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Scheduled Short-Term Prevention With Frovatriptan for Migraine Occurring Exclusively in Association With Menstruation

Authors

  • Stephen D. Silberstein MD,

    1. From the Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein); Endo Pharmaceuticals Inc., Chadds Ford, PA, USA (T. Berner, Q. Xiang, and J.C. Campbell); Vernalis Development Ltd., Winnersh, UK (J. Tobin).
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  • Todd Berner MD, FACOG,

    1. From the Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein); Endo Pharmaceuticals Inc., Chadds Ford, PA, USA (T. Berner, Q. Xiang, and J.C. Campbell); Vernalis Development Ltd., Winnersh, UK (J. Tobin).
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  • John Tobin BSc,

    1. From the Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein); Endo Pharmaceuticals Inc., Chadds Ford, PA, USA (T. Berner, Q. Xiang, and J.C. Campbell); Vernalis Development Ltd., Winnersh, UK (J. Tobin).
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  • Qinfang Xiang PhD,

    1. From the Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein); Endo Pharmaceuticals Inc., Chadds Ford, PA, USA (T. Berner, Q. Xiang, and J.C. Campbell); Vernalis Development Ltd., Winnersh, UK (J. Tobin).
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  • John C. Campbell BSc

    1. From the Thomas Jefferson University Hospital, Philadelphia, PA, USA (S.D. Silberstein); Endo Pharmaceuticals Inc., Chadds Ford, PA, USA (T. Berner, Q. Xiang, and J.C. Campbell); Vernalis Development Ltd., Winnersh, UK (J. Tobin).
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  • Parts of this manuscript were previously presented at the 54th Annual Meeting of the American College of Obstetricians and Gynecologists, May 6-10, 2006, Washington, DC.

  • Trial registry name: A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine. ID # NCT00644033 http://clinicaltrials.gov/ct2/show/NCT00644033?term=frovatriptan&rank=3

  • Conflict of Interest: Endo Pharmaceuticals Inc. financially supported the development of this manuscript, and the research was funded by Vernalis Development Ltd., Winnersh, UK, and Endo Pharmaceuticals Inc., Chadds Ford, PA, USA. The sponsors were responsible for study design, management of the study, collection of data, and statistical analyses of the data. The authors were responsible for the interpretation of the data and the preparation, review, and final approval of the manuscript before submission. With the exception of Dr. Silberstein, all authors are employees or former employees of the sponsors; Dr. Silberstein was an investigator in the clinical trial and primary author of the full study publication. All co-authors contributed scientifically to the manuscript but Dr. Silberstein, as primary author, exercised editorial control with final responsibility for content decisions and conclusions.

S.D. Silberstein, Jefferson Headache Center, 111 S. 11th Street, 8130 Gibbon, Philadelphia, PA 19107, USA.

Abstract

Objective.— This post hoc subgroup analysis evaluated scheduled short-term preventive frovatriptan therapy for women with migraine occurring exclusively in association with menstruation (occurring day −2 to +3; day 1 = menses start, no migraines outside this window).

Background.— A previously published randomized, double-blind, placebo-controlled 3-way crossover trial assessed the efficacy and safety of a scheduled 6-day preventive regimen with frovatriptan for the treatment of menstrual migraine; the study population included women experiencing both menstrual and non-menstrual migraine and women experiencing only menstrual migraine.

Methods.— Women received each treatment (placebo, frovatriptan 2.5 mg once daily, and frovatriptan 2.5 mg twice daily) once over 3 perimenstrual periods in randomized sequence. For this subset analysis, screening questions were used to identify women with migraine occurring exclusively in association with menstruation. Efficacy was evaluated by occurrence and severity of migraine, functional impairment, and rescue medication use. Adverse events and tolerability were also assessed.

Results.— Among 179 patients, the mean age (SD) was 37.3 (7.7) years and mean menstrual migraine history was 10.6 (8.7) years. Significantly fewer women experienced menstrual migraine during treatment with frovatriptan twice daily (37.7%, P < .001) or once daily (51.3%, P = .002) than during treatment with placebo (67.1%); a significant dose response was noted (P = .01, twice daily vs once daily). Significant treatment differences were also found for several secondary endpoints, but the data from this post hoc analysis must be interpreted with caution. Frovatriptan was well tolerated and most adverse events were mild or moderate and similar to those reported with the acute treatment of migraine with frovatriptan; the most common adverse events were nausea, dizziness, and headache.

Conclusions.— Scheduled short-term preventive frovatriptan therapy effectively reduced the occurrence of menstrual migraine in women with attacks occurring exclusively in association with menstruation.

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