Topiramate monotherapy in epilepsy and migraine prevention

Clinical Therapeutics

Volumn 27, Issue 2, 2005, Pages 154-165

  Silberstein, Stephen D ^a   Ben Menachem, Elinor ^b   Shank, Richard P ^c   Wiegand, Frank ^c  

^a THOMAS JEFFERSON UNIVERSITY HOSPITAL   (United States)

^b SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^c JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Adverse events; Antiepileptic; Dosage; Epilepsy; Migraine; Monotherapy; Paresthesia; Prevention; Prophylaxis; Titration; Tolerability; Topiramate

Indexed keywords

CARBAMAZEPINE; DIHYDROERGOTAMINE; LAMOTRIGINE; ORAL CONTRACEPTIVE AGENT; PHENOBARBITAL; PHENYTOIN; POTASSIUM; PRIMIDONE; PROPRANOLOL; SUMATRIPTAN; TOPIRAMATE; VALPROIC ACID;

ABDOMINAL PAIN; ALOPECIA; ANOREXIA; CLINICAL TRIAL; COGNITIVE DEFECT; COMORBIDITY; DIARRHEA; DISEASE ASSOCIATION; DIZZINESS; DOSE RESPONSE; DRUG CLEARANCE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FOCAL EPILEPSY; GASTROINTESTINAL SYMPTOM; GRAND MAL SEIZURE; HEADACHE; HUMAN; HYPESTHESIA; INCIDENCE; INSOMNIA; LANGUAGE DISABILITY; LOW DRUG DOSE; MAINTENANCE DRUG DOSE; MEMORY DISORDER; MENSTRUATION DISORDER; MENTAL CONCENTRATION; MIGRAINE; MIGRAINE AURA; NAUSEA; PARESTHESIA; PATHOPHYSIOLOGY; PHOTOPHOBIA; PRESCRIPTION; RASH; REVIEW; SEDATION; SIDE EFFECT; SOMNOLENCE; STEVENS JOHNSON SYNDROME; TASTE DISORDER; TITRIMETRY; TREATMENT OUTCOME; TREMOR; UPPER RESPIRATORY TRACT INFECTION; WEIGHT GAIN; WEIGHT REDUCTION;

EID: 16244386256     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2005.02.013     Document Type: Article

References (72)

1. 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
2. Published online Wilkes J.J., Nelson E., and Osborne M. Topiramate is an insulin sensitizing compound in vivo with direct effects on adipocytes in female ZDF rats doi: 10.1152/ajpendo.00437.2004 Am J Physiol Endocrinol Metab November 9, 2004
3. Shank R.P., Gardocki J.F., and Vaught J.L. Topiramate: Preclinical evaluation of structurally novel anticonvulsant Epilepsia 35 1994 450 460
4. Maryanoff B.E., Nortey S.O., and Gardocki J.F. Anticonvulsant O-alkyl sulfamates. 2,3:4,5-Bis-O(1-methylethylidene)-beta-d-fructopyranose sulfamate and related compounds J Med Chem 30 1987 880 887
5. Topamax (topiramate) tablets; Topamax (topiramate capsules) sprinkle capsules 2003 Ortho-McNeil Pharmaceutical, Inc Raritan, NJ
6. Johnson B.A., Ait-Daoud N., and Bowden C.L. Oral topiramate for treatment of alcohol dependence: A randomised controlled trial Lancet 361 2003 1677 1685
7. McElroy S.L., Arnold L.M., and Shapira N.A. Topiramate in the treatment of binge eating disorder associated with obesity: A randomized, placebo-controlled trial Am J Psychiatry 160 2003 255 261
8. Hoopes S.P., Reimherr F.W., and Hedges D.W. Treatment of bulimia nervosa with topiramate in a randomized, doubleblind, placebo-controlled trial, part 1: Improvement in binge and purgemeasures J Clin Psychiatry 64 2003 1335 1341
9. Berlant J.L. Topiramate in posttraumatic stress disorder: Preliminary clinical observations J Clin Psychiatry 62 Suppl 17 2001 60 63
10. Bray G.A., Hollander P., and Klein S. A 6-month randomized, placebo-controlled, dose-ranging trial of topiramate for weight loss in obesity Obes Res 11 2003 722 733
11. Silberstein S.D., Neto W., Schmitt J., Jacobs D. MIGR001 Study Group. Topiramate in migraine prevention: Results of a large controlled trial Arch Neurol 61 2004 490 495
12. Brandes J.L., Saper J.R., and Diamond M. Topiramate for migraine prevention: A randomized controlled trial JAMA 291 2004 965 973
13. Diener H.C., Tfelt-Hansen P., and Dahlof C. Topiramate in migraine prophylaxis: Results from a placebo-controlled trial including an active comparator-propanolol Cephalalgia 23 2003 691
14. Herrero A.I., Del Olmo N., Gonzalez-Escalada J.R., and Solis J.M. Two newactions oftopiramate: Inhibition of depolarizing GABA(A)-mediated responses and activation of a potassium conductance Neuropharmacology 42 2002 210 220
15. Russo E., and Constanti A. Topiramate hyperpolarizes and modulates the slow poststimulus AHP of rat olfactory cortical neurones in vitro Br J Pharmacol 141 2004 285 301
16. Ottman R., and Lipton R.B. Comorbidity of migraine and epilepsy Neurology 44 1994 2105 2110
17. Low N.C., and Merikangas K.R. The comorbidity of migraine CNS Spectr 8 2003 433
18. Low N.C., and Merikangas K.R. The comorbidity of migraine CNS Spectr 8 2003 434
19. Low N.C., and Merikangas K.R. The comorbidity of migraine CNS Spectr 8 2003 437 444
20. Leniger T., von den Driesch S., and Isbruch K. Clinical characteristics of patients with comorbidity of migraine and epilepsy Headache 43 2003 672 677
21. Leao A.A. Spreading depression of activity in the cerebral cortex J Neurophysiol 7 1944 359 390
22. Sanchez-del-Rio M., and Reuter U. Migraine aura: New information on underlying mechanisms Curr Opin Neurol 17 2004 289 293
23. Van Harreveld A. Two mechanisms for spreading depression in the chicken retina J Neurobiol 9 1978 419 431
24. Welch K.M. Pathogenesis of migraine Semin Neurol 17 1997 335 341
25. Privitera M., Fincham R., Penry J. Topiramate YE Study Group Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 600-, 800-, and 1,000-mg daily dosages Neurology 46 1996 1678 1683
26. Sharief M., Viteri C., and Ben-Menachem E. Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy Epilepsy Res 25 1996 217 224
27. Ben-Menachem E., Henriksen O., and Dam M. Double-blind, placebo-controlled trial of topiramate as add-on therapy in patients with refractory partial seizures Epilepsia 37 1996 539 543
28. Faught E., Wilder B.J., Ramsay R.E. Topiramate YD Study Group Topiramate placebo-controlled closeranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages Neurology 46 1996 1684 1690
29. Tassinari C.A., Michelucci R., and Chauvel P. Double-blind, placebo-controlled trial of topiramate (600 mg daily) for the treatment of refractory partial epilepsy Epilepsia 37 1996 763 768
30. Sachdeo R.C., Glauser T.A., Ritter F. Topiramate YL Study Group A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome Neurology 52 1999 1882 1887
31. Peeters K., Adriaenssen I., and Wapenaar R. A pooled analysis of adjunctive topiramate in refractory partial epilepsy Acta Neurol Scand 108 2003 9 15
32. Arroyo S., Squires L., Wang S., and Twyman R. Topiramate: Effective as monotherapy in dose-response study in newly diagnosed epilepsy Epilepsia 43 Suppl 7 2002 241
33. Gilliam F.G., Veloso F., and Bomhof M.A. A dose-comparison trial of topiramate as monotherapy in recently diagnosed partial epilepsy Neurology 60 2003 196 202
34. Privitera M.D., Brodie M.J., Mattson R.H. EPMN 105 Study Group Topiramate, carbamazepine and valproate monotherapy: Doubleblind comparison in newly diagnosed epilepsy Acta Neurol Scand 107 2003 165 175
35. Diener H.C., Tfelt-Hansen P., Dahlof C. MIGR-003 Study Group Topiramate in migraine prophylaxis results from a placebo-controlled trial with propranolol as an active control J Neurol 251 2004 943 950
36. Guberman A., Neto W., Gassmann-Mayer C. EPAJ-119 Study Group Low-dose topiramate in adults with treatment-resistant partial-onset seizures Acta Neurol Scand 106 2002 183 189
37. Lainez J.M., Neto W., and Jacobs D. Safety assessment of topiramate in migraine prevention: Pooled results from over 1500 patients Cephalalgia 23 2003 702
38. Young W., Hulihan J., and Wu S.-C. Characterization and time course of paresthesia associated with to piramate: Data from double-blind, placebo-controlled studies of topiramate in migraine prevention Neurology 62 Suppl 5 2004 A145
39. Mattson R.H., Cramer J.A., and Collins J.F. Early tolerance to antiepileptic drug side effects: A controlled trial of 247 patients Koella W.P. Tolerance to Beneficial and Adverse Effects of Antiepileptic Drugs 1986 Raven Press New York 149 156
40. Guberman A.H., Besag F.M., and Brodie M.J. Lamotrigine-associated rash: Risk/benefit considerations in adults and children Epilepsia 40 1999 985 991
41. Biton V., Edwards K.R., Montouris G.D. Topiramate TPS-TR Study Group Topiramate titration and tolerability Ann Pharmacother 35 2001 173 179
42. Dodson W.E., Kamin M., and Kraut L. Topiramate titration to response: Analysis of individualized therapy study (TRAITS) Ann Pharmacother 37 2003 615 620
43. NINDS paresthesia information page. National Institute of Neurological Disorders and Stroke Web site April 26, 2004
44. Kuzniecky R., Ho S., and Pan J. Modulation of cerebral GABA by topiramate, lamotrigine, and gabapentin in healthy adults Neurology 58 2002 368 372
45. Kiernan M.C., Hales J.P., and Gracies J.M. Paraesthesiae induced by prolonged high frequency stimulation of human cutaneous afferents J Physiol 501 1997 461 471
46. + channel heterogeneity Eur Neurol 36 1996 3 12
47. Krishtal O. The ASICs: Signaling molecules? Modulators? Trends Neurosci 26 2003 477 483
48. Voilley N., de Weille J., Mamet J., and Lazdunski M. Nonsteroid anti-inflammatory drugs inhibit both the activity and the inflammationinduced expression of acid-sensing ion channels in nociceptors J Neurosci 21 2001 8026 8033
49. Ichikawa H., and Sugimoto T. The coexpression of ASIC3 with calcitonin gene-related peptide and parvalbumin in the rat trigeminal ganglion Brain Res 943 2002 287 291
50. Akerman S., Kaube H., and Goadsby P.J. Vanilloid type 1 receptors (VR1) on trigeminal sensory nerve fibres play a minor role in neurogenic dural vasodilatation, and are involved incapsaicin-induced dural dilation Br J Pharmacol 140 2003 718 724
51. Markowitz S., Saito K., and Moskowitz M.A. Neurogenically mediated leakage of plasma protein occurs from blood vessels in dura mater but not brain J Neurosci 7 1987 4129 4136
52. Weissman-Fogel I., Sprecher E., Granovsky Y., and Yarnitsky D. Repeated noxious stimulation of the skin enhances cutaneous pain perception of migraine patients in-between attacks: Clinical evidence for continuous sub-threshold increase in membrane excitability of central trigeminovascular neurons Pain 104 2003 693 700
53. Ferrari M.D., Roon K.I., Lipton R.B., and Goadsby P.J. Oral triptans (serotonin 5HT[1 B/1D] agonists)in acute migraine treatment: A meta-analysis of 53 trials Lancet 358 2001 1668 1675
54. Gisclon L.G., Curtin C.R., and Kramer L.D. A comparative study of the steadystate pharmacokinetics of phenytoin (Dilantin) and topiramate (Topamax) in male and female epileptic patients onmonotherapy and during combination therapy Pharm Res 22 1994 S445
55. Gisclon L.G., Curtin C.R., and Kramer L.D. The steady-state (SS) pharmacokinetics (PK) of phenytoin (Dilantin) and topiramate (Topamax) in epileptic patients on monotherapy and during combination therapy Epilepsia 35 Suppl 8 1994 54
56. Sachdeo R.C., Sachdeo S.K., and Levy R.H. Topiramate and phenytoin pharmacokinetics during repetitive monotherapy and combination therapy to epileptic patients Epilepsia 43 2002 691 696
57. Sachdeo R.C., Ferron G.M., and Partiot A.M. An early determination of drug-drug interaction between val proic acid, phenytoin, carbamazepine, or topiramate and retigabine in epilepsy patients Epilepsia 42 Suppl 7 2001 298 299
58. Sachdeo R.C., Sachdeo S.K., and Walker S.A. Steady-state pharmacokinetics of topiramate and carba mazepine in patients with epilepsy during monotherapy and concomitant therapy Epilepsia 37 1996 774 780
59. Berry D.J., Besag F.M., and Pool F. Lack of an effect of topiramate on lamotrigine serum concentrations Epilepsia 43 2002 818 823
60. Doose D.R., Brodie M.J., and Wilson E.A. Topiramate and lamotrigine pharmacokinetics during repetitive monotherapy and combination therapy in epilepsy patients Epilepsia 44 2003 917 922
61. Johannessen S.I. Pharmacokinetics and interaction profile of topiramate: Review and comparison with other newer antiepileptic drugs Epilepsia 38 Suppl 1 1997 S18 S23
62. Doose D.R., Wang S.S., and Padmanabhan M. 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
63. Rosenfeld W.E., Doose D.R., Walker S.A., and Nayak R.K. Effect of topiramate on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in patients with epilepsy Epilepsia 38 1997 317 323
64. Meador K.J. Newer anticonvulsants: Dosing strategies and cognition in treating patients with mood disor ders and epilepsy J Clin Psychiatry 64 Suppl 8 2003 30 34
65. Letter Silberstein S.D. Control of topiramate-induced paresthesias with supplemental potassium Headache 42 2002 85
66. Paris, France Young W., Silberstein S., and Coughlin Bradley K. Evaluating the potential of potassium supplemen tation to reduce paresthesia associated with topiramate in patients with primary headache disorder Poster presented at: 8th Congress of the European Federation of Neurological Sciences September 4-7, 2004
67. Alves O.L., Doyle A.J., and Clausen T. Evaluation of topiramate neuroprotective effect in severe TBI using microdialysis Ann N Y Acad Sci 993 2003 25 34
68. Angehagen M., Ben-Menachem E., Ronnback L., and Hansson E. Topiramate protects against glutamate- and kainate-induced neurotoxicity in primary neuronal-astroglial cultures Epilepsy Res 54 2003 63 71
69. Maragakis N.J., Jackson M., Ganel R., and Rothstein J.D. Topiramate protects against motor neuron degeneration in organotypic spinal cord cultures but not in G93A SOD1 transgenic mice Neurosci Lett 338 2003 107 110
70. Smith-Swintosky V.L., Zhao B., Shank R.P., and Plata-Salaman C.R. Topiramate promotes neurite outgrowth and recovery offunction after nerve injury Neuroreport 12 2001 1031 1034
71. Hayes K.C., Potter P.J., and Hansebout R.R. Pharmacokinetic studies of single and multiple oral doses of fampridine-SR (sustained-release 4-aminopyridine) in patients with chronic spinal cordinjury Clin Neuropharmacol 26 2003 185 192
72. Ochs G., Penn R.D., and York M. A phase I/II trial of recombinant methionyl human brain derived neurotrophic factor administered by intrathecal infusion to patients withamyotrophic lateral sclerosis Amyotroph Lateral Scler Other Motor Neuron Disord 1 2000 201 206