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Academia Mexicana de Neurología, A.C.

2005, Number 1

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Rev Mex Neuroci 2005; 6 (1)

Open-label multicenter study to assess efficacy and safety of prophylactic migraine treatment with topiramate

Santos-Zambrano JA, Rodríguez-Leyva I, Salinas-Estebané R, Fernández Alvarado B, Núñez-Orozco L

Language: Spanish
References: 14
Page: 38-41
PDF size: 166.24 Kb.


ABSTRACT

Background: Topiramate (TPM), has demonstrated efficacy in migraine prevention in pilot trials. Objective: To evaluate efficacy and safety of topiramate in migraine prevention. Methods: We conducted a multicenter, open-label study. The primary efficacy measure was the change in mean monthly migraine frequency from baseline through the maintenance phase. Results: There were 31 patients in the intent-to-treat population, 5 (16%) male and 26 (84%) female. Mean age 31 ± 11 years (18-57 y), 21 patients (68%) had migraine with and 10 (32%) without aura. Initial weight mean was 61.25 ± 10.45 kg (mean BMI) 24.21 ± 3.7 kg/m2 and final mean weight 59.17 ± 10.3 kg and mean BMI 23.38 ± 3.4 kg/m2 (p = 0.008 and p = 0.006, respectively, t test). Final mean topiramate dose was 115 ± 75 mg/day. The initial mean of migraine attacks was 6.13 ± 5.7 and at week 4 was 0.8 ± 0.3 (p = 0.001, t test) and at the end of study 0.16 ± 0.5 (p = 0.0001). More than 75% of patients in the first month and 97% in month 3 and 6, patients were headache free. The adverse events were: paresthesia 3 (9%), and 1 patient (3%): nausea, vomiting, weight loss, dizziness. The quality of life was assessed by MIDAS with an initial mean score of 63 ± 8 points (severe impairment) and 49 points (low impact) at 4th week and was stabilized to a final score of 36 ± 11 points (none o mild impact). Conclusion: In this first Mexican trial, TPM significantly reduced migraine frequency at low doses and efficacy was observed since the first month of treatment.


REFERENCES

  1. Linet MS, Celentano DD, Stewart WF. Headache characteristics associated with physician consultation: a population-besed survey. Am J Prev Med 1991; 7: 40-6.

  2. Sillberstein SD, Lipton RB, Goadsby PJ. Headache in Clinical Practice. 2nd ed. Oxford, England: Martin Dunitz; 2002.

  3. Goadsby PJ, Lipton RB, Ferrari MD. Migraine. Current understanding and treatment. NEJM 2002; 346 (4): 257-70.

  4. Dahlöf CG, Dimanäs E. Migraine patients experience poorer subjective well-being/quality of life even between attacks. Cephalalgia 1995; 15: 31-6.

  5. Lipton RB, Reed M, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001; 41: 646-57.

  6. Connor GS. A double-blind placebo-controlled trial of topiramato treatment for essential tremor. Neurology. 2002; 59:132-4.

  7. Johnson BA, Ait-Daoud N, Bowden CL, et al. Oral topiramato for treatment of alcohol dependence: a randomized controlled trial. Lancet. 2003; 361: 1677-85.

  8. Von Seggern RL, Mannix LK, Adelman JU. Efficacy of topiramate in migraine prophylaxis: a retrospective chart analysis. Headache. 2002; 42: 804-9.

  9. Young WB, Hopkins MN, Shechter AL, Silberstein SD. Topiramate: a case series study in migraine prophylaxis. Cephalalgia. 2002; 22: 659-63.

  10. Stewart WF, Lipton RB, Kolodner KB, Sawyer J, Lee C, Liberman JN. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain 2000; 88: 41-52.

  11. Data from the Centers for Disease Control and Prevention, US Census Bureau, and the Arthritis Foundation. http://www.cdc.gov/nedss;http://www.arthritis.org; http://www.census.gov.

  12. Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality y Standards Subcommittee of the American Academy of Neurology. Neurology. 2000; 55: 754-62.

  13. Lipton RR, Silberstein SD, Saper JR, Bigal ME, Goadsby PJ. Why headache treatment fails. Neurology 2003; 60: 1064-70.

  14. Faught E, Wilder BJ, Ramsay E, Reife R, Kramer L, Pledger G, et al. Topiramate controlled dose ranging trial in refractory partial epilepsy using 200, 400 y 600 mg dialy dosages. Neurology 1996; 46: 1684-90.




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