepsia 1997 Mar; 38: 317-23
41. Liao S, Palmer M. Digoxin and topiramate drug interaction study in male volunteers [abstract]. Pharm Res 1993; 10 Suppl.: S-405
42. Rangel RJ, Penry JK, Wilder BJ, et al. Topiramate: a new antiepileptic drug for complex partial seizures - first use in epileptic patients [abstract]. Neurology 1988 March; 38 Suppl. 1: 234
43. Sharief M, Viteri C, Ben-Menachem E, et al. Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy. Epilep Res 1996 Nov; 25: 217-24
44. Rosenfeld W, Abou-Khalil B, Morrell M, et al. Double-blind placebo controlled trial of topiramate adjunctive therapy for partial-onset epilepsy [abstract]. Epilepsia 1996; 37 Suppl. 4: 5
45. Tassinari CA, Michelucci R, Chauvel P, et al. Double-blind, placebo-controlled trial of topiramate (600 mg daily) for the treatment of refractory partial epilepsy. Epilepsia 1996 Aug; 37: 763-8
46. Faught E, Wilder BJ, Ramsay RE, et al. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Neurology 1996 Jun; 46: 1684-90
47. Privitera M, Fincham R, Penny J, et al. Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 600-, 800-, and 1,000-mg daily dosages. Neurology 1996 Jun; 46: 1678-83
48. Ben-Menachem E, Henriksen O, Dam M, et al. Double-blind, placebo-controlled trial of topiramate as add-on therapy in patients with refractory partial seizures. Epilepsia 1996 Jun; 37: 539-43
49. Reife R, Pledger G, Lim P, et al. Topiramate: pooled analysis of six placebo-controlled trials [abstract]. Epilepsia 1996; 37 Suppl. 4: 74
50. Anonymous. Topiramate as adjunctive therapy in partial-onset seizures: the spectrum from adults to children. AED News 1997 Jun 29: 1
51. Kugoh T, Hosokawa K. Topiramate as add-on open therapy in patients with partial seizures [abstract]. Epilepsia 1995; 36 Suppl. 3: S151
52. Rosenfeld WE, Sachdeo RC, Faught RE, et al. Long-term experience with topiramate as adjunctive therapy and as monotherapy in patients with partial onset seizures: retrospective survey of open-label treatment. Epilepsia 1997; 38 Suppl. I: S34-6
53. Guerreiro C, Campos CJR, Campos MFCR, et al. Long-term efficacy and safety of topiramate in partial epilepsy [abstract]. Epilepsia 1997; 38 Suppl. 3: 70
54. Fincham RW, Schottelius DD. Long term therapy with toprimate in patients with partial seizures [abstract]. Epilepsia 1995; 36 Suppl. 4: 56
55. Canger R, Avanzini G, Tartara a, et al. Long-term efficacy and tolerability of topiramate add-on therapy: interim analysis after four years of treatment [abstract]. Epilepsia 1997; 38 Suppl. 3: 59
56. Mikkelsen M, Østergaard L, Dam M. Topiramate as long-term treatment in refractory partial epilepsy. Epilepsia 1993; 34 Suppl. 2: 123
57. Durisotti C, Garofalo P, DiFazio M, et al. Topiramate as add-on, open therapy in drug-resistant epilepsies: one year of follow-up [abstract]. Epilepsia 1996; 37 Suppl. 4: 89
58. Walker MC, Sharief MK, Sander JWAS, et al. Double-blind, placebo-controlled trial of topiramate in refractory partial epilepsy with open-label continuation [abstract]. Epilepsia 1996; 37 Suppl. 4: 80
59. Leuf G, Bauer G. Topiramate in drug-resistant partial and generalized epilepsies [abstract]. Epilepsia 1996; 37 Suppl. 4:69
60. Michelucci R, Passarelli D, Tassinari CA. Topiramate in the treatment of refractory epilepsy: a 2 year long-term follow-up [abstract]. Epilepsia 1996; 37 Suppl. 4: 70-1
61. Guberman A, Bruni J, Schneiderman J, et al. Canadian long-term experience with topiramate [abstract]. Epilepsia 1996; 37 Suppl. 4:67
62. Ben-Menachem E. Long-term follow-up of patients treated with topiramate for partial seizures [abstract]. Epilepsia 1995; 36 Suppl. 3: S152
63. Proest G, Steinboff S, Ried S, et al. Open add-on trial with topiramate (Topamax) in patients with partial epilepsy [abstract]. Epilepsia 1995; 36 Suppl. 3: S151
64. Engelskjøn T, Johannessen SI, Kloster R, et al. Long-term effect of topiramate in refractory partial epilepsy. Epilepsia 1993; 34 Suppl. 2: 123
65. Tartara A, Sartori I, Manni R, et al. Efficacy and safety of topiramate in refractory epilepsy: a long-term prospective trial. Ital J Neurol Sci 1996 Dec; 17: 429-32
66. Sachdeo RC, Reife RA, Lim P, et al. Topiramate monotherapy for partial onset seizures. Epilepsia 1997 Mar; 38: 294-300
67. Sachdeo RC, Rosenfeld WE. Experience with long-term topiramate monotherapy [abstract]. Epilepsia 1997; 38 Suppl. 3: 59
68. Biton V, Montouris GD, YTC Study Team. Topiramate double-blind trial in patients with generalised tonic-clonic seizures non-focal origin [abstract]. Epilepsia 1997; 38 Suppl. 3: 59
69. Biton V, Montouris GD, Riviello JD, et al. Topiramale as adjunctive therapy in generalised seizures of non-focal origin. Cilag. (Data on file)
70. Anonymous. Generalised tonic-clonic seizures and the spectrum of associated seizures in generalised epilepsy: responsiveness to topiramate. AED News 29 June 1997; 4.
71. Montouris GD, Biton V. Topiramate YTC Study Team. Long-term topiramate therapy in generalised seizures of non-focal origin [abstract]. Epilepsia 1997; 38 Suppl. 3: 82
72. Crawford PM. Use of topiramate in primary generalised seizures [abstract]. Epilepsia 1997; 38 Suppl. 3: 80
73. Glauser TA, Sachdeo RC, Ritter FJ, et al. Topiramate in Lennox Gastaut-syndrome: a double-blind trial [abstract]. Neurology 1997 Jun; 48: 1729
74. Anonymous. Expanding the options of Lennox-Gastaut syndrome: efficacy and tolerability of topiramate. AED News 1997 June 29; 3
75. French JA, Bourgeois BFD, Dreifus FE, et al. An open-label multicenter study of topiramate in patients with the Lennox-Gastaut syndrome [abstract]. Neurology 1995 Apr; 45 Suppl. 4: A250
76. Herranz JL, Arteaga R, de las Cuevas I. Topiramate in the treatment of children with Lennox-Gastaut syndrome [abstract]. Epilepsia 1997; 38 Suppl. 3: 37
77. Manreza MLG, Guerreiro M, Ferreira VB, et al. Long-term efficacy and safety of topiramale in Lennox-Gastaut syndrome [abstract]. Epilepsia 1997; 38 Suppl. 3: 98
78. Kugler SL, Sachdeo R, Wenger E, et al. Efficacy of toprimate in Lennox-Gastaut syndrome [abstract]. Ann Neurol 1996 Aug; 40: 303
79. Elterman R, Glauser T, Ritter FJ, et al. Efficacy and safety of topiramate in partial seizures in children [abstract]. Neurology 1997 Jun; 48: 1729
80. Glauser TA. Preliminary observations on topiramate in pediatric epilepsies. Epilepsia 1997; 38 Suppl. 1: S37-41
81. Rosenfeld WE. Topiramate: a new anti-epileptic drug with success in children [abstract]. Ann Neurol 1995 Sep; 38: 555
82. Espe-Lillo J, Ritter FJ, Frost MD, et al. Topiramate in childhood epilepsy: titration, adverse events, and efficacy in multiple seizure types [abstract]. Epilepsia 1995; 36 Suppl. 4: 56
83. Glauser TA, Clark PO, Strawsburg R. Topiramate in subjects with infantile spasms: a pilot study. Cilag. Data on file.
84. Polizzi G, O'Donoghue MF, Duncan JS, et al. A prospective, pragmatic, open label study of efficacy and tolerability of topiramate in the treatment of severe epilepsies [abstract]. Epilepsia 1997; 38 Suppl. 3: 67
85. Bill P, Bhigjee AI, Eastman R, et al. Long term open label study of topiramate [abstract]. Epilepsia 1997; 38 Suppl. 3: 63
86. Abou-Khalil B, The YOL Topiramate Study Group. Topiramate therapy in the long-term management of epilepsy [abstract]. Epilepsia 1997; 38 Suppl. 3: 60
87. Bauer G, Crawford P, Canger R, et al. Open-label, long-term topiramate therapy for epilepsy [abstract]. Epilepsia 1997; 38 Suppl. 38: 58
88. Anonymous. Use of topiramate in the broad spectrum of patients in clinical practice. AED News 29 June 1997; 5.
89. Shorvon SD. Safely of topiramate: adverse events and relationships to dosing. Epilepsia 1996; 37 Suppl. 2: 18-22
90. Reife RA, Pledger G, Doose D, et al. Topiramate: pk/pd analyses [abstract]. Epilepsia 1995; 36 Suppl. 3: 152
91. Betts T, Smith K, Khan G. Severe psychiatric reactions to topiramate [abstract]. Epilepsia 1997; 38 Suppl. 3: 64
92. Besag FMC, Berry D, Pool F. The relationship between topiramale dose, serum concentration, efficacy and toxicity in teenage and young adult patients [abstract]. Epilepsia 1997; 38 Suppl. 3: 93
93. Rosenfeld WE, Schaefer PA, Pace K. Weight loss patterns with topiramate therapy [abstract]. Epilepsia 1997; 38 Suppl. 3: 58
94. Wasserstein AG, Rak I, Reife A. Nephrolithiasis during treatment with topiramate [abstract]. Epilepsia 1995; 36 Suppl. 3: S153
95. Sander JWAS. Practical aspects of the use of topiramate in patients with epilepsy. Epilepsia 1997; 38 Suppl. 1: S56-58
96. Pledger GW, Schmidt D. Evaluation of antiepileptic drug efficacy: a review of clinical trial design. Drugs 1994; 48 (4): 498-509
97. Garnett WR. Epilepsy. In: DiPiro JT, Talbert RL, Hayes PE, et al., editors. Pharmacotherpy: a pathophysiologic approach. New York: Elsevier, 1989: 611-31
98. Shorvon SD. The epidemiology and treatment of chronic and refractory epilepsy. Epilepsia 1996; 37 Suppl. 2: S1-3
99. Holmes GL. Critical issues in the treatment of epilepsy. Am J Hosp Pharm 1993; 50 Suppl. 5: S5-16
100. Anonymous. Economic impact of refractory epilepsy in the US. Pharmacoecon Outcomes News 1996 Jun 1; 64: 6
101. van Hout B, Gagnon D, Martens L, et al. Cost-effectiveness of topiramate as add-on therapy in stable refractory patients with partial-onset epilepsy [abstract]. Epilepsia 1997; 38 Suppl. 3: 42
102. Marson AC, Kadir ZA, Chadwick DW. New antiepileptic drugs: a systematic review of their efficacy and tolerability. BMJ 1996 Nov 9; 313: 1169-74
103. Chadwick DW. An overview of the efficacy and tolerability of new antiepileptic drugs. Epilepsia 1997; 38 Suppl. 1: S59-62
104. Elferink AJA, Van Zweiten-Boot BJ. Analysis based on number needed to treat shows differences between drugs studied [letter]. BMJ 1997 Feb 22; 314: 603