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Topiramate in the Preventive Treatment of Episodic Migraine: A Combined Analysis From Pilot, Double-Blind, Placebo-Controlled Trials

Published online by Cambridge University Press:  07 November 2014

Abstract

The safety and efficacy of medications for preventive treatment of migraine is the subject of current concern and investigation in health care. Two single-center, double-blind, placebo-controlled studies were conducted to evaluate the efficacy and safety of topiramate for migraine prophylaxis. Seventy patients with a diagnosis of migraine were randomly assigned to topiramate-treated and placebo groups. The studies consisted of a 4-week baseline phase, a 6—8 week titration, and 8–12 weeks of maintenance. Topiramate was titrated from an initial dose of 25 mg/day to a target dose of 100 mg BID. The primary efficacy measure, the mean 28-day migraine frequency, was lower in topiramate-treated patients than in the placebo group (3.2 versus 3.8, P=.001). Similarly, topiramate treatment resulted in a significantly greater mean reduction in migraine frequency than did placebo (1.55 versus 0.47, P=.001) and a significantly higher responder rate (35.3% versus 8.3%, P=.008). Paresthesia was the most common side effect reported with topiramate treatment. Other topiramate-associated adverse events included altered taste, memory impairment, diarrhea, and appetite suppression/weight loss. The rates of discontinuation were similar for the topiramate group (n=10) and the placebo group (n=8). These results suggest that topiramate is effective and well tolerated in the preventive treatment of migraine headaches.

Type
Original Research
Copyright
Copyright © Cambridge University Press 2003

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References

REFERENCES

1.Dahlof, CGH, Dimenas, E. Migraine patients experience poorer subjective well-being/quality of life even between attacks. Cephalalgia. 1995;15:3136.CrossRefGoogle ScholarPubMed
2.Lipton, RB, Stewart, WF. Migraine headaches: epidemiology and comorbidity. Clin Neurosci. 1998;5:29.Google ScholarPubMed
3.Lipton, RB, Stewart, WF, Simon, D. Medical consultation for migraine: results from the American Migraine Study. Headache. 1998;38:8796.CrossRefGoogle ScholarPubMed
4.Hu, XH, Markson, LE, Lipton, RB, Stewart, WF, Berger, ML. Burden of migraine in the United States: disability and economic costs. Arch Intern Med. 1999;159:813818.CrossRefGoogle ScholarPubMed
5.Silberstein, SD, Lipton, RB, Goadsby, PJ. Headache in Clinical Practice. Oxford, England: Isis Medical Media Ltd.; 1998.Google Scholar
6.Edmeads, J, Findlay, H, Tugwell, P, Pryse-Phillips, W, Nelson, RF, Murray, TJ. Impact of migraine and tension-type headache on life-style, consulting behaviour, and medication use: a Canadian population survey. Can J Neurol Sci. 1993;20:131137.CrossRefGoogle ScholarPubMed
7.Duke University Center for Clinical Health Policy Research. Drug Treatments for the Prevention of Migraine Headache. Publication #290-94-2025 (Technical Review 2.3). Springfield, VA: U.S. Department of Commerce; 1999.Google Scholar
8.Moskowitz, MA, Macfarlane, R. Neurovascular and molecular mechanisms in migraine headaches. Cerebrovasc Brain Metab Rev. 1993;5:159177.Google ScholarPubMed
9.Welch, KM, D'Andrea, G, Tepley, N, Barkley, G, Ramadan, NM. The concept of migraine as a state of central neuronal hyperexcitability. Neurol Clin. 1990;8:817828.CrossRefGoogle ScholarPubMed
10.Shank, RP, Gardocki, JF, Streeter, AJ, Maryanoff, BE. An overview of the preclinical aspects of topiramate: pharmacology, pharmacokinetics, and mechanism of action. Epilepsia. 2000;41(suppl 1):S3S9.CrossRefGoogle ScholarPubMed
11.White, HS. Comparative anticonvulsant and mechanistic profile of the established and newer antiepileptic drugs. Epilepsia. 1999;40(suppl 5):S210.CrossRefGoogle ScholarPubMed
12.Taverna, S, Sancini, G, Mantegazza, M, Franceschetti, S, Avanzini, G. Inhibition of transient and persistent Na+ current fractions by the new anticonvulsant topiramate. J Pharmacol Exp Ther. 1999;288:960968.Google ScholarPubMed
13.White, HS, Brown, SD, Woodhead, JH, Skeen, GA, Wolf, HH. Topiramate modulates GABA-evoked currents in murine cortical neurons by a nonbenzodiazepine mechanism. Epilepsia. 2000;41(suppl 1):S17S20.CrossRefGoogle ScholarPubMed
14.Shuaib, A, Ahmed, F, Muratoglu, M, Kochanski, P. Topiramate in migraine prophylaxis: a pilot study. Cephalalgia. 1999;19:379380.Google Scholar
15.Krusz, JC, Scott, V. Topiramate in the treatment of chronic migraine and other headaches [abstract]. Headache. 1999;39:363.Google Scholar
16.Von Seggern, RL, Mannix, LK, Adelman, JU. Efficacy of topiramate in migraine prophylaxis: a retrospective chart analysis [abstract]. Neurology. 2000;54(suppl 3):A267A268.Google Scholar
17.Storey, JR, Calder, CS, Hart, DE, Potter, DL. Topiramate in migraine prevention: a double-blind, placebo-controlled study. Headache. 2001;41:968975.CrossRefGoogle ScholarPubMed
18.Edwards, KR, Glantz, MJ, Norton, JA, Cross, N. Prophylactic treatment of episodic migraine with topiramate: a double-blind, placebo-controlled trial in 30 patients [abstract]. Cephalalgia. 2000;20:316.Google Scholar
19.American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 1994.Google Scholar
20.Klapper, J. Divalproex sodium in migraine prophylaxis: a dose-controlled study. Cephalalgia. 1997;17:103108.CrossRefGoogle ScholarPubMed
21.Silberstein, SD, Collins, SD. Safety of divalproex sodium in migraine prophylaxis: an open-label, long-term study. Headache. 1999;39:633643.CrossRefGoogle ScholarPubMed
22.Storey, JR, Calder, CS, Potter, DL. Role of topiramate for refractory migraine prophylaxis: a retrospective pilot study [abstract]. Ann Neurol. 2000;46:495.Google Scholar
23.Chengappa, KNR, Levine, J, Rathore, D, Parepally, H, Atzert, R. Long-term effects of topiramate on bipolar mood instability, weight change and glycemic control: a case-series. Eur Psychiatry. 2001;16:186190.CrossRefGoogle Scholar
24.Edwards, KR, Glantz, MJ, Button, J. Efficacy and safety of topiramate in the treatment of painful diabetic neuropathy: a double-blind, placebo-controlled study [abstract]. Neurology. 2000;54(suppl 3):A81.Google Scholar
25.Ben-Menachem, E, Smith, U, Hellstrom, K, Stagge, A. Predictors of weight loss in patients with epilepsy treated with topiramate [abstract]. Epilepsia. 2001;42(suppl 7):252.Google Scholar
26.Slater, JD, Reife, RA, Kamin, M. Weight changes in epilepsy patients treated with topiramate [abstract]. Neurology. 2002;58(suppl 3):A422.Google Scholar
27.Burstein, R, Collins, B, Jakubowski, M. Defeating migraine pain with triptans: a race against the developing allodynia [abstract]. Neurology. 2003;60(suppl 1):A92A93.Google Scholar
28.Mathew, NT, Schmitt, J, Jacobs, D, Neto, W. Topiramate in migraine prevention (MIGR-001): effect on migraine frequency [abstract]. Neurology. 2003;60(suppl 1):A336.Google Scholar
29.Brandes, JL, Jacobs, D, Neto, W, Bhattacharaya, S. Topiramate in the prevention of migraine headache: a randomized, double-blind, placebo-controlled, parallel study (MIGR-002) [abstract]. Neurology. 2003;60(suppl 1):A238.Google Scholar