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Oral Zolmitriptan in the Short-Term Prevention of Menstrual Migraine

A Randomized, Placebo-Controlled Study

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Abstract

Objective: To evaluate the efficacy and tolerability of oral zolmitriptan as a short-term preventative therapy for menstrual migraine.

Methods: This was a randomized, double-blind, parallel group, placebo-controlled, multicentre, two-phase study. The results of the second phase are reported here (the first phase evaluated zolmitriptan in the acute treatment of menstrual migraine and is reported elsewhere). Women who successfully completed phase I (with either a positive or negative outcome, and who still fulfilled the inclusion criteria) were randomized to zolmitriptan 2.5 mg oral tablet three times daily, zolmitriptan 2.5 mg twice daily or placebo three times daily. Patients were treated for three consecutive menstrual cycles, starting 2 days prior to the expected onset of menses, for 7 days in total.

Results: Two hundred and fifty-three patients completed phase I and were eligible for phase II. The intention-to-treat population comprised 244 patients (zolmitriptan three times daily [n = 83]; zolmitriptan twice daily [n = 80]; placebo [n = 81]). Both zolmitriptan regimens demonstrated superior efficacy versus placebo, as measured by the proportion of patients with a ≥50% reduction in the frequency of menstrual migraine attacks (zolmitriptan three times daily [58.6%], p = 0.0007 vs placebo; zolmitriptan twice daily [54.7%], p = 0.002 vs placebo; placebo three times daily [37.8%]). The mean frequency of breakthrough migraine attacks per menstrual cycle was reduced accordingly. Fewer breakthrough attacks were treated with escape medication in the zolmitriptan three times daily (61.6% of attacks; p = 0.0004 vs placebo) and twice daily (60.7%; p = 0.0055 vs placebo) treatment groups than in the placebo group (74.4%). Short-term preventative therapy with zolmitriptan was well tolerated.

Conclusion: Zolmitriptan 2.5 mg oral tablet is effective and well tolerated as a short-term preventative therapy for menstrual migraine attacks.

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Notes

  1. 1 The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

This study was supported by AstraZeneca. The authors would like to thank Steve Winter, Wolters Kluwer Health, who provided medical writing support funded by AstraZeneca. Dr Tuchman has received research funding from AstraZeneca, Allergan, GlaxoSmithKline, Merck, Sanofi, Ortho-McNeil, Pozen, Pfizer, Takeda, Eisai and Neurochem, and has received honoraria for speaking or consultations from AstraZeneca, GlaxoSmithKline, Merck, Pfizer and Eisai. Angela Hee was an employee of AstraZeneca at the time the study was completed. Ugochi Emeribe is an employee of AstraZeneca. Stephen Silberstein has received research funding from Abbott, Advanced Bionics, Advanced NeuroModulation Systems, AGA, Allergan, AstraZeneca, Eli Lilly, Endo Pharmaceuticals, GlaxoSmithKline, Medtronic, Merck, Ortho-McNeil, Pfizer, Pozen, ProEthic, Valeant Pharmaceuticals and Vernalis, and has received honoraria for acting as a speaker and/or advisory board member for Allergan, AstraZeneca, Endo Pharmaceuticals, GlaxoSmithKline, Medtronic, Merck, Ortho-McNeil, Pfizer, Pozen and Valeant Pharmaceuticals.

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Authors and Affiliations

  1. Palm Beach Neurological Center, 4520 Donald Ross Road, Palm Beach Gardens, Florida, 33418, USA

    Michael M. Tuchman

  2. AstraZeneca, Wilmington, Delaware, USA

    Angela Hee & Ugochi Emeribe

  3. Department of Neurology, Jefferson Headache Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA

    Stephen Silberstein

Authors
  1. Michael M. Tuchman
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  2. Angela Hee
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  3. Ugochi Emeribe
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  4. Stephen Silberstein
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Corresponding author

Correspondence to Michael M. Tuchman.

Additional information

Although an employee of AstraZeneca at the time this study was completed, Angela Hee is currently employed by Johnson & Johnson Consumer & Personal Products Worldwide.

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Tuchman, M.M., Hee, A., Emeribe, U. et al. Oral Zolmitriptan in the Short-Term Prevention of Menstrual Migraine. CNS Drugs 22, 877–886 (2008). https://doi.org/10.2165/00023210-200822100-00007

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